The 20^th Annual Food Safety Summit, held earlier in May, proved once again to be an engaging and informative meeting for all in attendance. During the four-day event, food safety professionals participated in interactive sessions focused on food safety in the supply chain.

Throughout the Summit, Kestrel’s food safety experts observed several common themes and challenges that the food industry is facing — challenges that your business may be encountering today. Here are some of our key takeaways:

Key Topics

This year’s Summit featured a supply chain focus. Every company in the food supply chain—those that produce, handle, or distribute food-grade products/ingredients—has an obligation to its customers to provide safe and quality food. The Summit began with six certification programs related to food safety across the supply chain, including Preventive Control for Human Food, Foreign Supplier Verification, Professional Food Safety Auditor Training, Seafood HACCP, HACCP Training, and Certified in Comprehensive Food Safety.

The focus on food safety throughout the supply chain was discussed in lessons learned from recent food safety case studies, as well as in four afternoon workshops focused on departmental cooperation, traceability, effectively managing food safety, and global regulatory systems. In addition, the new Community Cafes provided attendees the chance to meet with the subject matter experts, including experts from Kestrel, for more in-depth conversations about topics focused on the supply chain.

Industry Trends

As is evident from the key topics covered at the Summit, the current trend is a much stronger focus on food safety within the global supply-chain, particularly coordination of various global regulatory systems, requirements, and agencies. Steve Mandernach of the Association of Food and Drug Officials (AFDO), Dr. Robert Tauxe of the Centers for Disease Control (CDC), Paul Keicker of the U.S. Department of Agriculture (USDA), and Stephen Ostroff from the U.S. Food and Drug Administration (FDA) participated in sessions on how the agencies are working together on food safety initiatives and the impact food safety. This included a conversation on whole genome sequencing of pathogens as a game changer for disease monitoring and response.

Ongoing Challenges

A major concern and ongoing challenge within the food safety community involves training regarding food safety responsibility across all levels of the organization. This not only includes large organizations with individuals who are directly responsible for food safety programs, but also smaller organizations where these responsibilities must be understood and followed by everyone at all levels. This corresponds to the need for food organizations to establish a much more comprehensive and effective food safety culture. The lack of this training, organizational responsibility, and overall culture is considered one of the primary causes of continued contaminated food outbreaks.

Regulatory Updates

In addition to the discussion regarding the use and benefits of whole genome sequencing, enforcement of FSMA and the expanding rules of Intentional Adulteration and Food Fraud Prevention Programs continue to be top areas of regulatory concern. Inspections and investigations related to supporting Food Safety Plans under these requirements will continue to expand, as evidence of compliance is required by all food organizations under the law.

Food Safety Summit 2019

Plans are already being made for the 21st Anniversary of the Food Safety Summit, which will again be held at the Donald E. Stephens Convention Center in Rosemont, IL from Monday, May 6 through Thursday, May 9, 2019. Mark your calendar. Kestrel looks forward to being an active sponsor and participant again next year.

Since it was launched in May 2000 following a number of major food safety scares, the Global Food Safety Initiative (GFSI) has aimed to “provide continuous improvement in food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide.”

Recognized Schemes

GFSI is not a scheme in itself, nor does it carry out any accreditation or certification activities. Rather, a benchmarked scheme (e.g., BRC, SQF, IFS, FSSC 22000) is recognized by GFSI when it meets the minimum food safety requirements, as set out in the GFSI Guidance Document.

Strategy for Certification

Companies have the flexibility to choose which GFSI-recognized scheme they want to adopt, and can achieve certification through a successful third-party audit. Under GFSI’s concept of “once certified, accepted everywhere,” certification to any GFSI-recognized scheme is accepted by many international, national, and regional retailers and suppliers.

