Regulatory Open Forum

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks! 

For the medical device sector, be sure your corrective action process clearly and formally distinguishes between "correction" (e.g., ISO 13485 / ISO 9000 action to eliminate a detected nonconformity) vs. "corrective action" (e.g., ISO 13485 / ISO 9000 action to eliminate the cause of a nonconformity).

When verifying the effectiveness of a corrective action (e.g., per ISO 13485 clause 8.5.2 second paragraph indent f), remember that such verification of effectiveness is to verify that the corrective action(s) prevented recurrence of the nonconformity the next time(s) the process is executed.

If nonconforming labeling is corrected including corresponding regulatory approval, then I would call that "correction", not "corrective action".  Accordingly, the regulatory approval of the revised/corrected labeling is not a verification of effectiveness of the corrective action; instead, that is part of correcting the nonconforming labeling.

Instead, the verification of effectiveness of the corrective action needs to show that nonconforming labeling content doesn't happen again the next time(s) labeling is designed and implemented using the revised process for label content.  For example, you might consider requiring three consecutive future new label implementations whereby the revised label content process yields proper label content. That kind of approach shows that the new process indeed eliminated the root cause of the prior label content nonconformities.

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks! 

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks! 

First, there is no CAPA, since they are separate processes which address different kinds of problems. You have a corrective action, since you are dealing with a detected nonconformity.

There are two significant steps at the end of the process, both of which are often called closure. This gets confusing.

The penultimate step is to implement all the changes to eliminate the cause of the nonconformity.

The ultimate step is the effectiveness check to demonstrate that the changes did, in fact, eliminate the cause.

I usually recommend calling the steps "closed pending effectiveness" and "closed" respectively.

The difference is dead time. Since the actions are complete, there is no active work being done on the corrective action. You need to distinguish in your metrics of closure time.

In most cases one can't reach "closed pending effectiveness" until after implementing all of the actions. However, this case is out of the ordinary. I would create a category called "action pending regulatory approval". You can't "close pending effectiveness" because you have not completed all the actions. On the other hand, it is dead time until get regulatory approval.

Update your corrective action process and metrics with the new category.

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks! 

Further to my initial post and Dan's (and other instances about this in this Forum and elsewhere) about the "CAPA" acronym, I advise that, despite the pitfall of misunderstanding the meaning of "CAPA", we should nonetheless tread very lightly (if at all) if asserting that there is no such thing as "CAPA". To make such a gesture with an auditor or a premarket submission reviewer reasonably risks alienating and souring the relationship with the regulator, and could even lead to unnecessary issuance of nonconformities.  Indeed, "CAPA" does in fact exist, in the most tangible of ways, in the minds and operations of regulators.

Here are some examples of why we should continue to cooperate with the pervasive vocabulary "CAPA" (while assuring proper operational and procedural separation of CA from PA) rather than snubbing the regulators and the many firms who still employ that acronym:

• European notified bodies pervasively use the term "CAPA" and will ask you for your associated "CAPA" records/evidence. Snubbing them on that vocabulary is not advisable.

• ISO registrars pervasively use the term "CAPA" and will ask you for your associated "CAPA" records/evidence. Snubbing them on that vocabulary is not advisable.

• Even though the MDSAP audit model and ISO TC/210 (the author of ISO 13485) do a good job of avoiding the "CAPA" acronym, my experience is that MDSAP auditors still pervasively use the term when asking for records/evidence. Snubbing them on that vocabulary is not advisable.

• When enforcing actions like Warning Letters, FDA Compliance Officers routinely use the "CAPA" acronym, and require corresponding compliance.  For example, in a current active project for which the client approached me for help, the Compliance Officer via official correspondence said, "...your firm is required to ensure CAPAs are implemented. An FDA observation related to CAPA was previously cited at the conclusion of your [redacted] and [redacted] FDA inspections. Furthermore, a CAPA observation was listed within the Warning Letter issued to your firm in [redacted]..."

• FDA 483s and Warning Letters routinely use the acronym CAPA.

• The U.S. FDA officially segregates corrective and preventive action into a dedicated quality subsystem that the FDA officially calls "CAPA". 

• U.S. FDA PMA guidance: "...provide a copy of the procedure(s) for your corrective and preventive action (CAPA) system...explain how your CAPA system is tied to your risk management program...define how your CAPA system will address nonconforming practices...define how and what type of CAPA information will be submitted...explain how design changes made under your CAPA program interact with your design change control system...[and other pervasive use of CAPA" [emphasis added]

• U.S. FDA Quality System Inspectional Technique: "...four major subsystems are...CAPA... [emphasis added]

• U.S. FDA procedures for investigators: "...For all inspections covering CAPA - indicate which data sources were available for review...The Quality System regulation can be grouped into seven subsystems; however, the following four subsystems are considered major subsystems and are the basic foundation of a firm's quality management system:..CAPA..." [emphasis added]

• U.S. FDA CDRH Learn: "...your CAPA procedures are going to have a very broad scope and go throughout your quality system...complaints, as per 820.198, could trigger and feed into a CAPA...the preamble talks about CAPA activities...": [emphasis added]

• Although FDA will soon "converge" its current Quality System Regulation and related practices with ISO 13485:2016, I still continue to encounter FDA investigators and ISO 13485 auditors who pervasively use the term "CAPA".

