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Chip Bennett

Recent Posts

QRM and the System Classification “Big Reshuffle”: Don’t Miss the Forest for the Trees

By Chip Bennett, November 2, 2020

Recently, under its new Insights offering, KenX published an article, The Big Reshuffle – Impact Assessments and System Criticality, discussing the implications regarding the change in approach from System Level Impact Assessment (SLIA) and Component Criticality Assessment (CCA) to System Classification (SC) and System Risk Assessment (SRA) in ISPE Baseline Guide Volume 5, Commissioning & Qualification, 2nd Edition (2019). It is, on the whole, an excellent article and well-worth the time to read. In describing the impact of the “big reshuffle”, the article addresses some common practices and paradigms that I believe merit further discussion, particularly with respect to understanding the role of System Classification and System Risk Assessment in the application of Quality Risk Management (QRM) principles to the integrated Commissioning & Qualification (C&Q) process.

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Building Trust – Engineering to Quality/Validation

By Chip Bennett, September 6, 2019

Over the years, the roles and responsibilities of Engineering and Quality/Validation have evolved for Commissioning and Qualification (C&Q) activities. Now more than ever, risk-based approaches rely heavily on Engineering Subject Matter Experts (SMEs) and the application of Good Engineering Practices (GEPs) as an Engineering Quality Process to underpin C&Q.

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Download the Whitepaper: Power of Design Review

By Chip Bennett, May 30, 2019

Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in CQV projects? What are the risks of not performing Design Review? And more importantly, aside from regulatory expectations, what are the benefits of performing Design Review?

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How to Understand ASTM E2500