Implementing Quality
Implementing Quality
Save time and money on the shortcut to quality assurance and regulatory compliance
About the Book
A distillation of all the knowledge you need to become an expert in quality and validation complete with a toolset to help you do it.
About the Author
Table of Contents
-
Preface
- Executive Summary
- Scope
- References
-
Scientific Thinking
- The Scientific Method
- Definitions
- Avoiding Jargon
-
Focus
- Risk Based Approach to Quality
- Pre-existing Systems
- Sorting Risk
- Product Quality Impact Assessment
- Functional Risk Assessment
- Supplier Assessment
- Iteration
-
FMECA Risk Assessment Method
- FMECA Fields
- Risk Control Fields
- Risk Appetite
- Risk Assessment Policy
- Risk Assessment Memory Jogger
- Sample Risk Register
- Sample Risk Controls
- Lifecycle Management
- V-Model
- PLAN
- DO
- CHECK
- Traceability Reporting
- ACT
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