-->

Apr 2, 2014

Making SMART Choices When Managing Quality Events: More Helpful CAPA Tips

By James Jardine, Marketing Communications, MasterControl Inc.

A previous blog post provided an overview of a portion of quality guru Ken Peterson’s “Taking Effective Action” webinar (the second of a three-part series) that outlines the keys to successful CAPA programs. This post summarizes the remainder of the second webinar in the series which can be viewed here.

Peterson provides a handy acronym to help us remember to make SMART actions when managing quality events and he provides helpful examples of each principle:

  • Specific: Is the action well stated and easy for the affected departments and stakeholders to understand?
  • Measurable: Can the action be validated and verified so that confirmation can be made easily in order to determine whether or not the action is indeed solving the problem?
  • Aligned: Does the action relate specifically to the root cause or is it possible that it is more closely related to a different cause?
  • Realistic: What makes you believe the action can actually be accomplished? Do you have the resources to take the action?
  • Time Bound: When does the action need to be accomplished? Are speed and efficiency factors?

Using the SMART criteria, Peterson gives some specific examples that illustrate how actions can and should be taken. He also reiterates the importance of documenting all actions. 


One segment of the webinar is also dedicated to the consideration of prevention, specifically:
  • How corrective actions can potentially affect the overall process or any other aspect of use downstream. 
  • How knowledge from one CAPA can be applied to other similar systems that have a likelihood of experiencing the same problem.
  • Potential problems that may occur that could possibly be addressed at the same time.
Because timing is everything, Peterson admonishes viewers to identify and eliminate potential problems ahead of time whenever possible. The key to preventive actions, he says, is to examine each cause and identify possible ways to prevent that potential problem from occurring. Selecting the areas of highest impact is the best starting point for reducing the possibility of occurrence.

When it comes time to implement the planned action, several factors come into play, such as:
  • Communications: Who needs to be “in the know”?
  • Required resources: Is the participation of other departments required?
  • Approvals: Who needs to be involved in the approval process?
  • Timeline: When does the action need to be accomplished by and what happens if the CAPA is left open too long?
When planning is thorough, Peterson says, it is much easier to avoid incomplete plans, unrealistic plans, and deviations from the plan. A focused plan effectively captures: the task, the appropriate owner, a realistic due date, an official date of completion, an action item, and an effectually communicated launch task.

To see the entire second episode of the three-part complimentary webinar series, click here. Look for upcoming posts to this blog that will summarize the third part of the CAPA webinar series, which will be focused on verification and validation. 



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