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Welcome
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ISO
9001 - QS-9000 Information Exchange
The following document is provided as a service to those seeking to achieve and/or maintain QS 9000 compliance.
This specific document was e-mailed to me in 1995.
The original source was the ISO 9000 / QS-9000 Support Group.
A QS9000 Compliance Document
This was written to address the first edition of QS9000. Ovbiously, it does not address issues which have arisen since. However, it may serve to press you to think a bit about QS9000. It should also be noted now that it is January 2000 that 16949 is the inheritor - QS9000 is for all intents and purposes a dead document.
When you read through this document, if you consider it with respect to the way QS-9000 is interpreted, it will prove informational. Do remember that this was written as an example and may not reflect well on your specific company and industry.
Also note that, to a large degree, a lot of the requirements have not in essence changedin so far as intent goes.
Elements 4.1 and 4.2 of QS-9000 deal with management responsibility and the quality plan used at a company. These are the two elements companies fail most often. Also, you should note that all of Section One of QS-9000 makes heavy use of ISO 9001: 1994, Section 4.0. Therefore, other ISO standard can be used as guidelines.
Remember, QS-9000, especially Section One, is a standard on the management system of quality assurance. As such, the QS-9000 standard begins by assuming that your company has a consistent, well-documented system of quality assurance that is understood by all employees. A lead assessor is interested in finding out if every person in your organization knows their job and how that job affects the quality of the product.
Therefore, if you read elements 4.1 and 4.2, they ask for the following,
- A written quality policy related to business goals and understood
by all employees
- An established quality organization
- Regular management review of the system
- Written quality procedures
- Effective use of procedures
- verification and process/product inspection system
- Well defined roles within the system
- Continuous improvement of the system
- Criteria of acceptability
- Quality records
- An organizational chart showing lines of responsibility
- An QS-9000 representative from an executive level
- A written business plan
- Statistical monitoring of business trends against objectives
- A method for determining customer satisfaction
- Written quality plans
- Written quality records
- Use of advanced product quality planning process (APQP) using cross-
functional teams
- Feasibility reviews
- Use of failure mode and effects analysis (FMEA)
- Use of production part approval process (PPAP)
As usual, ISO 9004-1 and ISO 9000-2 expands these elements by providing guidelines for implementation. For these particular elements, ISO 9004-1, sections 4.0 and 5.0, make it exceptionally clear that meeting management and quality system requirements is not an easy task.
To begin with, ISO 9004-1 makes it clear that only the top manager at a site is ultimately responsible for quality, not the quality manager. It is then this top manager's responsibility to assure that the company's quality policies are understood by all employees.
As for documentation, the first step is to develop a general, company-wide quality policy. Not one of those "motherhood" policy statements you see at the front of a company's sales literature. The QS-9000 standard requires a real policy that identifies specific goals and methods. For example,
"Our policy is for management to provide the training and leadership to all employees in the art of continuous improvement to constantly seek improved quality at reduced costs that still exceed the expectations of our customers."
See how this type of policy is more specific and to the point than one like this,
"The AXC company supports the concept of quality and the importance of maintaining customer satisfaction."
Once this company-wide policy is in place, you can begin to assemble your QS-9000 related documents. The first should be a detailed, company-wide quality plan that contains objectives, goals, time lines, and responsibilities based on your company's business plan.
Any plan should be broken down into the specific objectives, such as the objective of training all workers in the use of continuous improvement techniques. This is where you specify what particular training will be delivered to which people. You also list who is responsible for implementing the training and when it should be done. For other parts of this detailed quality plan you should also address the issue of costs, reliability, manufacturability, the meeting of customer needs, and other important considerations.
With a well thought out quality plan, you now focus on implementation of your quality system. This is where you write your Level I documents for each of the elements of the QS-9000, Section One. In addition, your procedures must be written or updated to match the quality plan's intentions.
When you develop your quality system, you are developing your Level I, II, and III documents. These should always be written to conform to the type of business you conduct. Remember, the idea behind QS-9000 is that you have a quality system that makes sense for the type of business you are in. It is inappropriate to place more layers of bureaucracy on your company just to meet the QS-9000 requirements.
When you are writing your documentation to meet the other elements of QS-9000, keep in the back of your mind these ideas:
Element 4.2 is actually the requirement for writing procedures for all the other requirements in QS-9000. The closest procedure for this particular section would be your method of writing and approving new procedures and policies. However, the lack of a specific Level II document for this requirement does not save you from danger. Instead, any other element that is found out of conformance with QS-9000 is also a violation of element 4.2's requirement for a consistent and conforming quality system. Therefore, to conform to element 4.2, you have to conform to all other elements of the QS-9000.
Element 4.1 requires a different set of documents. The first one to consider developing is an organizational chart of your company that shows lines of responsibility under the quality system. If you don't know these lines, then now is a good time to find out. If any job titles are not connected to the quality system, now is the time to develop those links.
To evaluate element 4.1, assessors look at how well the top management has identified who is responsible for each element of the standard. That is why we have been telling you to list the job title of the person responsible for each element in your Level I documents. Lines of responsibility and communication need to be well defined.
In addition, the assessors look at your system of identifying current and potential quality problems. They are particularly interested in your history of corrective action and preventive measures. A good company will have a documented history of reacting quickly to problems and also spending time looking for and eliminating potential problems.
For your top managers, this comes back to the need for regular internal audits of your quality system. The top managers should review the system and work towards continuous improvement of the system. These audits need to be formal and well-documented. They should also include documented corrective actions with follow-up until the close of the file.
Your management must also assure that adequate resources and well-trained personnel are provided for every function within the quality system. This includes the need for appropriate equipment for test, measurement, and verification.
Finally, the company-wide quality plan should lead directly to written work instructions for every employee. At a minimum, any quality related activity must have written instructions that include a list of the equipment and resources needed to complete the activity. This includes the obvious tasks of testing, inspection, and auditing. However, it also includes less obvious tasks such as, preventive maintenance, design review, keeping communication records, housekeeping, supplier evaluation, and so on.
The quality control plans are developed for each product, service, or family of products that your company offers. These are discussed in detail in our story on advance product quality planning.
Also, a business plan for your company is necessary. It should look closely at your position in the market place and how you plan to be a top leader in your niche. Although QS-9000 says that this is not audited, it is hard for an auditor to examine your system without making reference to this document. Questions such as "How did you come to write your quality policy?" will lead back to the business plan.
You should also have a regular system of monitoring the performance of your company. The measurements should be based on the objectives and goals laid out in your business plan. Thus, you can envision a wall of charts showing how much market share you have, the price per unit, the level of non-conformance, and so on. Each should be heading for its stated target and beyond. Management has to leave behind a written record of reviewing this data, the internal audits, and other related activities. They should also show in writing that they reacted to the reviews with changes to your system. Regular management review minutes should be kept.
Then there is the issue of measuring customer satisfaction. This is not always an easy task. Your primary customers will be the OEMs or a tier one supplier. You have to interview them and your staff to see what makes the customer happy. Is it no rejects, on-time delivery, attached process information, or all of these items?
Finally, you must use cross-functional teams to deploy techniques such as FMEA, APQP, PPAP, and problem-solving. Each of these have been addressed in previous articles, and they represent a major expansion of the QS-9000 requirements. It is these techniques that make QS-9000 lose its well defined border of compliance. With ISO 9001, there are ends to each requirement. With QS-9000, once you get into a technique like APQP, you open a can of related methods. Methods like designed experiments, team building, problem-solving tools, risk assessment, value analysis, and the like.
Elements 4.1 and 4.2 lay the foundation for the conformance of your company to all elements of QS-9000. If you begin with a solid policy and back it up with detailed plans that can be quickly adjusted to meet changing market needs, then writing your Level I, II, and III documents for all QS-9000 elements because much easier.
Element 4.3 One of the more interesting requirements of QS-9000 is contract review. Most companies believe they are performing contract reviews when, in fact, they are not when compared to the parameters of element 4.3 in Section One of QS-9000
Element 4.3 states you should review contracts and have procedures for the review process. This review will include the following:
Naturally, records of these reviews are to be kept. You also need a method of amending contracts so that changing customer needs can be addressed. This will also require you to define the process of contract review and the responsible people.
But, what is meant by a "contract?" This, it turns out, is precisely where the confusion usually starts for a company. Verbal agreements may even be a legitimate way to start a contract review. Therefore, any contact with a customer may imply the creation of a contract. Thus, all communications with customers should be documented.
Any contract should set off a review process to assure that you can meet customer needs. In addition, information should be gathered to form the first design inputs that will be sent into the design control process.
It turns out that the extent of your contractual relationship with another company or customer is dependent upon the type of business you conduct. Let's take a specific example.
Let's suppose you are a distributor of fasteners. Typically customers fill out one of your order forms from a catalog and you ship the requested material. The extent of the contract is the order form and any additional conditions of sale you print in the catalog.
Review would be more of an audit of the accuracy of fulfilling the orders and whether there was a warning system in your computer entry program to warn of orders that would be difficult or impossible to fill.
Now let's suppose your top sales person is out to lunch with your largest client. The client turns over a napkins and draws the picture of a clip-lock fastener. He says he wants half a million of these. Your sales representative notes at the bottom of the napkin that shipments are to be 50,000 each month for ten months. Is the napkin a contract?
The answer is yes. Your best move at this point would be to have the sales person return to the company with the napkin, photocopy it and attach the copy to a confirming order that repeats all the items agreed to verbally. Then your contract review would involve looking at your capability to meet the order and whether all customer requirements, spoken and unspoken, would be met.
Now let's take the example of a company that manufactures goods to the specifications supplied by a customer. Just as one example, let's take the case of a munitions maker. A national government defense group places orders for smoke canister ammunition for field artillery. Blueprints and specifications are part of the contract along with the actual order.
In contract review, such a company would look at more than just whether the specification and quantities could be met on a fixed delivery schedule. Perhaps unspoken was the assumption that the quality of the ammunition had to be near perfect. The company might establish that only ten rounds in one million would fail to detonate in use. Establishing specifications for the unspoken is yet another part of contract review.
So too is the addition of the requirements of society. Health, safety, and environmental concerns have to be addressed with some products. Especially in the case of the munitions maker, these issues should be spelled out as part of the contract and reviewed to assure such issues can be met.
QS-9000 dedicates an entire section to customer specific requirements. What that means is that your entire company will have to implement additional systems and procedures by customer. You may find that Ford is adding in several additional requirements into specific contracts, for example. Thus, someone on your contract review team has to be well educated in the requirements of QS-9000 to recognize new additional requirements.
Also, the amount of information to submit in a method like PPAP will be determined by your customer. Thus, you will also have to note these as part of your contract review and make sure that the appropriate departments are clearly informed of the exact information they need to submit.
Section 7.0 of ISO 9004-1 talks about the importance of Marketing in the Quality Assurance system. Specifically, the lead role marketing plays in discovering and documenting the needs of the customer.
With a firm hand on the pulse of a market, a Marketing department can establish the two critical types of quality characteristics that a customer doesn't specify. The first is the unspoken "givens" of a contract - those aspects of product and service quality that are assumed to be present, such as the use of proper tools, people, and procedures.
The other important quality characteristic that has to be found is the "excitement quality" of the product or service. That is, the extras a company can add to a product or service to distinguish it from the competition. By remembering these aspects of customer needs while fulfilling the requirements of contract review, a company not only meets the criteria of QS-9000, they also inject a strong dose of competitive energy into the product or service.
All of this market evaluation should take final form as a product brief based on both research and customer feedback. The product brief is a statement of the customer's needs and expectations. This would include suggested specifications for performance, quality, delivery, serviceability, installation, fit and finish, packaging, reliability, perceived quality, and so on. These characteristics should be selected by importance toward meeting the stated customer needs. Most important of all is a suggested system of verifying that recommended targets of acceptability are met.
Your Level I (policy) statement should mention who is ultimately in charge of contract review and then cover the main points of the requirements. For example,
"4.3 Contract Review The Sales Manager is responsible for coordinating and supervising contract review teams. Both catalog orders and special orders are submitted to contract review. The contract review team is responsible for assuring that the needs of the customer are well understood and documented, that any differences with the original quote are resolved, and that we can meet all requirements. The results of these review meetings will be documented. Amendment of a contract is negotiated between the customer and the Sales Manager"
This simple five sentence statement of policy covers all the bases. However, the procedure for contract review is not so simple. In your Level II document (procedure) you need to spell out two forms of contract review for our example company above. The first procedure would be for catalog order or other "ship from stock" situations. The other procedure would be for orders built to customer specifications.
Both situations require you to name who would be on the teams, their specific duties and responsibilities, and the type of reports that are delivered to engineering, quality, and manufacturing as a result of their work.
Level III documents (work instructions), if necessary, would most likely be some form of instruction on how to fill out a standard contract review report form. Such a form would be circulated to the affected departments so they could make the necessary changes to your quality plan for this product to assure complete customer satisfaction. In other words, a clear link is now established between contract review and the beginning steps taken in design control.
Another work instruction would be the transmittal form for passing information about the expectations of the contract to the appropriate people. For example, Quality Assurance may receive instructions for which capability studies have to be performed as part of the contract.
Contract review should end with a clearly stated list of the needs of the customer. Design control should begin by using this same list as the starting point for drawing up a list of design inputs.
Let's begin by looking at a simple policy statement (Level I document) for contract review.
*********************************************************************** 4.3 Contract Review 4.3.1 The Vice President of Operations shall be responsible for the review of contracts between 123 corporation and its customers. 4.3.2 Contract review shall be the process of gathering the stated and unstated needs and expectations of our customers and communicating these needs and expectations to all departments within the company. The capability to meet these needs shall be assessed and only those contracts 123 corporation and its subcontractors can fully complete to customer specifications will be accepted. Any conflict between our capabilities and customer needs shall be resolved before manufacture begins. All contract review activities shall be documented and studied for opportunities for improvements. *************************************************************************
This is a good example of how a policy statement for any element in QS-9000 should be less than one page in length. Basically, you state who is ulitmately responsible for this element and what requirements you meet.
Below is an example of the procedure for contract review. It also illustrates where one procedure can cover two or more QS-9000 requirements. In this case, contract review is just the beginning of Advanced Product Quality Planning. Thus, element 4.3 and part of 4.4 are both covered in this procedure.
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3.0 ADVANCED QUALITY PLANNING:
3.1 PURPOSE:
3.1.1 Define a logical and structured planning process used prior to implementing
new products or processes and prior to changes to products or processes.
3.1.2 Identify the procedures to ensure the highest possibly quality and lowest
practical costs.
3.1.3 Provide the forms and procedures needed to implement this policy.
3.2 SCOPE:
All products and services provided by the company shall be encompassed by
this policy. The policy includes new and existing products, processes and
services.
3.3 RESPONSIBILITIES:
The company Vice-President will be responsible for administering the advanced
quality planning function.
3.7 POLICY AND PROCEDURE INSTRUCTIONS:
3.7.1 The product development and advanced quality planning will follow the logical
flow as described below:
3.7.1.1 Product brief from marketing:
The product brief will provide the initial idea for a product based upon market
requests and demand. The brief will contain as much information as possible
about the idea regarding:
Form, fit and function
Estimated annual quantities
Expected selling cost
Competitive products
3.7.1.2 Design Concept
The design concept step involves the conception and initial design of a seat
assembly. Engineering has the primary responsibility for this step with input
from other departments.
3.7.1.3 Initial Assessments
3.7.1.3.1 Design FMEA
a) The purpose of the design Failure Mode and Effect Analysis (FMEA) is to
analyze the design of a new product (or design change) and assess the
potential failure modes, severity, and probability of occurrence of that failure in
a formalized and documented manner.
b) Section 8 describes in detail the FMEA procedures.
3.7.1.3.2 Preliminary feasibility analysis
a) A review team is assembled consisting of Engineering, Manufacturing,
Industrial Engineering, Production Control, Purchasing, Quality, and Marketing.
b) The feasibility meeting is conducted once the design FMEA is released and
manufacturing process design is starting.
c) During the meeting, review the design to determine if it can be
manufactured, assembled, tested, packaged and shipped to the customer at
acceptable quality and quantity levels, as proposed.
d) Manufacturing considerations include material type, material hardness,
tooling vs. quantity, process controls, tolerances, and capability of tooling.
e) Assembly concerns include standardization, tool clearances, adjustments, fit,
process controls, and operator fatigue.
f) Testing concerns include requirement of special equipment or measuring
devices, fixtures and jigs, calibration, what and how to measure.
g) Packaging concerns include weight, cost, special handling equipment,
operator safety, and shipping industry standards.
h) Shipping concerns include method of shipment, and expenses.
i) The feasibility analysis check sheet (QA004) will be used to guide the
feasibility analysis.
3.7.1.3.3 Quality history review
a) Assemble the team used for the feasibility analysis and conduct a meeting.
During that meeting, review seat of seat components of similar series and/or
processes. During this review, consider the following areas:
Warranty records Field return analysis
Field service reports In-house Quality
indicators
Discrepant material reports Engineering reports
SQA survey report Vehicle audit reports
Production problem reports Dealer visitation
Pilot production runs Assembly problem reports
New model launch Market studies
Test results
b) The quality history review checklist (QA005) will be used to guide in the
history review.
3.7.1.3.4 Process FMEA
a) The Process potential FMEA is a formalized structure of the manufacturing
engineer's thoughts. The potential process problems are identified and ranked
in order of effect on the customer so priorities and control points can be
established.
b) Section 8 describes the FMEA development in detail.
3.7.1.3.5 Critical characteristics (process & product)
a) The critical characteristic identifies a specific portion or specification of a
part, assembly, or process in which it has been determined that a failure of
that item would result in serious consequences. A critical characteristic can
also be designated by the customer or by a specific industry such as items
which affect human safety.
b) The product engineer is responsible for assigning non-regulated critical
characteristics. The method for determining these critical characteristics is
through the design FMEA.
3.7.1.3.6 Gage & test equipment (attribute vs. variable)
a) The purpose of the gage and test equipment review by the advanced quality
planning team is to ensure that the gage, fixture, or equipment does check the
characteristic to meet engineering specification, duplicate the actual conditions
as closely as possible, and will withstand repeated usage.
b) The Gage, fixtures and test equipment will be reviewed during the control
plan meetings.
3.7.1.3.7 Determine performance tolerance and attributes.
The advance quality planning team will determine the limits of operation for the
product. Keep in mind form, fit, and function for the end use of the product.
3.7.1.3.8 Contract review for:
a) Requirements are defined and documented.
b) Any differences in the requirements are
resolved.
c) Supplier capability
3.7.1.4 Standards Preparation
3.7.1.4.1 Process flow chart including control points
Develop a process flow chart for the product production. This chart will
illustrate each step of the process including check points. Refer to section 13
for examples.
3.7.1.4.2 Control plan including SPC requirements
Develop the control plan using the process flow chart and critical
characteristics. The control plan documentation is explain in section 9.
3.7.1.4.3 Inspection instruction sheet
The inspection instruction sheet is a detailed explanation of the inspection
process that is outlined on the control plan.
3.7.1.4.4 Develop acceptance/rejection criteria
Develop specific acceptance and rejection criteria. Color, gloss, and surface
finish must be specified by examples and numerical figures.
3.7.1.5 Prototype - Build/verification
3.7.1.5.1 Prototype build with process potential to support feasibility.
Build a prototype or prototypes of the product and test for performance and
reliability. Use statistical techniques to verify and establish specification limits,
product safety, and reliability.
