6 Quality System Assessment- Aiag Manual

Quality SystemAssessment

(QSA)

Second Edition, Second Printing, Issued August, 1998Second Edition, Issued March, 1998First Edition, Issued August, 1994

Copyright © 1998Chrysler Corporation, Ford Motor Company, General Motors Corporation

This Second Printing of the Second Edition makes several formatting changes and revisesQuestion 11.17 to fully align with the QS-9000 Third Edition text.

Quality System Assessment (QSA)First Edition, August, 1994

Second Edition, March, 1998Second Edition, Second Printing, August, 1998

Further copies are obtainable from AIAG at 01-248-358-3003

* * * *In Europe contact Carwin Continuous 44-1708-861333

FOREWORD TO THE SECOND EDITION

The QSA Second Edition is based upon the content of the QS-9000 Third Edition and it iseffective coincident with QS-9000 Third Edition.

The QSA Second Edition incorporates several key changes as follows:

- Incorporates questions covering all “shalls” and “shoulds” from the QS-9000 ThirdEdition. The Quality System Development Checklist published by AIAG, which isreplaced by the QSA Second Edition, has been incorporated. Certain questions addressmultiple QS-9000 requirements as indicated within the ( ) following the question.

- The “variables score” method is now based on a 0 to 10 point score for each element.

- The inclusion of company specific questions.

Acknowledgments for this effort are due the AIAG Sub-Tier Quality Assessment Workgroup andthe Chrysler, Ford, GM Supplier Quality Requirements Task Force, as well as the Task ForceSteering Committee for their guidance and support.

March 1998

i

ii

QUALITY SYSTEM ASSESSMENT

Table of ContentsForeword ....................................................................................................................................................... ii

Purpose ......................................................................................................................................................... 1

Application ................................................................................................................................................... 1

Assessment Process ...................................................................................................................................... 1

Assessment Method ...................................................................................................................................... 1

Audit Summary Alternatives ........................................................................................................................ 2

Definitions .................................................................................................................................................... 2

Evaluation Process for Using Recommended/Not Recommended Method ................................................. 3

Evaluation Process for Using a Variables Score Method.............................................................................. 4

Reporting of Audit Findings ......................................................................................................................... 5

Use of Scores in Sourcing Decisions ............................................................................................................ 5

Process for Second Party Assessment .......................................................................................................... 6

Quality System Assessment Cover Sheet ..................................................................................................... 9

Quality System Assessment Record of Findings ........................................................................................ 10

Quality System Assessment General Comments ........................................................................................ 11

Document Review ...................................................................................................................................... 13

Element 4.1 - Management Responsibility ................................................................................................ 154.1.1 Quality Policy .............................................................................................................................. 154.1.2 Organization ................................................................................................................................ 154.1.3 Management Review ................................................................................................................... 164.1.4 Business Plan .............................................................................................................................. 164.1.5 Analysis and Use of Company Data ............................................................................................ 164.1.6 Customer Satisfaction ................................................................................................................. 17

Element 4.2 - Quality System ..................................................................................................................... 184.2.2 Quality System Procedures ......................................................................................................... 184.2.3 Quality Planning ......................................................................................................................... 184.2.4 Product Approval Process ........................................................................................................... 194.2.5 Continuous Improvement ............................................................................................................ 204.2.6 Facilities and Tooling Management ............................................................................................ 20

Element 4.3 - Contract Review ................................................................................................................... 224.3.2 Review......................................................................................................................................... 224.3.3 Amendment to Contract .............................................................................................................. 224.3.4 Records ....................................................................................................................................... 22

Element 4.4 - Design Control ..................................................................................................................... 234.4.1 General ........................................................................................................................................ 23

iii


Table of Contents (Continued)

iv

4.4.2 Design and Development Planning ............................................................................................. 234.4.3 Organizational and Technical Interfaces ..................................................................................... 234.4.4 Design Input ................................................................................................................................ 234.4.5 Design Output ............................................................................................................................. 244.4.6 Design Review ............................................................................................................................ 244.4.7 Design Verification ..................................................................................................................... 244.4.8 Design Validation ........................................................................................................................ 244.4.9 Design Changes .......................................................................................................................... 244.4.10 Customer Prototype Support ..................................................................................................... 254.4.11 Confidentiality .......................................................................................................................... 25

Element 4.5 - Document and Data Control ................................................................................................ 264.5.1 General ........................................................................................................................................ 264.5.2 Document and Data Approval and Issue ..................................................................................... 264.5.3 Document and Data Changes ...................................................................................................... 26

Element 4.6 - Purchasing ............................................................................................................................ 284.6.1 General ........................................................................................................................................ 284.6.2 Evaluation of Subcontractors ...................................................................................................... 284.6.3 Purchasing Data .......................................................................................................................... 284.6.4 Verification of Purchased Product .............................................................................................. 29

Element 4.7 - Control of Customer Supplied Product ................................................................................ 304.7.1 Customer Owned Tooling ........................................................................................................... 30

Element 4.8 - Product Identification and Traceability................................................................................ 30

Element 4.9 - Process Control .................................................................................................................... 314.9.1 Process Monitoring and Operator Instructions ........................................................................... 324.9.2 Maintaining Process Control ....................................................................................................... 334.9.3 Modified Process Control Requirements .................................................................................... 334.9.4 Verification of Job Setups ........................................................................................................... 334.9.5 Process Changes .......................................................................................................................... 344.9.6 Appearance Items ........................................................................................................................ 34

Element 4.10 - Inspection and Testing ........................................................................................................ 354.10.1 General ...................................................................................................................................... 354.10.2 Receiving Inspection and Testing .............................................................................................. 354.10.3 In-Process Inspection and Testing ............................................................................................. 354.10.4 Final Inspection and Testing ...................................................................................................... 364.10.5 Inspection and Test Records ...................................................................................................... 364.10.6 Supplier Laboratory Requirements ........................................................................................... 364.10.7 Accredited Laboratories ............................................................................................................ 37

Element 4.11 - Inspection, Measuring and Test Equipment ....................................................................... 384.11.1 General ...................................................................................................................................... 384.11.2 Control Procedure ..................................................................................................................... 38

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Table of Contents (Continued)

4.11.3 Inspection, Measuring and Test Equipment Records ................................................................ 404.11.4 Measuring System Analysis ...................................................................................................... 40

Element 4.12 - Inspection and Test Status .................................................................................................. 414.12.1 Supplemental Verification ......................................................................................................... 41

Element 4.13 - Control of Nonconforming Product ................................................................................... 424.13.1 General ...................................................................................................................................... 424.13.2 Review and Disposition of Nonconforming Product ................................................................ 424.13.3 Control of Reworked Product ................................................................................................... 424.13.4 Engineering Approval Product Authorization ........................................................................... 43

Element 4.14 - Corrective and Preventative Action.................................................................................... 444.14.1 - General .................................................................................................................................... 444.14.2 Corrective Action ...................................................................................................................... 444.13.3 Preventative Action ................................................................................................................... 45

Element 4.15 - Handling, Storage, Packaging, Preservation and Delivery ................................................ 464.15.2 Handling .................................................................................................................................... 464.15.3 Storage ...................................................................................................................................... 464.15.4 Packaging .................................................................................................................................. 464.15.5 Preservation ............................................................................................................................... 464.15.6 Delivery ..................................................................................................................................... 46

Element 4.16 - Control of Quality Records ................................................................................................ 484.16.1 Record Retention ...................................................................................................................... 48

Element 4.17 - Internal Quality Audits ....................................................................................................... 494.17.1 Internal Audit Schedules ........................................................................................................... 49

Element 4.18 - Training .............................................................................................................................. 504.18.1 Training Effectiveness ............................................................................................................... 50

Element 4.19 - Servicing ............................................................................................................................ 514.19.1 Feedback of Information from Service ..................................................................................... 51

Element 4.20 - Statistical Techniques ......................................................................................................... 524.20.1 Identification of Need ............................................................................................................... 524.20.2 Procedures ................................................................................................................................. 524.20.3 Selection of Statistical Tools ..................................................................................................... 524.20.4 Knowledge of Basic Statistical Concepts ................................................................................. 52

Chrysler Specific ........................................................................................................................................ 53

Ford Specific .............................................................................................................................................. 55

General Motors Specific ............................................................................................................................. 56

This Quality System Assessment (QSA) is used todetermine conformance to the Quality SystemRequirements QS-9000. Proper use of the QSA willensure that all requirements are addressed andpromote consistency between activities andpersonnel determining QS-9000 conformance.