The following factors should be considered to ensure a successful GFSI strategy:

1. Adequate knowledge of the GFSI standards (e.g., BRC, SQF, IFS, FSSC 22000) and how they work within food manufacturing and packaging companies
2. Ability to use and implement document and records management and control
3. Training to implement the chosen standard and ongoing training in the standard/key program areas, including Hazard Analysis and Critical Control Points (HACCP) and internal audit
4. Meeting the building requirements of the GFSI standard
5. An integrated pest management system that meets the requirements of the standard
6. Dedicated role of a qualified plant sanitarian
7. A strategy that includes management commitment and allocation of budgets and resources
8. Proper management review meetings and records
9. Compliant food safety and security
10. A corrective and preventive action (CAPA) process that meets the requirements of the standard
11. Approved supplier programs
12. Control of non-conforming product through disposal
13. Change management and acceptance by the organization
14. Product specifications that meet the requirements of the standard
15. Sanitation and chemical control programs
16. Deviation and variance tracking, reporting, and response
17. Product and raw material storage
18. Food-level Good Manufacturing Practices (GMPs), operating prerequisites, and compliance
19. Calibration of measurement devices
20. Emergency response and contingency plans

The GFSI system provides a high degree of confidence that food safety management systems are adequately designed, implemented, and maintained. Certified companies tend to be more efficient and profitable and have more effective shared risk management tools for brand protection. Ultimately, certification results in improved consumer confidence, simpler buying, and safer food throughout the supply chain.

Kestrel is pleased to be growing our resources to the food industry with the addition of Senior Consultant Melody Ge.

Melody brings a diverse background to the Kestrel team. She started her career in product development, including production and quality control of a vegan “chicken meat” product. She then transitioned to a Compliance Specialist at SQF Institute, where she established and developed the SQFI Compliance Program and maintained the integrity of the SQF certification; and developing the SQF Code.

Immediately prior to joining Kestrel, Melody served in a number of quality management and business development roles at Lidl, an international grocery chain. As the Deputy Quality Assurance Director, she oversaw suppliers, food safety control, and product quality monitoring and management to maintain quality and safety of product routine tasks.

At Kestrel, Melody will be serving as project manager for food safety-related projects. She will be supporting clients in developing and implementing GFSI schemes and supplier approval programs, and sharing her expertise in GFSI, FSMA, FSVP, HACCP, GMP, SQF, IFS, FSSC 22000, and ISO.

Melody holds a Master’s Degree in Food Science from the University of Maryland, College Park, and a Bachelor’s Degree in Food Science and Technology from Shanghai Ocean University, and is fluent in English, Mandarin/Cantonese Chinese, French, and German. She is a member of the Institute of Food Technology (IFT) and holds certificates in HACCP, Extrusion Processing and Technology and Commercialization, and Commercially Sterile Packaged Foods.

The Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP) imperatives require companies to assess their foreign supply chain of food production and implement new programs to meet and achieve compliance. These programs must be implemented and ready for inspection under FDA FSMA enforcement by the compliance date. For many companies, that date was May 30, 2017.

FSVP Requirements

Effective May 30, 2017, impacted companies are expected to follow the FSMA FSVP legal requirements or face a disruption in supply, business impacts, possible fines, and penalties. In short, this requires that companies ensure that receipt of foreign food includes the necessary information to be adequately inspected and verified.

Key areas to demonstrate FSVP compliance include the following:

• Determine the receipt information under FSVP to verify approval of each shipment of each product by lot identity.
• Confirm the existing information that may already be required for each shipment, including COA by product lot and FDA registration number (with expiration date).
• Document the actual site of manufacture of the foreign-supplied product, including the location, contact information, operator, and Qualified Individual overseeing the Food Safety Plan.
• Require declarations with each shipment stating that the supplier is in good standing with FDA and their foreign government’s food safety regulations. Provide a list of all programs under FSMA (Food Safety Plan and Section 17 cGMPs) with each shipment under an authorized signature.
• Include any additional information that is required under the FSVP that adequately confirms compliance to the company’s program, product requirements, and FSMA.
• Establish and maintain receipt records on all information that can be accessed and inspected at the request of inspection authorities for at least two years.

Compliance Challenges

At first glance, the FSVP requirements seem basic—foreign supplied food product is approved by meeting the FDA requirements and the requirements of U.S. companies receiving these products. It looks to be the same as existing supplier qualifications for U.S.-supplied food product.

