10 replies to this topic

[bev]

Hi All,

Looking at clause 3.4.4 which requires documented inspections in open product areas at least once a month. We already audit ourselves to oblivion (internal ISO, BRC, GMP audits/inspections) so I wondered if any of you had a simple checklist which would satisfy this clause without reinventing what we already do.

Thank you,

Bev :-)

[Simon]

What do you audit in your GMP/BRC audits, surely you should be auditing 'high risk' open product areas on these audits anyway?

Regards,
Simon

[bev]

We don't have any 'high risk' open product areas. However all open product areas are audited during the course of a year but BRC Issue 6 specifically says that ....'in addition to the internal audit programme there shall be a programme of documented inspections to ensure that the factory environment and processing equipment is maintained in a suitable condition for food production.......'

I just wondered whether anyone had a checklist that we could use for these additional inspections or maybe I've misinterpreted this clause of the new standard.....????

What do you audit in your GMP/BRC audits, surely you should be auditing 'high risk' open product areas on these audits anyway?

Regards,
Simon

[mgourley]

We don't have any 'high risk' open product areas. However all open product areas are audited during the course of a year but BRC Issue 6 specifically says that ....'in addition to the internal audit programme there shall be a programme of documented inspections to ensure that the factory environment and processing equipment is maintained in a suitable condition for food production.......'

I just wondered whether anyone had a checklist that we could use for these additional inspections or maybe I've misinterpreted this clause of the new standard.....????

Your GMP audits are what the standard is talking about here. As long as you are doing the entire facility once per month, you are meeting the intent.

Marshall

[Tony-C]

Hi All,

Looking at clause 3.4.4 which requires documented inspections in open product areas at least once a month. We already audit ourselves to oblivion (internal ISO, BRC, GMP audits/inspections) so I wondered if any of you had a simple checklist which would satisfy this clause without reinventing what we already do.

Thank you,

Bev :-)

Hi Bev,

Sample attached.

 H&H Audit Blank Factory GMP Audit.pdf   158.4KB   747 downloads

Regards,

Tony

[mgourley]

Hi Bev,

Sample attached.

 H&H Audit Blank Factory GMP Audit.pdf   158.4KB   747 downloads

Regards,

Tony

While I appreciate the general format of this audit, it's not specific enough. Your GMP audits should be specific to the area being audited. and generally, do not conform to a checklist.
My GMP audits do not check for conformance, as conformance is expected. I believe that's one definition :)
In my GMP audits I look for things that could be done better, thus showing continual improvement.
For example.. "area after the pan oiler station has excessive buildup, detail clean and review cleaning frequency.". Determine if engineering controls can reduce amount of oil in area."
This then gets fed into the CA program.

Marshall

[bev]

Hi Bev,

Sample attached.

 H&H Audit Blank Factory GMP Audit.pdf   158.4KB   747 downloads

Regards,

Tony

Thank you Tony!!! Just what I was looking for

[GMO]

While I appreciate the general format of this audit, it's not specific enough. Your GMP audits should be specific to the area being audited. and generally, do not conform to a checklist.
My GMP audits do not check for conformance, as conformance is expected. I believe that's one definition :)
In my GMP audits I look for things that could be done better, thus showing continual improvement.
For example.. "area after the pan oiler station has excessive buildup, detail clean and review cleaning frequency.". Determine if engineering controls can reduce amount of oil in area."
This then gets fed into the CA program.

Marshall

I disagree. I agree there is a time to veer away from checklists but IMO a monthly GMP audit is something which should lend itself to scoring and for that you do need consistency. Also in section 3.4.3 it clearly states that audit reports shall identify conformity as well as non -conformity so you could be leaving yourself open to a non-conformance by just looking at improvement.


Remember a checklist does not have to be onorous, BRC is a checklist effectively after all. I don't like to share too many documents on here but I cover sections in my GMP audit which are vague enough for me to be able to have some flexibility to identify issues but tight enough so I can prove I've actually looked at the areas I need to. For example, if you don't have a checklist and you don't identify conformity then how can you prove that you've looked at pest control for example if you don't find an issue?

[mgourley]

I disagree. I agree there is a time to veer away from checklists but IMO a monthly GMP audit is something which should lend itself to scoring and for that you do need consistency. Also in section 3.4.3 it clearly states that audit reports shall identify conformity as well as non -conformity so you could be leaving yourself open to a non-conformance by just looking at improvement.


Remember a checklist does not have to be onorous, BRC is a checklist effectively after all. I don't like to share too many documents on here but I cover sections in my GMP audit which are vague enough for me to be able to have some flexibility to identify issues but tight enough so I can prove I've actually looked at the areas I need to. For example, if you don't have a checklist and you don't identify conformity then how can you prove that you've looked at pest control for example if you don't find an issue?

My GMP audits are done weekly. The facility is broken down into four areas and one area is done per week. The procedure for conducting the audit specifies what is to be looked at (pest proofing in the receiving area, for example).
The actual findings document only shows non-conformance and areas for improvement.

I consider many of the items on the example provided to be "yes/no" answers, thus difficult to assign a variable number to.

I do get your point however about showing conformance on an audit report. I will have to rethink what I have now, which is listing in the audit procedure what to look for and what observation(s) indicate conformance.

It should not be that difficult to incorporate into my current audit report and as you say can be vague enough that people doing the audit actually use their eyes, rather than focusing on what box to tic.

Marshall

[GMO]

My GMP audits are done weekly. The facility is broken down into four areas and one area is done per week. The procedure for conducting the audit specifies what is to be looked at (pest proofing in the receiving area, for example).
The actual findings document only shows non-conformance and areas for improvement.

I consider many of the items on the example provided to be "yes/no" answers, thus difficult to assign a variable number to.

I do get your point however about showing conformance on an audit report. I will have to rethink what I have now, which is listing in the audit procedure what to look for and what observation(s) indicate conformance.

It should not be that difficult to incorporate into my current audit report and as you say can be vague enough that people doing the audit actually use their eyes, rather than focusing on what box to tic.

Marshall

Absolutely. That's completely what I meant.

It would be easy to assign a number to your audit. Ok, say you have 10 questions, each with yes / no answers (I'm assuming "no" is bad). If you had three "no"s, then that audit could score 70% for example.

You could alternatively add in a bit more nuance by saying "score 2 if it's fine, score 1 if it's no imminent food safety risk but poor practice, score 0 if there is a food safety risk" or similar?

I've had lots of scoring systems in my time. Others I've used penalise serious issues more heavily. Honestly though as long as you have a way to measure improvement, what scoring system you use isn't important as long as it's consistent.

[vasil.emilov]

Hello,

 

I am new to the forum, and to QA in general,

 

I have a question regarding internal audits and factory inspections (walkaround)

 

how to decide the frequency of checks in the separate ares, obviously High Care will be most often,

 

but what often means - annually, monthly, weekly

 

and is 3.4.4 part if the internal audit, or should make it separate procedure.

 

Regards,

 

Vasil