"Closing Out" Corrective and Preventive Actions

Q

QA_Scot

#1
Hi All,

I have a number of issues where corrective actions have been raised to address external audit findings. One of the Audit finding requires every single analytical method to be updated- There are over 100!
Do I wait for all methods to be updated and approved ? If so, I will have a corrective action request open for over 12 months perhaps longer due to staff shortages.Any advicewould be appreciated as we have another external Audit coming up in July. I would really like to have a proposed plan of action.

If the C&PA/CAPA/CAR is "closed out" how do you ensure that all actions are implemented. In addition, any preventative action which may require monitoring over a prolonged period of time.

Thanks in advance.

QA_Scot.
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
Re: "Closing Out" Corrective and Preventative Actions

I can only comment on one aspect of your post: "If the C&PA/CAPA/CAR is "closed out" how do you ensure that all actions are implemented." Hopefully others will help out with your question as well.

Corrective Action(s) are Closed Out by Verification of Corrective Action(s) taken. This is the last step in the Corrective Action process. You may want to look at 8-D forms as they have the "standard steps" in the Corrective Action process. For all intents and purposes they are sequential.

How you verify the Corrective Action is Effective depends upon what the specific problem was. You have to determine what criteria to use to be able to be confident that your corrective action does, in fact, work (is *effective*). This helps to verify that what you determined to be the "Root Cause" was the *real* root cause. DISCLAIMER: This is not 100%, always true - True Root Cause of a nonconformance can be elusive in some cases.

Preventive Actions are part of the corrective action process where one looks at other processes and products which the root cause of the corrective action indicates may be affected.

You might want to take a look at The 8-D system. This is an old presentation and this slide really doesn't address the output (well, I guess in step 7 - Prevent Recurrence) where a corrective action system outputs what I consider an input into the Preventive Action system. I consider it a Preventive Action input because (for example) it *may* be a process issue where although other products may not yet have exhibited the failure mode, if not corrected possibly will - Different products made by the same process.

Just some thoughts.
 
P

PaulGr

#3
Re: "Closing Out" Corrective and Preventative Actions

Hi QA_Scot,

It seems you are looking for some sort of trick to hide a corrective action that takes over 12 months to solve? I would suggest following the basic approach of Marc (above) and prepare an answer for future audits why it is acceptable that this specific corrective action takes over 12 months...

Cheers, Paul
 
T

trainerbob

#4
Re: "Closing Out" Corrective and Preventative Actions

I guess I don't understand what is meant by "every single analytical method to be updated". Who is requiring this. Is this a major or a minor from a CB?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Re: "Closing Out" Corrective and Preventative Actions

I also want to know more details.

Which standard were you being audited to?

What was wrong with the analytical method, which causes over 100 of them to be noncompliant - what exactly is the nature of their noncompliance?

As has been stated, corrective action requires all of the needed "corrections" are made. But verifying effectiveness wants more from us. To be effective there needs to be some action taken to address the questions

1) Why did this happen in the first place?
2) Why did this thing manage to go along without detection?

These are to be addressed through a root cause analysis that determines the independent variable(s) - that which permanently changes the outcome, in this case the non-compliant condition of these analytical methods.

Without more details I'm afraid I can't offer anything better than this.
 

Ajit Basrur

Staff member
Admin
#6
Re: "Closing Out" Corrective and Preventative Actions

I think the poster refers to the analytical method verification or validation from the Pharmaceutical industry !

QA Scot, can you pl tell us more on the nature of those analytical methods ? Are they inhouse developed or Pharmacopeial methods ?
 
S

Saratogasix

#7
Re: "Closing Out" Corrective and Preventative Actions

I am seriously struggling with a Verification of effectiveness right now. The problem was a very limited situation that had occurred once in our company's history. A Quality Board recommendation outside of it's standard field action determnination was not implemented in a timely manner. I have fixed the gap in our process map but how do I prove effectiveness? It will only be utilized or tested maybe once in the next 10 years. I can't leave the CAPA open until it gets proven and I can't think of a way to simulate a scenario. Any suggestions?????
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: "Closing Out" Corrective and Preventative Actions

I can't leave the CAPA open until it gets proven
Why not? That's another paradigm that needs questioning... If the corrective action is product specific, then you CAN'T verify it's effectiveness until next time. If it is only exercised once every 10 years, you are safe.....everybody will forget the issue....:tg:

Where is the requirement that state that a corrective action implementation has to be verified for effectiveness within 1 month, 6 months, 2, 5, 10 years?
 

Stijloor

Staff member
Super Moderator
#9
Re: "Closing Out" Corrective and Preventative Actions

I am seriously struggling with a Verification of effectiveness right now. The problem was a very limited situation that had occurred once in our company's history. A Quality Board recommendation outside of it's standard field action determination was not implemented in a timely manner. I have fixed the gap in our process map but how do I prove effectiveness? It will only be utilized or tested maybe once in the next 10 years. I can't leave the CAPA open until it gets proven and I can't think of a way to simulate a scenario. Any suggestions?????
This is a classic example of a situation that happens at a very low occurrence level. Based on this you can determine recurrence very unlikely and close the CAPA.

Stijloor.
 

Jim Wynne

Staff member
Admin
#10
Re: "Closing Out" Corrective and Preventative Actions

I am seriously struggling with a Verification of effectiveness right now. The problem was a very limited situation that had occurred once in our company's history. A Quality Board recommendation outside of it's standard field action determnination was not implemented in a timely manner. I have fixed the gap in our process map but how do I prove effectiveness? It will only be utilized or tested maybe once in the next 10 years. I can't leave the CAPA open until it gets proven and I can't think of a way to simulate a scenario. Any suggestions?????
Why was formal corrective action deemed necessary to begin with? It seems that your company has painted itself into a corner with its CA requirements. You should be able to close the thing out now on the basis of the problem being an outlier that doesn't merit formal CA. If you can't do that, your system is at fault.
 
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