The QSA may be used in several different waysaccording to the needs of the customer and supplier:

- first party - supplier self-assessment of itsquality system , at a minimum the (*) and (**)questions.

- second party - customer assessment ofsupplier quality system (includes first tiersupplier assessment of subcontractors), allquestions or a subset. Certain customers will,as a minimum, use the questions marked witha double asterisk (**) for this purpose.

- third party - by a quality systems certificationbody/registrar as input to an audit checklist, ata minimum the (*) and (**) questions.

The QSA process is def ined in Appendix A ofQS-9000. The order of the questions in theQSA does not imply the audit sequence.

The assessment method is composed of three majorphases:

Phase I - Quality System Documentation ReviewThis review determines if the quality manual (andsupporting documentation as required) meets allrequirements of QS-9000. Use Question 0.1,Document Review of the QSA.

Phase II - On-site Audit This phase determines thedegree and effectiveness of the implementation of thequality system at the supplier’s site and remotelocations.


GENERAL ASSESSMENT INSTRUCTIONSAND GUIDELINES

Purpose

Application

Assessment Process

Assessment Method

1

Phase III - Analysis and Report A review of thefindings of the first two phases is used to determinesupplier conformance to QS-9000.

The auditor/customer will determine which of twoalternatives will be used to summarize audit findings:

- Recommended/not recommended- Variable score

Each of the elements may be classified in one of twoways, depending on the customer’s requirements:

- As a “conforms” or “minor/majornonconformance” status for that element.

- As a 0 to 10 point rating for the element, seeEvaluation Process for Using a Variables ScoreMethod.

A MAJOR NONCONFORMITY is either:

- The absence or total breakdown of a system tomeet a QS-9000 requirement. A number ofminor nonconformities against onerequirement which when combined canrepresent a total breakdown of the system andthus be considered a major nonconformity.

- Any noncompliance that would result in theprobable shipment of a nonconformingproduct. A condition that may result in thefailure or materially reduce the usability of theproducts or services for their intended purpose

- A noncompliance that judgment andexperience indicate is likely either to result inthe failure of the quality system or tomaterially reduce its ability to assurecontrolled processes and products.

A MINOR NONCONFORMITY is a QS-9000noncompliance that judgment and experience indicateis not likely to :

- result in the failure of the quality system, or- reduce its ability to assure controlled

processes, or- result in the probable shipment of

nonconforming product.

Audit SummaryAlternatives

Definitions

2

It may be either:

- a failure in some part of the supplier’sdocumented quality system relative toQS-9000, or

- one or more observed lapse(s) in following arequirement of the company’s quality system.

OPPORTUNITY FOR IMPROVEMENT - anobserved situation which is NOT a major or minornonconformity, but where results achieved, basedupon the auditor’s judgment and experience in thatcommodity, are not optimal. These opportunitiesshall be recorded in the final audit report for thebenefit of the customer.

CONFORMS - no major or minor nonconformitieswere noted in the audit.

ADEQUACY - as used in this document means thatthe specific supplier documentation meets QS-9000intent given the scope of the supplier’s operations.

In support of continuous improvement, the auditorshould identify quality system strengths, weaknessesand shall record opportunities for improvement.

An overall evaluation of “recommended” will begiven when the audit does not identify anynonconformities.

An “open” status exists under the followingconditions:

- a major nonconformity is noted in the audit, or- one or more minor nonconformity(ies) are

noted in the audit

This can be converted to a “recommended” withinninety days, or otherwise agreed to time frame, withacceptance of satisfactory evidence of conformity.On-site verif ication is at the discretion of theauditor(s). An overall evaluation of “notrecommended” will be given if the audit processidentifies more than one major nonconformity. Lackof nonconformity resolution within the specifiedtime frame will also result in a “not recommended”evaluation.

Evaluation Process forUsing Recommended/NotRecommended Method:

3

Evaluation Process for Usinga Variables Score Method:

Supplier is not familiar with the requirements of the element and has norelevant source documentation (flow charts, forecasts, plans, procedures,strategies, etc.) in this area.

Supplier is familiar with the requirements of the element but there is noevidence of source documentation, planning or implementation.

Supplier is familiar with requirements of the element and has preliminarysource documentation with incomplete plans for implementation.

Source documentation is available. Implementation (with assignedresponsibilities) has just started, (0 - 30% complete).

Source documentation is available and implementation is in progress (30 -60% complete). Deficiencies have been identified but improvements are notquantifiable.

Implementation has progressed (60 - 80% complete) and there is preliminaryevidence of relevant results.

Implementation is nearly complete (80 - 95%) and documented evidence ofimplementation effectiveness exists.

Full implementation of source documentation for the requirement andcomplete confirmed evidence of implementation effectiveness. The supplierhas met minimum requirements.

Analysis of results and on-going continuous improvement can bedemonstrated in key areas linked to customer satisfaction.

Supplier has reached world class performance and is able to show growthbeyond QS-9000 requirements and continuous improvement in all areas.

Supplier is best-in-class and is able to demonstrate significant innovation innew ways to show relevant results beyond the customer requirements. Thesupplier sets the industry benchmark.

Description Score

Within each element the result (0 to 10) is marked in the appropriate row on the Recordof Findings page. Final score is obtained by adding the point score column and dividingby the number of scored elements. TO BE RECOMMENDED A MINIMUM SCOREOF SEVEN IS REQUIRED ON EVERY APPLICABLE ELEMENT.

0

1

2

3

4

5

6

7

8

9

10

4

ELEMENTS NOT APPLICABLE TO APARTICULAR SUPPLIER

Certain elements such as 4.7 (Control of CustomerSupplied Product) and 4.19 (Servicing) will not applyto every supplier. In such cases, “N/A” is entered inplace of the score.

Where conformance to QS-9000 is demonstrated butdefinite opportunities for continuous improvementexist, these should be identified.

For first or second party audits only, the auditorshould identify quality system strengths andweaknesses.

Regardless of the scoring method each customer’spurchasing activity will establish their own policy forusing assessment results in sourcing decisions.

5

Reporting of AuditFindings

Use of Scores in SourcingDecisions

Evaluation Process...Variables Score Method(Continued)

6

To promote optimum use of resources, the manualand other requested materials should be provided tothe customer at least two weeks prior to the on-siteaudit. Also, the supplier will typically be asked toprovide:- a self-assessment as requested by the customer- plans, if any, for third party quality systems

registration- audits, if any, by other customers using the

QSA.

The customer reviews the materials provided by thesupplier for adequacy in meeting QS-9000 perQuestion 0.1 of the QSA. If requirements areidentified that go beyond QS-9000, they should benoted for inclusion in the audit checklist. Anyinadequacies found should be clearly defined andcommunicated to the supplier.

The customer advises the supplier of any revisionsrequired in the quality system documentation to meetQS-9000. Normally, the on-site audit will be delayedpending satisfactory resolution of the inadequacies.

The supplier revises the quality systemdocumentation as necessary.

The checklist for the on-site audit is the QSA plus anyadditional questions identified in the documentationreview. Additional space is provided in the QSA forsuch questions.

Process for Second Party Assessment

1. Supplier provides requestedmaterials [e.g. quality manual,procedures (level twodocumentation)] to customer.

2. Documentation Review.

3. Documentation OK?

4. Supplier makes necessaryrevisions.

5. Customer prepares AuditChecklist.

7


1Supplier provides

requestedmaterials

2DOCUMENT

REVIEW

3Documentation

OK?

5Customerprepares

auditchecklist

4Supplier makes

necessaryrevisions

6Customer

conducts on-siteaudit

7Customeridentifies

nonconformities

8Suppliercorrects

nonconformities;forwards

documentation

10Satisfactory

completion ofaudit

9Documentation

satisfactory? NOYES

The customer uses the checklist to evaluate thesupplier’s operations. This audit shall be conducted atsupplier sites and remote locations as applicable(Engineering, Purchasing, Etc.).

If there are multiple operations (production lines,stamping presses, etc.) within a plant that areessentially identical, the customer may audit these ona sampling basis. Significant observations should becommunicated immediately to the supplier. Somecustomers may conduct an audit using the questionsmarked with an asterisk (**) to evaluate potentialsuppliers.

All nonconformities found must be included in thesummary report. Some customers will also providethe detailed checklist.

