Food Safety Magazine

Signature Series | December 1, 2016

What Can You Do If You Have Not Yet Taken Action on FSMA?

By Simple Compliance Solutions, LLC

What Can You Do If You Have Not Yet Taken Action on FSMA?

If you are an executive in the food industry, you have undoubtedly been hearing about the U.S. Food and Drug Administration (FDA)’s Food Safety Modernization Act (FSMA) for a number of years. You probably also know by now that the final Preventive Controls rules required manufacturers to be in compliance beginning this past September 2016.

If you are running late in starting your compliance program, all is not lost. You can start today with these quick actions.

Choose Your Preventive Controls-Qualified Individual (PCQI)
First, designate the individual on your manufacturing site that will be the PCQI required by FDA to prepare a food safety plan and oversee its implementation. FSMA requires that this person must understand and be able to carry out all of the duties of a PCQI in the Preventive Controls rules for food, whether it be food for humans or food for animals.

What specifically does a PCQI do?
Your facility’s PCQI must prepare your food safety plan using a systematic and risk-based approach to identify those hazards in your process, sanitation program, supply chain and related to food allergens that require preventive controls to prevent foodborne illness or injury. A PCQI must also perform or oversee validation of the preventive controls, the records review and reanalysis of the food safety plan and other activities as appropriate to the food. Carefully consider who is most appropriate to carry out these duties.

Get Your PCQI Properly Trained
Book training for your PCQI to ensure the specific technical actions related to the food safety plan are done to the satisfaction of FDA. Although official training is just one way to meet the requirements of a PCQI, the official FDA-developed training on the Preventive Controls rule will help ensure your PCQI understands the role and is prepared to carry it out. Training classes are available. Just be sure you find an official course led by a lead instructor delivering the “Standardized Curriculum” developed by the Food Safety Preventive Controls Alliance and recognized by FDA. Simple Compliance Solutions, which has over 36 years of hands-on food safety experience, offers this PCQI training.     

Hire a Consultant
Find other help to jump-start your company into compliance. An experienced consultant can conduct a gap analysis of an existing food safety program against the new rules to determine what is already available and what is needed. Most food companies already have much of what is needed for a food safety plan under FSMA, so it is not necessary to reinvent the wheel. But because there are new provisions in the new current Good Manufacturing Practices, and because the Hazard Analysis under an existing Hazard Analysis and Critical Control Points program does not go as far as identifying hazards requiring a preventive control, there are going to be gaps in even the best food safety program. 

Not only must a company identify hazards requiring a preventive control, the appropriate preventive controls must also be determined. Then the preventive controls require documentation of the particulars of actions for implementation: critical limits/parameters, monitoring, specific corrective actions, verification and details for record-keeping. All of these implementation details must be determined for your particular product, process and market, and documented upfront in the company’s food safety plan.  

FSMA is here now, and it’s here to stay. Companies need to be ready not only for FDA but for any customers or third-party auditors who will also be questioning readiness for new regulatory requirements. Since FDA can and will be dropping in to check FSMA compliance any day now, book PCQI training and enlist an experienced consultant to expedite the compliance pathway.

Simple Compliance Solutions, LLC provides PCQI training and consulting services for food manufacturers. Visit FSMAComplianceTraining.com for more information.