FSMA answers: Preparing your facility

What should I be doing to prepare my facility for the Preventive Controls for Human Food Rule?

While there are still areas of the Preventive Controls for Human Food (PCHF) rule that need clarification for the fresh produce industry, there is plenty that facilities can do now to work toward compliance.

Facilities can focus on areas such as training, sanitary design, cleaning/sanitation programs, environmental monitoring and communication.

Employee training programs should be updated to be in compliance with the PCHF rule. Primarily, this requires that all employees be aware of their role in the company’s food safety culture, whether they are in the front office or on the packing line.

It is important to identify the Preventive Controls Qualified Individual (PCQI) for the facility and which jobs require Qualified Individuals (QI). Each facility is required to have at least one PCQI who has completed the Food Safety Preventive Controls Alliance training course or has comparable job experience.

The rule also requires that all employees involved in the packing process meet the requirements of a Qualified Individual, meaning that employee training specifically includes information related to food safety as it applies to their individual job duties.

It is critical to maintain detailed training records, including at a minimum the name of the employee, the date, the topic(s), and the signature of both the trainer and the supervisor or PCQI. It may also be beneficial to maintain a “training manual” for each job description, detailing the information covered during employee training.

This is also a good time to focus on sanitary design of the packing and storage facilities. While there may be areas or equipment that require expensive updates, there may also be many areas that can be updated easily.

The PCQI and food safety personnel should work closely with maintenance staff to identify areas for improvement, such as: 1) equipment with rust, rough welds and pinch points (especially in areas that have direct or indirect contact with the fruit); 2) temporary “fixes,” padding, tape, cardboard or other porous materials; 3) cracked, worn or damaged surfaces such as belts, rollers or brushes; and 4) damage to walls and floors, such as cracks, holes and standing water.

It may also be beneficial to look closely at the unique “tools” developed by line workers, such as decay nets, rollers/bumpers to push fruit through the brush beds and markers for between lots.

Cleaning and sanitation programs are another area that can be reviewed and updated. Work with the sanitation crews to ensure availability of resources: Do they have the time, training, materials and tools to do the job correctly?

Is hot water available and is it adequate and accessible in key areas? Evaluate your sanitation program, considering factors such as timing and frequency, chemicals and contact time, and monitoring results. Are there new technologies available that would strengthen your program (such as steam, foaming cleaners and alternative sanitizers)?

Also, review and evaluate your environmental monitoring plan. Map your results to identify “critical areas” for more frequent monitoring. Have an updated, written response plan, clearly outlining the steps to take if a positive test result is received (the response may differ by location of detection, and if it is a Listeria spp. detection versus a Listeria monocytogenes detection). Run a few practice tests to ensure that everyone is familiar with the process.

Finally, expand your communication network. Food safety should not be competitive, and some of the best resources are your neighboring facilities and industry organizations. Asking questions, comparing notes and collaborating with researchers are easy ways to strengthen your food safety program.

How is the Preventive Controls rule different from a HACCP plan?

The Preventive Controls rule was developed to prevent foodborne illness and outbreaks by addressing routes to contamination. As defined by FDA, Preventive Controls are reasonable, risk-based processes that a person knowledgeable about food safety would employ to significantly minimize or prevent hazards identified by the Hazard Analysis.

More simply, a preventive control should significantly minimize or prevent a hazard from occurring. In comparison, under HACCP, a Critical Control Point (or CCP) controls a hazard to an acceptable level.

What is the difference between validation and verification?

Validation determines if the critical limits or criteria are appropriate to control a hazard under specific conditions. Verification determines if the system or program is effective.

Validation of your food safety program should occur after the hazard analysis, when determining how to address the identified hazards. Are the critical limits identified in your food safety program appropriate under the conditions at your facility? Use available research and literature (including product labels) to justify your decisions.

It is important to note that under FSMA, validation is only required for a Process Preventive Control. For most fresh produce packing processes, there is no Process Preventive Control currently available. Instead, fresh produce facilities may rely on Sanitation Preventive Controls and Supply Chain Controls, as well as GAPS and GMPs to reduce the risk of contamination.

Verification is a review process, used to determine if the preventive controls and the overall food safety program is effective. This may include verification of monitoring programs and corrective actions, calibration of process monitoring and instruments, records reviews (may include a trend analysis or review of complaints), as well as environmental monitoring and product testing if appropriate.

Acceptable verification activities include onsite audits (such as internal audits or third party audits), environmental monitoring, sampling/testing of product, and review of relevant food safety records. The activity and frequency of verification activities should be based on the nature of the hazard, where/how it is controlled, and supplier performance.

What will FSMA inspectors look for at my packing facility?

FDA has communicated that the first inspections will be viewed as a learning opportunity for both parties, and the emphasis will likely be on the following: Has the facility made a strong effort to be in compliance with the rule?

Is there evidence of a “culture of food safety” at the facility; for example, does the facility look clean, are written policies actually being followed, and do the employees (at all levels) have an understanding of food safety and how it relates to their jobs?

An inspection will also likely include a general overview of the facility’s food safety program, including a document review, with special focus on training documents.

Be aware that swabs may be collected as a routine part of the inspection. Sampling may also occur if an inspector sees something that raises a red flag, such as workers picking up fruit from the floor and placing it back on a packing table or visibly poor sanitation practices.