Tag Archives: Preventive Controls

Compliance, food safety

Preventive Controls for Animal Food: What Does this Mean to Pet Food and Feed Manufacturers?

By Debby L. Newslow, Erika Miller
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Compliance, food safety

The Final Rule on Preventive Controls for Animal Food (21 CFR 507) was released in September 2015. The first compliance dates for CGMPs arrived in September 2016. All facilities that manufacture, process, pack or hold animal food for consumption in the United States are required to comply (see Figure 1 information on compliance dates.) Non-compliance is considered a prohibited act, but nonetheless this rule has not received the same amount of press as its human food counterpart. We must begin to spread awareness, because this rule has the potential to fundamentally change the pet food and animal feed industries over the next four years. Unlike human foods, animal food is typically intended to be fed as a sole source of nutrients. Thus, the regulation is fairly comprehensive and strict.

Business Size CGMP Compliance Date PC Compliance Date
Business other than small and very small One year Two years
Small business (fewer than 500 full-time employees) Two years Three years
Very small business (averages less than $2.5 million per year, during the three-year period preceding the applicable calendar year in sales of animal food + market value of animal food manufactured, processed, packed or held without sale Three years Four years except for records to support its status as a very small business
(January 1, 2017)
Figure 1. Compliance dates for CGMPs and PCs for Animal Food (from fda.gov).

During the 2016 Food Safety Consortium, Debby Newslow and Erika Miller will instruct: FSPCA Preventive Controls for Animal Food (21CFR507) Training | REGISTER FOR THE WORKSHOPSimilar to the Preventive Controls for Human Food regulation (21 CFR 117), there are two parts to the Animal Food rule: Current Good Manufacturing Practices (CGMPs) and Preventive Controls. Figure 2 provides more detail on the Subparts of the Regulation. Also, animal food covered by specific CGMP regulations must still comply with those regulations (specifically low-acid canned food and medicated feed).

Those who have taken a Preventive Controls Qualified Individual (PCQI) course will notice the remarkable similarity to the structure of the Human Food Rule. This is by design, for our animals are often a part of the family for whom we want to provide the highest level of quality and safety possible. That said, there is some overlap between the two regulations. For instance, when human food byproducts are diverted to use in pet food or animal feed, the human food CGMP rules apply to that food intended for use as animal food.

Subpart Topic
A General Provisions
B Current Good Manufacturing Practice
C Hazard Analysis and Risk-Based Preventive Controls
D Withdrawal of Qualified Facility Redemption
E Supply Chain Program
F Requirements Applying to Records that Must Be Established and Maintained
Figure 2. Subparts of 21 CFR 507, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals.

What Does this Regulation Mean for the Pet Food Industry?

Large companies that produce commercially available pet foods available in grocery stores and big box retailers (such as Pedigree, Iams, Nutro, Purina, etc.) are typically already compliant to a voluntary GFSI-approved food safety scheme (FSSC 22000, SQF, etc.). These companies already have most necessary processes in place to be compliant. There may be adjustments related to terminology, documentation, records and hazard analysis expansions to include mention of Preventive Controls.  However, most of the work has been completed already and only clarifications, in most instances, should be required.

However, there are many small “mom-and-pop” type establishments making niche pet food with high-quality, organic ingredients that may not have much knowledge about this regulation. These types of manufacturers want to make the best, safest, highest quality product they possibly can, but without knowledge and education, they may not know the questions to ask to point them in the right direction. When an inspector arrives and asks to see the written hazard analysis, even a high-quality niche processor may end up with the deer-in-the-headlights stare if they do not understand the question. This regulation has the potential to significantly impact their business, but in a small business most folks wear many hats, and it is not always possible to just jet away for a few days to attend a specialized training class.

It was indicated during our Lead Trainer course that FDA is developing a clear proactive approach to their inspections related to this rule. Our Lead Trainer courses also emphasized that the inspectors’ focus will be on the reasonably foreseeable hazards and potential hazards to ensure that each is in control. Control can be achieved through a Preventive Control or some other process, such as a GMP based pre-requisite program.

In order to be as effective and efficient as possible, it is critical that an organization understands the requirements of this regulation. For example, the Food Allergen Labeling and Consumer Protection Act (FALCPA) does not apply to food for animals, nor are there allergen provisions included in 21 CFR 507. Certainly there are specialty manufacturers that make special recipes for those pets that may have an allergy or sensitivity (i.e., wheat, rice, etc.); however, this is completely different than the required approach to allergens for the production of human food. The pet food or feed manufacturer is not bound by these restrictions. However, an uninformed processor may take it upon itself to redesign a label to include an allergen declaration assuming that requirements for human food also apply to them. This could result in a great expense for graphic design, reprinting, disposal and wasting of previously printed labels, and of course the time spent on the project.