If the supplier can correct minor nonconformitiesduring the course of the audit, such corrections willbe noted in the report. For other nonconformities, thesupplier will determine a date by which the correctiveaction will be complete. The supplier will advise thecustomer when the corrective action(s) arecompleted.

Based on the nature of the nonconformities, thecustomer will verify the effectiveness of thecorrective actions on-site and/or via documentationreview.

Customer provides final audit result to supplier (e.g.,recommended/not recommended).


6. Customer conducts on-site audit.

7. Customer identifies any

nonconformities.

8. Supplier corrects nonconformities

(and advises customer).

9. Customer verification.

10.Customer advises supplier of

audit result.

8

9

QUALITY SYSTEM ASSESSMENTCOVER SHEET

Supplier:

Facility Address:

Supplier Code: Audit Date:

Scope of Audit:

Products/Lines Audited:

Reason For Audit:

Audit Type: Initial Surveillance Follow-up Other

Audit Results: Recommended Open Not Recommended

Score, If Applicable

Follow-up Required: Yes No Date:

Comments:

Auditor Name Phone

Question ConformsNonconformities

Minor Major

Point Score

(if applicable)

Documentation Review

4.1 Management Responsibility

4.2 Quality System

4.3 Contract Review

4.4 Design Control

4.5 Document and Data Control

4.6 Purchasing

4.7 Control of Customer Supplied Product

4.8 Product Identification and Traceability

4.9 Process Control

4.10 Inspection and Testing

4.11 Inspection, Measuring, & Test Equipment

4.12 Inspection and Test Status

4.13 Control of Nonconforming Product

4.14 Corrective and Preventive Action

4.15 Handling, Storage, Packaging, Preservation, & Delivery

4.16 Control of Quality Records

4.17 Internal Quality Audits

4.18 Training

4.19 Servicing

4.20 Statistical Techniques

Customer-specific (if applicable)

Target date for correction of all nonconformities: _________________________

Point Score Calculation (if applicable)

Final score is obtained by adding the point score column and dividing by the number of scored elements.

TOTALS:

10

QUALITY SYSTEM ASSESSMENTRECORD OF FINDINGS

QUALITY SYSTEM ASSESSMENTGENERAL COMMENTS

CommentsElement No.

11

QUALITY SYSTEM ASSESSMENTGENERAL COMMENTS

CommentsElement No.

12

Question Assessor Notes - Implementation evidence

DOCUMENT REVIEW(Note: This is the basic documentation review for the audit.)

0.1 ** Has a quality manual covering therequirements of QS-9000 beenprepared? Does the quality manualinclude or make reference to qualitysystem procedures and outline thestructure of the documentation used inthe quality system? (4.2.1)

- Management Responsibility- Quality policy- Organization- Management Representative- Management Review- Business Plan- Customer Satisfaction

- Quality Planning- Cross Functional Teams- Feasibility Reviews- Control Plans- Process FMEAs- Contract Review- Design Control (as applicable)- Design Review- Design Verification- Design Validation- Design Changes

- Production Part Approval

- Continuous Improvement

- Facilities and Tooling Management

- Document and Data Control- Document Changes

- Purchasing- Subcontractor evaluation

- Control of Customer SuppliedProduct

- Product Identification and Traceability

- Process Control- Process Monitoring- Process Capability/Performance- Verification of Setups- Process Changes

- Planned Preventive Maintenance- Predictive Maintenance

- Inspection and Testing- Appearance Item Inspection

(if applicable)- Lab Accreditation (if required)

- Inspection, Measuring & TestEquipment- Measurement System Analysis

- Inspection and Test Status

- Control of Nonconforming Product- Control of Reworked Product- Eng. Approved Product Authorization

13

DOCUMENT REVIEW(Note: This is the basic documentation review for the audit.)

- Corrective and Preventive Actions

- Handling, Storage Packaging,

Preservation & Delivery

- Control of Quality records

- Internal Quality Audits

- Training

- Servicing

- Statistical Techniques

- Applicable Customer Specific

Requirements


14

15


ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY

4.1.1 Quality Policy

1.1 Has the supplier’s management withexecutive responsibility defined anddocumented its quality policy, objectivesfor quality, and its commitment toquality? (4.1.1)

1.2 Is the quality policy relevant toorganizational goals and theexpectations and needs of the customer?

(4.1.1)1.3 * Is the quality policy implemented,

understood and maintained throughoutthe organization? (4.1.1)

4.1.2 Organization

1.4 ** Has the responsibility, authority,interrelationship of personnel whomanage, perform, and verify workaffecting quality been defined anddocumented? (4.1.2.1)

1.5 Is authority delegated to personnel whohave the organizational freedom to:- Prevent nonconformity occurrence?- Identify & record quality problems?- Initiate, implement & verify

corrective action?- Control further processing?- Represent the needs of the customer

in internal functions? (4.1.2.1)

1.6 Has the supplier identified the resourcerequirements, and provided adequateresources including the assignment oftrained personnel for management,performance of work and verificationactivities, including internal audits?

(4.1.2.2)

1.7 * Is there a clearly identified managementrepresentative with authority andresponsibility to ensure QS-9000compliance, and to report on theperformance of the quality system?

(4.1.2.3)

1.8 Does the supplier have a system in placeto ensure management of appropriateactivities during concept development,prototype and production, (see APQPmanual)? (4.1.2.4)

ELEMENT ASSESSOR NOTES RESULTS

4.1 - ManagementResponsibility


ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)

1.9 Does the supplier use a multi-disciplinary approach for decisionmaking? (4.1.2.4)

1.10 Does the supplier have the ability tocommunicate necessary informationand data in the customer prescribedformat? (4.1.2.4)

1.11 Is management with responsibility andauthority for corrective action promptlyinformed of products or processes thatbecome non-compliant with specifiedrequirements? (4.1.2.5)

4.1.3 Management Review

1.12 ** Does the supplier’s management withexecutive responsibility review all qualitysystem elements at defined intervals toinsure its continuing suitability andeffectiveness? (4.1.3;4.1.3.1; 4.16)

4.1.4 Business Plan

1.13 ** Does the supplier utilize a formal,documented, comprehensive businessplan that includes short-term and longer-term goals and plan(s)? (4.1.4)

1.14 Is the business plan under documentcontrol? (4.1.4)

1.15 Are goals and plans based on analysis ofcompetitive products and benchmarkinginside and outside the automotiveindustry? (4.1.4)

1.16 * Are there methods in place to determinecurrent and future customerexpectations? (4.1.4)

1.17 Does the supplier have an objectiveprocess that def ines the scope andcollection of information (customerexpectations and customer satisfaction),frequency and methods of collection?

(4.1.4; 4.1.6)

1.18 * Are there documented methods to track,update, revise and review the businessplan to ensure it is communicated andfollowed throughout the organization, asappropriate? (4.1.4)

4.1.5 Analysis and Use of Company Level Data

1.19 Does the supplier document trends in thequality, operational performance, andcurrent quality levels for key product andservice features? (4.1.5)

16


ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)

ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

17

1.20 ** Are trends in data and informationcompared with:- competitors- appropriate benchmarks- progress toward business objectives,

to lead to appropriate action tosupport:• developing priorities for resolving

customer problems• determination of key customer-

related trends? (4.1.5)

4.1.6 Customer Satisfaction

1.21 * Is there a documented process tomeasure customer satisfaction thatincludes frequency of determination, andhow objectivity and validity are assured?

(4.1.6)

1.22 Are trends in customer satisfaction andkey indicators of customer dissatisfactiondocumented, supported by objectiveinformation, and reviewed by seniormanagement? (4.1.6)

1.23 * Is there evidence the supplier notifieswithin 5 working days the certificationbody/registrar when a customer placesthe site in any status listed in QS-9000?

(4.1.6.1)


4.2.2 Quality System Procedures

2.1 ** Are there adequate supportingprocedures (Level 2) for each element ofthe quality manual? (4.2.2)

4.2.3 Quality Planning

2.2 ** Is the quality planning process consistentwith all other requirements of the qualitysystem, documented in a suitable format,and does it consider as appropriate theelements of the quality system thataddress:- Identification and acquisition of all

inspection & production/serviceresources?

- Conducting design and processfeasibility studies?

- Updating and maintenance of allquality control and inspectionmethodology?

- Identification of suitable verificationat appropriate stages?

- Production, installation and servicingprocesses which directly affect quality

- Preparation of control plans andFMEAs?

