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ISO 9000 - QS-9000 Information Exchange

The following document is provided as a service to those seeking to achieve and/or maintain QS 9000 compliance. Note that approval of this specific document by one specific registrar. Does NOT mean YOUR registrar will approve it! Nor does it mean that 'NO MISTAKES' are contained herein... Each registrar is different, each auditor is different, and each audit/review is different.

Please help by contributing to the collective effort.

This Manual is Circa 1997

--Company X -- Quality Systems Manual

Section I
ISO 9000:1994 BASED REQUIREMENTS

SECTION ORGANIZATION

Management Responsibility Element 4.1

  1. Quality System Element 4.2
  2. Contract Review Element 4.3
  3. Design Control Element 4.4
  4. Document and Data Control Element 4.5
  5. Purchasing Element 4.6
  6. Control of Customer-Supplied Product Element 4.7
  7. Product Identification and Traceability Element 4.8
  8. Process Control Element 4.9
  9. Inspection and Testing Element 4.10
  10. Control of Inspection, Measuring, and Test Equipment Element 4.11
  11. Inspection and Test Status Element 4.12
  12. Control of Nonconforming Product Element 4.13
  13. Corrective and Preventive Action Element 4.14
  14. Handling, Storage, Packaging, Preservation and Delivery Element 4.15
  15. Control of Quality Audits Element 4.16
  16. Internal Quality Audits Element 4.17
  17. Training Element 4.18
  18. Servicing Element 4.19
  19. Statistical Techniques Element 4.20

Management Responsibility - Element 4.1

Quality Policy - 4.1.1
--COMPANY--'s management with executive responsibility has defined and documented its policy for quality, including objectives for quality and its commitment to quality. The quality policy is relevant to - --COMPANY--'s organizational goals and the expectations and needs of its customers. --COMPANY-- ensures that this policy is understood, implemented and maintained at all levels of the organization.

Organization - 4.1.2
Responsibility and Authority - 4.1.2.1

The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality is defined and documented, particularly for personnel who need the organizational freedom and authority to:

a) Initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system;
b) Identify and record any problems relating to the product, process and quality system;
c) Initiate, recommend or provide solutions through designated channels;
d) Verify the implementation of solutions;
e) Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.

Resources - 4.1.2.2
--COMPANY-- identifies resource requirements and provides adequate resources, including the assignment of trained personnel (see 4.18) , for management, performance of work and verification activities, including internal quality audits.

Management Representative - 4.1.2.3
--COMPANY--'s management with executive responsibility has appointed a member of --COMPANY--'s own management who, irrespective of other responsibilities, has defined authority for:

a) Ensuring that a quality system is established, implemented and maintained in accordance with QS 9000, and
b) Reporting on the performance of the quality system to --COMPANY--'s management for review and as a basis for improvement of the quality system.

NOTE 5: The responsibility of a management representative may also include liaison with external parties on matters relating to --COMPANY--'s quality system.

Organizational Interfaces
--COMPANY-- has systems in place to ensure management of appropriate activities during concept development, prototype and production (refer to Advanced Product Quality Planning and Control Plan reference manual) . --COMPANY-- uses a multi-disciplinary approach for decision-making and has the ability to communicate necessary information and data in the customer-prescribed format.

NOTE:Typical functions to be included are:

Management Review - 4.1.3
--COMPANY--'s management with executive responsibility reviews the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of QS 9000 and --COMPANY--'s stated quality policy and objectives (see 4.1.1) . Records of such reviews are maintained (see 4.16) .

Management Review
The Management Review requirement includes all elements of the entire quality system, not only those specifically required in other elements, e.g. 4.14.3d.

Business Plan - 4.1.4
--COMPANY-- has a formal, documented, comprehensive business plan. This plan includes as applicable:

The content of the Business Plan is not subject to third party audit.

Goals and plans cover short-term (1-2 years) and longer-term (3 years or more) . The goals and plans are based on analysis of competitive products and on benchmarking inside and outside automotive industry and --COMPANY--'s commodity. Methods to determine current and future customer expectations are in place. An objective valid process is used to collect information, which defines what information is ought, the frequency and methods of collection.

Methods to track, update, revise, and review the plan are documented to ensure that the plan is adhered to and communicated throughout the organization as appropriate.

NOTE:Data and information drives process improvement plans.
NOTE:--COMPANY-- provides a means for employee empowerment in meeting business goals.
NOTE: This is intended to encourage strategic business planning. Business plans and the business planning process are considered proprietary and will be reviewed with individual customers as appropriate. When --COMPANY-- is in direct competition with a customer's division, it is exempted from providing detailed cost data. The Business Plan is considered Company Private and is not furnished outside --COMPANY-- employees.

Analysis and Use of Company-Level Data - 4.1.5
--COMPANY-- documents trends in quality, operational performance (productivity, efficiency, effectiveness) and current quality levels for key product and service features. These are compared with those of competitors and/or appropriate benchmarks.

Trends in data and information are compared with progress toward overall business objectives and translated into actionable information to support:

1) Development of priorities for prompt solutions to customer-related problems,
2) Determination of key customer-related trends and correlations to support status review, decision making and longer-term planning.

Customer Satisfaction - 4.1.6
--COMPANY-- has a documented process for determining customer satisfaction, including frequency of determination, and how objectivity and validity are assured. Trends in customer satisfaction and key indicators of customer dissatisfaction is documented and supported by objective information. These trends are compared to those of competitors, or appropriate benchmarks, and reviewed by senior management.

NOTE:Consideration is given to both immediate and final customers.
Quality System - Element 4.2

General - 4.2.1
--COMPANY-- has established, documented and maintains a quality system as a means of ensuring that product conforms to specified requirements. --COMPANY-- maintains a quality systems manual covering the requirements of QS 9000. The quality manual includes or makes reference to the quality system procedures and outline of the structure of the documentation used in the quality system.

NOTE 6: Guidance on quality manuals given in ISO 10013 is utilized.

Quality System Procedures - 4.2.2
--COMPANY-- has

a) Prepared documented procedures consistent with the requirements of QS 9000, the range and detail of the procedures that form part of the quality system depend upon the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.
 

NOTE 7: Documented procedures make reference to work instructions that define how an activity is performed.

Quality Planning - 4.2.3
--COMPANY-- has defined and documented how the requirements for quality will be met. Quality planning is consistent with all other requirements of --COMPANY--'s quality system and is documented in a format to suit --COMPANY--'s method of operation. --COMPANY-- has given consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:

a) The preparation of quality plans (Control Plans) ;

Quality Planning
--COMPANY-- utilizes the Advanced Product Quality Planning and Control Plan reference manual.