However, the FSVP rule provides much information on “what” is required of companies but not “how” or how to validate and verify these programs. Many FSMA training programs, including the FDA-funded FSPCA, really do not provide a level of guidance for companies to develop and meet the anticipated inspection process, which could include shipments stopped at a foreign port or at the U.S. port of entry. Concurrently, established importers have programs to communicate import shipments based on the requirements prior to FSMA and the FSVP, but many have expressed confusion in determining the changes now required.

Leading up to the May 30th compliance date, many companies of all sizes and scale began to seek ways to best establish their programs to meet the full regulatory requirement. Much of the focus has been on establishing practices that informally address what is really required under the FSVP while making a casual determination of compliance. Other companies have developed programs consistent with the procedural requirements of the FSVP rule, as published.

Some companies have taken the requirements to an extreme by determining new supplier requisite information for each shipment to prove compliance. This has resulted in generating a significant amount of information for each shipment by each product. This level of information is not what FSMA intended. Much of the required information for FSVP is already in the established supplier qualification program and must be maintained but is not required in its entirety with each shipment. In fact, there are issues with the approach of requiring all information with each foreign supply shipment, including:

• Sheer volume of information
• Time required to assemble the information
• Inability of inspectors to assess all the information for compliance

All of this leads to the confusing situation that exists in the market today concerning the FSMA FSVP, where compliant practices have not been developed and newly established requirements have not been tested by enforcement. As a result, reports indicate that many foreign suppliers of varying company size, scale and sophistication are not openly willing to respond without clear, simple instructions from their U.S customers.

Establishing Reasonable Plans

Ultimately, many of the FSVP practice requirements will be developed and refined through the regulatory inspection actions of the rule. That being said, the industry cannot wait. Companies need to have reasonable plans established for all current shipments being made under the FSVP.

Companies should focus on the more fundamental aspects of the FSVP—those requirements that must be verified, recorded, and evident in the documents supporting all foreign shipments of food product under the rule. This information does not need to include the entire policy manual but select summary information.

An important consideration involves understanding how this law is expected to be inspected. Knowing this provides a basis to develop and implement an effective program. The premise is that the foreign shipments may not be stopped for inspection at the border level, but that inspections will more commonly occur at the receiving party location of the product shipment at delivery to their U.S. locations. Regulators will expect to inspect verified, recorded, and legal receipt of the foreign-supplied food product.

Areas to focus on to ensure compliance with the FSVP requirements includes the following:

Receipt of RSVP Products. Focus on verification of the necessary information for receipt of FSVP products based on the law and the company’s defined program. This does not mean all program information but information that adequately meets the level required for compliance.

Shipment Information for Receiving Records. Establish lists of shipment information for all shipments, which includes all products being received under FSVP, as summary forms with current and validated information. Summary information that can be effectively inspected as part of and aligned with the shipping paperwork will provide the necessary information as part of an FSVP receiving record.

Compliance Actions. Establish procedures and work instructions to ensure that compliant practices are approved, verified, and meet the minimum requirements. This will include modifying some existing documents and forms that are specifically required under the FSVP. This level of approved summary information must reflect the documented policies and procedures developed in the company’s FSMA Food Safety Plan and FSVP.

Internal Programs. Maintain internal programs, with oversight verification conducted diligently. All required information must be accounted for and records must be completed and maintained with a high level of accuracy and integrity. Verification must include oversight and multi-level signed approval.

Each year, Kestrel looks forward to the Food Safety Summit as one of the premier events in the food industry for networking with other food professionals, hearing about industry trends, and learning practical information to bring back to our food industry clients.

Kestrel is proud to provide our ongoing support for the manufacture, processing, and distribution of safe food, and to be taking an active role in the Summit again this year!

Food Safety Summit Expo & Conference
May 8-11, 2017
Donald Stephens Convention Center
Rosemont, Illinois
BOOTH #708

Connect with Kestrel

Stop by to visit with Kestrel representatives at our booth (#708). We are happy to also welcome special guests from Grainger to our booth, who will be on-hand to discuss their solutions. We look forward to talking further about your food safety needs and how Kestrel might be of assistance.

