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Back to Basics: Another Perspective
  • Consumer Goods - Retail/Wholesale, Healthcare
  • Open Access

Back to Basics: Another Perspective

Developing useful audit nonconformances

Publication:
Quality Progress
Date:
September 2025
Issue:
Volume 58 Issue 9
Pages:
pp. 56
Author(s):
Purdy, Derek
Organization(s):
Stellartech Research Corp., Milpitas, CA

Abstract

David Phillips had a great article in QP in which he described the right way to document nonconformances by answering: What is the source requirement? What specific evidence was observed? How does the evidence demonstrate a lack of compliance with the requirement?  I wish I could report that auditors follow Phillips’ framework for writing nonconformances faithfully, but that’s not always the case. Before even getting to a nonconformance, there are two questions that deserve consideration: "What, exactly, is a requirement?" and "What is a nonconformance?"

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