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How to conduct a GMP audit properly?


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Dat Hoang

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Posted 29 March 2017 - 02:03 PM

Hello everyone,

 

I'm working in a dairy plant. Currently, I'm fortunate to become one of the GMP internal auditors. Everything is quite new to me. 

 

At the moment, this is our way of working for GMP audit.

 

 . We have a set of corporate standards for prerequisite programs (mostly based on ISO 22000-01)

 . We would take site tour audit, find non-conformance against the standards.

 . We take photos of those non-conformance for evidence.

 .We then make a report, list out each NC agains each standard then have propose action for the responsible persons to fill the gaps. ( with due date for them)

 . Monthly, we summarize and monitor the filling gap progress just like the attach file and take actions accordingly

 

 

I'd like to ask for your advice if our way of auditing and reporting and monitoring is proper? And if you have other better way (guidance with templates). Pls give us for reference. Thanks very much!

Attached Files



JWert

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Posted 29 March 2017 - 02:36 PM

This is a basic GMP audit, but it fails to include observation of and discussions with personnel - this is invaluable in aiding positive change in the facility.  Additionally, I don't see policy and/or document and documentation review - recommend adding this.

 

-- Joyce



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Rosemary4

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Posted 29 March 2017 - 03:46 PM

Not sure about the GMP audits, but all the audits I've carried out against ISO9000 and BRC, the person against which you raise the non-conformance decides on the corrective action not the auditor. You as an auditor agree the corrective action will be a preventative measure. I may have misunderstood your detailing but it sounded as though you decide on the caction.



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Posted 30 March 2017 - 12:50 AM

From my impression this would be a GMP inspection, not an audit.



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Dat Hoang

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Posted 30 March 2017 - 02:25 AM

From my impression this would be a GMP inspection, not an audit.

 

You're absolutely right. This leans towards a GMP inspection rather than a GMP Audit. That's why I need more consult on how to conduct a formal interal GMP audit. After some audits conducted by external parties. I realized that most of the NC they found can be prevented through the internal GMP audits. 

Not sure about the GMP audits, but all the audits I've carried out against ISO9000 and BRC, the person against which you raise the non-conformance decides on the corrective action not the auditor. You as an auditor agree the corrective action will be a preventative measure. I may have misunderstood your detailing but it sounded as though you decide on the caction.

Yes, you could say that. The NC owner should be the one suggesting the correction/corrective actions. But as our current practice,  to take step further and speed up the progress, we decided to suggest the actions for them, though I think this could decrease somehow their ownership for the NC. In fact, I'm considering to let them decide themselves as you said because we still have to push them a lot on filling the NC.

 

This is a basic GMP audit, but it fails to include observation of and discussions with personnel - this is invaluable in aiding positive change in the facility.  Additionally, I don't see policy and/or document and documentation review - recommend adding this.

 

-- Joyce

 

You're right, we rarely have discussions with the PIC after this "you can say" GMP inspection. That's why I decided to convene a meeting with all PIC to align on the NC next time. 

Our company has a policy on the GMP audit which states that Production will be the ones who implement GMP, we-QA will support the effective implementation of GMP. 

Record review is absolutely important, we didnt do it on previous inspection which is a missing point. I'll conclude it in the next audit.

 

Besides, do you have any guideline for GMP audit or inspection. Much appreciated!



Charles.C

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Posted 30 March 2017 - 07:07 AM

Hi tombentom,

 

Thks for the pic but unfortunately half the x-axis is untranslated.

 

What do the y-axis values represent ? Hopefully not serious defect frequencies.


Kind Regards,

 

Charles.C


Dat Hoang

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Posted 31 March 2017 - 02:04 AM

Hi tombentom,

 

Thks for the pic but unfortunately half the x-axis is untranslated.

 

What do the y-axis values represent ? Hopefully not serious defect frequencies.

 

Hi Charles,

 

The X - axis represents for each certain area in our plant.

 

The Y-axis represents the number of findings in each area.

 

We choose to do that to better control GMP in each area 



Charles.C

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Posted 31 March 2017 - 02:43 AM

Hi Charles,

 

The X - axis represents for each certain area in our plant.

 

The Y-axis represents the number of findings in each area.

 

We choose to do that to better control GMP in each area 

 

Hi Tom,

 

Thks for the response. That is a heck of a lot of "findings" (but see below).

 

Well, assuming yr "findings" are compared against a corporate Standard (encyclopedia?), seems like an (internal) audit to me. Maybe it's just a question of terminologies.

 

Regarding improvements, i break the findings down RA-style, ie classify into critical/serious etc. IMO this approach has more impact/promotes discussion in a haccp sense and also alerts Top Management (if the Report ever gets that far). This is a "refined" version of BRC-style.


Kind Regards,

 

Charles.C


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Dat Hoang

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Posted 31 March 2017 - 09:19 AM

Hi Tom,

 

Thks for the response. That is a heck of a lot of "findings" (but see below).

 

Well, assuming yr "findings" are compared against a corporate Standard (encyclopedia?), seems like an (internal) audit to me. Maybe it's just a question of terminologies.

