QualitySystemAssessment(QSA)(PDF 64)

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
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QUALITY SYSTEM ASSESSMENT
Table of Contents (Continued)
iv
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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QUALITY SYSTEM ASSESSMENT
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
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