A Hard-to-place Audit Observation - Please Suggest Clause

A BRC auditor observes that a facility has a blood born pathogen control kit showing an expired date. Is this a non-conformity? If so, under what clause should it be raised?

Hi,
It is certainly a non-conformity and even be calssified as critcal non conformance. Reason being expired chemical may not have the desired effect on the pathogen at the recommended dosage.
Possible sections under which one may get NCR are as below;
Section 2.2.1 - prerequisite programSection 3.4 - Internal auditSection 4.11 -housekeeping and hygiene.
Refer to relaxant sections in the standard for further explanation.

Hi Gunapathi,

Thanks for the info.

gcse-fhp

A BRC auditor observes that a facility has a blood born pathogen control kit showing an expired date. Is this a non-conformity? If so, under what clause should it be raised?

IMO, the relevant sections/clauses to this nonconformity are:
2.2.1 - Prerequisite program
2.12 - Establish verification procedures
4.11 - Housekeeping and hygiene.

Regards:
M.Zeeshan

So far, it is confirmed that the observation is a non-conformity. The common clauses hitherto recommended are:

2.2.1 - Prerequisite program
4.11 - Housekeeping and hygiene.

Which is the best applicable clause since the non-conformity is to be recorded once?

1340106136[/url]' post='54622']
So far, it is confirmed that the observation is a non-conformity. The common clauses hitherto recommended are:

2.2.1 - Prerequisite program
4.11 - Housekeeping and hygiene.

Which is the best applicable clause since the non-conformity is to be recorded once?

It will be 4.11.1
Regards,
Guna

Gunapathi,

Thanks for the suggestion.

gcse-fhp

So far, it is confirmed that the observation is a non-conformity. The common clauses hitherto recommended are:

2.2.1 - Prerequisite program
4.11 - Housekeeping and hygiene.

Which is the best applicable clause since the non-conformity is to be recorded once?

I'm not sure how this would be a NC in 4.11. There is absolutely nothing in that section that even remotely covers your hypothetical.

It would be a pretty big stretch under 2.2.1 as well. You would have to have a blood borne pathogens program that specifies that the kits must be checked on a scheduled basis and be replaced if they expire.

As an aside, I've never seen any blood borne pathogen control kit that has any substance in it that would "expire".

Marshall

HiMarshall,

I take it you do not agree that this is a non-conformity. Is this correct?

By the way, it s general industry practice for manufactures of chemical/ medical
substances to provide expiration dates for such substances. The contents of
blood borne pathogen control kits are included in this practice.


Regards,
gcse-fhp

HiMarshall,

I take it you do not agree that this is a non-conformity. Is this correct?

By the way, it s general industry practice for manufactures of chemical/ medical
substances to provide expiration dates for such substances. The contents of
blood borne pathogen control kits are included in this practice.


Regards,
gcse-fhp

It would only be a non-conformance if your blood borne pathogen control program specifically stated that the control kits are to be inspected on a scheduled basis and replaced if expired. Because you had an expired kit, you were not doing what you say you do, therefore a non-conformity.

I won't argue with you. It may be general industry practice in Canada, but every Universal Precautions Compliance Kit I have ever seen, don't have expiration dates.

Marshall

It would only be a non-conformance if your blood borne pathogen control program specifically stated that the control kits are to be inspected on a scheduled basis and replaced if expired. Because you had an expired kit, you were not doing what you say you do, therefore a non-conformity.

I won't argue with you. It may be general industry practice in Canada, but every Universal Precautions Compliance Kit I have ever seen, don't have expiration dates.

Marshall

Marshall,

I find both points above interesting. It will be good if others with the same understanding and experience as you have described will share their thoughts.

Regards,

Felix

My 2 cents worth,


I presume that the kit would be used for when an employee has cut themselves and bled somewhere on the process line? I would have thought that this would only be an NCR if the use of the kit was the only method of dealing with this problem, (why not use hot water , detergent, then sanitise, then swab to ensure cleanliness), and was stated as such in the procedures. otherwise the kit is just a "nice to have" but not necessary, therefore not an NCR.



Anyway thats my thoughts.


Bawdy.

My 2 cents worth,


I presume that the kit would be used for when an employee has cut themselves and bled somewhere on the process line? I would have thought that this would only be an NCR if the use of the kit was the only method of dealing with this problem, (why not use hot water , detergent, then sanitise, then swab to ensure cleanliness), and was stated as such in the procedures. otherwise the kit is just a "nice to have" but not necessary, therefore not an NCR.



Anyway thats my thoughts.


Bawdy.

That's the inherent problem with a hypothetical question.

Marshall

That's the inherent problem with a hypothetical question.

Marshall

Since BRC does not have a single word relating to blood borne pathogens, the requirements to control them or any possible NC resulting from your lack of checking the kits you have, it's pretty much a waste of time.

Marshall

This hypothetical non-conformance is a sign of either a young, "world is my oyster" auditor or an embittered old "the world used to be my oyster" auditor. Either way gcse (and I hope that you realise that my comment is laced with humour rather that sociopathic intent) that auditor better have booked a taxi back to the airport themselves as unfortunately the set of golfclubs I have in the boot have become unstable and my first aid kit is 12 days beyond the duration date.