3.7.1.5.2 Final feasibility analysis and sign-off.
Review the preliminary feasibility analysis.
3.7.1.6 Processing Equipment - Verification
3.7.1.6.1 Order production tooling. (gages & test equipment)
Industrial engineering will order the tooling required for production and
inspection. The sources of the tooling must be approved by the quality
department.
3.7.1.6.2 Process potential studies on vendor's floor
The advanced quality planning team will qualify product at the suppliers using
process potential and capability studies as part of the vendor certification
program.
3.7.1.6.3 Set up & debug production & test equipment
The industrial engineering and quality departments will set up the production
and inspection operations and qualify the process.
3.7.1.6.4 Process potential studies for all major characteristics
The quality department will perform process capability analysis on the process
to establish good statistical control.
3.7.1.7 Final Evaluations:
3.7.1.7.1 Process review/production sign-off
a) Process sheets are prepared for the manufacturing personnel by the
industrial engineering department.
b) Gage & test equipment is set up and instructions written by the quality
department. These instructions are specific operation instructions for the
equipment. The instructions for inspecting or testing product with this test
equipment is written in the control plan.
c) Packaging is designed and documented by the industrial engineering
department. Written instructions with illustrations are prepared.
d) Develop installation, operation, and maintenance manuals.
3.7.1.8 Pilot Production:
3.7.1.8.1 Initial sample & first production part evaluation
An initial production run is made to verify process and produce the first
production parts for customer approval. The Quality department will use this
product for initial process capability and first part approval information. If
dimensional layouts are required, this first run will provide the product for the
layouts.
3.7.1.8.2 Start plotting control charts
The manufacturing personnel will begin collecting and plotting the appropriate
data on the control charts as specified on the control plan.
3.7.1.9 Review:
The advanced quality planning team will review the results of the pilot
production and authorize adjustments as required to bring the process into
good statistical control before authorizing production.
3.7.2 Planing team members:
Planning will include participants from engineering, manufacturing, purchasing,
industrial engineering, customer service, and quality departments.
3.7.3 Engineering tracking:
Engineering will track and provide feedback on time schedule of new product
and product release. This information will be updated and provided to other
departments and customer as appropriate.
3.8 AUDIT STATEMENT:
This policy and procedure will be audited on an annual basis for proper
implementation and applicability.
3.9 CUSTOMER PRIORITY:
The additional requirements of any customer, with regard to this policy will be
fully satisfied in addition to this document. These additional requirements will
be approved by sales and quality managers and added to the written work
instructions for that customer.
Element 4.4 Design control is one of the weakest areas noted during assessment. Therefore, we will spend some time and examine both the requirements and the documentation you will need to comply.
Design Control is only a requirement for companies seeking ISO 9001 registration or that have direct design responsibility as a supplier. The element is broken down into several parts. The general requirement is that you have procedures to control and verify that specified requirements are being met by your designs. The element then has specific requirements for,
Needless to say, this is a demanding and comprehensive requirement. It requires you to plan and designate interdepartmental relationships for the design process, assign specific design tasks, collect data on what the design should include, assure that all design requirements are met, independently verify the design work, and have a design change procedure in place.
To fully understand the requirements of Design Control, we recommend a procedure called the "ISO Dance." You begin with QS- 9000 and read through the actual requirements for Design Control. Then look up the ISO 9004-1 paragraphs that apply to Design Control. These will be your guidelines to better understanding the requirement. In this case, you would read through all of element 8.0 in ISO 9004-1.
As usual, ISO 9004 provides an explanation of the ISO 9001 requirement and it also suggests a few additional activities, such as periodic design requalifications. What you are primarily interested in is the specific methods it suggests for meeting the Design Control requirement. QS-9000 specifically requires the use of advance product quality planning as part of the design process. Specifically, the APQP manual from AIAG.
In the case of Design Control, both QS-9000 and section 8.0 of ISO 9004-1 suggests many activities, over two pages worth. This includes FMEAs, CAD, GD&T, DOE, value engineering, design for manufacturability, QFD, and other types of activities. This means that your design staff has to be trained in these skills.
To see how to develop the proper documentation, we must now briefly review the design process as envisioned within the QS- 9000 standards.
In element 4.3 of QS-9000, there is the requirement for the review of contracts to develop a product brief of customer requirements. This brief is where Design Control begins. The design team takes the brief and adds to it the regulatory, safety, and environmental specifications. Some companies also look for specifications the customer didn't mention that are needed or that will add value/competitiveness to the product. The new list of specifications constitutes design inputs.
The design process under QS-9000 specifically calls for the use of multi-disciplinary teams using the APQP process. This includes the ability to clearly communicate back and forth with the customer about specifications and requirements within the design. Thus, you need to develop a multi-department method of communication with the customer that relays all conversations back to each department.
Design inputs are examined to make sure that they don't conflict with one another and that they seem to meet the needs the customer has spelled out in their contract. Now the design is usually built as a prototype so that the specifications can be tested to assure that they perform as expected. This also helps to firm up the acceptance criteria for each specification during production. It is highly recommended that you look into the manufacturability, reliability, serviceability, and ease of use questions while developing product requirements.
The automakers expect you to have on-site or subcontracted CAD/CAE capabilities so that drawings and specifications can be delivered electronically. In addition, you should carefully assure that special characteristics are identified and marked with the appropriate symbols, such as the diamond, triangle, or shield markings already in use in the auto industry.
The results of all of your research and engineering is a list of requirements for the new product, in other words the design output. These usually take the form of calculations, list of requirements, blueprints, and so on. These outputs have to be independently verified as correct and meeting the customers needs. This can be accomplished using a separate engineer to re- check calculations, holding regular design review meetings, performing tests on prototypes, and the like.
In addition, you must explore the possibilities of making the design output less expensive to produce and at higher qualities. Methods such as Taguchi's approach to DOE, response surface analysis, QFD, design for manufacturability, and the like should be used. The goal is less waste and less cost to produce.
At regular intervals, you should conduct design reviews. This is where a representative from each affected department is called into a single meeting to discuss the current state of the design against customer requirements. You conduct design reviews to assure that all tasks are being completed correctly, that you are on time, and that all customer needs are being fulfilled. The review meetings should be documented as evidence of compliance.
Another similar function is design verification. This is where you make a direct comparison of design outputs against design inputs. Specifically, you recheck calculations, match the outputs against other proven designs, review documentation, consider possible alternatives to existing design outputs, and make tests on the design. In design review, you make sure the design process is complete. In design verification, you are assuring that the design itself is complete.
If you are required to produce a prototype of the product, then you will also be expected to verify the design outputs through physical testing. Here you confirm the dimensions, use, and performance of the product.
After that, a design validation is conducted. This is a third set of tests. In this case, the final product (or the final prototype) is tested under the actual conditions of usage by the customer. For example, in design verification, you may test a hinge for reliability on a machine in your lab. For design validation, you put the hinge on an actual car and let a customer use it for several weeks. Then you can judge whether the engineering predictions of performance match performance in a "real world."
Once this is all completed, you can release your design for production. To accomplish this multitude of tasks your management must create a formal and documented system of design development and control. Usually, this takes the form of cross- departmental teams working within project management guidelines. Timelines, milestones, regular review meetings after each milestone, and PERT charts dominate these methods. Every meeting should be documented with meeting minutes and memos of instruction to carry out actions the teams decide are critical to the design process.
In addition to this, you also have to leave in place a procedure for changing a design that involves going through many of the decisions used for an original design. You also have to obtain customer approval for a change and possibly report on the expected effects of the change on product performance.
The level of design effort within companies and between companies can vary widely. The most common situation we encounter during audits is a company that hurries the design process to "get into production" and that later fixes problems as they are discovered. This is very much a non-conformance to both QS-9000 and ISO 9001.
Remember, ISO 9001: 1994 is an international standard. As such, it uses the international view that most engineering effort should be put into the design before production release. Everything has to be checked and double checked thoroughly.
Another weak area in many companies we have looked at is the failure to document large parts of the engineering process. At most, we usually see a company write down its FMEA results. It is a rare occasion when we find regular meeting minutes for project teams or the use of designed experiments on prototypes to verify the qualities of a design.
Although it looks like a pain in the neck and a mountain of paperwork to conform to the Design Control requirement, the truth is that it is easier than it looks and it can be used for a great competitive advantage. Specifically, by being careful in your design process, not only can you avoid very costly manufacturing problems, but you can take the opportunity to design a higher quality product at a lower cost (a la designed experiments for robustness).
The first step you must take in conforming is to perform a self examination on your design process. Read through QS-9000, Section One, Element 4.4 and form a check list of requirements, such as this one below.
1. Do you have a written design development procedure that your company follows religiously? 2. Are you using a project management type approach to design development? 3. Are properly trained, educated, and experienced staff assigned to the design teams? Are these teams properly supported? 4. Is a product brief updated and transmitted regularly among interested parties? 5. Is the relationship between departments and teams spelled out in some form of document (usually an organizational chart)? 6. Are product requirements documented and reviewed for clarity and consistency? 7. Are design outputs published as calculations, requirements, and prints and are these verified by an independent source? 8. Do the design outputs meet regulatory, safety, health, environmental, and other external requirements? 9. Are acceptance criteria also part of the design output? 10. Are the acceptance criteria and other product requirements tested or otherwise verified? 11. Is a documented system of design review, verification, and validation used with qualified personnel to assure that design outputs meet customer requirements? 12. Do you have a written procedure for the modification of an existing design that requires formal approvals?
You would use this check list while reviewing your own design development system. We strongly recommend that you talk to the people involved and pull actual design development records to see if each of the above items can be verified.
This internal audit of your design development system should result in a list of deficiencies. These will be the holes you have to plug before seeking QS-9000 registration. Where a requirement is not being met, your new procedure will have to address the problem. Where documentation is not being kept, the implementation of the new procedure will have to include education to the people involved on the importance of collecting information during design work.
The Level I, or policy statement, for design control would be written to state the requirements you meet and who is ultimately responsible for the design control process. The example below is a suggested approach.
************************************************************ 4.4 Design Control 4.4.1 General The Vice President of Operations is responsible for design control. Such design control will include the active collection of information on the requirements of the customer, the capability of 123 Company in meeting those requirements, and the review of the design for manufacturability and quality assurance. 4.4.2 Approach Designs will be assigned to design review team that will treat them according to our project management procedures. Milestones will be established with review meetings after each significant accomplishment. Qualified staff provided with adequate resources shall make up the design review teams. Where conflicts exists between customer requirements and company capabilities, the Vice President of Operations will assign the issue to a conflict resolution team consisting of all affected department managers. Continuous communications will be established and maintained between 123 Company and the customer, including CAD information exchanges. Advanced Product Quality Planning is a key method used for designing our products. 4.4.3 Design Inputs Customer, regulatory, and statutory design characteristics shall be identified. Initial information will come from contract review. The inputs will be reviewed for completeness and we shall ensure that 123 Company has the capability to meet these needs. Conflicting requirements will be quickly resolved with the customer. Special characteristics shall be duly noted with the appropriate symbols. 4.4.4 Design Outputs All customer expectations, acceptance criteria, internal needs, and regulatory requirements shall be listed for each new product design. These design outputs will be verified by an independent source. If necessary, design changes will be suggested to the Vice President for action. He, in turn, will notify the customer of the proposed change. We shall also focus our efforts on finding better ways to produce the product at lower costs and higher states of quality. 4.4.5 Design Review and Verification Periodically, each stage of the design process will be reviewed by a multi-disciplinary team. Such reviews will be documented. In addition, the proposed product itself will be verified by comparing design outputs against design inputs. 4.4.6 Design Validation Final products or prototypes will be validated under carefully described and controlled conditions that simulate actual usage by the customer. Where multiple uses are expected, multiple environments will be simulated. 4.4.7 Design Changes Any changes to a final or existing design shall go through the same procedures as a new design. Changes in designs require written approval of our customers after we have informed them of the performance characteristics the change will affect. **********************************************************
Note how this policy didn't follow the numbering sequence of the requirements. Instead, some of the requirements, like design review and verification, where combined for brevity and clarity.
Now let's look at just one of the procedures that would be written to cover design control. Specifically, let's look at the creation of control plans as part of your APQP effort.
***********************************************************
9.0 CONTROL PLANS:
9.1 PURPOSE:
9.1.1 Define the standards for control plans.
9.1.2 Provide the methods of preparing control plans. This instruction
will outline the steps to properly develop and document a new or
revised control plan for the manufacturing floor.
9.2 SCOPE:
The control plan developing procedure described in this section
will be a significant portion of the advanced quality planning of
new products, processes and changes to the products or process.
The control plan developed with this procedure is a method of
determining sample size and frequency, how to measure control
items, and how to document or chart the data for timely feedback.
9.3 RESPONSIBILITIES:
The Quality department manager shall be responsible for the
development and maintenance of these plans.
9.4 PROCEDURE INSTRUCTIONS:
9.4.1 The plan will summarize the significant characteristics and
methods used to control these in the manufacturing process as
selected per section 17.
9.4.2 A planning team will include the following department
representatives:
Quality (chairman)
Engineering
Industrial engineering
Manufacturing
9.4.3 The control plan will list all the information needed in an outline
format on page 1. This will also include an inspection drawing
when appropriate. Page 2 will contain the detailed instructions for
inspection, test, or verification. The method described in the
Advanced Product Quality Planning manual (AIAG) and its related
forms will be used.
9.4.4 All manufacturing operations will have control plans.
9.4.5 Final control plans will be incorporated into the design file.
9.5 AUDIT STATEMENT:
The director of engineering will audit this process at least annually.
9.6 CUSTOMER PRIORITY:
The additional requirements of any customer, with regard to this
procedure will be fully satisfied in addition to this document.
These additional requirements will be approved by the sales and
quality managers and added to the written work instructions for
that customer.
*********************************************************
Notice how this procedure is very short. Because the control plan method is fully described in the AIAG manual of APQP, the company only has to note this in their procedure and the manual becomes the work instructions.
Element 4.5 Element 4.3 Section One of QS-9000 is based directly upon Section 4.0 of ISO 9001: 1994. Also copied was the scheme of preparing your documentation so that you can demonstrate your management system of quality assurance to an automotive OEM.
Just like ISO 9000, QS-9000 requires you to have three types of documents available to meet the requirements of the standard. The first is called a Level I document. It is the quality policy statement for each of the topics in Section One of the QS-9000. This represents 20 elements that have to be addressed with separate policy statements (except for suppliers that do not design their products, they are exempted from the design control element, and have to write 19 policy statements).
The next required set of documents is the Level II documents. These are the standard operating procedures relating to each topic in the standard. If you already have a quality manual and other procedural manuals, you will update these procedures to meet the Level II requirement. This will be demonstrated below.
Finally, there are the Level III documents. These are the work instructions and other documents that result from the implementation of the Level II procedures. Once you have written the Level I and II documents, you implement the new procedures by issuing specific instructions to individuals. These instructions form the Level III documents.
During an audit for QS-9000 certification, the assessors will read your Level I and II documents before they actually visit your site. They will approve the Level I document by assuring that it meets requirements and references the correct Level II documents. Then they will use your Level II documents to form their audit checklist. The desk reading of the Level II documents is only to assure written conformance. The audit will assure that what you have written is what you practice. The Level III documents and related quality records will be gathered as evidence of implementation.
Before you begin to craft your various documents to support QS-9000, you should take time to create a matrix. This particular matrix should have the twenty topics of QS-9000 listed down the vertical side of the matrix. In addition, your Section Two and other customer specific requirements should be added to the list. Then across the top of your matrix, list out the procedures you already have in place.
Now, in the spirit of quality function deployment, place a mark at each cross reference location for a procedures that applies to a particular requirement. If the procedure is directly related to the requirement, place an "X" in the corresponding box. If the procedure is only partially related, place an "o" in the box. If there is no relationship, leave the box empty.
When you complete this task you will have a nice summary of your current documentation. Look for rows that are blank. These mean that you need to write a new procedures for this requirement. For blank columns, you have a procedure that doesn't address any customer needs. Either drop it from your matrix and look into the need to maintain this procedure. Any columns or rows with only "o" markings mean that more direct procedures need to be written.
To create your Level I document, you start with your company-wide quality policy and an organizational chart that shows lines of responsibilities. Then you carefully study the QS-9000, topic by topic. For each topic, create a separate checklist of requirements. Then refer to ISO 9000 guidelines, such as ISO 9000-1, 9000-2, and 9004-1, as well as QS-9000 interpretations to gather hints on how to conform to the topic under study. We will demonstrate how this is done below. These will be the facts of the requirement as denoted on your checklist. However, you can then extend your checklist by adding the published opinions of lead assessors on what the QS-9000 is actually looking for. We have interviewed several assessors and lead assessors to create the lists presented below.
This checklist is then used to write a page or less on what your company's policy is on implementing a particular topic. In the end you will have about twenty pages forming your Level I document. The document will be a separate document from your Quality Procedures Manual. Although it is acceptable to place such policy statements at the top of each related procedure and then merely reference each procedure in a one page version of the Level I document, we recommend against this approach. Such a technique means that you have the potential of having to repeat the same policy statement on several related procedures. It is easier and more efficient to state the policies separately and cite the related procedures in a unique document.
Once the Level I document statement has been written, you return to the matrix and see which procedures apply to the related requirement. These procedures then become your Level II document.
Once the Level I and II documents have been prepared, approved, and issued you institute the issuing of instructions related to these documents. These Level III documents should be issued and acted upon for at least three to six months before you request an QS-9000 audit.
QS-9000, Section One, spells out some specific requirements for the control of documents for all company departments. To interpret the requirement you need a copy of QS-9000 to obtain the specifics and a copy of ISO 9000-2 and ISO 9004-1 to glean hints as to the application of the requirement.
In QS-9000, Section One, Element 4.5, several points are made in this particular topic. All documents related to your management system of quality assurance have to be strictly controlled, there has to be a document approval authority, documents have to be at the right locations, only current versions of a documents should be available, changes have to be made using a standard procedure, a master list of documents should exist, and re-issue is recommended after several changes. These are the requirements that come directly from ISO 9001: 1994 and its supporting guidelines.
To these requirements the automotive industry adds a list of documents that should be under control, the need to identify customer special characteristics on your documents, the review of customer standards or specifications, and a record of change production effective dates.
These requirements go onto our checklist for this particular topic.
Now we can turn to the opinions expressed by those that audit for QS-9000. Lead assessors indicate that the key item they look for in the Level I document is an identification of who is responsible for the various requirements called out in Element 4.5. Specifically, they want to see the job title of who is responsible. Therefore, the first sentence in the Level I document should begin with a description of the job titles responsible for meeting the requirements of the topic.
There is no reason why this requirement has to be seen as a Quality Assurance Department function. It is perfectly acceptable to divide responsibilities between the affected departments. Therefore, in larger organizations, the engineering manager may be responsible for the control of drawings and specifications while the quality manager is in charge of quality related procedures, and so on.
Different documents may require different methods of approval. Thus, it is also acceptable to have different approval procedures for say, purchasing documents versus engineering documents. What is vital is that each procedure be documented. What will assist you in such multiple controls is the requirement for a master list of documents. Modern word processing programs have cross-reference abilities between documents and document library functions. An alternative would be to link a database of information on existing documents with the actual documents (using a program such as Lotus Notes). Either approach should allow you to print out, on request, the current version of all documents and who possesses them. This allows you to conduct internal audits of document control and verify your system. The report on such audits will lend evidence of compliance.
