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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: