6 Quality System Assessment - Aiag Manual

Quality System Assessment (QSA)
Second Edition, Second Printing, Issued August, 1998 Second Edition, Issued March, 1998 First Edition, Issued August, 1994 Copyright 1998 Chrysler Corporation, Ford Motor Company, General Motors Corporation
Quality System Assessment (QSA) First Edition, August, 1994 Second Edition, March, 1998 Second Edition, Second Printing, August, 1998
This Second Printing of the Second Edition makes several formatting changes and revises Question 11.17 to fully align with the QS-9000 Third Edition text.
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 is effective 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 Third Edition. The Quality System Development Checklist published by AIAG, which is replaced by the QSA Second Edition, has been incorporated. Certain questions address multiple 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 and the Chrysler, Ford, GM Supplier Quality Requirements Task Force, as well as the Task Force Steering Committee for their guidance and support.
March 1998
ii
QUALITY SYSTEM ASSESSMENT

Table of Contents
Foreword ....................................................................................................................................................... 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 ................................................................................................ 15 4.1.1 Quality Policy .............................................................................................................................. 15 4.1.2 Organization ................................................................................................................................ 15 4.1.3 Management Review ................................................................................................................... 16 4.1.4 Business Plan .............................................................................................................................. 16 4.1.5 Analysis and Use of Company Data ............................................................................................ 16 4.1.6 Customer Satisfaction ................................................................................................................. 17 Element 4.2 - Quality System ..................................................................................................................... 18 4.2.2 Quality System Procedures ......................................................................................................... 18 4.2.3 Quality Planning ......................................................................................................................... 18 4.2.4 Product Approval Process ........................................................................................................... 19 4.2.5 Continuous Improvement ............................................................................................................ 20 4.2.6 Facilities and Tooling Management ............................................................................................ 20 Element 4.3 - Contract Review ................................................................................................................... 22 4.3.2 Review ......................................................................................................................................... 22 4.3.3 Amendment to Contract .............................................................................................................. 22 4.3.4 Records ....................................................................................................................................... 22 Element 4.4 - Design Control ..................................................................................................................... 23 4.4.1 General ........................................................................................................................................ 23
iii

Table of Contents (Continued)
4.4.2 Design and Development Planning ............................................................................................. 23 4.4.3 Organizational and Technical Interfaces ..................................................................................... 23 4.4.4 Design Input ................................................................................................................................ 23 4.4.5 Design Output ............................................................................................................................. 24 4.4.6 Design Review ............................................................................................................................ 24 4.4.7 Design Verification ..................................................................................................................... 24 4.4.8 Design Validation ........................................................................................................................ 24 4.4.9 Design Changes .......................................................................................................................... 24 4.4.10 Customer Prototype Support ..................................................................................................... 25 4.4.11 Confidentiality .......................................................................................................................... 25 Element 4.5 - Document and Data Control ................................................................................................ 26 4.5.1 General ........................................................................................................................................ 26 4.5.2 Document and Data Approval and Issue ..................................................................................... 26 4.5.3 Document and Data Changes ...................................................................................................... 26 Element 4.6 - Purchasing ............................................................................................................................ 28 4.6.1 General ........................................................................................................................................ 28 4.6.2 Evaluation of Subcontractors ...................................................................................................... 28 4.6.3 Purchasing Data .......................................................................................................................... 28 4.6.4 Verification of Purchased Product .............................................................................................. 29 Element 4.7 - Control of Customer Supplied Product ................................................................................ 30 4.7.1 Customer Owned Tooling ........................................................................................................... 30 Element 4.8 - Product Identification and Traceability................................................................................ 30 Element 4.9 - Process Control .................................................................................................................... 31 4.9.1 Process Monitoring and Operator Instructions ........................................................................... 32 4.9.2 Maintaining Process Control ....................................................................................................... 33 4.9.3 Modified Process Control Requirements .................................................................................... 33 4.9.4 Verification of Job Setups ........................................................................................................... 33 4.9.5 Process Changes .......................................................................................................................... 34 4.9.6 Appearance Items ........................................................................................................................ 34 Element 4.10 - Inspection and Testing ........................................................................................................ 35 4.10.1 General ...................................................................................................................................... 35 4.10.2 Receiving Inspection and Testing .............................................................................................. 35 4.10.3 In-Process Inspection and Testing ............................................................................................. 35 4.10.4 Final Inspection and Testing ...................................................................................................... 36 4.10.5 Inspection and Test Records ...................................................................................................... 36 4.10.6 Supplier Laboratory Requirements ........................................................................................... 36 4.10.7 Accredited Laboratories ............................................................................................................ 37 Element 4.11 - Inspection, Measuring and Test Equipment ....................................................................... 38 4.11.1 General ...................................................................................................................................... 38 4.11.2 Control Procedure ..................................................................................................................... 38
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Table of Contents (Continued)
4.11.3 Inspection, Measuring and Test Equipment Records ................................................................ 40 4.11.4 Measuring System Analysis ...................................................................................................... 40 Element 4.12 - Inspection and Test Status .................................................................................................. 41 4.12.1 Supplemental Verification ......................................................................................................... 41 Element 4.13 - Control of Nonconforming Product ................................................................................... 42 4.13.1 General ...................................................................................................................................... 42 4.13.2 Review and Disposition of Nonconforming Product ................................................................ 42 4.13.3 Control of Reworked Product ................................................................................................... 42 4.13.4 Engineering Approval Product Authorization ........................................................................... 43 Element 4.14 - Corrective and Preventative Action.................................................................................... 44 4.14.1 - General .................................................................................................................................... 44 4.14.2 Corrective Action ...................................................................................................................... 44 4.13.3 Preventative Action ................................................................................................................... 45 Element 4.15 - Handling, Storage, Packaging, Preservation and Delivery ................................................ 46 4.15.2 Handling .................................................................................................................................... 46 4.15.3 Storage ...................................................................................................................................... 46 4.15.4 Packaging .................................................................................................................................. 46 4.15.5 Preservation ............................................................................................................................... 46 4.15.6 Delivery ..................................................................................................................................... 46 Element 4.16 - Control of Quality Records ................................................................................................ 48 4.16.1 Record Retention ...................................................................................................................... 48 Element 4.17 - Internal Quality Audits....................................................................................................... 49 4.17.1 Internal Audit Schedules ........................................................................................................... 49 Element 4.18 - Training .............................................................................................................................. 50 4.18.1 Training Effectiveness ............................................................................................................... 50 Element 4.19 - Servicing ............................................................................................................................ 51 4.19.1 Feedback of Information from Service ..................................................................................... 51 Element 4.20 - Statistical Techniques ......................................................................................................... 52 4.20.1 Identification of Need ............................................................................................................... 52 4.20.2 Procedures ................................................................................................................................. 52 4.20.3 Selection of Statistical Tools ..................................................................................................... 52 4.20.4 Knowledge of Basic Statistical Concepts ................................................................................. 52 Chrysler Specific ........................................................................................................................................ 53 Ford Specific .............................................................................................................................................. 55 General Motors Specific ............................................................................................................................. 56

GENERAL ASSESSMENT INSTRUCTIONS AND GUIDELINES Purpose
This Quality System Assessment (QSA) is used to determine conformance to the Quality System Requirements QS-9000. Proper use of the QSA will ensure that all requirements are addressed and promote consistency between activities and personnel determining QS-9000 conformance.
Application
The QSA may be used in several different ways according to the needs of the customer and supplier: first party - supplier self-assessment of its quality system , at a minimum the (*) and (**) questions. second party - customer assessment of supplier quality system (includes first tier supplier assessment of subcontractors), all questions or a subset. Certain customers will, as a minimum, use the questions marked with a double asterisk (**) for this purpose. third party - by a quality systems certification body/registrar as input to an audit checklist, at a minimum the (*) and (**) questions.
Assessment Process Assessment Method
The QSA process is def ined in Appendix A of QS-9000. The order of the questions in the QSA does not imply the audit sequence.
The assessment method is composed of three major phases: Phase I - Quality System Documentation Review This review determines if the quality manual (and supporting documentation as required) meets all requirements of QS-9000. Use Question 0.1, Document Review of the QSA. Phase II - On-site Audit This phase determines the degree and effectiveness of the implementation of the quality system at the suppliers site and remote locations.
Phase III - Analysis and Report A review of the findings of the first two phases is used to determine supplier conformance to QS-9000.
Audit Summary Alternatives
The auditor/customer will determine which of two alternatives will be used to summarize audit findings: Recommended/not recommended Variable score
Each of the elements may be classified in one of two ways, depending on the customers requirements: As a conforms or minor/major nonconformance status for that element. As a 0 to 10 point rating for the element, see Evaluation Process for Using a Variables Score Method.
Definitions
A MAJOR NONCONFORMITY is either: The absence or total breakdown of a system to meet a QS-9000 requirement. A number of minor nonconformities against one requirement which when combined can represent a total breakdown of the system and thus be considered a major nonconformity. Any noncompliance that would result in the probable shipment of a nonconforming product. A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose A noncompliance that judgment and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products.
A MINOR NONCONFORMITY is a QS-9000 noncompliance that judgment and experience indicate is 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.
It may be either: a failure in some part of the suppliers documented quality system relative to QS-9000, or one or more observed lapse(s) in following a requirement of the companys quality system.
OPPORTUNITY FOR IMPROVEMENT - an observed situation which is NOT a major or minor nonconformity, but where results achieved, based upon the auditors judgment and experience in that commodity, are not optimal. These opportunities shall be recorded in the final audit report for the benefit of the customer. CONFORMS - no major or minor nonconformities were noted in the audit. ADEQUACY - as used in this document means that the specific supplier documentation meets QS-9000 intent given the scope of the suppliers operations. In support of continuous improvement, the auditor should identify quality system strengths, weaknesses and shall record opportunities for improvement.
Evaluation Process for Using Recommended/Not Recommended Method:
An overall evaluation of recommended will be given when the audit does not identify any nonconformities. An open status exists under the following conditions: 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 within ninety days, or otherwise agreed to time frame, with acceptance of satisfactory evidence of conformity. On-site verif ication is at the discretion of the auditor(s). An overall evaluation of not recommended will be given if the audit process identifies more than one major nonconformity. Lack of nonconformity resolution within the specified time frame will also result in a not recommended evaluation.
Evaluation Process for Using a Variables Score Method:

Description
Supplier is not familiar with the requirements of the element and has no relevant source documentation (flow charts, forecasts, plans, procedures, strategies, etc.) in this area. Supplier is familiar with the requirements of the element but there is no evidence of source documentation, planning or implementation. Supplier is familiar with requirements of the element and has preliminary source documentation with incomplete plans for implementation. Source documentation is available. Implementation (with assigned responsibilities) 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 not quantifiable. Implementation has progressed (60 - 80% complete) and there is preliminary evidence of relevant results. Implementation is nearly complete (80 - 95%) and documented evidence of implementation effectiveness exists. Full implementation of source documentation for the requirement and complete confirmed evidence of implementation effectiveness. The supplier has met minimum requirements. Analysis of results and on-going continuous improvement can be demonstrated in key areas linked to customer satisfaction. Supplier has reached world class performance and is able to show growth beyond QS-9000 requirements and continuous improvement in all areas. Supplier is best-in-class and is able to demonstrate significant innovation in new ways to show relevant results beyond the customer requirements. The supplier sets the industry benchmark.
Score 0 1 2 3 4 5 6 7 8 9 10
Within each element the result (0 to 10) is marked in the appropriate row on the Record of Findings page. Final score is obtained by adding the point score column and dividing by the number of scored elements. TO BE RECOMMENDED A MINIMUM SCORE OF SEVEN IS REQUIRED ON EVERY APPLICABLE ELEMENT.
Evaluation Process... Variables Score Method

(Continued)
ELEMENTS NOT APPLICABLE TO A PARTICULAR SUPPLIER Certain elements such as 4.7 (Control of Customer Supplied Product) and 4.19 (Servicing) will not apply to every supplier. In such cases, N/A is entered in place of the score.
Reporting of Audit Findings
Where conformance to QS-9000 is demonstrated but definite opportunities for continuous improvement exist, these should be identified. For first or second party audits only, the auditor should identify quality system strengths and weaknesses.
Use of Scores in Sourcing Decisions
Regardless of the scoring method each customers purchasing activity will establish their own policy for using assessment results in sourcing decisions.
Process for Second Party Assessment

1. Supplier provides requested materials [e.g. quality manual, procedures (level two documentation)] to customer.
To promote optimum use of resources, the manual and other requested materials should be provided to the customer at least two weeks prior to the on-site audit. Also, the supplier will typically be asked to provide: 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.
2. Documentation Review.
The customer reviews the materials provided by the supplier for adequacy in meeting QS-9000 per Question 0.1 of the QSA. If requirements are identified that go beyond QS-9000, they should be noted for inclusion in the audit checklist. Any inadequacies found should be clearly defined and communicated to the supplier.
3. Documentation OK?
The customer advises the supplier of any revisions required in the quality system documentation to meet QS-9000. Normally, the on-site audit will be delayed pending satisfactory resolution of the inadequacies.
4. Supplier makes necessary revisions. 5. Customer prepares Audit Checklist.
The supplier revises the documentation as necessary.
quality
system
The checklist for the on-site audit is the QSA plus any additional questions identified in the documentation review. Additional space is provided in the QSA for such questions.

1 Supplier provides requested materials
2 DOCUMENT REVIEW
3
Documentation OK?
4 Supplier makes necessary revisions
5 Customer prepares audit checklist
6 Customer conducts on-site audit
7
Customer identifies nonconformities
8 Supplier corrects nonconformities; forwards documentation
10 Satisfactory completion of audit
9 YES
Documentation satisfactory?
NO

6. Customer conducts on-site audit.
The customer uses the checklist to evaluate the suppliers operations. This audit shall be conducted at supplier sites and remote locations as applicable (Engineering, Purchasing, Etc.). If there are multiple operations (production lines, stamping presses, etc.) within a plant that are essentially identical, the customer may audit these on a sampling basis. Significant observations should be communicated immediately to the supplier. Some customers may conduct an audit using the questions marked with an asterisk (**) to evaluate potential suppliers.
7. Customer identifies any nonconformities. 8. Supplier corrects nonconformities (and advises customer).
All nonconformities found must be included in the summary report. Some customers will also provide the detailed checklist.
If the supplier can correct minor nonconformities during the course of the audit, such corrections will be noted in the report. For other nonconformities, the supplier will determine a date by which the corrective action will be complete. The supplier will advise the customer when the corrective action(s) are completed.
9. Customer verification.
Based on the nature of the nonconformities, the customer will verify the effectiveness of the corrective actions on-site and/or via documentation review.
10.Customer advises supplier of audit result.
Customer provides final audit result to supplier (e.g., recommended/not recommended).

