Implementing Quality
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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.

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  • Categories

    • Quality Management
    • Systems Engineering
    • Management
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About the Author

David Paspa
David Paspa

Engineer, working mainly in the Life Sciences since 1988.

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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