11 replies to this topic

[astro]

HI

 

GMP Audits - Weekly or Monthly?

 

We currently do ours weekly where I would prefer to do Monthly due to the issues raised and the non conformance are not closed out before the next weekly audit. Plus resource is an issue to keep this up weekly as it is rushed.

 

So monthly.... would this be acceptable to BRC V8 

 

Thanks

[pHruit]

Assuming these are intended to satisfy clause 3.4.4, the requirement is "no less than once per month in open product areas". In theory you would therefore potentially be fine with this, but as with all things BRC you're expected to have a risk assessment behind it to determine the actual frequency required. You've presumably got an existing risk assessment in place that concluded a weekly frequency was required, so the question is what can you use to show that the risk status has changed - e.g. perhaps the history of findings for the weekly ones shows that the risk had been overestimated originally?

Insufficient resource isn't likely to be accepted as a reasonable defence (indeed probably the exact opposite, considered in the context of 1.1.7 ) so some more solid substantiation may be required. Your post mentions issues raised and failure to close NCs in time, which perhaps doesn't work in your favour here? Nonetheless it will probably depend on the specific nature, context, and number of these.

[Charles.C]

I wonder as to the OP's Product/Process ?

 

It's a curiously lax BRC clause IMO. And, similarly IMO  is 4.11.2

 

Surely most companies do daily hygiene checks regardless of above ?  Otherwise QC can take an early morning "nap".

[pHruit]

I wonder as to the OP's Product/Process ?

 

It's a curiously lax BRC clause IMO. And, similarly IMO  is 4.11.2

 

Surely most companies do daily hygiene checks regardless of above ?  Otherwise QC can take an early morning "nap".

I'd never realised it was an option, but I quite like the idea of an early morning nap

You make a very good point though, Charles - its perhaps somewhat taken for granted that this daily inspection is conducted, but I'm sure we've all had the misfortune of visiting sites that make one wonder if it really is as universal as one would hope...

 

I suspect there could be an argument that checks of this nature fall under 4.11.5, but it's relatively specific (i.e. equipment, vs. broader environmental hygiene status) and even then it is not exactly unequivocal in the expectations, even with the added "insight" of the interpretation guide.

[GMO]

If it's an audit, I'd say monthly are preferable.  If it's a "check before we start up" then daily.  Sure.

 

I feel the intent is that it's an audit but some people treat it as an inspection.

 

My preference for monthly are around you need to give the team a chance to improve.  If you're hitting them every day, how do they improve?

[Charles.C]

If it's an audit, I'd say monthly are preferable.  If it's a "check before we start up" then daily.  Sure.

 

I feel the intent is that it's an audit but some people treat it as an inspection.

 

My preference for monthly are around you need to give the team a chance to improve.  If you're hitting them every day, how do they improve?

 

Unfortunately, despite being in the glossary, "GMP" does not occur in the Standard.

 

3.4.4 (??) states additional to the IA.......inspections.

 

Further heavenly input necessary.

[VThiruselvi]

its says" The frequency of these inspections shall be based on risk but will be no less than once per month in open product areas". The frequency of the inspections should be based on risk. For open product areas, inspections need to be at least monthly, whereas inspections in high-care and high-risk areas are likely to be more frequent (e.g. daily or weekly); seasonal products or activities should be included where appropriate. Line start-up checks, which may occur daily or at shi changes in many operations, can form part of this inspection programme.

[Charles.C]

its says" The frequency of these inspections shall be based on risk but will be no less than once per month in open product areas". The frequency of the inspections should be based on risk. For open product areas, inspections need to be at least monthly, whereas inspections in high-care and high-risk areas are likely to be more frequent (e.g. daily or weekly); seasonal products or activities should be included where appropriate. Line start-up checks, which may occur daily or at shi changes in many operations, can form part of this inspection programme.

Yes, thks, but note that the OP refers to an "audit" ( > 3.4.3 ?)

 

Basically BRC seems to be requesting an overload of "checking" exercises.

[GMO]

Yes, thks, but note that the OP refers to an "audit" ( > 3.4.3 ?)

 

Basically BRC seems to be requesting an overload of "checking" exercises.

 

I think it's because BRC are trying to become more international.  In the UK we refer to GMP audits which you're right seem to now be missing from the standard.  

 

To my mind your previous comment around quality people putting up their feet if they don't have to do daily inspections, that's not a QA role.  Most modern plants now have QC functions built into operations.  So the operator does a "start up check" or similar.  You could argue these operations "inspections" comply with the standard and yes, they do but without a quality focused GMP style audit to verify those standards are actually being checked, you tend to find they slip.  Admittedly it's all about your organisation's maturity.  Sadly mine is still in the policing phase.

[Charles.C]

I think it's because BRC are trying to become more international.  In the UK we refer to GMP audits which you're right seem to now be missing from the standard.  

 

To my mind your previous comment around quality people putting up their feet if they don't have to do daily inspections, that's not a QA role.  Most modern plants now have QC functions built into operations.  So the operator does a "start up check" or similar.  You could argue these operations "inspections" comply with the standard and yes, they do but without a quality focused GMP style audit to verify those standards are actually being checked, you tend to find they slip.  Admittedly it's all about your organisation's maturity.  Sadly mine is still in the policing phase.

Hi GMO,

 

After some digging it seems the UK(GMP) is rather different to the US(GMP).

 

BRC's glossary "GMP" is sort of amorphous - "Implemented procedures and practices undertaken using best-practice principles."

 

Whatever, I guess It is improbable that  astro would have said "GMP audit" meaning "internal audit" in which case Post 2 has answered the OP.

 

 

Astro, Astro, Wherefore art thou Astro ? Come in Ground Control..... ??

[astro]

Hi 

 

Thanks all for your comments, I have moved to monthly audits.

 

Thanks Again

[Charles.C]

Hi 

 

Thanks all for your comments, I have moved to monthly audits.

 

Thanks Again

Thanks but was the OP (intended to be) related to 3.4.3 or 3.4.4 ?