COVER SHEET
Supplier: Facility Address: Supplier Code: Scope of Audit: Products/Lines Audited: Reason For Audit: Audit Date:
Audit Type: Audit Results:
Initial Recommended
Surveillance Open
Follow-up Not Recommended
Other
Score, If Applicable Follow-up Required: Comments: Yes No Date:
Auditor Name
Phone

RECORD OF FINDINGS
Question
Documentation Review 4.1 Management Responsibility 4.2 4.3 4.4 Quality System Contract Review Design Control Conforms Nonconformities Minor Major Point Score
(if applicable)
4.5 Document and Data Control 4.6 Purchasing
4.7 Control of Customer Supplied Product 4.8 4.9 Product Identification and Traceability 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)
TOTALS:
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.
10

GENERAL COMMENTS
Element No. Comments
11

GENERAL COMMENTS
Element No. Comments
12
DOCUMENT REVIEW (Note: This is the basic documentation review for the audit.)
Question 0.1 ** Has a quality manual covering the requirements of QS-9000 been prepared? Does the quality manual include or make reference to quality system procedures and outline the structure of the documentation used in the 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 Supplied Product - 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 & Test Equipment - Measurement System Analysis - Inspection and Test Status - Control of Nonconforming Product - Control of Reworked Product - Eng. Approved Product Authorization Assessor Notes - Implementation evidence
13
DOCUMENT REVIEW (Note: This is the basic documentation review for the audit.)
Question Corrective and Preventive Actions Handling, Storage Packaging, Preservation & Delivery Control of Quality records Internal Quality Audits Training Servicing Statistical Techniques Applicable Customer Specific Requirements Assessor Notes - Implementation evidence
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ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY

ELEMENT ASSESSOR NOTES RESULTS
4.1 - Management Responsibility
Question 4.1.1 Quality Policy 1.1 Has the suppliers management with executive responsibility defined and documented its quality policy, objectives for quality, and its commitment to quality? (4.1.1) Is the quality policy relevant to organizational goals and the expectations and needs of the customer? (4.1.1) Is the quality policy implemented, understood and maintained throughout the organization? (4.1.1) Has the responsibility, authority, interrelationship of personnel who manage, perform, and verify work affecting quality been defined and documented? (4.1.2.1) Is authority delegated to personnel who have 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) Has the supplier identified the resource requirements, and provided adequate resources including the assignment of trained personnel for management, performance of work and verification activities, including internal audits? (4.1.2.2) Is there a clearly identified management representative with authority and responsibility to ensure QS-9000 compliance, and to report on the performance of the quality system? (4.1.2.3) Does the supplier have a system in place to ensure management of appropriate activities during concept development, prototype and production, (see APQP manual)? (4.1.2.4)
Assessor Notes - Implementation evidence
1.2
1.3 *
4.1.2 Organization 1.4 **
1.5
1.6
1.7 *
1.8
15
ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)

Question 1.9 Does the supplier use a multidisciplinary approach for decision making? (4.1.2.4) Does the supplier have the ability to communicate necessary information and data in the customer prescribed format? (4.1.2.4) Is management with responsibility and authority for corrective action promptly informed of products or processes that become non-compliant with specified requirements? (4.1.2.5) Assessor Notes - Implementation evidence
1.10
1.11
4.1.3 Management Review 1.12 ** Does the suppliers management with executive responsibility review all quality system elements at defined intervals to insure its continuing suitability and effectiveness? (4.1.3;4.1.3.1; 4.16) 4.1.4 Business Plan 1.13 ** Does the supplier utilize a formal, documented, comprehensive business plan that includes short-term and longerterm goals and plan(s)? (4.1.4) 1.14 1.15 Is the business plan under document control? (4.1.4) Are goals and plans based on analysis of competitive products and benchmarking inside and outside the automotive industry? (4.1.4) Are there methods in place to determine current and future customer expectations? (4.1.4) Does the supplier have an objective process that def ines the scope and collection of information (customer expectations and customer satisfaction), frequency and methods of collection? (4.1.4; 4.1.6) Are there documented methods to track, update, revise and review the business plan to ensure it is communicated and followed throughout the organization, as appropriate? (4.1.4) Does the supplier document trends in the quality, operational performance, and current quality levels for key product and service features? (4.1.5)
1.16 *
1.17
1.18 *
4.1.5 Analysis and Use of Company Level Data 1.19
16
ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)

Question 1.20 ** Are trends in data and information compared with: - competitors - appropriate benchmarks - progress toward business objectives, to lead to appropriate action to support: developing priorities for resolving customer problems determination of key customerrelated trends? (4.1.5) 4.1.6 Customer Satisfaction 1.21 * Is there a documented process to measure customer satisfaction that includes frequency of determination, and how objectivity and validity are assured? (4.1.6) Are trends in customer satisfaction and key indicators of customer dissatisfaction documented, supported by objective information, and reviewed by senior management? (4.1.6) Is there evidence the supplier notifies within 5 working days the certification body/registrar when a customer places the site in any status listed in QS-9000? (4.1.6.1) Assessor Notes - Implementation evidence
1.22
1.23 *
ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
17
ELEMENT 4.2 - QUALITY SYSTEM

4.2 - Quality System
Question 4.2.2 Quality System Procedures 2.1 ** Are there adequate supporting procedures (Level 2) for each element of the quality manual? (4.2.2) Is the quality planning process consistent with all other requirements of the quality system, documented in a suitable format, and does it consider as appropriate the elements of the quality system that address: - Identification and acquisition of all inspection & production/service resources? - Conducting design and process feasibility studies? - Updating and maintenance of all quality control and inspection methodology? - Identification of suitable verification at appropriate stages? - Production, installation and servicing processes which directly affect quality - Preparation of control plans and FMEAs? - Review of standards and specifications? (4.2.3) Is there evidence of an implemented advanced product quality planning process? (4.2.3.1; 4.2.3.2) Does the supplier convene multidisciplinary teams for the production of new or changed products, that use appropriate techniques as listed in the Advanced Product Quality Planing and Control Plan reference manual? (4.2.3.1) When required by the customer, are the process steps that affect Special Characteristics in process control guidelines and similar documents marked with the customers special characteristic symbol? (4.2.3.2) Is manufacturing feasibility investigated, conf irmed, and documented, (Team Feasibility Commitment form) prior to contracting proposed products? (4.2.3.3)
4.2.3 Quality Planning 2.2 **
2.3 *
2.4
2.5
2.6 **
18
ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)

Question 2.7 Do the suppliers design control and process control policies and practices consider as appropriate due care and product safety? (4.2.3.4) Does the supplier promote internal awareness of safety considerations? (4.2.3.4) 2.9 * 2.10 Do process FMEAs consider all Special Characteristics? (4.2.3.5) Is there evidence of efforts to achieve defect prevention versus detection, using PFMEA information? (4.2.3.5) Assessor Notes - Implementation evidence
2.8 *
2.11 ** Are mistake proofing techniques utilized where appropriate, which include but are not limited to planning of process, facilities, equipment and tooling, and in problem resolution? (4.2.3.6; 4.10.3; 4.14.1.2) 2.12 * Are control plans developed by multidisciplinary approach to the system, subsystem, component, and/or material level, and list all controls used for process control? (4.2.3.7) Does the control plan include the information required in the Control Plan form in QS-9000 Appendix J? (4.2.3.7)
2.13 *
2.14 ** Do control plans cover three phases: prototype, pre-launch, and production, as required by the customer? (4.2.3.7) 2.15 ** Are control plans reviewed and updated as appropriate when any of the following occurs: - 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 all requirements set forth in the PPAP manual? (4.2.4.1) Does the supplier utilize a part approval process for subcontractors? (4.2.4.2) Is there evidence that product changes are properly validated? (4.2.4.3)
2.17 * 2.18 *
19

Question 4.2.5 Continuous Improvement 2.19 ** Is there evidence of continuous improvement in quality (extending to product characteristics), service (timing and delivery) and price, that benefit all customers? (4.2.5.1; 4.1.6) 2.20 Does continuous improvement extend to product characteristics with the highest priority on special characteristics? (4.2.5.1) Does the supplier have a prioritized action plan for continuous improvement in processes that have demonstrated stability, acceptable capability and performance? (4.2.5.1) Has the supplier identified opportunities and implemented appropriate projects for quality and productivity improvement? (4.2.5.2) Has the supplier demonstrated knowledge and used appropriate continuous improvement measures and methodologies? (4.2.5.3) Is a multi-disciplinary approach used for developing facilities, equipment, and process planning in conjunction with the advanced quality planning process? (4.2.6.1; 4.2.3.7) Assessor Notes - Implementation evidence
2.21
2.22 *
2.23
4.2.6 Facilities and Tooling Management 2.24
2.25 ** Does the plant layout minimize material travel and handling, facilitate synchronous material flow, and maximize value-added use of floor space? (4.2.6.1) 2.26 Are methods developed for evaluating the effectiveness of existing operations and processes which consider the overall work plan, appropriate automation, ergonomics and human factors, operator and line balance, storage and buffer inventory levels, and value added labor content? (4.2.6.1) Has the supplier established and implemented a system for tool management that includes maintenance and repair facilities and personnel, storage and recovery, set-up, and tool change programs for perishable tools, tool modification including tool design modification? (4.2.6.2)
2.27*
20

Question 2.28 Are appropriate technical resources available for tool and gage design, fabrication and full dimensional inspection? (4.2.6.2) If tooling activities are subcontracted, is there a system to track and follow-up these activities? (4.2.6.2) Assessor Notes - Implementation evidence
2.29 *
21
ELEMENT 4.3 - CONTRACT REVIEW

4.3 - Contract Review
Question 4.3.2 Review 3.1 * Does the supplier review a tender, contract or order to ensure that the requirements are understood and can be met, and if any misunderstanding arises that the differences are resolved prior to contract or order acceptance? (4.3.2) Are customer specif ic contract requirements, including those in QS9000, Section II deployed to the functions concerned and fully met? (4.3.2; 4.12.1) Are there provisions to document and deploy contract amendments to the functions concerned? (4.3.3) Are records of contract reviews maintained? (4.3.4; 4.16)
3.2 *
4.3.3 Amendment to Contract 3.3 *
4.3.4 Records 3.4 **
22
ELEMENT 4.4 - DESIGN CONTROL

4.4 - Design Control
Question 4.4.1 General 4.1 Is there a process to deploy information gained from previous design projects to current and future ones of similar nature? (4.4.1.1) Have design plans for each project been established and responsibility assigned? (4.4.2) Are plans updated as the design evolves? (4.4.2) Are responsible personnel qualified in the Required Skills and equipped with adequate resources as appropriate? (4.4.2.1; 4.18) Are the organizational interfaces between groups defined and is there evidence of the necessary information being documented, transmitted and regularly reviewed? (4.4.3) Are design input requirements including the applicable statutory and regulatory requirements identified, documented and reviewed? (4.4.4;. 4.3) Are incomplete, ambiguous conflicting requirements resolved? or
4.4.2 Design and Development Planning 4.2 *
4.3 4.4 *
4.4.3 Organizational and Technical Interfaces 4.5
4.4.4 Design Input 4.6 *
4.7
(4.4.4; 4.3) 4.8 ** Do the following exist, if not waived by the customer: - Appropriate resources and facilities available to use computer aided design, engineering and analysis? - If CAD/CAE is subcontracted, has the supplier provided technical leadership? - Are CAD/CAE systems capable of two way interface with customer systems? (4.4.4.1)
23
ELEMENT 4.4 - DESIGN CONTROL (CONTINUED)

Question 4.4.5 Design Output 4.9 * Has the design output been documented and expressed in terms that can be verified and validated against design input 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) Was the design output a result of a process 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) Assessor Notes - Implementation evidence
4.10 *
4.4.6 Design Review 4.11 ** Are there records of formal documented design reviews by the appropriate functions conducted at appropriate stages of design per the design plan? (4.4.6; 4.16) 4.4.7 Design Verification 4.12 Are there records to demonstrate that design verification has been performed to ensure that design output meets design input requirements. (4.4.7; 4.16) Has design validation been performed to ensure that product conforms to defined user needs and/or requirements? (4.4.8) Is design validation performed in conjunction with the customer timing requirements? (4.4.8.1) Are there records for design validation, and do they include design failures? (4.4.8.1; 4.16) Are design failures addressed through the designated corrective and preventive action procedures? (4.4.8.1) Are design changes identified, documented, reviewed and approved by authorized personnel before implementation? (4.4.9)
4.4.8 Design Validation 4.13
4.14 *
4.15
4.16 *
4.4.9 Design Changes 4.17 *
24
ELEMENT 4.4 - DESIGN CONTROL (CONTINUED)

Question 4.18 * Has written customer approval or waiver been obtained prior to a design change being implemented into production? (4.4.9.1) For proprietary designs, does the supplier evaluate with the customer the impact of the design change on form, fit, function, performance and/or durability? (4.4.9.1) 4.20 * Does the supplier consider the impact of design changes on the system in which the product is used? (4.4.9.2) Assessor Notes - Implementation evidence
4.19
4.4.10 Customer Prototype Support 4.21 ** When required by the customer, does the supplier have a comprehensive prototype program ? (4.4.10) 4.22 Wherever possible, are the subcontractors tooling and process for prototype the same as the ones that will be used in production? (4.4.10)
4.23 ** Is the performance testing (that considers and includes as appropriate life, durability, reliability) tracked for timely completion and conformance? (4.4.10) 4.24 If design verification services have been subcontracted has the supplier provided technical leadership? (4.4.10) Does the supplier ensure confidentiality of customer contracted product under development, and related product information? (4.4.11)
4.4.11 Confidentiality 4.25
25
ELEMENT 4.5 - DOCUMENT AND DATA CONTROL

4.5 - Document and Data Control
Question 4.5.1 General 5.1 Are documents of external origin under document control? (4.5.1) Are documents and data reviewed and approved by authorized personnel prior to issue? (4.5.2) Is there a master list (or equivalent) identifying document revision status readily available? (4.5.2) Has the supplier established a process to ensure that pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed? (4.5.2.a) Has the supplier established a process to ensure that invalid and/or obsolete documents are promptly removed from all points of use, or otherwise assured against unintended use? (4.5.2.b) Are obsolete documents retained for legal and/or knowledge base purposes suitably identified? (4.5.2.c) Is there timely review, distribution and implementation of customer engineering standards/specifications and changes? (4.5.2.1) 5.8 * Does the supplier maintain a record of the date on which engineering changes are implemented in production? (4.5.2.1; 4.16) Does implementation of changes include updates to all appropriate documents? (4.5.2.1) Are changes in documents and data reviewed and approved by the same functions/organizations that originally performed the review and approval, (unless specifically designated otherwise)? (4.5.3)
4.5.2 Document and Data Approval and Issue 5.2 **
5.3 **
5.4 *
5.5
5.6
5.7 *
5.9
4.5.3 Document and Data Changes 5.10
26
ELEMENT 4.5 - DOCUMENT AND DATA CONTROL (CONTINUED)

Question 5.11 Do the designated functions or organizations have access to pertinent background information upon which to base the review and approval? (4.5.3) Are all changes in documents identified either in the document or in attachments? (4.5.3) Assessor Notes - Implementation evidence
5.12
27
ELEMENT 4.6 - PURCHASING

4.6 - Purchasing
Question 4.6.1 General 6.1 Where there is a customer-approved subcontractor list, is it used by the supplier as required? (4.6.1.1) Do all purchased materials used in part manufacture conform to all applicable governmental, safety and environmental regulations as they apply to the country of manufacture and sale? (4.6.1.2) Are subcontractors evaluated and selected based on their ability to meet quality system and quality assurance requirements? (4.6.2.a) Does the supplier define the appropriate type and extent of control over subcontractors? (4.6.2.b) Are quality records (4.16) of acceptable subcontractors established and maintained? (4.6.2.c) Is subcontractor quality system development being conducted using the QS-9000, Section I as the fundamental quality system requirement with the goal of subcontractor compliance to QS-9000? (4.6.2.1) Is 100% on time delivery a requirement of the subcontractors? (4.6.2.2) Is there appropriate planning information and purchasing commitments, provided by the supplier, to enable the subcontractors to meet the required 100% on-time delivery? (4.6.2.2) Is there evidence of a system to monitor the delivery performance of subcontractors, including all premium freight and evidence of appropriate corrective action? (4.6.2.2) Do the purchasing documents contain data clearly describing the product or service being ordered? (4.6.3)
6.2
4.6.2 Evaluation of Subcontractors 6.3 **
6.4 **
6.5 **
6.6 *
6.7 ** 6.8 *
6.9 *
4.6.3 Purchasing Data 6.10 *
28
ELEMENT 4.6 - PURCHASING (CONTINUED)

Question 6.11 Is there evidence of supplier review and approval of purchasing documents for adequacy to the specif ied requirements prior to release? (4.6.3) When applicable, do purchasing documents specify verification arrangements and method of product release for purchased product at the subcontractors premises? (4.6.4.1) Where specified in the contract (4.3), is the customer (or their designated representative) afforded the right to verify product conformance to the requirements at the suppliers/ subcontractors premises? (4.6.4.2) Assessor Notes - Implementation evidence
4.6.4 Verification of Purchased Product 6.12
6.13
29
ELEMENT 4.7 - CONTROL OF CUSTOMER SUPPLIED PRODUCT

4.7 - Control of Customer Supplied Product
Question 7.1 Is there evidence that product that is lost, damaged or otherwise unsuitable for use is recorded and reported to the customer? (4.7; 4.16) Are customer-owned tools and equipment permanently marked so that ownership of each item is visually apparent? (4.7.1)
4.7.1 Customer Owned Tooling 7.2 *
ELEMENT 4.8 - PRODUCT IDENTIFICATION AND TRACEABILITY

4.8 - Product Identification and Traceability
Question 8.1 * Is product identification maintained through all stages of production, delivery and installation? (4.8) Is traceability maintained and recorded when required by the customer? (4.8; 4.16)
8.2 **
30
ELEMENT 4.9 - PROCESS CONTROL

4.9 - Process Control
Question 9.1 * Do controlled conditions include documented procedures defining the manner of production, installation and servicing, where their absence could adversely affect quality? (4.9.a) Do controlled conditions include use of suitable production, installation and servicing equipment, and suitable working environment including but not limited to maintaining premises in a state of order, cleanliness and repair? (4.9.b; 4.9.b.1; 4.10.6.4) Does the supplier have contingency plans to reasonably protect the customers supply of product in the event of emergency? (4.9.b.2) Do controlled conditions include compliance with reference standards/ codes, quality plans and/or documented procedures? (4.9.c) Do controlled conditions include the monitoring and control of suitable process parameters and product characteristics, including designation and documentation of Special Characteristics? (4.9.d; 4.9.d.1) Do controlled conditions include the approval of processes and equipment, as appropriate? (4.9.e) Do controlled conditions include criteria for workmanship stipulated in the clearest practical manner? (4.9.f) Do controlled conditions include suitable maintenance of equipment to ensure continuing process capability? (4.9.g)
9.2 **
9.3 *
9.4
9.5 *
9.6
9.7
9.8
31
ELEMENT 4.9 - PROCESS CONTROL (CONTINUED)

Question 9.9 ** Is there an effective planned preventive maintenance system that identifies key process equipment, provides appropriate resources, 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 for key manufacturing equipment? - Documenting, evaluating and improving maintenance objectives? (4.9.g.1) Are qualified operators and/or continuous monitoring and process control used where the results of the processes cannot fully be verified by subsequent inspection and testing? (4.9) Are qualification requirements for special process operations and associated equipment and personnel specified and are records maintained? (4.9; 4.16; 4.18) Assessor Notes - Implementation evidence
9.10 *
9.11
4.9.1 Process Monitoring and Operator Instructions 9.12 ** Have documented process monitoring and operator instructions derived from the sources listed in the Advanced Product Quality Planning and Control Plan reference manual, or equivalent sources, been prepared for all employees having responsibilities for operation of processes and are they accessible at the workstation? (4.9.1)
32

Question 9.13 ** Do process monitoring and operator instructions include or reference, as appropriate: - 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 the process capability or performance as approved by PPAP through the implementation and adherence to the Control Plan, Process Flow Diagram, measurement technique, sampling plans, and reaction plans when acceptance criteria 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 appropriate reaction plan for unstable or non-capable characteristics (identified on the Control Plan), and is it supported by appropriate records? (4.9.2) Does the reaction plan include as appropriate: - containment and 100% inspection? - specific corrective action timing? - responsibility assignment? - customer approval? (4.9.2) Are control plans annotated accordingly when the customer requires different capability or performance? (4.9.3) Does the supplier verify job setups, using statistical methods where applicable? (4.9.4) Assessor Notes - Implementation evidence
9.17 *
4.9.3 Modified Process Control Requirements 9.18
4.9.4 Verification of Job Setups 9.19 *
33

4.9.5 Process Changes 9.20 * Does the supplier maintain record(s) of process change effective dates? (4.9.5; 4.5.3) For customer designated appearance items: - Is there appropriate lighting for the evaluation area(s)? - Are all appropriate masters available? - Are the masters and evaluation equipment adequately maintained and controlled? - Is there verification that personnel making appearance evaluation are qualified? (4.9.6; 4.1.2.2)
4.9.6 Appearance Items 9.21 *
34
ELEMENT 4.10 - INSPECTION AND TESTING

4.10 - Inspection and Testing
Question 4.10.1 General 10.1 * For attribute data with acceptance criteria other than zero defects, does the supplier document acceptance criteria and have customer approval? (4.10.1.1)
4.10.2 Receiving Inspection and Testing 10.2 ** Does the supplier ensure that incoming product is not used or processed (except for urgent production purposes), until it has been inspected or otherwise verified as conforming to specified requirements in accordance with the quality plan and/or documented procedures? (4.10.2.1) 10.3 Is the amount and nature of receiving inspection based on the control exercised at the subcontractors premises and records of conformance? (4.10.2.2)
10.4 ** Is positive identification provided and recorded for material used in production but not verified? (4.10.2.3; 4.16) 10.5 * Does the supplier incoming quality system use one or more of the following methods: - Receipt and evaluation of statistical data by supplier? - Receiving inspection and/or testing? - Second or third party assessments or audits of subcontractor sites when coupled with records of acceptable performance? - Evaluations by accredited laboratories? (4.10.2.4)
4.10.3 In-process Inspection and Testing 10.6 ** Does the Supplier inspect and test product as required by the quality plan (Control Plan) and/or the documented procedures? (4.10.3.a) 10.7 ** Does the supplier hold product until the required inspections and tests have been completed or necessary reports have been received and verified, except for release under positive recall (see 4.10.2.3)? (4.10.3.b)
35
ELEMENT 4.10 - INSPECTION AND TESTING (CONTINUED)

Question 10.8 Are process activities directed towards defect prevention methods, such as statistical process control, mistake proofing, visual controls, rather than defect detection? (4.10.3.c) Assessor Notes - Implementation evidence
4.10.4 Final Inspection and Testing 10.9 ** Does the supplier carry out final inspection and testing in accordance with the quality plan (Control Plan) and/ or documented procedures? (4.10.4) 10.10 Does the quality plan (Control Plan) mandate that all specified inspections and tests, incoming, in process, and final, must be performed and that they meet specified requirements? (4.10.4)
10.11 ** Does the supplier assure that no product is dispatched until all activities specified in the documented procedures have been satisfactorily completed and that the associated data and documentation is available and authorized? (4.10.4) 10.12 * Are layout inspection and functional verification performed for all products at frequencies established by the customer (see QS-9000, Section II)? Are results from layout inspection and functional testing available for customer review? (4.10.4.1) 10.13 * Does the supplier conduct audits of the packaged final verify conformance to all requirements? 4.10.5 Inspection and Test Records 10.14 * Does the supplier maintain records which provide evidence that the product has been inspected and/or tested clearly showing whether the product has passed or failed inspection based on the defined acceptance criteria, and identifying the authority responsible for the product release? (4.10.5; 4.16) 10.15 Is product that fails any inspection and/ or test addressed under control of nonconforming product? (4.10.5;4.13; 4.16) scheduled product to specif ied (4.10.4.2)
4.10.6 Supplier Laboratory Requirements 10.16 * Does the laboratory have a scope and document its policies, systems, programs, procedures, instructions and f indings to assure the quality of calibration and tests performed? (4.10.6.1; 4.10.6.3)
36
ELEMENT 4.10 - INSPECTION AND TESTING (CONTINUED)

Question 10.17 Do lab personnel have appropriate background and experience? (4.10.6.2) Assessor Notes - Implementation evidence
10.18 * Are items retained until final data is complete to enable traceability to raw data? (4.10.6.3) 10.19 * Does the laboratory use test and/or calibration methods which meet the needs of the customer and are appropriate for the intended use? (4.10.6.5) 10.20 Is test capability verif ied prior to performing the testing work? (4.10.6.5)
4.10.7 Accredited Laboratories 10.21 ** When the supplier uses independent/ commercial laboratories are they accredited? (4.10.7) ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
37
ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT

4.11 - Inspection, Measuring and Test Equipment
Question 4.11.1 General 11.1 Is inspection, measuring, and test equipment used in a manner which insures that the measurement uncertainty is known and is consistent with the required measurement capability? (4.11.1) Where test software or comparative references such as test hardware are used as suitable forms of inspection, are they checked to prove that they are capable of verifying the acceptability of the product prior to release for use during production, installation, or servicing? (4.11.1) Does the supplier establish the extent and frequency of such checks, and maintain records as evidence of control? (4.11.1; 4.16) Is technical data pertaining to the inspection, measuring and test equipment available for review by the customer, if they so require, for verification that the inspection, measuring, and test equipment is functionally adequate? (4.11.1) Has the supplier determined the measurements to be made and the accuracy required? (4.11.2.a) Has inspection, measuring, and test equipment been provided that is capable of the required accuracy and precision? (4.11.2.a) Has the supplier identified all inspection, measuring and test equipment that can affect product quality? (4.11.2.b)
11.2
11.3 *
11.4
4.11.2 Control Procedure 11.5
11.6 *
11.7 *
11.8 ** Is each piece of equipment calibrated at prescribed intervals, against certified equipment having a known valid relationship to internationally or nationally recognized standards, and in the correct environment? (4.11.2.b; 4.10.6.5)
38
ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT (CONTINUED)

Question 11.9 Is the calibration of inspection, measuring or test equipment performed by a qualified laboratory (see QS-9000, 4.11.2.b.1) or customer recognized government agency? (4.11.2.b.1) Assessor Notes - Implementation evidence
11.10 ** Does the process for calibration of inspection, measuring and test equipment 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 a suitable indicator or approved identification record to show the calibration status? (4.11.2.d) Does the supplier maintain calibration records for inspection, measuring and test equipment? (4.11.2.e; 4.16) Does the supplier assess and document the validity of previous inspection and test results when inspection, measuring and test equipment is found out of calibration? (4.11.2.f) Has the supplier ensured that the environmental conditions are controlled, recorded and suitable for inspections, measurements and tests being carried out? (4.10.6.4; 4.11.2.g; 4.16)
11.12
11.13
11.14
11.15 ** Has the supplier ensured that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy for fitness for use is maintained? (4.11.2.h) 11.16 * Has the supplier safeguarded the inspection, measuring and test facilities, including both hardware and test software, from adjustments which would invalidate the calibration setting? (4.11.2.i)
39
ELEMENT 4.11 - INSPECTION, MEASURING AND TEST EQUIPMENT (CONTINUED)

Question 11.17 * Do records of the calibration/verification activity for all gages, measuring, and test equipment, including employee-owned gages, 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 been shipped? (4.11.3) 4.11.4 Measurement System Analysis 11.18 ** For measurement systems referenced in the Control Plan is there evidence that appropriate statistical studies have been conducted to analyze the variation present in the results of each type of measuring and test equipment system? (4.11.4) ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE Assessor Notes - Implementation evidence 4.11.3 Inspection, Measuring and Test Equipment Records
40
ELEMENT 4.12 - INSPECTION AND TEST STATUS

4.12 - Inspection and Test Status
Question 12.1 * Is the inspection and test status of product identified by suitable means, so that the conformance status of the product with regard to inspection and tests performed is recognizable and understood? (4.12) Is identification of inspection and test status maintained as defined in the quality plan (Control plan) and/or documented procedures throughout production, installation and servicing of product? (4.12) When required by the customer, are additional verif ication/identif ication requirements met? (4.12.1)
12.2
4.12.1 Supplemental Verification 12.3
41
ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT

4.13 - Control of Nonconforming Product
Question 4.13.1 General 13.1 ** Does the control of nonconforming product and suspect material or product provide for identification, documentation, evaluation, segregation (when practical), disposition, and for notification of all appropriate functions? (4.13.1; 4.13.1.1) 13.2 * Does the supplier provide for visual identif ication of nonconforming or suspect product, and for quarantine areas? (4.13.1.2)
4.13.2 Review and Disposition of Nonconforming Product 13.3 * Is the responsibility for review and authority for the disposition of nonconforming product defined? (4.13.2) 13.4 * Are nonconforming and suspect products reviewed in accordance with documented procedures, and: - Reworked to meet the specified requirements, - Accepted with or without repair by concession, - Regraded for alternative applications, or - Rejected or scrapped? (4.13.2) When required, is the proposed use or repair of product which does not conform to specified requirements reported for concession to the customer? (4.13.2) Is the description of nonconformity that has been accepted, and of repairs, recorded to denote the actual condition? (4.13.2; 4.16)
13.5
13.6
13.7 ** Are repaired and/or reworked/ products reinspected and/or tested according to the quality plan (Control plan) and/or documented procedures? (4.13.2) 13.8 * Does the supplier quantify and analyze nonconforming product, establish a prioritized reduction plan and track progress? (4.13.2.1) Are the rework instructions accessible and utilized by the appropriate personnel in their work areas? (4.13.3)
4.13.3 Control of Reworked Product 13.9 *
42
ELEMENT 4.13 - CONTROL OF NONCONFORMING PRODUCT (CONTINUED)

Question 13.10 Are service application products with visible exterior rework approved by the customer service parts organization? Assessor Notes - Implementation evidence
(4.13.3) 4.13.4 Engineering Approved Product Authorization 13.11 * Does the suppler obtain customer authorization prior to shipment whenever product or process is different from the current PPAP approval? (4.13.4) 13.12 Does the supplier maintain records of the expiration dates for Engineering Approved Product Authorizations (EAPAs) and quantities authorized? (4.13.4) Is compliance with the original or superseding specif ication and requirements ensured when authorization expires? (4.13.4) Is material shipped on an authorization properly identified on each shipping container? (4.13.4)
13.13
13.14
43
ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION

4.14 - Corrective and Preventive Action
Question 4.14.1 General 14.1 ** Are the appropriate corrective or preventive actions developed to eliminate the causes of actual or potential nonconformances? (4.14.1) 14.2 Are changes to the documented procedures resulting from corrective or preventive action implemented and recorded? (4.14.1)
14.3 ** Does the supplier use a disciplined problem solving method to address internal or external nonconformances? (4.14.1.1) 14.4 Does the supplier respond to external nonconformances in the customer prescribed manner? (4.14.1.1) Does the supplier use mistake proofing methodology, as appropriate, in their corrective and preventive action process? (4.14.1.2)
14.5
4.14.2 Corrective Action 14.6 ** Do procedures for corrective action include effective handling of customer complaints and reports of nonconformances? (4.14.2.a) 14.7 Do procedures for corrective action include investigation of the causes of nonconformances relating to product, process and quality system, and recording of the results? (4.14.2.b; 4.16) Do procedures for corrective action include determination of the corrective action needed to eliminate the cause of nonconformance? (4.14.2.c)
14.8 *
14.9 ** Do procedures for corrective action include application of controls to ensure that corrective action is taken and that it is effective? (4.14.2.d) 14.10 * Are returned parts from customer manufacturing plants, engineering facilities, and dealerships analyzed, and are records of this analysis kept and made available upon request? (4.14.2.1) 14.11 Where appropriate, does the supplier initiate corrective action and process changes to prevent recurrence? (4.14.2.1)
44
ELEMENT 4.14 - CORRECTIVE AND PREVENTIVE ACTION (CONTINUED)

Question 14.12 * Where applicable, does the supplier consider the impact of corrective actions on other products? (4.14.2.2) 4.14.3 Preventive Action 14.13 * Do procedures for preventive action include the use of appropriate sources of information, e.g., product quality, deviation, audit result, quality records, etc., to develop preventive actions? (4.14.3.a) 14.14 Do procedures for preventive action include the determination of steps needed to deal with problems requiring preventive action? (4.14.3.b) Do procedures for preventive action include initiation of preventive action and application of controls to ensure that it is effective? (4.14.3.c) Assessor Notes - Implementation evidence
14.15
14.16 ** Do procedures for preventive action include provisions that the relevant information on actions taken is submitted for management review? (4.14.3.d; 4.1.3) ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE
45
ELEMENT 4.15 - HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY

4.15 - Handling, Storage, Packaging, Preservation and Delivery
Question 4.15.2 Handling 15.1 ** Have methods for the handling of product to prevent damage or deterioration been provided? (4.15.2) 4.15.3 Storage 15.2 Are designated storage areas or stock rooms used to prevent damage or deterioration of the product pending use or delivery? (4.15.3) Have appropriate methods for authorizing receipt to and dispatch from designated storage areas or stock rooms been stipulated? (4.15.3) Is the condition of product in stock assessed at appropriate intervals to detect deterioration? (4.15.3)
15.3
15.4 *
15.5 ** Does the supplier use an inventory management system to optimize inventory turns, assure stock rotation and minimize inventory levels? (4.15.3.1) 4.15.4 Packaging 15.6 Does the supplier control the packing, packaging and marking processes so as to ensure product conformance to specifications? (4.15.4)
15.7 ** Are applicable customer packaging standards/guidelines (including service part packaging standards) complied with? (4.15.4.1) 15.8 ** Has a system been developed to ensure that all materials shipped are labeled according to customer requirements? (4.15.4.2) 4.15.5 Preservation 15.9 * Have appropriate methods for preservation and segregation of product been applied when the product is under the suppliers control? (4.15.5)
4.15.6 Delivery 15.10 * Does the supplier arrange for the protection of the quality of product after final inspection and test, and when contractually specified does it extend to include delivery to destination? (4.15.6)
46
ELEMENT 4.15 - HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY (CONTINUED)

Question 15.11 ** Has the supplier established a system to support 100% on-time shipments to meet customer production and service requirements? (4.15.6.1) 15.12 ** If the suppliers delivery performance is not 100% to schedule, is there evidence of implemented corrective actions, and of communication regarding delivery problem information to the customer? (4.15.6.1) 15.13 Does the supplier have a systematic approach to develop, evaluate and monitor adherence to established lead time requirements? (4.15.6.1) Assessor Notes - Implementation evidence
15.14 * Has the supplier implemented a system to track performance to customer delivery requirements and premium freight? (4.15.6.1) 15.15 Are materials shipped in conformance with the customer requirements, adhering to up-to-date customer specified transportation mode, routings and containers? (4.15.6.1)
15.16 * Is suppliers production scheduling activity order driven? (4.15.6.2) 15.17 Does the supplier have a computerized system for receiving customer planning information and ship schedules, unless waived by the customer? (4.15.6.3)
15.18 * Does the supplier have a computerized system for transmitting advanced ship notices to the customer, unless waived by the customer? (4.15.6.4) 15.19 * Does the supplier have a back-up method in the event the on-line system fails? (4.15.6.4) 15.20 Has the supplier verified that all ASNs match shipping documents and labels? (4.15.6.4)
47
ELEMENT 4.16 - CONTROL OF QUALITY RECORDS

4.16 - Control of Quality Records
Question 16.1 * Are records maintained to demonstrate conformance to specified requirements and the effective operation of the quality system? (4.16) Does the control of quality records include pertinent subcontractor quality records? (4.16) Are all quality records legible, readily retrievable and stored in a suitable environment to prevent deterioration, damage, and loss? (4.16) Are retention times for quality records established and maintained? (4.16)
16.2 *
16.3 *
16.4
16.5 ** Where agreed contractually are quality records available to the customer for evaluation for an agreed period? (4.16) 4.16.1 Record Retention 16.6 * Are the following retained at a minimum for: - Production parts approvals, tooling records, purchase orders and amendments for the time the part is active for production and service plus one calendar year? - Quality performance records for one calendar year after the year in which they were created? - Internal quality audits and management review records for three years? (4.16.1) Is there evidence of records disposal as established in the record retention? (4.16.1)
16.7 *
48
ELEMENT 4.17 - INTERNAL QUALITY AUDITS

4.17 - Internal Quality Audits
Question 17.1 ** Does the supplier carry out internal quality system audits as planned? (4.17) 17.2 ** Are the audits scheduled on the basis of the status and importance of the activity? (4.17, 4.17.1) 17.3 * Are personnel conducting the audit independent of the function being audited? (4.17)
17.4 ** Are the audit results recorded and brought to the attention of the responsible personnel? (4.17; 4.16) 17.5 ** Are corrective actions carried out on a timely basis? (4.17) 17.6 ** Are there follow-up audit activities for recording and verifying the effectiveness of the corrective actions taken? (4.17; 4.16) 4.17.1 Internal Audit Schedules 17.7 17.8 Does internal auditing cover all shifts? (4.17.1) Is the internal auditing audit schedule updated annually? (4.17.1)
49
ELEMENT 4.18 - TRAINING

4.18 - Training
Question 18.1 * Have the training needs for all personnel performing activities affecting quality been met? (4.18)
18.2 ** Are personnel qualified based upon appropriate education, training requirements, and/or experience as required? (4.18; 4.10.6.2) 18.3 Are appropriate training records maintained? (4.18; 4.16) Is training periodically evaluated for effectiveness? (4.18.1)
4.18.1 Training Effectiveness 18.4 *
50
ELEMENT 4.19 - SERVICING

4.19 - Servicing
Question 19.1 * Is there documented evidence that servicing meets the specified requirements? (4.19) Have reporting and verification systems been established to communicate information on service concerns to supplier manufacturing, engineering and design activities? (4.19.1)
4.19.1 Feedback of Information from Service 19.2 *
51
ELEMENT 4.20 - STATISTICAL TECHNIQUES

4.20 - Statistical Techniques
Question 4.20.1 Identification of Need 20.1 * Has the supplier identified the need for statistical techniques for establishing, controlling and verifying the capability of process parameters and product characteristics? (4.20.1; 4.10.6.6) Are there documented procedures established and maintained to implement and control the application of statistical techniques? (4.20.2) Are appropriate statistical tools for each process determined during advanced quality planning and included in the control plan? (4.20.3) Are the concepts of variation, control (stability), capability, and overadjustment understood throughout the organization as appropriate? (4.20.4)
4.20.2 Procedures 20.2 *
4.20.3 Selection of Statistical Tools 20.3 *
4.20.4 Knowledge of Basic Statistical Concepts 20.4 *
52
CHRYSLER SPECIFIC
Chrysler Specific
Question C.1* Is the Chrysler Product Assurance Planning (PAP) or the Advanced Quality Planning (APQP) and Control Plan being used in the product creation process? Are special characteristics identified with the symbols <S>, <E>< <N>, <T>, and <H> being controlled with appropriate measurement systems? Does the supplier demonstrate knowledge of the following standards, if required for product manufactured (<S> PF-Safety, <E> PF-Emissions, <N> PFNoise, <T> PF-Theft Prevention, <H> PS-9336)? Does the supplier demonstrate knowledge and understanding of standard PS-7300? Are internal quality audits performed on an annual basis, unless otherwise specified? Is design validation/production verification performed at least once per model year on all new and carryover products, unless otherwise specified? Are Chrysler 7-Step reports completed for all nonconformances? Are all appearance masters approved by Chryslers Design Office? Is the supplier familiar with the Chrysler packaging, shipping and labeling instructions? Has a Process Sign-Off been completed for all product identified as high risk or out of production for 12 months or longer? Has the supplier performed the Process Sign Off on all medium and low risk parts? Has the PSO been completed prior to C1 build? Is there evidence of approved PSO prior to PPAP submission?
C.2
C.3*
C.4
C.5
C.6*
C.7* C.8 C.9
C.10
C.11*
C.12 C.13
53
CHRYSLER SPECIFIC (CONTINUED)

Question C.14* Are there records of written notification to designated customer functions prior to implementation of proposed material, process and/or manufacturing location changes? Does the supplier notify the designated customer functions of sub-supplier issues and/or potential supply or capacity issues? Does the supplier have access to the Chrysler SPIN system? Assessor Notes - Implementation evidence
C.15
C.16
54
FORD SPECIFIC
Ford Specific
Question F.1 * Are Control plans and FMEAs, and their revisions, signed by Ford quality engineers for all inverted delta or equivalent symbol parts? Are all shipping containers identified with an inverted delta symbol or equivalent symbol proceeding the Ford part number as required? Have all specified characteristics been addressed in a Control Plan or annual layout inspection? Have changes to test/inspection requirements pertaining to Control Item parts obtained Ford Product Engineering and Quality approval? Does the supplier have a procedure to notify the customer of ES test failures, suspension of shipments, identification of any suspect lots, and stoppage of production shipments? Has ES test failure resulted in the immediate stoppage of production shipments? Are requirements for - process and product monitoring being met? - qualif ication of all product characteristics being met? When applicable, has the supplier made effective use of prototype fabrication data to plan the production process? Does the supplier implement the Ford QOS methodology? Has the supplier utilized the APQP Reporting Guidelines? Has the supplier demonstrated compliance to Ford Heat Treat Standard, W-HTX, where applicable? Does the supplier verify the set-up for Critical and Significant Characteristics, where applicable? Is Run-at-Rate an integral part of the suppliers PPAP/PSW process?
F.2
F.3
F.4
F.5 *
F.6
F.7
F.8 * F.9 * F.10 *
F.11 *
F.12
55
GENERAL MOTORS SPECIFIC

General Motors Specific
Question G.1 Does the supplier have procedures and processes in place to address the appropriate General Procedures? Are suppliers to NAO locations on-line with the TFE Data Base? (GP-5) Is there evidence of compliance with the appropriate General Procedures, e.g. GP-9, GP-10, GP-12, and GM specif ic requirements, e.g. GM 1825, GM 1797, etc.? Do NAO suppliers verify annually that they have the latest version of the General Procedures? Does the supplier have current customer contact information? Does the supplier meet the customerspecified PPM target or have in place customer-approved quality improvement plans to meet the customers specified PPM targets? Do shipping labels contain the latest revision number or date? Does the supplier have a timed action plan to address Year 2000 (Y2K) readiness regarding products, business operating systems and subcontractors which provides for individual unit and enterprise testing? Is the supplier in compliance with GMNAO system requirements for electronic communications and ASNs, if applicable? (4.15.6.3, 4.15.6.4)
G.2 G.3 *
G.4
G.5 G.6 *
G.7 G.8*
G.9
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Quality System Assessment (QSA)

FOREWORD TO THE SECOND EDITION

QUALITY SYSTEM ASSESSMENT

QUALITY SYSTEM ASSESSMENT

QUALITY SYSTEM ASSESSMENT

QUALITY SYSTEM ASSESSMENT

Assessment Process Assessment Method

Audit Summary Alternatives

Evaluation Process for Using Recommended/Not Recommended Method:

Evaluation Process for Using a Variables Score Method:

Evaluation Process... Variables Score Method

Reporting of Audit Findings

Use of Scores in Sourcing Decisions

Process for Second Party Assessment

4. Supplier makes necessary revisions. 5. Customer prepares Audit Checklist.

The supplier revises the documentation as necessary.

Process for Second Party Assessment

4 Supplier makes necessary revisions

5 Customer prepares audit checklist

6 Customer conducts on-site audit

8 Supplier corrects nonconformities; forwards documentation

10 Satisfactory completion of audit

Process for Second Party Assessment

10.Customer advises supplier of audit result.

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

QUALITY SYSTEM ASSESSMENT

Audit Type: Audit Results:

Follow-up Not Recommended

Score, If Applicable Follow-up Required: Comments: Yes No Date:

QUALITY SYSTEM ASSESSMENT

4.5 Document and Data Control 4.6 Purchasing

QUALITY SYSTEM ASSESSMENT

QUALITY SYSTEM ASSESSMENT

ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY

4.1 - Management Responsibility

Assessor Notes - Implementation evidence

4.1.2 Organization 1.4 **

ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)

4.1.5 Analysis and Use of Company Level Data 1.19

ELEMENT 4.1 - MANAGEMENT RESPONSIBILITY (CONTINUED)

ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

ELEMENT 4.2 - QUALITY SYSTEM

4.2 - Quality System

Assessor Notes - Implementation evidence

4.2.3 Quality Planning 2.2 **

ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)

ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)

4.2.6 Facilities and Tooling Management 2.24

ELEMENT 4.2 - QUALITY SYSTEM (CONTINUED)

ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

ELEMENT 4.3 - CONTRACT REVIEW

4.3 - Contract Review

Assessor Notes - Implementation evidence

4.3.3 Amendment to Contract 3.3 *

4.3.4 Records 3.4 **

ADDITIONAL SUPPLIER QUALITY SYSTEM REQUIREMENTS TO BE AUDITED ON-SITE

ELEMENT 4.4 - DESIGN CONTROL

4.4 - Design Control

Assessor Notes - Implementation evidence

4.4.2 Design and Development Planning 4.2 *

4.4.3 Organizational and Technical Interfaces 4.5

4.4.4 Design Input 4.6 *