- Review of standards andspecifications? (4.2.3)

2.3 * Is there evidence of an implementedadvanced product quality planningprocess? (4.2.3.1; 4.2.3.2)

2.4 Does the supplier convene multi-disciplinary teams for the production ofnew or changed products, that useappropriate techniques as listed in theAdvanced Product Quality Planing andControl Plan reference manual? (4.2.3.1)

2.5 When required by the customer, are theprocess steps that affect SpecialCharacteristics in process controlguidelines and similar documentsmarked with the customer’s specialcharacteristic symbol? (4.2.3.2)

2.6 ** Is manufacturing feasibility investigated,conf irmed, and documented, (TeamFeasibility Commitment form) prior tocontracting proposed products? (4.2.3.3)

18

ELEMENT 4.2 - QUALITY SYSTEM


4.2 - Quality System


ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)

2.7 Do the supplier’s design control andprocess control policies and practicesconsider as appropriate due care andproduct safety? (4.2.3.4)

2.8 * Does the supplier promote internalawareness of safety considerations?

(4.2.3.4)

2.9 * Do process FMEAs consider all SpecialCharacteristics? (4.2.3.5)

2.10 Is there evidence of efforts to achievedefect prevention versus detection, usingPFMEA information? (4.2.3.5)

2.11 ** Are mistake proofing techniques utilizedwhere appropriate, which include but arenot limited to planning of process,facilities, equipment and tooling, and inproblem resolution?

(4.2.3.6; 4.10.3; 4.14.1.2)

2.12 * Are control plans developed by multi-disciplinary approach to the system,subsystem, component, and/or materiallevel, and list all controls used forprocess control? (4.2.3.7)

2.13 * Does the control plan include theinformation required in the ControlPlan form in QS-9000 Appendix J?

(4.2.3.7)

2.14 ** Do control plans cover three phases:prototype, pre-launch, and production, asrequired by the customer? (4.2.3.7)

2.15 ** Are control plans reviewed and updatedas appropriate when any of the followingoccurs:- product or process changes- processes are found to be unstable or

non-capable- inspection method, frequency, etc. is

revised? (4.2.3.7)

4.2.4 Product Approval Process

2.16 * Does the supplier fully comply with allrequirements set forth in the PPAPmanual? (4.2.4.1)

2.17 * Does the supplier utilize a part approvalprocess for subcontractors? (4.2.4.2)

2.18 * Is there evidence that product changesare properly validated? (4.2.4.3)

19



20

4.2.5 Continuous Improvement

2.19 ** Is there evidence of continuousimprovement in quality (extending toproduct characteristics), service (timingand delivery) and price, that benefit allcustomers? (4.2.5.1; 4.1.6)

2.20 Does continuous improvement extendto product characteristics with thehighest priori ty on specialcharacteristics? (4.2.5.1)

2.21 Does the supplier have a prioritizedaction plan for continuous improvementin processes that have demonstratedstability, acceptable capability andperformance? (4.2.5.1)

2.22 * Has the supplier identified opportunitiesand implemented appropriate projects forquality and productivity improvement?

(4.2.5.2)

2.23 Has the supplier demonstratedknowledge and used appropriatecontinuous improvement measures andmethodologies? (4.2.5.3)

4.2.6 Facilities and Tooling Management

2.24 Is a multi-disciplinary approach usedfor developing facilities, equipment,and process planning in conjunctionwith the advanced quality planningprocess? (4.2.6.1; 4.2.3.7)

2.25 ** Does the plant layout minimize materialtravel and handling, facilitatesynchronous material flow, andmaximize value-added use of floorspace? (4.2.6.1)

2.26 Are methods developed for evaluatingthe effectiveness of existing operationsand processes which consider the overallwork plan, appropriate automation,ergonomics and human factors, operatorand line balance, storage and bufferinventory levels, and value added laborcontent? (4.2.6.1)

2.27* Has the supplier established andimplemented a system for toolmanagement that includes maintenanceand repair facilities and personnel,storage and recovery, set-up, and toolchange programs for perishable tools,tool modification including tool designmodification? (4.2.6.2)



21

2.28 Are appropriate technical resourcesavailable for tool and gage design,fabrication and full dimensionalinspection? (4.2.6.2)

2.29 * If tooling activities are subcontracted,i s the re a sys tem to t r ack andfollow-up these activities? (4.2.6.2)



4.3.2 Review

3.1 * Does the supplier review a tender,contract or order to ensure that therequirements are understood and can bemet, and if any misunderstanding arisesthat the differences are resolved prior tocontract or order acceptance? (4.3.2)

3.2 * Are customer specif ic contractrequirements, including those in QS-9000, Section II deployed to thefunctions concerned and fully met?

(4.3.2; 4.12.1)

4.3.3 Amendment to Contract

3.3 * Are there provisions to document anddeploy contract amendments to thefunctions concerned? (4.3.3)

4.3.4 Records

3.4 ** Are records of contract reviewsmaintained? (4.3.4; 4.16)


22

ELEMENT 4.3 - CONTRACT REVIEW


4.3 - Contract Review


23

4.4.1 General

4.1 Is there a process to deploy informationgained from previous design projects tocurrent and future ones of similarnature? (4.4.1.1)

4.4.2 Design and Development Planning

4.2 * Have design plans for each project beenestablished and responsibility assigned?

(4.4.2)

4.3 Are plans updated as the design evolves?(4.4.2)

4.4 * Are responsible personnel qualified inthe “Required Skills” and equipped withadequate resources as appropriate?

(4.4.2.1; 4.18)

4.4.3 Organizational and Technical Interfaces

4.5 Are the organizational interfacesbetween groups defined and is thereevidence of the necessary informationbeing documented, transmitted andregularly reviewed? (4.4.3)

4.4.4 Design Input

4.6 * Are design input requirements includingthe applicable statutory and regulatoryrequirements identified, documented andreviewed? (4.4.4;. 4.3)

4.7 Are incomplete, ambiguous orconflicting requirements resolved?

(4.4.4; 4.3)

4.8 ** Do the following exist, if not waived bythe customer:- Appropriate resources and facilities

available to use computer aideddesign, engineering and analysis?

- If CAD/CAE is subcontracted, hasthe supplier provided technicalleadership?

- Are CAD/CAE systems capable oftwo way interface with customersystems? (4.4.4.1)

ELEMENT 4.4 - DESIGN CONTROL


4.4 - Design Control

24


ELEMENT 4.4 - DESIGN CONTROL (CONTINUED)

4.4.5 Design Output

4.9 * Has the design output been documentedand expressed in terms that can beverified and validated against designinput requirements:- Meet the design input requirements?- Contain or reference acceptance

criteria?- Identify Special Characteristics?- Include a review of design output

documents before release (4.4.5)

4.10 * Was the design output a result of aprocess that included:- efforts to simplify, optimize,

innovate, and reduce waste ?- GDT (as applicable)?- analysis of cost/performance/risk

trade offs?- feedback from testing, production

and the field?- analysis of design failure mode and

effects (DFMEA)? (4.4.5.1)

4.4.6 Design Review

4.11 ** Are there records of formal documenteddesign reviews by the appropriatefunctions conducted at appropriatestages of design per the design plan?

(4.4.6; 4.16)

4.4.7 Design Verification

4.12 Are there records to demonstrate thatdesign verification has been performedto ensure that design output meets designinput requirements. (4.4.7; 4.16)

4.4.8 Design Validation

4.13 Has design validation been performed toensure that product conforms to defineduser needs and/or requirements? (4.4.8)

4.14 * Is design validation performed inconjunction with the customer timingrequirements? (4.4.8.1)

4.15 Are there records for design validation,and do they include design failures?

(4.4.8.1; 4.16)

4.16 * Are design failures addressed throughthe designated corrective and preventiveaction procedures? (4.4.8.1)

4.4.9 Design Changes

4.17 * Are design changes identif ied,documented, reviewed and approved byauthorized personnel beforeimplementation? (4.4.9)

4.18 * Has written customer approval or waiverbeen obtained prior to a design changebeing implemented into production?

(4.4.9.1)

4.19 For proprietary designs, does thesupplier evaluate with the customer theimpact of the design change on form, fit,function, performance and/or durability?