Next thing they'll want AIDS tests for the guy who puts his dick in the bacon slicer (she's a great girl - got a sharp tongue though)

We had a non conformance a few years ago (so against BRC V5) because a pack of our colour change swabs which are used as an indication of equipment cleanliness were out of date, the auditor put it as a non conformance against the traceability section - 3.9.1 Identification of raw materials including primary and any other relevant packaging and processing aids, intermediate/semi-processed products, part-used materials, finished products and materials pending investigation, shall be adequate to ensure traceability

Dear gcse-fhp!

It should be cleared that all the things (documents, areas, planned arrangements, infrastructure etc) that comes under the scope of applicable/auditable standard should be in conformance with the specified and reasonably expected requirements. Although BRC standard is not specifically mentioning control of blood borne pathogens program but since it is currently a part of your system it should be controlled. NCR is necessary to initiate and proceed for any remedial action appropriately. Action may be any of the following:

1- If it is decided to keep the program as it is, it should be documented/modified to avoid recurrence of same non conformance.

2- If it is decided to withdraw the program, justifications should be recorded, analyzed by food safety team and actioned accordingly.

Regards:
M.Zeeshan

Tentative against calibration perhaps but tbh I've never even seen one of these packs and I don't think they're necessary, so therefore no Non Con! Is this an attempt to find a non conformance outside of the scope of BRC?

Tentative against calibration perhaps but tbh I've never even seen one of these packs and I don't think they're necessary, so therefore no Non Con! Is this an attempt to find a non conformance outside of the scope of BRC?

Are you suggesting that this is outside of the BRC scope?

A quick literature search (even a search on the internet) may convince you otherwise about the necessity of good control measures for blood-borne pathogens in the event of a bleeding injury in a food processing facility. Special precautions and procedures outside of the usual sanitation procedures arenecessary.

Dear gcse-fhp!

It should be cleared that all the things (documents, areas, planned arrangements, infrastructure etc) that comes under the scope of applicable/auditable standard should be in conformance with the specified and reasonably expected requirements. Although BRC standard is not specifically mentioning control of blood borne pathogens program but since it is currently a part of your system it should be controlled. NCR is necessary to initiate and proceed for any remedial action appropriately. Action may be any of the following:

1- If it is decided to keep the program as it is, it should be documented/modified to avoid recurrence of same non conformance.

2- If it is decided to withdraw the program, justifications should be recorded, analyzed by food safety team and actioned accordingly.

Regards:
M.Zeeshan

I agree. These are good suggestions.

Are you suggesting that this is outside of the BRC scope?

A quick literature search (even a search on the internet) may convince you otherwise about the necessity of good control measures for blood-borne pathogens in the event of a bleeding injury in a food processing facility. Special precautions and procedures outside of the usual sanitation procedures arenecessary.

A quick search of the BRC Standard may convince you that there is nothing in there about blood borne pathogen control.

This is not to say that Universal Precautions are not necessary. Within the scope of the Standard though, you can't raise a NC against a non-existent clause.

Marshall

A quick search of the BRC Standard may convince you that there is nothing in there about blood borne pathogen control.

This is not to say that Universal Precautions are not necessary. Within the scope of the Standard though, you can't raise a NC against a non-existent clause.

Marshall

You are correct. No standard is complete, fail-safe and addresses everything that must be considered in protecting the consumer. Food operations and food safety managers must look beyond the audit standards and do much more to protect consumers.

1340274620[/url]' post='54654']
Dear gcse-fhp!

It should be cleared that all the things (documents, areas, planned arrangements, infrastructure etc) that comes under the scope of applicable/auditable standard should be in conformance with the specified and reasonably expected requirements. Although BRC standard is not specifically mentioning control of blood borne pathogens program but since it is currently a part of your system it should be controlled. NCR is necessary to initiate and proceed for any remedial action appropriately. Action may be any of the following:

1- If it is decided to keep the program as it is, it should be documented/modified to avoid recurrence of same non conformance.

2- If it is decided to withdraw the program, justifications should be recorded, analyzed by food safety team and actioned accordingly.

Regards:
M.Zeeshan

I agree Zeeshan, I haven't come across any FS standards that are prescriptive. It is upto the FS manager to ensure the procedure and process on site complies with standard and doesn't affect the safety or quality of food manufactured either directly or indirectly.

I agree Zeeshan, I haven't come across any FS standards that are prescriptive. It is upto the FS manager to ensure the procedure and process on site complies with standard and doesn't affect the safety or quality of food manufactured either directly or indirectly.

Dear Gunapathi,

?

Admittedly the terms are subjective but i think BRC Food is often categorised as prescriptive. Relative to ISO22000 for example. And despite its love of risk assessment.

Rgds / Charles.C

I'm not sure if people are aware that this is the second thread started about finding Non Cons outside of scope.

My view on this one, is the pack is unnecessary and good hygiene can be achieved without it so whether or not it's in date is a moot point.

My view on the topic is, can we drop it now?