In summary, no one should be able to revise, remove, or copy a document in your company without the permission of a central authority. One possibility is to issue documents like tools, where people have to check them in and out, and any misuse of a document will result in the personal retribution of the individual who has signed out the document. Another alternative is the use of computer networks to limit specific user nodes in their access to documents. For example, each user can read current documented procedures on the screen, but print-outs and modifications are only possible by the systems manager.
Things to avoid include desk copies of documents, hand written notes on blueprints, undocumented agreements or contacts between staff and suppliers/customers, and unwritten procedures used in the production area. All corrections or adjustments to documents should be signed and dated.
Finally, QS-9000 mentions that an explanation of why a change took place and what was changed should be issued. Commonly, this takes the form of a memo attached to the changed document. Again, computer technology can assist in meeting this requirement. Redlining features in word processing programs, such as WordPerfect and Word, allow a document to be issued in a modified form and an explanation issued that reprints the original document with the changes noted in shaded text.
Now, pulling together all of the above information, we can create our final checklist of items to hit in our Level I and Level II documents.
- central document approval authority
- identify central authority by job title
- master list of documents
- right documents in the right place
- no obsolete documents in circulation
- nature of any change shall be explained
- re-issue documents after a specified
number of revisions
- sub-contractor documents are included
- documents should be signed, dated, and
numbered
- time-sensitive documents are removed
when out-of-date
- internal audits will check on this
document control procedure
- approval is needed to revise, remove, or
copy a controlled document
- list which documents are under control of
procedure
- describe procedure for each unique set of
documents (if applicable)
- all corrections should be signed and
dated
- a separate procedure is used to initiate
corrections
The Level I document is a policy statement. Keep it simple and to the point. Begin by identifying who is responsible for meeting the requirements, then briefly describe what objectives are being achieved.
A good Level I statement for any topic should be less than one page in length. The following is an example of a Level I document written for a small manufacturer's document control system. And, remember to write only about what you actually do at your company.
Section 4.5 - Document Control 4.5.1 All new or revised documents shall be approved by a central authority. This central authority will then track the status, revision number, and location of all documentation. Special characteristic symbols used by customers will be reflected on all affected internal documents. 4.5.2 The central authority for each type of document is as follows: QA Manual and documents related to testing and inspection - QA Manager Engineering drawings, customer specifications, and similar documents - Engineering Manager. Engineering Specifications and Standards from customers will be reviewed, distributed, and implemented in a timely manner. A record of change production effective dates will be maintained. Purchase orders, customer contact forms, and similar documents - Purchasing Manager. Sales related documents - Sales Manager Other documents - Office Manager 4.5.3 Each authority will assure that the documents under his responsibility are up to date, available where needed, signed and dated with revision numbers, and reissued when appropriate. 4.5.4 A master list of document locations and revisions will be created, maintained, and audited at least once a year for effectiveness. See Procedures QA-15.6, ENG-12, SAL-3, and GEN-071.
Now this is a short and simple Level I document. Essentially, it is a statement of the policy on how to assure quality and control of documents within your organization. Documents are approved, distributed, monitored, and removed by a central authority. Control of revisions and distribution is clearly delegated to decentralized authorities. A master list of document status is maintained and regularly audited.
We should pause here to make an important point. The intention of QS-9000 is not to force your company into changing its method of operations. Instead, you should examine your current system for any unusual practices or unnecessary practices for your particular industry. These should be modified for maximum cost efficiency and management effectiveness.
What the QS-9000 is asking you to do is demonstrate that you have an excellent system of management. If you currently do little or no document controlling, then how do you know the quality of your documents? How do you know if the right people are getting the right information? In short, the idea behind this element of QS- 9000 is to force you into using strict management practices so that you know how you produced a quality product.
This is why we want you to examine your particular operation very closely and write the documentation to both meet the standard and match your current practices closely. As a side note, it is perfectly acceptable to specifically note which QS- 9000 clause a policy or procedure conforms to.
Once the Level I document is in place, it is time to look up the procedures being used for this element of QS-9000. In our example, we are looking at document control. Therefore, we note that one such procedure is QA procedure 15.6. You would now pull that procedure and read through it to see if it matches the requirements of QS-9000 for document control.
NOTE: I personally believe flow charts are
a better vehicle for compliance here...
Marc
The following is the quality procedure you find for document control in the Quality Assurance department. Let's see how much work will be needed to meet requirements.
15.6 Quality Assurance Document Control 15.6.1 Authority and Responsibilities The Quality Assurance Manager will be defined as the central authority for the control of quality assurance documents. This will include: - the twice a year audit of the effectiveness of the control system - the maintenance of a master list of documents - the approval of new or revised documents 15.6.2 Document Tracking All documents created or revised by the Quality Assurance personnel shall have as minimum identification a title, date of creation, date of revision, signature of the Quality Assurance Manager, page number, and file name. These characteristics will be on every page. The document must be neatly formatted and legible. Documents will be produced using the word processing system. Handwritten or typewritten documents are not allowed. 15.6.3 Initiating a Document To initiate a document, an individual needs to submit a document approval form (DAF) to the QA Manager. Attached to this form should be the proposed document. The QA Manager will then check the proposed document to assure that it is in the proper format, does not duplicate existing documents, and that a list of people who should receive copies is completed. Approval shall be indicated by the QA Manager's signature and appropriate distribution of the document. Once approved the document is stored in the database of the QA Local Area Network (LAN). The distribution list is noted in the document description section of the software. The QA Managers Administrative Assistant is then charged with printing enough copies of the document for all destinations listed on the circulation sheet. 15.6.4 Changing an Existing Document To change an existing document, a Change Request Form (CRF) is attached to a copy of the document in question. The CRF should specify what is being changed and why. This is then processed by the QA Manager for approval. When distributed, a memo shall be attached explaining why the change was necessary. Now obsolete versions of the documents will be removed from the system. 15.6.5 Removal of Obsolete Documents After no more than six revisions of a document, a new document should be issued under a new version number. If a document becomes obsolete, or if time- sensitive documents expire, then the QA Manager should be notified. The distribution list for the document is used to confirm the retrieval of the documents involved. A notification of successful retrieval is sent to the QA Manager. If a document cannot be retrieved, then the party to whom the document was assigned is responsible for accounting for its location or confirmation of its destruction. A Document Incident Report is filed by the QA Manager describing the circumstances surrounding the inability to retrieve a document. Unauthorized copies of documents are also reported using this form. 15.6.6 Audit of the Document Control system Twice a year, the QA Manager will initiate an internal audit of this document control procedure. An internal auditor will be selected from outside of the QA function. This auditor will receive a mandate and a set of instructions from the QA Manager. The auditor will follow the internal audit procedure listed in the Quality Assurance Manual.
Returning to our original check list, we can now examine this procedure for compliance. Again, a central authority is named. Note how the actions for starting, changing, and removing a document are broken out into individual sections in this Level II document. This helps to clarify the procedure by splitting up sections according to the actual actions taken to perform a specific task.
Next, we note that a master list is called out in the procedure. This master list, and the documents involved, are kept on a local area network of computers. Such a system helps a person to control documents. After all, the network manager can be instructed to tag certain documents as "read only." Thus, people working in the QA department can't make copies that would drift out of the sphere of control of the procedure. Also, the QA manager can make sure only current revisions of a document are available by replacing obsolete documents in the network. Personnel only need to read their computer screens to see the newest document.
In addition, documents are re-issued after six revisions. Documents are signed, dated, and given a revision number. Time-sensitive documents are removed when obsolete or out-of-date. An internal audit is performed to confirm the effectiveness of this control procedure. And, a separate procedure is used to change documents.
What's missing is any mention of documents from sub-contractors, special characteristic characters, and the role of QA in reviewing engineering specifications/standards from customers. Therefore, these missing items would have to be added to the procedure to make it ready for QS-9000 certification.
In summary, we want to note again that Level I and II documents should be written for your own advantage. The QS-9000 is only asking for discipline and a good system of control. Taking your current situation, update your policies and procedures to match the requirement, while taking this opportunity to improve your own internal operations.
Most important of all, make sure that you are doing what you say you are doing. The QS-9000 audit will be an investigation of whether you actual are performing the procedures you have documented. The evidence they gather will come from the level III documents and quality records.
Above, we looked at an example level II document (procedure) for assuring the control of documentation created by the quality department. Similar procedures would exist for other departments.
In brief, the procedure listed the documents affected by the procedure and that the quality assurance manager was ultimately responsible for their approval and control. Documents were initiated with a Document Approval Form (DAF). The example document was then reviewed by the quality assurance manager and any affected departments. Once modified and approved, it was sent for inclusion on the local area network (LAN) being used within our example company.
The use of a LAN to control document control was highly recommended because a LAN manager can control who sees, prints, and can edit each document. The users need only call up selected documents on a nearby computer screen to get the current procedure or to fill in the correct forms.
We should pause a moment here and discuss the basic difference between a standard procedure and a work instruction. A procedure is typically a description of a process involving many people. In contrast, a work instruction tend to be a list of steps taken for an individual to complete a task.
Thus, Level III documents tend to be the work instructions that are generated by the written procedures. They are important in two regards. The first being that most companies in the United States don't have level III documents. All too often, companies rely on verbal orders and direct supervision to communicate what needs to be done to assure quality during manufacturing or service processes. Written instructions based on a careful study of tasks and job functions, with an eye towards efficiency, can increase communications while reducing costs by eliminating wasted efforts.
The second is that level III documents and the data they generate are going to be examined by QS-9000 certification assessors as confirmation that you are following your written procedures. Take the example of document control, the following are just a few examples of the type of level III documents that this procedure might generate.
Let's look at each of these in more detail.
As part of any procedure for QS-9000 certification, you should include a section on how you will audit this procedure from time to time to assure that it is being properly implemented and used. This will generate audit reports.
The reports for QA procedure 15.6 would be generated by someone independent of the quality assurance document control system performing the audit. You should have a separate audit procedure within your company that trained personnel could follow. The document control procedure would then include the audit questions to be answered related to document control.
For example,
Quality Assurance Department Work Instruction: Randomly select six documents under the document control procedure's scope. Answer the following questions for all selected documents.
1. Are all documents properly dated, signed, and assigned a revision number? 2. Are these documents being routed according to procedure? Check the document routing map on the LAN. 3. Are the documents chosen the proper revision? 4. Are the selected documents noted in the document control log kept by the quality manager? 5. Is all related paperwork filed with the DAF and a copy of the document? 6. Are customer special characteristic symbols used where appropriate?
For specific forms, a set of work instructions should exist. These should be developed based on the process flow of the paperwork and the intended purpose of the form. For example, the purpose of the Change Request Form (CRF) is to document the need to update or edit an existing document, say a procedure in the Quality Assurance Procedures Manual. The process flow for this form must take it to the affected departments so that they can be notified of the impending change and comment on it appropriately.
Therefore, the work instructions for the form would spell out the exact steps each affected person should take in filling out the form. For example,
1. Filling out the form if you are the initiator. a) Enter the affected document's control number. b) Date and sign the form. c) Briefly describe need for the change and note the affected paragraphs. And so on.
Naturally, you would include a copy of the form for reference. We find it especially helpful if you indicate on the copy of the form the lines to be filled out in reference to the work instructions.
This same method would be used for other forms, such as the new document request sheet. Again, work instructions would be spelled out and illustrated. In addition, initiating documents, such as this one, would also include a procedure reference that would call for the creation of a file to store all of the paperwork this initial request could generate. In the case of a New Document Request, the comments sent to the quality manager in memos or meeting minutes would be added to this file.
Our final example is the master list for document control.
The master list should be capable of creating a list of all current documents and their holders at any time. In this regard, a computer data base is highly recommended. You will need what is called a flat database program, such as Q&A, Professional File, and the like, if you control just one area's documents with the program. A relational database, such as Paradox and dBase, are used when you wish to tie together document control with other tracking functions. For example, when you want a document that references other procedures to track the current status of those referenced documents concurrently.
We selected document control as an example of how to write your QS-9000 related documents because this is one of the major areas of weakness reported to us by several lead assessors. It is also a procedure that has to be in place before you write your other Level I, II, and III documents.
In the meantime, keep in mind that controlling the location, distribution, and relevance of documents is critical to meeting many of the requirements of the QS-9000. Your method of control does not have to be complex or disruptive, just complete and used religiously. This is best accomplished with good written policies and procedures, written work instructions that make particular people responsible for specific tasks, and with the use of a good plan of action.
Elements 4.6 and 4.7 These two elements of QS-9000 can be combined in many situations. Typically, it is the purchasing department that has to accept and trace goods from both suppliers and items sent by the customer.
In element 4.6, the general requirements state that you have to have a system of procedures for assuring that purchased products conform to your specifications. This is typically covered in your purchasing procedures with the terms of contract listed on the purchase orders. QS-9000 is much more specific on this than ISO 9001. It goes on to state that you have to ensure that you only purchase from approved suppliers, when you have an approved supplier list. Also, you have to check materials against local regulations for safety, engineering, and environmental conformance. This is written to make it applicable to whichever country your purchasing department operates from.
Element 4.6.2 addresses the evaluation of your own suppliers. Your suppliers should be chosen on the basis of their capabilities and the terms of your purchasing contracts. QS-9000, sections one and two, are seen as the basic standard to use to develop your suppliers.
The most frequent question we receive about section 4.6 is, "Do we have to require QS-9000 of our suppliers?" The answer is "yes." The automotive makers want to see a uniform quality model used throughout the hierarchy of suppliers. You should plan on auditing your suppliers against QS-9000, or requiring third-party registration as an alternative.
This brings up a another frequently asked question. Paragraph 4.6.2 states you can have varying levels of control over suppliers based on their historic performance - e.g. a list of preferred suppliers. The question then is, "What system of preferred suppliers conforms to the requirements."
This particular area is open for interpretation. However, the generally accepted view is you should develop a written procedure for qualifying your suppliers to different levels of relationships. Thus, echoing the old extra surveillance, normal control, and reduced control designations. The important point to remember is the way you sort and treat your suppliers should be well documented and your records should reflect you follow your own procedure.
Finally, 4.6.2 also states that your suppliers should have 100% on-time deliveries. That implies a just-in-time system with accompanying posted schedules of ordering, advanced warnings of low stock, and the other trappings of JIT.
Element 4.6.3 requires the purchasing department to produce well documented lists of requirements on their purchasing agreements. This includes the contractual requirements, such as type, grade, quantity, and so on. It would also include the assumed characteristics of the product, such as quality expected, standards used, and services to be rendered. Plus, you have to identify how the material will be approved on delivery and the way it will be identified. The use of restricted substances (i.e. toxins) have to be noted and regulations on its handling and use specified.
Finally, element 4.6.4 looks at the verification of purchased goods. This is your procedure for confirming that the goods you order meet all of your requirements. Specifically, it talks about verification at the supplier's site. Either you or your customer can do this. However, the process and its limitations have to be spelled out as part of the purchasing agreement.
As a whole, Element 4.6 requires you to ensure purchased goods conform to your stated requirements. Element 4.7 states that products sent to you by your customer for processing or general use have to be protected and tracked. It is a common practice to incorporate the procedure for handling customer-supplied products into the methods you use for supplier-supplied products.
Keep in mind that customer supplied products include measurement devices, computer information, color standards, and the like. These are not the obvious items, such as materials for incorporation into your product. Therefore, look carefully before deciding you do not get customer supplied products.
Element 4.7 requires customer-supplied products be well protected and tracked at your company and that any damage or loss will be documented and reported. If you receive no products supplied by your customer, then you may be exempt from 4.7. Be sure to check with your registrar to find out if this is the case. If you are not exempt, write a Level I document saying what you would do if you had to conform (see below).
As you can see by reading the standard, these elements leave some flexibility in interpretation. It is critical to evaluate the standard practices of your industry. If you buy products from distributors, the supplier requirements will be less than if a company that depends heavily upon the technological expertise of their suppliers to survive.
Begin by talking to your purchasing people. Ask them what they do to approve suppliers, state requirements, and verify their work. Then have the Purchasing Department conducts review of practices among your competitors. Using this background information, upgrade or change your procedures to form a purchasing system that makes sense and conforms to QS-9000.
For example, the policy statements (Level I documents) should reflect the language of the standard. In addition, it should clearly indicate the nature of your purchasing system and why it is the system of choice for your company.
For example,
"The purchasing manager is responsible for assuring that products purchased by our company comply with stated requirements. All terms, conditions of sale, and qualification of goods will be clearly stated on the purchase order."
And so on.
Level II documents (standard operating procedures) for the Purchasing Department should emphasize verification and documentation. One procedure should be your method of selecting and approving suppliers. This procedure should discuss how you create your list of approved suppliers. The approval of suppliers should include the use of QS-9000 as the fundamental model of management for quality assurance. The existence of the list and your method of developing suppliers is critical evidence of conformance.
Another procedure should be the verification of your stated requirements. Purchasing Departments typically get a wish list from Engineering, Quality Assurance, Finance, and other such departments. This information should be pared down into a comprehensive summary on a single document that the supplier receives. Again, which document holds this information is dependent upon what is traditional in your industry. Sometimes, the terms, needs, specifications, referred standards, and the like are listed right on a purchase order. Other times, a separate contract or specification list attached to a contract is used.
The intention of paragraph 4.6.3 is to require your company to clearly and completely communicate needs to your suppliers. The idea is that the more clearly you communicate your needs and then check for accuracy of response, the more likely smooth, uninterrupted purchasing transactions will take place. Specifically, transactions that put the right level of quality part exactly where it is needed.
We recommend a couple of additional steps to help assure successful purchasing. Specifically, the full use of the Production Part Approval Process (PPAP). Although PPAP is intended for use between you and the auto makers, it can also be used as a model of communications between you and your suppliers.
Another good idea which ISO 9001 encourages is the verification of your purchasing documents before release. In other words, someone other than a purchasing agent goes over the terms of the contract or the Purchase Order and confirms that the right needs were correctly spelled out.
Don't lose sight of continuous improvements. You can collect enough history on suppliers to demonstrate a level of trust where you don't need to perform surveillance any longer.
Finally, element 4.7 says you must have a procedure for assuring the quality of customer-supplied products. The usual practice is to incorporate the paperwork and notification requirements of this element into the procedure for purchased products. Sometimes, the handling, storage, and shipment procedure is incorporated under element 4.15 of QS-9000.
We strongly recommend you mark customer-supplied products with the logo of the customer and keep it as segregated from your materials as possible. Your records should clearly indicate the actual owner of the material so that separate reports would exist if requested.
Let's look at a specific procedure written to cover both element 4.6 and 4.7.
11.0 VENDOR CERTIFICATION:
11.1 Purpose and objectives:
The purpose of this section is to establish the vendor certification program and
provide guidance as to the administration of the program. This procedure is
written to conform to elements 4.6 and 4.7 of QS-9000. In addition, the
development of suppliers to the first two sections of QS-9000 is encouraged.
11.2 Scope:
The policies and procedures established in this section will apply to all suppliers
of raw material, sub-assemblies, out source processing, services, and
customer-supplied products.
11.3 Responsibility:
The purchasing department manager will be have the main responsibility for vendor
certification. This will include the maintenance of standards and certification
documentation.
11.4 Instructions:
The vendor certification program has two functions: Certify a vendor as reliable,
dependable, and consistent. This is measured by a conformance score from a
supplier survey. Our company desires to do business with capable and upright
companies, relationships, respect, and credibility should develop.
