Tag Archives: preventive controls qualified individual

By Earl Arnold

“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.

One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.

Assemble a HACCP team
Describe the finished product
Define intended use and consumer
Create process and flow diagram
Verify process and flow diagrams

This is followed by the seven principles of HACCP.

Conduct the hazard analysis
Identify critical control points
Establish critical limits
Establish monitoring requirements
Establish corrective actions for deviations
Procedures for verification of the HACCP plan
Record keeping documenting the HACCP system

HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.

When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.

HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.

Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.

For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.

Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:

Assemble a food safety team
Describe the product and its distribution
Describe the intended use and consumers of the food
Develop a flow diagram and describe the process
Verify the flow diagram on-site

Their recommended plan also requires a number of additional steps, including:

A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
A written recall plan if a facility identified a Preventive Control.
Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.

While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.

June 6, 2019

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Is Your Facility Properly Prepared to Ensure Preventive Controls are Met?

By Laura Lombard

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Under FSMA, you are required to have at least one Preventive Control Qualified Individual (PCQI) on your staff at all times to build and manage your food safety plan(s) for your manufacturing facilities. Per the regulation, PCQIs “have 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.” (Subpart C Section 117.180 (c) (1))

First and foremost, have you met the basic requirement of having at least one trained PCQI? There are now both online and in-person options to ensure your that food safety or quality assurance manager has had the proper training. Most online options require set times and dates like the in-person version to complete the training. Only one PCQI training currently on the market is completely self-paced and available 24-7. No matter which option you choose, it is a baseline that you ensure you have checked that regulatory box before the FDA comes to inspect your facility.

But what if your PCQI needs to take extended medical leave or moves on to another job? It is a proactive and smart move to have a back-up PCQI trained to both help support your PCQI under regular circumstances and be ready to step in if your quality assurance manager becomes unavailable. For a relatively small investment, you can ensure your company is meeting the regulatory requirement and has the training to provide a safe, quality product.

The FSMA regulation does not require you to have a PCQI for every facility but does require an individual food safety plan per location. Depending on how many facilities your particular company has, you may want to consider more than one PCQI to ensure that food safety plans are regularly updated and properly implemented. Many companies are now training the entire quality assurance department or a facility cross-functional team to be PCQIs and participate on the food safety team. Again, the relatively small investment in properly training personnel can save your company hundreds of thousands or millions of dollars in costly recalls, lost revenue due to negative brand reputation, and FDA fines. The average recall costs $10 million, not including brand damage and lost customers.

It is simply prudent to invest in PCQI training beyond the basic requirement of the FSMA regulation. Companies should train their quality assurance or food safety staff at the PCQI level to protect a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more that can be saved in costly recalls, loss of current or potential customers, and brand reputation. Lastly, a company with a robust safety culture has a competitive advantage over competitors who are less inclined to invest sufficiently in their food safety training and may suffer financial repercussions and damage to reputation as a result of recalls and customer quality assurance complaints.

January 24, 2019

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The Business Case for PCQI Training

By Laura Lombard

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Beyond reducing liability or checking a regulatory box, investing in robust training can reap measurable business impact. The FSMA regulation requires that Preventive Control Qualified Individuals (PCQIs) “have 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,” as per Subpart C Section 117.180 (c) (1). Even if the person serving in the role of PCQI is qualified through job experience, FDA investigators will expect adherence to development and application of risk-based controls as contained in the standardized PCQI curriculum material or the alternative training allowed in the regulation.

Let’s face it: Our employees serving in the role of PCQI come from a spectrum of food safety plan experience. In addition, many are mentoring new members as Qualified Individuals on the food safety team. Others are building a whole new team from scratch. Team members may be specialized department heads or hold several titles and job duties within a manufacturing facility. Your PCQI is charged with overseeing the development and analysis of the food safety plan. The PCQI needs a team that has had consistent training in the language of the new rules and how to comply to support the PCQI’s charge.

Beyond meeting the regulation, companies should train at the PCQI level to safeguard a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more you save in costly recalls, loss of current or potential customers, and your brand’s reputation. A company with a robust safety culture has a competitive advantage over competitors who are more lax in their food safety and may suffer financially and reputationally from recalls and customer quality assurance complaints. In an era when customers are seeking more information about the food they consume, being a trusted food safety brand can make your company stand above the crowd.

