CAPA effectiveness verification methods for different types of CA

#1
I am working to set up the effectiveness verification process for corrective and preventive actions at my work. All we are doing now is validating the completion of actions by looking at documents, installing of new tools, etc but not effectiveness. The CAPA are categorized into different groups such as documentation updates, Improve Mfg. Process/Recipe, Poka Yoke, and so on. Is there a guideline as to what kind of verification methods can be used based on action type?
 
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Alan_DB

Starting to get Involved
#2
Hi Hnin MO,

The verification of effectiveness will very much depend what your original problem was. You can use any method you like to verify that your actions have been effective in preventing reoccurrence or potential occurrence. Of course, if it is possible to use statistics this is even better but not mandatory.

I have seen some instances where each for each individual action there is an effectiveness check, or all of them together as a whole.

Personally, I don't like to write myself into a corner so I provide space for a plan to be documented, how that is completed will very much depend on circumstance.
 

Thee Bouyyy

Multiple Personalities
#3
Is there a guideline as to what kind of verification methods can be used based on action type?
There is no such guideline exist. As @Alan_DB said in above post, the verification of effectiveness will very much depend what your original problem was. Adding more,

Still as an example what my clients are doing as of now, below are some activities that are performed to verify the effectiveness of the corrective actions.

1. Corrective action type - Providing resources
Method of evaluation of effectiveness of corrective action - Physical verification shall be done to ensure the effective utilization of resources provided.

2. Corrective action type - Changes/ revision in QMS
Method of evaluation of effectiveness of corrective action - Auditing shall be done to ensure the effective implementation of revised QMS and/or interviewing the concern personnel to understand whether the changes have been properly communicated.

3. Corrective action type - Imparted training
Method of evaluation of effectiveness of corrective action - Training effectiveness evaluation shall be done by self and by superior to assess the effectiveness of the training.
 

Tidge

Trusted Information Resource
#4
The verification of effectiveness will very much depend what your original problem was. You can use any method you like to verify that your actions have been effective in preventing reoccurrence or potential occurrence. Of course, if it is possible to use statistics this is even better but not mandatory.
While I agree that there are some circumstances where it wouldn't be worth the effort to construct a study design for Corrective Actions (and frankly, I am not sure that it is mathematically possible, absent mental gymnastics, to do so for Preventive Actions), I do encourage CAPA teams to consider what sort of study design could be created for every action item in a CAPA. My motivation is that by trying to construct a study design to gage the effectiveness of an action item, the team will have to make some meaningful assessments about the seriousness of the problem and the seriousness of the proposed action item.

Usually by the time a problem has escalated to CA, someone has already made a determination that "this must be fixed", but occasionally the thing "to be fixed" isn't as well understood as folks presumed. I have occasionally seen corrective actions implemented that would be impossible to prove are doing anything. In such cases, I'd rather not implement those... but at least with math I can argue that we don't have to spend much effort on an effectiveness check.
 
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