Tag Archives: FSMA

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

By Bill Bremer

Compliance to FSMA requires companies to meet existing program requirements and new ones being published or face regulatory consequences. A part of FSMA also requires that companies follow established food safety plans, which includes GFSI certification.

With these changes, GFSI-level programs must integrate into an aligned Food Safety Management System (FSMS) and strategy. Key considerations include sustainability, multi-year planning, effective organizational structures and expectations, well-defined roles and expectations, compliance, and business objectives.

The value of GFSI certification depends on how the company uses its organizational resources to maximize return on investment, while meeting the changing FDA requirements. Effective management of a GFSI-certified FSMS can have a significant impact on FDA/FSMA compliance. The risk of not meeting established programs while implementing new FSMA programs must be measured, and attention must be given to addressing FSMA compliance, while maintaining established programs.

Complying with FSMA Food Safety Programs
The implementation of FSMA-compliant programs requires having an established GFSI FSMS and demonstrating conformance with one’s own policies. Programs must be maintained and improved as the FSMA requirements are developed and implemented. Each of the GFSI schemes has been vetted to meet a significant level of FDA/FSMA requirements—a key benefit to these industry programs.

Developing a compliant FSMS with proper alignment of your existing programs to FSMA must be assessed. For example, companies with more than 500 employees must include requirements in their programs for the FSMA Preventive Controls rule, which is set for compliance September 19, 2016. In this regard, registered food facilities must evaluate and implement preventive control provisions and meet the requirements by the approaching deadline. This requires effectively updating current programs, establishing key imperatives including cGMPs (Section 117), identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA requirements:

cGMP, Controls and Preventive Controls. Must be identified, modified, and implemented to further minimize or prevent the occurrence of hazards based on Section 117 requirements.
Food Safety Plan, Hazard Analysis, and HACCP. Companies must identify and evaluate changes in their existing programs to include FSMA Preventive Controls.
Qualified Individual. Must be trained with authority to oversee Preventive Control program aspects, developments and impacts.
Written Programs and Documentation. Up-to-date GFSI-level FSMS provides documented programs, procedures, and records for meeting requirements under FDA/FSMA.
Management & Monitoring. All controls, including under FSMA and existing GFSI-level, must be monitored, validated, and verified for effectiveness.
Management of Corrective Actions. Procedures including traceability response for addressing failures of procedures, GMPs and controls must be under management review and confirmed for prevention of adulterated food from entering commerce.
Recordkeeping. Records must be complete and accurate for all food production and safety activities and kept for two years, including the testing level verification of all programs under FSMA and GFSI-level programs.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to GFSI-level programs meeting FSMA. To complete your own planning assessment, review your progress compared to the questions in Table I.

FSMA, GFSI — Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of FSMS and GFSI preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their existing food compliance and GFSI programs in good standing to comply with FSMA or face possible violations, fines and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage GFSI certification—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

July 25, 2016

FST Soapbox

Sanitary Transportation Rule: Ignore at Your Own Peril

By Randy Fields

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FDA posted the FSMA rule on the Sanitary Transportation of Human and Animal Food in April. The majority of retailers, wholesalers, suppliers and carriers will have one year to comply with this new rule. The sanitary transportation rule sets out to prevent practices that would introduce contamination risk during the transportation of food through the supply chain.

For retailers, wholesalers, suppliers and carriers, the final rule is really the sleeper regulation among the new FSMA laws. You probably have your HAACP plans and preventative control procedures in place, but do you have the necessary documents in place with your carriers to meet the FDA’s requirements? And, are those documents easily accessible?

Under FSMA, you must address all FDA record inquiries within 24 hours, and these inquiries can go back two years, plus 12 months beyond the expiration of related service agreements. Failure to respond to an FDA records inquiry is considered a “prohibited act” and can land you in hot water with both the FDA and Department of Justice, which acknowledged they will enforce FSMA through civil and criminal penalties. That’s a game changer.

