Risk Assessment and micro testing to determine need for EMP

We produce corrugated containers, some of which are designated for direct food contact. During our first BRC packaging 6 audit we received a Minor non conformance against 4.8.5. I had a copy of the BRCGS P558 Position statement and quickly pointed out page 4 the states "Most packaging materials are unsuitable for the survival and growth of pathogens and therefore will not require an environmental monitoring program to be in place".

This led to a discussion of us being told to create a risk assessment, "do some testing for a couple quarters then just do yearly thereafter". 

Can anyone in the same or similar industry provide any guidance for me on this? I have contacted a couple labs and they are not been very helpful.

We produce corrugated containers, some of which are designated for direct food contact. During our first BRC packaging 6 audit we received a Minor non conformance against 4.8.5. I had a copy of the BRCGS P558 Position statement and quickly pointed out page 4 the states "Most packaging materials are unsuitable for the survival and growth of pathogens and therefore will not require an environmental monitoring program to be in place".

 

This led to a discussion of us being told to create a risk assessment, "do some testing for a couple quarters then just do yearly thereafter". 

 

Can anyone in the same or similar industry provide any guidance for me on this? I have contacted a couple labs and they are not been very helpful.

^^^^^red - unclear whether the suggestion included pathogens ?

I enclose three relevant links to previous threads.

IIRC these suggest a BRC- acceptable combo can be -  (no pathogens [for reasons you mention above] + Enterobacteriaceae  + Y&M) as a routine swabbing package

https://www.ifsqn.co...ng/#entry155254

https://www.ifsqn.co...ht/#entry145707

https://www.ifsqn.co...ng/#entry151317

.

PS - i note that in first link, an example is given where no swabbing was required !

Thank you Charles.

I think I can adapt the Risk Assessment in the first link to match our materials/process.  In addition, we can swab for Enterobacteriaceae  + Y&M on some finished goods and direct contact areas on some equipment as discussed with our auditor to back up our assessment as being low risk. Does this sound reasonable?

I am assuming the testing we perform for Enterobacteriaceae  + Y&M would be accomplished through swabbing only. The labs I have contacted previously would not offer any general help or guidance as to what would be acceptable or a standard test as it was on the fringe of "consulting".

Are there any general parameters I can measure our test results against ?

Thank you Charles.

 

I think I can adapt the Risk Assessment in the first link to match our materials/process.  In addition, we can swab for Enterobacteriaceae  + Y&M on some finished goods and direct contact areas on some equipment as discussed with our auditor to back up our assessment as being low risk. Does this sound reasonable?

 

I am assuming the testing we perform for Enterobacteriaceae  + Y&M would be accomplished through swabbing only. The labs I have contacted previously would not offer any general help or guidance as to what would be acceptable or a standard test as it was on the fringe of "consulting".

 

Are there any general parameters I can measure our test results against ?

^^^^^^red

Most published data is for food contact surfaces. A compilation is here -

https://www.ifsqn.co...ces/#entry60958

There is some packaging env. data in threads linked in post 2.

IIRC the 2nd file in this post is quite env. useful as are attachments in surrounding posts for the packaging itself -

https://www.ifsqn.co...ing/#entry51214

The expected levels for things like APC, Y&M, Enterobacteriaceae  for a packaging facility will presumably be low, hygienic factors  are likely borrowed from food and will again be low.

PS - I did a very mini forum survey in 2018 which see here -

https://www.ifsqn.co...ng/#entry122998

within above survey I noticed a modicum of data-related  here -

https://www.ifsqn.co...ing/#entry20496

https://www.ifsqn.co...ing/#entry20547