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
iii
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
v
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
..............................