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GMP Inspection versus Monthly Facility Audit


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#1 DN_QAMGR

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Posted 06 December 2017 - 08:12 PM

Hi All,

 

I'm revising my GMP Inspection to be more detailed based on risk.

I'm at the point where my GMP Inspection is as detailed as my monthly facility audit (reiterating the same facility inspection points). 

 

Would you recommended if I should combine my Monthly Facility Audit with my GMP Inspections? or am I setting myself up? 

 

 

This would help because my Monthly Facility Audit is 28 pages and my GMP Inspections will be close.

Attached is my monthly audit and my preliminary GMP Inspections.  

 

 

My monthly inspections are going to be fun, btw!

thanks all, have a good day!

 

DN



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#2 Simon

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Posted 06 December 2017 - 09:08 PM

Hi DN, duplication is inefficient, so my personal opinion is to combine. That said if you have recurring findings then split those out as "high risk" and audit them more frequently.  You only have limited time so you want best vaue for your audting time.

 

Have a great day.

 

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Simon


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#3 GMO

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Posted 13 December 2017 - 12:29 PM

I would combine but if that creates an audit which is so long as to be virtually impossible to achieve, then why don't you break it down into zones then do a zone at a time?  That way you're likely to audit more frequently but not the whole plant each time.  It will save you getting blind to issues and seeing something in one area can result in corrective actions put in place in all areas so you get more "bang for your buck". 



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#4 zechzplz

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Posted 19 December 2017 - 05:54 PM

Whoa! I am loving your forms! 

I agree with everyone in that I don't like duplication (or as I like to call it double-work). However, I think there is a benefit in separating the GMP audits from the facility audit. 

I have a few questions that I think will help in determining the best way to capture information. Note, I am not familiar with the BRC audit (we are SQF certified) 

  • Do you have a separate internal audit program or does your internal audit program consist of the facility audit and GMP audit? My company conducts internal audits that are dictated to the SQF code so between our internal and GMP audits, we do not have an additional formal and written facility audit (we of course have supervisors doing walkthroughs an writing up corrections/CA’s as needed). Are you doing internal audits specific to the BRC code in addition to your facility and GMP audits? If so, I assume, there are several places of overlap that you can cut down on.  
  • Are there some items that can be done at a certain frequency? For example, if corrections don’t happen on a frequent basis and don’t require monthly inspections, can some facility items be inspected on a quarterly basis? Twice-a-year basis?
  • Do you conduct preventative maintenance or pre-op inspections? These can also be reasons for a reduced frequency.

 

A few questions on your form (not exactly related to your questions, if you don’t mind me asking and you answering!): 

  • How long does it take you to do your GMP audit? How long does it take you to do your facility audit?
  • Do you change the version every time you have to add an additional line item? 


#5 DN_QAMGR

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Posted 20 December 2017 - 04:45 PM

 

Whoa! I am loving your forms! 

I agree with everyone in that I don't like duplication (or as I like to call it double-work). However, I think there is a benefit in separating the GMP audits from the facility audit. 

I have a few questions that I think will help in determining the best way to capture information. Note, I am not familiar with the BRC audit (we are SQF certified) 

  • Do you have a separate internal audit program or does your internal audit program consist of the facility audit and GMP audit? My company conducts internal audits that are dictated to the SQF code so between our internal and GMP audits, we do not have an additional formal and written facility audit (we of course have supervisors doing walkthroughs an writing up corrections/CA’s as needed). Are you doing internal audits specific to the BRC code in addition to your facility and GMP audits? If so, I assume, there are several places of overlap that you can cut down on.  
  • Are there some items that can be done at a certain frequency? For example, if corrections don’t happen on a frequent basis and don’t require monthly inspections, can some facility items be inspected on a quarterly basis? Twice-a-year basis?
  • Do you conduct preventative maintenance or pre-op inspections? These can also be reasons for a reduced frequency.

 

A few questions on your form (not exactly related to your questions, if you don’t mind me asking and you answering!): 

  • How long does it take you to do your GMP audit? How long does it take you to do your facility audit?
  • Do you change the version every time you have to add an additional line item? 

 

Hi Zechzplz,

 

1. The internal audits I use is the BRC Standard. I took the standard and did a risk analysis on each standard. From there I created a Internal Audit based on the standard and risk. In short, the Standard is a combination of all areas for my internal audit. 

2. The reason why I have separate monthly GMP and facility audits is because there were non-conformance during my previous audits in the past. So, based on risk, I created additional monthly audits to ensure my internal audits and 3rd party audits are supported.  

3. Production conducts pre-op inspections and I try to stay away from maintenance inspections to annually because that is a story in itself. I deal with food packaging so my risk is low even though my product is high risk. 

 

GMP Audit - They usually last me about an hour of inspection and 3-4 hours creating the Non-conformance & Corrective Actions. My facility audit takes me 1/2 a day and a day to take care of the Non-conformance & Corrective Actions. 

 

Do I change the version any time? - Any time the form is edited or additions or removal of steps are made, my version changes.

 

Thank you for appreciating the work and your questions. 

 

I've combined my two audits (GMP & Monthly Facility). **Attached is my final copy waiting for approval. I just need to do a risk analysis and hopefully I included all the correct standards. 

 

Have a happy holidays!

Attached Files



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#6 tdunkley

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Posted 08 June 2018 - 12:46 AM

Hi! Just curious what the outcome was - did you find you needed to make any further changes to meet the auditor's requirements? May I ask what approach you took to completing the risk assessment? Did you use a 3x3 scoring system, for example?






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