Special Characteristics
During the advanced product quality planning process, and particularly during the preparation of FMEAs and Control Plans, the planning team finalizes Special Characteristics. Appropriate process controls are established for all Special Characteristics.

NOTE: Customers use unique symbols to designate special characteristics that can affect safe vehicle operation, compliance with government regulations, fit/function, etc. Initially, the customer may determine Special Characteristics and identify them.

b) The identification and acquisition of any controls, processes, equipment (including inspection and test equipment) , fixtures, resources and skills needed to achieve the required quality;
c) Ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation;
d) The updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation.
e) The identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;
f) The identification of suitable verification at appropriate stages in the realization of product;
g) The clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;
h) The identification and preparation of quality records (see 4.16) .
NOTE 8:The quality plans referred to (see 4.2.3a) may be in the form of a reference to the appropriate documented procedures that form an integral part of --COMPANY--'s quality system.

Use of Cross-Functional Teams
--COMPANY-- has established and implemented an advanced product quality planning process. - --COMPANY-- convenes internal cross-functional teams to prepare for production of new or changed products. These teams use appropriate techniques identified in the Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that accomplish the intent are acceptable.

Team actions include:

NOTE: Cross-functional teams typically include --COMPANY--'s design, manufacturing engineering, quality, production, and other personnel. These teams may include the customer's Purchasing, Quality, Product Engineering, customer plant personnel as well as subcontractors.

Feasibility Reviews
--COMPANY-- investigates and confirms the manufacturing feasibility or proposed products prior to contracting to produce those products. Feasibility is an assessment of the suitability of a particular design, material, or process for production, while conforming to al engineering requirements at the required statistical process capability and at specific volumes.

Feasibility reviews are documented using the Team Feasibility Commitment in the Advanced Product Quality Planning and Control Plan reference manual.

Process Failure Mode and Effects Analysis (Process FMEAs)
Process FMEAs consider all special characteristics. Efforts are taken to improve the process to achieve defect prevention rather than defect detection. Certain customers have FMEA review and approval requirements that are met prior to production part approval. --COMPANY-- utilizes the Potential Failure Mode and Effects Analysis reference manual as a guide.

The Control Plan
--COMPANY-- develops Control Plans at the system, subsystem, component and/or material level, as appropriate for the product supplied.

The Control Plan requirement encompasses processes producing bulk material (e.g., steel, plastic resin, paint) as well as those producing parts.

The output of the advanced quality planing process, beyond the development of robust processes, is a Control Plan. Control Plans may be based on existing plans (for mature products and capable processes) . New plans are required when products or processes differ significantly from those in current production.

The Control Plan covers three distinct phases as appropriate:

Prototype - a description of the dimensional measurements and material and performance tests that will occur during Prototype build.

NOTE: Prototype control plans may not be required if a contract specifically specifies the relief.

Pre-launch - a description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production.
Production - a comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production.

--COMPANY-- has established cross-functional teams to develop Control Plans for approval by the appropriate customer engineering and quality personnel unless this approval requirement is waived by the customer. In some cases, the customer will establish a cross-functional team to develop the Control Plan.

Control Plans are living documents and are reviewed and updated as appropriate when any of the following occur:

The production is changed
The processes are changed
The processes become unstable
The processes become non-capable
Refer to the Advanced Product Quality Planning and Control Plan reference manual and Production Part Approval Process manual.

Contract Review - Element 4.3

General - 4.3.1
--COMPANY-- has established and maintains documented procedures for contract review and for the coordination of these activities.

Review - 4.3.2
Before the submission of a tender, or the acceptance of a contract or order (statement of requirement) , the tender, contract or order is reviewed by --COMPANY-- to ensure that:

a) The requirements are adequately defined and documented; where no written statement of requirement is available for an order received by verbal means, --COMPANY-- ensures that the order requirements are agreed before their acceptance;
b) Any differences between the contract or order requirements and those in the tender are resolved;
c) --COMPANY-- has the capability to meet contract or order requirements;
d) All customer requirements can be met.

Amendment to a Contract - 4.3.3
--COMPANY-- identifies how an amendment to a contract is made and correctly transferred to the functions concerned within --COMPANY--'s organization.

Records - 4.3.4
Records of contract reviews are maintained (see 4.16) .

NOTE 9: Channels for communication and interfaces with the customer's organization in these contract matters are established.

Design Control - Element 4.4

General - 4.4.1
--COMPANY-- has established and maintains documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met.

Design and Development Planning - 4.4.2
--COMPANY-- has prepared plans for each design and development activity. The plans describe or reference these activities, and define responsibility for their implementation. The design and development activities are assigned to qualified personnel equipped with adequate resources. The plans are updated, as the design evolves.

Required Skills
--COMPANY--'s design activity is qualified in the following skills as appropriate:

Organizational and Technical Interfaces - 4.4.3
Organizational and technical interfaces between different groups which input to the design process is defined and the necessary information documented, transmitted and regularly reviewed.

Design Input - 4.4.4
Design input requirements relating to the product, including applicable statutory and regulatory requirements, are identified, documented and their selection reviewed by --COMPANY-- for adequacy. Incomplete, ambiguous or conflicting requirements are resolved with those responsible for imposing these requirements.

Design input takes into consideration the results of any contract review activities.

Design Input - Supplemental
--COMPANY-- has appropriate resources and facilities to utilize computer-aided product design, engineering and analysis. If these functions are subcontracted, --COMPANY-- provides technical leadership. The CAD/CAE systems are capable of two way interface with customer systems. The requirement for computer-aided systems can be waived by the customer.

Design Output - 4.4.5
Design output is documented and expressed in terms that can be verified and validated against design input requirement.

Design output:

a) Meets the design input requirements;
b) Contains or make reference to acceptance criteria;
c) Identifies those characteristics of the design that are crucial to the safe and proper functioning of the product (e.g. operating, storage, handling, maintenance and disposal requirements) .

Design output documents are reviewed before release.

Design Output - Supplemental
--COMPANY--'s design output is the result of a process that includes:

Efforts to simplify, optimize, innovate, and reduce waste (e.g., QFD, DFM/DFA, VE, DOE, tolerance studies, response surface methodology, or appropriate alternatives)
Utilization of geometric dimensioning and tolerancing as applicable

Design Review - 4.4.6
At appropriate stages of design, formal documented reviews of the design results are planned and conducted. Participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews are maintained (see 4.16) .

Design Verification - 4.4.7
At appropriate stages of design, design verification is performed to ensure that the design stage output meets the design stage input requirements. The design verification measures are recorded (see 4.16) .

