Tag Archives: corrective actions

Melody Ge, Kestrel Management
FST Soapbox

Still Have Questions about FSMA Preventive Controls?

By Melody Ge
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Melody Ge, Kestrel Management

In September 2015, the FSMA Preventive Controls for Human Food Rule was published, requiring affected companies to comply with all FDA timelines. The last of these deadlines required that all very small businesses (less than $1 million per year) be in compliance with the FSMA rule by September 17, 2018.

With most companies having implemented FSMA preventive controls at this point, what have we learned? What’s still not clear? What major challenges remain? This article shares some questions that could help more companies on their journey to FSMA compliance.

What Is the Preventive Controls (PC) for Human Food Rule?

In plain language, under FSMA’s preventive controls for human food, FDA asks companies to identify any known and foreseeable potential hazards to finished products, and then apply control measures to prevent those hazards from happening and to ensure companies produce safe products. This rule changes the mentality from reactive to proactive.

Let’s break the term preventive control apart:

  1. What are we preventing? We are preventing any potential hazards that could occur. FDA identified four major categories of hazards. Food companies must look at their production processes and identify any foreseeable hazards within these categories:
    • Physical
    • Chemical
    • Biological
    • Intentional adulteration for economic gain
  2. What are we controlling? We are controlling the risks from all those hazards identified. Control measures should be identified for each risk from a particular hazard identified so they can be effectively applied.

Melody Ge will close out the 2018 Food Safety Consortium with the Plenary Session, “What Have We Learned After FSMA Implementation?” | November 15Where Do We Start?

A logical starting point involves understanding all hazards at your production facility. How can you ensure all hazards are assessed and evaluated? Consider mapping out the process line as one effective way. It is important to thoroughly understand your processes, as well as all raw materials, equipment, and personnel associated with each processing step. The more details gathered at the beginning, the easier it is to understand the hazards and risks as a foundation. A hazard can always be eliminated later if it is not applicable nor likely to occur.

Are All Control Measure or PRPs Considered Preventive Controls?

The short answer is not necessarily. Only those associated with a potential hazard will be considered a preventive control. For example, for an approved supplier program controlling incoming goods and suppliers, if an allergen is identified as a potential foreseeable hazard, the approved supplier program at the receiving step will be identified as a preventive control. Once a preventive control is determined, it must be evaluated to ensure it is proper and applicable to control and minimize the risks (117.420).

The same mentality should be applied for other control measures. Is there is a hazard and, if so, can this control measure actually control the risk? Once preventive controls are determined and identified, monitoring and validation are the next steps to ensure preventive controls are functioning effectively to control the risks as expected. If not, proper corrective actions should be identified.

Are Corrective Actions Always Required?

Not always—it depends! It is important to remember the intent of FSMA’s preventive controls, which is to prevent any potential hazards and control the risks to ensure safe products are produced. Per 117. 150, corrective action is a must when:

  • There is a potential pathogen threat in RTE products
  • There is a potential pathogen threat from the environmental monitoring program
  • A preventive control is not properly implemented and a corrective action procedure has not been established
  • A preventive control(s) or the food safety plan as a whole is not effective
  • Records are not completed after review

Other than the above-mentioned, corrections can be applied to address minor and isolated problems in a timely manner. As with all other food safety management systems (FSMS), once a corrective action is determined and implemented, a verification of its effectiveness shall be conducted. In addition, everything should be documented, as records are a vital component of the preventive control rule.

The FSMA Preventive Controls Rule is not scary. It is simply a series of requirements to assist the industry in proactively identifying the best control measure for operations. Foreseeable hazards must be controlled. As with all other management systems, knowledgeable and experienced personnel can help develop a valid food safety plan, including preventive controls, and ensure it is effectively implemented and maintained onsite.

FSMA Preventive Controls Corrective Action Requirements

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Listeria

How One Company Eliminated Listeria Using Chlorine Dioxide Gas

By Kevin Lorcheim
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Listeria

The previous article discussed the various decontamination options available to eliminate Listeria. It was explained why the physical properties of gaseous chlorine dioxide make it so effective. This article focuses on one company’s use of chlorine dioxide gas decontamination for both contamination response and for preventive control.

The summer of 2015 saw multiple ice cream manufacturers affected by Listeria monocytogenes. The ice cream facility detailed in this article never had a supply outage, but ceased production for a short amount of time in order to investigate and correct their contamination. After a plant-wide review of procedures, workflows, equipment design and product testing, multiple corrective actions were put into place to eliminate Listeria from the facility and help prevent it from returning. One such corrective action was to decontaminate the production area and cold storage rooms using chlorine dioxide gas. This process took place after the rest of the corrective actions, so as to decontaminate the entire facility immediately before production was set to resume.

Responsive Decontamination

The initial decontamination was in response to the Listeria monocytogenes found at various locations throughout the facility. A food safety investigation and microbiological review took place to find the source of the contamination within the facility in order to create a corrective action plan in place. Listeria was found in a number of locations including the dairy brick flooring that ran throughout the production area. A decision was made to replace the flooring, among other equipment upgrades and procedural changes in order to provide a safer food manufacturing environment once production resumed. Once the lengthy repair and upgrade list was completed, the chlorine dioxide gas decontamination was initiated.

The facility in question was approximately 620,000 cubic feet in volume, spanning multiple rooms as well as a tank alley located on a different floor. The timeline to complete the decontamination was 2.5 days. The first half-day consisted of safety training, a plant orientation tour, a meeting with plant supervisors, and the unpacking of equipment. The second day involved the setup of all equipment, which included chlorine dioxide gas generators, air distribution blowers, and a chlorine dioxide gas concentration monitor. Gas injection tubing was run from the chlorine dioxide gas generators throughout the facility to approximately 30 locations within the production area. The injection points were selected to aid its natural gaseous distribution by placing them apart from one another. Gas sample tubing was run to various points throughout the facility in locations away from the injection locations to sample gas concentrations furthest away from injection points where concentrations would be higher. Sample locations were also placed in locations known to be positive for Listeria monocytogenes to provide a more complete record of treatment for those locations. In total, 14 sample locations were selected between plant supervisors and the decontamination team. Throughout the entire decontamination, the gas concentration monitor would be used to continuously pull samples from those locations to monitor the concentration of chlorine dioxide gas and ensure that the proper dosage is reached.

As a final means of process control, 61 biological indicators were brought to validate that the decontamination process was effective at achieving a 6-log sporicidal reduction. 60 would be placed at various challenging locations within the facility, while one would be randomly selected to act as a positive control that would not be exposed to chlorine dioxide gas. Biological indicators provide a reliable method to validate decontamination, as they are produced in a laboratory to be highly consistent and contain more than a million bacterial spores impregnated on a paper substrate and wrapped in a Tyvek pouch. Bacterial spores are considered to be the hardest microorganism to kill, so validating that the process was able to kill all million spores on the biological indicator in effect also proves the process was able to eliminate Listeria from surfaces. The biological indicators were placed at locations known to be positive for Listeria, as well as other hard-to-reach locations such as the interior of production equipment, underneath equipment and inside some piping systems.

In order to prepare the facility for decontamination, all doors, air handling systems, and penetrations into the space were sealed off to keep the gas within the production area. After a safety sweep for personnel, the decontamination was performed to eliminate Listeria from all locations within the production area.

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