You are now required to ensure that transportation equipment does not cause the food it is carrying to become unsafe. You must also maintain adequate temperatures throughout your portion of the supply chain and prevent cross contamination. And, you must train your personnel in sanitary practices. All of these factors—processes and procedures, agreements and formal training of personnel—must be documented and made available to the FDA. Put simply, compliance with FSMA is proven through documentation because according to the FDA, if it is not documented, it did not happen!

So what’s the best way to comply with the new rules? Having the information on paper in filing cabinets simply won’t do. Can you imagine searching for specific confirmation that an employee received the proper training in a bank of file cabinets? Even with an efficient system, that could be like looking for a needle in a haystack. Collecting the information in spreadsheets is only slightly better, as it simply digitizes the disorganization.

Retailers, wholesalers, suppliers and carriers need to start their compliance process by reviewing and understanding all of the FSMA rules, guidance procedures and responsibilities. You ignore them at your own peril.

Then, consider automating your recording keeping system. It is really the only way to efficiently collect and manage the documentation needed to comply with the new law. When reviewing technology options, make sure you choose a system that is not only easy to use by frontline workers, but also provides sophisticated reporting and alerts to point out potential problems in real time. And, if possible, the solution should do more than just report on food safety activities. As long as you’re investing in a technology to meet FSMA requirements, you might as well implement a system that can potentially save money in other areas such as managing business or training documentation, new vendor approvals, or carrier optimization.

The bottom line is that the sanitary transportation rule will require that you devote additional resources to make the entire extended grocery channel more risk free for consumers and companies alike. And the best way to do that is to implement new technology that gives visibility to product transfers from point of production or processing to the point of purchase, and documents each step along the way.

Deirdre Schlunegger, CEO of STOP Foodborne Illness

July 21, 2016

Food Safety Culture Club

We Know the Why

By Deirdre Schlunegger

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Food safety culture is not just a catchy phrase or the right thing to say. It is the right thing to embrace and the right thing to implement. But how is it achieved? It is relevant to start with understanding “The Why” behind food safety. Why is it important? Do people really get sick and die? Why does that happen, and what is our role in preventing it? How do we integrate aspects of FSMA with a culture that embraces a robust food safety culture, and how do we create passion around the culture? I continue to address this issue, because at nearly every meeting I attend, in committees in which I serve and in simple conversations with colleagues, I hear the frantic voices of those who have so much to do, results to produce, bosses to please, and staff to supervise, and the why behind food safety is rarely mentioned.

STOP Foodborne Illness, Why Behind Food Safety — We need to truly understand the “why: behind food safety.

I speak to and read about individuals daily who have been sick or lost children or parents to this preventable problem. I see the photos of their children and hear about their loving attributes, yet this aspect is often neglected in the equation of the busy lives of those involved in growing, producing and distributing our food. I get it—who wants to talk about the problem when there is a product to promote and sell? But in reality, the only reason any of us live this frantic life with a long to-do list is because people get sick and die from foodborne illnesses, and because it is our job to do what we can to prevent the illnesses. And while consumers can practice safe food handling, there is nothing they can do about Salmonella in peanut butter, or Listeria in ice cream, cantaloupe or caramel apples. Let’s start the conversation of HOW to change and sustain a strong food safety culture and include the why as our rationale in the conversation. STOP Foodborne Illness is interested and will devote more time to the how, and I hope you will join us in this conversation and endeavor. I would love to hear your thoughts.

July 14, 2016

FDA Finalizes Rule on Food Facility Registration

By Food Safety Tech Staff

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As part of FSMA implementation, FDA has announced a final rule, effective today, that will better protect public health by improving accuracy of the food facility registration database. The Amendments to Registration of Food Facilities will also help the agency more efficiently use its resources to conduct inspections and aid in a faster response to food-related emergencies.

The final rule adds provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of the regulation, according to an FDA update. Provisions require:

Email address for registration
Registration renewal every two years
Registrations must have assurance that FDA will be allowed to inspect the facility at any time

Important dates:

Final rule effective July 14, 2016. Registrations must contain type of activity conducted at the facility for each food product category.
Requirement of electronic submission of facility registrations takes effect January 4, 2020.
As part of registration proves, food facilities must provide unique facility identifier (UFI) beginning October 1, 2020.

