The newly finalized FDA FSMA Preventive Controls require that all registered food supply entities establish what the feds call “valid” preventive control plans and organizational systems. According to the rules, your plan must be validated by a Preventive Controls Qualified Individual before you begin production.
These requirements are not sufficiently covered in FSPCA PCQI certification training and most PCQI certified personnel do not understand validation requirements or have the knowledge base required to protect themselves and the company from prosecution in the event of an outbreak.
Four critical process validation areas must be covered:
Process Design (Scaling-up the process from design to full volume)
Process Qualification (Process must be capable of reproducible commercial manufacturing)
Assurances that the process is in and can remain in a state of control.
Validation means that you must:
Understand the sources of hazardous variation
Detect the presence and degree of variation
Understand the impact of variation on the process and ultimately on product attributes
Control the variation in a manner commensurate with the risk it represents to the process and product
Reduce and eliminate the hazards
Provide documented proof
Validation of the plan means that your company will have to prove that it can control biological, chemical and physical hazards and is working to eliminate those hazards. This means you must establish systems to implement environmental sampling and be able to use the data from the samples to gain control over potential hazards. The data that is returned to you from the samples will provide you with baseline and ongoing monitoring information regarding how preventive your processes currently really are.
For more details and registration visit: www.compliancetrainingpanel.com
