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Reporting nonconformities: Separate or combined?


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#1 mind over matter

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Posted 11 July 2011 - 11:04 AM

I remember the time I was writing an audit report on internal audit. I was not sure how to count the number of nonconformities. I'd like to pose some questions to satisfy my curiosity. Can anyone give me an objective method of reporting/counting audit findings? For example,

1) The water reservoir tank was not secured from access of unauthorized personnel as this was not locked and located near workers canteen.
2) The inside surface of the water reservoir tank and its cover had corroded portions.
3) There was no documented cleaning procedure and records to show that water reservoir tank was regularly cleaned.
4) The water source, deep well, was located within 10feet from the septic tank of the worker’s toilets. The water supply passed filtration, carbonation and softening but there was no record to ensure the safety of water supply.
5) The water distribution pipelines and/or water hoses were not properly maintained as indicated below:
a) Adhering slimy black dirt and corroded portions on outside surface of water pipelines at processing and CIP Rooms.
b) Adhering slimy black dirt on the outside and end portions of the inside surface of the water hoses at Processing Room.
c) End portion of water hoses touched the floor.

Some of my questions –

As an auditor, are you going to count the above deviations as 5 separate nonconformities, or the 5 deviations could be counted as 1 nonconformity? (note: all deviations are related to Safety of Water and/or Ice Supply)

Is it up to the auditor if 1 to 5 would be one, two, or three nonconformities?

What is the logic of combining any or all of them?


Edited by mind over matter, 11 July 2011 - 11:09 AM.


#2 Madam A. D-tor

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Posted 11 July 2011 - 12:27 PM

Dear MoM,

It does not matter if you count this as one or as 7 non-conformities, as long as all these items are handled and corrective actions are implemented and verified.


Kind Regards,

Madam A. D-tor

#3 mind over matter

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Posted 12 July 2011 - 05:29 AM

Dear MoM,

It does not matter if you count this as one or as 7 non-conformities, as long as all these items are handled and corrective actions are implemented and verified.

Hi Madam A. D-tor,

Thank your for your response and I understand your point. It's just that my former company has defined quality & food safety objective something like "X incidence of nonconformity during internal and external audits" or "Increase the GMP score from X% compliance to X% compliance"

They should not measure or report NC by quantity.

#4 Kamwenji Njuma

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Posted 12 July 2011 - 10:05 AM

Dear M.O.M,

For me.i will take each nonconformity on its own,do a root cause analysis and implement corective actions.The idea is to close these nonconformances within the shortest time possible and avoid recurence.This way you will have less non conformances or none in the main audits.

Regards,
Kamwenji Njuma



#5 Anish

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Posted 12 July 2011 - 12:19 PM

I recommend to separate the water quality issue as one non conformance ( you can comhine 2, 4, 5, 6, 7, 8), Cleaning as one non conformance and the point 1 -related to safety as one issue and send the report. While the correction and corrective actions are done you have to verify whether the issues are properly addressed.

Pls. share us your conclusion on this.

Rgds,
anish





#6 mind over matter

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Posted 25 July 2011 - 12:50 PM

I'm also not in favor of grading internal audit nonconformities for reasons of subjectivity etc. All findings needs fixing regardless of quantity.

But...

What about
your view on classification of deficiency as minor, major, serious, and/or critical against GMP internal audit?





#7 Madam A. D-tor

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Posted 25 July 2011 - 12:57 PM

Dear MoM,

As you said: All findings needs fixing regardless of quantity.

Minor, Major, Critical classification can help the organisation to set priorities. e.g. criticals need to be solved in a day. Majors in a month an minors in 3 months.
On the other hand it can staff make less interested, in the way: ".. it is only a minor. Why shall we bother....


Edited by Madam A. D-tor, 25 July 2011 - 12:57 PM.

Kind Regards,

Madam A. D-tor

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#8 KemiA

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Posted 04 July 2012 - 09:59 AM

Hi, does anyone have an example of a non-conformance form






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