 

Regarding improvements, i break the findings down RA-style, ie classify into critical/serious etc. IMO this approach has more impact/promotes discussion in a haccp sense and also alerts Top Management (if the Report ever gets that far). This is a "refined" version of BRC-style.

 

Well, that our GMP picture after my 1st involved audit. We have our own corporate set of standards. I think it's time to put in some disciplines.

Thanks for your idea for improvement. I'll consider about it.

About RA, I'd like to know if there's already some proper guideline to do it. Any reccommendation Mr. Charles? Thank you.



Charles.C

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Posted 31 March 2017 - 12:00 PM

Well, that our GMP picture after my 1st involved audit. We have our own corporate set of standards. I think it's time to put in some disciplines.

Thanks for your idea for improvement. I'll consider about it.

About RA, I'd like to know if there's already some proper guideline to do it. Any reccommendation Mr. Charles? Thank you.

Hi Tom,

 

I do have a simple example of RA/GMP style but unfortunately only hard copy. Will try and upload a copy if I can locate a scanner.

The concept is a highly simplified version of the CFIA’s prodigious list/evaluation procedure at the link below.  The difference is that 4 categories are used instead of 3 and overall assessment is based on a Table.  (See the pdf  attachment below for details).

 

http://www.inspectio...89?chap=0#s19c3

 

The overall scheme was intended for determining official inspection frequencies for facilities rather than for routine checking.

Regardless of actual scoring, it offers some interesting (subjective) insights on  risk viewpoints of GMP characteristics.  I have used it in modified form(s) for internal training, trend analyses and external audits

 

Attached File  Ranking Scheme.pdf   39.84KB   220 downloads


Kind Regards,

 

Charles.C


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Dat Hoang

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Posted 03 April 2017 - 01:24 PM

Hi Tom,

 

I do have a simple example of RA/GMP style but unfortunately only hard copy. Will try and upload a copy if I can locate a scanner.

The concept is a highly simplified version of the CFIA’s prodigious list/evaluation procedure at the link below.  The difference is that 4 categories are used instead of 3 and overall assessment is based on a Table.  (See the pdf  attachment below for details).

 

http://www.inspectio...89?chap=0#s19c3

 

The overall scheme was intended for determining official inspection frequencies for facilities rather than for routine checking.

Regardless of actual scoring, it offers some interesting (subjective) insights on  risk viewpoints of GMP characteristics.  I have used it in modified form(s) for internal training, trend analyses and external audits

 

attachicon.gifRanking Scheme.pdf

 

Thanks Charles, very useful reference.

By the way, today I just check the cleaning record of processing area. Could you make some comment on its adequacy? 

Attached Files



Dat Hoang

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Posted 03 April 2017 - 02:51 PM

Thanks Charles, very useful reference.

By the way, today I just check the cleaning record of processing area. Could you make some comment on its adequacy? 

 

In addition, do you know where I can find template for cleaning record of equipment and premises? Thank you!



Charles.C

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Posted 03 April 2017 - 02:52 PM

Hi Tom,

 

I deduce yr attachment is part of a routine Pre-Op checklist rather than a customised scheme for internal audit purposes.

As a basic QA check for the former, IMO, its fine.

 

The scope of an internal audit will inevitably vary with the product/process/"Standard". For example the (GMP) focus on a (combined) raw/RTE process should be somewhat different to a purely raw production setup due to the additional risks involved (even without an explicit haccp overlap). I'm not entirely sure as to the nature/output of yr production, it can be relevant.

 

As I understand, you are required to audit against yr Corporate (GMP) Standards. Yr own scope should be geared accordingly. I deduce their GMP Standards are not explicitly "risk-based", ie are more like traditional QA. Fair enough, especially if no immediate likelihood of being involved with HACCP, or Private Standards like BRC.

 

If you are interested in what i mean by "risk-based", can have a look at some of the various checklists, etc in this BRC thread -

http://www.ifsqn.com...dit-34-brc-v-7/

 

For contrast, this SQF thread focuses more on basic Pre-Op checklists (BRC are a bit risk-fanatical as compared to SQF)  -

http://www.ifsqn.com...tion-checklist/

 

Audit checklists are a  very subjective topic, ie I doubt there is one checklist which fits all processes. If what you are doing works for you/Top management/external auditors, you must be doing something right. :smile:

 

PS - not forgotten the missing file, just time constraints.


Kind Regards,

 

Charles.C


Charles.C

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Posted 03 April 2017 - 03:29 PM

In addition, do you know where I can find template for cleaning record of equipment and premises? Thank you!

 

Hi Tom,

 

There are literally dozens of templates scattered over this Forum. The problem is that everybody has a different idea of presentation. It really depends on yr own preferences, for example have a look at this thread -

 

http://www.ifsqn.com...checklist-form/

 

PS - JFI, this document (from a famous website) ends with a rather neat albeit highly condensed, Pre-Op checklist -

 

Attached File  meat haccp - Model SSOP.doc   115.5KB   108 downloads

 

 


Kind Regards,

 

Charles.C





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