Use of Good Manufacturing
Practices (GMPs) in HACCP Programs
Successful HACCP programs depend upon prerequisite programs, such as good manufacturing practices (GMPs) to ensure the production of safe food products. GMPs provide the operating and environmental conditions that are needed to protect food products during processing and storage. They typically apply to all related processes in a facility and not to individual products or processes. GMPs include procedures related to the following topics (but are not limited to this list):
· Receiving meat/ingredients
· Storage of raw materials and finished products
· Sanitary design principles for facilities (construction, maintenance, linear product flow, traffic control, etc.)
· Supplier control (guarantees and system verification), chemical handling (segregation and proper use of cleaners, sanitizers, pesticides, etc.)
· Specifications for ingredients, products and packaging materials
· Sanitary design principles for equipment (construction, installation, preventive maintenance and calibration)
· Personal hygiene
· Training (personal hygiene, GMP, sanitation, HACCP, etc.)
· Recall programs, etc.
Regardless of size, most companies have procedures they follow that fit the above definition of GMPs. Whereas, employees in smaller operations typically learn the GMPs by verbal instructions, it is best if they could be written down. Putting the GMPs in writing makes training of employees easier and more complete.
GMPs can support a processors’ HACCP programs, however, they cannot be used to directly control a hazard. Some processors have determined in their hazard analysis that a hazard is not likely to occur at a particular point in the process, because of a GMP. This would mean that the GMP would need to be monitored in some way, and the data made available to USDA or ODA inspectors. The big difference between a GMP and a CCP is that if the critical limits of a GMP are not met, a food safety concern would not arise, nor would corrective actions that satisify 9 CFR 417.3 be required.
Enforcement and Investigative Analysis Officers (EIAO’s) are to determine that GMPs (or other pre-requisite programs) are being used properly in relation to a processor’s HACCP program. EIAOs are checking to be sure that a GMP is not being used where a CCP is needed in a plan. They verify GMPs by determining if the processor has the program on file, is executing the program as designed and maintaining records. Records will provide evidence that the GMPs are being done as designed and that the GMP continues to support the decisions made in the hazard analysis (FSIS Directive 5000.1).
Over the past few years, I have proposed that if processors were unsure if a hazard was likely to occur (in the absence of HACCP controls), that they could establish GMPs that they would monitor over a period of time, to determine if a food safety hazard actually existed. More recently, I have realized that I need to do a better job explaining this. Simply monitoring a critical limit, similar to what might exist in a CCP would not work
By Lynn Knipe, Ohio State University
as a GMP.
For example, if metal detection was the potential food safety hazard, a GMP could be established in which preventive maintenance was done to prevent metal shavings to occur, as well as a regular check on the metal parts of equipment most likely to wear, or monitoring the use of a magnet that could be passed through the product. A GMP for potential metal hazard might also include obtaining letters from suppliers that the product received had been tested (and failed) for metal content. Monitoring the metal detectors would not work as a GMP, in place of a CCP for such a hazard.
If chilling of cooked products (stabilization) was the potential food safety hazard, a GMP could be established in which cooked product temperature was checked as it entered the cooler, as well as continuous monitoring of the cooler temperature, and/or the air speed of the cooler. These parameters are all important in ensuring that fully cooked products are chilling rapidly enough to minimize the growth of C. perfringens. [F1] Monitoring of the chilling rate alone, in place of a CCP for stabilization would not meet the requirements mentioned above and described in Directive 5000.1.
For receiving of raw beef materials, most smaller processors already have a GMP established to obtain letters of guarantee or some means of documenting that the raw beef that they received had come from a slaughter establishment that had used an intervention procedure on the carcass(es) at harvest, to destroy E. coli O157:H7.
Accumulating records while monitoring GMPs could serve to justify that a hazard was not likely to occur, in a hazard analysis of a new plan or in a reassessment of an existing plan. However, months of monitoring records of a CCP will demonstrate that a processor is meeting their critical limit, but would not justify that that a hazard is not likely to occur at that point.
[F1]Chilling wouldn’t be the food safety hazard, Clostridium P’s outgrowth would be. Anyway, before the last sentence you may want to clarify just a little further. “In this case the GMPs could support that all variables influencing chilling are at the proper and constant ranges thus ensuring the cooked product would chill (stabilize) in a safe time frame.”