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Seeking advice on the frequency, format, and scope of GMP Audits


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#1 trubertq

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Posted 09 January 2014 - 03:11 PM

For the new year i have been asked to put in place a schedule of GMP audits. Well, that's not strictly true, the management team have been asked and they have politely tried to slide it over onto my desk

 

( I am an external technical support, I do Internal audits, Hygiene/fabrication/equipment audits monthly and generally keep the documentation around BRC certification up to date and in control).

 

Now, I believe that GMP audits are a tool for showing personnel on site the things that appear day-to-day in a facility, and are not just for the purpose of generating long lists of non-conformances, which I do anyway on a monthly basis.

 

Can you guys give me some pointers on how you deal with GMP audits, frequency, format, and scope. I have a meeting on Monday and I hope to have some cool ideas to pour forth!

 

Thanks and HAPPY NEW YEAR to all here and all the IFSQN Team

 

 


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#2 Mr. Incognito

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Posted 09 January 2014 - 04:03 PM

One of the plants I worked at, that had about 120 employees, had everyone, including the office personnel, perform one every month.  All employees were broke up among the weeks of the month so there was like 30ish done every week. It was mandated so of course some people just checked that everything was good and handed it in.   At one point they tied in doing them to bonus percentage calculation but that was because only about 80% of them were being turned in every month... I got to the point on the floor I would fill out at least 2 a month just to be sure mine was in lol.

 

The thing was nobody ever put someone's name on it.  If you observed people not wearing hairnets or whatever you just put a check in no.  You can have one check or a check for everyone they observe... etc.

 

I was going to upload a sanitized file of what I made at my last plant that was based off the plant I worked at before but for some reason I can't upload it.  If you shoot me an email address I can send it over to you and upload it for everyone else.

 

Simon:  For some reason when I go to upload a file to the forms directory it's not working.  It says Forbidden in the "Select File" and "Add Screenshot" blocks above the attach file box.  I'm using IE 11.


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#3 Mr. Incognito

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Posted 09 January 2014 - 08:10 PM

Now it appears to have worked. Here is the link to the file I uploaded:

 

http://www.ifsqn.com...mp-audit-sheet/

 

The boxes at the top of the page were giving me major issues setting them properly they would probably  have to be moved around.  I finally set them where Excel would work by printing and moving them around  until they looked decent on the page (though not perfect).

 

Is this what you were looking for?


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#4 trubertq

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Posted 14 January 2014 - 10:43 AM

Yes Thanks, that is a good start. I appreciate your feedback


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#5 Mr. Incognito

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Posted 14 January 2014 - 06:01 PM

Your welcome I hope it helps you as you move forward.

 

Good luck!

 

Merle


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#6 Tony-C

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Posted 15 January 2014 - 04:55 AM

Hi Truebertq

 

Your schedule should be based on risks associated with the area for example:

Attached File  H&H Audit Factory GMP Audit Schedule_001.jpg   124.65KB   5 downloads

 

Examples of the type of format and report also:

 

Attached File  H&H Audit Factory GMP Audit Report.pdf   210.48KB   128 downloads

 

Attached File  H&H Audit Factory GMP Audit Report Sample.pdf   183.19KB   104 downloads

 

I like to score the audits as the scores can be used for trend analysis.

 

Regards,

 

Tony



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#7 CBJuice

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Posted 04 August 2014 - 04:59 AM

Thanks for the forms. It gives me a great idea of other ways to monitor GMP's. Our form is very generic






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