Merry Keating

How to Assure Quality in Plastics

Hanser Publishers, Munich Vienna New York

Hanser/Gardner Publications, Inc., Cincinnati

Contents

1 The Beginning 1 1.1 Quality Policy 1 1.2 Personnel Organization and Job Descriptions 3

1.2.1 Job Descriptions 4 1.3 Quality Manual 5

2 Advanced Quality Planning 9 2.1 Voice of the Customer 9 2.2 Design and Feasibility Reviews 10

2.2.1 Phase 1 11 2.2.2 Phase 2 11 2.2.3 Phase 3 12

2.3 Process Flow Charts 12 2.4 Failure Mode and Effects Analysis (FMEA) 13 2.5 Control Plans 18 2.6 New Job Launch 19

3 Sampling and Submissions 31 3.1 Prototype Sampling and Submission 31 3.2 Production Sample Run Tryouts 31

3.2.1 Sample Quantities 32 3.2.2 Deviation from Sample Quantities 32 3.2.3 Sample Identification and Distribution 32 3.2.4 Sample Storage Area 32 3.2.5 Sample Storage Records and Activity 33 3.2.6 Maintenance of Storage Area 33

3.3 Sample Submissions to the Customer or Production Approval Source 34 3.3.1 Records 35 3.3.2 Submission Tracking 35

3.4 Pilot Run and Submission 36

4 Supplier Development and Control 41 4.1 Supplier Guidelines 41 4.2 Supplier Assessments 43

viii Contents

4.3 Receiving Inspection 45 4.3.1 Designated Receiving Hold Area 45 4.3.2 Inspection 45 4.3.3 Inspection Instructions 45 4.3.4 Inspection Records 46 4.3.5 Approval/Rejection 46

4.4 Supplier Statistical Process Control (SPC) 47 4.4.1 Procedures 48 4.4.2 Supplier Submission of SPC Data 48 4.4.3 Evaluating and Reporting on Received SPC Data 49

4.5 Supplier Performance Tracking and Reporting 50 4.5.1 How to Begin a Tracking Program 50 4.5.2 Supplier Performance Reporting 51 4.5.3 Corrective Action Process 51 4.5.4 Supplier Development 52 4.5.5 Procedures 52

4.6 Elimination of Receiving Inspection 52 4.6.1 Formal Plan 53

5 Inspection 57 5.1 Engineering Standards/Testing 57

5.1.1 Certifications and Warrants 58 5.1.2 Equipment and Testing Capabilities 58 5.1.3 Useful Documents 59

5.2 Inspection Instructions 61 5.2.1 Instruction Contents 61 5.2.2 Lot Acceptance Sampling Table 63 5.2.3 Maintenance and Location of Instructions 63 5.2.4 Instruction Improvements and Revisions 63 5.2.5 Procedure 64

5.3 Start-Up Inspection 65 5.3.1 Starting Up the Process 65 5.3.2 Approval of the Process 65 5.3.3 Procedures and Instructions 66 5.3.4 Helpful Hints 66

5.4 Process Inspection 67 5.4.1 Establishing Frequencies 67 5.4.2 Inspection Records 68 5.4.3 Procedures 68

5.5 End-of-Run Inspection 69 5.5.1 Documentation of Inspection 69 5.5.2 Initial Evaluation of Results 70 5.5.3 Recommendations for Review 70

Contents ix

5.5.4 Formal Review—Comparison of First and Last Samples.... 70 5.5.5 Helpful Hints 71 5.5.6 Procedures 71

5.6 Final Inspection 71 5.6.1 Procedure 72 5.6.2 Frequencies/Quantities 72 5.6.3 Inspection Records 73 5.6.4 Helpful Hints 73

5.7 Dock Audit Inspection 73 5.7.1 Types of Dock Audit Processes 73 5.7.2 Who Should Perform Dock Audits? 74 5.7.3 Documentation 75 5.7.4 Continuous Improvement Opportunity 76 5.7.5 Helpful Hints 77

5.8 Regrind Control 77 5.8.1 Control System 78 5.8.2 Traceability 78 5.8.3 Regrind Approval for Use 79 5.8.4 Helpful Hints 79

