By Chip Bennett, PMP, Assistant Director, Global C&Q
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.
Under the Quality Risk Management (QRM) model, all testing adds value as verification activities; testing is commensurate with product risk; GEPs and Engineering SMEs are emphasized in the process; and Quality is focused on the identification, mitigation, control of risks to product quality and verification of the process risk control strategy. Under this model, GEPs as an Engineering Quality Process (EQP) enable the C&Q process.
However, historically, the Quality unit has not had sufficient trust in GEPs to facilitate their effective use in risk-based C&Q. Why has that trust been missing, and how can it be built?