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2022 ISPE Annual Meeting & Expo

SES104a - ISPE Good Practice Guide: Good Engineering Practice Overview


Oct 31, 2022 11:00am ‐ Oct 31, 2022 12:30pm


Description

This presentation will focus on the main principles and application of the new Good Engineering Practices Good Practice Guide. When the 2nd Edition of Baseline Guide 5, Commissioning and Qualification, was published in 2019, most of the attention about the new Guide was focused on the incorporation of Quality Risk Management (QRM) into the integrated Commissioning and Qualification (C&Q) approach. That attention was merited, as the Guide established the industry-standard approach, strategy, and rationale for science- and risk-based design and delivery of engineered systems. However, equally important, both from a business and regulatory perspective, the Guide established Good Engineering Practice (GEP) as a key enabler for the integrated C&Q process. Just as QRM drives effectiveness of the integrated C&Q process, GEP drives the efficiency of that process. Accordingly, the 2021 publication of the 2nd Edition of the Good Practice Guide: Good Engineering Practice (GEP GPG) updated the definition and understanding of GEP within regulated industry, establishing GEP as a lifecycle system supporting the effective, efficient design and delivery of engineered systems and enabling the QRM-based integrated C&Q process.

Speaker(s):

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