5.9 Color Control 80 5.9.1 Inspection Phases 80 5.9.2 Color Inspection Tools 80 5.9.3 Helpful Hints 81

6 Gage Control 85 6.1 Gage Fixture Certification 85

6.1.1 Third Party Certification 85 6.1.2 In-House Gage/Fixture Verification and Acceptance 86

6.2 Gage Repeatability and Reproducibility (R&R) 86 6.2.1 Short-Form and Long-Form Studies 86 6.2.2 How to Conduct a Gage R&R Study 87 6.2.3 How to Evaluate the Results 88 6.2.4 Helpful Hints 89

6.3 Calibration 89 6.3.1 Frequency 89 6.3.2 Standards 89 6.3.3 Records and Calibration Identification 90 6.3.4 Gage Control 90 6.3.5 Suspect Stock 90 6.3.6 Helpful Hint 91

6.4 Gage and Fixture Maintenance 91 6.4.1 The Process 91 6.4.2 Helpful Hints 92

x Contents

7 Statistical Process Control 95 7.1 Training and Implementation 95

7.1.1 Training Requirements 95 7.1.2 The Training Approach 96 7.1.3 Implementing the SPC Program 97 7.1.4 Helpful Hints 98

7.2 Capability Studies 99 7.2.1 Cp AND Cpk Indexes 99 7.2.2 Process Potential 99 7.2.3 Long-Term Process Capability 100 7.2.4 Tracking 101

7.3 Closed-Loop Approach 102 7.3.1 The Beginning of the Process 102 7.3.2 Different Phases of Reaction 103

7.3.2.1 Phase 1—The Floor 103 7.3.2.2 Phase 2—Key Management 104 7.3.2.3 Phase 3—Top Management 105

7.3.3 Standards for Report Circulation and Continuous Improve­ment 106

7.3.4 SPC as Part of Total Quality Management 107 7.4 Automation in SPC 107

7.4.1 Computers 108 7.4.2 SPC Software Programs 108 7.4.3 Automatic Data Collectors 108 7.4.4 Helpful Hints 109

7.5 Progressive SPC—The Elimination of "Product" Monitoring 110 7.5.1 How to Convince the Customer 110 7.5.2 The Process of Eliminating Statistical Product Control 111 7.5.3 Helpful Hints 113

8 Process Control and Optimization 117 8.1 Design of Experiments 117

8.1.1 Beginning an Experiment 117 8.1.2 Different Methods of DOE 117 8.1.3 Continuing the Preparation for Setting Up the Experiment 118 8.1.4 Set-Up Example 119 8.1.5 Orthogonal Arrays 120 8.1.6 Preparing to Conduct the Experiment 120 8.1.7 Conducting the Experiment 121 8.1.8 Processing the Data 122 8.1.9 Confirmation Run 122 8.1.10 Helpful Hints 123

8.2 Process Parameter Specification Development 123 8.2.1 Developing Resin Processing Resources 123

Contents xi

8.2.2 Taking Advantage of the Initial Sample Run 124 8.2.3 Documented Process Parameter Settings 124

8.3 Process Control/Verification 125 8.3.1 The Control Benefits of Verification 125 8.3.2 Deviating from the Process Specification 126 8.3.3 Reviewing the Data 126

8.4 Continuous Process Optimization 126 8.4.1 Evaluating Process Verification Data for Process Optimiza­

tion 127 8.5 FMEAs—Are They Really "Living Documents?" 128

9 Problem Solving 133 9.1 Various Techniques of Problem Solving 133

9.1.1 Problem Solving Tools 133 9.1.2 Disciplined Problem Solving 134 9.1.3 Unique Problem Solving Procedures 135

9.2 Customer Concerns 135 9.2.1 Initial Reactions 136 9.2.2 Plantwide Communication of Customer Concerns 136 9.2.3 Corrective/Preventative Action Planning and Execution 137 9.2.4 Tracking and Follow-Up Process 137 9.2.5 Helpful Hints 138

9.3 Proactive Problem Solving 138 9.3.1 Warranty and Service Center Reviews 139 9.3.2 Scheduled Customer Visits 139 9.3.3 Helpful Hints 141

10 Nonconforming Material Control 147 10.1 In-House Rejections 147

10.1.1 Different Stages of In-House Rejections 147 10.1.2 The Rejection Process 148 10.1.3 Reporting and Action Plan Documentation 148 10.1.4 Tracking and Improvement Efforts 149