(4.4.9.1)

4.20 * Does the supplier consider the impact ofdesign changes on the system in whichthe product is used? (4.4.9.2)

4.4.10 Customer Prototype Support

4.21 ** When required by the customer, does thesupplier have a comprehensive prototypeprogram ? (4.4.10)

4.22 Wherever possible, are thesubcontractor’s tooling and process forprototype the same as the ones that willbe used in production? (4.4.10)

4.23 ** Is the performance testing (that considersand includes as appropriate life,durability, reliability) tracked for timelycompletion and conformance? (4.4.10)

4.24 If design verification services have beensubcontracted has the supplier providedtechnical leadership? (4.4.10)

4.4.11 Confidentiality

4.25 Does the supplier ensure confidentialityof customer contracted product underdevelopment, and related productinformation? (4.4.11)

25


ELEMENT 4.4 - DESIGN CONTROL (CONTINUED)



4.5.1 General

5.1 Are documents of external origin underdocument control? (4.5.1)

4.5.2 Document and Data Approval and Issue

5.2 ** Are documents and data reviewed andapproved by authorized personnel priorto issue? (4.5.2)

5.3 ** Is there a master list (or equivalent)identifying document revision statusreadily available? (4.5.2)

5.4 * Has the supplier established a process toensure that pertinent issues ofappropriate documents are available atall locations where operations essentialto the effective functioning of the qualitysystem are performed? (4.5.2.a)

5.5 Has the supplier established a process toensure that invalid and/or obsoletedocuments are promptly removed fromall points of use, or otherwise assuredagainst unintended use? (4.5.2.b)

5.6 Are obsolete documents retained forlegal and/or knowledge base purposessuitably identified? (4.5.2.c)

5.7 * Is there timely review, distribution andimplementation of customer engineeringstandards/specifications and changes?

(4.5.2.1)

5.8 * Does the supplier maintain a record ofthe date on which engineering changesare implemented in production?

(4.5.2.1; 4.16)

5.9 Does implementation of changes includeupdates to all appropriate documents?

(4.5.2.1)

4.5.3 Document and Data Changes

5.10 Are changes in documents and datareviewed and approved by the samefunctions/organizations that originallyperformed the review and approval,(unless specif ically designatedotherwise)? (4.5.3)

26

ELEMENT 4.5 - DOCUMENT AND DATA CONTROL


4.5 - Document and DataControl

5.11 Do the designated functions ororganizations have access to pertinentbackground information upon which tobase the review and approval? (4.5.3)

5.12 Are all changes in documents identifiedeither in the document or inattachments? (4.5.3)


ELEMENT 4.5 - DOCUMENT AND DATA CONTROL (CONTINUED)

27



28

ELEMENT 4.6 - PURCHASING


4.6 - Purchasing

4.6.1 General

6.1 Where there is a customer-approvedsubcontractor list, is it used by thesupplier as required? (4.6.1.1)

6.2 Do all purchased materials used in partmanufacture conform to all applicablegovernmental, safety and environmentalregulations as they apply to the countryof manufacture and sale? (4.6.1.2)

4.6.2 Evaluation of Subcontractors

6.3 ** Are subcontractors evaluated andselected based on their ability to meetquality system and quality assurancerequirements? (4.6.2.a)

6.4 ** Does the supplier define the appropriatetype and extent of control oversubcontractors? (4.6.2.b)

6.5 ** Are quality records (4.16) of acceptablesubcontractors established andmaintained? (4.6.2.c)

6.6 * Is subcontractor quality systemdevelopment being conducted using theQS-9000, Section I as the fundamentalquality system requirement with thegoal of subcontractor compliance toQS-9000? (4.6.2.1)

6.7 ** Is 100% on time delivery a requirementof the subcontractors? (4.6.2.2)

6.8 * Is there appropriate planning informationand purchasing commitments, providedby the supplier, to enable thesubcontractors to meet the required100% on-time delivery? (4.6.2.2)

6.9 * Is there evidence of a system to monitorthe delivery performance ofsubcontractors, including all premiumfreight and evidence of appropriatecorrective action? (4.6.2.2)

4.6.3 Purchasing Data

6.10 * Do the purchasing documents containdata clearly describing the product orservice being ordered? (4.6.3)


ELEMENT 4.6 - PURCHASING (CONTINUED)


6.11 Is there evidence of supplier reviewand approval of purchasing documentsfor adequacy to the specif iedrequirements prior to release? (4.6.3)

4.6.4 Verification of Purchased Product

6.12 When applicable, do purchasingdocuments specify verificationarrangements and method of productrelease for purchased product at thesubcontractor’s premises? (4.6.4.1)

6.13 Where specified in the contract (4.3), isthe customer (or their designatedrepresentative) afforded the right toverify product conformance to therequirements at the supplier’s/subcontractor’s premises? (4.6.4.2)

29





8.1 * Is product identification maintainedthrough all stages of production, deliveryand installation? (4.8)

8.2 ** Is traceability maintained and recordedwhen required by the customer?

(4.8; 4.16)

30

ELEMENT 4.7 - CONTROL OF CUSTOMER SUPPLIED PRODUCT

ELEMENT 4.8 - PRODUCT IDENTIFICATION AND TRACEABILITY


4.7 - Control of CustomerSupplied Product


4.8 - Product Identificationand Traceability

7.1 Is there evidence that product that is lost,damaged or otherwise unsuitable for useis recorded and reported to thecustomer? (4.7; 4.16)

4.7.1 Customer Owned Tooling

7.2 * Are customer-owned tools andequipment permanently marked so thatownership of each item is visuallyapparent? (4.7.1)

9.1 * Do controlled conditions includedocumented procedures defining themanner of production, installation andservicing, where their absence couldadversely affect quality? (4.9.a)

9.2 ** Do controlled conditions include use ofsuitable production, installation andservicing equipment, and suitableworking environment including but notlimited to maintaining premises in astate of order, cleanliness and repair?

(4.9.b; 4.9.b.1; 4.10.6.4)

9.3 * Does the supplier have contingencyplans to reasonably protect thecustomer’s supply of product in the eventof emergency? (4.9.b.2)

9.4 Do controlled conditions includecompliance with reference standards/codes, quality plans and/or documentedprocedures? (4.9.c)

9.5 * Do controlled conditions include themonitoring and control of suitableprocess parameters and productcharacteristics, including designationand documentation of SpecialCharacteristics? (4.9.d; 4.9.d.1)

9.6 Do controlled conditions include theapproval of processes and equipment, asappropriate? (4.9.e)

9.7 Do controlled conditions include criteriafor workmanship stipulated in theclearest practical manner? (4.9.f)

9.8 Do controlled conditions include suitablemaintenance of equipment to ensurecontinuing process capability? (4.9.g)


31

ELEMENT 4.9 - PROCESS CONTROL


4.9 - Process Control

9.9 ** Is there an effective planned preventivemaintenance system that identifies keyprocess equipment, provides appropriateresources, and includes at a minimum:- A procedure describing planned

maintenance activities?- Scheduled maintenance activities?- Predictive maintenance methods?- A procedure providing for packaging

and preservation of equipment,tooling and gaging?

- Availability of replacement parts forkey manufacturing equipment?

- Documenting, evaluating andimproving maintenance objectives?

(4.9.g.1)

9.10 * Are qualif ied operators and/orcontinuous monitoring and processcontrol used where the results of theprocesses cannot fully be verified bysubsequent inspection and testing? (4.9)

9.11 Are qualif ication requirements forspecial process operations andassociated equipment and personnelspecified and are records maintained?

