Tag Archives: Focus Article

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FSIS to Share Food Safety Data from Slaughter and Processing Facilities

By Food Safety Tech Staff
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USDA’s Food Safety and Inspection Services (FSIS) has announced a plan to share more information about food safety at domestic slaughter and processing facilities. The Establishment-Specific Data Release Strategic Plan will serve to help consumers make more informed food choices, encourage facilities to improve performance, and provide more insights into the strengths and weaknesses of practices at the facilities.

“FSIS’ food safety inspectors collect vast amounts of data at food producing facilities every day, which we analyze on an ongoing basis to detect emerging public health risks and create better policies to prevent foodborne illness,” said USDA Deputy Under Secretary for Food Safety Al Almanza in an agency release. “Consumers want more information about the foods they are purchasing, and sharing these details can give them better insight into food production and inspection, and help them make informed purchasing decisions.”

The datasets will be published quarterly on data.gov, beginning 90 days after they are published in the Federal Register. FSIS will provide information about processes used at each facility, along with facility codes to allow for the combination of future datasets by facility. The agency will also release results for Listeria monocytogenes and Salmonella in ready-to-eat and processed egg products; Shiga Toxin-producing Escherichia coli and Salmonella in raw, non-intact beef products; Salmonella and Campylobacter in young chickens and turkeys, comminuted poultry and chicken parts; testing data of routine chemical residue in meat and poultry; and advanced meat recovery test data.

FDA

Experts in Produce Safety: FDA Wants You

By Food Safety Tech Staff
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FDA

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.

Alert

Five Errors That Impact GFSI Compliance

By Jason Dea
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Alert

The Global Food Safety Initiative (GFSI) is a global initiative for the continuous improvement of food safety management systems. From a functional standpoint, you might be surprised to learn that one of the most challenging elements of keeping up with GFSI compliance for many food producers is sufficient document control. In fact, data compiled by SQF shows that document control-related issues are one of the most common sources of a non-conformance during GFSI-benchmarked audits. Examples of these non-conformances are associated with documentation of training requirements, business continuity planning, and corrective and preventative actions.

The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain. This work is accomplished through collaboration between the world’s leading food safety experts from retail, manufacturing and food service companies, as well as international organizations, governments, academia and service providers to the global food industry. They meet together at technical working group and stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry. GFSI is facilitated by The Consumer Goods Forum (CGF), a global, parity-based industry network, driven by its members.

So what exactly are some of the most common causes for document control issues as it relates to non-conformances? Keep an eye out for the following five errors that can affect compliance.

1. Lack of document control altogether

Lack of correct usage of document control in the context of GFSI compliance is a common error. This is an issue that often occurs as a result of document sprawl—specifically as it pertains to duplicate documents and supporting documents. For example, an organization might create internal reference material designed to be cheat sheets or summaries of larger policies. These could include simple charts that list key equipment set-up parameters or charts summarizing abbreviated information from product specification sheets. Many organizations fail to realize that because of the nature of the information in these files, these reference documents must also be included in their document control program to ensure that the information in them is current and universally applied.

2. Document version control

From using outdated forms to referencing outdated employee procedures, lack of proper document version control and enforcement is the most common GFSI compliance-related non-conformance. These issues can arise from operational errors (employees don’t know where to find up-to-date documentation or how to ensure that it is being used) to technical errors (the document control system is unable to properly manage document versioning, or in the case of home-grown document control software systems, they may be unable to do so altogether). To avoid these errors, it’s necessary to establish where controlled versions of documents are located and ensure that they are kept up to date. It’s also important remove obsolete versions of these documents—this is a basic principle of document control, but it’s often an area where errors compound over time. Reinforcing training so employees are made aware of document control best practices and policies is critical to keeping your compliance activities current.

3. Document revision errors

One of the most common activities and most common sources of error within any document control program involves publishing revisions to documents. These errors include:

  • Updating the contents of a document but forgetting to update information such as the version number
  • Improper tracking of revision history
  • Adding new documents to the database rather than revising or updating existing documents

4.  Inclusion of documents from external sources

If your food safety management system includes or makes use of external documents, these must be controlled in the same manner in which you control internal documents.

Some examples of external documents that may need to be included in your document control program include:

  • Sample labels provided by your chemical and pest management suppliers
  • Raw material specifications provided by your suppliers
  • Customer expectations manuals provided by your customers

5.     Improper identification of approval personnel

A best practice of document control is for the person knowledgeable about the content of a document to be assigned the responsibility of approving updates to it. In many organizations, this is interpreted to mean that all approval responsibilities are assigned to a single person across the organization. This could be the food safety coordinator or the document control administrator, despite the fact that it is not reasonable for a single person to be knowledgeable about all the procedures across the organization.

