GMP site inspections compliance definitions
Hi.
I am writing a procedure for GMP site inspections and the ratings that I have been told to use are Full compliance, Partial compliance & Non-Conformance.
Would anyone have some definitions I could use for the procedure, that would also help with consistency between the audit team when completing the inspections?
Thanks
HI,
When we are looking for GMP's non-conformance during an audit I always tell my team to have in mind that we are looking for anything that can be a treat to food safety. If you see that it could become a food safety tread it will be a minor (partial compliance) and if you see that is a food treat it will be a non- conformance.
Hope it helps
rellie,
Try this for simplicity. It has worked for me in past GMP/GDP audits and passed muster in our 1st SQF certification audit.
Full Compliance = Good on.
Partial Compliance = Deficiency may cause a food adulteration issue.
Non Comformance = Deficiency will cause a food adulteration issue.
Not having complete thermometer calibration logs is a Partial.
Having birds flying overhead in the buiiding means you better update your resume. Serious point deduction in GMP, automatic fail in SQF audit
Hi.
I am writing a procedure for GMP site inspections and the ratings that I have been told to use are Full compliance, Partial compliance & Non-Conformance.
Would anyone have some definitions I could use for the procedure, that would also help with consistency between the audit team when completing the inspections?
Thanks
Dear rellie,
Told by Whom ? With respect to what auditable Standard ?
I anticipate these terminologies will have an Australian/Standard Interpretation. If otherwise they are totally arbitrary. You might as well consult a kookaburra.
Rgds / Charles.C
PS - I can remember seeing these ratings used for at least one specific standard AIB?, NSF ?
Partial compliance is something you can most likely handle on a one to one basis and not involve management because you don't see it as a routine, more like an isolated issue, and is not a food safety issue. If it's a blatant disregard for the code it would be a non-conformance and/or a direct food safety issue.
Full compliance: Wearing the hairnet correctly over the ears covering all head hair.
Partial compliance: Wearing the hairnet like a beret exposing hair.
Non-Conformance: Not wearing a hairnet at all.
Full compliance: Floor is dry.
Partial compliance: Floor is wet with possible standing water.
Non-Conformance: Production is using high pressure water hoses to clean the floor while production is working.
I try an stay away from 'partial' compliance as it really ends up being subjective between auditors. It is either pass or fail, compliance or non-compliance, yes or no, acceptable or not acceptable. You can then better define the expectation for each of the elements that you are auditing. I also have found that as an auditor, when the word 'partial' is used, limited action is taken to rectify the issue identified.
You need to review the requirements of the standard you are using to determine compliance.
My opinion: Full compliance - you meet all the requirements in all locations where the requirement applies (all hazards are controlled everywhere) Partial compliance - you are missing some compliance to requirements or you don't have consistent compliance in all locations or areas (some hazards are not well controlled). Noncompliance - you have no or very little compliance indicating you no real control over the hazards.