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"
You can rely on it," J. C. Stephens, APICS The Performance Advantage, January (2003)
"When do design controls start?" J. C. Stephens, Regulatory Affairs Focus, February (2003).
"Effective Risk Assessment," J. C. Stephens, Regulatory Affairs Focus, March (2003).
"Improving Visual Inspection," J. C. Stephens, Manufacturing Engineering, April (2003).
Forms, Checklists, and Guides
Good Documentation Practices Quick Reference Guide
Generic Calibration Form
Generic Complaint Investigation Form
Generic Complaint Log
Computer System Validation Documentation Checklist
Generic Corrective / Preventive Action Form
Generic Design Review Form
Generic Design Failure Mode and Effects Analysis (DFMEA) Spreadsheet
Document Review Checklist
Generic Engineering Change Request Form
Generic Inspection Form
Installation Qualification Checklist
Generic Internal Audit Form
Generic Managment Review Form
Generic Raw Material Traceability Form
Generic Preventive Maintenance Form
Generic Quality Plan
Generic Medical Device Servicing Form
Generic Training Form
FDA Documents
Quality System Regulation, Final Rule
Design Control Guidance for Medical Device Manufacturers
Recommended Books
The FDA Worldwide Quality System Requirements Guidebook for Medical Devices, Amiram Daniel & Ed Kimmelman, ASQ Press (2008)
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