CHAPTER 1 - QUALITY ASSURANCE FOR SEMICONDUCTOR DEVICES
1.1 Approach toward Quality Assurance................................................................................10
1.1.1 Basic Policies........................................................................................................10
1.1.2 ISO 9000 Series and QS-9000 ............................................................................10
1.1.2.1 Construction of a Quality System Based on the ISO 9000 Series ....10
1.1.2.2 Deployment to QS-9000 Certification Activities ............................11
1.1.3 Six Sigma ............................................................................................................11
1.1.4 Scientific Approach .............................................................................................12
1.1.4.1 Statistical Process Control (SPC) ....................................................12
1.1.4.2 Failure Mode and Effects Analysis (FMEA) ....................................13
1.1.5 Approach toward Quality Certification .............................................................15
1.2 Quality Assurance System for Semiconductor Devices .................................................16
1.2.1 Quality Assurance in the Development Stage ..................................................18
1.2.1.1 Product Planning ..............................................................................18
1.2.1.2 Product Development and Design ..................................................18
1.2.1.3 Design Review ..................................................................................18
1.2.2 Quality Assurance in the Mass Production Stage ............................................19
1.2.2.1 Process Quality Control in Manufacturing .....................................19
1.2.2.2 Process Quality Control for Outsourced Items ..............................21
1.2.3 Quality Assurance for Materials and Parts .......................................................22
1.2.4 Facility and Measuring Instrument Control and Environment Control ..........24
1.2.5 Change Control ...................................................................................................25
1.3 Product Shipping Quality Assurance................................................................................26
1.3.1 Quality Assurance Test (QAT) ............................................................................26
1.3.1.1 Shipping Inspection .........................................................................26
1.3.1.2 Periodic Reliability Tests .................................................................27
1.3.2 Handling Customer Complaints ........................................................................27
1.3.2.1 Complaints Information ...................................................................27
1.3.2.2 Return of Complaint Samples .........................................................28
1.3.2.3 Return of Analyzed Samples ...........................................................28
1.3.3 Corrective Action ................................................................................................28
1.3.4 Product Identification and Traceability .............................................................28
1.3.4.1 Product Lot Indication (Traceability) ..............................................28
1.3.4.2 Product Name Indication .................................................................29
1.4 Product Liability (PL) Act ...................................................................................................29
1.4.1 Purpose of Activities ...........................................................................................29
1.4.2 Management Structure for Promoting Safety and Peace of Mind .................29
1.4.3 Activities for Promoting Safety and Peace of Mind .........................................30
1.4.4 Systems for Promoting Safety and Peace of Mind ..........................................30
CHAPTER 1 - QUALITY ASSURANCE FOR SEMICONDUCTOR DEVICES
1.1 Approach toward Quality Assurance................................................................................10
1.1.1 Basic Policies........................................................................................................10
1.1.2 ISO 9000 Series and QS-9000 ............................................................................10
1.1.2.1 Construction of a Quality System Based on the ISO 9000 Series ....10
1.1.2.2 Deployment to QS-9000 Certification Activities ............................11
1.1.3 Six Sigma ............................................................................................................11
1.1.4 Scientific Approach .............................................................................................12
1.1.4.1 Statistical Process Control (SPC) ....................................................12
1.1.4.2 Failure Mode and Effects Analysis (FMEA) ....................................13
1.1.5 Approach toward Quality Certification .............................................................15
1.2 Quality Assurance System for Semiconductor Devices .................................................16
1.2.1 Quality Assurance in the Development Stage ..................................................18
1.2.1.1 Product Planning ..............................................................................18
1.2.1.2 Product Development and Design ..................................................18
1.2.1.3 Design Review ..................................................................................18
1.2.2 Quality Assurance in the Mass Production Stage ............................................19
1.2.2.1 Process Quality Control in Manufacturing .....................................19
1.2.2.2 Process Quality Control for Outsourced Items ..............................21
1.2.3 Quality Assurance for Materials and Parts .......................................................22
1.2.4 Facility and Measuring Instrument Control and Environment Control ..........24
1.2.5 Change Control ...................................................................................................25
1.3 Product Shipping Quality Assurance................................................................................26
1.3.1 Quality Assurance Test (QAT) ............................................................................26
1.3.1.1 Shipping Inspection .........................................................................26
1.3.1.2 Periodic Reliability Tests .................................................................27
1.3.2 Handling Customer Comp