NOTE 10: In addition to conducting design reviews (see 4.4.6) , design verification may include activities such as the following:

Design Verification - Supplemental
--COMPANY-- has a comprehensive prototype program, unless this requirement is waived by the customer or the product being supplied is a standard item. --COMPANY-- uses the same subcontractors, tooling and processes, as will be used in production wherever possible.

Performance tests consider and include as appropriate product life, reliability and durability.

All performance testing activities are tracked to monitor timely completion and conformance to requirements.

Where these services are contracted, --COMPANY-- provides technical leadership.

Design Validation - 4.4.8
Design validation is performed to ensure that product conforms to defined user needs and/or requirements.

NOTES

11 Design validation follows successful design verification (see 4.4.7) .
12 Validation is normally performed under defined operating conditions.
13 Validation is normally performed on the final product, but may be necessary in earlier stages prior to product completion.
14 Multiple validations may be performed if there are different intended uses.

Design Changes - 4.4.9
All design changes and modifications are identified, documented, reviewed and approved by authorized personnel before their implementation.

Design Changes - Supplemental
All design changes, including those proposed by subcontractors, have written customer approval, or waiver of such approval, prior to production implementation. See the Production Part Approval Process manual.

For proprietary designs, impact on form, fit, function, performance, and/or durability is determined with the customer so that all effects can be properly evaluated.

Document and Data Control - Element 4.5

General - 4.5.1
--COMPANY-- has established and maintains documented procedures to control all documents and data that relate to the requirements of QS 9000 including, to the extent applicable, documents of external origin such as standards and customer drawings.

Reference Documents
Where customer drawings of specifications reference other documents, --COMPANY-- has currently released editions of these documents available at all appropriate manufacturing locations. Examples of documents that are available are:

NOTE: --COMPANY-- may consolidate customer reference documents locally; however, the customer source documents are readily available.

Document Identification for Special Characteristics
--COMPANY--'s process control guidelines and similar documents are marked with the customer's special characteristics symbol (or --COMPANY--'s equivalent symbol or notation) to indicate those process steps that affect special characteristics, when required by the customer.

NOTE 15: Documents and data can be in the form of any type of media, such as hard copy or electronic media.

Document and Data Approval and Issue - 4.5.2
The documents and data are reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents is established and be readily available to preclude the use of invalid and/or obsolete documents.

This control ensures that:

a) The pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;
b) Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;
c) Any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified.

Engineering Specifications
--COMPANY-- has established a procedure to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes. --COMPANY-- maintains a record of the date on which each change is implemented in production (subject to record control, see 4.16) . Implementation includes updates to all appropriate documents.

 

NOTE:An appropriate unit of measure for "timely review" is business "days", not weeks or months. Changes to documents and data are reviewed and approved by the same function/organizations that performed the original review and approved, unless specifically designated otherwise. The designated functions/organizations have access to pertinent background information upon which to base their review and approval.

Where practicable, the nature of the change is identified in the document or the appropriate attachments.

Purchasing - Element 4.6

General - 4.6.1
--COMPANY-- has established and maintains documented procedures to ensure that purchased product (see 3.1) conforms to specified requirements.

Approved Materials for Ongoing Production
Where the customer has an approved subcontractor list, --COMPANY-- purchases the relevant material from subcontractors on the list. Any additional subcontractors are only be used after they have been added to the list by the customer's Materials Engineering activity.

All materials used in part manufacture satisfy current government and safety constraints on restricted, toxic and hazardous materials; as well as environmental, electrical and electromagnetic considerations applicable to the country of manufacture and sale (see Glossary) .

Evaluation of Subcontractors - 4.6.2
--COMPANY--:

a) Evaluates and selects subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements;
b) Defines the type and extent of control exercised by --COMPANY-- over subcontractors. This is dependent upon the type of product, the impact of subcontracted product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of subcontractors;
c) Has established and maintains quality records of acceptable subcontractors (see 4.16) .

Subcontractor Development
--COMPANY-- performs subcontractor quality system development using Sections I and II of QS-9000 as the fundamental quality system requirement. Assessments, if part of subcontractor development, occur at a defined, specific frequency. Subcontractor assessments to QS-9000 by the OEM customer, and OEM customer-approved second party, or an accredited third party registrar are recognized in lieu of audits by --COMPANY--.

NOTE:Acceptance of the above audits or ISO registration is not intended to limit more specific - --COMPANY--/subcontractor quality system and product development.

The use of customer-designated subcontractors does not relieve --COMPANY-- of the responsibility for ensuring the quality of subcontracted parts, materials and services.

Scheduling Subcontractors
--COMPANY-- requires 100% on-time delivery performance from subcontractors. --COMPANY-- provides appropriate planning information and purchase commitments to enable subcontractors to meet this expectation.

--COMPANY-- has implemented a system to monitor the delivery performance of subcontractors, including tracking of premium or excessive freight.

Purchasing Data - 4.6.3
Purchasing documents contain data clearly describing the product ordered, including where applicable:

a) The type, class, grade or other precise identification;
b) The title or other positive identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel.

--COMPANY-- reviews and approves purchasing documents for adequacy of specified requirements prior to release.

Restricted Substances
--COMPANY-- has a process to assure that governmental and safety constraints on restricted, toxic and hazardous substances are complied with relative to purchased products and the manufacturing process.

Verification of Purchased Product - 4.6.4
--COMPANY-- Verification at Subcontractor's Premises (ISO) - 4.6.4.1
Where --COMPANY-- proposes to verify purchased product at the subcontractor's premises, --COMPANY - specifies verification arrangements and the method of product release in the purchasing documents.

Customer Verification of Subcontracted Product (ISO) - 4.6.4.2
Where specified in the contract, --COMPANY--'s customer or the customer's representative is afforded the right to verify at the subcontractor's premises and --COMPANY--'s premises that subcontracted product conforms to specified requirements. Such verification is not used by --COMPANY-- as evidence of effective control of quality by the subcontractor.

Verification by the customer does not absolve --COMPANY-- of the responsibility to provide acceptable product, nor does it preclude subsequent rejection by the customer.

Control of Customer-Supplied Product - Element 4.7
--COMPANY-- has established and maintains documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies of for related activities. Any such product that is lost, damaged or is otherwise unsuitable for use is recorded and reported to the customer (see 4.16) .

Verification by --COMPANY-- does not absolve the customer of the responsibility to provide acceptable product.