Qualify specific products to establish that the material conforms to specifications and
the process is in good statistical control by proving a process capability of 1.33 (Cpk)
or higher within a six month time period. In addition, all materials should conform to
corresponding regulations for environmental and safety concerns. This is especially
true for materials affected by the "Right to Know" legislation.
The quality, engineering, and purchasing departments will be ready and available to
assist the vendor to become registered and to qualify products. The assistance can
encompass training and site visits.
The quality department shall provide a vendor certification manual and maintain this
manual with the latest information. The manual will be written in such a way as to
provide the function of an operations handbook.
Once the vendor is registered and the material is qualified, the incoming material will
ship to stock. Verification will be mainly conducted upon delivery. However,
verification at the supplier's site can be conducted by either our company or our
customer. When required, this will be specified in the purchase order.
11.4.1 The need to purchase materials, goods, or services shall be initiated with a
request for stock report from either engineering, manufacturing, or marketing. This
report will contain a full description of the items needed, an outline of the critical
characteristics, a checklist of how verification will be conducted, and notes on the
assumed quality of the goods.
11.4.2 Purchasing shall draw up a draft purchase order to be reviewed by both
purchasing and the requesting department. The list of approved suppliers will be
checked for who can supply the items. When an item cannot be delivered by an
approved supplier, the new supplier purchasing procedure (PR-01-004) is activated.
11.4.3 After review and approval, a final purchase order is typed and delivered to the
purchasing manager for approval. Once approved, the purchase order is issued and
entered into the purchasing database.
11.4.4 Upon receipt of either a purchased item or a customer supplied item, it is
confirmed for proper identification, quantities, qualities, and any other requirements of
the purchase order. It is then placed into stock and entered into the MRP database.
11.5 Outputs and Deliverables:
The following reports and forms shall be created by this procedure:
Purchase request report
Purchase order with approval signature
Receipt of goods
Inspection report
Log entry into purchasing database
Log entry into MRP database
11.6 Audit statement:
The director of engineering will audit this process at least annually.
11.7 Records to be Retained
The purchase order, receipt of goods, and inspection report shall be retained and filled
in the appropriate part-number file folders.
11.8 Related Procedures
(list the related purchasing, traceability, and customer supplied material procedures
here)
As you can see, this Level II document covers many of the points in both element 4.6 and 4.7.
There will be a host of work instructions related to purchasing and customer-supplied goods. For example,
As you can see, any of these would make a complete Level III document. And, this list is not exhaustive.
The best approach to use here is to look at which instructions have to be used to assure the success of your purchasing operations. You want the minimal set of instructions that will have maximum impact. Also, you want to test each instruction set to make sure that it can be easily read, clearly understood, and carefully followed.
Work instructions for the activities of the Purchasing Department may already exist. A Purchasing Manager that has been through legal scraps over contracts will more than likely require careful documentation of all transactions, communications, and reports.
However, about two-thirds of the companies I have consulted over the past ten years do not have any formal system of work instructions. Instead, someone is brought into the department as a purchasing assistant and an apprentice/mentor training takes place. Many of purchasing decisions are roughed out on the back of envelopes and cocktail napkins.
In such circumstances, a good approach is to slowly increase the amount of documentation that takes place. Start by having purchasing representatives write down the terms they agree to with a supplier. Then issue phone logs to each agent. Inspect these weekly and train the agents in their proper use. Don't sign any purchase orders that haven't spelled out the details of the requirements properly. And, of course, issue brief work instructions on how to fill in phone logs, write up purchase orders, file reports, document a conflict, and so on.
Element 4.8 The issue of traceability is a variable discussion under ISO 9001 or 9002. The amount of conformance required will vary according to the industrial environment you operate within. Since QS-9000 is specific to the automotive industry, product I.D. and traceability will be serious concerns.
Looking at QS-9000, the standard asks for identification of the product during all stages of production, including delivery and installation. The standard also says that where required, traceability has to be present and recorded. The key phrase is "where appropriate." This refers to all situations where product I.D. is not an obvious requirement. In other words, expect identification and traceability requirements from your automotive customer. Then examine where I.D. or traceability would be a good idea in your process.
As for traceability, if you are under strict traceability requirements in your contracts, such as GMPs from the FDA or automotive product recall systems, use these models to conform. You don't need to add anything to your customer requirements.
Before you do anything with traceability, look hard at your product identification system. When possible, design your product identification system to also meet the traceability requirements.
Suppose that under contract you have to be able to trace a product back to its raw materials. At the same time you need to identify each raw material and component part anywhere in the manufacturing process.
By using a carefully formatted lot code system, you can meet both identification and traceability requirements. For example, raw material sources, shifts, machines, and dates can all be incorporated into an identification code.
ABX-19693-B2
ABX = Component AB, revision X
19693 = 196th day of 1993
B2 = 2nd production line, 2nd shift
If you now keep complete quality and process records that record the identification code during each process step traceability would be a breeze. The critical step is to assure that you can identify that the right materials and components are being used in your product. In other words, someone on the line can use the identification system to correctly draw the right materials as specified on drawings and such. Thus, you must make sure that the identification system directly relates to the drawing, specifications, and other documented customer needs.
The policy statement for element 4.8 is just a paraphrasing of the standard's requirements. For example,
"The Manufacturing Manager is responsible for product identification and traceability of product at all stages of production, delivery, and installation. Where appropriate, products will be identified from drawing, specifications, and other related documents.""When required contractually, the traceability of the product will be assured to meet customer needs. The product identifications and traceability codes will be recorded."
In other words, you name a person as being ultimately responsible for this system and then cover the important points of this element of QS-9000.
Writing a new procedure for element 4.8 might not be necessary if you are already using identification and traceability procedures as part of your process control procedure. Again, the critical characteristic of your identification system is that it can trace a finished product back to the list of materials and parts called out in drawings, specifications, and the like.
Therefore, to write a good procedure for product identification, you have to keep in mind:
As an auto supplier, already under strict traceability requirements, then you should have an existing traceability procedure. If you have minor traceability requirements from customers, incorporate it into the identification procedure. If you are under a strict traceability requirement but don't do complete product identification, use the traceability requirements as the model for your identification system.
Let's take the example of a seat manufacturer for Chrysler products. This might be the type of procedure they would create.
MP011 - Manufacturing Practice for Product Identification
11.0 Purpose and Goals
To correctly identify products by day of production, shift, and any significant changes
in the process so that traceability is assured.
11.1 Scope
All final assemblies will be identified using the procedure described below.
11.2 Responsibility
The plant manager is responsible for the implementation and maintenance of the
product identification system.
11.3 Procedure
11.3.1 All seating assemblies will be marked in two places as to their lot code
identification. The first will be a metal plate affixed to the inside runner. The
second is a paper copy of the same with bar codes that reflect the lot code
number.
11.3.2 Bar coding will use the UPS method of date encoding.
11.3.3 The lot code will be determined by the shift supervisor on each line and
entered into the computer. The code will be changed after each shift and after
any significant change in the manufacturing process.
11.3.4 The lot code is made up of three letters, six numbers, and then a single
letter. The first three letters identify the customer. The middle six numbers
represent the day of the year (in sequential order from January 1), the year,
and the shift number. The final letter is used to note changes in the process.
For example,
CHY012921A
represents a Chrysler seat made on the twelfth day of 1992 on the first shift
with no alteration of the manufacturing process.
11.3.5 The letter "A" at the end of the lot code signifies a unchanged process.
If materials are changed, a problem detected, a significant machine adjustment
made, or any other event that might affect the quality of the product, the letter
is changed sequential for each occurrence.
For example, if maintenance was required on one of the machines and its
capability is still under test, the next letter, that is "B" would be placed at the
end of the lot code.
11.3.6 Each occurrence of changing a lot code is to be noted in the process
log by the line supervisor. The reason for the change should also be noted.
11.4 Related Procedures
(list related procedures here)
11.5 Outputs and Deliverables
Lot code identification tags, entries into the production scheduling system
11.6 Records
All lot codes by batch, shift, or lot shall be entered into the process log and noted on
the appropriate process sheets.
11.7 Audit Statement
The plant manager shall audit this system at least twice a year and report its
conformance to the QS-9000 steering committee.
As you can see, the roles of each department is spelled out and the amount of identification is listed clearly. In addition, identification is either on the product or attached as a shop floor traveler. That traveler can also be used for process control and test and inspection status requirements.
Work instructions would focus on how to fill out the identification forms and store the records when the production is completed. Particularly critical to these instructions will be the correct way to compile the identification/traceability code.
Record keeping under section 4.8 has to be very strict. If the ultimate result of the system is the ability to trace problems to their source, then a complete system of records is required.
Product identification and traceability go hand in hand for most companies. As we will see later in test and inspection status requirements, the system will be beneficial for other QS-9000 requirements. Outside of QS-9000, a good system for tracking the production flow is still beneficial for solving manufacturing problems, making quality improvements, planning a just-in-time system, and other similar routes to continuous improvement.
Element 4.9 The requirements under element 4.9 of QS-9000 are very straight-forward. Essentially, you must create a manufacturing environment where each worker clearly understands his job and how it affects the quality of production. Where possible, it is beneficial to have the workers directly evaluate the success of their efforts.
Of all of the elements in section one of QS-9000, element 4.9 has the largest number of additional text on top of the language from ISO 9001.
The most frequently asked question of this element is whether statistical process control (SPC) is required. The answer is a definite yes.
Let's look at the actual requirements of element 4.9.
A key phrase to note in paragraph 4.9.1 is "which directly affect quality." It refers to any production and installation processes used at your company. You have to identify these processes and plan the appropriate process control. However, don't' think that you can duck this requirement by saying a process doesn't affect the quality of your production. It is very difficult to show that any process doesn't have some impact on the quality of production.
In summary, the process control element requires the following.
- Documented work instructions
- Suitable work environment
- Compliance with standards and codes
- Compliance with your own quality plans
- Monitoring and control of critical characteristics
- An approval process for new processes and equipment
- Criteria for workmanship
- Special control for special processes
- Compliance with APQP and PPAP requirements
- Continuous improvement
After laying down the basic requirements, element 4.9 then goes into a long description of specific actions you should take. For example, preliminary process capability studies are required. Cpk and Ppk index requirements are given. A list of required information for the process instruction sheets is given. Set-up verifications are expected. When processes do change, then PPAP may be required. Appearance items require suitable lighting and color standards.
To understand this element we must look at the philosophy behind it. In a nutshell, the ISO 9000 standard wants you to be proactive. In other words, you take every effort to prevent quality problems by making every effort to design and run a successful process.
Start with a flow chart of the process involved. For example, the production of a microchip. You go through several steps of laying down the appropriate chemical layers, etching in circuits, baking, cutting off chips, mounting, and finally testing the chips. At each stage of production there will be critical elements of the design which must meet your specifications and requirements. These will have to be monitored and controlled. Your customer may also specify special characteristics.
At the same time, environmental, process, and personnel characteristics are also critical to success. You must have well trained people with clear instructions armed with proper quality monitoring tools. While you might think that this would make this a difficult requirement, it actually is very profitable and easy to accomplish if done right.
If you are attempting to comply with QS-9000, then you basically paraphrase paragraphs the element. If you have no special processes, then you state what you would do if you had a special process. A special process is one where the product cannot be immediately checked. Examples include welding, plating, destructive testing, and the like.
An example policy might read:
"The XYZ Company will identify and plan process controls for all processes that directly affect quality. Such process control shall include written work instructions with examples of workmanship standards, where possible, conformance to standards and codes that apply to our industry, the continuous monitoring of the process, and approval of all processes and new machinery. Special processes will be continuously monitored to assure conformance to requirements."
Then you would make the usual statement about keeping records.
Now armed with a policy, you can draw up procedures for each of your processes, or a general procedure for the entire production area. This latter strategy will make you more dependent on the work instructions. In other words, you will have to carefully coordinate work instructions and procedures.
Let's use an example to demonstrate how this is done. Let's assume that you are a manufacturer of automotive parts. This means that you already have strict auto requirements and codes cope with. These should form the base of your process control plan.
When you lay out the flow chart of the production process, the customer-specific requirements can be added at each appropriate stage in the process. For example, traceability and recording the materials used to create one unit of your product has to be documented. Therefore, each production station will have a process log. The existence and use of this log is mentioned in your procedure. The exact entry instructions will be the work instructions at that station. Thus, you may have four or five different types of entry instructions throughout the plant, but you can reference them all with a single procedure.
Next you add in your own internal requirements for process control. This usually begins with a quality plan for the product involved. For one product you need to identify the special characteristics that are critical to the successful production. For each of these critical characteristics, you plan where and how they must be monitored. To best serves your purposes, this is where you would insert an SPC system. If other forms of monitoring, such as active computer data collection, is more reasonable, then also use it.
Finally, you look at the other internal requirements, such as contamination control, housekeeping, safety, and other issues. When put together, you will have a flowchart of the process with critical operations and characteristics noted. The job now is to make sure that properly trained people are at the right locations with the right tools to monitor and adjust your process to keep it on its path towards success.
The actual procedure for process control will likely be lengthy. Therefore, let's just look at a small portion of one possible procedure - the creation of a control plan.
9.7 Creation of the Quality Control Plan.
9.7.1 The quality control plan will summarize the significant characteristics and
methods used to control these in the manufacturing process as selected
per section 17. It shall also include criteria of acceptance and reaction
plans for when these criteria are not obtained.
9.7.2 A multi-departmental team will include the following department
representatives:
Quality (chairman)
Engineering
Industrial engineering
Manufacturing
Sales
9.7.3 The control plan will list all the information needed in an outline format.
This will also include an inspection drawing when appropriate. An
attached page will contain the detailed instructions for inspection, test,
and verification. Blank form QA009 will be used.
9.7.4 All manufacturing operations will have control plans. All quality control
plans will follow the instructions given in the AIAG manual "Advanced
Product Quality Planning and Control Plan."
In other words, you write your procedure to reference both the requirements and the other AIAG, regulatory, and customer manuals that may come into play.
In many cases a company will already have many work instructions present on the factory floor. Sometimes they are written out, other times they are in the heads of the operators and supervisors. Either way, converting these into a standard set of forms is highly recommended. Please use the document control element of the QS-9000 standard as your guideline for writing, approving, issuing, and maintaining work instructions. Then refer to the list of required data in work instructions given in paragraph 4.9.1.
For each stage of production, you should think about conducting task and skills analysis. What is involved in completing this job successfully? What skills are required? What critical characteristics should be monitored?
These questions can be answered through analysis and then successfully implemented through well-written work instructions. For example, let's assume that part of the process is to mill out three holes, each one inch from a reference point. The operator will need specific instructions on what material to use, how to identify the job, which tools are involved, how to measure the results, and a method for monitoring the success of the job.
A simple instruction sheet that is identified by the part number will take care of most of these requirements. A quick check with a precision measurement gage followed by recording the results on an X-bar/R or precontrol chart will take care of the monitoring. A sample of a correctly completed part will account for the standard of workmanship.
Let's return to the case of the quality control plan. Blank form QA009 was referenced in the procedure. A work instruction might be attached to this form so that people know how to fill it out properly. It might look something like this:
Instructions for completing the quality control plan form QA009
For each box on the sample form, there is a letter or number identification. The list
below details what is to be entered into each box or area.
a) Write in the customer name.
b) Write in the customer product number.
c) Write in the effective date of the control plan.
d) Write in the product name.
e) Write in the revision level of this plan.
f) Type in tools required and final application of the product. Type in any
special instructions below the inspection drawing.
g) List the inspection outline from QA009 and describe the inspection steps in
detail. The check that involves SPC or special checks will printed in bold.
h) Signature of approval from the quality manager.
i) Date that the quality manager approves the plan.
j) Signature of approval from the engineering manager.
k) Date that the engineering manager approves the plan.
1) Write in the hourly manufacturing rate.
2) Write in the warning #. This is 1% of the hourly rate. If this reject level is
attained, the manufacturing supervisor is notified immediately.
3) Write in the stop #. This is 3% of the hourly rate. If this level is attained,
The manufacturing stops until the problem is corrected. Notify the general
manager immediately. All product produced in the previous hour is rejected
according to the non-conforming material procedure.
4) Write in any standards which are reference in this plan. Indicate in this
block any special customer requirements.
5) Write in any critical components or items that require special handling. Use
the customer's identification for special characteristics where appropriate.
6) List out the process flow for this operation. This is specific with material
requirements, color, or other attributes.
7) Reaction plan: List out a brief description of action to take when the
corresponding process step fails. Be specific.
8) Write in the inspection outline of abbreviated instructions for each inspection
item.
9) Write in the type of inspection method to use including the tool(s) needed.
10) Write in the spec limits or other criteria for the inspection occurring at this
step.
11) Write in the inspection frequency or how often this check is made.
12) Attach an inspection drawing where possible.
A detailed work instruction like this one can also be used to create training materials for the workers. The instructions can be reviewed with the employee, and then an actual practice run conducted.
The results of all of this effort will be a well-planned, smoothly running production process. That means you also use your internal auditing, design review, corrective action, and training requirements of ISO 9000 to help prevent manufacturing problems before they happen. This has been documented as being highly efficient and profitable. In addition, a well- planned production system will also include reaction plans for when problems do occur. That will allow you a faster reaction time to invoke countermeasures.
By demonstrating that a process will produce successful results before it is put into place or purchased you are assuring future profitability.
The process control requirement of ISO 9000 are not difficult to implement if your management is already dedicated to forming a well-planned, efficient production operation. In today's economic climate, most companies are very motivated to pursue this course. Therefore, this particular requirement gives you the excuse to proceed with implementation of ISO 9000 and a platform for getting into Just in Time, and other such technologies.
It should also be noted that element 4.9 lays out many requirements for a preventive maintenance program. This gives you the ability to do predictive maintenance, and to tie together the process monitoring data with the performance of your processes. This should result in less down time and less cost of manufacturing.
Elements 4.10 and 4.11of the QS-900 standard deal with inspection, testing, calibration, test and measurement equipment. Implementation of each of these elements can be done together.
The key point to remember is that you have to plan your system of test and inspection in advance. Such plans should be developed to look for non-conforming materials and to confirm the level of quality you desire in your product. The system must be both reactive and proactive.
In addition, you should take a step back and see how inspections and tests are part of the overall process flow. The standard has already required you to carefully design your product and plan your production system. Now you must verify that all stages of production have been conducted correctly. At the same time, you must have a preventive maintenance program for your measurement equipment that rivals the one you would use for production equipment.
In general, the two elements are fairly self-explanatory on their requirements. Policy statements can be written by paraphrasing these elements. For example, element 4.10 asks for the following:
All inspection and testing activities should be noted in quality control plans. The control plan outlines the process of creating your product and then notes where, when, and how inspection and testing takes place. In addition, it give acceptance criteria and reaction plans for nonconforming goods. This is just one more element of QS- 9000 that requires the use of a control plan.
When you write your Level I document, keep these points in mind. Also read through each of the elements to ensure that all requirements are being address. And, always make sure to identify the management title responsible for each element.
Element 4.11 addresses how you care for and use your inspection, measurement, and test equipment. Like any good quality standard, a lot of emphasis is place on the tools of verification. If the measurement gauges are inaccurate, so are your conclusions on the quality of your product.
QS-9000 calls out the following requirements for element 4.11:
In short, the element is asking for a very strict system of gauge control that ensure that the equipment is properly calibrated, maintained, used, checked, and verified against its intended use. In one plant, they used to store gauges in the tool room and check them in and out against a bill of material. That way, the correct gauge was assigned to the correct part numbers.
The use of repeatability and reproducibility studies are required. These will tell you if the gauge can properly monitor the critical characteristics of your product.
Both element 4.10 and 4.11 can be incorporated into a single procedure or two sister procedures.
One way to prepare inspection procedures is to look through the QS-9000 requirements and try to meet all requirements. A better way is to look at your current practices, the requirements, and what happens during an audit to get a very good picture of the type of procedures you will have to write.
Let's look at the way one set of auditors recently examined a test and inspection system at a small manufacturing plant. After checking over the level one and two documents, they interviewed the quality manager and chief inspector. As part of the interview, they asked for the master list of all inspection equipment. From this list they drew 32 randomly selected gages.
Armed with this sample of gages, the auditors then began to look up the calibration records for each gage. They looked specifically to see if the schedule for calibration was being maintained. Then they asked to see the gages themselves. Out on the shop floor they examined the gages to ensure that they were at the right location and that they had the required sticker showing the next date for calibration. In addition, they looked at other gages in use on the floor to ensure that they were marked and calibrated.
Next, they looked for work instructions on how to use the gages. This involved both the operators using a gage and the inspectors performing formal verifications. After that, they looked at the quality records produced by the use of the gages. Of particular interest were any critical characteristics marked on the drawings or in your quality plans. Wherever a critical characteristic is marked for verification, you can almost bet that some of the audit time will focus on those areas.
Therefore, this serves as a warning that your test, inspection, and measurement systems should be thoroughly reviewed and updated to the requirements of the standard. We suggest an internal audit of your existing gage records and quality measurement records. You may find that a new and higher level of discipline is required.
At the same time, a common question that is asked concerns which gages to have in your calibration and tracking system. The QS-9000 standard requires that any instrument that checks the quality of your product has to be tracked, maintained, properly used, and calibrated. Therefore, you have to determine if every gage fits that description, or if some gages are for process control.
For example, a temperature gage on a mixing tank may be there as feedback on the tank's condition. The actual temperature is not part of the quality characteristics of the chemicals involved. Instead, there is a process range that should be monitored. Such a gage can be marked as an exception and does not need regular calibration.
A good test, measurement, and inspection procedures will establish how a gage enters your system, when it will be calibrated, how people are trained to use the gage, what records are kept, and how the gage is taken out for repair or retirement.
This will take care of much of element 4.11.
Once you have established a well documented and disciplined system of assuring the accuracy and appropriateness of your measurement equipment, then you can establish a process of inspection. A good inspection system with lousy gages will be a waste of time.
For element 4.10 you will need a single or multiple procedure for incoming, in-process, and final inspections. The key points to remember are:
Finally, you will need to fold your excellent measurement equipment program and inspection process into the actual manufacturing process to create a coherent and sensible system.
Let's look at a procedure written for inspections and testing that incorporates some of the elements of 4.11. The original procedures was several pages long, so we will focus only on in-process inspections.
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4.7 In-Process Inspections
Each machine operator is responsible for holding parts until the required
inspection and tests are complete.
The quality assurance inspector will consult the file on the part number to be
inspected. From that file, he should find the identification number for the
gauge(s) to be used during inspections and a copy of the control plan for that
part.
The gauge(s) drawn from the QA lab will be checked against known standards
to assure that they are measuring accurately.
The quality assurance inspector confirms that the setup piece matches the
specifications. The quality manager approves the setup piece and signs the top
of form QA-8-B "Inspection Report."
If the setup piece is rejected, the following occurs:
The original drawing is consulted for the actual tolerances to be obtained.
The inspector issues a corrective action request on the setup piece. If
necessary, the customer is notified.
The setup procedures are repeated until a proper setup piece is
produced.
Affected production parts are re-inspected.
The inspector uses the control plan to determine the type of checks to be made
and the sample sizes to draw.
The inspector records the inspection results onto the Inspection Report. This
report is placed into the shop floor traveler envelope after it is signed by both
the inspector and the machine operator. After shipment of part, the report is
filed in the master file for part numbers. A copy is sent to the customer.
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For each unique gage or other measurement equipment, there should be a brief set of work instructions explaining its proper usage. You can write a single work instruction for each family of similar gages as well. For example, all micrometers could be covered under a single instruction.
In addition, you will need inspection work instructions for incoming, in-process, and final inspections, as per 4.10. This type of work instruction should include examples of correct parts and samples of common defects.
The following is an example of the type of work instructions an operator should have at his station. A small folder was clearly marked with the part number being processed. Inside was the drawing that should the operations this operator had to conduct and the characteristics to check. Written processing instructions followed along with an SPC chart. The type of gages to use were listed on the print and instruction on their proper use were attached. Following this was a history of problems experienced with this part and the corrective actions suggested. This included drawings and descriptions of the defects to look out for. Finally, a process log sheet was included so that the operator could record events. The shop floor traveler included a space for him to sign after he checked the parts.
As you can see, this set of papers covered 4.10, 4.11, 4.12 and also was part of several other requirements of QS-9000. The operator knew the job to do and how to assure the quality of the part. Everything he needed to know was written down, including who to call if he couldn't find a written answer.
Let's assume that for each part number in your plant there is a file of information. You should have a final inspection procedure in place for any part. However, for a particular part, the specific gages to use, how to use them, how to record the results, and how to fill out the report should be in form of a work instruction in the part file.
Thus an inspector goes to the QA files, looks up the part number, pulls out a controlled copy of the work instruction (usually laminated), and a blank data form for that particular part. Using the instructions, she will perform the final inspection and file the report as per the procedure and put the work instruction back into the folder.
The two elements of QS-9000 that deal with inspections can be planned and implemented together. Element 4.11, which if fairly self-explanatory, is implemented first to assure proper working measurement and test equipment. Element 4.10 is then established to create your inspection system.
Verification is an often repeated requirement within QS-9000. Therefore, you great care in setting up your test, measurement, and inspection systems. Pay particular attention to your record keeping and maintenance/calibration schedule. These will be primary targets in an ISO 9000 audit.
Element 4.12 is one of the shortest and easiest to implement elements in QS-9000. Basically, the element says that you need a procedure for ensuring that the test and inspection status of your product is identified at each stage of production. What that means is that you have to use your quality control plan to first identify where inspection and test status have to be identified. Then you have to make sure that this is obvious to those handling the parts.
You should note that 4.12 can also be incorporated into your process control and product identification and traceability requirement. For element 4.12, you can expand the procedure you already wrote for process control to include shop floor travelers that indicate the verification at each stage of production. Added to these descriptions will be a place for the verifier to sign. That way, one stage of production will not take goods until the previous stage has signed off.
In addition, the mere location of the product will not constitute a suitable means of identification unless it is very obvious. Plus, you may encounter additional identification requirements with special situations, such as early launches, prototypes, and the like.
The list of how you can mark your product's status can be found in ISO 9000-2.
An example of complying with this requirement would be a quality control plan that calls for a milled part to be checked for its final outside diameter before the inside milling operation (which are based on the outside surface location) begin. The operator is instructed to take five randomly selected parts each 30 minutes and check that the outside diameter is 150 +/- 1mm. If they are, he would sign off this particular set of parts before moving them to the next machining cell a few feet away. The operator of the next cell would check to see that the outside diameter test was conducted before accepting the parts.
The policy for element 4.12 would essentially paraphrase the short list of requirements. You would then add who (by job title) is ultimately responsible for this system being in place and properly used. Typically, the plant manager would have this responsibility if it is incorporated into the process control procedure. You would also add any customer specific requirements for test and inspection identification added to the requirements of element 4.12.
The procedure would most like be incorporated into the process control procedure and might look something like the example below. This part of the procedure would be placed with the description of lot identification and traceability.
4.1 Receiving Status
Parts and materials received are checked according to the receiving inspection requirements for that particular part number. A shop floor traveler is attached to the base material or primary components. The documents for the traveler are printed by the receiving clerk. The document of interest is the quality control plan. The receiving inspector must confirm it is in the traveler and that the space for receiving inspection tests results are filled in, signed, and dated. A green acceptance sticker attached to each box, tub, or container indicates that receiving inspection has approved the lot and it can go into process. A red rejection sticker indicates the lot is to be move to a holding area and dispositioned according to the procedure for nonconforming goods.
4.2 In-Process Status
The quality control plan summary in the shop floor traveler will indicate the work station number and sequence of operation in the assembly of this part number. Each work station indicated will have to perform the tests listed for that station, record the results, sign, and date the form. No station can accept material until they confirm that all previous operations have completed their tests or inspections.
4.3 Final Status
The final inspections and tests will be conducted by QA personnel in the shipping area. These results will also be noted on the quality control plan summary. The now completed form will be sent to the QA manager for a signature and date that indicates that he has approved the lot for shipment. The form is then filed in the parts number folder with a copy kept for QA records and another copy sent to sales.
4.4 Status After Installation
Products that are installed at customer sites will include an installation checksheet that includes basic tests and inspections. The installer needs to perform each test as indicated and record its results. Test failures have to be corrected at the time of installation and the required corrective actions noted on the back of the form. One copy is sent back to the company for its records and another to the installer's contractor as a record of installation success.
As you can see, this is a very simple and straight forward requirement and the procedures should be the same. Work instructions should not be more complicated than a note at the bottom of the forms explaining how they are to be filled out.
Element 4.12 is a simple requirement that allows your company to keep strict control over the implementation of the quality control plan. By following its advice, you will find that you have a much better paper trail to trace down the source of problems or mistakes. When we next discuss nonconforming materials, you will find that this intelligence information is critical to the success of preventive actions.
Element 4.13 A central theme in QS-9000 is the prevention of defects, not just the detection of defects. To accomplish this, you must have an aggressive program of corrective actions, preventative actions, and a process for controlling the non-conforming goods you discover. Therefore, elements 4.13 and 4.14 (Control of Nonconforming Product and Corrective/Preventive Action) address this issue. We will begin by examining element 4.13.
Element 4.13 of QS-9000 says that it is your responsibility to "ensure that product that does not conform to specified requirements is prevented from inadvertent use..." As a popular song asks, "which part of no didn't you understand?" In other words, the requirements of element 4.13 are very clear. Nonconforming products are to be treated as a form of contamination. As quickly and effectively as possible you must segregate it from your production and installation processes. In addition, suspicious goods must be treated in the same manner.
Before we look at the requirements in detail. Let's talk about what we have seen during ISO 9000 audits.
A common sight is the nonconforming disposition area being clearly marked out within a factory. Typically, a large yellow square is painted on the floor with the words "Rejected material" written in large letters in the square. Then right next to the pile of nonconforming goods in the square are perfectly good parts. In fact, the boxes of the two groups are touching. "How," we ask, "do you assure that the bad parts don't get mixed up with the good parts?"
Another thing we find regularly is the nonconforming goods disposition log. Here is a record of every lot that was found nonconforming. Our question is "what happened to thesegoods?" Typically, we can trace most of the dispositions. However, about 5 to 10 percent have no final disposition. In fact, we often find nonconforming goods from two or three years ago still sitting in a storage area. This is, of course, assuming that we found any paperwork at all concerning nonconforming goods.
To ensure that your company's nonconforming goods system is in conformance with the QS-9000 standards, you have to begin with a little homework before writing your policy.
First, you have to read the complete element. It states that the following have to be accounted for in your system.
The element also gives you a few suggestions for the fate of nonconforming goods. Specifically, to rework it, accept it as is, re-grade it for an alternative use, or reject it. This does not exhaust all possibilities but it does cover the more common fates of nonconforming goods. What is more important to consider by this requirement is the concept that nonconforming goods aren't necessarily "bad" goods. In other words, just because a product or material is outside the specifications of the customer, that doesn't mean it's not usable.
For example, you may discover that a product out of specification actually performs better than what the design calls for. In such a case, you have to notify the customer for approval to use the materials out of specification. At the same time you should look into why this strange occurrence was possible. Why didn't the design review catch this?
Before we get too far off the track, you need to turn to ISO 9004-1, paragraph 14, "Nonconformity." This is an excellent example of where ISO 9004-1 clarifies a QS- 9000 requirement using simple and straight forward language. Also note how additional steps are suggested for controlling nonconforming goods.
Specifically, ISO 9004-1 says that once you detect nonconforming materials or products, you should take the following steps.
Notice how prevention is mentioned . This is the clear link to element 4.14, "Corrective and Preventive Action." Therefore, you should read through the corrective action requirements of the standard before finishing the policies and procedures for this element.
With all of this in mind, you are ready to write your policy statement (Level I document) for nonconforming goods and their control. Such a statement should start by naming an authority that is ultimately responsible for the system. Please note that the material review board used in most companies can be named as a part of the system but that ultimate authority usually has to be placed with an individual job title.
Next you need to outline your commitment to the control of nonconforming goods. This should hit all of the points made above.
For example,
"The Farpoint Company Production manager is responsible for the control of nonconforming goods. He also serves as chair of the material review board. Procedures will exist to assure that nonconforming goods are not inadvertently used. Nonconforming material shall be identified, segregated, reviewed, and dispositioned. Proper functions will be notified. Complete records will be kept on the cause of the nonconforming material and its final disposition. Management will search for methods and means to prevent reoccurrence of nonconforming materials. When materials are reworked or repaired the customer will be notified and the materials reinspected Written authorization shall be obtained from the customer before the shipment of goods deviating from the quality control plan."
Next comes the procedures to support this policy. The most obvious procedure will be the activities of the material review board. Another procedure is the identification, segregation, and tracking of nonconforming goods. Let's look at an example of such a procedure.
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Procedure for Nonconforming Goods
1.0 It is the responsibility of machine operators and line
inspectors to identify the occurrence of nonconforming
goods. Nonconforming goods are defined as those that fail
to meet customer specifications as defined in the quality
control plan. If the conformance of goods cannot be
determined, then a quality assurance auditor should be
contacted to make a final determination.
1.1 Once nonconforming goods are detected, the operator
needs to fill out a nonconforming goods report. As part of
this report he should describe the lot codes involved, the
process involved, and the time of detection. This report is
forwarded to quality assurance and manufacturing control.
A copy is placed in the production traveler for the lot
involved. The lot is tagged with a red "Rejected Material"
sticker and moved to an identified nonconforming material
hold area.
1.2 Quality Assurance auditors must then examine the
material further to determine what portion of the lot is
affected. They must also check previously processed
material to assure that the problem is localized.
Conforming portions of the lot can be re-released into
production after approval is obtained from the
manufacturing supervisor and the parts are noted on the
nonconforming material report.
1.3 The nonconforming goods are then evaluate for whether
they require repair, rework, scrapping, or whether they can
be regraded and used "as is." The auditor's findings are
submitted along with the nonconforming material report to
the material review board for final disposition.
...and so on.
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The idea is to lay out a clear path for the nonconforming goods which prevent accidental use and empowers the company to prevent reoccurrence. This much of the procedure shows that records are being collected to help the material review board to clearly see the root cause of the problem.
Please note that this procedure could easily be incorporated into either the process control procedure or the material review board procedure.
There are several examples of where work instructions would be created to support the nonconforming material procedures. The nonconforming material report would need a set of instructions for completion. This would probably include standard codes for describing causes or defects.
The material review board would need to issue work instructions for the dispositioning of scrapped material. There would also need to be a brief work instruction from quality assurance describing the use of red, green, and yellow quality status stickers. The lift truck operators would need instructions on how to be authorized to move materials into and out of nonconforming hold areas.
In short, this one requirement of QS-9000 could generate several work instructions. However, you need to think through your corrective action procedure before drafting and work instructions for nonconforming goods. Chances are that a work instruction will start with nonconforming goods and end with the corrective actions to be taken.
Keep in mind that a material review board that has regularly scheduled meetings is a symptom of a company with too much nonconforming material occurring. The objective of controlling nonconforming goods is to eliminate their occurrence. Therefore, element 4.13 is another representation of where conformance to ISO 9000 opens up new opportunities for running a more efficient and effective company. By looking for and eliminating sources of nonconformance you will tend to cut costs and increase quality.
If you currently do not have a corrective action procedure, you are two steps away from QS-9000 conformance.
QS-9000 assumes that you will have a normal system of corrective action. It wants you to take a proactive stance in preventing the problems that would normally force you to use corrective actions. By examining the requirements of this section we can understand why is wants you to take a proactive stance.
In addition, this is a sister element with element 4.13 - Control of Nonconforming Product. Once you identify the need for a corrective action, chances are that products are involved. In such a case, you will need to strictly control the handling and disposition of those goods.
In QS-9000, element 4.14 is divided into a few specific requirements. Your company must have a system and written procedure for:
Previously, we addressed the proper method for taking corrective action. In every case, you need to look for a root cause of the problem, take remedial actions to minimize the immediate problem, re-examine affected materials, and eventually attack the root cause. In addition, you should look at what happened and why it happened to plan out a countermeasure that prevents recurrence.
ISO 9004-1, part 15.0 spends a considerable amount of time discussing these same points. It is strongly suggested you review this part of the standard to obtain a better understanding of the requirements of corrective actions.
One of the more interesting aspects of corrective action under QS-9000 is the concept of response in proportion to the situation. In other words, when a problem arises, you first sit down and ask yourself, "How important is this problem?" You then respond accordingly. By doing this, you can apply your resources on the most pressing problems, such as those that involve safety, consumer satisfaction, or scheduling.
A policy statement on corrective action can be formed by paraphrasing element 4.14 in QS-9000. I have recently performed some Level I document reviews as part of a registration and have seen this policy statement completed in four sentences or less.
Begin by identifying the authority for the corrective action system. The quality manager or plant manager is the usual choice. Then, state that you investigate the cause of nonconformances and needed corrective actions, analyze all information to prevent problems, react in accordance with the level of risk, apply controls, check to make sure controls are effective, and then make system or procedure changes to permanently prevent recurrence.
The real work with this requirement comes at the procedural level. Let's follow a lead assessor on an audit of this element.
"May I see your corrective action log?" the lead assessor asked the quality manager. The manager reached into a file drawer and drew out a large three ring binder with many pages. The assessor looked through the entries and then turned to the quality manager. "I see no close out signature on these three items. Could you please produce the corrective action reports for these three incidents?" The quality manager dug through another file drawer and produced the paperwork. The assessor read through these and said, "I see that one of these involved a request for recalling the product, yet no paperwork exists showing if the recall was agreed to or not by management."
As you can see by this example, assessors tend to look first for a documented procedure for corrective actions. The assessor found a procedure that stated every corrective action request would be logged and tracked until completion. Naturally, he moves to confirm that every action is tracked until completed. The above company is not doing too well!
You need to plan a corrective action system that makes sense for your company. One that accounts for different levels of problems, is friendly and workable, and that is carefully tracked. One way to do this is to empower any employee to report a potential problem. Then, in rapid response, a supervisor or manager can authorize a corrective action, if needed.
For example: ****************************************************************** Corrective Action Procedure: 1. Any employee believing there is a problem with a process, a potential defect, an observed defect occurring, or other cause of nonconformity to customer requirements or internal goals, must note this on a Request for Corrective Action form. The Request for Corrective Action form may also be used for communication with suppliers and sub- contractors. 2. The Request for Corrective Action form is submitted to the appropriate supervisor for examination. If the need for corrective action is confirmed, then an entry is made in the corrective action log and a Corrective Action Report is filled out. The number from the CAR should be noted in the corrective action log. 3. The supervisor approving the CAR should fill out a description of the problem, proposed methods of investigating the root cause, and potential risk from any nonconformances. Then the CAR is submitted to the QA manager for signature and investigation of the level of risk and the best controls to apply. and so on. *************************************************************************
The emphasis in any system is to be quick, effective, and thorough.
