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Corrective Action for a scenario where Assignable Cause is not confirmed


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View Poll Results: How to Handle CA-PA when root cause is NOT established/assignable.
A separate CA is not required or relevant. 0 0%
CA, must still be prioritized to the most probable root cause. 6 100.00%
CA and PA are same. 0 0%
Voters: 6. You may not vote on this Poll because you are not Logged In.


Related Topic Tags
assignable causes, corrective action (ca)
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  Post Number #1  
Old 23rd December 2016, 06:47 AM
v9991

 
 
Total Posts: 892
Apple Corrective Action for a scenario where Assignable Cause is not confirmed

by definition,
* CA is ensuring/ arresting the recurrence of problem or root-cause ( process of reacting to product problems, customer
complaints or other non-conformities and fixing them)
* PA is about ensuring other 'potential' recurrence of problems/root-cause. (detecting potential problems or nonconformance's and eliminating
them)

now how to handle CAPA in a scenario where root-cause is NOT- established/assignable.

Last edited by v9991; 23rd December 2016 at 06:54 AM.

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  Post Number #2  
Old 23rd December 2016, 07:49 AM
Pancho's Avatar
Pancho

 
 
Total Posts: 775
Re: Corrective Action for a scenario where assignable cause is not confirmed.

Here's my take: Corrective and preventive actions are improvements (desirable modifications) to a process. And vice versa - improvements to a process are CA or PA, whether or not they were done formally (through the CAPA procedure). Conversely, if an action doesn't modify a process then it is not corrective nor preventive. I wish this was clear in the standard. It would eliminate a lot of the confusion.

If a NC exists, then there is a root cause. If the root cause hasn't been established, then dig deeper using one or several problem solving methodologies. Once you've established the root cause, then it may be such that you really can't modify your process to eliminate it, perhaps because it would be too expensive or because no one in your team can think of a way of modifying the process. In that case, you may have to live with inspecting the recurring NCs out of the product. But that, itself, can be your CA, as the healing inspections become part of your process and thereby it is modified for the better.

If no NC exists, and you can't establish a root cause for the first occurrence of a potential NC, then maybe you don't need to take preventive action. That means that you wouldn't modify your process.

Last edited by Pancho; 23rd December 2016 at 08:21 AM.
Thank You to Pancho for your informative Post and/or Attachment!
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  Post Number #3  
Old 23rd December 2016, 02:08 PM
PaulJSmith's Avatar
PaulJSmith

 
 
Total Posts: 544
Re: Corrective Action for a scenario where assignable cause is not confirmed.

If there is indeed a nonconformance, then there is indeed also a root cause of that nonconformance. Something had to cause it. Just because you haven't yet discovered it doesn't mean it doesn't exist. As Pancho noted, you just need to dig deeper, or maybe in a different direction, until you find it. Not until that point can you turn to the task of developing a corrective action for it.
  Post Number #4  
Old 23rd December 2016, 03:11 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,451
Re: Corrective Action for a scenario where Assignable Cause is not confirmed

Quote:
In Reply to Parent Post by v9991 View Post

now how to handle CAPA in a scenario where root-cause is NOT- established/assignable.
If you can't pinpoint the actual cause, you end up with potential cause(s). You then institute preventive action(s) in such preventive cause(s) and the end result should be the same: no repeat NC's.
Thanks to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #5  
Old 24th December 2016, 12:53 PM
v9991

 
 
Total Posts: 892
Re: Corrective Action for a scenario where assignable cause is not confirmed.

Quote:
In Reply to Parent Post by Pancho View Post

Here's my take: Corrective and preventive actions are improvements (desirable modifications) to a process. And vice versa - improvements to a process are CA or PA, whether or not they were done formally (through the CAPA procedure). Conversely, if an action doesn't modify a process then it is not corrective nor preventive. I wish this was clear in the standard. It would eliminate a lot of the confusion.
if you meant the product-process-step, .... there are instances where the process (not the product-itself, but the activity, (business-process-step )might have slipped. (relevant more so, from perpsective of a regulated environment perspective, and also from compliance to standard (s))

Quote:
In Reply to Parent Post by Pancho View Post

If a NC exists, then there is a root cause. If the root cause hasn't been established, then dig deeper using one or several problem solving methodologies. Once you've established the root cause, then it may be such that you really can't modify your process to eliminate it, perhaps because it would be too expensive or because no one in your team can think of a way of modifying the process. In that case, you may have to live with inspecting the recurring NCs out of the product. But that, itself, can be your CA, as the healing inspections become part of your process and thereby it is modified for the better.
Quote:
In Reply to Parent Post by Sidney Vianna View Post

If you can't pinpoint the actual cause, you end up with potential cause(s). You then institute preventive action(s) in such preventive cause(s) and the end result should be the same: no repeat NC's.
True, if we dig deep, we will eventually figure out the cause; however,
the time-effort spent for such instance where the root-cause might not be always relevant-pertinent to be established,; viz., even in software, there are bugs which are difficult to reproduce.! ref. another example!
"
Quote:
Solutions can be re-injected as part of an investigation where a transient equipment malfunction is suspected. Such hypotheses are difficult to prove. However, reinjections can provide strong evidence that the problem should be attributed to the instrument, rather than the sample or its preparation.
"

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Quote:
In Reply to Parent Post by Pancho View Post

If no NC exists, and you can't establish a root cause for the first occurrence of a potential NC, then maybe you don't need to take preventive action. That means that you wouldn't modify your process.
i personally feel, that there is an opportunity to see PA as a sub section of continual improvement. ( CI intended to provide positive benefit, and when we see PA as an extension of CI, which eliminates the negative impact of the process.!
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