Measuring effectiveness is one oft-overlooked part of a mature and robust food safety program. Even experienced managers sometimes overlook this crucial step, so it is unlikely that most people would be able to come up with the concept on their own without assistance. If a facility has a rule in place that people must wear gloves, but do not have the experience to train on proper glove use and the reasons gloves are worn, confusion and improper glove use will result. This results in the company wasting money on providing the gloves in the first place. No matter how conscientious a program is, it still requires effective programs for identifying and maintaining records. These provide evidence of compliance with the regulation. There must also be documents in place that define the operational requirements and explain how to demonstrate effectiveness.

Industry representatives also must fully understand how to distinguish between Current Good Manufacturing Practices (CGMPs), other prerequisite programs and preventive controls, and to determine where they fit into their operation and the regulatory framework. The logic used to determine whether a specified hazard is reasonably foreseeable is based on science, experience and education. There are different record-keeping requirements for different types of controls.

It is critical to the process to ensure that reliable resources are used to develop the foundation of the program. This is considered so important that the PCQI Preventive Control for Animal Food material references examples of credible resources in each chapter. Examples of these include trade associations, universities, industry-focused events, relevant informational emails and webinars. We have experienced first-hand that expanding a professional network using these types of resources increases the rate of attrition for knowledge when a sink-or-swim situation is presented.

Keep in mind that an operation must take an active role in defining, implementing and maintaining its food safety program. It is usually recommended that a consultant knowledgeable in your food sector be engaged to assist. However, the word of the day is “assist”.  If the consultant writes a turnkey program, then whose program is it? And better yet, where are they going to be when you are in an audit and can’t explain (justify) what is stated in the program?

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FSMA

Small Businesses: FDA Releases Preventive Controls Guidance

By Food Safety Tech Staff
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FSMA

In order to help small businesses with implementation of the FSMA Preventive Controls for Human Food and Animal Food rules, FDA has released compliance guidances. In an FDA release, the agency highlighted the following:

  • Small businesses (fewer than 500 full-time employees): Compliance with the human and animal food rules required by September 18, 2017
  • Very small businesses (those averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales): Required to maintain records supporting Qualified Facility status as of January 1, 2016
  • Qualified facilities must comply with the human and animal food rules by September 17, 2018

Both guidances are available on FDA’s website:

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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FSMA Preventive Controls Corrective Action Requirements

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

FSMA Preventive Controls and Food Safety Plans must document specific use and management of corrective actions within Food Safety programs to satisfy the regulations and meet associated compliance dates. This requirement recently took effect under the Preventive Controls Rule on September 19, 2016 for companies with more than 500 corporate employees; food companies with fewer than 500 corporate employees have an additional year.

TEST YOUR FSMA SMARTS! Take the FSMA IQ TESTAs the FSMA Preventive Control rules move to enforcement status, food companies must prepare to best respond to the requirements and, correspondingly, to add the required written corrective action programs and records within Food Safety Plans. This may include providing an additional level of evidence that the company distributes safe food products to and from the United States.

With pending scheduled inspections on the horizon and the expanded authority of the FDA to conduct at-will inspections, it is critical for these programs to be written, verified and maintained at all times.  Important to note, even if this is a previously established program, you must be in compliance with the provisions of Section 117 of FSMA.

Learn more about FSMA Preventive Controls  at the 2016 Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERThe more formalized programs and supporting evidence of compliance must include internal audits by Qualified Auditors, with coordinated oversight by your Qualified Individuals. Inspectors now have the authority to enforce the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Qualified Auditors, in addition to Food Safety Plan Qualified Individuals, to oversee corrective action audits for evidence assurance.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to implementing and managing corrective actions under FSMA Preventive Controls. To complete your own assessment, review and compare your programs to the questions below.

FSMA, Corrective Actions checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of corrective action programs for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate programs to comply with FSMA corrective actions or face possible willful non-conformance, which can include fines and criminal penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider regarding their corrective action programs. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.

Allergens

Allergen Management: Best Practices For Food Manufacturers

By Evan Rosen
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Allergens

Allergenic foods are a serious safety risk. While harmless to most of the consumer population, they are harmful and even life threatening to some, causing serious medical reactions, such as anaphylactic shock, when foods with the allergenic protein are consumed. Scientific research and legislation have helped us understand a great deal about managing these food allergens in manufacturing. Yet so much more needs to be done in making these risks safer for the growing allergic population. In 2013, the CDC reported that food allergies among children increased by half from 1997 to 2011. As these numbers continue to rise for children and adults alike, what are the best practices for food manufacturers to include in managing food allergens? Here’s what you need to know.