Preventive actions are handled in a similar fashion, except they tend to be carried out by top management. As we will see with the internal audit requirement, and as we have seen with the list of management responsibilities, management must constantly review the QS-9000 system. The major emphasis is a search for opportunities for improvement.
Thus, management must examine every corrective action issued with a thought towards how to prevent the problem from ever occurring again. You may recall from discussions on Just-in-Time implementation the analogy of a river being drained until the rocks are exposed. The water level represents excess inventories. The rocks are the problems hidden by the water.
This same analogy is applicable to your QS-9000 system. You must actively seek out the hidden problems and prevent them from recurring. And then you must seek out potential problems and prevent them from ever occurring. This is why Failure Mode and Effects Analysis and Advanced Product Quality Planning are emphasized in QS- 9000.
The written work instructions for corrective action tend to group around the use of a corrective action report, or CAR. The CAR is one opportunity to let QS-9000 make your company more efficient. By designing a CAR that applies to any situation, paperwork can be reduced along with the time needed to cope with each CAR.
For example, the same CAR can be used for nonconforming materials, customer complaints, or safety problems. You need only to group problems into areas handled by particular mangers. For example, if a sales person reports a customer complaint on a CAR, the instructions with the form might include the need to route copies to marketing and engineering.
The reaction to each type of problem might vary by the type of problem and the level of risk it presents the company. Take the example of a safety hazard discovered by an employee. Perhaps a dangerous oil leak is discovered on a stamping press. The instructions on the CAR form may tell the employee to file a safety hazard with the president of the company immediately. In addition, the employee might even be empowered to stop production so corrective actions can be immediate.
In contrast, the discovery of an extra bolt with each package of assembly material would call for a milder corrective action. The urgency would be far less than our previous example. A CAR would be approved and sent to the supplier of the packages of nuts and bolts pointing out the error. Customer satisfaction isn't threatened but there is the opportunity to save money for the supplier.
Previously, we talked about nonconforming materials. The use of corrective action (element 4.14) goes hand in glove with how to cope with nonconforming materials. However, keep in mind, a corrective action program that accounts for more than just reacting to nonconformances holds the potential of greater efficiency and effectiveness for your company.
Remember to track all corrective actions and to keep management an active player in following up and planning countermeasures for prevention. Management that takes an active interest in the root causes of problems and how to prevent problems, is management well on its way to being very competitive.
If you have not already done so, change your procedures to reflect a management system that actively looks for potential problems and opportunities for improvement. Make sure that you take full corrective actions on problems you discover at the system level, including preventive measures. The idea now is to avoid problems or avoid repeating them if they do occur. Management should be in the loop of information on what problems are occurring.
Element 4.15 Think of quality in a product as being a perishable substance and you will understand the need for control of handling, storage, packaging, preservation, and delivery.
While you are able to design and build in good quality, improper handling, storage, packaging, preservation, and delivery can take some of that quality away. Sometimes it even removes the quality altogether.
QS-9000, element 4.15, addresses the requirements for a good management system for handling, storage, packaging, preservation, and delivery. Let's look at each element, see how to prepare documentation, and discuss a few interesting issues.
Element 4.15 separates the requirements by area. For example, paragraph 4.15.2 covers handling. It states simply that the supplier shall provide methods and means for handling that prevent damage or deterioration.
Normally, you would think a company that reads this requirement would understand what is being said. However, several of the companies I have audited have shown a real weakness in this area. Let me explain.
Most companies have already written handling procedures. However, these were written with a concern for safety and inventory control. Quality is rarely mentioned. So, when a company is checking itself for QS-9000 compliance, it reads that it needs a handling procedure. Their list of existing procedures is examined, they see that one exists, and give it no further thought.
Unfortunately, you must pay attention to the last part of the requirement that says the procedure has to be designed to prevent damage or deterioration. The proper way to do this is to establish a threat list. For all items handled, such as raw materials, parts, assemblies, packaging materials, software, and the like, you have to think about the possible threats.
Take sheets of steel as an example. They can rust, be dented, scratched, or bent. All of these threats can happen during handling. Have you written a procedure specifying the countermeasures to these threats? Does the handler inspect the material to assure that damage or deterioration hasn't already taken place? Is there a system in place for reporting damage or deterioration?
Look at another example, software. If you load software into your product, have you written a procedure for handling that accounts for threats such as magnetic fields?
Another requirement is proper storage management. The standard says you have to prevent damage or deterioration in storage. It requires periodic audits of stored products. It also says that movement of products into and out of a storage area has to be controlled.
You must have a storage procedure for prevention, maintenance, and management of a storage area. Keep in mind this will include all storage areas, such as receiving storage, in-process storage, retains, stock rooms, and warehousing of finished products. The idea is to know what is in an area and whether its quality is being threatened by storage in that area.
Let's take a specific example. If you manufactured yogurt, you would be very sensitive to the expiration date on the lots and the threat of a too-high temperature on your product. If you use raw chemicals as part of a manufacturing process, are you as sensitive to the time and temperature effects on your stored chemicals.
Naturally, you can see a lot of tie-ins with other concerns. Your inventory control system should use the oldest materials first. At the same time, the supervisor in charge of the storage area would be keenly interested in checking the current age of stored materials to prevent costly waste.
Storage is also an area that sets QS-9000 apart from ISO 9000. The automotive makers want you to optimize inventory turns for minimal inventory levels. In most cases, this is pushing you to low number lot sizes and just-in-time inventory systems.
The requirement for packaging is also interesting. It says you must control the packing, preservation, and marking processes with written procedures. It goes on to state that you shall do so from the time of receipt until your responsibility for the product ends.
This open-ended remark leaves a lot a leeway for interpretation. If you are responsible for the packing of repair parts used at the dealership, does that mean you have to account for the product up until the time of use by the customer? Chances are this could be correct. As an auditor, I use two guides. The first is whether there are other standards or regulations that apply. If a company is legally responsible for a product up to, or including customer usage, then I audit to that same point.
Lacking legal guidelines, I use the norm for the industry. If a stamping plant normally takes responsibility up to the point where a truck picks up the parts, then that is all the further I check during an audit.
You should note that in this part of the element, you need to use any special packaging or labeling requirements stated by your customer.
As noted above, materials such as steel, can be damaged by improper preservation and storage. In the case of steel, it may pay to have a light coating of oil on the steel sheets and to store them out of the weather to prevent deterioration.
Related to the question of how far a company takes responsibility for a product, is the question of delivery. Delivery is defined in the standard as being after final inspection and testing. In reality, things can be different. For example, a company might ship products back and forth to a customer to have components added. Another company might start the packing cycle after final inspection and before delivery. Some software companies ship their products via the telephone using modems.
Whatever your particular situation, account for it in your delivery procedures. If the customer picks up the product, then make sure that your customer's shipping company's responsibilities are clearly defined in your purchasing agreements.
Delivery is also an area of considerable expansion by QS-9000. For one thing, you will need to have a documented system for maintaining 100% on-time shipments. This can be incorporated into your overall procedure for element 4.15. Your procedure for element 4.14 can include a corrective action and preventive action for delivery failures. This includes a method for keeping within lead time requirements of your customers.
Again, the just-in-time production system is all but required under QS-9000. You should look into this method when conforming to the standard. A good place to start a JIT system is to get your advance shipment notification (ASN) system working well. That would include a back-up system.
The Level I document for this standard is very easy to prepare. Name the job titles responsible for each requirement. Then state you actively seek to prevent damage or deterioration during handling, storage, packaging, preservation, and delivery. You would also want to mention the periodic checking of products and the strict control of their movement. This would include your systems for just-in-time deliveries.
To prepare your Level II documents, keep a few things in mind. The first is that handling, storage, packaging, preservation, and delivery should not be seen as a process separate from production. Materials are received, processed, moved about, inspected, and prepared for shipment during manufacture. This includes a lot of handling, some storage, some packaging, preservation, and eventually delivery.
Therefore, you should include the procedures for handling and storage, at a minimum, in your process control procedures. A separate warehouse operation or packaging department will call for separate procedures. The key is to look at the level of independence of your handling, packing, storing, and shipping people and determine if separate procedures are necessary.
Another idea to keep in mind is the need to clearly identify a product that is easily threatened with damage or deterioration. As mentioned earlier, yogurt should have an expiration date so it is not stored too long. At the same time, the boxes should be marked with the proper temperatures for storage and shipment. These identifications should be spelled out in either Level II or Level III documents.
An Example Procedure
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4. Procedure
4.1 General
The inventory control manager will oversee the processes for handling, storage,
packaging, preservation, and delivery
The warehouse manager generates and updates procedures for storing parts
and assemblies.
4.2 Handling
Employees in the receiving, processing, warehouse, and shipping departments
participate in training for handling
To prevent damage during material handling the following devices may be
used:
rack guards
tub covers
temporary wrappings
Disposal of environmentally sensitive material or hazardous wastes follow
procedure ENV-1-002.
4.3 Prevention of Rust
Rust is a major cause of making our stampings unusable. Therefore, all
employees charged with handling raw materials and finished parts will be
trained in rust prevention methods and will be regularly evaluated for the
effectiveness at using such methods.
4.4 Storage
Bar-coding on all lots identify both the components and the physical
characteristics of critical items. The label also describes proper handling and
storage methods. These labels must be confirmed as being in place before any
materials or goods are placed in storage, whether in the warehouse or a
process holding area.
4.5 Temperature and Humidity Control
Because of the high precision required in our manufacturing area, the
temperature and humidity will be checked by an industrial engineering
technician at least twice during every shift. Deviations will be reported promptly
to the plant manager and corrective actions taken immediately.
4.6 Shelf-Life Control
No part can remain in storage for over 30 days. Therefore, a first-in, first-out
system of storage will be used in the warehouse. The system will be based on
an order-driven system of production control.
4.7 Storage of Hazardous Materials
Materials marked as hazardous are stored in the leak-proof, blast protected
storage closet of the warehouse. All materials placed there will be logged into
the inventory system promptly and they must receive an internal control
number.
4.8 Storage Access
Access to general warehouse storage areas are restricted to lift truck drivers
able to produce a valid bill of goods for the materials they seek, quality
assurance personnel showing valid requests for inspection, and the warehouse
clerk. Hazardous materials area access is restricted to a lift truck driver having
proper training in the handling hazardous material and having proper safety
equipment.
4.9 Storage Maintenance
The warehouse clerk and the lift truck driver are responsible for the cleanliness
of the warehouse and the temporary storage areas in the production
department.
4.10 Storage Inspection
A regular audit of all storage areas will be conducted by a team appointed by
the plant manager and the warehouse manager. This team will assure at least
twice a year that no stock has been stored for over 30 days and that the
preservation, handling, and storage of material has been properly handled.
4.11 Just-in-Time Deliveries
The customer sends our company a parts production schedule that locks in
seven days before the date of shipment. The shipping department should have
this information at their disposal to plan accordingly. Proper packing and
labeling methods will be attached to each lot of parts requiring shipment.
Advance shipment notifications (ASNs) shall be prepared by the shipping clerk
and sent via modem to the appropriate customer. Planning for shipment and
preparation of the shipment must be timed so that the delivery is neither too
early or too late.
4.12 Packaging Instructions
Packaging instructions will explain the methods of cleaning off the excess rust
inhibitors and how to properly package the parts so that environmental threats
to the condition of the parts are minimized. The instructions are generated by
the manufacturing clerk as part of the shop floor traveler.
4.13 Verification
The shipping worker that packages the parts will confirm that they have been
through final inspection, that proper paperwork is in the shipment, and that the
proper labels have been applied. Once verified, the shipping worker signs off
on the shop floor traveler and send the manufacturing paperwork to the
manufacturing secretary for proper distribution and filing.
4.14 Delivery
Finished and packaged goods awaiting delivery are stored in the shipping area
storage facility. The area is secured by a fence and gate watched over by the
shipping dispatcher's clerk. The clerk verifies the identity of the shipment and
logs it into and out of the area.
All deliveries are F.O.B. Other customer specific shipping instructions may be
required. These should be noted by the dispatcher's clerk.
4.15 Records
The packing list, bill of lading, and other shipping records are retained by the
dispatcher until confirmation of arrival is received from the customer. The
dispatcher also maintains a shipping log that shows the current status of all
shipments.
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As you can see by this lengthy example, several other related requirements of QS- 9000 have been incorporated. These include environmental and safety issues, corrective measures, preventive measures, and links to the production system.
The Level III documents, work instructions, will flow from how you designed your Level II documents. If you have called out the need for package markings that warn against mishandling, then a work instruction should exist. The instructions should state who places the warning on the package, when this happens, and it should have an example of what it should look like. The person responsible for placement should also have instructions on how to tell if the placement was proper.
What should you do if your company contracts its shipping? For example, a contracted commercial hauler handles all of your shipping. There is very little guidance from the standards themselves. Auditors have pondered this question and come up with some general ideas.
If the contractor is independent of your organization, then look into a contract that includes a description of how quality is maintained during delivery. In other words, you pass the responsibility of the delivery requirement onto the contractor. Naturally, you record their success.
If the contractor is actually owned by your company or corporation, then the responsibility for quality during delivery falls back on your shoulders.
Another interesting question is the need for installation instructions. ISO 9001 only hints at the need for installation instructions. How can you assure the proper unpacking and installation of a product without written instructions? The answer is you can't. Therefore, installation instructions are strongly recommended where proper installation will assure continued quality. This can range from a picture on the product showing the right way to install the battery up to documented installation classes for the service technicians.
Handling, storage, packaging, and delivery each represent opportunities to degrade the quality of your product. For example, the mere act of handling panty hose almost assures the creation of defects. You must take the time to study and outline the threats to your products from handling and the environment. By designing proper countermeasures, you assure the level of quality you expected in your product.
Element 4.16 "Show me where you store your quality records," requested the lead assessor.
"Right here in this room," replied the quality manager.
"Show me the oldest record stored in this room," said the lead assessor as he smiled slightly.
Element 4.16 of QS-9000 has several interesting aspects. The most important of these is the fact it is cited in almost every other requirement of the standard. It seems like every element of ISO 9001 and the first section of QS-9000 ends with "see 4.16."
There is good reason why this citation is made so often. The heart of your registration audit will be the collection of physical evidence of compliance to the standard. That means you must be able to demonstrate to the assessors you have fully deployed your QS-9000 system. And, what better way to do this than written quality records?
In fact, the keeping of quality-related information is critical to corrective actions, quality planning, continuous improvement, design reviews, and several other related activities. Therefore, the proper recording and storing of quality data is critical to a successful QS-9000 system.
Element 4.16 of QS-9000 has several requirements. The first is a written procedure for the collection, handling, storage, indexing, disposal, retrieval, and maintenance of quality records. This includes data collected during inspections, corrective action reports, SPC charts, design verifications, audit results, and any other quality related information.
The standard then goes on to state your system of record storage must promote legible, traceable, and retrievable information. The records are considered "readily retrievable" if you can locate them before an audit is completed. In reality, you should be able to lay your hands on needed information as quickly as possible to facilitate your own internal system of reaction and continuous improvement.
To achieve legibility and usefulness of a record, forms should be easy to fill out and understand. All forms should have an accompanying work instruction on how to properly complete the form. Other good ideas include an example of a completed form and a table of commonly used codes with explanations.
The storage of quality records should be conducted with the rules used for normal record protection and retention. Paper records should be kept in a fire-proof area and under conditions that prevent deterioration. Standard filing and retrieval systems should be used and strictly followed. Computer-based records should be backed up frequently with the back-up tape being stored in a safe, physically separated facility. We like to lock ours in the local bank vault. Again, computer records should be easily retrievable.
Remember, the records are used as demonstrated evidence of the effectiveness of your quality system. Plan which records to keep based on both the QS-9000 standard and your own internal needs for readily retrievable information. For example, the certificates sent by your suppliers to confirm the acceptability of a shipment become part of your record retention system. Retained production samples stored become part of the record system. Logs and supervisor notebooks also could become part of the system.
Finally, it is required the length of time you retain records within your system be specified. The length of time should be at least three years for internal audit and management review reports. Information related to production parts and purchasing actions should be kept one year past the end of requests for the part. QA records should be retained at least a year after creation. The QS-9000 spells out other similar requirements. It is important to remember that any government or customer regulations supersede QS-9000's suggestions on retention.
When writing the Level I document for element 4.16, you can almost quote the standard section by section. However, a line should be included to indicate who is ultimately responsible for the quality record system. The policy should be personalized to fit your company. For example, if the FDA says you must retain records for up to five years, mention this in the policy.
"The Quality Manager at Stopper Corporation is responsible for the quality record system. A written procedure shall exist that describes the identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. Computer based records will also be backed up according to the electronic data retention procedure. Records will be retained for up to five years where required by the FDA and three years for all other records.
The quality records shall be legible, identifiable, and readily retrievable. Preservation of the records shall be of the highest concern. These records are used to demonstrate the effectiveness of our overall management system of quality assurance and to promote continuous improvement. Vendor-supplied records related to the quality of purchased goods shall also be part of this system of record retention."
As you can see, the requirements have been addressed while the actual operation of the organization is reflected in the policy statement. Two paragraphs is all that was required.
The bulk of time and effort with this particular element is in the creation of a written procedure. You have already seen where the procedure will have to address who is responsible, when and where are records collected, how are they indexed and filed, how are they retrieved, and how they are to be stored to prevent deterioration.
The clever question at the beginning of this article shows how an auditor might check your system. If it is a good system, you should be able to find the oldest set of records. Then an examination of these old records will reveal how retrievable and legible they are. In addition, signs of deterioration can also be checked.
What is less obvious is that there are other issues the standard doesn't mention, but that you have to address. For example, what is the policy on the release of records to staff, customers, or suppliers? If a record has to be modified, corrected, or have data added, how is that handled? How to track a record that is withdrawn from storage by an individual?
The best course to follow is to study the techniques perfected by professional data storage people, such as the medical records clerks. Hospitals have to be able to lay their hands on a patients records quickly. This has resulted in efficient paper and computer-based records storage systems. Copy these as models.
You should have an organized filing plan that makes records retrievable by more than one criteria, such as customer, part number, or production shift. The computer software solutions to this problem fall into two categories. The first is imaging software that physically stores an image of each record in the computer with an attached field of keywords for retrieval. It is based on the way microfilm is used for record retention.
Possibly better for industrial applications are the software programs that organize and track records created by other software application programs. The data gathered by a final inspection is in a word processing program, but the file is tracked by several keywords or by a highly intelligent searching routine.
For example, you want all records related to part number 123-AB-98. You enter this and the computer searches all records for any occurrence of this part number. It then summarizes what it found and make them available for display on your terminal. If you are working with this level of sophistication, or a simple paper system, it still has to have a written procedure for operations.
In most cases, your document control procedure (element 4.5) should spell out the creation, handling, and use of quality records. Storage, indexing, and disposition are either incorporated into the same procedure, or broken out into a separate procedure. Below is an example of part of such a procedure.
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4.1 Storage of Quality Records
Quality records are stored in designated file area by department. The storage
and retrieval system for these records are the responsibility of the department's
senior manager. All records will be indexed by part number and date. They
shall also be readily retrievable.