First, there is no CAPA, since they are separate processes which address different kinds of problems. You have a corrective action, since you are dealing with a detected nonconformity.

There are two significant steps at the end of the process, both of which are often called closure. This gets confusing.

The penultimate step is to implement all the changes to eliminate the cause of the nonconformity.

The ultimate step is the effectiveness check to demonstrate that the changes did, in fact, eliminate the cause.

I usually recommend calling the steps "closed pending effectiveness" and "closed" respectively.

The difference is dead time. Since the actions are complete, there is no active work being done on the corrective action. You need to distinguish in your metrics of closure time.

In most cases one can't reach "closed pending effectiveness" until after implementing all of the actions. However, this case is out of the ordinary. I would create a category called "action pending regulatory approval". You can't "close pending effectiveness" because you have not completed all the actions. On the other hand, it is dead time until get regulatory approval.

Update your corrective action process and metrics with the new category.

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks! 

Further to my initial post and Dan's (and other instances about this in this Forum and elsewhere) about the "CAPA" acronym, I advise that, despite the pitfall of misunderstanding the meaning of "CAPA", we should nonetheless tread very lightly (if at all) if asserting that there is no such thing as "CAPA". To make such a gesture with an auditor or a premarket submission reviewer reasonably risks alienating and souring the relationship with the regulator, and could even lead to unnecessary issuance of nonconformities.  Indeed, "CAPA" does in fact exist, in the most tangible of ways, in the minds and operations of regulators.

Here are some examples of why we should continue to cooperate with the pervasive vocabulary "CAPA" (while assuring proper operational and procedural separation of CA from PA) rather than snubbing the regulators and the many firms who still employ that acronym:

• European notified bodies pervasively use the term "CAPA" and will ask you for your associated "CAPA" records/evidence. Snubbing them on that vocabulary is not advisable.

• ISO registrars pervasively use the term "CAPA" and will ask you for your associated "CAPA" records/evidence. Snubbing them on that vocabulary is not advisable.

• Even though the MDSAP audit model and ISO TC/210 (the author of ISO 13485) do a good job of avoiding the "CAPA" acronym, my experience is that MDSAP auditors still pervasively use the term when asking for records/evidence. Snubbing them on that vocabulary is not advisable.

• When enforcing actions like Warning Letters, FDA Compliance Officers routinely use the "CAPA" acronym, and require corresponding compliance.  For example, in a current active project for which the client approached me for help, the Compliance Officer via official correspondence said, "...your firm is required to ensure CAPAs are implemented. An FDA observation related to CAPA was previously cited at the conclusion of your [redacted] and [redacted] FDA inspections. Furthermore, a CAPA observation was listed within the Warning Letter issued to your firm in [redacted]..."

• FDA 483s and Warning Letters routinely use the acronym CAPA.

• The U.S. FDA officially segregates corrective and preventive action into a dedicated quality subsystem that the FDA officially calls "CAPA". 

• U.S. FDA PMA guidance: "...provide a copy of the procedure(s) for your corrective and preventive action (CAPA) system...explain how your CAPA system is tied to your risk management program...define how your CAPA system will address nonconforming practices...define how and what type of CAPA information will be submitted...explain how design changes made under your CAPA program interact with your design change control system...[and other pervasive use of CAPA" [emphasis added]

• U.S. FDA Quality System Inspectional Technique: "...four major subsystems are...CAPA... [emphasis added]

• U.S. FDA procedures for investigators: "...For all inspections covering CAPA - indicate which data sources were available for review...The Quality System regulation can be grouped into seven subsystems; however, the following four subsystems are considered major subsystems and are the basic foundation of a firm's quality management system:..CAPA..." [emphasis added]

• U.S. FDA CDRH Learn: "...your CAPA procedures are going to have a very broad scope and go throughout your quality system...complaints, as per 820.198, could trigger and feed into a CAPA...the preamble talks about CAPA activities...": [emphasis added]

• Although FDA will soon "converge" its current Quality System Regulation and related practices with ISO 13485:2016, I still continue to encounter FDA investigators and ISO 13485 auditors who pervasively use the term "CAPA".

First, there is no CAPA, since they are separate processes which address different kinds of problems. You have a corrective action, since you are dealing with a detected nonconformity.

There are two significant steps at the end of the process, both of which are often called closure. This gets confusing.

The penultimate step is to implement all the changes to eliminate the cause of the nonconformity.

The ultimate step is the effectiveness check to demonstrate that the changes did, in fact, eliminate the cause.

I usually recommend calling the steps "closed pending effectiveness" and "closed" respectively.

The difference is dead time. Since the actions are complete, there is no active work being done on the corrective action. You need to distinguish in your metrics of closure time.