NOTE: Customer-owned tooling and returnable packaging is included in this element (see 3.3 and 4.15.4)

Product Identification and Traceability - Element 4.8

Where appropriate, --COMPANY-- has established and maintains documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.

NOTE: "Where appropriate" in the above paragraph refers to those situations where the product identify is not inherently obvious.

Where and to the extent that traceability is a specified requirement, --COMPANY-- has established and maintains documented procedures for unique identification of individual product or batches. This identification is recorded (see 4.16) .

Process Control - Element 4.9

--COMPANY-- identifies and plans the production, installation and servicing processes which directly affect quality and ensures that these processes are carried out under controlled conditions. Controlled conditions include the following:

a) Documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality;
b) Use of suitable production, installation and servicing equipment, and a suitable working environment;

Government Safety and Environmental Regulations
--COMPANY-- has a process to ensure compliance with all applicable government safety and environmental regulations, including those concerning handling, recycling, eliminating or disposing of hazardous materials. This is evidenced by appropriate certificates or letters of compliance.

c) Compliance with reference standard/codes, quality plans and/or documented procedures;
d) Monitoring and control of suitable process parameters and product characteristics;

Designation of Special Characteristics
--COMPANY-- complies with all customer requirements for designation, documentation and control of special characteristics. --COMPANY-- provides documentation showing compliance with these customer requirements as requested by any customer.

NOTE: All product and process characteristics are important and need to be controlled. However, some characteristics, herein referred to as "special", are given extra attention because excessive variation in them might affect a product's safety, compliance with government regulations, fit, function, appearance or quality of subsequent manufacturing operations.

e) The approval of processed and equipment, as appropriate;
f) Criteria for workmanship, which is stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations) ;
g) Suitable maintenance of equipment to ensure continuing process capability.

Preventative Maintenance
--COMPANY-- identifies key process equipment and provide appropriate resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. At a minimum, this system includes:

Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product Is in use, the processes are carried out by qualified operators and/or require continuous monitoring and control of process parameters to ensure that the specified requirements are met.

The requirements for any qualification of process operations, including associated equipment and personnel (see 4.18) , are specified.

NOTE 16:Such processed requiring pre-qualification of their process capability are frequently referred to as special processed.

Records are maintained for qualified processes, equipment and personnel, as appropriate (see 4.16) .

Process Monitoring and Operator Instructions - 4.9.1
--COMPANY-- prepares documented process monitoring and operator instructions for all employees having responsibilities for operation of processes. These instructions are to be accessible at the work station. These instructions are derived from the sources listed in the Advanced Product Quality Planning and Control Plan reference manual.

Process monitoring and operator instructions may take the form of process sheets, inspection and laboratory test instructions, shop travellers, test procedures, standard operation sheets, the part number Control Plan, or other documents normally used by --COMPANY-- to provide the necessary information.

Process monitoring and operator instructions include or reference, as appropriate:

Preliminary Process Capability Requirements - 4.9.2
Preliminary process capability studies are required for each --COMPANY-- or customer-designated special characteristic for new processes. The data meets customer requirements. If no requirements have been specified, a Ppk value of more than 1.67 is achieved for preliminary results (less than 30 production days) and for chronically unstable processes. If these requirements are not met, --COMPANY-- proceeds in accordance with the Production Part Approval Process manual.

This information is reviewed with the customer as required through the various stages of quality planning.

Unacceptable preliminary capability results trigger re-evaluation of mistake-proofing activities. See Section II, Techniques for Continuous Improvement for additional techniques.

Inherent limitations of attributes data prevent their use for preliminary statistical studies. Attributes data from early production runs are used to prioritize process improvements and to begin control charts.

Ongoing Process Performance Requirements - 4.9.3
Ongoing process performance requirements are defined by the customer. If no such requirements have been established, the following default values apply:

For stable processes and normally distributed data, a Cpk value of more than 1.33 is achieved.

For chronically unstable processes with output meeting specifications and a predictable pattern, a minimum Ppk value of 1.67 is achieved.

For non-normal data, methods other the Cpk such as parts per million (PPM) , non-parametric analysis, or index techniques are utilized to determine performance based on customer requirements.

Significant process events (e.g., tool change, machine repair) are noted on the control charts.

When data from control charts and functional tests indicate a high degree of capability, --COMPANY-- may revise the Control Plan with customer concurrence.

Characteristics identified on the Control Plan that are either unstable of non-capable trigger initiation of the appropriate reaction plan from the Control Plan. Customer specified reactions are complied with. Reaction plans include containment of the process output and 100% inspection. --COMPANY-- corrective action plan will then be completed indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans are reviewed with and approved by the customer when so required.

Regardless of the capability requirement of the demonstrated process capability, continuous improvement isutilized, with the highest priority on special characteristics.

Modified Preliminary of Ongoing Capability Requirements - 4.9.4
In some cases, a customer may require either higher or lower capability requirements than the previously stated default requirements. In these cases, the Control Plan is annotated accordingly.

Verification of Job Set-Ups - 4.9.5
Job set-ups are verified as producing parts that meet all requirements. Documentation is available for set up personnel. Last-off part comparisons are recommended. Statistical verification is utilized where applicable.

Process Changes - 4.9.6
Production part approval is granted for a part number, engineering change level, manufacturing location, material source(s) and production process environment. Changes in any of these factors may require prior approval from the customer parts approval activity. --COMPANY-- refers to the Production Part Approval Process manual and customer-specific pages of QS 9000 for unique customer requirements.--

--COMPANY-- maintains a record of process change effective dates (see 4.5.3) .

NOTE: Changes to promote continuous improvement are encouraged.

Appearance Items - 4.9.7
For parts designated by the customer as "Appearance Items", --COMPANY-- provides:

Inspection and Testing - Element 4.10

General - 4.10.1
--COMPANY-- has established and maintains documented procedures for inspection and testing activities in order to verify that the specified requirements for the product are met. The required inspection and testing, and the records to be established, are detailed in the quality plan (Control Plan) or documented procedures.

Acceptance Criteria
Acceptance criteria for attribute data sampling plans is zero defects. Appropriate acceptance criteria for all other situations (e.g., visual standards) are documented by --COMPANY-- and approved by the customer.

Accredited Laboratories
--COMPANY-- uses accredited laboratory facilities when required by the customer.

Receiving Inspection and Testing - 4.10.2
4.10.2.1 --COMPANY-- ensures that incoming product is not used or processed (except in the circumstances described in 4.10.2.3) until it has been inspected or otherwise verified as conforming to specified requirements. Verification of conformance to the specified requirements is in accordance with the quality plan (Control Plan) and/or documented procedures.

