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Should I initiate CAPA for a nonconformance not recorded?

qualprod

Trusted Information Resource
#1
Hi everybody,

From the perspective of an auditor: If a have certification audit with external people (in short)
And internally I have an nc, and I Know about it.

Could I carry out an internal audit, identify the nc and raise the CA of this known nc? This way if the external audit, detect the nc, I can say that it was already detected and a Ca is underway, hoping that the nc will be ignored when detected.

Would my ca defend me against the nc raising?

Is it valid this action in audits?

It may be applied in internal and external audits.
Thanks
 
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Pancho

wikineer
Super Moderator
#2
I'm confused. If you have a NC and you know about it, why do you need an audit to identify it?

I'd simply follow the SOP for handling non-conformities. No internal or external auditor will have a problem with your system working as it should.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#3
<snip> Could I carry out an internal audit, identify the nonconformance and raise the Request for Corrective Action of this known nonconformance? This way if the external audit, detect the nc, I can say that it was already detected and a Ca is underway, hoping that the nc will be ignored when detected.

Would my corrective action request defend me against the nc raising? <snip>
Yes. However, be ready to talk about (and show evidence for) the corrective action request.

  • What is the status of the corrective action, and action item(s)?
  • Do you have a projected closure date?
 

qualprod

Trusted Information Resource
#4
Thanks , the transicion audit will take place next month.
The current nc it is because people dont attend the Ca's on time, for sure the auditor will raise a nc.
in order for the auditor doesnt raise the nc, could I open a ca addressing this problem, expecting that external auditor will not raise the nc, because I attended the issue?
Thanks
 

Marc

Fully vaccinated are you?
Staff member
Admin
#5
If you are not following through on your corrective actions, what valid excuse can you think of?

Why are you looking for excuses rather than effectively addressing and dealing with "...people do not attend the corrective action meetings on conformances..."?

My opinion is this not the "wild west" where people did what they wanted to do. If a person does not attend required meetings, of what ever the topic is, you have a systems problem.

If you are running a company, if employees do not follow the requirement(s) and policies, and you "excuse" them for what ever reason, it can only show that the requirement should be removed. Is it OK if a press operator (for example) decides to deviate from the documented requirement(s) for that operation at his or her "opinion" that (for example) it's not "that big of a deal" or is a "low risk"?

I'm all for employee involvement. However, if someone has a "better idea" (for example), they should present it and try to get the procedure and/or policy revised.
 

Golfman25

Trusted Information Resource
#6
Sounds to me like it is a timing issue. Do you have times in your CA process - I.e. Answer within 14 or 30 days? I don't like time constraints because every problem isn't the same. It's more important to monitor progress, imo.
 

Pancho

wikineer
Super Moderator
#7
Thanks , the transicion audit will take place next month.
The current nc it is because people dont attend the Ca's on time, for sure the auditor will raise a nc.
in order for the auditor doesnt raise the nc, could I open a ca addressing this problem, expecting that external auditor will not raise the nc, because I attended the issue?
Thanks
Hi Qualprod,

I would not be worried about the auditor raising NCs. That’s what you pay them for! You should welcome NCs. Every one of them is a clear opportunity to improve your system.

In your case, the one NC you’ve identified already should be in your NC handling process already, irrespective of any audit coming up. Depending on your own criteria, it may require root cause investigation and corrective action, or not.

As Marc points out, if folks do not tend CAs on time per your system, that in itself is a NC. Now you’ve identified another one. Log it in too. This is one you might be able to get some free consulting for from your external auditor. Ask them how other companies deal with this issue and what works.

NCs do not mean you will not be certified. Yes, you will have to tend to them before certification. But that is a good thing. It puts urgency into them NCs and into improvement. Get your folks used to that. It will make your system and your organization better.

Have a good audit! May it find some hidden NCs!
 

QuinnM

Involved In Discussions
#8
Hi Qualprod,

Adding to an internal audit would only increase the amount of paperwork. The nc should be resolved on its own, unless it’s a systemic issue and then you could consider creating a CAPA request. I have hired auditors to audit and in the opening meeting told them of known issues and asked them to avoid these. The issues were being address by nc(s) or CAPAs, and we wanted to identify new, unknown, gaps/problems.

All the best Quinn
 

qualprod

Trusted Information Resource
#9
Thanks Pancho
So if I open a CA for the said reason it would be something which the auditor will take into consideration.
Maybe will detect this issue but , when I show him/her the CA , maybe this wil be sufficient evidence for not reporting the nc, could it be this way?
Thanks
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
Maybe will detect this issue but , when I show him/her the CA , maybe this wil be sufficient evidence for not reporting the nc, could it be this way?
The question is: do you want an effective system, or do you want to "pass" an audit? You are, obviously, looking for a loophole.

Have a look at this post and the several threads linked therein, with special attention to the Should the Registrar write a NC for something identified during an Internal Audit? thread.
 
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