July 13, 2016

Go Beyond the Classroom to Improve Employee Performance

By Maria Fontanazza

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Employee training continues to be a hot topic as companies in the food industry gear up for FSMA compliance. Many are working with a much leaner staff and have several different generations of employees, many of whom absorb information in very different ways.

In a Q&A series with Food Safety Tech, Laura Nelson, vice president of business development at Alchemy Systems, discusses how training programs that may have historically been successful are no longer an effective means to educate today’s employees. “A vast majority of employees are doing what we ask and are doing it consistently. But the reality is that we have a subset of folks [who] aren’t doing that,” says Nelson. “I don’t think you can classroom train them to the point that they get it—I think some need that coaching and demonstration; they’re the kinesthetic learners that need to see you do it and then you watch them do it.”

Food Safety Tech: Where are the gaps in how food companies conduct employee education and training today?

Laura Nelson: It can be summarized in three areas.

1. Recognizing that the legacy training programs that food companies have is not effective. Companies are acknowledging that their historical training programs are not entirely effective in driving consistent behaviors. In [a recent] global food safety training [survey], we asked: “Despite our efforts in food safety classroom training, we still have employees not following our food safety program on the plant floor”. Over 60% said they agreed—yes, we still have employees not following our food safety programs. The survey involved 1200+ food safety professionals, so that’s a large number of folks acknowledging that their food safety training programs—largely classroom training—is not delivering the desired results and reducing inherent food safety risks.

There are so many things challenging the food industry and everyone is trying to manage these expanding expectations with their lean teams. The industry is changing dramatically—[from the perspective of] employee demographics, the business itself, pervasiveness of social media and exposure that it brings, and the different regulations—so a static food safety program established two, five or ten plus years ago is not going to address these changes. But who has the time and resources to continually update content, embrace technology and apply the latest behavioral science to the instructional design of new training content? Because of the lack of resources and time challenges, many in the industry are still trying to operate on their legacy training program. It might be old DVDs, PowerPoints, etc. —trainers are covering food safety, workplace safety and operational topics via PowerPoints in all-day sessions, sending around a sign-up sheet and ticking off their training compliance checkbox. Training has to be improved and enhanced for many key reasons—whether it’s considering different cultures, updating languages, engaging millennials or focusing on those critical employee behaviors that present a risk to an individual operation.

2. Understanding that training expands beyond the classroom. The industry as a whole continues to think that classroom training is their training program and that once the classroom training is complete and [the employee is] on the operations floor, that the training and education job is done. The reality is, it’s not. There’s lots more training happening beyond the classroom. Understanding that we need to formalize the extension of the classroom training and manage the ‘plant floor’ training aspect is really important. The industry is starting to embrace this [concept]. Anywhere from formal coaching and mentoring by frontline supervisors to posters and digital signage and short reminders to monthly campaigns on key critical items around food safety. Companies are starting to embrace the power of this holistic approach to training, leveraging new and emerging technology and tools to optimize employee behaviors.

3. Most people are not making the connection between training effectiveness and the ROI, the return on the investment. They think they don’t have the time to make improvements—yet, if they carved out time routinely to assess and evaluate best training practices to make training more effective and implemented these new and proven strategies, then all of a sudden the time and resource question becomes less of an issue because now you’re delivering on things like a decrease in food quality issues or reducing [employees] turnover, decreased downtime, reduced GMP non compliances, etc. It takes some time to establish those related training metrics, but once you’ve done that and have ensured that your holistic training program is current and behaviors are being exhibited consistently, you start to have fewer operational issues, enhanced customer satisfaction and motivated, engaged employees.

In part II of this Q&A series, Nelson shares her insights on training strategies based on employee demographics.

