GMP Audit vs Internal Audit

We are currently doing monthly in-house inspections along with our internal audits. Are they monthly in-house inspections required? I feel like we have put ourselves into a corner. Currently our SOPs say that we will do this monthly in-house inspection but if it not required by SQF, I would rather not put it in our SOP that we will do it monthly. I see where SQF requires internal audit to review the entire code (can be broken up if needed, but needs to be entirely reviewed annually). I would like to keep doing the monthly in-house inspections because they are very valuable but I would not like to have it in writing, because if it is written down and we miss it, out auditor could give us a minor. 

I should clarify, these are monthly GMP in-house audits.

My understanding of it and what we do at our facility is monthly GMP based audits of the facility/employees and an annual SQF review (which doesn't necessarily need to take place on the same day - similar to how SQF audits are conducted). Our annual document review takes place over a couple months and the facility portion is done on the same day. 

Hope this helps you out. 

We are currently doing monthly in-house inspections along with our internal audits. 

 

 

Are they monthly in-house inspections required? I feel like we have put ourselves into a corner. Currently our SOPs say that we will do this monthly in-house inspection but if it not required by SQF, I would rather not put it in our SOP that we will do it monthly.  

 

I see where SQF requires internal audit to review the entire code (can be broken up if needed, but needs to be entirely reviewed annually).

 

 

I would like to keep doing the monthly in-house inspections because they are very valuable but I would not like to have it in writing, because if it is written down and we miss it, out auditor could give us a minor. 

 

Per SQF V9 Code:

 

Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and facility and equipment maintenance are compliant to the SQF Food Safety Code: Food Manufacturing. The site shall:

i. Take corrections or corrective and preventative action; and

ii. Maintain records of inspections and any corrective actions taken.

 

You might look at it from a different frame of mind.  Your facility will fare much better from more regular plant inspections.  The more often that your eyes are on the floor examining what is going on, the fewer corrective actions you will have to make, and the better your facility will look/function.  Your auditor may actually question why you would want to examine GMPS on a less frequent schedule, unless you have data to prove that once a quarter or bi-monthly is sufficient.  Personally I have my employees do different portions of the monthly GMP audit on a weekly basis, so that it's spread out, and the entire audit feels less burdensome (especially when you have a small crew like we do). 

 

Hope this helps!

 

This is very helpful. I just wondered about the monthly because there are other things we have put ourselves into a corner with. For example, the SQF code says that the trace and recall plan needs to be tested annually. In our paperwork, we stated that we would do it twice annually. We missed this by one day and were written up. So we have now changed it to annually and figure it we do it more that is good.

I questioned the GMP monthly inspection as we are a very small facility (less than 10 people) and we are all on the floor almost daily, even the people who work in the office. The facility is brand new and is being cleaned constantly (which is fantastic that they are so on top of it). I just did not want to get into the same situation where we miss the monthly GMP audit by a day and get another minor.

Thanks! 

You can protect yourself from that by updating your programs. For example, in our recall program we say that we will perform a mock recall at a minimum annually, which shows we could potentially have more than one mock recall performed but it will be complete at least once within the calendar year. 

For the GMP monthly audit, I have it set in my calendar as a recurring event which shows up, for example, on the third Monday of every month so I don't ever miss it. Another part to this is if you do miss it for whatever reason, you will need to complete a non conformance for missing the audit. That way if an auditor is reviewing your paperwork and saw that you missed a month, you will have it documented as to why this happened and what you did to fix it, etc. 

I would recommend still completing the monthly audits even though you are on the floor everyday. We have a pretty small facility and am on the floor constantly but when I go out for the monthly audits, I always find something I don't necessarily find when I am working out there. 

Good morning Becca,

We had some great responses on your original question already, and my comment isn't too far removed from theirs. I just wanted to mention that a few years ago when I ran an SQF audited plant, it was pretty much standard that internal inspections be completed on at least a monthly basis. As YNA pointed out, the code states they must be regular, so it's not a hard and fast rule.

However, I believe monthly for internal inspections is still a bit of an industry standard.

You can protect yourself from that by updating your programs. For example, in our recall program we say that we will perform a mock recall at a minimum annually, which shows we could potentially have more than one mock recall performed but it will be complete at least once within the calendar year. 

 

For the GMP monthly audit, I have it set in my calendar as a recurring event which shows up, for example, on the third Monday of every month so I don't ever miss it. Another part to this is if you do miss it for whatever reason, you will need to complete a non conformance for missing the audit. That way if an auditor is reviewing your paperwork and saw that you missed a month, you will have it documented as to why this happened and what you did to fix it, etc. 

 

I would recommend still completing the monthly audits even though you are on the floor everyday. We have a pretty small facility and am on the floor constantly but when I go out for the monthly audits, I always find something I don't necessarily find when I am working out there. 

I have since had them change the paperwork to say that the mock recall will be completed at least once a calendar year. So we have "fixed" that issue. 

I am not the one who completes the GMP in-house audits and it seems to be done on a monthly basis but occasionally it takes two days and the second day falls into a new month which makes me a little nervous. 

I have since had them change the paperwork to say that the mock recall will be completed at least once a calendar year. So we have "fixed" that issue. 

 

I am not the one who completes the GMP in-house audits and it seems to be done on a monthly basis but occasionally it takes two days and the second day falls into a new month which makes me a little nervous. 

I missed ours in February of this year, must have forgotten about the short month and completed it the first or second day or march. The auditor did point it out but didn't have an issue with it. So I would say it would depend on the auditor and how forgiving they are. I would see if whoever is completing these for you can bump it back a day so that it doesn't potential continue into the next month OR you can simply write into your internal audit SOP that the monthly GMP internal audits will be started during the month of the audit and may be closed out within 7 days (or however you want to write that in). As long as you are doing what you are saying in your SOP you should be good. 

Hello all,

This is all very helpful.

We too are a small company like Becca Ann's and we recently underwent an audit.  We were conduction Monthly GMP Inspections but our auditor commented that it was too lengthy.  I was wondering if anyone would be willing to share their Monthly GMP Inspection?

Thank you in advance.

Best regards,

KBMB

Hello all,

 

This is all very helpful.

 

We too are a small company like Becca Ann's and we recently underwent an audit.  We were conduction Monthly GMP Inspections but our auditor commented that it was too lengthy.  I was wondering if anyone would be willing to share their Monthly GMP Inspection?

 

Thank you in advance.

 

Best regards,

 

KBMB

As you may already know, every facility is different so you really have to tailor it to what you guys need. What I have done is wrote down each area (exterior, Production room, Warehouse, shipping/receiving, break room, etc.) From there, I made a table with 4 columns. 

1st column is action items which is what I am inspecting, 2nd column is the findings, 3rd column I list corrective action to be taken for the finding and the 4th column I have a sign off that the CA was complete. The action items aren't too specific so the list isn't forever long and this will help whoever is auditing to look further than just the very specific item being asked about. 

Each action item pretty much carries over into each area then some areas have very specific call outs. For example, I have an action item for the absence of pests, adequate lighting, ceiling/wall clearance, etc. in each area. In production rooms I check for employees following GMP's, shipping I check dock door conditions, exterior I check for maintenance of foliage, etc.

Again, this works for us and we are not a very large facility. We are also not a high risk facility. 

Hope that helps you! 

Hello

Can anybody share an example of daily/ weekly GMP audit checklist ?

Your monthy gmp audit would fall under you internal list just like our am/pm pre op audits .

All audits done by facility owners, employees etc constitute internal audits and would be on the schedule.