Reference for sampling plan
We process RTE imitation crab.
When we do our (listeria, E.coli, Salmonella, Coliform, TPC) testing, we currently do a composite test of 3 bags (per 36 cases) which is about 30 tests per day.
We're looking to cut lab costs and wondering if we could do a composite of 6 bags (per 72 cases) which would drop our testing about in half.
It would be the same about of product being tested, just less tests. Which would save us a LOT of money per year. But we can't find any reference as to how many tests we should run.
I would think that cutting it in half would be fine as long as your results have been good (negative). This would be your justification.
The FDA doesn't have a reference. It's about how you control your hazards and proving that you are.
I agree with above. It's only an issue if you have a bad result, then your response is obviously larger.
We process RTE imitation crab.
When we do our (listeria, E.coli, Salmonella, Coliform, TPC) testing, we currently do a composite test of 3 bags (per 36 cases) which is about 30 tests per day.
We're looking to cut lab costs and wondering if we could do a composite of 6 bags (per 72 cases) which would drop our testing about in half.
It would be the same about of product being tested, just less tests. Which would save us a LOT of money per year. But we can't find any reference as to how many tests we should run.
Hi Miss Frankie,
There are 100's of references on sampling but you need to clearly define yr objective and define the LOT being sampled.
Yr list contains apples and oranges from a sampling POV.
PS - the problem with micro sampling is that statistical logic will either bankrupt if external lab required or hopelessly overload a typical in-house lab. The usual compromise is an ad hoc sampling plan which is purely intuitive.
I agree as well that based on your results. You would definitely want to document your decision and the risk analysis backing it up in case you are questioned by anyone on how you arrived at the decision. It would also change the plan as to how much product would need to be held if you did get a presumptive positive and what your resampling plan would be.
At another job, we pulled back up samples representative of each testing lot so that we could be ready to send in the backups if the circumstance allowed it (non- pathogenic test out of spec), and we wouldn't get stuck in the freezer digging through finished product.
In the past I've found that upper management is happy to save money on testing, but if a positive does come up they need to understand how it will affect the amount of product that is implicated if you get a positive test result. :)
Hi Miss Frankie,
There are 100's of references on sampling but you need to clearly define yr objective and define the LOT being sampled.
Yr list contains apples and oranges from a sampling POV.
PS - the problem with micro sampling is that statistical logic will either bankrupt if external lab required or hopelessly overload a typical in-house lab. The usual compromise is an ad hoc sampling plan which is purely intuitive.
We have searched everywhere and can't find anything as to how many/often micro sampling should be done.
We can find time/temp guidelines for heating and cooling, but not micro sampling.
Currently, we use about 5 pieces from case # 1, 11, 22, & 32 from a 36-case lot.
Our proposed change would be about 3 pieces from case #1, 11, 22, 33, 44, 55, & 66 from a 72-case lot.
We typically run the same product for 21 hours before shutting down for a clean-up. During that time, we product about 1100 cases.
Like the others say, you will have more product on hold if you end up with a positive, that will be need to be cleared with management.
But you need to make the call based on your risks and result history etc. ☺️
I am all for composite sampling personally.
We have searched everywhere and can't find anything as to how many/often micro sampling should be done.
We can find time/temp guidelines for heating and cooling, but not micro sampling.
Currently, we use about 5 pieces from case # 1, 11, 22, & 32 from a 36-case lot.
Our proposed change would be about 3 pieces from case #1, 11, 22, 33, 44, 55, & 66 from a 72-case lot.
We typically run the same product for 21 hours before shutting down for a clean-up. During that time, we product about 1100 cases.
Hi Miss Frankie,
2 micro situations are commonly involved -
(1) Sorry but for USA yr requirement is truly micro. 101 for zero acceptance pathogens such as Salmonella/l..monocytogenes (RTE) as detailed in FDA's BAM and FSIS publications. Both are referenced/attached in various Posts on this Forum.
(2) The situation (as intimated in Post 4) is more complicated for indicator items and non-zero-tolerant pathogens due a frequent lack of specific Regulatory Standards. However detailed Guidance information is available from multiple other sources and compiled on this Forum.
For (1) the sampling programs you mention are statistically questionable. I suggest you refer to BAM/FSIS however the PS in Post4 may dictate practical options for many in-house labs (also see caveat in next paragraph).
For (2) it is necessary to (a) define yr acceptance target(s) and (b) your yr methodology for evaluation (eg nmMc or "average" based Procedures). Sometimes (eg the PS in post4) method (b) is utilised (ie c=0) for Case (1) although this approach is statistically only meaningful to detect gross contamination.