While in storage, the records will be protected from damage or loss. Every
storage area will have fire protection systems, class one. They shall also use
fire-proof files for storage. The atmosphere in these rooms will be kept to a
reasonable level of temperature and humidity. Records drawn from the file
area will be signed out and returned within 24 hours.
Quality Records are legible and readily retrievable. Where computerized,
Quality records follow an established backup procedure.
4.2 Records to be Stored
The following tables list the Quality Record, where it is stored and length of
storage.
Record Area
QA reports and data QA file room
Purchasing records Administration file room
Parts related information Administration file room
Engineering data Engineering file room
Customer data Administration file room
Electronic data LAN server and data security vault
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The Level III documents will mostly be related to how to fill out particular forms, or when and where to file a record. The actual storage and retrieval of the records might be in the form of a work instruction. The need to file copies of particular records would be part of the procedures and work instructions for other elements of QS-9000.
For example, if a gage is calibrated by an outside lab, as per element 4.11, then the need to file the certificate of calibration as a quality record would be part of the gage calibration procedure.
There is one other step to consider and that is whether to put in place the requirement for an annual audit of the quality record system. Normally this system is checked as part of the total internal audit for QS-9000 conformance. However, it is recommended that the accuracy of the filing system, the completeness of the records, and the condition of storage be checked in great detail by the person responsible for record retention.
The best way to accomplish this is to have the person ultimately responsible appoint an independent expert to examine the system thoroughly. The expert could be an internal clerk with record storage training but should be from a different department. It could also be a record system consultant.
Putting aside the requirements for QS-9000, it is critically important to any management system to be able to retrieve needed information as quickly as possible if you plan to pursue preventive measures.
Take the situation where a design team is working on a new typewriter stand for a furniture company. If the team can quickly retrieve the quality data collected on the original design, they will extract important clues on how to improve the new design. Perhaps a review of customer complaints reveals that the new electronic typewriters are lower in profile and require a desk that can be adjusted in height to prevent stress on the wrists when typing.
The retention of quality records is critical to most of the elements of QS-9000. In fact, it is critical to the successful operation of most management systems. To assure a smooth running system that will benefit your company, you'll need to go beyond the requirements of the QS-9000 standard.
Element 4.17 of QS-9000 is actually the last requirement in the production process cycle. Allow me to explain.
Way back at element 4.1, we talked about management responsibilities. Part of those requirements was the need for management review of the QS-9000- based system. Elements 4.2 to 4.16 talked about the need to track various aspects of your production processes. This created records, instructions, and procedures.
At some point, you need to look over the entire system and make sure that it is working effectively. This is why internal quality audits are needed. The audit looks over your entire QS-9000 based system and reports to management. The key word to remember in this discussion is "effective." The audit will not only be a conformance audit. Instead, your auditors must look at how well the system is working and whether it can be improved.
There are two different concerns with internal audits. Before registration, the concern should be focused on conformance to the standard. After you are registered, the concern shifts to effectiveness and continuous improvement.
Before writing the policy for this element, you should be familiar with ISO 10011. This standard addresses how to audit to ISO 9000, or any quality standard (such as QS-9000). You should obtain a copy of all three parts of ISO 10011.
The key words to remember during the writing of the Level I statement are "independence" and "management reporting."
The auditors have to be independent of the functions under examination. In other words, if the quality manager is the author of many of the QS-9000 procedures, then he is not a suitable auditor. The range of suitable auditors is wide. Purchasing agents with a history of auditing suppliers, engineers, former quality personnel, outside consultants, and departmental managers all could be excellent choices for auditors.
At the same time, don't lose sight of the fact that the information gathered from an audit has to be reported to management. In turn, management has to take documented actions to correct or improve parts of the ISO 9000 system. It is this communication between the auditors and management that will be closely examined during a registration assessment.
Finally, set up an audit schedule and stick to it. Examine every element of the appropriate QS-9000 standard at least once every year. Critical elements of your system should be checked more often. Keep to the schedule. If you have not performed a scheduled audit on time, chances are the registrar will cite you for a non-conformance to element 4.17.
With all of that said, let's look at what a Level I statement might say. Read Element 4.17 first and note what is being added to our statement.
"The Quality Manager is responsible for the maintenance of the internal quality auditing system. The ABD Company will carry out, at least annually, a comprehensive audit of the management system of quality assurance and the work environment to confirm the planned system is fully implemented and to gauge its effectiveness. Elements of the system to be audited will be scheduled according to their importance and status by trained auditors that are independent of the function being examined. A written procedure will be used for conducting the audits and appropriate follow-up actions. The results will be presented as a written report delivered to ABD management and the managers of the areas being audited. Identified management will take timely corrective actions and report these actions in writing to the President of ABD and the audit coordinator."
Notice that independence and training of the auditors was stated. Also note how the term "audit coordinator" is used instead of naming a particular job title to conduct the audits. The quality manager has responsibility for maintaining the audit system, but this careful use of terms allows other managers to direct particular audits. As an example, the engineering manager could conduct the gauge calibration audit.
There are two schools of thought on how to train people to become auditors for QS-9000. One group suggests a two to three day internal auditor's course is adequate to bring people up to speed. Another group thinks the auditors should attend Certified Lead Assessor training, a one week course. After the course, these auditors should take the certification exam and file for official recognition. Then they should attend the two and half day QS-9000 auditor course given by the AIAG.
As usual, neither approach is entirely correct for every situation. The best first step is to look at your particular circumstances. What are your internal needs? How important is the QS-9000 system? How much experience do potential auditors already have? Are you a tier-one supplier?
Begin by looking at the size of your organization. If you are a 50-man job shop, only one person need be trained as an auditor. If you are a corporation with many sites, then perhaps a trained audit team is necessary. A medium size manufacturing firm usually uses two and five auditors.
Next, consider the experience of the people nominated to be auditors and the level of professionalism you wish to project. A nationally known corporation may want all auditors certified after attending the week-long lead assessor course. At the same time, a small manufacturing firm may feel a two-day course on internal auditing for QS-9000 given to experienced auditors of suppliers is adequate. Most people agree that the person in charge of the audit system should have at least the amount of training required of a qualified auditor.
As a first-tier supplier, you will be expected to attend the two and half day auditor training course given by AIAG. This is only a recommendation for lower tier suppliers. They should, as a minimum, attend the two day overview of QS- 9000 at AIAG.
A strongly recommended step is that the level of experience and training required for a qualified auditor be documented as part of your audit procedure. You can add to this your test of independence. In this way, you will have clearly demonstrated your auditors are appropriate for the job. This could also include a description of the communication and leadership skill an auditor must possess to be effective.
The audit cycle described in ISO 10011 should be used to create the procedure for internal audits. If you haven't already guessed from the discussion above, these internal quality audits have to be performed just like the registration assessments.
ISO 9004-1, paragraphs 5.4 and 5.5 delve into the techniques of auditing as well. By combining these two pieces of information, and with some training in auditing, you can create a simple, yet comprehensive system of internal audits. For maximum efficiency, this audit system can be used for other audit needs. Financial, supplier, and process audits can all use this same system.
A procedure should begin by naming those responsible for ordering an audit and to whom the results are reported. In the case of an internal quality audit, management calls for the audit and receives the report. Typically, the quality manager organizes and carries out the audit.
Next, there must be a comprehensive audit plan created. An audit plan lays out the scope of the audit by listing the activities and area to be checked. Then it describes the people to be involved and their qualifications to conduct an audit. Next, describe the way the audit is to be carried out. This might include the use of check lists to check the compliance and effectiveness of a particular procedure. Finally, it details how the results are to be gathered and reported.
In all cases, objective evidence must be gathered and reported in writing. It would take several issues to give instructions on how to conduct an actual audit. Instead, we will describe the basics of the system and suggest you either read one of the excellent texts on this subject or attend a class on quality audits.
The purpose of an audit is to report on the level of conformity for all elements of QS-9000. Strong areas should be praised and weak areas noted. When weaknesses are found, the audit report should cite the evidence that lead to this conclusion. Management should review and approve of these conclusions. In addition, the audit report should focus on the overall effectiveness of the quality system. It is acceptable for an internal audit team to suggest corrective actions.
Management should react to an audit report with a specific plan of corrective action. This should be broken into two parts. The first part should be the assignment of specific tasks to particular managers. These managers should respond in writing as the corrective actions are completed.
The second part is that of management looking at their overall system and exploring the possibility of updating or changing existing procedures to increase the effectiveness of the system. We recommend that in addition, the cost efficiency of procedures be examined as well. At the same time, ISO 9004 suggests that management keep an eye on changing market or economic situations, or changing internal strategies, to assess the need for change within the existing management system of quality assurance.
All actions taken must be documented. A simple memo reporting a successful corrective action, or a directive issued to change a procedure, are adequate evidence of management involvement. These documents will only help you during a registration audit.
The following is just one part of a possible auditing procedure:
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4. Procedure for Quality Audits
At least once a year, the management steering committee will call for a
complete audit of the QS-9000 system. The QA manager will be appointed at
the audit team leader. The results of the audit shall be reported in writing to
the management steering committee.
4.1 The Audit Team
The full quality system audit team is comprised of trained auditors from
QA, engineering, management, and purchasing. The auditors are
selected by the QA manager, who is responsible for the entire audit
process.
Selected auditors shall have at least five years of seniority.
4.2 Training
Each auditor has to have completed the AIAG course for QS-9000
auditors. In addition, they have to have attended the IQA certified
course for either internal auditing or lead assessor training. The
certificates of completion will be kept on file in the human resources
department.
Before the audit, the auditors will be provided with an audit scope, plan,
and set of checklists by the QA Manager.
4.3 Audit Plan
The audit plan will layout the schedule for the examination of each
department. The elements of QS-9000 to be checked in each
department will also be listed. Specific auditors will be given
assignments based on the audit plan.
A audit leader, the QA Manager will create the audit plan.
4.4 Audit Execution
The QA Manager will notify department heads of the upcoming audit at
least one week in advance.
An opening meeting shall be held with representatives from all
departments. At this meeting, the audit leader will review the scope and
intention of the audit.
During the audit, auditors will collect evidence to demonstrate that all
policies, procedures, and work instructions related to QS-9000 are being
followed and being used effectively.
Audit findings will be drawn up by the audit team and presented at a
closing meeting with all department heads. A written report on the audit
will be sent to the management steering committee within ten days of the
audit.
4.5 Corrective Action
Both minor problems and nonconformances require corrective actions.
The items requiring corrective action are to be sorted into their order of
importance by the management steering committee.
Specific actions to take for each corrective action request are assigned
to the affected department head. The head of each department can then
choose who will implement the corrections.
The QA Manager, as audit team leader, will maintain a log of required
corrective actions and expected times of completion. He shall also track
each corrective action to assure that they are completed on a timely
basis.
If necessary, the QA Manager will conduct a verification audit to assure
that the corrective action has taken place.
4.6 Closing an Audit
Audits are considered closed when all corrective actions have been
taken and the QA Manager has confirmed their success. All audits must
be closed before the next schedule audit takes place.
The QA Manager prepares a final audit report detailing the success of
the audit and corrective actions. This report is sent to the management
steering committee and all department heads.
The audit log should also reflect the completion of all corrective actions.
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The instructions on how to fill out an audit report, how to complete the audit plan, or how to file corrective actions, can all count as Level III documents. The number and scope of work instructions needed for internal auditing will vary. Let your procedure for auditing dictate the type of Level III documents to create.
The records generated by audits, and the audit schedule, will actually be the most vital documents examined during a registration audit. These form the evidence that you have been conducting regular audits and that the audits themselves have been complete and effective.
An audit schedule should cover all elements of the QS-9000 standard your customer has applied to your company. Each audit should be carried out on schedule. The completion of an audit should be noted on the schedule.
The call for an audit, the audit report, hand-written notes, corrective action plans, and confirmation of corrective actions should be filed together in a case file. Each audit is treated as a separate project. The person named as responsible for the whole audit system should keep and track these files. If many audits occur during the year, project tracking software is highly recommended. The trick is not to lose track of the progress of an audit. If the purchasing manager was supposed to report on a corrective action on the 15th of this month, a memo asking for the results should be sent out on the 16th.
Only when the audit coordinator keeps careful and complete control over the process, will audits be completed.
The end results of an internal audit should be a better internal system. This includes the use of preventive actions. When you look at the function of the internal quality audit, you can see it is the final and confirming step in your management system of quality assurance. It feeds needed information back to your management. Then, your management can use the information to begin the upward spiral of continuous improvement.
Element 4.18 Although not the weakest area during an assessment, training is still an area in need of much improvement within most companies. The intention of QS-9000 is to assure that everyone in your plant knows his job functions and that this includes their role in your overall system of quality assurance.
If we take a look at the actual language of element 4.18, we can see that their are some key words to pay attention to. The key words to read are "needs" and "qualified." Training is actually a two part requirement. The first part is to identify the training needs for particular jobs. That means that you have to write up formal job descriptions that include education, experience, and training needs.
The second part of the requirement is to assure that qualified people perform specific jobs and task. Therefore, you will need a training matrix to track the training status of each job description created above. Then you will have to regularly evaluate your training effectiveness. QS-9000 treats training as a strategic issue.
This opens up the opportunity for a skill for pay type of personnel system at your company. Because you have specified the minimal requirements in skills for each job and track the status of each employee, you can easily add in a contract that pays more to people that learn more than the minimum. By adding in the requirement of these people being able to demonstrate their new skills before raises are handed out you gain two advantages. The first is that you motivate your people to learn more skills. The second is that you can easily track the strengths and weaknesses within your workforce and plan appropriately.
Next comes the question of how to implement a simple training system that also meets the requirements of QS-9000. As usual, the best first step is to turn to ISO 9004-1.
ISO 9004-1 dedicates an entire section to the topic of Personnel and Training. It begins by emphasizing that all employees should be part of some regular training program. In other words, you don't just train people for the fad of the month. Instead, you have a longterm plan for training and everyone participates.
ISO 9004-1 also suggests that you pay particular attention to people that are new hires or transferred to a new job. They should either have the skills necessary for the new job, or be in training to get the missing skills.
The standard goes on to note that all members of management should be trained in the operation of your quality assurance system. It also suggest that all employees receive training in statistical techniques, problem solving, and other team related, continuous improvement activities. This would include the FMEA, PPAP, and APQP requirements mentioned in QS-9000.
In general, ISO 9004-1 says that a properly motivated employee is one that is thoroughly trained in the performance of his job and aware of his role in the quality system. Therefore, the person in charge of training at your company has to create some plans and procedures.
Conformance to the Training requirement involves several steps. The first is to develop an overall plan for training. If your company emphasizes employee participation or empowered workteams, then a program of problem solving and team participation training should be a requirement for all employees. In addition, you need to specify the specific training for each family of job descriptions. These usually break down into specific departmental activities.
For example, engineers might be required to know how to conduct a designed experiment. If they cannot demonstrate this knowledge, then they are scheduled for training.
Next, specific job descriptions are either written or updated to specify particular skills, education, and training required for a particular job. Let's stay with the engineering example. An apprentice engineer may be required to have a four-year engineering degree, at least one year of drafting experience, and training in team problem solving and statistical methods.
Such requirements lead to the need for a training matrix. Across the top of such a matrix are the regularly scheduled training activities. Down the side of the matrix are the job titles and the names of the people holding those titles. After each job title should be a series of Xs or other marks to indicate each level of training required for the job. After each person's name would be the completion dates or scheduled attendance dates for the training requirements.
Your procedure for training should detail the information discussed above. Then it should talk about the specific types of training your company offers and how records are retained.
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4.0 Training Procedure
4.1 Formal Training for all Employees
The director of Human Resources shall use job and task analysis to determine
both job descriptions and training needs for each classification of employees.
New hires and temporary employees will attend the following training:
- Orientation
- Basic SPC
- Overview of QS-9000
- Safety training
Successful completion of these courses and any other off-site courses are
documented with a certificate of completion, which is then stored in the
employees personnel file.
On-the-job training programs are described individually in the OTJ manual.
4.2 Audit Assessment
The effectiveness of training will be assessed annually by the director of Human
Resources. All training programs should be developed to meet demonstrated
employee needs.
Content analysis will be performed on any training package developed by
outside sources.
4.3 Safety Training
Safety training involving the proper use of company equipment, the company
safety rules, the right to know law, and other related topics is given to any
employee whose job involves activities on the shop floor.
Training on safety rules will be given to all employees.
Records of safety training completion will be retained in the Human Resources
department.
4.4 Management Training
All manager will attend orientation, SPC, QS-9000, and safety training upon
hiring or promotion into a management position.
The CEO committee can approve any additional training that a manager feels is
necessary.
All managers will attend at least one course related to their job function at least
once a year. In addition, the CEO committee, as part of the strategic plan, will
determine additional training needs.
Certificates of completion will be retained in personnel files in Human
Resources.
4.5 Training Records
The director of Human Resources shall maintain a training matrix that details
required training versus job title. The successful meeting of these training
objectives shall be documented and maintained. The director of Human
Resources will encourage the other department head to keep training up to
date.
All training related data will be retained by the Human Resources department.
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For training, there are usually very few, if any, Level III documents. Work instructions for conducting job and task analysis, or completing training schedules are just two possibilities.
When you write your level I document (policy) for training, be sure to identify someone as being responsible. Make sure that the person is identified by job title. Also make sure that you state how you identify and meet training needs.
When you write your level II document (procedure) be sure to include the need for all employees to receive quality awareness training. Then note that job descriptions will specify the training requirements for each job. You should also note that experience or educational achievements might exempt some training requirements. The use of a training matrix should be very helpful in this regard.
Finally, you will look even better during an assessment if you can document how particular skills relate to your quality system needs. For example, team problem- solvers also implement continuous improvement.
Elements 4.19 and 4.20 These last two elements of QS-9000, Section One resemble add-ons to the standard. It is almost like someone remembered these at the last moment and wrote out two quick sentences. However, they still represent requirements that have to be met.
Let's start with element 4.19 of QS-9000. Later, we will look at element 4.20. Element 4.19 starts with a key phrase, "Where servicing is a specified requirement..."
This means that if you perform no servicing of your product by contractual agreement, then you may be exempt from this requirement. Ask your customer and your registrar. If this is true, then you write a policy statement that basically says you don't do servicing, but if you did this would be our policy.
If your company does supply service for the product by contractual agreement. Then you need to write the usual level I, II, and III documents. But how do you know if your service is contractual?
Here are some examples to use as guidelines. If you produce home furnaces and your company trains the service technicians. If you manufacture a product like a software and you provide technical support to customers. If your engineers go out into the field or to a project site to assist in servicing. Or, if you make a product and also own the "factory service" business as well. An example of this would be a chain of official service centers for your product. In the automotive supply business, if you send people to the assembly plants or dealer repair shops to assist in installing your product, you provide a service.
As for service, ISO 9004-1, section 16.4 to 16.6 talks about service, market-feedback, and after-sales servicing. It mentions that special servicing tools and devices should go through the same design control the product experienced. Measuring and test equipment has to be part of your calibration and gage maintenance system. Spare parts and other backup services have to be in place. And, instructions have to be clearly understood and documented. In other words, servicing, installation, and other post-sale instructions have to be user friendly.
ISO 9000-2 expands on these suggestions by adding several more ideas.
1. You should spend some time developing a clear organization of the servicing personnel, their procedures and work instructions, and their communication network.
2. Train service personnel to a standard sets of instructions.
3. Test service personnel for competency.
4. Tell service personnel to supply information about the success of the product in the field and provide lists of problems encountered. That information goes back to the design review team.
