Internal Non Conformances and Root Causes
Hi all,
I am a bit perplexed about internal non conformances. my boss likes to see all deviations from norm opened as a non conformance EX: if the metal detector found metal , if we found a positive of listeria ssp. in a transition zone during environmental monitoring, paperwork errors, production errors. etc. I sometimes don't know what to writer as a root causes for items like these....
Normally I write an internal non-conformity resolution for minor NC which is how we resolve the issue immediately. it is only after 3 of the same minor NC that we do root cause analysis. my understanding is for edition 9 you must do a Root Cause Analysis for all Major NCs. what do you guys consider a major NC besides CCP deviations?
How do you respond to typical production minor NC's ?
thank you!
Maybe your boss is concerned about repetitive NCs? (like you mentioned: 3 of the same minor NCs) In this case, all root cause analyses are useless as your solutions haven't solved the problem...
yes I agree i think its a way she set it up in order not to do root cause analysis for errors that don't happen often ( we don't really have repetitive NC) but we do have a lot of NC due to human error data entry which the root cause seems so simple?( human error) and the resolution difficult as we can re-train and monitor more closely but is that it? open to suggestions for change as I feel with the new SQF edition 9 it has to change anyways.
Let's see what other forum members would suggest (I'm not with SQF, my scheme is FSSC). However, re-training seems a good solution...
A training sesh is what I'd do....
You cannot train away human errors.............they will continue to happen
Perhaps in the scenario, the actual root cause is humans performing data entry, when it should/could be an automated process??
We have a process where by corrective and preventative measures (almost always) are implemented (even in short form) WITHOUT a root cause
A well done root cause (5 whys or fishbone for example) take quite a bit of time, and for that reason should not be used for minor NCs
our CCP would be a major, as would a titration of no-rinse sanitizer, that sort of thing that could cause
A) product that is adultered
B) significant loss of production hours
C) possibility of a recall
D) large amount of rework
I'm sure others may have a different view, that is how I sail my ship
Hi. Regarding production paperwork errors, you can review the paperwork and try to make filling-in easier and more user friendly: circling/ticking instead of writing, reduction the number of checks, reduction the amount of checksheets, removing duplicating questions, combining two questions into one, etc. We used to have some startup sheets where people had to sign and time every single question they answer. We replaced it with just the time and signature at the bottom of the sheets.
Hi. Regarding production paperwork errors, you can review the paperwork and try to make filling-in easier and more user friendly: circling/ticking instead of writing, reduction the number of checks, reduction the amount of checksheets, removing duplicating questions, combining two questions into one, etc. We used to have some startup sheets where people had to sign and time every single question they answer. We replaced it with just the time and signature at the bottom of the sheets.
Hi sjegorov,
I agree the Principle but logically IMO it also relates to the significance of the paperwork errors, eg some threads here have people omitting to fill in CCP monitoring forms.
Not too easy to combine Metal Detection and Listeria ? Similar Root Cause ?
I'm with Scampi here.
If I am walking around doing a GMP inspection and notice some cobwebs in the ceiling in the warehouse, there is not much point doing a RCA.
Just have someone remove the cobwebs. You might want to have the Sanitation Manager review the Master Cleaning Schedule to ensure that this area is in fact being cleaned on a scheduled basis, but to spend the time and effort doing RCA makes no sense.
Now as far as the OP goes, metal detectors finding metal is not a non-conformance. That's what they are supposed to do. You of course investigate to see if you can find the source of the metal.
A positive Listeria hit is certainly a bit more serious.
Paperwork errors and the like always happen and IMO, are not candidates for a full blown RCA/CAPA. Unless of course if you have the time and people to do so.
Your Corrective Action program/policy should indicate at what point a full blown RCA/CAPA investigation needs to take place.
Marshall
Hi all,
I am a bit perplexed about internal non conformances. my boss likes to see all deviations from norm opened as a non conformance EX: if the metal detector found metal , if we found a positive of listeria ssp. in a transition zone during environmental monitoring, paperwork errors, production errors. etc. I sometimes don't know what to writer as a root causes for items like these....
Normally I write an internal non-conformity resolution for minor NC which is how we resolve the issue immediately. it is only after 3 of the same minor NC that we do root cause analysis. my understanding is for edition 9 you must do a Root Cause Analysis for all Major NCs. what do you guys consider a major NC besides CCP deviations?
How do you respond to typical production minor NC's ?
thank you!
Hi cgarces,
Maybe try studying the Guidance and Glossary, eg -
RCA.PNG 79.17KB 4 downloads
A minor non-conformance is evidence of a random or infrequent failure to maintain compliance to a requirement, but which does not indicate a breakdown in the food safety management system or that food safety is compromised. It is evidence of an incomplete or inappropriate implementation of SQF requirements which, if not corrected, could lead to system element breakdown
etc
GMP-related checklists can include categorisation of Mi/Ma/Cr defects.
@ Marshall, If the MD is a CCP, i cannot see how a positive result can avoid raising an RCA. The NC is directed to the CL.
Listeria per se is not a hazard so IMO the documentary consequences depend on the context.
I concur yr final sentence.
Charles,
I stated that any presence of metal detected should of course be investigated to attempt to find the source.
Does that need to be a full blown RCA/CAPA? I guess that all depends on your assumption of risk.
If we have a metal detector trip, we investigate, but do not do a full RCA/CAPA. If there are multiple trips within a designated time frame, then yes.
Marshall
Charles,
I stated that any presence of metal detected should of course be investigated to attempt to find the source.
Does that need to be a full blown RCA/CAPA? I guess that all depends on your assumption of risk.
If we have a metal detector trip, we investigate, but do not do a full RCA/CAPA. If there are multiple trips within a designated time frame, then yes.
Marshall
Hi Marshall,
Assuming you do set the MD as a CCP, sounds like you have an interestingly "layered" Corrective Actions section in your haccp plan. :smile: