Our Service Focus: Validation of Preventive Controls
The wait for final FSMA Rules is over. On September 17, 2015 the FDA published the final rules for the Preventive Controls for Human and Animal Foods. Being able to design, implement and validate process controls is probably the most critical aspect of all food safety programs. Those capable of preventive control and process validation will be able to maintain food safety while those who do not understand or cannot manage process validation will be exposed to FDA enforcement. Large businesses have less than one year to fully implement the rules.
The clock has now started for the required implementation of all members of food supply chains for food to be consumed in the United States. The long wait for finalization and clarification of rule requirements is over. Implementation deadlines are published and most large companies have one year to fully implement and comply with these seemingly complicated requirements.
According to the FDA all food facilities must “monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions".
The law requires an expert trained individual to oversee your preventive controls plan and implementation. Dr. John Ryan is a Preventive Controls Qualified Individual (PCQI) specializing in validation studies and documentation. He is a retired quality assurance administrator for the Hawaii State Department of Agriculture and holds a Ph.D. in research and statistical methods. He has over 30 years designing and implementing strong preventive process control systems for international corporations. His work includes small and large facility start-up, upgrade and turn-around success.
New Training Course
Validating Your Food Safety Preventive Control Plan With Teams & SPC
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.
Keeping Processes Under Control (Statistical Process Control)
Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but you must prove your plan actually works. Find out how to do that.
Validation and Verification of Preventive Process Controls We consult with your company fo help your personnel
Get the professional help you need from Ryan Systems.
Meet FSMA requirements for validation of preventive controls
Bet basic FSMA preventive controls validation training at your worksite or online
Understand preventive controls validation
Learn to use team focused integrated approach to prreventive control validation
Control attributes and parameters
Understand the required statistical, documentation and reporting needs
Establish valid repeatable and reliable measures, reports and procedures
Implement and use process experiments
Qualify processes, suppliers, materials, equipment and utilities
We train and work with:
Food Shippers, Processors, Carriers, Retail and Restaurant Purchasing Groups
CEOs, VP and Director Level Personnel
Food Safety and Quality Team Members
Food Testing Labs and Quality Personnel
Food Process Engineers
Our newest contribution to food professionals:
Author: Dr. John M. Ryan, Ryan Systems, Palm Bay, Florida
Is your company commiting Food Fraud? Food Fraud goes far beyond substituting one ingredient for another or making false labeling claims. This new publication is a comprehensive review of the many food industry-wide dimensions of food fraud considered acceptable by today’s food supply chain.This book provides practical information on food fraud, including the complex issues that increasing international food trade presents, especially in countries that have inadequate oversight or control over the products that are eventually ending up in supermarkets, restaurants, and refrigerators around the world.
Food shippers, processors, retail and restaurant purchasing groups, ingredient buyers and sellers, food safety managers and team members
Published: October 2015
Imprint: ACADEMIC PRESS
Order on Amazon or Elsevier Press at: https://www.elsevier.com/books/food-fraud/ryan/978-0-12-803393-7
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