Explanation on definition CA/PA directly from ISO or FDA

01mercy

Involved In Discussions
Does anyone know of material directly from ISO or FDA which explains CA/PA beyond the definition but with examples?

Thanks
 

Bev D

Heretical Statistician
Leader
Super Moderator
@01mercy what is your real question? Your posted question is quite general and vague; we can provide much better advice if we know specifically what you are actually asking about….we have answered many many questions on this topic and provided many many examples so we can probably address your concerns pretty well…
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
This is an example from CHATGPT that appears to be correct and has depth

ChatGPT said:​


A Corrective and Preventive Action (CAPA) response to the FDA must address the root cause of an identified issue, clearly outline the actions taken to correct it, and prevent recurrence. The FDA expects that CAPA responses adhere to 21 CFR Part 820 (Quality System Regulation) for medical devices, or 21 CFR Part 211 (cGMP for finished pharmaceuticals), depending on the nature of the business.
Here is an example of a CAPA response that could meet FDA expectations for a medical device manufacturer:

Subject: CAPA Response to Observation #X from FDA Form 483
Date: [Insert Date]
FDA Reference: Observation #X from FDA Form 483 issued on [Date]

1. Problem Description and FDA Observation:
During the FDA inspection conducted from [Date] to [Date], the inspector noted the following issue, documented as Observation #X on FDA Form 483:
Observation: Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, CAPA #12345, initiated to address non-conformances in Product XYZ, did not identify the root cause of the issue or include appropriate corrective and preventive actions.
2. Immediate Correction:
Upon receiving FDA Form 483, the following immediate actions were taken:
  • Affected product lots (Lot #ABC123) were placed on hold.
  • A product recall was initiated for the impacted batches to avoid risk to patients.
  • Manufacturing of Product XYZ was suspended until the CAPA was fully investigated and implemented.
3. Root Cause Investigation:
We initiated a comprehensive root cause analysis in compliance with 21 CFR 820.100(a)(2), using the following methodologies:
  • Failure Modes and Effects Analysis (FMEA) to identify potential failure points in the production process.
  • Interviews with production operators and review of batch records from the last 12 months to identify deviations.
  • Laboratory testing of retained samples.
The root cause of the non-conformance was traced to a malfunction in the automated dispensing system that was incorrectly calibrated, leading to incorrect measurements of a critical raw material. This was confirmed by historical review of machine calibration logs and operator error reports.
4. Corrective Actions:
The following corrective actions have been implemented, per 21 CFR 820.100(a)(3) and 820.100(a)(4):
  • The automated dispensing system was recalibrated and validated, with detailed verification performed to ensure accuracy within acceptable limits.
  • Affected products (Lot #ABC123) were recalled, and impacted devices were retrieved from the market.
  • Operators involved in the process have been retrained on equipment calibration procedures and the importance of reporting equipment malfunctions.
5. Preventive Actions:
To prevent recurrence, the following preventive actions have been established, as required by 21 CFR 820.100(a)(5) and 21 CFR 820.100(a)(6):
  • A new calibration schedule has been implemented, requiring more frequent validation of the dispensing system, in line with ISO 13485 and internal procedures.
  • An automated alert system has been added to notify the quality team when calibration falls outside the acceptable range.
  • Updated SOPs have been distributed to ensure that deviations related to calibration are flagged and addressed immediately.
6. Verification of Effectiveness:
We have established monitoring procedures per 21 CFR 820.100(a)(7) to ensure the effectiveness of the corrective and preventive actions. The verification plan includes:
  • Quarterly audits of the dispensing system’s calibration status and the production line for the next 12 months.
  • Periodic reviews of operator training effectiveness through competency tests.
  • Review of non-conformance trends at the monthly CAPA review board meeting to detect any emerging issues.
7. Conclusion:
All CAPA-related actions have been completed, and we are confident that the risk of recurrence has been minimized. Documentation of all actions taken has been archived in accordance with 21 CFR 820.100(b).
We respectfully request FDA’s approval of the above CAPA actions and are available to provide any additional documentation or clarification if required.
Sincerely,
[Name]
[Title]
[Company]
[Contact Information]

Regulatory References:​

  1. 21 CFR 820.100(a) – Corrective and preventive action procedures must be established and maintained to ensure issues are identified and resolved.
  2. 21 CFR 820.100(a)(2) – Requires investigation of the cause of nonconformities.
  3. 21 CFR 820.100(a)(3) – Requires identification of corrective action needed to prevent recurrence.
  4. 21 CFR 820.100(a)(4) – Requires verification or validation of corrective actions to ensure effectiveness.
  5. 21 CFR 820.100(a)(5)-(6) – Establish procedures for implementing preventive actions.
  6. 21 CFR 820.100(b) – Requires documentation of all corrective and preventive actions.
This response demonstrates compliance with the FDA’s Quality System Regulation (QSR) requirements while addressing the specific FDA observation in detail.
 

01mercy

Involved In Discussions
Hi all thank you.
Sorry if my post was vague, it was clear in my mind.

@Bev D I will be more specific by using the answer of @Ed Panek

Since my core work is now on CAPAs I feel the need to resolve an issue which is part of discussion throughout my career but it was not as important as now to have it straight.

I stumbles upon an old video on YouTube
I once watched and again I think in the big global cooperation I work for I think we have a wrong view on what corrective actions and preventive actions really are. I identify that this is caused because people can interpret the definitions of them differently. Occurence and reoccurence in relation to the cause of it seems to give room for stating preventive actions to be corrective actions while I suspect they aren't.

To put it simple there is a defect product found in the field. This one gets a correction.
A few batches are suspected to have them also. They are recalled and of those, the defects also get a correction. The recall is seen as product containment preventing the issue from exposing itself further.
The related make proces of that product gets a process containment of products being inspected 100% and the defect product found also gets correction.
Now RCA is being conducted and shows the primary root cause is a missing instruction in the process.
The corrective action is to write and implement this instruction.

This is how we define it where I work and even FDA auditors accept this.

However from the chat gpt and my yt vid it seems that the recall is a corrective action and implementing the work instruction is a preventive actions.

99% of our CAPAs here don't have preventive actions defined whereas from the examples I understand most of them should but those are designated as corrective actions.

Now in order for me in the environment I work (a company just like Heineken interms of size and span) to make a solid case, I must have more than only a YouTube vid and people on a forum explaining (no doubt in the knowledge).
Therefore I was asking if any of the institutes like ISO or FDA have an example that makes this clear just like the chat got example, because if I have a clear example from them people will be more open to listen and consider the feedback.

But I do find it strange that no auditor ever mentioned this or corrected on it.
 
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Tidge

Trusted Information Resource
However from the chat gpt and my yt vid it seems that the recall is a corrective action and implementing the work instruction is a preventive actions.

That's doesn't strike me as strictly correct, neither for the specific example (for a found defect) nor in general (if both are done for some reason). Both a recall and a revised work instruction are action items. For an example where a WI is revised in anticipation of a possible defect that hasn't occurred, that would be an example of a preventive action (in FDA's view... at least as far as medical devices are concerned). There is IMO a slight difference between CA (or PA) records and individual action items which are part of the CA (or PA) process. Theoretically a CA record could spawn a separate PA record, but once a defect has been observed it is almost certainly cleanest(*1) just to have the diverse action items (and their effectiveness checks) in the same Corrective Action record.

(*1) I mean "cleanest" in the narrative and record-keeping senses, but also from the perspective of "Finally, was the observed issue resolved?" I'm sure we could share plenty of examples of observed defects that had multiple action items for which only some were "effective" (e.g. "train operators harder") while others (e.g. "specify a different component") did not prevent reoccurrence of the defect. [I realize I am sidestepping some root-cause analysis and critical thinking here, but those are common action items in my experience.]

It is rare in my experience that medical device manufacturers will formally implement Preventive Actions per their QMS. This is not to say they won't have things like preventive maintenance procedures for equipment, a calibration program for measurement systems, line clearance procedures, training/development, etc... it is more than there is overhead involved with a QMS' CA/PA process (often "8-D") that organizations don't have an appetite for. At an immature (CMMI) company that I was very familiar with, there had been less than 50 PA (*2), but there were likely tens-of-thousands of CAs (no exaggeration! I don't want to get into it).

