I am in need of some advice this morning. We are a very low risk facility (dry environment producing injected molded cups/containers using Polypropylene, LDPE and Styrene resins). We have an environmental monitoring program in place that passed our initial certification audit with no trouble. We test for Enterobacteriacea using the Microsnap EB detector and enrichment devices, and have seen very low to negative results (well within passing range) on all surfaces we've tested. We began swabbing monthly, then quarterly, then every 6 months based on the results of testing.
We just completed our first re-certification audit for SQF, Ed. 8 for Modules 2 and 13 (Manufacture of Food Packaging) and we have received a non-conformance for Clause 184.108.40.206 (Product Sampling, Inspection & Analysis).
Specifically, the clause states: 220.127.116.11 On-site personnel that conduct testing of finished product shall participate in an applicable proficiency testing program at least annually to ensure accuracy of results.
The non-conformance we received states: The site has not checked the environmental results conducted in-house against an outside testing authority.
In a nutshell, the auditor had no problem with our program, frequency or methods of testing. What he gave this non conformance for was that we didn't test our EMP results against a 3rd party authority. My thoughts are this:
- I don't see in the code anywhere in the Environmental Monitoring section where we need to verify/validate our test results with an outside party - this is a non-mandatory element anyway (and I realize this is currently somewhat hotly contested/discussed)
- The non-conformance we received goes against clause 18.104.22.168 which does not relate to Environmental Testing in our process (visual inspections, tape tests, rub tests are performed, but no swabbing necessary, passive release is approved and all operators are given a proficiency/performance review annually).
I perform the swabs/testing and what the auditor seemed to take issue with was that although I had done somewhat extensive research, and have on file very comprehensive instructions from Hygiena on how to use/calibrate the testing device(s), there was no outside verification that I was doing this correctly.
Would this be something that I should contest (we only received one other minor non-conformance unrelated to this topic)? And if so, who would be the best person to go to - the auditor, CB, SQFI?
And if I should accept this non-conformance and decide to move forward with finding an outside authority to verify our test results, what would be my best option?