Need advice on audit non-conformances identified with our Environmental Monitoring Program
Hi All,
During one of our recent customer audits we had been given a non-conformance with a lot of goals for our EMP program. One of which being that all of our results should be <10 for enterobacteriaceae. Currently in our program we have our max set at <10,000. We have not had any issues with this limit in the past including in our SQF audits. A lot of our swabs already do come back to <10 but I fear that now we will constantly have to be retesting. Also if we do set our new limit at <10 does that mean that for anything that comes in >10 that we will need to retest? or will it only need to be retested if it comes in at a higher number, for example >100? Has anyone else been asked to keep their numbers at <10.
Another topic that came up is testing for more than EB. Currently we test for EB and salmonella in some zones but during this audit we were requested to start testing for APC. Is this something that is necessary or will EB and salmonella suffice?
Lastly, part of this non-conformance was including in our EMP to start swabbing things like our floor scrubber, pallets, and reusable totes. I;m not sure if some of this is over kill as a lot of these things we have kept in separate areas very far from our production. Our pallets are recycled between us and other customers that we deal we with so by the time we swab that pallet and if it comes back >10 that pallet could already be at another warehouse.
I want to make sure we have all of our bases covered but I also do not want to "shoot ourselves in the foot" if I am explaining that correctly. Has anyone else been asked to do anything similar or could anyone offer some advice on what might be the best route to take?
Thank you,
Chris
The main objective of monitoring is verification that the process has been under control prior to the release of product. In addition to this, monitoring allows for the continuous improvement of preventive measures/procedures.
Searching intensively for potential contaminant sources provides the factory with an insurance policy. All monitoring must be meaningful and data must be used to eliminate any developing source of contamination and hence keep our products safe – OUR FIRST PRIORITY.
Normally for high hygiene area EB is one of the best indicator to judge overall hygiene condition:
If count 10<EB<100 Green
100<EB<1000 Yellow (Alarm)
>1000 EB Red ( Need corrective action) as probability increased of detection of S. or can say hygiene conditions are not under control
Action in case deviation may depends on sampling point ( P1, P2 or P3), sample quality, past history etc.
Regards
The main objective of monitoring is verification that the process has been under control prior to the release of product. In addition to this, monitoring allows for the continuous improvement of preventive measures/procedures.
Searching intensively for potential contaminant sources provides the factory with an insurance policy. All monitoring must be meaningful and data must be used to eliminate any developing source of contamination and hence keep our products safe – OUR FIRST PRIORITY.
Normally for high hygiene area EB is one of the best indicator to judge overall hygiene condition:
If count 10<EB<100 Green
100<EB<1000 Yellow (Alarm)
>1000 EB Red ( Need corrective action) as probability increased of detection of S. or can say hygiene conditions are not under control
Action in case deviation may depends on sampling point ( P1, P2 or P3), sample quality, past history etc.
Regards
Ndri,
Do you do anything if you are in the green or yellow like do some cleaning/sanitizing? If I understand correctly you will only reswab if you get a result that is >1,000?
Best regards
Hi Chris,
Micro. limits for surfaces for species other than non-zero tolerant pathogens are subjective.
Possibly also related to product/process which are unknown.
See -
If your swabs are all coming back with <10 are you really getting anything in return? Then again, if you lower the limit to 10 and end up with out of compliance issues you need to assess the real risk.
I think the customer has some valid points. A limit of <10,000 and you consistently achieve <10 is a rather meaningless limit IMO. You also need to consider expanding to other areas, like the customer pointed out, because you need to try and find sources; not just do the monitoring to do it.
If you expand to other areas and get hits more than 10, then evaluate them and assess the risk. You will likely find you have different limits for different areas, equipment, and zones which is perfectly valid.
Testing limits also depends on when you are sampling and what you are sampling. For example if you are testing right after sanitation and before equipment or an area is used then the count limits should be low such as <5 or <10 CFU / sq inch. If you are testing during production then the limits could be increased some as micros will occur as a general rule, especially APC. If you are testing in a Ready-to-Eat area you limits should be lower than testing in a non-Ready-to-Eat area.
You could build into your program or SOP that if you receive 3 consecutive results at 10 or above or one result over 100 or maybe make the limit 500 then you will investigate, take corrective action and retest. It kind of depends on the dilution of the test also. If you are plating at a 1:10 then I would definitely have something about consecutive results. If you are plating at 1:1 then that gives you a little better margins and the chance of knowing that one growth is not actually a 10 and a fail.
APC are a general indicator and often used in the industry to test sanitation. I do not think it is unreasonable to ask for you to test for APC.
As for broadening you sampling sites, I think that is a good idea, especially if you are testing right after sanitation. It helps you to verify that all equipment and areas are being addressed during the cleaning process and/or at an adequate frequency.
Also, consider the customer, are they significant to your business? If so, then you probably want to make them happy. If they are not that significant to your business then you could talk to them and determine how important this is to them and/or if they are willing to compromise the limits? If it is not a deal breaker and it is just something they make note of in their audits and review of your facility then determine if this is a non-compliance you are willing to accept each year from them.
I do agree that your limits are pretty excessive so either way you might want to re-look at them. SQF usually wants you to have justification on why your limits are what they are. If there is nothing regulatory or a white paper out there that supports the limits used then you should have an internal justification such as taking the average of the results from last year and using that as a limit.
4 log of EB on a 4 sqin portion of "clean" stainless steel would be an alarm. From my sampling experience that's what I would expect to find swabbing a dirty handwashing sink...