July 13, 2016

FST Soapbox

Chilean Gourmet Food Companies Eager to Learn about FSMA

By Patty Murray

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Whenever possible, I try to spread the word about food safety and share the knowledge gained from my years of experience in various sectors of the food industry, especially from my time managing the Food Safety Tech conferences and webinars. Recently, I even worked it into a presentation about social media marketing for a Pro-Chile Trade Board Event where food safety issues were hot topics throughout the day.

Representatives of more than 30 food manufacturers from Chile attended the event, which was held at the Summer Fancy Food Show in New York City and organized with The Food Institute and Grover Global Food Marketing. Well established in Chile, these producers of gourmet specialty food products wanted to learn the intricacies of selling their cured meats, olive oils, edible flowers, teas, preserves, desserts and snacks in the United States.

(left to right) vent sponsor, Mauricio Banchieri, Trade Commissioner, Trade Commission of Chile in New York - ProChile, with speakers Lauren Handel, Janis Grover, Patty Murray and Andrea Sapag of the Trade Commission. — (Left to right) vent sponsor, Mauricio Banchieri, Trade Commissioner, Trade Commission of Chile in New York – ProChile, with speakers
Lauren Handel, Janis Grover, Patty Murray and Andrea Sapag of the Trade Commission.

The reason: Americans spend a lot on food—$1.5 trillion annually, which is 28% of all retail trade in the United States, according to Brian Todd, president and CEO of The Food Institute, a firm that provides industry news, data and trends. He shared that consumer spending was up 2.3% in 2014 to $6,759 per year per household. Products on the rise include fresh fruits and vegetables, dairy, olive oil, confections and beverages. Key qualities include grab-and-go/convenience, non-GMO, organic, all-natural, healthy, fortified, gluten-free and air-popped/baked.

Todd and other speakers addressed new U.S. government regulations including FSMA, food labeling (nutrition and front of package), bioterrorism, customs, facility registration and certifications. Drilling down into many of the legal details was Lauren Handel, Esq., of Handel Food Law in New Jersey. Handel emphasized the importance of FSMA compliance, in particular, preventive controls, produce safety and foreign supplier verification.

Janis Grover, of Grover Global Food Marketing, who has more than 30 years experience in brand management, pointed out that non-U.S. food manufacturers have an extra hurdle to overcome with the new food safety laws. Grover explained that establishing food safety confidence in their brand with U.S. buyers is critical before they can begin negotiating any importing and distribution deals. According to Grover, to be successful, non-U.S. food manufacturers need to verify with U.S. buyers that they will comply will all U.S. food manufacturing and labeling laws, and that they have the required certifications and other quality control documentation to support their claims.

Sometimes at our FST conferences, speakers and attendees ask about the implementation of our new food safety laws. Will top management provide the funding for quality systems and traceability? Will companies be vigilant about the entire supply chain? Will there be significant and meaningful enforcement by government? Will foreign suppliers comply? I was heartened by the tone and content of the Pro-Chile event and optimistic as I walked the Summer Fancy Food Show with another international client. One of the first statements made to us by a potential U.S. partner was “Do you have a GFSI certificate?” My client did.

July 11, 2016

Experts in Produce Safety: FDA Wants You

By Food Safety Tech Staff

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Do you have a background in science and policy? Are you interested in produce safety? Do you want to work for the FDA? If you answered ‘yes’ to these three questions, then FDA might have a job for you.

The agency is looking for eight experts to help build the Produce Safety Network, which will support implementation of the FSMA produce safety rule. These folks will be part of the first phase of new FDA hires to support compliance with the rule and will work with state public health and agricultural agencies throughout the United States.

If you’re interested in the consumer safety officer position, you’ll need to move quickly. According to the agency’s listing on usajobs.gov, the position listing closes on Friday, July 15.

Later this year FDA will hire 40 more consumer safety officers to work domestically and internationally on inspection, investigations and technical assistance.

June 30, 2016

How Not to Fail at Online Food Safety Training

By Maria Fontanazza

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Training plays a crucial role in the FSMA Preventive Controls rule. As online learning becomes a more integral part of employee learning, companies may want to reexamine the methods they use to boost more effective outcomes. And for companies that currently use face-to-face training, investing in a virtual approach could encourage a more proactive employee learning experience.