A better approach to approval responsibilities is to identify individuals who can be responsible for authorizing changes based on function or discipline. By spreading the responsibilities across more people, your document control program is more likely to be current and accurate.

When it comes to food safety compliance and best practices, particularly as they relate to GFSI, it’s often the basic principles that get overlooked once your organizations processes and systems are up and running. Setting up a process for document control and maintaining this process over time is a key to achieving and maintaining compliance. As such, it’s important to revisit your controlled document process and library regularly to ensure things are operating as designed and avoid costly compliance surprises at the same time.

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USDA Touts Food Safety Progress Under Obama Administration

By Food Safety Tech Staff
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Between 2009 and 2015 there was a 12% reduction in foodborne illnesses associated with meat, poultry and processed egg products. “We’re better now at keeping unsafe food out of commerce, whether it’s made unsafe because of dangerous bacteria, or because of an allergen, like peanuts or wheat,” said Agriculture Secretary Tom Vilsack in a USDA release. “Over the course of [President Obama’s] Administration, we have tightened our regulatory requirements for the meat and poultry industry, enhanced consumer engagement around safe food handling practices, and made smart changes to our own operations, ultimately moving the needle on the number of foodborne illness cases attributed to products that we regulate.”

USDA’s Food Safety and Inspection Service (FSIS) has implemented a number of initiatives since 2009, including:

  1. Establishing a zero-tolerance policy for raw beef products that contain shiga-toxin producing E. coli: O26, O103, O45, O111, O121 and O145.
  2. Labeling mechanically tenderized meat. The blades or needles used to tenderize meat an introduce pathogens into the meat.
  3. First-ever pathogen reduction standards for poultry parts in order to reduce consumer exposure to Salmonella and Campylobacter. The standard is expected to prevent 50,000 cases of foodborne illness each year.
  4. Requiring that all poultry facilities create a plan to prevent contamination with Salmonella and Campylobacter, instead of addressing the problem after it occurs. Poultry companies must collect samples at two points in the production line and test them to show control of enteric pathogens.
  5. Requiring meat and poultry companies to hold all products that are undergoing lab analysis until USDA microbial and chemical tests for harmful hazards are complete.
Recall

More E. Coli Illnesses, General Mills Expands Flour Recall

By Food Safety Tech Staff
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Recall

Consumers should check their pantry. As a result of newly reported illnesses connected to raw dough or batter consumption, General Mills has expanded its recall of Gold Medal flour, Wondra flour and Signature Kitchens flour to include products made last fall. The FDA and CDC have warned consumers against eating any raw products made with flour.

According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states. No deaths have been reported. The bacteria was isolated from samples of General Mills flour that was collected from the homes of those sickened in Arizona, Colorado and Oklahoma.

General Mills has already conducted a voluntary recall of 10 million pounds of flour (unbleached, all purpose and self rising). A full list of the products included in the recall are available on FDA’s website.

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

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.

Senate Deal Requires Nationwide GMO Labeling

By Food Safety Tech Staff
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The U.S. Senate Committee on Agriculture, Nutrition, and Forestry has come to an agreement on the first-of-its-kind nationwide mandatory labeling of food products that contain genetically modified organisms (GMOs).  Although the deal requires labeling on far more products than those required under the Vermont GMO labeling law (which goes into effect July 1), the way in which disclosure of genetically engineered ingredients is revealed on food products is not as straightforward as it seems.  Under the bill, disclosure methods of GMOs on labeling includes on the actual packaging; an electronic/digital link that a consumer can scan with a smartphone to retrieve more information online; or a phone number in which a consumer can call to get more information. Thus, companies are not required to include all of the information on the product label.

The Center for Food Safety estimates that 75% of processed foods contain genetically engineered ingredients.The Senate Agriculture Committee praises the bill as a “win for consumers”, but there are industry folks who disagree. “While we are pleased this proposal will finally create a national, mandatory GMO disclosure system, protects organic labels, and will cover more food than Vermont’s groundbreaking GMO labeling law, we are disappointed that the proposal will require many consumers to rely on smart-phones to learn basic information about their food.,” said Gary Hirshberg, chairman of Stonyfield Farm and advocacy group Just Label It in a release.

The National Bioengineered Food Disclosure Standard is available on the Senate Agriculture Committee’s website.

Zia Siddiqi, Orkin
Bug Bytes

Get Your Food Manufacturing Facility Audit-Ready

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

Being audit-ready at any moment can be a daunting task, but pest management is one aspect of your audit that you can ace if you’re doing the right things. Pest control can account for up to 20% of your score, so taking it seriously can give you a huge boost the next time an auditor comes to your facility.

There are two components needed to help ease the stress of a third-party audit: An Integrated Pest Management (IPM) program and proper documentation.

