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Mar 4, 2014

Be SMART: 5 Critical Factors in CAPA

Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.
Cindy Fazzi

By Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.


It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.
“The focus of CAPA is to arrive at a solution. And some solutions are better than others,” said Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team (1).
The February 2014 edition of GxP Lifeline features a free CAPA webinar, in which Peterson explained what “three loops in one” CAPA process means and why it’s critical for regulated companies.


Four Possible Actions
In the second part of the webinar, Peterson talked about the importance of selecting the right action for your quality event. To do that, you must have a clear understanding of the following basic actions:
No Action: As soon as the quality event has occurred (e.g., customer complaint), you and your quality team should be watching and observing, recording and tracking it. “No action” doesn’t mean inaction. It refers to monitoring low impact (non-risk) events and only taking action if the impact of the situation warrants it.
Containment Action: Depending on the issue, you may need to act right away. The goal for containment is to take the symptoms and bring them to a manageable level, so the issue won’t disrupt your day-to-day operations, cause safety or health problems, etc.
Corrective Action: Quality events with significant impact need a more permanent fix.  You need to know the root cause. This requires an investigation and a corrective response. Your goal is to eliminate the root cause.
Preventive Action: Often you need to address what quality issues are likely to occur and determine their likely causes. “Bear in mind that a corrective action is, oftentimes, a change and you’re going to need to consider how this change is going to affect other elements downstream in the process,” said Peterson. “If there’s a potential problem, it’s good to address it as a preventive action before the problem occurs and creates a new CAPA.”

Be SMART
In selecting the best action for a quality event, Peterson identified five factors that will lead you to what he called a SMART action: specific, measurable, aligned, realistic, and time bound (2).
1.    Specific: Is the corrective action articulate? Will affected stakeholders and departments understand it?

2.    Measurable: Can the corrective action be verified and validated? Can you easily confirm that the action is indeed solving the problem?

3.    Aligned: The corrective action must have one-to-one relationship with the cause of the problem. It must relate specifically to the cause and not something else.

4.    Realistic: To be realistic with your corrective response, you have to ask certain things, such as: Do we have the necessary resources? Will it involve other departments? Is the time frame realistic?

5.    Time Bound: You need to consider the speed and efficiency factor. When does the action need to be completed? You also have to consider the consequences of leaving CAPAs open too long, especially the possibility that it might result in negative audit results.
To view this webinar, click here.  If you missed the first part of Peterson’s webinar about closed-loop CAPA process, click here.
Reference:
(1)  Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team, has helped many organizations (including Abbott Laboratories, Johnson & Johnson, and IBM) come up with new quality management solutions that allow them to achieve enhanced and breakthrough results. He frequently speaks at industry events for organizations such as AAMI, PDA, the American Society for Quality Control (ASQ), Barnett International, The Executive Committee (TEC), and other industry forums. To learn more about Ken Peterson and the QCC, go to: http://www.mastercontrol.com/quality-management-software/quality-control/compliance-consulting.html?lne=lkey
(2)  The concept of SMART was introduced by Peter Drucker, who was world famous for his management theories. From “Management of Peter Drucker, Key Terms”; viewed on Jan. 31, 2014 at: http://www.business.com/guides/management-theory-of-peter-drucker-key-terms-36042/

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments.  Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York.  She has a master's degree in journalism from Ohio State University.




Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Watch Videos

CAPA Part 1: Improving CAPA Systems with a Closed-loop Methodology (38:22)
CAPA Part 2: Taking Effective Action (32:03)
Improving Quality with MasterControl (2:59)


Free Downloads
White Paper: Simplifying CAPA: Seven Steps
White Paper: How to Use Risk-Based Monitoring and Clinical CAPA to Ensure Compliance
White Paper: Does Your CAPA Need a CAPA?




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