Should CA be separated from PA? The debate continues!
CAPA, or Corrective and Preventive Action, continues to be a challenging topic in MedTech.
Medical device manufacturers are required to establish procedures for implementing corrective and preventive action. Yet, CAPA continues to be the top category of observations in FDA 483's and warning letters.
Generally speaking, the practice of CAPA in the medical device industry is through a single procedure. A common practice is to require both corrective and preventive action following an investigation of a nonconformance.
However, these are two very different concepts.
Corrective action (CA) - action taken to prevent recurrence of an observed nonconformity.
Preventive action (PA) - action taken to prevent occurrence of a potential nonconformity.
In short, preventive action is before a nonconformity actually occurs. Once a nonconformity has already occurred, can there be any preventive action?
This is why ISO 13485:2016, the International Standard for a Quality Management System applicable to medical devices, separates requirements for CA and PA in two different clauses.
Recently, I asked this question in a LinkedIn poll:
Agree/Disagree: Since ISO 13485 separates Corrective from Preventive action (CA vs PA), they should be covered in 2 different procedures.
A majority of respondents either strongly or somewhat disagreed with the statement above!
This poll, and a related post, collectively generated over 12000 views, and over 100 comments!
Clearly, CAPA is a topic of great interest in our industry! Here is a brief recap of the discussion captured in comments.
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The case for keeping CA and PA together
As noted above, a majority of respondents did not agree with the statement that CA and PA should be separated in different procedures. Here are some of the key points in favor of keeping them together:
The case for separating CA from PA
Even though a majority of respondents disagreed, 35% favored the separation of CA and PA. Here a few key points in favor of separating the two:
Bottom Line
Whether we should separate CA and PA into two different procedures is not the important issue.
But, there seems to be a broad consensus for applying a more proactive, risk-based approach to quality management. If we continue to focus only on fixing problems, we are not doing enough to prevent them from occurring in the first place.
It should be noted that CA and PA requirements in ISO 13485:2016 appear under the section on Improvement (Clause 8.5). One way to interpret this positioning is that in a continually improving quality system, we should see a gradual decrease in the number of observed nonconformities over time. This should be considered as an effectiveness measure for the CAPA process.
What do you think? Please share your opinion in comments below ??and continue the conversation.
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Please refer to IMDRF guidance on Correction, Corrective Actions and Preventive Actions. It is system in Quality Management System to support defect or non conformity occurrence/ reoccurrence!! https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n18-2010-qms-guidance-on-corrective-preventative-action-101104.pdf
Very helpful
Managing Partner, Compliance Architects LLC | Bringing innovation and strategic vision to FDA-regulated manufacturing
1 个月I've been doing CAPA work for more than half my career. It is remarkable the lack of understanding about what "it" is in both the medical device and pharma industries. CAPA is NOT a procedure. Or, not a single procedure. That's not how to think about it. It COULD be if you have a simple company with a simple set of activities but it's unlikely that a single procedure will cover adequately the integrated nature of what CAPA is supposed to be. CAPA is a system. It is a system for evaluating failures (potential and actual, broadly speaking) in first-pass quality and determining cause, impact, and response. CA and PA are important, but not the only aspects. It actually should be called "event response" because that more properly covers what CAPA should involve. Most companies struggle with even the basics -- how do things get into CAPA, and where do they come from? That lack of clarity and criteria is so problematic for many companies. What's in, what's out, and why. How do you evaluate? The other aspects are equally as important, and challenging, but with the proper application of system definition, structure, training, oversight, and review, CAPA can be a valuable system in your continuous improvement process.
Experienced Quality and Regulatory senior leader. I build teams that enable growth via risk based patient and customer focused Quality Management Systems, globally compliant documentation, and continual improvement.
1 个月Please, please, please! Preventive actions are related to, but are not the same as, corrective actions. The fact that they are defined similarly causes confusion and inconsistency when implementing them within the QMS, undermining their intended purpose. Not every organization has an experienced QMS professional at the helm, nor should they need to. The confusion caused by misinterpretation, as well as weak root cause analysis, ineffective corrective actions, and the lack of proactive implementation of preventive actions, could be avoided by providing additional clarity on these subjects in the standards and regulations that are being referenced.
These concepts may be separate, but they are as inexorably linked as right and left. When something goes wrong, we figure out why, which enables us to then determine how to prevent it. Far better we should figure out what could go wrong and prevent it before it happens! The acronym ought to be PACA -- prevention first.