Non-functional Corrective Action - Could Not Find some Documents

[itsbiodiversity]

I started a new job a few months ago as QM from a retiree who did not keep up with things the way they should have. Prior to even glancing at a document I was hit with an internal audit that requested our CAPAs...well I could not locate them so we got a Corrective Action. For my Corrective Action I notified the auditor that since I was new I could not locate the files, they were located, completed, etc etc. I also updated the verbiage to ensure that I received the complaints and could manage them directly.

Now with my External Auditor (registrar) he thinks that's a pretty sorry excuse and wants another Corrective Action on what I suppose is my "newness" to the job at the time...because at this point there's not much I can do to improve the Corrective Action system it would seem. We are a small company and making great headway and listening to customer concerns. I did create a customer communication log to track any repetitive issues.

Can someone help me determine a root cause? My root cause of starting new and having another person's system in place on that date didn't please the auditor one iota.

Thanks.

 

[PaulJSmith]

It might be helpful to know exactly what requirement your external auditor is citing as non-conforming.

As to the first audit, it sounds to me like you may have some internal issues which need to be addressed.

 

[Golfman25]

So let me get this straight. You're on the job at a small company for a few weeks and boom they hit you with an internal audit. (Who in their right mind would do that?) You fumble around looking for some documents because you are still learning how the company and how your predecessor operated. The "auditor" issues a corrective action. You eventually find everything, update and "correct" the system.

Now some external auditor arrives and determines that the substance of your "root cause" analysis and corrective action is insufficient. So now, even though it seems you fixed any issues you need to redo. That's helpful.

Here is your root cause: You're internal/external auditors are _______ (fill in the blank).

To me there is no substance in either of the "findings." I would be more concerned with how your system is working today, under you're supervision than any hiccup while you where learning the ropes. And people wonder why ISO gets a bad rap. Good luck.

 

[somashekar]

I started a new job a few months ago as QM from a retiree who did not keep up with things the way they should have. Prior to even glancing at a document I was hit with an internal audit that requested our CAPAs...well I could not locate them so we got a Corrective Action. For my Corrective Action I notified the auditor that since I was new I could not locate the files, they were located, completed, etc etc. I also updated the verbiage to ensure that I received the complaints and could manage them directly.

Now with my External Auditor (registrar) he thinks that's a pretty sorry excuse and wants another Corrective Action on what I suppose is my "newness" to the job at the time...because at this point there's not much I can do to improve the Corrective Action system it would seem. We are a small company and making great headway and listening to customer concerns. I did create a customer communication log to track any repetitive issues.

Can someone help me determine a root cause? My root cause of starting new and having another person's system in place on that date didn't please the auditor one iota.

Thanks.

I would suggest you add that you need to review and understand the document control and records control procedures as well, and find out if they are not respected.

 

[itsbiodiversity]

You pretty much summed it up. I even have added a customer communication log to show adherence to 17025. I feel like it is getting a corrective action for not being able to locate a retiree's file on his personal computer. My corrective action was basically to redirect the complaints via a file to the QM for registration in to the capa system. I thought it solved the issue and my root cause was clearly my predecessor's storage locations of files without the higher ups knowing where he stored them.

So if anyone has any help finding a root cause for this issue that would be presentable, and especially a solution that would be great. Any information to lead me in the right direction would be appreciated.

Thanks again for the help and reassurance.

 

[Wes Bucey]

You pretty much summed it up. I even have added a customer communication log to show adherence to 17025. I feel like it is getting a corrective action for not being able to locate a retiree's file on his personal computer. My corrective action was basically to redirect the complaints via a file to the QM for registration in to the capa system. I thought it solved the issue and my root cause was clearly my predecessor's storage locations of files without the higher ups knowing where he stored them.

So if anyone has any help finding a root cause for this issue that would be presentable, and especially a solution that would be great. Any information to lead me in the right direction would be appreciated.

Thanks again for the help and reassurance.

Would it be possible to give us the exact quote of the outside auditor's finding? With that, we can give you a precise response to include a

1. root cause
2. proposed solution
3. method of periodically evaluating the solution to confirm it does, indeed, provide a continuing, workable process to prevent ANY documents from being irretrievable.

 

[Mike S.]

I agree with Wes, seeing the exact text of the auditor's finding and your response so far will help. The Devil lurks in the details.......

 

[itsbiodiversity]

XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.

 

[Wes Bucey]

XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.

HOW does this auditor KNOW the "true root cause" was not found? I recognize that many auditees say "operator error - operator retrained" which would rankle ANY auditor, but WHAT did your organization say was "true root cause?" What process did your organization offer to eliminate [or substantially reduce] recurrence? How does your organization propose to periodically evaluate this process to assure it works?

There are many auditors who are jerks, but most are not. It can really rub salt into a wound when an auditee tries to "jawbone" an explanation or excuse without documentation.

 

[Golfman25]

XXXXX had # (small #) of corrective actions for the year. Both had shallow RCA performed and did not find true root cause.

Was a RCA even required? Not every corrective action needs a full blown RCA. Has there been a reoccurrence?

And besides, your corrective action is already in place -- YOU.