QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q
Complimentary
Learning Level: Intermediate
Time: 1100 - 1200 EST
Session Length: 1 hour
GEP during the project execution lifecycle, (i.e., requirements definition, design development, fabrication, installation, and commissioning), provides the foundation of an integrated C&Q approach. GEP represent the first and most impactful step for implementation of the ISPE best practices for project delivery. GEPs can be implemented without a major change to the existing global or site quality management systems and SOPs. Getting GEPs right has shown to drastically impact project delivery timelines.
EQP can be viewed as a philosophy that fosters modifications of the appropriate site Quality Systems, such as engineering, QA, validation, and manufacturing, to enable the site PQS to accept the application of good engineering practices during project execution for the purpose of meeting cGMP needs for qualification.
Learning Objectives
- The key area of understanding is that the application of GEP to FSE for qualification addresses both quality impacting and quality non-impacting user requirements and verifies conformance to all supporting engineering specifications and support the operational user requirements
- Good Engineering Practice (GEP) should be the basis for how SMEs review and confirm engineering designs are incorporated during fabrication and construction.
- The successful implementation of GEP and the Engineering Quality Process (EQP) are crucial for the effective delivery of FSE fit for intended purpose
