QRM Based Integrated C&Q Series—System Boundaries and System Classification

Complimentary
Learning Level: Intermediate
Time: 1000 - 1130 EST 
Session Length: 1.5 hour

This is the sixth webinar in the C&Q CoP ten-part webinar series. System boundary definition and system classification is a key project deliverable of the QRM C&Q process applied to commercial manufacturing production projects. The ability to define and classify systems as Direct Impact and not-direct impact provides both a valuable project management and project control tool for the Project Manager and the project team and the identified DI Systems will transition to the next step of the C&Q process: System Risk Assessment. In addition to providing the rational for doing SC, this webinar will also provide some background and history, explain the various approaches and considerations that need to be addressed in setting system boundaries, and provide an overview of the System Classification question and answer process as described in ISPE Baseline 5, 2nd Edition. As part of the webinar example systems and system P&IDs will be presented to enable understanding of the boundary setting rational. The webinar will also provide a better understanding of the relationships between URSs and systems boundaries, how boundaries may be adjusted to incorporate quality impacting elements/components within DI System boundaries, and how scalability can be applied to the boundary setting process.

Learning Objectives

  • Understand the process for establishing system boundaries, the importance of providing system boundaries, the relationship between system boundaries and URS, and how to apply scalability.
  • Understand the rational in support of defining Direct-Impact Systems and not-direct impact systems and how SC is positioned in the QRM C&Q process.
  • Insight into the System Classification process and how to apply a scalable approach.

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Speakers

Steven Wisniewski
CAI Retired Principal Consultant
Matthew Galley
Sr. Director, Commissioning and Qualification
VEQTOR