Preface.
Acknowledgments.
Chapter 1: Understanding Quality and Quality Requirements.
The End Result.
Quality.
Quality Control.
Quality Assurance.
The Quality System.
Quality Requirements and Specification Review.
Quality Requirements.
Final Thoughts.
Chapter 2: Testing.
Testing: What Is It?
Testing: Location, Technicians, and Training.
Procedures.
Final Thoughts.
Chapter 3: Inspection and Data Handling.
Inspection.
Plans and Procedures.
Data, Data, Everywhere!
Final Thoughts.
Chapter 4: Calibration.
Gauge Identification.
Calibration Standards.
Calibration Recall and Data Management System.
Moving beyond the Simple Recall System.
Out-of-tolerance Conditions.
Final Thoughts.
Chapter 5: Corrective, Preventative Action and Error Proofing.
When Is Corrective Action Required?
Requirements for a Corrective Action System.
Investigating and Resolving a Corrective Action Issue.
Corrective Action Resolution.
Error Proofing.
Preventative Action.
Final Thoughts.
Chapter 6: Document Control: Ensuring Vital Information Is Available to Those Who Need It.
Why Go to All This Effort?
Paper-based Systems.
Revision Control.
Document Distribution.
Uncontrolled Copies.
Electronically-based Systems.
Guidelines and Audits.
Final Thoughts.
Chapter 7: Process Control.
How Do I Do It?
Identifying Key Process Variables.
The Control Plan.
Equipment Set-up/Documentation and Verification.
Process Capability.
Monitoring.
Final Thoughts.
Chapter 8: Process Changes.
Request Submission.
External Communication of Changes.
Final Thoughts.
Chapter 9: Raw Materials, Services, and Suppliers.
Sourcing: Raw Materials.
Sourcing: Services.
After Sourcing: The Start of a New Relationship.
Final Thoughts.
Chapter 10: Customers.
The Start of a Beautiful Relationship.
Accessibility.
Contacts.
Availability.
Responsiveness.
Follow-up.
Customer Care.
Customer Satisfaction.
Customer Recruitment and Retention.
Final Thoughts.
Chapter 11: Physical Facilities.
Maintenance.
The Work Area.
Final Thoughts.
Chapter 12: People.
Education.
Training.
Mentoring.
Empowerment.
Employee Benefits.
Final Thoughts.
Conclusion.
Appendix: Quality Requirements Checklist.
About the Author.
Index.