Verifying the Effectiveness of Corrective Action

Verification isn't an act of suspicion; it’s a necessary part of problem solving.

Wed, 06/17/2009 - 04:00

When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were effective or ineffective? My assumptions were as follows:

  • If they said they did something, then they certainly did it.
  • Whatever they did was directly related to the problem causes, or they wouldn’t have done it.
  • The action must have been effective; they would have told me otherwise.

 

All of these assumptions had to be correct, because I was working with seasoned professionals, right? Ha! Boy, did I learn a lesson.

People just want to get paperwork off their desks or out of their in-boxes as quickly as possible. Taking actions on problems is one of many responsibilities that people have and, unfortunately, it's not always top priority. That’s why it’s crucial that action be carefully verified. Verification is not an act of suspicion or disrespect; it’s simply a necessary part of problem solving.

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Comments

I've worked for several biotech companies that require the CAPA owners to verify the effectiveness of the corrections they put in place before QA will sign-off. This makes the CAPA owner accountable for their work and removes the requirement to randomly check effectiveness. Also, if management puts good performance metrics in place for their nonconformance investigations, it's easy enough to determine if your CAPA's are effective.

Sandra Gauvin
http://CurrentQuality.com

Why take responsibility from the manager responsible for determining and removing the root causes of the problem from the system?

Offer training, develop competence and ask the CEO to hold managers accountable for effective preventive and corrective actions instead of expecting the System's Manager to do their PACA verifications for them.

Then follow-up to examine the evidence they used to verify effectiveness.

John R. Broomfield

PS: Why do we say CAPA instead of PACA, surely preventive action happens before corrective action?

Idealy preventative action would have been built into the process of providing a service. Upon failure or inefficiency of the process resulting in noncompliance, a corrective action plan is done. The CAPlan includes the peventative, which becomes an improvement of the original process.

For me if we go PACA, it implies process design that is robust enough when implemenetd in such a manner that there is no noncompliance. 

Submitted by kingtim04 on Tue, 07/28/2015 - 17:34

Ensuring CAPA effectiveness is such a critical point when it comes to eliminating root cause. Other than the common effectiveness criteria of no repeat occurrences over a period of time, what are some other ways/techniques to verify your CAPA has been effective?

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