4.10.2.2 In determining the amount and nature of receiving inspection, consideration is given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided.

4.10.2.3 Where incoming product Is released for urgent production purposes prior to verification, it is positively identified and recorded (see 4.16) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements.

Incoming Product Quality
--COMPANY--'s incoming quality system uses one or more of the following methods:

In-Process Inspection and Testing - 4.10.3
--COMPANY--:

a) Inspects and tests the product as required by the quality plan (Control Plan) and/or documented procedures;
b) Holds product until the required inspection and tests have been completed or necessary reports have been received and verified, except when product is released under positive-recall procedures (see 4.10.2.3) . Release under positive-recall procedures do not preclude the activities outlined in 4.10.3a) .
c) All process activities are directed towards defect prevention methods, such as statistical process control, error proofing, visual controls, rather then defect detection.

Final Inspection and Testing - 4.10.4
--COMPANY-- carries out all final inspection and testing in accordance with the quality plan (Control Plan) and/or documented procedures to complete the evidence of conformance of the finished product to the specific requirements.

The quality plan (Control Plan) and/or documented procedures for final inspection and testing require that all specified inspection and tests, including those specified either on receipt of product or in-process, have been carried out and that the results meet specified requirements.

No product is dispatched until all the activities specified in the quality plan (Control Plan) and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.

Layout Inspection and Functional Testing
A layout inspection and a functional verification (to applicable customer engineering material and performance standards) is required for all products at a frequency established by the customer. Results are available for customer review upon request.

Inspection and Test Records - 4.10.5
--COMPANY-- has established and maintains records which provide evidence that the product has been inspected and/or tested. These records show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for the control of nonconforming product apply (see 4.13) .

Records identify the inspection authority responsible for the release of the product (see 4.16) .

 

Control of Inspection, Measuring and Test Equipment - Element 4.11

General - 4.11.1
--COMPANY-- has established and maintains documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by --COMPANY-- to demonstrate the conformance of product to the specified requirements. Inspection, measuring and test equipment is used in a manner which ensures that the measurement uncertainty is known and is consistent with the requirement measurement capability.

Where test software or comparative references such as test hardware are used as suitable forms of inspection, they are checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation, or servicing, and are rechecked at prescribed intervals. - --COMPANY-- has established the extent and frequency of such checks and maintains records as evidence of control (see 4.16) .

Where the availability of technical data pertaining to the inspection, measuring, and test equipment is a specified requirement, such data is made available, when required by the customer or customer's representative, for verification that the inspection, measuring, and test equipment is functionally adequate.

NOTE 17: For the purposes of this document, the term "measuring equipment" includes measurements devices.

Control Procedure - 4.11.2
--COMPANY--:

a) Determines the measurements to be made and the accuracy required, and selects the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision;
b) Identifies all inspection, measuring and test equipment that can affect product quality, and calibrates and adjusts them at prescribed intervals, or prior to use, against certified equipments having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration is documented;
c) Defines the process employed for the calibration of inspection, measuring and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory;
d) Identifies inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status;
e) Maintains calibration records for inspection, measuring and test equipment (see 4.16) ;
f) Assesses and documents the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration;
g) Ensures that the environmental conditions are suitable for the calibrations, inspection, measurements and tests being carried out;
h) Ensures that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use is maintained;
I) Safeguards inspection, measuring and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting.

NOTE 18: The metrological confirmation system for measuring equipment given in ISO 10012 is used for guidance.

Inspection, Measuring and Test Equipments Records - 4.11.3
Records of the calibration/verification activity on all gages, measuring, and test equipment, including employee-owned gages, includes:

Measurement System Analysis - 4.11.4
Evidence is maintained that appropriate statistical studies have been conducted to analyze the variation present in the results of each type of measuring and test equipment system. This applies to all measurement systems referenced in the customer approved Control Plan. The analytical methods and acceptance criteria used conforms to those in the Measurement Systems Analysis reference manual [e.g., gage repeatability and reproducibility (gage R&R) studies]. Other analytical methods and acceptance criteria may be used if approved by the customer.

Inspection and Test Status - Element 4.12
The inspection and test status of product is identified by suitable means, which indicates the conformance or nonconformance of product with regard to inspection and tests performed. The identification of inspection and test status is maintained, as defined in the quality plan (Control Plan) and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests [or released under an authorized concession (see 4.13.2) ] is dispatched, used or installed.

Product Location
Location of product in the normal production flow does not constitute suitable indication of inspection and test status unless inherently obvious (i.e. material in automated production transfer process) .

Supplemental Verification
When required by the customer, additional verification/identification requirements are met (e.g., early launch control) .

Control of Nonconforming Product - Element 4.13

General - 4.13.1
--COMPANY-- has established and maintains documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation. This control provides for identification, documentation, evaluation, segregation (when practical) , disposition of nonconforming product, and for notification to the functions concerned.

Suspect Product
This element applies to suspect as well as to nonconforming product.

Review and Disposition of Nonconforming Product - 4.13.2
The responsibility for review and authority for the disposition of nonconforming product is defined.

Nonconforming product is reviewed in accordance with documented procedures. It may by

a) Reworked to meet the specified requirements,
b) Accepted with or without repair by concession,
c) Re-graded for alternative applications, or
d) Rejected or scrapped.

Where required by the contract, the proposed uses or repair of product (see 4.13.2b) which does not conform to specified requirements are reported for concession to the customer or customer's representative. The description of nonconformity that has been accepted, and of repairs, is recorded to denote the actual condition (see 4.16) .

Repaired and/or reworked product is reinspected in accordance with the quality plan (Control Plan) and/or documented procedure.

Control of Reworked Product - 4.13.3
Rework (see Glossary) instructions are accessible and utilized by the appropriate personnel in their work areas.

--COMPANY-- quantifies and analyzes nonconforming product and has established a prioritized reduction plan. Progress towards the plan is tracked.

No rework visible on the exterior of the product is permissible on those products supplied for service applications without prior approval of the customer service parts organization.

 

NOTE: Service applications refers to parts and materials provided to dealers and other distribution channels for the purpose of vehicle maintenance and repair.

Engineering Approved Product Authorization - 4.13.4
Prior written customer authorization is required whenever the product or process is different from that currently approved (see Production Part Approval Process manual) . This applies equally to products or services purchased from subcontractors. --COMPANY-- concurs with any requests by a subcontractor before submission to the customer. --COMPANY-- maintains a record of the expiration date or quantity authorized. --COMPANY-- also ensures compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization are properly identified on each shipping container.