IPM programs focus on incorporating green prevention and exclusion tactics into your facility’s ongoing sanitation and facility maintenance strategies, only using chemical solutions as a last resort. FSMA established that these tactics should be used when dealing with food safety issues and that thorough records should be kept to document the risk-based prevention efforts. This gives food manufacturing facilities even more of a reason to employ an IPM program.

A strong IPM program already has documentation built into it, as tracking pest activity and monitoring results over time are crucial steps to implementing the most effective pest prevention techniques for your business. Every IPM plan is tailored to your facility’s needs, so it needs to be dynamic and adaptable over time as new technologies emerge and your business needs change. Having the ability to show documentation of these changes and their positive effects will get you off to a great start on your next audit in showing your risk-based prevention food safety plan. If you do not already have an IPM program in place, speak with your pest management provider about establishing one.

Auditors like to see IPM programs in place because it means your business is taking a proactive approach and keeping detailed records.

Think about it like this: If the auditor is the judge and there’s no jury, would you ever walk into a court case without any evidence to prove your innocence? Of course not! So you wouldn’t want to walk into an audit without any documentation either.

In other words, document everything. Facilities must prepare and implement written food safety plans that identify potential risks to food safety, enumerate the steps and processes that will be executed to minimize or prevent those dangers, identify and implement monitoring procedures, keep detailed records of the food safety program, and list actions that will be taken to correct problems that do arise. If you’re doing all of this, you’ll make an auditor’s life that much simpler and improve the chances of receiving a high score.

When working to get audit-ready, you’ll want to have the following forms of documentation ready to go:

Proof of Training and Certification

Even though you know that your pest management professional is properly trained and certified, your auditor does not. Keep documentation on hand at your facility, as auditors may want to see one or more of the following documents:

  • A copy of the valid registration or certification document
  • hysical, written evidence that your pest management provider has been properly trained to use the materials necessary for your IPM program
  • Evidence of training on IPM and Good Manufacturing Practices (GMPs)

Proof of Service and Material Changes

A strong IPM program changes as new technologies emerge and your business’s needs shift over time, so be sure to have detailed documentation of these changes as they occur. It’s also important to note the reasons for making changes. Auditors will be looking for written documentation for even the smallest of changes to your IPM program, so take careful notes as your program adapts along with your business.

It can also help to assign specific roles to your employees. This not only will give employees clear direction on how they can contribute to your IPM program, but it can also help your case with an auditor by showing that your facility is maintained by an entire team rather than just a few people. Teamwork is a key part of any IPM program, so be prepared to show how your team runs effectively.

Pest Sighting Reports That Correspond with Corrective and Preventive Actions

When there is a pest sighting in your facility, record it immediately. Keeping records of sightings will help ensure that steps are taken to improve and show accountability to an auditor. Once action is taken, record exactly what was done and the results of the counteractive efforts. That way, you’ll have a paper trail that shows an auditor that for every pest problem, your pest management provider came up with a proactive pest solution that resolved—or is working to resolve—the issue.

After taking corrective action, continue monitoring the issue over time and note any developments in order to help prevent the issue from reoccurring. Creating a trend report that keeps track of which pests your facility is dealing with over time can help, too, as it will help you determine which pests are the most problematic. Your provider can help build such a report.

Records of Pest Monitoring Devices and Traps with Corrective Actions

Pest monitoring devices and traps are great for giving insight into areas around your facilities that are most susceptible to pests. Along with these devices, however, you’ll need to show the following information to an auditor:

  • When and how often the monitoring devices and traps were checked
  • The type and quantity of each pest found
  • Corrective actions taken to reduce pest activity and prevent further issues

Work with your pest management provider to gather all of this information, as it is usually the technician who works on these devices regularly. Being able to give an auditor the full picture can certainly help you on your inspection as it demonstrates attention to detail throughout your entire facility.

Annual Pest Management Assessments and Resulting Actions Taken

With most IPM programs, your pest management provider will thoroughly inspect your facility annually to identify areas that can be improved. Many auditors require these annual check-ups, and they will be looking for proof that these facility assessments occurred and that action was taken as a result that led to positive changes. Year-over-year improvement is important, so measure your success against the areas of improvement specified in these annual inspection reports. That way, you can meet the objectives prior to an audit.

These annual inspections give you a chance to look back and see the progression over the years. If there are any pest issues that pop up year after year, make them a priority in order to show that your program is trending in the right direction.

This proactive approach to pest management will help protect your business from pests and the inherent risks, as well as help give you a better chance of receiving an excellent score on your next audit.

So don’t be afraid of an audit the next time one comes around. With a strong IPM program in place and detailed documentation over the course of the year, there won’t be an exorbitant amount of preparation needed. Stay organized and keep all of the above-mentioned documents together and on-site to keep things simple for both you and your auditor. All of these elements will help your facility receive a strong score and be audit-ready at a moment’s notice.

