FSMA Roadmap: 5 Steps to Preventive Control Compliance

Are you trying to determine where to start on your journey to Preventive Controls Compliance? Well, you are not alone. It seems every day uncovers a new, little nuance that does not fit in a neat FSMA box. Start on the path to Preventive Controls compliance with our five steps below:

1. Focus on what we already know. Many rules have yet to be implemented, and the guidelines are not available. So, focus on finding a Preventive Controls Qualified Individual (PCQI) training program. Attending a PCQI training program will jump start your efforts toward Preventive Controls compliance. After training, assemble your team to review the process flow chart, your raw material(s) and an ingredient hazard analysis. If a flow chart or hazard analysis has not been developed, this should be your first step. It is important to note that the preventive control rule does not require a flow chart, but it is almost impossible to perform a hazard analysis without one.

2. Review your Hazard Analysis, starting with raw materials and ingredients, and then move to the products or process. Traditionally, we have not been thorough in our ingredient hazard analysis to accurately assess the hazards (biological, chemical [including radiological], and physical) present in those materials. We must demonstrate that we have evaluated each material for hazards and implemented a supplier monitoring process (called supplier verification activities under the preventive controls rule) to ensure our suppliers are controlling any identified hazards. Many companies require assistance from a third party to accurately assess the hazards in raw materials or ingredients. Do not wait to start this process, as it requires a substantial amount of time to implement.

3. Review the process flow or steps in the hazard analysis to determine if all hazards have been identified and to determine if prerequisite programs, GMPs (Good Manufacturing Practices) or other quality/food safety programs are controlling an identified hazard. Most companies have identified prerequisite programs (PRs) to control hazards in their Food Safety/HACCP plans. In the past, we have used rather generic programs to control sanitation, allergen, and supply-chain hazards in food or in the processing environment. The Preventive Control rule requires more specificity in monitoring, verification, and correcting documented deficiencies that were once reserved only for HACCP programs. This specificity requires a fresh assessment and targeted identification of those steps or components in programs actually controlling hazards.

4. Determine if facility personnel possess the skills and knowledge to implement and execute Supplier Verification Activities (based on the hazard analysis in step two). Based on the outcome of the hazard analysis (ingredients can be grouped if they possess the same hazards), we will determine supplier verification activities. The rule requires that qualified individuals (QIs) conduct these activities. We must determine if facility personnel are qualified to assess the validity and accuracy of certificates of analysis (COAs), or to audit supplier facilities, if identified as a supplier verification activity. COAs have become a standard in incoming ingredient activity and assessment. We must determine if the COAs contain a statistically valid sampling plan, and if the hazard identified in the hazard analysis has been tested and reported on the COA. If an on-site audit is required, then we must determine if facility staff are qualified to conduct an audit.

5. Once we have evaluated or created our hazard analysis, we must determine adequate monitoring, verification, and corrections/corrective action for each preventive measure identified to control the specific hazards. Most companies will have already determined process preventive controls (traditionally called CCPs). Monitoring, verification, and corrections/corrective actions must be developed for any sanitation and allergen preventive measures identified in step 3 above. Process preventive controls (CCPs) will then have to be validated (only process preventive controls require validation).

These five steps provide the roadmap to Preventive Controls Rule compliance. Attending a PCQI training program, reviewing or creating the hazard analysis and beginning the supplier verification activity (supply-chain management) represent the initial phases for program development.

For more information on how to become FSMA-compliant, Mérieux NutriSciences presents the recording of our free, 30-minute webinar, “FSMA Compliance: A 5 Step Plan.” Watch it on-demand now!

Meet the Author

Jeff Lucas
Technical Director, Mérieux NutriSciences

Jeff Lucas is a food industry professional with over 30 years of experience in food safety management. He currently instructs and consults on issues such as HACCP, FDA Preventive Controls, environmental monitoring, pathogen reduction, and food quality management. Jeff has experience with food safety and Global Food Safety Initiative management.

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