I am veterinarian by trade that after 15+ years of mixed animal practice worked for 10+ years as a Supervisory Public Health Veterinarian and Enforcement Investigations and Analysis Officer with USDA-FSIS before starting my own company providing food safety and humane handling consultation to USDA-FSIS regulated facilities 3+ years ago. I have recently branched out into FDA food manufacturing facilities and recently completed PCQI training from Alchemy Academy. I am now helping a small FDA RTE facility that makes vegetable filled hand pies to rewrite their entire food safety system so that it is FSMA Part 117 compliant. While developing their EMP I have reviewed multiple guidance documents and presentations so that I am comfortable with the EMP I have developed and am recommending to the facility owner. This facility has never conducted sampling and testing and they do not have a lot of financial resources to conduct large scale upfront sampling and testing. Dr. Marshall from Eurofins suggests in his EMP presentations that when first starting facilities should sample numerous sites, but that is as far as I can see in all of the guidance documents and presentations regarding how many sites and how often in the beginning, i.e. to build a baseline. To begin with I am having them sample and test 5 Zone 1 FCS twice weekly for L. species, APC, EB, and Coliforms; 5 Zone Non-FCS twice weekly for Salmonella, L. species, APC, EB, and Coliforms; 5 Zone 2 Non-FCS twice weekly for Salmonella, L. species, APC, EB, and Coliforms; and the same for 5 Non-FCS in Zones 3 and 4; all for 4 weeks. This is about $15,000 of sampling and testing. So, I am trying to determine if this sampling scheme has a chance to provide me adequate information to further determine the following so that I can reduce the ongoing sampling and testing expenses.
- frequency and number of sample locations for ongoing sampling in each zone; and
- if APC, EB, and/or Coliforms can be correlated adequately to Salmonella so that one or more of the indicators can used instead of Salmonella on a regular basis with perhaps bi-annual or quarterly Salmonella verification.
I have some basic statistics knowledge, and have used an online sample size calculator, http://powerandsamplesize.com, previously, but was burned by FSIS-RIMS for using it in a poultry slaughter establishment validation study, so I am not confident with using it, unless someone can help me understand how to support its use or offer a better suggestion. I have seen references to Microorganisms in Foods 8 as a resource that may offer some further guidance but I am not yet ready to spend a couple of hundred dollars on a possibility unless someone can say that this reference text will really provide guidance. Any guidance would be greatly appreciated. Thank you to all that take the time to read my novella and provide assistance!