Suresh Neethirajan, University of Guelph
In the Food Lab

Identifying Peanut and Other Allergens Outside the Lab

By Suresh Neethirajan, Ph.D
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Suresh Neethirajan, University of Guelph

Judging the nature and suitability of items we put in our mouths is a task we perform daily, whether it’s due to different taste preferences, being on a diet, or from particular foods not agreeing with our metabolisms. Some foods can trigger mild reactions such as an upset stomach, or more serious skin rashes and outbreaks, from shortness of breath to even death.

Many of us have been somewhere where someone with a peanut allergy has been brought to everyone’s attention. The situation may have been publicized before boarding a plane, at a school where parents are asked to refrain from giving their children any food containing peanut products, or restaurants that clearly indicate which dishes are peanut-free on their menu, or that the kitchen is absent of the legume.

The number of people with food allergies continues to rise, and although many theories have been provided for the increase, the exact cause is unknown. Many foods are documented as being able to produce an allergic reaction—milk, eggs, soy and shellfish, to name a few—but peanuts and gluten are highlighted as major offenders. Canadian government regulations require that manufacturers label products that contain certain allergens, even if they are made in a facility where allergens are in another product.

The Threat of Gluten and Peanuts

Gluten contained in wheat has become a widely avoided food substance, although the reason for this might has more to do with health concerns than allergies. The American College of Allergy, Asthma and Immunology (ACAAI) estimates that 400,000 U.S. school children have a peanut allergy, with many of those also having other food allergies. According to the ACAAI, many children will eventually outgrow most food allergies, but only 20% of those who have a peanut tolerance will outgrow it.

The charity organization Food Allergy Canada states that 2.5 million people suffer from a food allergy in Canada, while 2 in 100 children are susceptible to peanuts causing a reaction. There isn’t a cure for food allergies, so governments and food inspectors have the weighty task of ensuring that commercially produced products are packaged or served with proper labeling and information to protect consumers. This requires constant checking and testing of products that may have come in contact with peanuts or gluten.

New Tool for Food Inspectors

To provide regular analysis, the procedure has been lengthy and expensive, but scientific researchers at Canada’s University of Guelph have developed an apparatus that can identify allergens in a much shorter time span while being considerably more cost effective. The new allergen detector could expedite allergen reporting and possibly reduce the number of allergic reactions through more timely results.

Biosensor, University of Guelph
Schematic of the biosensor for the rapid detection of food allergens. Image courtesy of BioNanoLab, University of Guelph.

Based on the ELISA (enzyme-linked immunosorbent assay) platform that is widely used in diagnostic labs to identify allergens, the new apparatus provides comparable accuracy. The technology has been miniaturized so that equipment is portable, about the size of an audiocassette case, and tests can be conducted on location instead of relying on a lab that may be far away.

An Allergen that Glows

In the case of peanuts, the scientists focused on a prominent allergen named Ara h 1, because it can be identified through non-radioactive fluorescence. Although there are other allergens in peanuts, they don’t share the same property by which they can be identified, as does Ara h 1.

The process requires a small amount of the suspected food to be liquefied in a suspension so that it can be injected using a filter syringe into a silicon-based plate, or chip, of microcapillaries. As the sample passes through tiny tubes of the microfluidic chip using capillary action, it travels through a beam of light from a LED source that is monitored by a specialized camera, which is also a product of the scientists’ work.

The image captures Ara h 1 protein particles that fluoresce when they come in contact with the chemical properties of the suspension. Currently, the camera records the data and sends it to a computer to be analyzed and deciphered with a result being provided within 20 minutes, compared to a conventional lab test that takes up to four hours after a sample has been received.

In a modification to provide an extremely portable system, research is underway to develop an app to enable results via a smartphone. Testing foods in the near future will be as convenient and prompt as holding the detector in one hand and a smartphone in the other so that a restaurant owner, for example, will be assured that dishes are allergen-free before being served to customers.

Imitating the Human System for Detection

To enable the allergen to fluoresce, the compound graphene oxide (GO) was utilized in combination with a bio-sensing component, known as an aptamer. The aptamer acts similarly to antibodies that identify and attach themselves to foreign and hostile elements that enter our blood system. Once a GO-aptamer mixture is attached to the allergen, the light source allows the protein particle to be detected and its image captured electronically.

By altering an aptamer’s composition to identify other allergens, such as gluten, the detector is a versatile piece of scientific equipment for identifying potentially hazardous food ingredients. The developers of the technology are confident that their discovery will change the future of identifying potentially hazardous food components. The final step in the allergen detector’s development seems to be fine tuning the detection process for certain processed foods, such as roasted peanuts, that can alter the composition of Ara H 1 making it less obvious to be identified.

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.