In addition, consistent training can help with internal culture change and worker productivity. Working on hazard analysis and defining preventive controls requires that employees show critical thinking and problem-solving skills. Team members taking a curriculum with standardized material and consistent learning objectives can reflect together to identify and document gaps and corrections to practices or processes. They can quickly apply their learning for more accurate analysis of the components of the food safety plan. This is the true impact from investment in high quality instruction—motivating employees to learn updated food safety practices, change their behavior, and make more efficient and effective decisions to keep the quality and safety of your products. Well-trained food safety employees are a key factor in the protection of your customers, your company’s brand and the prevention of costly food recalls. The investment in training at the PCQI level is strategic on all fronts.

November 7, 2016

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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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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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 1, 2016

Keep Calm and Be Sure You Have a PCQI—Soon!

By Rachel Montgomery

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You will hear some new abbreviations being tossed around in questions by executives in food manufacturing and processing these days. “Do I need a PCQI? Who is my PCQI? What is a PCQI?”

Strangely, many of these executives do need a PCQI, and they need one very soon. A PCQI is the “Preventive Controls Qualified Individual” needed to oversee implementation of the HARPC rule under FSMA. Last September FDA published the final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Unless a food manufacturer is specifically exempt, the date for compliance with implementation of the rule’s preventive controls portion is September 19, 2016. A facility’s PCQI is responsible for overseeing the implementation process. For companies that have yet to prepare for compliance, the good news is that several organizations, such as the Food Safety Preventive Controls Alliance, offer training to meet the requirement for having a PCQI.

For large companies (those with more than 500 employees), time is of the essence to meet the September 19 compliance date; for companies with less than 500 full-time-equivalent employees, you have more time to prepare, with September 18, 2017 being the compliance date.

Whether your due date is this year or 2017, your food safety plan is the primary document that guides your preventive controls food safety system. It must be developed using a systematic and risk-based approach that uses scientific principles to identify the hazards that require preventive controls to prevent foodborne illness or injury. It is most effectively prepared not only by a single PCQI but also a cross-functional food safety team that includes individuals with executive support and leadership. In addition to including the hazard analysis in which you must analyze for hazards requiring a preventive control for your product(s), your food safety plan must have preventive controls for your process and for food allergens, sanitation, supply chain and any other appropriate areas where you identified that preventive controls were needed.

Further, your food safety plan must include a recall plan, procedures for monitoring, corrective action and verification when a hazard requiring a preventive control is identified, along with science-based validation for process preventive controls. Of course, Good Manufacturing Practices (GMPs) and other prerequisite programs must be in place to provide a solid foundation for your food safety plan. And there’s more news: FSMA includes significant changes in the GMPs. For example, all formerly non-binding provisions are now binding, including education and training. One of the new GMP requirements is cleaning of non-food contact surfaces “as frequently as necessary” to protect against allergen cross-contact and contamination of food contact surfaces and food packaging.

Back to the possibility that you may qualify for a specific exemption, if you heard that processors subject to the low-acid and acidified canned foods regulation are not subject to the preventive controls rule, the exemption is only for hazards that are microbiological. For physical and chemical hazards, including allergens, a hazard analysis must be conducted to determine whether hazards are an issue and whether preventive controls are needed. This analysis must be documented, even if you determine that no preventive controls are needed. And if preventive controls are needed, they must be developed and documented with verification and possibly validation as previously described. Of course the new GMPs also apply to low-acid and acidified canned food manufacturers.

If you heard that warehouses are in the clear due to a specific exemption, there is more to the story. Only facilities such as warehouses that store strictly unexposed packaged materials for which refrigeration is not required are exempt from preventive controls. Facilities that store raw agricultural commodities that are fruits and vegetables are not exempt from hazardous analysis and risk-based preventive controls. All of these facilities, and even those subject to seafood and juice HACCP and not required to do preventive controls, are not exempt from updated GMP requirements.

Take the obvious first or next step for your organization’s compliance with FSMA: Ensure you have a PCQI and start working on your hazard analysis and food safety plan now.

What Does this Regulation Mean for the Pet Food Industry?

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