“Industry research tells us that company leaders want training that is relevant, in which employees can apply skills right away.” – Kathryn Birmingham, ImEpik

“Under the [Preventive Controls for] Human Food rule we have legal roles that didn’t exist before—we must create smarter career pathways for these new positions and responsibilities, such as the Qualified Individual under the PCQI, the Preventive Controls Qualified Individual, and the auditor,” says Kathryn Birmingham, vice president, research and development at ImEpik. “The compliance required for these new positions is a great opportunity to use innovative and scalable training models. This becomes even more important for ROI (return on investment) in training, when turnover is likely or when companies want to attract new talent into the food safety industry.”

In a Q&A with Food Safety Tech, Birmingham explains how companies can navigate some of the additional training requirements under FSMA and how interactive online learning may offer both employees and companies more successful results.

Food Safety Tech: What employee training challenges do today’s food companies face?

Kathryn Birmingham: As an educator, business owner and researcher who has designed certification and degree programs for workforce training in several industries, I see [that] the food manufacturing industry must move from lifetime experience training to training standards. For the first time, the evidence of QI training and PCQI credential are owned by the person as they move from company to company.

Food companies need a cost-effective training system that can assess knowledge, skills and competency standards. Industry research tells us that company leaders want training that is relevant, in which employees can apply skills right away. They want to be able to test the knowledge of persons in these new roles who are accountable for regulatory compliance. Thus they expect valid assessments in their certification training.

The demand is for smarter pathways to reach these new legal roles in the legislation for the QI and PCQI. Assisting in this area, we need to remember that food manufacturing companies view their number one job as making food, not completing paperwork or digital documentation, so when it comes to FSMA we have to come up with relevant training that can be applied right away.

FST: In what areas do you think companies are unprepared for FSMA implementation and compliance?

Birmingham: Companies seem to be least confident in terms of training in a few areas: For the legal role of the PCQI, they seem to be least confident about the record keeping requirements and foreign supplier verification areas.

For the role of the QI, standardized training doesn’t exist, but we know from the PCQI training that if the QI is required to implement the food safety plan under the PCQI, then QIs must understand components of the food safety plan and the hazard analysis. So it follows that the QI must also understand some scientific and regulatory factors related to the preventive controls along with the new language that must be used in the food safety plan and documentation.

FST: What tools or technologies should companies leverage?

Birmingham: Research and successful practice in workforce training tells us a few things. In order to speed learning and verify the trainee’s learning, knowledge and competencies, we recommend instructional methods that are immediately relevant, engaging and motivating. Effective training for food safety regulatory compliance helps the learner with stronger critical thinking for decision-making and encourages the learner to apply the skills right away. Modular instruction allows time for practice and reflection while increasing the odds of retention of the material. Relevant work simulations can teach technical and scientific knowledge as well as communication skills.

We recommend online training that demonstrates proficiency and mastery rather than passive learning. The learner must engage and practice what they’re learning, show an understanding, practice critical thinking, and pass valid assessment exercises.

Food safety online training, ImEpik — ImEpik’s survey aimed to understand expectations as well as effectiveness of online training. Infographic excerpt courtesy of ImEpik.

FST: Do you think a lot of passive learning is happening in the food industry?

Birmingham: [Birmingham cites a food safety online training survey conducted by ImEpik earlier this year; see Table I.] Survey responses from a sample of 140 companies are telling us that they’re not satisfied with lack of engagement in training offerings. Those overseeing training would like to see more valid assessments. In terms of passive learning, they don’t want to click through voice-over narration for training or have face-to-face training that is lecture style without a lot of engagement. They want to understand the learning outcomes and what they should be getting out of the curriculum as they move through the training.