(4.9; 4.16; 4.18)


ELEMENT 4.9 - PROCESS CONTROL (CONTINUED)

4.9.1 Process Monitoring and Operator Instructions

9.12 ** Have documented process monitoringand operator instructions derived fromthe sources listed in the AdvancedProduct Quality Planning and ControlPlan reference manual, or equivalentsources, been prepared for all employeeshaving responsibilities for operation ofprocesses and are they accessible at theworkstation? (4.9.1)

32


ELEMENT 4.9 - PROCESS CONTROL (CONTINUED)

33

9.13 ** Do process monitoring and operatorinstructions include or reference, asappropriate:- Operation name and number keyed to

process flow diagram?- Part name and part number?- Current engineering level/date?- Required tools, gages and other

equipment?- Material identif ication and

disposition instructions?- Customer and supplier designated

Special Characteristics?- SPC requirements?- Relevant engineering and

manufacturing standards?- Inspections and test instructions?- Reaction plan- Revision date and approvals?- Visual aids?- Tool change intervals and set-up

instructions? (4.9.1; 4.9.4)

4.9.2 Maintaining Process Control

9.14 ** Does the supplier maintain or exceed theprocess capability or performance asapproved by PPAP through theimplementation and adherence to theControl Plan, Process Flow Diagram,measurement technique, sampling plans,and reaction plans when acceptancecriteria is not met? (4.9.2; 4.10.1)

9.15 ** Are significant process events recorded,(on the control charts)? (4.9.2)

9.16 * Does the supplier initiate the appropriatereaction plan for unstable or non-capablecharacteristics (identified on the ControlPlan), and is it supported by appropriaterecords? (4.9.2)

9.17 * Does the reaction plan include asappropriate:- containment and 100% inspection?- specific corrective action timing?- responsibility assignment?- customer approval? (4.9.2)

4.9.3 Modified Process Control Requirements

9.18 Are control plans annotated accordinglywhen the customer requires differentcapability or performance? (4.9.3)

4.9.4 Verification of Job Setups

9.19 * Does the supplier verify job setups, usingstatistical methods where applicable?

(4.9.4)

34

ELEMENT 4.9 - PROCESS CONTROL (CONTINUED)4.9.5 Process Changes

9.20 * Does the supplier maintain record(s) ofprocess change effective dates?

(4.9.5; 4.5.3)

4.9.6 Appearance Items

9.21 * For customer designated appearanceitems:- Is there appropriate lighting for the

evaluation area(s)?- Are all appropriate masters available?- Are the masters and evaluation

equipment adequately maintained andcontrolled?

- Is there verif ication that personnelmaking appearance evaluation arequalified? (4.9.6; 4.1.2.2)


4.10.1 General

10.1 * For attribute data with acceptancecriteria other than zero defects, does thesupplier document acceptance criteriaand have customer approval? (4.10.1.1)

4.10.2 Receiving Inspection and Testing

10.2 ** Does the supplier ensure that incomingproduct is not used or processed (exceptfor urgent production purposes), until ithas been inspected or otherwise verifiedas conforming to specified requirementsin accordance with the quality planand/or documented procedures?

(4.10.2.1)

10.3 Is the amount and nature of receivinginspection based on the control exercisedat the subcontractor’s premises andrecords of conformance? (4.10.2.2)

10.4 ** Is positive identification provided andrecorded for material used in productionbut not verified? (4.10.2.3; 4.16)

10.5 * Does the supplier incoming qualitysystem use one or more of the followingmethods:- Receipt and evaluation of statistical

data by supplier?- Receiving inspection and/or testing?- Second or third party assessments or

audits of subcontractor sites whencoupled with records of acceptableperformance?

- Evaluations by accreditedlaboratories? (4.10.2.4)

4.10.3 In-process Inspection and Testing

10.6 ** Does the Supplier inspect and testproduct as required by the quality plan(Control Plan) and/or the documentedprocedures? (4.10.3.a)

10.7 ** Does the supplier hold product until therequired inspections and tests have beencompleted or necessary reports havebeen received and verified, except forrelease under positive recall (see4.10.2.3)? (4.10.3.b)

ELEMENT 4.10 - INSPECTION AND TESTING


4.10 - Inspection and Testing

35


ELEMENT 4.10 - INSPECTION AND TESTING (CONTINUED)

10.8 Are process activities directed towardsdefect prevention methods, such asstatistical process control, mistakeproofing, visual controls, rather thandefect detection? (4.10.3.c)

4.10.4 Final Inspection and Testing

10.9 ** Does the supplier carry out finalinspection and testing in accordancewith the quality plan (Control Plan) and/or documented procedures? (4.10.4)

10.10 Does the quality plan (Control Plan)mandate that all specified inspectionsand tests, incoming, in process, andfinal, must be performed and that theymeet specified requirements? (4.10.4)

10.11 ** Does the supplier assure that no productis dispatched until all activities specifiedin the documented procedures have beensatisfactorily completed and that theassociated data and documentation isavailable and authorized? (4.10.4)

10.12 * Are layout inspection and functionalverification performed for all products atfrequencies established by the customer(see QS-9000, Section II)? Are resultsfrom layout inspection and functionaltesting available for customer review?

(4.10.4.1)

10.13 * Does the supplier conduct scheduledaudits of the packaged final product toverify conformance to all specif iedrequirements? (4.10.4.2)

4.10.5 Inspection and Test Records

10.14 * Does the supplier maintain recordswhich provide evidence that the producthas been inspected and/or tested clearlyshowing whether the product has passedor failed inspection based on the definedacceptance criteria, and identifying theauthority responsible for the productrelease? (4.10.5; 4.16)

10.15 Is product that fails any inspection and/or test addressed under control ofnonconforming product?

(4.10.5;4.13; 4.16)

4.10.6 Supplier Laboratory Requirements

10.16 * Does the laboratory have a scope anddocument its policies, systems,programs, procedures, instructions andf indings to assure the quality ofcalibration and tests performed?

(4.10.6.1; 4.10.6.3)

36

37


ELEMENT 4.10 - INSPECTION AND TESTING (CONTINUED)


10.17 Do lab personnel have appropriatebackground and experience? (4.10.6.2)

10.18 * Are items retained until f inal data iscomplete to enable traceability to rawdata? (4.10.6.3)

10.19 * Does the laboratory use test and/orcalibration methods which meet theneeds of the customer and areappropriate for the intended use?

(4.10.6.5)

10.20 Is test capability verif ied prior toperforming the testing work? (4.10.6.5)

4.10.7 Accredited Laboratories

10.21 ** When the supplier uses independent/commercial laboratories are theyaccredited? (4.10.7)


4.11.1 General

11.1 Is inspection, measuring, and testequipment used in a manner whichinsures that the measurement uncertaintyis known and is consistent with therequired measurement capability?

(4.11.1)

11.2 Where test software or comparativereferences such as test hardware areused as suitable forms of inspection, arethey checked to prove that they arecapable of verifying the acceptability ofthe product prior to release for useduring production, installation, orservicing? (4.11.1)

11.3 * Does the supplier establish the extentand frequency of such checks, andmaintain records as evidence of control?

(4.11.1; 4.16)

11.4 Is technical data pertaining to theinspection, measuring and testequipment available for review by thecustomer, if they so require, forverif ication that the inspection,measuring, and test equipment isfunctionally adequate? (4.11.1)

4.11.2 Control Procedure

11.5 Has the supplier determined themeasurements to be made and theaccuracy required? (4.11.2.a)

11.6 * Has inspection, measuring, and testequipment been provided that is capableof the required accuracy and precision?

(4.11.2.a)

11.7 * Has the supplier identif ied allinspection, measuring and testequipment that can affect productquality? (4.11.2.b)

11.8 ** Is each piece of equipment calibrated atprescribed intervals, against certifiedequipment having a known validrelationship to internationally ornationally recognized standards, and inthe correct environment?

(4.11.2.b; 4.10.6.5)

38

ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT


4.11 - Inspection, Measuringand Test Equipment

11.9 Is the calibration of inspection,measuring or test equipment performedby a qualified laboratory (see QS-9000,4.11.2.b.1) or customer recognizedgovernment agency? (4.11.2.b.1)

11.10 ** Does the process for calibration ofinspection, measuring and testequipment include the following:- Type of equipment?- Unique identification?- Location?- Frequency of checks?- Check method?- Acceptance criteria?- Corrective actions? (4.11.2.c)

11.11 Has the supplier identified inspection,measuring and test equipment with asuitable indicator or approvedidentif ication record to show thecalibration status? (4.11.2.d)

11.12 Does the supplier maintain calibrationrecords for inspection, measuring andtest equipment? (4.11.2.e; 4.16)

11.13 Does the supplier assess and documentthe validity of previous inspection andtest results when inspection, measuringand test equipment is found out ofcalibration? (4.11.2.f)

11.14 Has the supplier ensured that theenvironmental conditions are controlled,recorded and suitable for inspections,measurements and tests being carriedout? (4.10.6.4; 4.11.2.g; 4.16)

11.15 ** Has the supplier ensured that thehandling, preservation and storage ofinspection, measuring and testequipment is such that the accuracy forfitness for use is maintained? (4.11.2.h)

11.16 * Has the supplier safeguarded theinspection, measuring and test facilities,including both hardware and testsoftware, from adjustments which wouldinvalidate the calibration setting?