10.2 Returned Goods 150 10.2.1 Customer Concerns Process for Returned Goods 150 10.2.2 Disposition of Returned Goods 151 10.2.3 Sort/Rework Operations on Returned Goods 151

10.3 Quarantine Procedures 151 10.3.1 Quarantine Area Location and Design 152 10.3.2 Quarantine Contents and Dispositions Tracking 152

10.4 Sort and Rework Operations 153 10.4.1 Different Definitions of Stock Status 153 10.4.2 Rework/Sort Area and Instructions 153 10.4.3 Rework/Sort Records and Inspection 154

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11 Lot Control and Traceability 159 11.1 Lot Control 159

11.1.1 Documenting the Lot Control System 159 11.1.2 Lot Control Further Defined 159

11.2 Traceability 160 11.2.1 Traceability Methods 160 11.2.2 Documentation of the Process 161

12 Document Control 163 12.1 Record Retention 163

12.1.1 The Policy 163 12.1.2 The Procedure 164

12.2 Procedure and Instructions Revisions 165 12.2.1 Reasons for Revisions/Updates 165 12.2.2 Revisions Tracking and Control 165

12.3 Work Station Documents 166 12.3.1 What Should be Posted 166 12.3.2 Standardization of Work Station Documents 166

12.4 Files 167 12.4.1 Color Coding 167 12.4.2 Organizing a Filing System 167 12.4.3 File Audits 168 12.4.4 Helpful Hints 168

13 Internal Systems Control 173 13.1 Self-Assessments 173

13.1.1 Assessment Contents and Procedures 173 13.1.2 Responsibilities and Scheduling 174 13.1.3 Action Plans 175 13.1.4 Reporting and Improvement Tracking 175

13.2 Annual Product Validation 175 13.3 Floor Audits 176 13.4 Housekeeping 177

14 ISO-9000 181 14.1 The Origination and Purpose of ISO-9000 181 14.2 The Standards of the ISO-9000 Series 182

14.2.1 Guidance Standards 182 14.2.2 Conformance Standards 182

14.3 The ISO Registration and Certification Process 184 14.3.1 How to Find and Choose a Registrar 184 14.3.2 Costs 185

15 Systems Implementation and Maintenance 187 15.1 Top Management's Role 187

Contents

15.1.1 How a System Fails 187 15.1.2 Top Management Defined 188

15.2 Plans and Goals 188 15.2.1 Identify Strengths and Weaknesses 189 15.2.2 Continued Employee Ownership of Goals 189 15.2.3 Employee Ownership 190

15.3 Education and Training 190 15.3.1 Review When Training is not Needed 190 15.3.2 Education 191 15.3.3 Training the Trainer 192 15.3.4 Evaluate the Effectiveness of the Training 193 15.3.5 Ongoing Training 193

15.4 Follow-Up (The Art) 194 15.4.1 Becoming Disciplined in Daily Follow-Up Planning 194

Continuous Improvement 201 16.1 Identifying, Tracking, and Reporting Indicators 201

16.1.1 Identifying Measurable Indicators 201 16.1.2 Tracking Indicators 202 16.1.3 Reporting and Reacting to Indicators 203 16.1.4 Helpful Hints 203

16.2 Eliminating Gray Areas 204 16.2.1 Examples of Gray Areas 204

16.2.1.1 Good/Bad Visual Aids with Windows 204 16.2.1.2 Inspection Criteria with Ambiguous Wording 205 16.2.1.3 Instructions and Procedures That are Not

Enforced 206 16.2.2 Make New Decisions Only Once 206

16.3 Employee Involvement 207 16.3.1 Sharing and Soliciting Information 207 16.3.2 Formal EIGs 208

16.4 Employee Incentives 210 16.4.1 Compensation Motivates an Employee to Show Up to

Work 210 16.4.2 Monetary Bonuses are Short-Lived Incentives 211 16.4.3 Back to Recognition 212

Relationships 219 17.1 Departmental 219 17.2 Interdepartmental 220

17.2.1 Scenario I—Poor Understanding of Other Departments' Responsibilities 221

17.2.2 Scenario II—Good Understanding of Other Departments' Responsibilities 221

xiv Contents

17.3 The Customer 222 17.4 The Supplier 224

117.4.1 Little Customer—Big Supplier 225

Index 227