Evan Rosen is participating as a panelist in the session “Rubber Meets the Road: Practical Compliance with FSMA and Preventive Controls” at the 2016 Food Safety Consortium. The session will be moderated by Rajan Gupta and Dana Johnson Downing of TraceGains | LEARN MOREResearch and Development for Allergen Programs

Thorough development and foresight are essential for any food manufacturer to succeed when implementing an allergen program in its processing. It is wise for food manufacturers to select the individuals in their company who are a good fit to lead the allergen program. When developing your program, create an “allergen map” to understand where allergenic ingredients are located in your plant and how they travel while products are processed.

The R&D stage is the optimal time to plan every step of the allergen management process—from supplier sourcing to cross contact in processing, to labeling and every step in between—before the risks are actually encountered. This is in line with the new preventive controls approach to be taken with FSMA’s Food Safety Plan model.

Purchasing, Labeling and Storing Ingredients

When purchasing ingredients from suppliers, your supply sources should be just as stringent about allergen management as you are in order to reduce liability. Require your suppliers to have an allergen map of their own and lettered documentation declaring that the items you are purchasing are free from contact with food allergens. The FDA food label law currently recognizes the top eight food allergens as:

  • Peanuts,Tree nuts—including almonds, walnuts and hazelnuts, among others
  • Milk (not to be confused with lactose intolerance)
  • Eggs
  • Wheat
  • Soy
  • Fish
  • Crustacean shellfish (crab, lobster, crawfish, etc.)

Also, be mindful of allergens that apply to the country of export, such as Sesame Seeds, Sulfites and Mustard Seed in Canada.

When receiving and storing supplier ingredients, check the labeled contents for any updates and tag the units that contain allergens so they can be easily identified and stored separately. A pictorial system is very effective. Ensure that each unit is tightly sealed, as even slight amounts of leaked allergens can pose recalls and elevated risks to your consumers.

Processing and Cleaning Cross-Contamination

Human error is only one factor that predisposes risk of cross-contact; production timing, processing lines, facility traffic, protein structure (e.g. powder, liquid, paste) and even the type of equipment used can be a game changer when it comes to the proper handling of allergens. In order to prevent allergen cross contact, scheduling long lines of products with common allergens is recommended to minimize changeovers. Dedicate unique tools, utensils and equipment that will handle the allergen if possible, as every piece contacting an allergen must be washed before handling allergen-free processing.

Assign plant employees to specific locations to avoid risk of cross-contact travel—color coding uniforms helps a great deal in managing this concept. Manufacturing equipment that is designed for easy cleaning is also ideal. For cleaning procedure of cross-contact removal, wet cleaning methods are most effective followed by dry methods. These procedures should be validated using a recognized protein-specific test method such as lateral flow or ELISA. When flushing, be sure to keep the flushed material isolated from all allergen-free areas. Careful separation and mindfulness is key to a successful allergen program.

Staff Training and Education

In order for any allergen program to be effective, all plant, production staff, contractors and visitors must be aware of the importance of it and understand the impact it has on consumers. Incorporating different learning methods helps to communicate this to them. Occasional testing and validation of applying this knowledge ensures the integrity of your allergy-free claims and establishes trust. Passion and commitment also play a vital role in achieving success in your program as a whole.

From purchasing ingredients to staff education and cross-contact prevention, one can see that plenty of work and forethought goes into having an allergen management program. With these best practices in place, food manufacturers can be well prepared for the increasing demand of allergen safe products for consumers across national and international markets.

FSMA, Food Safety Tech, FDA

FDA Sheds Light on FSMA’s Preventive Controls

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

Today, September 19, marks the first major FSMA compliance date. Larger companies (500 employees or more) must meet certain requirements of the Preventive Controls for Human Food final rule related to current good manufacturing practice requirements. In anticipation of the questions surrounding these requirements, FDA has released a Q&A with Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of the agency’s Food and Feed Program in the Office of Regulatory Affairs.

“We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans,” says FDA’s Joanna Givens. “Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.”

FDA

FDA Extends Compliance Dates for FSMA Rules, Releases Draft Guidance on PC Rule

By Food Safety Tech Staff
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FDA

FDA recently took action to aid industry with the upcoming FSMA compliance dates. The agency issued two draft guidances with the intent of helping both domestic and foreign companies comply with the CGMP requirements and the human food by-product requirements in the FSMA Preventive Controls for Animal Food rule.

FDA is also extending compliance dates for provisions within the FSMA Preventive Controls, Foreign Supplier Verification Programs and Produce Safety rules. According to an agency release:

“The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the timeframe for agricultural water testing.”

In addition, FDA also released the draft guidance, Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.

All three drafts are available for public comment. More information is available on FDA’s website.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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Managing GFSI Certification a New FSMA Requirement

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

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.

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.

Kathryn Birmingham, ImEpik
“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.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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FSMA Preventive Controls: Are You Prepared?

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

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.
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.

Debby Newslow
FST Soapbox

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

By Debby L. Newslow
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Debby Newslow

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.