(4.11.2.i)


ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT (CONTINUED)

39

40


ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT (CONTINUED)


4.11.3 Inspection, Measuring and Test Equipment Records

11.17 * Do records of the calibration/verificationactivity for all gages, measuring, and testequipment, including employee-ownedgages, include:- Revisions following engineering

changes (if appropriate)?- Any out of specification readings as

received for calibration?- Statements of conformance to

specification after calibration?- Notification to customer if suspect

material or product may have beenshipped? (4.11.3)

4.11.4 Measurement System Analysis

11.18 ** For measurement systems referenced inthe Control Plan is there evidence thatappropriate statistical studies have beenconducted to analyze the variationpresent in the results of each type ofmeasuring and test equipment system?

(4.11.4)

41



ELEMENT 4.12 - INSPECTION AND TEST STATUS


4.12 - Inspection andTest Status

12.1 * Is the inspection and test status ofproduct identified by suitable means, sothat the conformance status of theproduct with regard to inspection andtests performed is recognizable andunderstood? (4.12)

12.2 Is identification of inspection and teststatus maintained as defined in thequality plan (Control plan) and/ordocumented procedures throughoutproduction, installation and servicing ofproduct? (4.12)

4.12.1 Supplemental Verification

12.3 When required by the customer, areadditional verif ication/identif icationrequirements met? (4.12.1)


4.13.1 General

13.1 ** Does the control of nonconformingproduct and suspect material or productprovide for identif ication,documentation, evaluation, segregation(when practical), disposition, and fornotification of all appropriate functions?

(4.13.1; 4.13.1.1)

13.2 * Does the supplier provide for visualidentif ication of nonconforming orsuspect product, and for quarantineareas? (4.13.1.2)

4.13.2 Review and Disposition of Nonconforming Product

42

ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT


4.13 - Control ofNonconforming Product

13.3 * Is the responsibility for review andauthority for the disposition ofnonconforming product defined? (4.13.2)

13.4 * Are nonconforming and suspect productsreviewed in accordance with documentedprocedures, and:- Reworked to meet the specif ied

requirements,- Accepted with or without repair by

concession,- Regraded for alternative

applications, or- Rejected or scrapped? (4.13.2)

13.5 When required, is the proposed use orrepair of product which does notconform to specif ied requirementsreported for concession to the customer?

(4.13.2)

13.6 Is the description of nonconformity thathas been accepted, and of repairs,recorded to denote the actual condition?

(4.13.2; 4.16)

13.7 ** Are repaired and/or reworked/ productsreinspected and/or tested according tothe quality plan (Control plan) and/ordocumented procedures? (4.13.2)

13.8 * Does the supplier quantify and analyzenonconforming product, establish aprioritized reduction plan and trackprogress? (4.13.2.1)

4.13.3 Control of Reworked Product

13.9 * Are the rework instructions accessibleand utilized by the appropriate personnelin their work areas? (4.13.3)


ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT (CONTINUED)

13.10 Are service application products withvisible exterior rework approved by thecustomer service parts organization?

(4.13.3)


43

4.13.4 Engineering Approved Product Authorization

13.11 * Does the suppler obtain customerauthorization prior to shipment wheneverproduct or process is different from thecurrent PPAP approval? (4.13.4)

13.12 Does the supplier maintain records of theexpiration dates for EngineeringApproved Product Authorizations(EAPAs) and quantities authorized?

(4.13.4)

13.13 Is compliance with the original orsuperseding specif ication andrequirements ensured when authorizationexpires? (4.13.4)

13.14 Is material shipped on an authorizationproperly identif ied on each shippingcontainer? (4.13.4)


4.14.1 General

14.1 ** Are the appropriate corrective orpreventive actions developed to eliminatethe causes of actual or potentialnonconformances? (4.14.1)

14.2 Are changes to the documentedprocedures resulting from corrective orpreventive action implemented andrecorded? (4.14.1)

14.3 ** Does the supplier use a disciplinedproblem solving method to addressinternal or external nonconformances?

(4.14.1.1)

14.4 Does the supplier respond to externalnonconformances in the customerprescribed manner? (4.14.1.1)

14.5 Does the supplier use mistake proofingmethodology, as appropriate, in theircorrective and preventive action process?

(4.14.1.2)

4.14.2 Corrective Action

14.6 ** Do procedures for corrective actioninclude effective handling of customercomplaints and reports ofnonconformances? (4.14.2.a)

14.7 Do procedures for corrective actioninclude investigation of the causes ofnonconformances relating to product,process and quality system, andrecording of the results? (4.14.2.b; 4.16)

14.8 * Do procedures for corrective actioninclude determination of the correctiveaction needed to eliminate the cause ofnonconformance? (4.14.2.c)

14.9 ** Do procedures for corrective actioninclude application of controls to ensurethat corrective action is taken and that itis effective? (4.14.2.d)

14.10 * Are returned parts from customermanufacturing plants, engineeringfacilities, and dealerships analyzed, andare records of this analysis kept andmade available upon request? (4.14.2.1)

14.11 Where appropriate, does the supplierinitiate corrective action and processchanges to prevent recurrence? (4.14.2.1)

44

ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION


4.14 - Corrective andPreventive Action


ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION (CONTINUED)


45

14.12 * Where applicable, does the supplierconsider the impact of corrective actionson other products? (4.14.2.2)

4.14.3 Preventive Action

14.13 * Do procedures for preventive actioninclude the use of appropriate sources ofinformation, e.g., product quality,deviation, audit result, quality records,etc., to develop preventive actions?

(4.14.3.a)

14.14 Do procedures for preventive actioninclude the determination of stepsneeded to deal with problems requiringpreventive action? (4.14.3.b)

14.15 Do procedures for preventive actioninclude initiation of preventive actionand application of controls to ensure thatit is effective? (4.14.3.c)

14.16 ** Do procedures for preventive actioninclude provisions that the relevantinformation on actions taken issubmitted for management review?

(4.14.3.d; 4.1.3)


4.15.2 Handling

15.1 ** Have methods for the handling ofproduct to prevent damage ordeterioration been provided? (4.15.2)

4.15.3 Storage

15.2 Are designated storage areas or stockrooms used to prevent damage ordeterioration of the product pending useor delivery? (4.15.3)

15.3 Have appropriate methods forauthorizing receipt to and dispatch fromdesignated storage areas or stock roomsbeen stipulated? (4.15.3)

15.4 * Is the condition of product in stockassessed at appropriate intervals todetect deterioration? (4.15.3)

15.5 ** Does the supplier use an inventorymanagement system to optimizeinventory turns, assure stock rotation andminimize inventory levels? (4.15.3.1)

4.15.4 Packaging

15.6 Does the supplier control the packing,packaging and marking processes so asto ensure product conformance tospecifications? (4.15.4)

15.7 ** Are applicable customer packagingstandards/guidelines (including servicepart packaging standards) compliedwith? (4.15.4.1)

15.8 ** Has a system been developed to ensurethat all materials shipped are labeledaccording to customer requirements?

(4.15.4.2)

4.15.5 Preservation

15.9 * Have appropriate methods forpreservation and segregation of productbeen applied when the product is underthe supplier’s control? (4.15.5)

4.15.6 Delivery

15.10 * Does the supplier arrange for theprotection of the quality of product afterfinal inspection and test, and whencontractually specified does it extend toinclude delivery to destination? (4.15.6)

46

ELEMENT 4.15 - HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY


4.15 - Handling, Storage,Packaging, Preservationand Delivery

15.11 ** Has the supplier established a system tosupport 100% on-time shipments to meetcustomer production and servicerequirements? (4.15.6.1)

15.12 ** If the supplier’s delivery performance isnot 100% to schedule, is there evidenceof implemented corrective actions, andof communication regarding deliveryproblem information to the customer?

(4.15.6.1)

15.13 Does the supplier have a systematicapproach to develop, evaluate andmonitor adherence to established leadtime requirements? (4.15.6.1)

15.14 * Has the supplier implemented a systemto track performance to customerdelivery requirements and premiumfreight? (4.15.6.1)

15.15 Are materials shipped in conformancewith the customer requirements,adhering to up-to-date customerspecified transportation mode, routingsand containers? (4.15.6.1)

15.16 * Is supplier’s production schedulingactivity order driven? (4.15.6.2)

15.17 Does the supplier have a computerizedsystem for receiving customer planninginformation and ship schedules, unlesswaived by the customer? (4.15.6.3)

15.18 * Does the supplier have a computerizedsystem for transmitting advanced shipnotices to the customer, unless waived bythe customer? (4.15.6.4)

15.19 * Does the supplier have a back-up methodin the event the on-line system fails?

