2 replies to this topic

[Lelouch_rayne]

Hi,

 

We recently conducted internal audit using the new BRCGS standard (version 9), do you have any idea on what clauses can we raised below findings:

 

1. During the sanitation pre-ops observation, stainless steel screens in the surge tanks were in poor repair with gaps between the screen and the sides.

2. Loose caulking was observed on oil inlet piping over a unit mix tank.

3. The condition of syrup pipe insulation had peeling caulk. 

4. The following issues were found during the review of production records: Verification of the process control records including CCPs was not available during the audit. While the plant caught the issue during the record review, there was no corrective action completed at the time of the audit.

 

I am summarizing all findings to prepare the full audit report, some members failed to provide the clause number.

Thank you!

[pHruit]

Points 1 through 3 could arguably sit under more than one clause IMO.

I'd have a look at section 4.7 as this sounds like there are potentially several maintenance issues in terms of inspection frequency and/or action taken in the event that an issue is observed or reported.

The issue with the screens in (1) might also sit under 4.10.2.2 - i.e. if these are inspected at a sufficient frequency, how have they be able to deteriorate to this extent?

 

Arguably most of the points, i.e. equipment getting into this condition, could be interpreted as an issue under 3.4.4 - e.g. is it the case that the issues are not being detected because the audits aren't conducted at a sufficiently high frequency, or possibly that the frequency is fine but the thoroughness of the audits is not sufficient?

This one is not definitively applicable as it'll depend on the context of the findings, but it's something you may want to consider (and document that you've considered).

[AJL]

1,2,3 sit under 4 somewhere - for example where there is a risk to product it could be 4.9 (physical and chemical product contamination) or it could also be building fabrication.

PHruit is completely right, one of the new things with ver. 9 is that they will start looking into internal and GMP audits or other sections with these types of non conformities.
Like the issues with repairs will possibly be a non conformity under state of the equipment, but you will also get pinged under maintenance (is the maintenance schedule not sufficient) and audits (why didn't the GMP audit find these issues? Are these issues registered as a non conformity, if no, why not?)
So there is more 'cross checking' between the different clauses.


Last point is definitely somewhere under 2- Control of CCPs.
But then also if they had no corrective action
it could also be that their procedure for corrective action isn't sufficient...which sits under section 3. Then you can start asking, was it due to a lack of training in the procedure?
Which sits under training, as staff mustt be trained on CCP checks.
Sorry it's not very specific with the numbering, but hope that you have an insight into how they are going to start coming after us in 2023 😉