The Food Safety Modernization Act (FSMA) includes new requirements for food site inspections. Beyond that, the Act increases the frequency of established inspections. For example, FSMA mandates that high-risk facilities must be inspected within five years of enactment and no less than every three years following the initial inspection. The Act also requires inspection of at least 600 foreign facilities initially and double that number every year for the next five years. Routine inspections from FDA and other enforcement agencies will continue based on schedules to be communicated.

With FSMA rules moving to the compliance stage, food companies must prepare to best respond to the requirements and, correspondingly, to additional inspections beyond GFSI or as part of customer requirements.

Be Prepared

Inspectors will focus heavily on new requirements and the “letter of the law”. Therefore, a well-established inspection program and response that is implemented and tested will help to achieve the most favorable outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources. It is critical to have established roles, planning, and testing as part of any inspection readiness program.

Inspection Agencies

As reported, the FDA is underfunded to conduct the scheduled inspection of food operations under FSMA. While many inspections will be administered by the FDA, which will continue to expand internal resources, some local agencies are already under contract for conducting inspections that will be much more detailed than visits from them in the past.

These local regulatory agencies, including state health departments, are providing the “boots on the ground” to conduct inspections for direct compliance under FSMA or as a means of communicating more serious issues to the FDA. Based on recent experience, more critical issues are being raised to the FDA level for final action.

Roles and Responsibilities

Regardless of a company’s experience with FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals. Additionally, organizations under the FSMA Preventive Control Rule must have multiple Food Safety Plan Qualified Individuals, Qualified Auditors, competent sanitation management, and competent plant operators. Ultimately, all food company employees must be prepared for their roles in an FDA compliance inspection.

Planning

As preparation for FDA inspections, companies must establish a program to best address an inspection.  The focus must be on compliance to FDA, FSMA, and internal requirements—with the inspection providing this for the company in question. The biggest concern is gaps in compliance or known non-compliances; however, with FSMA there is no tolerance or excuse for ignorance.

A response procedure should be well-orchestrated to meet and respond to the representative of the FDA or the agency visiting the site for an FDA inspection. Along with the immediate response to any inspection (including those planned and those unplanned), food companies should consider the following:

1. Completely develop an FSMA Food Safety Plan to ensure that it is aligned with a possible audit and includes reference to all supporting programs, cCMPs, resource qualifications, and records. The plan must be developed under the oversight, validation, and verification of preventive controls Qualified Individual, as trained, qualified and designated.

2. Have the most appropriate organizational structure (i.e., with Qualified Individuals, Qualified Auditor, sanitation leads and food plant operators) to meet FSMA resources and minimize the organizational impacts.

3. Regularly review the FSMA Food Safety Plan as part of a general and management review process, including the internal audit by the Qualified Auditor, to ensure the up-to-date compliance of the Plan.

4. Review all records to maintain verification requirements for FSMA, as required by Section 117. Ensure that all records are complete, validated, and verified.

5. Conduct mock regulatory inspections to ensure readiness and understanding of the responsibilities of each employee based on their roles in the process. This should include following the program and confirming all actions, roles, and responsibilities. All improvements from this process should be updated into programs and implemented for possible inspection purposes.

6. Ensure compliance with all other regulatory requirements, including FSMA Sanitary Transportation, Foreign Supplier Verification, site registration, and any other related regulatory requirements.

7. Confirm compliance with Management of Change (MOC) to ensure that all building, equipment, and process changes are reflected in current Food Safety Plans and Section 117 cGMPs. This must include product-level specifications, including packaging, ingredients, and processing.

8. Document and update review and mock drills of regulatory inspection programs with any non-conformances addressed as quickly as possible. Consider the process for verifying the inspector’s credentials, opening the session, and ensuring that all required personnel or backups are onsite in the case of an inspection. In cases where all cannot be present or for outside contacts, ensure availability of ownership, corporate compliance management, and designated legal counsel.