At that company, whenever there was a discussion about a PA (and there were many "true" PA proposed, to be sure) the outcomes were almost always one of the following:

  • "Yes, that is something we should do. Run the change but don't start a PA."
  • "Leadership is unconvinced a change is necessary, after all we've never had that problem. Don't bother with a PA."
  • "A director has been given a mandate to make certain changes, we'll put it in their Quality Improvement Plan so don't start a PA.
(*2) Approximately half of the PA that had been started at that company were cancelled. I can recall only two PA that progressed through what most Quality professionals would recognize as a legitimate 8-D process, and those were both spear-headed by a newish Quality Manager who I think was partially motivated to demonstrate that the PA part of the CA/PA process worked.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Tidge is correct that a recall is NOT in itself a corrective action but a correction that is part of the overall process of corrective action. Adn work instructions can be preventive actions IF implemented BEFORE the defect ocsurs. If afterward it is a corrective action to prevent recurrence.

Auditors and the FDA/ISO don’t really publish examples or discuss them as they are typically intellectual property and covered by NDAs. Also these entities aren’t exactly experts in “root cause analysis”. I have posted some examples of root cause analysis in the resources section.

First the exact definitions.
Correction is the act of bringing specific units or events into specification. Rework or sometimes repair (although in some industries (FAA and aerospace) repair has a definition that varies from rework. But for the purposes of this application they are similar enough). Correction does nothing for future builds.
Corrective action is taking action against the causal mechanism (aka root cause) that will prevent future occurrences. Corrective Action takes place AFTER a defect has occurred.
Preventive Action is an action taken BEFORE a defect occurs and it prevents the occurence. Preventive action examples are mistake proofing, single piece flow, FMEA/Design, etc. Of course these actions can also be corrective action when taken AFTER a defect occurs. ISO has abandoned the “Preventive Action” as it was confusing and too many auditors, consultants and internal people tried to copy the Corrective Action approach of a form and data and review and approval which was not necessary and only served to slo down real preventive actions as it was so bureaucratic.

Chat GPT is not an expert and often pulls information from non-expert sources, so reader beware.

Unfortunately too many people get these wrong and mis-state them. These individuals are also not expert at “root cause analysis”. The experts are here (and in other places, in reputable consulting firms and have published. You can find many of these published resources in my material in the resources section. There are NO RCA experts at the FDA or ISO. There are some at the NTSB as they investigate crashes…
 

01mercy

Involved In Discussions
So basically my understanding and our way of working is correct.
Corrective actions are towards the primary and other identified root causes.

My understanding of a preventive actions as a simple example is that someone spots something wrong in a process that ,could, lead to a defect/NC but has not done so yet and therefore it is fixed by a preventive actions that adresses its root cause.

I think the confusion comes for many people when people challenge and debate that corrective actions to address the root cause of a defect/NC that has already occurred are preventive actions because they fix the root cause and prevent the defect/NC from reoccuring in the future
 

Tidge

Trusted Information Resource
These individuals are also not expert at “root cause analysis”. The experts are here (and in other places, in reputable consulting firms and have published. You can find many of these published resources in my material in the resources section. There are NO RCA experts at the FDA or ISO. There are some at the NTSB as they investigate crashes…
This is IMHO the most important thing to keep in mind: getting to the root cause(s), implementing correction(s), and verifying the effectiveness of the correction(s) with legitimate effectiveness strategies. If each of those isn't happening, then it isn't CA (or PA).
 

Bev D

Heretical Statistician
Leader
Super Moderator
While I disagree with your use of the words correction(s) and PA in the context of the standards’ definitions in the end it doesn’t matter what the words mean as long as the actions are correct. (The downside of not beino correct and precise in our definitions is that the wrong interpretation can be used to sty my true improvement; e.g. if someone says remediation (rework, repair scrap) is a “corrective action” then that correction stops true corrective action against cause to prevent future defects. Seen it too many times)

I do agree with you that there are few people who actually know how to determine the causal mechanism (the use of the term ‘root cause’ itself gets in the way) and to determine and implement actions that will prevent recurrence and then to demonstrate effectiveness is tough fro many people - as witnessed by the thousands of questions we’ve gotten here on the topic. There are some organizations that have narrow manufacturing products where the processing is well known and therefore ‘problems’ are usually very simple and straightforward….but most of us deal with complex products that incorporate many engineering and scientific disciplines in our products and processes so Problem solving is also complex. And human based problems can be complex and not well understood in any industry.

When I teach problem solving it takes 4 40-hour weeks and I still have to coach and mentor the trainees to proficiency in the skill… the definitions of the terms are only the first high barrier.
 
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