Recommendations for criteria on creating a CAPA (Corrective and Preventive Action)

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Sidney Vianna

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Staff member
Admin
#2
Re: CAPA Criteria

Hi QACen, your question is too short and generic for anyone willing to help to give you meaningful advice. It would behoove to take the time and effort to clearly explain what you are trying to reach, the context of your question, the type of system/product, etc...

The quality of the answers one might get here at The Cove are proportional to the caliber of the questions. Questions that are too generic and too broad in scope normally are not answered to it's fullest potential.

If I were you, I would refine the question and expand it.
 

qusys

Trusted Information Resource
#4
Re: CAPA Criteria

wow?

does the CAPA also have a standard?
I try to help.
I think you could use a method related to problem solving , for instance in the sector of automotive there is 8D. It is very common and applicable in alle sector.
Make a research on the forum in 8D methology.
Other tools of quality functional for this are brainistorming, pareto analysys, 5 Why's, IS/IS not, fishbone diagram, decision making etc...
Hope this helps:bigwave:
 
S

ssz102

#5
Re: CAPA Criteria

I try to help.
I think you could use a method related to problem solving , for instance in the sector of automotive there is 8D. It is very common and applicable in alle sector.
Make a research on the forum in 8D methology.
Other tools of quality functional for this are brainistorming, pareto analysys, 5 Why's, IS/IS not, fishbone diagram, decision making etc...
Hope this helps:bigwave:
thanks for your help! i see
 
Q

QACen

#6
Re: Recommendations for criteria on creating a CAPA (Corrective and Preventive Action

Sorry for being too "generic". I want to help other employees in the company understand how to identify when an issue becomes a CAPA without sounding like a walking book of standards nor always having to come to the "only QA person" in the company. Is there a bullet list criteria that perhaps worked for others that was in plain and simple english? Thank you!
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Recommendations for criteria on creating a CAPA (Corrective and Preventive Action

Sorry for being too "generic". I want to help other employees in the company understand how to identify when an issue becomes a CAPA without sounding like a walking book of standards nor always having to come to the "only QA person" in the company. Is there a bullet list criteria that perhaps worked for others that was in plain and simple english? Thank you!
Not an exhaustive list, but as a starter, the following would normally call for CAPA:

- A recurring NC with a non-diminishing trend
- A severe problem, in terms of either safety or business impact
- A cited regulatory/legal deviation
 
#8
Re: Recommendations for criteria on creating a CAPA (Corrective and Preventive Action

Since this is in the 13485 forum, allow me to offer you this guidance document, which I previously found here in Elsmar Cove after searching along similar lines. This document may seem a little complex at first, but stay with it. It really does a good job of outlining the possible directions CAPA can go in as far as when escalation to full-scale action is appropriate, and distinguishes correction from corrective action, which really helped me plan and determine which kind(s) of action were appropriate in different cases.
 

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Q

QACen

#9
Re: Recommendations for criteria on creating a CAPA (Corrective and Preventive Action

Thank you! This will give some ideas.
 
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