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?
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!