Corrective and Preventive Action - Element 4.14

General - 4.14.1
--COMPANY-- has established and maintains documented procedures for implementing corrective and preventive action.

Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities is to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.

--COMPANY-- uses a disciplined problem solving methods when an internal or external nonconformance to specification or requirements occurs. When external nonconformances occur, --COMPANY-- responds in a manner prescribed by the customer.

Corrective Action - 4.14.2
The procedures for corrective action include:

a) The effective handling of customer complaints and reports of product nonconformities;
b) Investigation of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation (see 4.16) ;
c) Determination of the corrective action needed to eliminate the cause of nonconformities;
d) Application of controls to ensure that corrective action is taken and that it is effective.

Returned Product Test/Analysis
--COMPANY-- analyzes parts returned from the customer's manufacturing plants, engineering facilities, and dealerships. Records of these analyses are kept and made available upon request. --COMPANY-- performs effective analysis and where appropriate, initiates corrective action and process changes to prevent recurrence.

Preventive Action - 4.14.3
The procedures for preventive action include:

a) The use of appropriate sources of information such as processes and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyze and eliminate potential causes of nonconformities;
b) Determination of the steps needed to deal with any problems requiring preventive action;
c) Initiation of preventive action and application of controls to ensure that it is effective;
d) Ensuring that relevant information on actions taken is submitted for management review (see 4.1.3) .
Handling, Storage, Packaging, Preservation and Delivery - Element 4.15

General - 4.15.1
--COMPANY-- has established and maintains documented procedures for handling, storage, packaging, preservation and delivery of product.

Handling - 4.15.2
--COMPANY-- provides methods of handling product that prevent damage or deterioration.

Storage - 4.15.3
--COMPANY-- uses designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas are stipulated.

In order to detect deterioration, the condition of product in stock is assessed at appropriate intervals.

Inventory
An inventory management system is established and documented to continuously optimize inventory turns over time, assure stock rotation and minimize inventory levels.

Packaging - 4.15.4
--COMPANY-- controls packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

Customer Packaging Standards
Refer to unique customer packaging standards/guidelines, including applicable service part packaging standards.

Labeling
--COMPANY-- has a system to ensure that all materials shipped are labeled according to customer requirements.

Preservation - 4.15.5
--COMPANY-- applies appropriate methods for preservation and segregation of product when the product is under --COMPANY--'s control.

Delivery - 4.15.6
--COMPANY-- arranges for the protection of the quality of product after final inspection and test. Where contractually specified, this protection is extended to include delivery to destination.

--COMPANY-- Delivery Performance Monitoring
--COMPANY-- has established systems to support 100% on-time shipments to meet customer production and service requirements. If 100% on-time shipments are not maintained --COMPANY-- implements corrective action to improve delivery performance, including communication of delivery problem information to the customer.

--COMPANY-- uses a systematic approach to develop, evaluate and monitor adherence to established lead time requirements. --COMPANY-- has implemented a system to track performance to the customer delivery requirements.

--COMPANY-- ships all materials in conformance with customer requirements, adhering to up-to-date customer-specific transportation mode, routings and containers.

Production Scheduling
--COMPANY--'s production scheduling activity is order-driven.

NOTE: The use of small lots with a goal of one piece flow in a synchronous manner is encouraged.

Shipment Notification System
--COMPANY-- has a computerized system for on-line transmittal of advance shipment notifications (ASNs) , transmitted at the time of shipment, unless waived by the customer.

--COMPANY-- has a back-up method in the event that the on-line system fails. --COMPANY-- verifies that all ASNs match shipping documents and labels.

Control of Quality Records - Element 4.16

--COMPANY-- has established and maintains documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition (DISPOSAL) of quality records.

Quality records are maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the subcontractor are an element of these data.

All quality records are legible and are stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records are established and recorded. Where agreed contractually, quality records are made available for evaluation by the customer or the customer's representative for an agreed period.

NOTE 19: Records can be in the form of any type of media, such as hard copy or electronic media.

Record Retention
Production part approvals, tooling records, purchase orders and amendments are maintained for the length of time that the part (or family of parts) is active for production and service requirements plus one calendar year.

Quality performance records (e.g., control charts, inspection and test results) are retained for one calendar year after the year in which they were created.

Records of internal quality system audits and management review are retained for three years.

These requirements do not supersede any governmental or customer requirements. All specific retention periods are considered "minimums".

Superseded Parts
Copies of documents from superseded parts required for new part qualification are retained in the new part file.

Internal Quality Audits - Element 4.17

--COMPANY-- has established and maintains documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

Internal quality audits are scheduled on the basis of the status and importance of the activity to be audited and are carried out by personnel independent of those having direct responsibility for the activity being audited.

The results of the audits are recorded (see 4.16) and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area take timely corrective action on the deficiencies found during the audit.

Follow-up audit activities verify and record the implementation and effectiveness of the corrective action taken (see 4.16) .

NOTES

20 The results of internal quality audits form an integral part of the input to management review activities (see 4.1.3) .
21 Guidance on quality system audits given in ISO 10011 is followed.

Inclusion of Working Environment
Suitable working environment is considered as part of the internal audit process.

 

Training - Element 4.18

--COMPANY-- has established and maintains documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks and/or experience, as required. Appropriate records of training are maintained (see 4.16) .

Training as a Strategic Issue
Training is viewed as a strategic issue affecting all of --COMPANY--'s personnel. Training effectiveness is periodically evaluated.

Servicing - Element 4.19

Where servicing is a specified requirement, --COMPANY-- has established and maintains documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.

Feedback of Information from Service
A procedure for communication of information on service concerns to manufacturing, engineering and design activities are established and maintained.

Statistical Techniques - Element 4.20

Identification of Need - 4.20.1
--COMPANY-- identifies the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics.

Procedures - 4.20.2
--COMPANY-- has established and maintains documented procedures to implement and control the application of the statistical techniques identified in 4.20.1.

Selection of Statistical Tools
The selection of appropriate statistical tools for each process is determined during advanced quality planning and are included in the Control Plan.

Knowledge of Basic Statistical Concepts
Basic concepts such as variation, control (stability) , capability and over-adjustment is understood throughout --COMPANY--'s organization as appropriate.

Consult the Fundamental Statistical Process Control reference manual.


Section II
SECTOR-SPECIFIC REQUIREMENTS

ORGANIZATION

  1. Production Part Approval Process
  2. Continuous Improvement
  3. Manufacturing Capabilities
Production Part Approval Process

General - 1.1

--COMPANY-- fully complies with all requirements set forth in the Production Part Approval Process (PPAP) manual.