(4.15.6.4)

15.20 Has the supplier verified that all ASNsmatch shipping documents and labels?

(4.15.6.4)


ELEMENT 4.15 - HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY (CONTINUED)


47

48



16.1 * Are records maintained to demonstrateconformance to specified requirementsand the effective operation of the qualitysystem? (4.16)

16.2 * Does the control of quality recordsinclude pertinent subcontractor qualityrecords? (4.16)

16.3 * Are all quality records legible, readilyretrievable and stored in a suitableenvironment to prevent deterioration,damage, and loss? (4.16)

16.4 Are retention times for quality recordsestablished and maintained? (4.16)

16.5 ** Where agreed contractually are qualityrecords available to the customer forevaluation for an agreed period? (4.16)

4.16.1 Record Retention

16.6 * Are the following retained at a minimumfor:- Production parts approvals, tooling

records, purchase orders andamendments for the time the part isactive for production and service plusone calendar year?

- Quality performance records for onecalendar year after the year in whichthey were created?

- Internal quality audits andmanagement review records for threeyears? (4.16.1)

16.7 * Is there evidence of records disposal asestablished in the record retention?

(4.16.1)

ELEMENT 4.16 - CONTROL OF QUALITY RECORDS


4.16 - Control of QualityRecords

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ELEMENT 4.17 - INTERNAL QUALITY AUDITS


4.17 - Internal Quality Audits

17.1 ** Does the supplier carry out internalquality system audits as planned? (4.17)

17.2 ** Are the audits scheduled on the basis ofthe status and importance of the activity?

(4.17, 4.17.1)

17.3 * Are personnel conducting the auditindependent of the function beingaudited? (4.17)

17.4 ** Are the audit results recorded andbrought to the attention of theresponsible personnel? (4.17; 4.16)

17.5 ** Are corrective actions carried out on atimely basis? (4.17)

17.6 ** Are there follow-up audit activities forrecording and verifying the effectivenessof the corrective actions taken?

(4.17; 4.16)

4.17.1 Internal Audit Schedules

17.7 Does internal auditing cover all shifts?(4.17.1)

17.8 Is the internal auditing audit scheduleupdated annually?

(4.17.1)

18.1 * Have the training needs for all personnelperforming activities affecting qualitybeen met? (4.18)

18.2 ** Are personnel qualified based uponappropriate education, trainingrequirements, and/or experience asrequired? (4.18; 4.10.6.2)

18.3 Are appropriate training recordsmaintained? (4.18; 4.16)

4.18.1 Training Effectiveness

18.4 * Is training periodically evaluated foreffectiveness? (4.18.1)



50

ELEMENT 4.18 - TRAINING


4.18 - Training



19.1 * Is there documented evidence thatservicing meets the specifiedrequirements? (4.19)

4.19.1 Feedback of Information from Service

19.2 * Have reporting and verification systemsbeen established to communicateinformation on service concerns tosupplier manufacturing, engineering anddesign activities? (4.19.1)

ELEMENT 4.19 - SERVICING

51


4.19 - Servicing

4.20.1 Identification of Need

20.1 * Has the supplier identified the need forstatistical techniques for establishing,controlling and verifying the capabilityof process parameters and productcharacteristics? (4.20.1; 4.10.6.6)

4.20.2 Procedures

20.2 * Are there documented proceduresestablished and maintained to implementand control the application of statisticaltechniques? (4.20.2)

4.20.3 Selection of Statistical Tools

20.3 * Are appropriate statistical tools for eachprocess determined during advancedquality planning and included in thecontrol plan? (4.20.3)

4.20.4 Knowledge of Basic Statistical Concepts

20.4 * Are the concepts of variation, control(stability), capability, and overadjustmentunderstood throughout the organizationas appropriate? (4.20.4)



52

ELEMENT 4.20 - STATISTICAL TECHNIQUES


4.20 - Statistical Techniques

C.1* Is the Chrysler Product AssurancePlanning (PAP) or the “AdvancedQuality Planning (APQP) and ControlPlan” being used in the product creationprocess?

C.2 Are special characteristics identif iedwith the symbols <S>, <E>< <N>, <T>,and <H> being controlled withappropriate measurement systems?

C.3* Does the supplier demonstrateknowledge of the following standards, ifrequired for product manufactured (<S>PF-Safety, <E> PF-Emissions, <N> PF-Noise, <T> PF-Theft Prevention, <H>PS-9336)?

C.4 Does the supplier demonstrateknowledge and understanding ofstandard PS-7300?

C.5 Are internal quality audits performed onan annual basis, unless otherwisespecified?

C.6* Is design validation/productionverification performed at least once permodel year on all new and carryoverproducts, unless otherwise specified?

C.7* Are Chrysler 7-Step reports completedfor all nonconformances?

C.8 Are all appearance masters approved byChrysler’s Design Office?

C.9 Is the supplier familiar with the Chryslerpackaging, shipping and labelinginstructions?

C.10 Has a Process Sign-Off been completedfor all product identified as high risk orout of production for 12 months orlonger?

C.11* Has the supplier performed the ProcessSign Off on all medium and low riskparts?

C.12 Has the PSO been completed prior to C1build?

C.13 Is there evidence of approved PSO priorto PPAP submission?


53

CHRYSLER SPECIFIC

Chrysler Specific



CHRYSLER SPECIFIC (CONTINUED)

C.14* Are there records of written notificationto designated customer functions prior toimplementation of proposed material,process and/or manufacturing locationchanges?

C.15 Does the supplier notify the designatedcustomer functions of sub-supplier issuesand/or potential supply or capacityissues?

C.16 Does the supplier have access to theChrysler SPIN system?


54



F.1 * Are Control plans and FMEAs, and theirrevisions, signed by Ford qualityengineers for all inverted delta orequivalent symbol parts?

F.2 Are all shipping containers identifiedwith an inverted delta symbol orequivalent symbol proceeding the Fordpart number as required?

F.3 Have all specified characteristics beenaddressed in a Control Plan or annuallayout inspection?

F.4 Have changes to test/inspectionrequirements pertaining to Control Itemparts obtained Ford Product Engineeringand Quality approval?

F.5 * Does the supplier have a procedure tonotify the customer of ES test failures,suspension of shipments, identificationof any suspect lots, and stoppage ofproduction shipments?Has ES test failure resulted in theimmediate stoppage of productionshipments?

F.6 Are requirements forprocess and product monitoring being

met?- qualif ication of all product

characteristics being met?

F.7 When applicable, has the supplier madeeffective use of prototype fabricationdata to plan the production process?

F.8 * Does the supplier implement the FordQOS methodology?

F.9 * Has the supplier utilized the APQPReporting Guidelines?

F.10 * Has the supplier demonstratedcompliance to Ford Heat Treat Standard,W-HTX, where applicable?

F.11 * Does the supplier verify the set-up forCritical and Significant Characteristics,where applicable?

F.12 Is Run-at-Rate an integral part of thesupplier’s PPAP/PSW process?

55

FORD SPECIFIC


Ford Specific

56

G.1 Does the supplier have procedures andprocesses in place to address theappropriate General Procedures?

G.2 Are suppliers to NAO locations on-linewith the TFE Data Base? (GP-5)

G.3 * Is there evidence of compliance with theappropriate General Procedures, e.g. GP-9,GP-10, GP-12, and GM specif icrequirements, e.g. GM 1825, GM 1797,etc.?

G.4 Do NAO suppliers verify annually thatthey have the latest version of theGeneral Procedures?

G.5 Does the supplier have current customercontact information?

G.6 * Does the supplier meet the customer-specified PPM target or have in placecustomer-approved quality improvementplans to meet the customer’s specifiedPPM targets?

G.7 Do shipping labels contain the latestrevision number or date?

G.8* Does the supplier have a timed actionplan to address Year 2000 (Y2K)readiness regarding products, businessoperating systems and subcontractorswhich provides for individual unit andenterprise testing?

G.9 Is the supplier in compliance with GM-NAO system requirements for electroniccommunications and ASN’s, ifapplicable?

(4.15.6.3, 4.15.6.4)



GENERAL MOTORS SPECIFIC

General Motors Specific


Documents

6 Quality System Assessment- Aiag Manual