Help with preventive action plan

Hello everyone!

After finishing my first audit for BRC A&B (posting the question here due to the gerneral nature) with only 6 minors i am super happy. However it turned out to be more tricky than I thought to finish these off..

I am kind of stuck on the part vid root cause analysis and preventive action plans, since some of the non-confomaties  and corrections are quite straight forward.

The one giving me the biggest headache is the following non-confomity: "The need to inform the Certification Body within three working days in case of a product recall is not stipulated in the company product withdrawal and recall procedure."

Added to the recall procedure - easy! But what now? Basically the root cause would be that I did´nt think about including this in the procedure. Or should i think in a bigger percpective like: "QM not experienced enough and could miss to include important stuff in the procedures inless she is given xxx hours of BRC training  :lol2:

Any ideas of what they are after?

Hello, and grattis!

It could seem very “simple”, however, it’s important to take into account that the CB shall be advised also weather there is an important change that could have impact of food safety, or legality, since, as you know, the audit is once per year, but the certificate lasts all the year.

Example: if there is a new allergen not considered before, or a new technology – i.e: low pressure, or has happen some crisis beyond a recall: i.e, a fire of a raw material tank, or water tank; and then, you have to solve that, not putting into risk the product/process, but the process that has been audited, the one in the scope, has changed.

So, basically, action plan could be based on a review of the standard and understand when to put in contact with the CB.

Hope this helps!

Leila

In cases like this it can be a challenge to come up with a suitable root cause.

Section 3.11.4 says that the requirement is to notify the certification body within three days but even the interpretation guide doesn't specify how that is to be accomplished.  Specifying it in the Recall procedure is probably the most common option but if you met the requirement somehow I don't think it is even a reasonable non conformance.  

If you were not aware of the requirement and if you want more training then you could use that as the root cause and include more training as your CA plan.  You could also consider assigning the root cause to a miss on the internal audit since if that clause had been audited adequately you would have identified the need to have a method to ensure that they were notified.  Again that method does not have to be part of the Recall Plan but that modification will probably most easily satisfy the auditor.

Most likely they will not look very closely at the root cause for this deviation as long as you have added it to the Plan.

I suggest you keep it simple and manageable.  People with years of experience could and most likely have made the same error.  

Hi Zarina,

For me I wouldn't get too hung up on it, you have covered it in your procedure so that's the appropriate action taken.

For root cause and solution I would put staff not aware of requirement/relevant staff briefed on new procedure/requirement

Kind regards,

Tony

Awsome, have some new inspiration now! Thank you everyone :)

Yeah probably its really no big deal if I just correct it. Just want to get everything right and since its my first BRC audit I am not sure what the auditor expect from us.. 

In cases like this it can be a challenge to come up with a suitable root cause.

 

Section 3.11.4 says that the requirement is to notify the certification body within three days but even the interpretation guide doesn't specify how that is to be accomplished.  Specifying it in the Recall procedure is probably the most common option but if you met the requirement somehow I don't think it is even a reasonable non conformance.  

 

If you were not aware of the requirement and if you want more training then you could use that as the root cause and include more training as your CA plan.  You could also consider assigning the root cause to a miss on the internal audit since if that clause had been audited adequately you would have identified the need to have a method to ensure that they were notified.  Again that method does not have to be part of the Recall Plan but that modification will probably most easily satisfy the auditor.

 

Most likely they will not look very closely at the root cause for this deviation as long as you have added it to the Plan.

Yeah I thought about it aswell that it shouldn´t be a non conformance when just reading the standard.. It felt like the auditor was not super sure about this one from the beginning so he will probably not put too much weight in the root analysis :) 

In cases like this it can be a challenge to come up with a suitable root cause.

 

Section 3.11.4 says that the requirement is to notify the certification body within three days but even the interpretation guide doesn't specify how that is to be accomplished.  Specifying it in the Recall procedure is probably the most common option but if you met the requirement somehow I don't think it is even a reasonable non conformance. 

Yeah I thought about it aswell that it shouldn´t be a non conformance when just reading the standard.. It felt like the auditor was not super sure about this one from the beginning so he will probably not put too much weight in the root analysis :) 

I agree with Sandima if there has been no recall then there is no non-conformance and the statement about the non-conformance shouldn't specifically refer to your procedure but if the auditor asked you a question about notification and you did not reply that you would notify the certification body within 3 days then that would be a non-conformance as there is no evidence that you would notify the certification body (clearly you have now covered this off so don't worry about it).

Kind regards,

Tony

From the OP It seems to me that the NC was purely "documental".

The RC was "forgot". Or perhaps >>> "Oversight".

I anticipate the auditor simply wants it corrected. Unless there were numerous similar "oversights" which looks to not be the case.

Hello Zarina,

We'd got NC like that on our very first audit. You can put "over-looked" as the root cause. Then on you corrective action to close the NC, include in your procedure that CB will be informed when withdrawal/recall happens. As evidence present your procedure and the list of entity that will be contacted during the withdrawal/recall process. Of course, CB must be on the list.

Regards,

redfox

I got this when we had our first BRC 6 audit. I had in a timely manner instead of within three days... got dinged for it.

I think I just amended the procedure and said it was an oversight.