Good Practice Guide: Applied Risk Management for C&Q

Good Practice Guide: Applied Risk Management for C&Q cover image

Title:

Good Practice Guide: Applied Risk Management for C&Q

Author(s):

Andreopoulos, Nicholas; Block, Joerg; Calnan, Nuala F.; Cebular, Vincent J.; Chew, Robert E., PE; Christensen, Peter Werner; Dahmen, Kimberly A.; Dolgin, David D.; Dollard, Rose Mary A.; Franklin, Daniel G., CIRM, CxA; Hamm, Matthew Scott; Howard, Timothy P., CPIP, PE; McCarthy, Angela; McMenamin, Matthew; Nahabedian, Armen J.; Stewart, Ryan W.; Wingate, Guy; Wisniewski, Steven J.

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Author(s): Andreopoulos, Nicholas; Block, Joerg; Calnan, Nuala F.; Cebular, Vincent J.; Chew, Robert E., PE; Christensen, Peter Werner; Dahmen, Kimberly A.; Dolgin, David D.; Dollard, Rose Mary A.; Franklin, Daniel G., CIRM, CxA; Hamm, Matthew Scott; Howard, Timothy P., CPIP, PE; McCarthy, Angela; McMenamin, Matthew; Nahabedian, Armen J.; Stewart, Ryan W.; Wingate, Guy; Wisniewski, Steven J.

The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move from established baseline practice to a more efficient science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional commissioning and qualification practices, linking traditional terminology and approaches to the newer science- and risk-based specification and verification terminology and approaches applied in ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.

The approach described in the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification allows companies to achieve the benefits of a science- and risk-based model by outlining bridging strategies for organizations with well-established qualification-based Quality Management Systems and providing a roadmap showing the spectrum of potential approaches for this transition.

Table of Contents

Good Practice Guide: Applied Risk Management for C&Q

Pages: 140
Published: October 2011