12 replies to this topic

[aps]

I have currently been audited by our majr customer and they have give me a non conformance regarding auditing. Currently i carry out Hygiene GMP Audits, glass audits, wood audits and traceability audits.

They have picked up that i need to audit my prerequisties but i capture this in my GMP.

Does any body have a guidance regarding this?

Thanks

[Charles.C]

Dear a stoker,

Welcome to the forum

Auditing to what Standard ?

Presumably the specific nonconformance was detailed ?

Rgds / Charles.C

[cazyncymru]

I have currently been audited by our majr customer and they have give me a non conformance regarding auditing. Currently i carry out Hygiene GMP Audits, glass audits, wood audits and traceability audits.

They have picked up that i need to audit my prerequisties but i capture this in my GMP.

Does any body have a guidance regarding this?

Thanks

What i suspect they are getting at is that they are "assuming" that your pre-requisites form part of either your HACCP procedure or your Quality Manual (mine are referenced in both these procedures) and they will want you to demonstrate that you audit your HACCP plans and your Quality Manual. Your GMP audits is that you are ensuring that there is no broken glass, broken pallets etc, but the audit you need to carry out is to show that the GMP audit procedure is current and up to date

if you are working to the BRC you need to demonstrate that the frequency of auditing is risk assessed.

Cx

[aps]

cazyncymru

I sometimes get confused with this,

Curently i carry out:
Glass audits (Monthly)
Wood Audits (Monthly)
Traceability Audits (2 times per year)
BRC Section Audits (Yearly) Completed by QA Manager from another site
GMP Audits (montly) as far as i am concernred on this audit i go into alot of detail which covers of most Prerequisites i.e. It covers:

Raw Materials, storage, stock rotation
Hygiene
Foreign Body / Physical contamination
Pest Control
Allergen Control and storage
Waste & Handling of
Personal Hygiene / Facilities
HACCP Monitoring

Does this look adequete or is there a major issue?

Please anybody reply

Edited by a stoker, 28 January 2009 - 04:56 PM.

[cazyncymru]

cazyncymru

I sometimes get confused with this,

Curently i carry out:
Glass audits (Monthly)
Wood Audits (Monthly)
Traceability Audits (2 times per year)
BRC Section Audits (Yearly) Completed by QA Manager from another site
GMP Audits (montly) as far as i am concernred on this audit i go into alot of detail which covers of most Prerequisites i.e. It covers:

Raw Materials, storage, stock rotation
Hygiene
Foreign Body / Physical contamination
Pest Control
Allergen Control and storage
Waste & Handling of
Personal Hygiene / Facilities
HACCP Monitoring

Does this look adequete or is there a major issue?

Please anybody reply

Hello

What about your Top Tier Procedures? lets say you have a Quality Manual and it has a procedure for Product Recall. Now you carry out an annual Product Recall test, but do you audit the procedure? you need to demonstrate not only have you done a product recall exercise, but you have audited the PROCEDURE that you would follow during a Product Recall

For example, your procedure may say that the Managing Director makes the decision to advise the press, but in reality, this is done by the Operations Director. This means a non-conformance against the procedure. You would need to demonstrate that you have identified this non-conformance, record the non-conformance and issue a corrective action for the non-conformance ( document that OPs Director is deputy for MD say in the procedure).


I'm only guessing here, but it seems that you are confusing your pre-requisites with your top tier Quality Manual, when they should be a supporting document.

C x

[aps]

C

I audit this and test this on an annual basis (forgot to mention this)

Top tier procedures, do you have any other examples. This sounds quite incompetant of me but i am the only Technical body on site and my tecnical team at head office are no real help as they talk in riddles so i dont really have any other tech body to discuss with.

This is new to me as my auditing mentioned above has managed to give me a grade A for the past 2 years. I know it sounds like i am askng you to do the job for me but i am after some gudance and are intrested to further comments.

Do you have an audit template regarding auditing the top tier procedures.

Thank

Edited by a stoker, 28 January 2009 - 11:28 PM.

[cazyncymru]

hi

if you look in the documents exchange sub folder, ive put a template there.

caz x

[SriramB]

Hi cazyncmyru,

Are the top tier procedures audit , the same as 'system" audits which test the adequacy of Core systems. The reason I ask is that we do "system" audits annually.

We also do "compliance " audits more frequently. this consists of stuff ,like checking that QA tests are being done etc, and include PRP audits as part of the Compliance audits.

Some PRP features are also audited during GMP , as APS mentioned, but this is to insure the rules set in the PRP are followed.

I do not have BRC, but am keen to know more on using risk assessment as a basis for decidng audit frequencies. do you have any examples please.

thanks

[GMO]

Hmm. I would have thought that during the yearly section audits the auditor from the other site would be covering this? However, maybe the scope of the audit isn't sufficient or maybe they feel yearly isn't sufficient frequency or has not been arrived at through a logical (risk assessed) process.

I think you should go back to the auditor and ask for clarification before changing too much of your internal auditing system and creating work for yourself.

[Dr Ajay Shah]

I agree with GMO in that you should consult your customer and get more specific information from them rather than doubling up.

Regards

Ajay

[birmingham2000]

hi

if you look in the documents exchange sub folder, ive put a template there.

caz x

Where is the documents exchange sub folder? Thanks

[Simon]

Where is the documents exchange sub folder? Thanks

Is this the file you're looking for: Internal audit checklist

[IConnectVA]

Great library of files. However, I'm not extraordinarily active (as I'm just learning and severely new to the game).
Is there an alternate path, excluding purchasing?