Preference for Specific Online Learning Attributes
	I Dislike It	I Can Tolerate	I Expect It	I Like It
Multi-languages	—	10%
Valid Assessments	—	—	91%
Research-based Instructional Methodologies	—	—	79%
Learner Engagement	—	—	77%
Interactive Activities	—	—	73%
Certificate of Completion	—	—	65%
Supplementary Manual	—	—		55%
Animation	—	—	35%
Learning Analytics	—	—	55%
Table I. Results from ImEpik survey about food safety online training. While animation and learning analytics are not as expected in online learning, these attributes are an important part of simulating the work experience in order to apply new knowledge, test specific content areas for clarity and assist the learner in remediation as needed. Data courtesy of ImEpik.

In the 2015 survey, 73% said they expect interactive activity in training while 91% expect valid assessment. People are looking for feedback as they progress through training. In the end they want to have the ability to prove what they know and can do.

With the emphasis now on FSMA, for companies to develop their entire food safety team, we need to rethink training and remember that it is possible to look at other industries and see what they’ve done with these career pathways for new roles that have been legislated. We can compare online training that is accessible anywhere and agile enough to train for new concepts quickly. Science and GMPs change. This is where a tool like online learning—not only full-course certification courses but also micro-learning modules—can really help the industry. And in the long run, it could be a better return on investment than face-to-face and long-term experiential learning.

June 28, 2016

FST Soapbox

FSMA Preventive Controls: Are You Prepared?

By Bill Bremer

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Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.

Complying with the Preventive Controls Rule

The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.

Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA Preventive Controls Rule:

Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
Monitoring. Preventive controls must be monitored for effectiveness.
Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
Recordkeeping. Records must be kept for two years.
Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.

Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.

Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have their training, planning and development underway to comply, or face possible violations, fines, and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

June 15, 2016

FST Soapbox

FSMA’s Preventive Control’s and Current GFSI-Approved Scheme Compliance

By Debby L. Newslow

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Confusion reigns in many organizations and especially with our food safety and quality professionals, as we debate and attempt to decide how best to address the requirements of FSMA. With the first compliance date of September 2016 drawing near, companies are feeling increased pressure to take action. As many are already accredited to a GFSI-approved food safety scheme such as SQF Level 3, BRC, Primas, IFS or FSSC 22000, often the question is, how does my current system fit into FSMA, and where do I need to make changes? The undercurrent to this question is the implication that changing the system to fit FSMA will cause it to no longer be tailored for the desired GFSI food safety scheme, and that a change could cause issues with those audits (which are crucial for purchasing, marketing and sales).

The Food Safety Consortium will discuss critical industry issues, including FSMA compliance. The event takes place in Schaumburg, IL | December 5–9, 2016 | LEARN MOREAs with so many of our industry challenges, there is no easy and prescriptive answer to these questions. Each organization has to make the decision for their own system based on their individual hazard analysis, risk tolerance and resources. Some over-arching themes begin to emerge, which may be analyzed to assist the decision makers in the creation of a road map to FSMA compliance.

During our FSMA Preventive Control Qualified Individual (PCQI) training courses we are repeatedly asked, “What qualifies as a preventive control? Are our critical control points (CCPs) automatically a preventive control? How about our operational prerequisite programs (OPRPs)—are these PCs also?” While there is no easy answer (yes or no), there are some important things to keep in mind that can help in the decision.

The official answer is that a preventive control should be any point in the process where, with a loss of control, it is reasonably foreseeable that a significant food safety hazard either will occur or has an increased likelihood of occurrence. Remember this is intended to be a single point in the process, not the entire process. For example, the sanitation program may be managed as a prerequisite program; however, there may be a point in the process that requires special sanitation attention and without it, there is a reasonably foreseeable likelihood of a hazard.

Thinking about the concept, a logical conclusion is that a loss of control leads to a significant food safety hazard or, at the very least, increases the likelihood of said hazard. It follows that a loss of control would beget the need for a withdrawal if the product had already left the organization’s control. Therefore, one should only designate a point as a preventive control if the implications of conducting a recall in the event of failure have been analyzed as part of the risk assessment. The organization must be fully prepared to conduct such a recall in the event of failure.