Compliance with both FSMA and GFSI requirements means fully conforming with the other. A non-conformance to the GFSI food safety system represents a potential FSMA violation; correspondingly, lack of conformance to FSMA can be a non-conformance to GFSI certification. Criminal violations for non-compliance to FSMA begin with misdemeanor charges starting at $250,000 and up to one year in jail. With these consequences on the line, the importance of FDA inspections must be taken very seriously.

All types of business and operational processes demand a variety of audits and inspections to evaluate compliance with standards—ranging from government regulations to industry codes, to system standards (i.e., ISO), to internal corporate requirements.

Audits provide an essential tool for improving and verifying compliance performance. Audits may be used to capture regulatory compliance status, management system conformance, adequacy of internal controls, potential risks, and best practices.

By combining effective auditing program design, standardized procedures, trained/knowledgeable auditors, and computerized systems and tools, companies are better able to capture and analyze audit data, and then use that information to improve business performance. Having auditing software of some sort can greatly streamline productivity and enhance quality, especially in industries with many compliance obligations.

The following tips can help ensure that companies are getting the most out of their auditing process:

1. Have a computerized system. Any system is better than nothing; functional is more important than perfect. The key is to commit to a choice and move forward with it. Companies are beginning to recognize the pitfalls of “smart people” audits (i.e., an audit conducted by an expert + notebook with no protocols or systems). While expertise is valuable, this approach makes it difficult to compare facilities and results, is not replicable, and provides no assurance that everything has been reviewed. A defined system and protocol helps to avoid these pitfalls.

2. Invest time before the audit. The most important time in the audit process is before the audit begins. Do not wait until the day before to prepare. There is value in knowing the scope of the audit, understanding expectations, and developing question sets/protocol. This is also the time to ensure that the system collects the data desired to produce the final report.
   

3. Capture data. Data is tangible. You can count, sort, compare and organize data so it can be used on the back end. Data allows the company to produce reports, analytics, and standard metrics/key performance indicators.
   

4. Don’t forget about information. Information is important, too. The information provides descriptions, directions, photos, etc. to support the data and paint a complete picture.
   

5. Be timely. Reports must be timely to correct findings and demonstrate a sense of urgency. Reports serve as a permanent record and begin the process of remediation. The sooner they are produced, the sooner corrective actions begin.
   

6. Note immediate fixes. During the audit, there may be small things uncovered that can be fixed immediately. These items need to be recorded even if they are fixed during the audit. Unrecorded items “never happened”. Correspondingly, it is important to build a culture where individuals are not punished for findings, as this can result in underreporting.
   

7. Understand the audience. Who will be reading the final report? What do they need to know? What is their level of understanding? Not all data presentation is useful. In fact, poorly presented data can be confusing and cause inaction. It is important to identify key data, reports desired, and the ways in which outputs can be automated to generate meaningful information.
   

8. Compare to previous audits. The only way to get an accurate comparison is if audits have a common scope and a common checklist/protocol. Using a computerized system can ensure that these factors remain consistent. Comparisons reinforce and support a company’s efforts to maintain and improve compliance over time.
   

9. Manage regulatory updates. It is important to maintain a connection to past audits and the associated compliance requirements at the time of the audit. Regulations might change and that needs to be tracked. Checklists, however, may remain the same. Companies should have a process for tracking regulatory updates and making sure that the system is updated appropriately.
   

10. Maintain data frequency. For data, the frequency is key. Consider what smaller scope, higher frequency audits look like. These can allow the company to gather more data, involve more people, and improve the overall quality and reliability of reports.

A well-designed and well-executed auditing program—with analysis of audit data—provides an essential tool for improving and verifying business performance. Audits capture regulatory compliance status, management system conformance, adequacy of internal controls, potential risks, and best practices. And using a technology tool or system to manage the audit makes that information even more useful.

This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.

At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.

GFSI Conformance

The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.

GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.

With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.

As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.

FSMA Compliance

During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.

By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.

The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.

This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.

Bringing GFSI and FSMA Together

The presence of GFSI in the U.S., as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the U.S. and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.

As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).

In this new order of food safety in the U.S., those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. However, there is also a benefit to starting with FSMA and moving to a GFSI certification.

Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.