ISO 9000-2 ends by saying that even if you don't do the servicing, you might want to tap into the information others are gathering by servicing your product. The obvious approach is to gather data from the service representatives in the field. Less obvious is gathering data from the company that uses your parts in their product.
Now you are ready to write your policy statement. You state that you have a written procedure for performing and verifying that servicing meets written requirements. In addition, you have an active method of collecting feedback from the service people to share with your manufacturing, engineering, and customer support departments.
The procedure for servicing is going to depend on the nature of the service you provide. If your company has specific people that go into the field to service products, then they will work under a specific set of procedures. One will cover the way servicing is handled, another will talk about the training service people receive, another will outline certification of outside service people, and so on.
In most companies, a simple procedure on how the service people do their job will suffice. This same procedure can mention the amount, type, and timing of training received.
Let's look at the core of a rather complete service procedure. In most cases, your procedure will be a simpler version.
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4.0 Service Procedure
4.1 Specification
Product contracts with Ford and GM stipulate the product maintenance required
after manufacture. The customers may also purchase extended warranties and
service contracts.
The Sales Manager will generate the specific agreement with the customer.
This agreement is copied and sent to engineering for use in their advanced
quality planning. A second copy is kept on file in the Sales Department.
4.2 Service Manuals
Service manuals will be placed under the procedure for document control.
Service manuals are to be developed by the Engineering Department as part of
the design process.
Service manuals are to be used by warranty, service, and customer contact
personnel. Other personnel can use the manuals for reference purposes.
4.3 Training
Customer support personnel receive training in communication skills, business
law, and the QS-9000 standard.
Service technicians employed by this company and our affiliates are trained in
geometric dimensioning and tolerancing, blueprint reading, installation
procedures, and warranty reporting. Human Resources tests potential service
technicians for their reading, writing, and math skill levels.
As new product instructions are generated, the appropriate personnel will be
trained in their methods.
The Human Resources Manager will maintain all training records.
4.4 Tools
The Customer-Support Supervisor will assure that all tools and equipment used
to service our products by our personnel in the field are appropriate for the task
and pass the same calibration requirements designated in Procedure QA-4.10.
Service tools will be stickered to identify the next scheduled calibration. The
tool histories will be maintained by the QA manager
4.5 Dissemination
The Customer-Service Supervisor and his aide handle all incoming customer
calls for service. A log of these calls is maintained.
The Customer-Service staff will conduct replies by documented phone call or
FAX to solve reported problems. All information on a particular customer
request will be filed in one folder. A summary of service activity will be reported
to management once a week.
The Customer-Service Supervisor will assign service personnel on an as-
needed basis.
If the product is under warranty, then a warranty response report is kept.
When a product is not under warranty, then a cost of service report is kept.
4.6 Records
The Customer-Service person in contact with the customer will document all
related activities. The completed report is signed by the Customer-Service
Supervisor and filed in the Sales Department.
Services performed by factory personnel are documented on a separate labor
use report and filed with Sales and the Plant manager.
4.7 Followup
Upon completion of a repair or service request, a customer action report is
completed. Copies of this report are given to the managers of manufacturing
and engineering for their use in planning improvements to the product.
Customer-Service personnel are encouraged to prompt the customer to provide
comments on the success of the service delivered, their level of satisfaction,
and suggestions for improvements in the product. These will be reviewed by
management.
4.8 Product Verification
The Customer-Service Supervisor will work with the QA Manager to maintain
failure data on serviced parts for later statistical analysis. This information will
be shared with the engineering and manufacturing managers.
4.9 Credits
Credits will be applied against job costs when the Customer-Service Supervisor
determines that our company is at fault for a defect or when warranty work is
involved.
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For servicing operations, the work instructions will rotate around the actual task of performing service. The key to work instructions is to make them very task specific. If you manufacture air conditioning units for automotive use, then installation instructions should exists. Another set of instructions should exist for upkeep and repair of your units. If the service personnel have to fill out papaerwork to verify completed servicing, then instructions for this will also have to be present.
Service and Statistical Methods are the last two requirements of QS-9000. It is too easy to neglect these because of all of the attention placed on other requirements. However, both requirements tie into your design process, process control, corrective action, and continuous improvement plans. Give them the full attention they deserve. After all, these are the requirements being expanded in future revisions of the standard.
Element 4.20 Just like the service requirement, statistical methods opens with a critical phrase, "The supplier shall identify..."
This means that you have to sit down and look at every aspect of your manufacturing cycle and decide where statistical methods are required and where they would be beneficial to the company. For most suppliers statistical process control will be required at several stages of production for special characteristics.
Statistical methods are widely recognized as being valuable in design, process control, corrective actions, and continuous improvement. In addition, they are invaluable for tracking the success of meeting customer needs. Therefore, many additional statistical methods need to be considered. A partial list would include:
In most cases, you would select the proper tools to use during your Advanced Product Quality Planning and then document your choices in the quality control plan. Naturally, your work force has to be trained on how to understand, calculate, and use each statistical method they will be required to perform.
Your first step should be to study ISO 9004-1 and ISO 9000-2 concerning this element.
ISO 9004-1, Section 20 addresses the subject of sampling and other statistical techniques. Thus, several paragraphs and additional standards are dedicated to a topic covered by four sentences in the standard. Like the iceberg, the requirements for statistical methods lies mostly below the surface.
ISO 9004-1 lists out many examples of statistical methods that can be used by any business. This includes SPC, designed experiments, reliability testing, regression analysis, statistical problem-solving charts, and the like. It is important for a company to select the minimal number of methods that best meets its needs. For example, implementing SPC may be all that a small manufacturer can handle for a year or two. In such a case, only SPC should be mentioned in the QS-9000 documents. Remember, any method you mention will be open for inspection during an audit.
ISO 9000-2 points out the many benefits of various statistical methods in running a company and meeting the needs of customers. Each method suggested by ISO 9004-1 is explained further in ISO 9000-2 by describing the potential benefits of the method. ISO 9000-2 also explains that the data generated by statistical methods represents evidence of conformance to the quality system and quality records.
Finally, you should consult Fundamental Statistical Process Control, the official SPC manual from AIAG. This will give you very deep information on SPC, control charts, capability studies, and gage analysis.
For statistical methods, you begin by naming who is ultimately responsible for controlling the use of statistical methods. Then, you state that you have a written procedure for each method used at your company and that they have a component for identifying when to use the method to verify customer needs. Then you can expand the policy statement to briefly outline your main statistical methods, such as SPC. Doing so will personalize your Level I document and help the registrar to better understand your company. However, be brief and never mention a method you aren't actively using. Finally, you state how you select statistical methods and how you assure that everyone using the methods is properly trained.
For statistical methods, a procedure will be developed for each method, or group of methods. For example, the problem-solving methods of Pareto analysis, flow charting, cause and effect charts and the like can be grouped under one procedure.
Let's take a moment and look at a specific procedure that is the most likely one to be written, statistical process control. Such an SPC procedure would outline who is in charge of what, where the charts are placed, how control limits are calculated, when to take corrective action, and so on.
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1. The quality manager is responsible for assuring that the SPC system is fully implemented. The SPC coordinator handles all shop-floor communications.
2. Engineering supplies the SPC coordinator with a quality control plan that identifies the critical characteristics of the product being manufactured. The SPC coordinator establishes control charts for each critical characteristic. These charts are then sent to the appropriate point in the manufacturing process. The control charts become part of the work instruction package for that point in manufacturing.
3. The SPC coordinator briefs each operator responsible on monitoring a critical characteristic on the limits of statistical control, the data to be gathered, the method of recording information, and the reaction plan.
4. When a point plotted on a chart is found to be out of statistical control, it is circled and the operator initiates the reaction plan attached to the chart. The problem encountered and solutions attempted are to be noted on the back of the chart. A supervisor must sign these notes before the process continues.
And so on...
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The idea is to write a procedure that can be used in any situation requiring SPC.
For statistical methods, there should be specific work instructions for the method, when it is critical to consistent and accurate use of the method. Take the example of SPC. In most businesses, there is a set of work instructions on how a chart is to be prepared and put into use when required. Once in use, there is usually a second set of instructions on how to fill it out and interpret its results. Typically, these are either part of the process instructions for the worker, or part of the actual chart. The same holds true for instructions on reacting to out of statistical control situations.
If you look at the brief reaction instructions on an SPC chart, this can be a model of how brief work instructions can be to be effective. At the same time, you want to present enough step-by-step information that you can use the work instruction as a training aid for new employees.
Service and Statistical Methods are the last two requirements of QS-9000. It is too easy to neglect these because of all of the attention placed on other requirements. However, both requirements tie into your design process, process control, corrective action, and continuous improvement plans. Give them the full attention they deserve. After all, these are the requirements being expanded in future revisions of the standard.
We would like to point out that coping with QS-9000 only requires a full knowledge of the previous quality assurance standards used by the automotive industry and ISO 9000. Oh yes, it also helps to get hold of four books from the AIAG (810) 358-3570. They are,
We will begin by examining Production Part Approval Process or PPAP.
In the past, the big three had their own systems for a production part approval process. That all changed with the introduction of the AIAG standard for PPAP. This single standard serves as the common reference work. However, it also serves as the minimal instruction set for PPAPs. For each company, you may find that individual contracts will specify additional conditions or the limitations on the use of the standard.
Much to the benefit of supply companies, the PPAP standard gives each company a single set of instructions, forms, and procedures to follow to satisfy the demands of several customers at the same time. For ISO 9000 based companies, the PPAP standard gives a potential method for their own application. For companies seeking QS-9000 registration, the PPAP is a necessary procedure that has to be part of your Level II documentation.
Production part approval involves the examination of a new process to ensure that the statistically predicted capability of the process will comply with tolerance requirements. In most cases, the PPAP is used any time a new part is proposed, an old part significantly changed, a customer quality concern is reported and corrected, the manufacturing process changed, new materials used, and other situations where the capability of the manufacturing process might change.
In most situations, 300 pieces will be produced and from this, a random sample drawn or the whole population used to determine capabilities. Multiple cavities, molds, lines, and so on have to be represented in the sample. Capability index Ppk is calculated along with other relevant statistics to determine whether the full production run is likely to stay well within tolerance. The typical value to be achieved for Ppk is 1.67. Naturally, any of these methods and outcomes can be changed for particular contracts.
In addition, a visual quality methodology is presented. This is reported back to the customer on an Appearance Approval Report.
As a customer to the big three, each contract you sign to produce a part or assembly will contain a submission level for PPAP. Any one of five levels can be noted. Each has an increasing number of forms to fill out and procedures to follow.
The number of items to submit under PPAP is lengthy. However, they are not necessarily difficult to assemble and prepare.
- Part warrant - Appearance approval report - Ttwo sample parts - All design data (prints, math, CAD, etc.) - All engineering change documentation - Dimensional results - List of checking aids used - Material, performance, and durability test results - Process flow charts - Process and design FMEAs - Quality control plans - Process performance evaluation - Gage error testing results - Design engineering approval
As you can see, this is everything a company needs to use to plan and carry out the production of any part. The big three want to see it all. On most contracts, this list will be limited. The PPAP standard contains a cross reference table that tells you which items to submit for each submission level.
You should also see that many statistical methods are called for under this standard. These include risk calculations in FMEAs, gage R&R studies, process capability studies, statistical process control, and sampling statistics, to name a few. Geometric dimensioning and tolerancing are highly recommended for the engineering prints and for submitting your dimensional results versus customer specifications.
Your results are sent to the customer. Eventually, they tell you if your production part has been approved. A "self-certifying" supplier, only has to submit the documents and materials to assume that they have been approved. Rejection means you must contact the customer and start corrective actions. Interim approval means that a limited run will be permitted by improvements have to be made in short order.
The PPAP standard ends with a series of the forms you will have to fill out. One copy of the form is marked to explain what information is needed. After that a blank form appears that you can copy and use. This is perhaps the best feature of the PPAP standard, clearly written instructions for using the forms. The examples include the part submission warrant, appearance approval report, dimensional results, and performance test results.
QS-9000 calls for a documented program of continuous improvement. Element 3 in section two calls for a system of manufacturing capabilities. These two elements represent something different from all of the previous elements. For example, production part approval process is a fairly straight forward methodology. In fact, there is a complete manual on how to conduct production part approval processes.
However, elements two and three of section two represent very large gateways into a myriad of possible methodologies. That means that these two elements can be practically endless in their possibilities.
Let's begin by examining the requirement for continuous improvement. QS-9000 calls for a comprehensive philosophy of continuous improvement within your company. This means that every day for management must spend some time considering where small incremental improvement can be made each day in quality, service, and price.
This also means that management will have to develop written action plans for continuous improvement within specific processes. That also means processes of related to manufacturing and to service components of your business. The initial goal of such plans will be stable, predictable, and capable processes that meet customer needs.
For attribute data this means the perfection of processes to the point where they can meet customer expectations constantly. For variable data this means aiming first for the target value and then reducing variation. For service components of your business this means 100 percent accuracy and timely response to meet customer expectations.
Targets for continuous improvement our spelled out in paragraph 2. 2 of this element. Examples given include machine downtime, waste, set-up, machine capability, labor usage, cost of quality, and ease of manufacturing. In no means does this represent a complete list of the possibilities. You and your management should spend a considerable amount of time thinking about what is important to your customers and to your own internal needs.
Once, the targets for continuous improvement are identified you should then use some method for prioritizing your list. Then specific people and especially cross-functional teams should be assigned specific tasks based on your action plan.
QS-9000 in this element also talks about possible methods you could use in your pursuit of continuous improvement. Please keep in mind that the methods are not the whole core of the process of continuous improvement. Problem solving and continuous improvement methods are merely the means to an end.
Every employee should be familiar with at least a few of these methods. The leaders of the improvement teams should stay focused on project management. That means the organization, focusing, and coordination of the cross functional teams. The trick is to select the simplest and most effective method for methods to address the problem at hand.
some of the methods suggested by QS-9000 include capability studies, control charts, designed experiments, theory of constraints, value analysis, benchmarking, and mistake-proofing. again, this is only a partial listing of the possibilities. In fact, the actual list of possibilities could be quite extensive.
Therefore, one of the jobs for the management teams implementing QS-9000 is to identify the specific methods that the company will use in general. Thus, you can quickly see that this particular element of QS-9000 opens a considerable gateway to other activities. Not only will your company have to comply with the long list of QS- 9000 requirements, it will also have to examined a wide range of additional methodologies and technologies.
This, in turn, makes QS-9000 an open-ended standard. As you comply with section one of the standard you will find that things are fairly straight-forward. But, as you start to work with section two you will find that you must balance the needs of your customers with your own internal needs for improvement.
we could write an entire book on the subject of continuous improvement. In fact, many people have already done just that. Therefore, you must carefully limited how much continuous improvement you can implement at one time. QS-9000 only says that you must have a documented approach to continuous improvement. The scope and nature of that approach is left up to you. So, look first at the areas inside your company which need improvement. Then select the best methods for achieving those needed improvements. After that, you train your cross-functional teams and set them loose. Each team leader should report back to management their activities. In this way you will have management review and better coordination of the teams.
If there has been a common theme with automotive suppliers since the1980s it has been cost reduction. The demands of automotive manufacturers has been both obvious and subtle.
This has placed upon automotive suppliers an undue series of demands. Sometimes these demands have been contradictory. With the release of QS-9000, the conflicts should be reduced thanks to the clarity that comes from using a common standard. Section two, element three-manufacturing capabilities, represents a tying together of not only the requirements of QS-9000 but also dozens of other automotive and manufacturing technologies.
What section two, element three is asking for is continuous improvement with value added that each step of the manufacturing process. Let me explain this further.
Manufacturing capabilities refers to the process of continuously improving the efficiency and effectiveness of your primary processes. QS-9000 recommends strongly that you use cross-functional teams to achieve these improvement. Let's look at a particular example.
Ralph Roberts owns a small automotive supplier company. It is located in Michigan, near Detroit. His firm produces small injection molded parts. To assess his plant's manufacturing capabilities Ralph will have to look at several aspects of his operations.
First, Ralph looks at the physical layout of his plant. Flowcharting his layout against the flow of materials and information, Ralph looks for ways to minimize material handling, work in storage, distances to move materials, synchronized material flow, and how to obtain maximum floor space usage.
To accomplish this Ralph uses methods such as efficient work plans, some use of automation, quality of the work place, operator balance, line balance, inventory level efficiency methods, and more efficient labor practices. These represent a major commitment by the management at Ralph's company. Thus the management team needs to meet regularly and effectively using project management techniques to make sure that these goals are met.
As you can see, the QS-9000 requirement for management responsibility is clearly needed to fulfil this particular element. In addition, there is a pressing need for continuous improvement to be part of the implementation of this element. Other requirements of QS-9000 will also be touched upon by this particular element. Thus element three, section two represents a tying together of many of the requirements of QS-9000.
Next this element addresses the idea of mistake-proofing your processes. Mistake- proofing any process can quickly become a long and sometimes difficult task. However, if you have conformed to the requirements of QS-9000, you should find that the implementation of mistake-proofing will be easier and shorter than you may have suspected.
The key to mistake-proofing is to first identify we're there are high potentials or mistakes to be made. You then sort out those potential problems that would affect a critical characteristic. Wants you have a list of this critical risk points in your process, you focus your mistake-proofing efforts.
Techniques like failure mode and effects analysis book (FMEA) will be invaluable in helping you to first identify the problem points in your process and then helping to to develop countermeasures. To mistake-proof a particular part of a process means to literally make it impossible for the operator or the machine to make a mistake.
A good example of this would be the case of the assembly fixture that was altered so that the welding equipment would not function until micro switches on the fixture were activated. Activation of those switches only happens when the parts to be assembled are placed in the fixture correctly.
This element of QS-9000 seems to focus on tooling in particular. You must provide technical resources for tool design and fabrication. In addition, you must have full capability for dimensional inspection. That would imply the use of coordinate measuring machines at your facility.
any aspect of your tooling, gauge, and measurements system that is subcontracted must be fully documented and tracked. If your automotive customer supplies any tooling for gauge equipment, then these should be clearly marked. We recently saw a company using an elaborate fixture device from Chrysler. Boldly marked on this machine was a large sign saying property of Chrysler corporation.
For all of the tools that you use at your facility to should have the following.
That last point requires a brief explanation. When you use tools that wear out you must track how quickly these tools wear out. Your statistical process control charts and capability studies should supply to with this information. You may also study alternative tools to improve the life-cycle performance of your tooling. Once the condition of a tool threatens the capability of your process than tool exchange should take place. The whole idea is to use tools for as long as possible and yet maintain a high level of quality.
This would also represent a good example of adding value to your process. And, that is the whole point of this element of section two.
When you plan to implement QS-9000, be sure to read through all 20 elements of section one and then study section two. What you will find is that section two represents an extension of the first 20 elements, a gateway to other techniques, and an integration of many other QS-9000 elements.
Thus, the key to implementation of QS-9000 is the concept of adding value to everything that you do. If your company does anything that does not and value then you should consider never doing that again. In the future there will be more demands for lower cost automotive parts of higher quality. Luckily the automotive manufacturers are giving more ownership to the suppliers. In addition, QS-9000 and the other AIAG standards are a great introduction to be methods needed to survive as an automotive company.
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This page last reviewed or edited: Sun, 2007-02-04 17:39 (Coordinated Universal Time [ZULU] -5 hours)