8 replies to this topic

[AJL]

Hi :)
Does anyone have an prep list for unannounced audit?
I am not talking prep of paperwork, more a list you can give to production so they can make sure we don't get in trouble for obvious errors.
Thanks in advance.

[Bluedevils87]

I'm not sure if this is what you're looking for, but a good place to start would be GMP/hygiene/product handling. Best option would likely be to have occasional training sessions, but if you're just looking for something quick, give their supervisor/manager a copy of the relevant SOPs (GMP, etc.) or type up a revised list of the important points. Short and simple is often more effective than trying to load them up with a bunch of info that they likely are not particularly interested in anyways. Ideally you would document these "trainings" as well so you could show to an auditor that, despite any non-compliances that they might observe, you are generally being proactive. 

[olenazh]

Don't get stressed much about that. I use this trick: when an auditor wants to speak to some of our production or warehouse operators - I point to the most knowledgeable/experienced person in that dpt. If an auditor says "Oh, I wanna speak to another one!" I always have this response "This person doesn't speak good English, and gets nervous". That always works perfectly:) 

[AJL]

Hi, think I might not have been clear enough.
🙂
I meant like a GMP check list our production manager can check off against (is everyone wearing the protective clothing? Is the chemical cupboard Locked?) For example.
Like a quick dash so we avoid dumb, easily avoided non conformities.
Our staff are awesome and the auditor can talk to whoever they want. Everyone trained. 🙂🌞

[olenazh]

You've said it yourself: just create a list outlining personnel (e.g. protective clothing, hairnets are covering all hair, wash hands, concentrated on their tasks, obey rules, etc.), equipment (e.g., functioning properly (you don't want any surprises, right?), lubricated, no unnecessary stuff scattered around, clean, etc.), cleaning (e.g., everything is cleaned properly, all cleaning equipment is on their places, all cleaning buckets, if any, are labeled, etc.), chemicals (e.g., chemical cupboard is locked, chemicals are properly labeled and match to SDS you have, etc.), storage (e.g., all ingredients/packaging/materials are on their dedicated places, area is clean and neat, dry/ref/frozen appropriate, distance from the walls, skids are not broken or at least neat, etc.), receiving (e.g., receiving personnel is doing their tasks properly, inspection, truck check, etc.), building (e.g., lights, walls, floors, etc. are clean, proper, no rust/peeling paint, etc.), and so on. I usually prepare this kind of list for my Production manager to be ready any time.

[SHQuality]

I am not talking prep of paperwork, more a list you can give to production so they can make sure we don't get in trouble for obvious errors.

That list would be the procedure(s) they're (supposed to be) following.

If you do regular rounds on the factory floor and talk to workers about problems they run into, you'll have a good idea what might trip them up.

Those points need to be mentioned during their daily or weekly team meetings long before the audit ever happens. Repeatedly if necessary.

[AJL]

Totally with you! I'm in there every day, and monthly GMP audit. But doesn't hurt to give them a list they can check up on, to avoid obvious small things. 🙂

[Tony-C]

Hi :)
Does anyone have an prep list for unannounced audit?
I am not talking prep of paperwork, more a list you can give to production so they can make sure we don't get in trouble for obvious errors.
Thanks in advance.

 

Hi AJL,

 

There is obviously quite a lot to cover in preparation. This is the relevant part of Unannounced Audit Preparation guidance that is included as a supplement in our Implementation Packages, it covers responsibilities by area when the audit is "live". I think it will give you enough ideas for generating your own.

 

 Unannounced Audit Preparation Page 4.pdf   36.75KB   80 downloads

 

Kind regards,

 

Tony

[Gelato Quality Lead]

Personally, I think that having a list of things for your production manager to look out for might be difficult since there is just so much.

 

What I did the past two months while waiting for our unannounced audit was, everyday that I knew they would not be coming in, I would go through the production area with a fine toothed comb and point out anything an auditor could comment on. I would communicate these to the production manager and shift leads so that they would be able to work on it and let their teams know. 

 

I also made sure to include my production manager in a GMP self-inspection not too long before so that he can have an idea of what an auditor will keep an eye out for. I also took a look at all our previous deviations found in GMP self-inspections, as well as previous third-party audits, and communicated those to the production manager to keep a closer eye on before the audit.

 

You got this!!