Production part approval is granted for a part number, engineering change level, manufacturing location, material subcontractor(s) and production process environment. Change to any of these triggers customer notification and possible resubmission. See PPAP.

--COMPANY-- is responsible for subcontracted material and services.

IF THERE IS ANY QUESTION CONCERNING THE NEED FOR PRODUCTION PART APPROVAL, - --COMPANY-- CONTACTS THE RESPONSIBLE CUSTOMER PART APPROVAL ACTIVITY.

ADDITIONAL APPROVALS ARE SECURED FOR PARTS DESIGNATED BY THE CUSTOMER AS "APPEARANCE ITEMS".

Engineering Change Validation - 1.2

It is --COMPANY-- 's responsibility to verify that changes are properly validated. See 4.12, 4.16 and PPAP.

 

Continuous Improvement

General - 2.1

A comprehensive continuous improvement philosophy is fully deployed throughout --COMPANY--'s organization. --COMPANY-- continuously improves in quality, service, (including timing and delivery) and price for all customers. This requirement does not replace the need for innovative improvements.

--COMPANY-- has specific action plans for continuous improvement in processes that are most important to the customer once those processes have demonstrated stability and acceptable capability.

For characteristics that can only be evaluated using attribute data, continuous improvement means perfection of process methods to ensure that the requirement is always met.

NOTE: For those product characteristics and process parameters that can be evaluated using variables data, continuous improvement means optimizing the characteristics and parameters at a target value and reducing variation around that value.

NOTE: --COMPANY-- extends continuous improvement philosophy to all business processes and support services.

Quality and Productivity Improvements - 2.2

--COMPANY-- identifies opportunities for quality and productivity and implement appropriate improvement projects. Examples are:

Techniques for Continuous Improvement - 2.3

--COMPANY-- has a demonstrated knowledge of the following measures and methodologies and uses those that are appropriate:

Manufacturing Capabilities

Facilities, Equipment, and Process Planning and Effectiveness - 3.1

--COMPANY-- uses a cross-functional team approach for developing facilities, processes and equipment plans in conjunction with the advanced quality planning process. Plant layouts minimize material travel and handling, facilitate synchronous material flow, and maximize value-added use of floor space. --COMPANY - evaluates the effectiveness of existing operations and processes considering the following factors: overall work plan, appropriate automation, ergonomics and human factors, operator and line balance, storage and buffer inventory levels, value-added labor content.

Mistake Proofing - 3.2

Mistake proofing is the use of process or design features to prevent manufacture of nonconforming product. When potential sources of nonconforming units are identified by FMEAs, capability studies and service reports, these sources are addressed using mistake proofing methodology during the planning of processes, facilities, equipment and tooling as well as during problem resolution.

Tool Design and Fabrication - 3.3

--COMPANY-- provides appropriate technical resources for tool and gage design, fabrication and full dimensional inspection. If any of this work is subcontracted, a tracking and follow-up system is required. Customer-owned tools and equipment is permanently marked so that ownership of each item is visually apparent.

Tooling Management - 3.4

--COMPANY-- has established and maintains a system for tooling management, including:

If any of this work is subcontracted, a tracking and follow-up system is established.


Acronyms and Their Meanings

Acronym -- Meaning

AIAG -- Automotive Industry Action Group
APQP -- Advanced Product Quality Planning
ASQC -- American Society for Quality Control
ASN -- Advance Shipping Notification
ASTM -- American Society for Testing of Materials
A2LA -- American Association of Laboratory accreditation
CAD -- Computer aided design
CC -- Critical characteristic
CUSUM -- Cumulative Sum
DFA -- Design for assembly
DFM -- Design for manufacturing
DIN -- German Standards Institute
DOE -- Design of Experiments
DVP&R -- Design Verification Plan and report (Chrysler, Ford)
EAPA -- Engineering Approved Product Authorization
ES -- Engineering specification (Ford)
EVOP -- Evolutionary Operation of Processes
FEA -- Finite Element Analysis
FMEA -- Failure Mode and Effects Analysis
GD&T-- Geometric Dimensioning and Tolerancing
ISO -- International Organization for Standardization
KCC -- Key Control Characteristic (General Motors)
KPC -- Key Product Characteristic (General Motors)
MILTFP-41 -- Make it like the finished print - for once
MSA -- Measurement System Analysis
NACCB -- National Accreditation Council for Certification Bodies
(British accreditation body)
OEM -- Original Equipment Manufacturer
PPM -- Parts per Million
PPAP -- Production Part Approval Process
QFD -- Quality Function Deployment
QOS -- Quality Operating System (Ford)
RAB -- Registration Accreditation Board (U.S. Accreditation body)
RvC -- Raad voor de Certificatie (Dutch Council for Certification)
SAE -- Society of Automotive Engineers
SC -- Significant Characteristic (Chrysler, Ford)
SCC -- Standards Council of Canada
SPC -- Statistical Process Control
TGA -- German Association for Accreditation
VA -- Value Analysis
VE -- Value Engineering

Glossary
Accredited Laboratory
Accredited Laboratory is one that has been reviewed and approved by a nationally-recognized accreditation body [e.g. American Association for Laboratory Accreditation (A2LA) or the Standards Council of Canada (SCC) ]. GM-NAO may continue to recognize laboratory accreditation in accordance with GP-10.

Accredited Registrars
Accredited Registrars are qualified organizations certified by a nation body (e.g. the Registrar Accreditation Board in the U.S.) to perform audits to the QS-9000 and to register the audited facility as meeting these requirements for a given commodity.

Active Part
An active part is one currently being supplied to the customer for original equipment or service applications. The part remains active until tooling scrap authorization is given by the appropriate customer activity. For parts with no customer-owned tooling or situations where multiple parts are made from the same tool, written confirmation from the customer Purchasing activity is obtained to deactivate a part.

Approved Material
Approved Materials are materials governed either by industry standard specifications (e.g., SAE, ASTM, DIN, ISO) or by customer specifications.

Assessment
An evaluation process including a document review, an on-site audit and an analysis and report. Customers may also include a self-assessment, internal audit and other materials in the assessment.

Audit
An on-site verification activity used to determine the effective implementation of a supplier's documented quality system.

Capability
Capability is the total range of inherent variation in a stable process. It is determined using data from control charts. The control charts shall indicate stability before capability calculations can be made. Histograms are to be used to examine the distribution pattern of individual values and verify a normal distribution. When analysis indicates a stable process and a normal distribution, the indices Cp and Cpk can be calculated. If analysis indicates a non-normal distribution, advanced statistical tools, such as PPM analysis, is utilized to determine capability. If control charts how the process to be non-stable, the index Ppk can be calculated (see Fundamental Statistical Process Control reference manual) .

Consulting
For the purposes of QS-9000, consulting is the provision of training, documentation development, or assistance with implementation of quality systems to a specific customer. If these activities are open to the public, advertised, and not customer specific, they are considered training rather than consulting (refer to EAC Guidelines to EN 45012, May 10, 1994 draft) .

Control Plans
Control Plans are written descriptions of the systems for controlling parts and processes. They are written by suppliers to address the important characteristics and engineering requirements of the product. Each part shall have a Control Plan, but in many cases, "family" Control Plans can cover a number of parts produced using a common process. Customer approval of Control Plans may be required prior to production part submission. See Advanced Product Quality Planning and Control Plan reference manual and Production Part Approval Process manual. In this document, the terms "control plan" and "quality plan" are generally interchangeable.

Corrective Action Plan
A Corrective Action Plan is a plan for correcting a process or part quality issue.

Documentation
Material defining the process to be followed (e.g. quality manual, operator instructions, graphics, pictorials) .

Environment
Environment is all of the process conditions surrounding or affecting the manufacture and quality of a part or product.

Functional Verification
Functional Verification is testing to ensure the part conforms to all customer and supplier engineering performance and material requirements. Functional verification (to applicable customer engineering material and performance standards) may be required by some customers annually unless another frequency is established in a customer approved control plan. Results shall be available for customer review upon request.

Engineering Approved Product Authorization (EAPA)
Written customer authorization that is required whenever the product or process varies from those currently customer approved (see Production Part Approval Process manual) . This applies equally to products or services purchased from subcontractors.

Job Instructions
Describes work conducted in one function in an company (e.g. set-up, inspection, rework, operator) and considered to be level three (3) quality system documentation.

Layout Inspection
Layout Inspection is the complete measurement of all part dimensions shown on the design record. A layout inspection may be required by some customers for all products annually unless another frequency is established in a customer approved control plan. Results shall be available for customer review upon request.

Last Off Part Comparison
Last Off Part Comparison is comparing the last part made in a production run with a part from the next production run to verify that the quality level of the new parts is at least as acceptable as that of the previous run.

Match Check
Match Check is a design check and tryout of dimensionally correct parts from production tooling to ensure that they fit together and can be used to build assemblies and vehicles to design specification and intent.

Nonconformance
Nonconformance is product or material which does not conform to the customer requirements or specifications.

Nonconformity
Nonconformity is a process which does not conform to a quality system requirement.

Ongoing Process Capability
Ongoing process capability is a long term measure of statistical process control or process performance. It differs from preliminary process capability by utilizing data from a longer time period so as to include all common causes of variation, in particular, those common causes that may result in process shifts affecting a number of sample intervals. Systematic or repetitive patterns of special cause may also be included if the underlying reasons for these special causes are understood. The time required for ongoing capability evaluation depend on the time required for the sources of variation to vary throughout their full ranges, but will typically be three to six months.

Part Per Million (PPM)
PPM is a way of stating the performance of a process in terms of actual or projected defective material. PPM data can be used to indicate areas variation requiring attention.

Preliminary Process Capability
See Preliminary Process Capability Studies.

Preliminary Process Capability Studies
Preliminary Process Capability Studies are short-term studies conducted to obtain early information on the performance of new or revised processes relative to internal or customer requirements. In many cases, preliminary studies are conducted at several points in the evolution of new processes (e.g., at the equipment or tooling subcontractor's plant, after installation at the supplier's plant) . These studies are based on as many measurements as possible. When X-Bar and R charts, at least twenty subgroups (typically three to five pieces) , are checked to obtain sufficient data for decision making. When this amount of data is not available, control charts are started with whatever data is available.

Procedures
Documented processes that are used when work affects more than one function or department of an organization. Procedures are considered to be level two (2) quality system documentation.

Quality Manual
Quality manual is the supplier's document that describes the elements of the quality system used to assure customer requirements, needs, and expectations are met. Quality manuals shall include responsibilities and authorities for each element of the quality system. The Quality Manual is considered to be level one (1) Quality Systems Documentation.

Quality Planning
Quality Planning is a structured process for defining the methods (i.e., measurements, tests) that will be used in the production of a specific product or family of products (i.e., parts, material) . Quality planning embodies the concepts of defect prevention and continuous improvement as contrasted with defect detection (see Advanced Product Quality Planning and Control Plan reference manual) .

Quality Records
Quality Records are the documented evidence that the supplier's processes were executed according to the quality system documentation (e.g. inspection and test results, internal audit results, calibration data) and records results.

Reaction Plan
A Reaction Plan is the action specified by a Control Plan when nonconforming product of process instability is identified.

Registered Suppliers/Subcontractors
Registered Suppliers/Subcontractors are suppliers/subcontractors who have received third party registration/certificaqtion to a specific quality system standard for the commodity supplied.

Registrar
For this document, a Registrar is a company that conducts quality system assessments to the QS 9000 Quality System Requirements. Chrysler, Ford, and General Motors recognize only those registrars that have been certified by an appropriate national organization such as the Registrar Accreditation Board (RAB) in the United States, National Accreditation Council for Certification Bodies (NACCB) in the United Kingdom, or Dutch Council for Certification (RvC) in the Netherlands.

Repair
Action taken on nonconforming product so that the product will fulfill the intended usage although the product may not conform to the original requirements.

Rework
Action taken on nonconforming product so that it will meet the specified requirement.

Set-up Verification
A recommended method is to produce enough product to constitute a subgroup of the size used for SPC. The parts are measured and the results are entered on the control chart. If these results fall within the central third of the control limit zone, the set-up can be approved for production. If the results fall in the outer two-thrids, the set-up is adjusted and this sequence repeated. If the point falls in the central third, the set-up can be approved for production.

Subcontractors
Subcontractors are defined as providers of production materials, or production or service parts, directly to a supplier to Chrysler, Ford, General Motors or other customers. Also included are providers of heat treating, painting, plating or other finishing services. --COMPANY-- vendors are subcontractors to Chrysler, Ford, General Motors.

Suppliers
Suppliers are defined as provider of: a) production materials, b) production or service parts, or c) heat treating, plating, painting or other finishing services, directly to Chrysler, Ford, General Motors. - --COMPANY-- is a supplier directly to Chrysler, Ford, General Motors.


   

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This page last reviewed or edited: Sun, 2007-02-04 17:05 (Coordinated Universal Time [ZULU] -5 hours)