As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the Food Safety Plan, which can be based on HACCP but with the proper additions to meet FSMA requirements.

Global Food Safety Conference

The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the U.S. this year. The conference will provide U.S. companies attending, as well as foreign suppliers of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:

• Food safety management commitment and corporate governance
• Required training of food safety roles, including management, staff and operations
• Specific requirements of the documented food safety program or written programs under FSMA
• FDA requirements of the past and existing requirements prior to FSMA and the relationship of these as comparable to GFSI
• Implications for FDA enforcement under FSMA of these previous requirements and program requirements that may need to be formalized under FSMA
• The proof of evidence with supporting records required by FSMA that may be addressed in part by existing or GFSI-level food safety programs
• How to adapt a FSMA-level food safety plan and preventive controls cGMPs from existing programs, including GFSI, or develop these to function with existing programs
• Levels and numbers of qualified individuals, qualified auditors and competent sanitation for oversight and management of FSMA food safety plans
• Management reanalysis and update of the written FSMA programs to ensure compliance and readiness for inspection by FDA FSMA investigators
• Process used to ensure compliance with FSMA Preventive Controls and the other FSMA rules being issued in 2017 and 2018, including Foreign Suppler Verification, Sanitary Transportation and Intentional Adulteration

Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participant, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.

Kestrel is pleased to be growing our resources to the food industry with the addition of Senior Consultant Roberto Bellavia.

Roberto comes to Kestrel following a successful career with US Foods, where he provided leadership for quality and food safety programs; managed and developed HACCP, GMP, SSOP, and SOP programs; and planned and implemented GFSI certification for FSSC 22000 at 13 national locations.

At Kestrel, Roberto will be serving as project manager for food safety-related projects and supporting clients in developing and implementing GFSI schemes and supplier approval programs. He will focus on meat, dairy, RTE, bakery, and other related food industry segments.

Roberto holds a number of food qualifications that will enhance Kestrel’s ability to serve the food industry, including GFSI, HACCP, GMP, SSOP, SOP, FSPCA, Lead Auditor certifications. He has nearly 20 years of food quality experience and a Master’s Degree in Animal Production Science from the University of Camerino in Italy.

Compliance with the Food Safety Modernization Act (FSMA) has presented a new and difficult challenge for the industry, the public, and the FDA since it passed on January 4, 2011. When it comes to the Preventive Controls Rule, the prime question for companies, regardless of size, is whether they have aligned their preventive controls development with existing HACCP programs to meet current FSMA requirements.

Overview of Requirements

Under the Preventive Controls Rule, registered food facilities must evaluate and implement preventive control provisions to meet the requirements and the compliance deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Controls 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.

Key Questions

The following questions can help organizations assess their compliance with the Preventive Controls Rule and better determine their current state of planning for FSMA compliance:

• • In determining the appropriate preventive controls under FSMA for your food operation, have you evaluated your compliance requirements and categories?
  • Have you assessed hazards outside or not part of your existing HACCP flows for determining preventive controls?
  • Are the preventive controls you have identified supported by science-based justification?
  • Is the science-based information supported by means such as statistical methods, published reports, peer review, industry/second-party verification, or other documentation?
  • Have you determined the program requirements for preventive controls for implementation in your Food Safety Management System (FSMS), as required by the FSMA Food Safety Plan requirement?
  • Have the cGMP-based policy, procedure, work instruction, test/validation, forms, and records criteria been established for preventive controls at your food operation(s)?
  • Have you determined the functional organizational responsibilities of preventive controls, your preventive control Food Safety Plan, and Qualified Individual?
  • Does organizational responsibility include oversight by process owners of preventive controls and comprehensive FSMA management?
  • Will completion of your program, as documented with cGMPs and a validated Food Safety Plan, meet FSMA and customer deadlines?
  • Will internal auditing of program elements meet established timing and allow for preventive control and Plan verification and management review?

Companies must have their training, planning and development underway to comply or face possible violations, fines, and penalties under FDA enforcement. These questions will help identify the areas in need of attention to ensure that companies have aligned their preventive controls development with existing HACCP programs to meet requirements and any pending deadlines.