The FSMA Preventive Control regulation (§21CFR117.135 – Preventive Controls) requires a recall program only if there is a preventive control identified in the process. Of course, any food processing organization would be remiss if they did not have an effective recall program defined and tested by regular mock recalls. Waiting for a true recall is no time to find out that your program has issues. Even without a preventive control, what happens if a supplier contacts the processor with an issue that requires a recall?

Through the evolution of compliant and mature food safety management systems, it is common for an organization to initially identify multiple CCPs and then, through data collection and process improvements, slowly reduce the CCPs to control points managed through OPRPs or PRPs over time. So, should an OPRP (Operational Prerequisite Program – ISO 22000:2005 Section 7.5) also be designated preventive control? This is perhaps one of the grayest of gray areas in this arena. A deviation in a preventive control, if the product has left the organization’s control, requires a recall. A recall for a deviation in an OPRP is not absolute, and it is actually handled by the food safety team and management on a case-by-case basis, depending on the risk. In addition, although identified when possible, a critical limit is not required for an OPRP (ISO 22000:2015 Section 7.5). Parameters are required for a preventive control.

There really isn’t one answer that fits every situation, but it is important to remember that the requirements for FSMA Preventive Controls regulation (§21CFR117.135) are designed for those operations that in the past have not had the opportunity to define, implement and maintain a food safety program—one that includes a hazard analysis based on HACCP guidelines (Codex Alimentarius Commission [Annex to CAC/RCP 1-1969, Rev. 3 (2003)]) and/or a GFSI-approved food safety scheme. Personally, we feel that if an organization has evaluated their process in compliance with a GFSI-approved food safety scheme, then any reasonably foreseeable hazards have been identified and addressed through a control point such as a CCP, OPRP or PRP. However, that said, upwards of 90% of recalls are linked to either ineffective or nonexistent PRPs such as allergen mislabeling, which accounted for 53% of all recalls last year. Thus, it is imperative that we evaluate all aspects of our processes with the same scrutiny that we do our microbial pathogen and metal control programs, which are common CCPs in today’s world of food safety.

Risks must be evaluated through an effective risk assessment based on science and facts. We start almost all of our workshops with the great American Society for Quality (ASQ) video: Cost of Poor Quality. This highlights the lack of an effective risk assessment performed on January 28, 1986, related to the launch of the Challenger. Unfortunately, emphasis was not on the fact that the engineers presented about the lack of cold temperature stability of critical O-rings, but rather on the fact that the launch had already been postponed for two days, and there was intense media and political hype surrounding the event. An effective risk assessment must be based on facts and objectivity, not on our feelings about what we want or need the decision to be.

FSMA PCQI training stresses the use of reliable and credible resources such as academia, trade organizations and process authorities. The internet itself can also be a valuable resource. Jon Porter stated in 2004, “HACCP, as we know it, would not exist without the internet.” (If Jon could only see us now.) However, again, we must be sure we are choosing credible information from the internet. We all know that we can usually find any answer we desire on the internet, but is it credible and accurate?

Competent industry sector-experienced consultants may also be good options if the organization ensures their credibility. Sometimes, a set of independent eyes can be just what the doctor ordered. Even in cases where the organization has a fully qualified team that is perfectly capable of managing the food safety program on their own, the right external resource (i.e., consultant) may provide an additional, independent viewpoint to your process. A friendly debate with an external resource can oftentimes open a whole new vista of previously unconsidered possibilities for the team.

The FSMA Preventive Controls regulation (§21CFR117.135) states that “each organization is required to have a PCQI that has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system”. What qualifies an individual to be qualified through job experience is not specifically defined but is judged by the effectiveness of their food safety program. However, if FDA visits the facility and asks for the PCQI and no one has taken an FDA-recognized course—but there is someone that the organization has identified as qualified—this has the potential to start the visit off with a negative focus. We urge each organization to send two food safety associates to an FDA-recognized FSMA PCQI training course regardless of their background (this provides a back-up person in case the primary representative is ill, traveling for business or pleasure, wins the lottery, or otherwise leaves the company, etc.). This provides a strong foundation for the future, as ownership of the system is always crucial to not just surviving an inspection, but excelling—and as food safety professionals that is an idea we can all support.

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