In most cases one can't reach "closed pending effectiveness" until after implementing all of the actions. However, this case is out of the ordinary. I would create a category called "action pending regulatory approval". You can't "close pending effectiveness" because you have not completed all the actions. On the other hand, it is dead time until get regulatory approval.

Update your corrective action process and metrics with the new category.

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks! 

It's what you call a "sturdy indefensible".

Probably because it's so pronounceable.

Original Message:
Sent: 25-Oct-2023 11:54
From: Kevin Randall
Subject: Close CAPA pending Regulatory Approval of Actions

Further to my initial post and Dan's (and other instances about this in this Forum and elsewhere) about the "CAPA" acronym, I advise that, despite the pitfall of misunderstanding the meaning of "CAPA", we should nonetheless tread very lightly (if at all) if asserting that there is no such thing as "CAPA". To make such a gesture with an auditor or a premarket submission reviewer reasonably risks alienating and souring the relationship with the regulator, and could even lead to unnecessary issuance of nonconformities.  Indeed, "CAPA" does in fact exist, in the most tangible of ways, in the minds and operations of regulators.

Here are some examples of why we should continue to cooperate with the pervasive vocabulary "CAPA" (while assuring proper operational and procedural separation of CA from PA) rather than snubbing the regulators and the many firms who still employ that acronym:

• European notified bodies pervasively use the term "CAPA" and will ask you for your associated "CAPA" records/evidence. Snubbing them on that vocabulary is not advisable.

• ISO registrars pervasively use the term "CAPA" and will ask you for your associated "CAPA" records/evidence. Snubbing them on that vocabulary is not advisable.

• Even though the MDSAP audit model and ISO TC/210 (the author of ISO 13485) do a good job of avoiding the "CAPA" acronym, my experience is that MDSAP auditors still pervasively use the term when asking for records/evidence. Snubbing them on that vocabulary is not advisable.

• When enforcing actions like Warning Letters, FDA Compliance Officers routinely use the "CAPA" acronym, and require corresponding compliance.  For example, in a current active project for which the client approached me for help, the Compliance Officer via official correspondence said, "...your firm is required to ensure CAPAs are implemented. An FDA observation related to CAPA was previously cited at the conclusion of your [redacted] and [redacted] FDA inspections. Furthermore, a CAPA observation was listed within the Warning Letter issued to your firm in [redacted]..."

• FDA 483s and Warning Letters routinely use the acronym CAPA.

• The U.S. FDA officially segregates corrective and preventive action into a dedicated quality subsystem that the FDA officially calls "CAPA". 

• U.S. FDA PMA guidance: "...provide a copy of the procedure(s) for your corrective and preventive action (CAPA) system...explain how your CAPA system is tied to your risk management program...define how your CAPA system will address nonconforming practices...define how and what type of CAPA information will be submitted...explain how design changes made under your CAPA program interact with your design change control system...[and other pervasive use of CAPA" [emphasis added]

• U.S. FDA Quality System Inspectional Technique: "...four major subsystems are...CAPA... [emphasis added]

• U.S. FDA procedures for investigators: "...For all inspections covering CAPA - indicate which data sources were available for review...The Quality System regulation can be grouped into seven subsystems; however, the following four subsystems are considered major subsystems and are the basic foundation of a firm's quality management system:..CAPA..." [emphasis added]

• U.S. FDA CDRH Learn: "...your CAPA procedures are going to have a very broad scope and go throughout your quality system...complaints, as per 820.198, could trigger and feed into a CAPA...the preamble talks about CAPA activities...": [emphasis added]

• Although FDA will soon "converge" its current Quality System Regulation and related practices with ISO 13485:2016, I still continue to encounter FDA investigators and ISO 13485 auditors who pervasively use the term "CAPA".

First, there is no CAPA, since they are separate processes which address different kinds of problems. You have a corrective action, since you are dealing with a detected nonconformity.

There are two significant steps at the end of the process, both of which are often called closure. This gets confusing.

The penultimate step is to implement all the changes to eliminate the cause of the nonconformity.

The ultimate step is the effectiveness check to demonstrate that the changes did, in fact, eliminate the cause.

I usually recommend calling the steps "closed pending effectiveness" and "closed" respectively.

The difference is dead time. Since the actions are complete, there is no active work being done on the corrective action. You need to distinguish in your metrics of closure time.

In most cases one can't reach "closed pending effectiveness" until after implementing all of the actions. However, this case is out of the ordinary. I would create a category called "action pending regulatory approval". You can't "close pending effectiveness" because you have not completed all the actions. On the other hand, it is dead time until get regulatory approval.

Update your corrective action process and metrics with the new category.

What is the recommended practice for CAPA's whose actions require regulatory approval in order to be implemented.

For example, if the process for label content was updated and addressed the root cause however the necessary label updates cannot be fully implemented until regulatory approval is obtained, do you keep the CAPA open until all label updates have been fully implemented and regulatory approved or close the CAPA with the process/procedure updates in place that address the root cause. 

Keen to know people's opinions, CAPA's could be open for up to a year waiting on regulatory approval on remediated labels in the example above, however leaving the CAPA open until the label update is fully implemented closes the loop.

Thanks!