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Chasing FSMA Compliance: How far should you go

Actually, the answer is quite simple. Until you have assurance that the significant hazard that is likely to occur that you have identified has reasonable evidence of Preventive Control. Simple right? Let’s take a small example of a program that was a PRP before and now probably will become a PC (preventive control), glass and brittle plastic prevention in the facility.

Given that many food processing facilities do not have x ray units to detect this type of foreign material, they rely on the Glass and Brittle Plastic check sheet to conduct audits on any equipment or parts of the building that may have these material present. Once a month, the QA manager will make sure that these items are not missing or broken. Of course, a lot can happen from one month to the next month and you end up finding the broken item. Next step? place everything you have manufactured on hold for the last month? X ray inspection the entire month’s production run at a third party?  Destroy the product? Make a business decision that the broken item was not going to contaminate the product and release to trade the held stock. Given the results of the PCA trial, the decision making process to release product previously held for a food safety failure is going to be much more difficult and carefully thought through. Could a business decision for product release result in jail time if a person is hurt or killed?

Or maybe, I will be proactive and eliminate all glass and brittle plastic from my manufacturing plant. No Hazards, No Worries. Except, wait one minute, what about the risk of glass and brittle plastic coming into your manufacturing facility in the ingredients, packaging materials or pallets? What kind of inspection program do you have to prevent hazards in those materials upon receipt? How much do you know about your supplier’s preventive controls for glass and plastic? What if your ingredient is coming from a farm or even a very small farm, do you know if they have a pre harvest field inspection program? Do they review their finding for foreign material found during any post harvest cleaning? If they do, what do they do about the findings?

So, would it be possible that you could end up with foreign material in your finished goods from a pop bottle that got thrown into a field of spinach, or carrots, or tomatoes? Or the glass from the unprotected light bulbs in a warehouse that stores these commodities in bins prior to shipment to you. You need to check whether the commodity is stored covered or uncovered, different set of rules depending on how it is stored.

Remember to put in your specification “Free of Foreign Material” , perhaps even ask for a certificate of analysis. Actually, this approach may be the extent of some food processor’s foreign material prevention programs. A good food processor has a great deal of work ahead and must have great systems in place to prevent an admin nightmare.

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