CAPA (Corrective and Preventive Action) Plan Templates

E

epspolymer

We were recently audited by a medical company (we are not ISO certified); however, we do have a Quality system in place.

We had six findings in the audit, one major, the rest minor. They are requesting a CAPA plan for all six observations.

I have been scrounging the Internet for CAPA plan templates with no luck.

Does anyone know of a site that offers this type of template (among others)??

Please help!! :thanx:

~Joan~
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
If you scroll down this page, you will find a list of related threads discussing this topic.

Although, one thing puzzles me ... you indicate that your organization has a Quality system in place (albeit not registered to an ISO standard) and yet you do not have corrective/preventive action processes established? Am I reading the situation correctly?
 
E

epspolymer

RCBeyette said:
If you scroll down this page, you will find a list of related threads discussing this topic.

Although, one thing puzzles me ... you indicate that your organization has a Quality system in place (albeit not registered to an ISO standard) and yet you do not have corrective/preventive action processes established? Am I reading the situation correctly?
Click to expand...
You are partially correct. We established a Quality System and have intentions of ISO certification down the road (when finances permit). However, we have some weaknesses in the system which we are trying to correct, one of them being the Corrective/Preventive Action process. What I am lacking mostly are document templates, such as a CAPA action plan, in order to respond to the auditor properly. This is a first time occurrence for us, and we lack proper experience to respond.
 
Y

yodon

Leader
Super Moderator
Bear in mind that a template does not make the process! Understand the expectations for a CAPA system first and then the template more or less falls out of that. Blindly using a template from someone else may lead you to doing things that don't make sense for your company, for a CAPA system, or for any good whatsoever.
 
Pancho

Pancho

wikineer
Super Moderator
epspolymer said:
We were recently audited by a medical company (we are not ISO certified); however, we do have a Quality system in place.

We had six findings in the audit, one major, the rest minor. They are requesting a CAPA plan for all six observations.

I have been scrounging the Internet for CAPA plan templates with no luck.

Does anyone know of a site that offers this type of template (among others)??

Please help!! :thanx:

~Joan~
Click to expand...

Hi Joan,

Are the "findings" actual non-conformities, potential non-conformities or something else? If non-conformities, are they against your contract or against something else? An advantage of not claiming conformance to a standard is that you can't be held responsible for not conforming to that standard.;)

Assuming that the NCs are indeed against your commitments: The CA (Corrective Action) part of CAPA is the modification to your processes that prevents recurrence of a non-conformity. The PA (Preventive Action) part is a modification that prevents the occurrence of a non-conformity that hasn't happened yet. In either case, they are actions that prevent future occurrences of the non-conformity. They are not the fixing of the non-conformities themselves.

In order to take effective CA or PA you need to determine the Root Cause (or root causes) of your non-conformities. To determine the Root Cause, you can use one or more methods such as the 5-whys, fishbone, or Failure Mode and Effects Analysis. These methods are often lumped together into the term "Root Cause Analysis".

Once you have determined the root cause (or causes), the corrective (or preventive) action plan follows naturally. It is what must be done to eliminate the root cause. Thus, if you know the root cause for your NCs then your plan should describe how the process will be modified to eliminate it.

If you do not know the root causes, then your plan can't really be written for anything beyond finding the root cause. If you must reply immediately, then propose that you will conduct a Root Cause Analysis of the problem, and that the plan will be further developed once the RCs are determined.

Good luck!
Pancho
 
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