Justification/Rationale for not investigating a nonconformance

Q

QA Systems Manager

#1
I am looking for some examples of justification and or rationale for not investigating a nonconformance. Preferably something that an auditor would find acceptable! We all have instances in our plants that we deem doesn't warrant an investigation...how do you write that into a justification or rationale to show compliance to 820.90? Thank you.
 
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A

achorste

#2
Re: Justification/Rationale

Has the non-conformance been investigated & solved before? (ie did the non-conformance occur before previous corrective actions were implemented)

Can you justify it statistically? If the non-conformance is a very small proportion of the total you may be able to justfy it as being too small to bother with.

It all depends on the nature of the non-conformance, the risk associated with the non-conformance and the cost implications of investigated / correcting / preventing the non-conformance.

Please provide a bit more detail (as above).
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Re: Justification/Rationale

It would be helpful to know what kinds of non conformance you have found to be not worth investigating.

Most standards are pretty clear that a real nonconformance mus tbe investigated and corrected. In that light, one might say that if the nonconformance isn't real (the auditor didn't have his or her facts correct) then you woudln't have to investigate further; just prove it's not real.
 
Q

QA Systems Manager

#4
Re: Justification/Rationale

Hi, good questions. Sometimes the quantity is low, 1 out of 200. I like your statement, "a real nonconformance", maybe that is an idea. I am looking at nonconformances identified by inspectors, and then dispositioned by Quality Engineer or Process Engineers. What would prove that it is not real?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Re: Justification/Rationale

(ie did the non-conformance occur before previous preventive actions.
If it already happened, there is no preventive action possible.
What would prove that it is not real?
Only if the products were incorrectly rejected. I.e., the inspectors rejected an acceptable product. But even that would require an "investigation".

ISO 13485 is pretty clear about the need for an investigation. What might happen is that, after investigation, a determination is made that no corrective action is justified nor necessary.
 

RoxaneB

Super Moderator
Super Moderator
#8
While I'm not in the medical profession or field and, quite honestly, the sight of blood or even the mere mention of it makes me queasy.....I can talk about nonconformances very easily! :rolleyes:

1. Define a nonconformance at your site...the parameters for what makes a nonconformance a nonconformance
2. Define triggers for when you will take action...and to what level action will be taken.
3. Formalize process.
4. Record data.
5. Review nonconformances on a regular basis.
6. Adjust definitions for nonconformance and triggers accordingly.

Here's how we look at...

If the process has an unscheduled delay of let's say 5 seconds. There is no impact to the product. Machines are still okay. We don't sweat it. We do, however, record the fact that the delay occured, where it occured, when, etc.

If the delay was 20 minutes, that's more of an issue and we do all the above, but resolve the issue and get back to making product.

If the delay is 40 minutes, wow! That's caused a lot of problems and we'll do a full-blown corrective action on that nonconformance.

But we also have stats on our process that back us up on our defined triggers. And, as we start to see the larger problems decrease in number, we start to lower our triggers so that we can still focus on nonconformances.

This approach also helps in the demonstration of continual improvement.
 

Ajit Basrur

Staff member
Admin
#9
I am looking for some examples of justification and or rationale for not investigating a nonconformance. Preferably something that an auditor would find acceptable! We all have instances in our plants that we deem doesn't warrant an investigation...how do you write that into a justification or rationale to show compliance to 820.90? Thank you.
I am not sure if you can do away with an investigation.

21 CFR Part 820.90 says -

(a)Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.

Being in the medical devices, I would definitely initiate an investigation with corrections and corrective actions but may or may not include preventive actions. This all depends on the type of nonconformance.

PS - you referred section 820.90 which is applicable for the product and not for non product conformances.
 
T

trainerbob

#10
The time spent justifying the non-investigation of the non-conformance would be much better spent taking care of the issue. I certainly don't know your particualar issue, but remember that we need to work at improvement, not avoidance or justification for non-action. If these are internal issues you are dealing with and they are not "true" issues then it sounds like internal auditor training is your real problem, rather than justification of non-investigation of items that don't pertain to your quality management system. This is the type of rationale that an auditor can understand and live with.
 
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