-->

Mar 25, 2014

Taking Effective Actions: CAPA Webinar Part 2

By James Jardine, Marketing Communications, MasterControl Inc.

Taking Effective Actions: CAPA Webinar Part 2In the second webinar of a three-part series from MasterControl, quality expert Ken Peterson demonstrates how companies can develop better corrective and preventive actions (CAPA) to ensure quality and compliance. In the second installment, Peterson focuses on key decision points and the types of actions that should be taken depending on the quality event. He points out the importance of containing issues at the department level, if possible, before moving them into a formal CAPA process. Peterson discusses four possible actions to be taken when dealing with quality events: no action (the “wait and see” approach), corrections (with a focus on the immediate situation or containment), corrective actions, and preventive actions (to preemptively deter issues from occurring in the future). 


In the CAPA process, any action taken must be oriented toward finding and eliminating a root cause. As such, Peterson reminds viewers that every solution has a cost, so there are a few questions that need to be taken into consideration when selecting the best action for eliminating a root cause:
  •  Are multiple components needed to achieve complete removal?
  • Will the solution completely remove the root cause?
  • Is there a possibility that the solution will cause other problems?
Once these determinations are made, it is time to find the best solution for resolving a quality event. At this point, Peterson points out that you must first know the criteria: what are the absolutes that must be satisfied completely and what are the desirables that you hope to satisfy but are not necessary in order to resolve the issue? Also, you’ll need to determine if speed is more important than effectivity or vice versa.  

In the end, a final decision must be made that satisfies the absolutes and meets as many desirables as possible. According to Peterson—and common sense—some desirables are more important that others and need to be ranked for further separation or clarification. Any risks inherent to the actions also need to be taken into account.

Upcoming posts will summarize additional segments of the video series, so be sure to stay tuned to this blog. Or, you can view the webinar in its entirety here.  


James Jardine, Marketing Communications, MasterControl Inc.James Jardine is a Marketing Communications Specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.







Watch Videos

CAPA Part 2: Taking Effective Action (32:03)
The Power of an Integrated Quality Management System (47:47)

Free Downloads
Product Data Sheet: MasterControl CAPA Pharma™
White Paper: 21 CFR Part 11 Risk of Non-compliance

     



Related Links