On August 14, the U.S. Food and Drug Administration issued guidance to clarify that a waiver to the Food Safety Modernization Act (FSMA) Sanitary Transportation of Human and Animal Food final rule (Sanitary Transportation rule) covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals.
Designing and implementing a compliant Food Safety Management System (FSMS) can help organizations improve in many areas beyond the system’s defined tasks. It is critical for management to align the food safety objectives with the business needs for a successful and meaningful program implementation. Here are some of the top reasons why companies that work in the food industry may want to pursue developing and implementing an FSMS:
10. Identify and categorize the organization’s food safety risks.
Once this information is known, management can prioritize and decide how to eliminate or reduce business risks and liabilities to acceptable levels. These risks are often better controlled through strict management accounting. As a bonus, employees will become more attuned to thinking about risks and helping management improve overall operations.
9. Develop work instructions and/or procedures to guide employees’ actions and to ensure that each food safety task is completed in a disciplined manner and approved by management.
This will reduce the risk to an organization of an employee accidentally making a food safety mistake that causes the employee or others to be harmed (or worse). It also reduces the company’s risk of government inspections, fines, poor public perception, and loss of business due to a possible recall.
8. Assure management that they, in fact, know and understand the regulatory food safety requirements that must be met daily.
These requirements can be a driver of continual improvement by ensuring that the company has up-to-date procedures and work instructions for employees to follow every day.
7. Develop meaningful goals and objectives that drive food safety performance improvements and possibly reduce additional costs.
Each business will have different goals and these goals will likely change each year. Goals assure continuous improvement in food safety performance for the business over time.
6. Create a strong training and educational program that stems from well-written procedures and work instructions and that clearly defines the company’s requirements.
A well-trained workforce is a motivated and happy workforce. Turnover is reduced, accidents and incidents decrease, and production efficiencies increase. Employees are very aware when an organization takes time to ensure that each job requested is completed in the safest manner possible.
5. Develop appropriate monitoring and measurement practices.
Once all food safety requirements (e.g., FSMA, USDA, GFSI) are known and understood, the organization will be able to gauge food safety performance based on scientific data and regulations, and then guide the organization’s actions in a direction of continuous improvement and compliance.
4. Verify the FSMS is functioning as designed and implemented.
By continuously auditing each food safety program and function, the organization will discover issues of concern and non-conformances prior to an incident or agency/certifying body finding. Routine, non-biased audits allow the company to choose a timeframe that will help improve the situation without undue influence by outsiders.
3. Monitor and trend issues of concern and/or non-conformance and the actions used to rectify them through a fully functioning corrective/preventive action program.
As employees watch management fix problems, they will learn that management is concerned about continuous improvement. This will prompt employees to start making their own improvement suggestions. These suggestions will further drive improvement in areas outside the original FSMS.
2. Evaluate the business model and the FSMS in a holistic fashion.
By using this self-reflection and identifying improvement opportunities, management can direct responsibilities for improvement actions across many departments of the company. Each of these improvement opportunities has the potential to help the bottom line and reduce the possibility of a food safety liability now or in the future.
1. Know that the company has done everything to maintain the business in a manner that meets all food safety rules and regulations.
The last and most important benefit for an organization that goes through the process of designing and implementing a compliant FSMS is knowing that the organization has done everything possible to maintain its business in a manner that meets all food safety laws, regulations, and statutes every day the doors are open for business. To a business owner, that knowledge is priceless. This is how brands are built and how they maintain the promise of food safety to consumers.
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.
Kestrel invites you to join us for an upcoming free webinar that we will be presenting in advance of this year’s Process Expo to help you gain a full understanding of the fundamentals of HACCP.
The FDA and leaders across the food safety industry (academics, certifying body leaders, GFSI leaders) fully agree that HACCP hazardous analysis is necessary for establishing FSMA Food Safety Plan preventive controls. This webinar will prepare attendees to meet this requirement by discussing the fundamentals of HACCP and hazardous analysis leading to FSMA.
Kestrel’s Roberto Bellavia will help attendees gain an understanding of the following:
- Requirements for hazard analysis
- Preventive controls required for Qualified Individuals
- FSMA requirements impacting individual responsibilities and companies
This webinar provides an introduction to the 2-day HACCP Certification Training that is being offered at Process Expo September 20-21. Hope to “see” you there!
This year (2017), most U.S. companies that source food from foreign sources will be obligated to adopt and follow the Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP) requirements. Under the FSVP, these new 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.
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.
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.
On behalf of the Food Processing Suppliers Association (FPSA), Kestrel Management is pleased to be offering a 2-day Hazard Analysis and Critical Control Point (HACCP) certification training course at the 2017 PROCESS EXPO in Chicago.
HACCP Training Course Description
The 2-day HACCP course will cover the current Food Safety Modernization Act (FSMA) compliance requirements, with focus on the Preventive Controls Rule and how this aligns with the existing industry HACCP requirements. Training will assist food industry professionals in understanding the requirements for hazard analysis, preventive controls required for Qualified Individuals, and the FSMA requirements impacting their responsibilities and their companies. Course content is based directly on the FSMA regulations and cGMPs under FDA CFR Section 117.
For the incredibly low price of $699 ($799 after July 19), course enrollees can get the benefit of this valuable industry certification AND enjoy admission to PROCESS EXPO, including access to the innovative show floor, additional educational programming, and networking opportunities with colleagues from across the country and around the world.
*Participants will be certified to HACCP and as Qualified Individuals.
This course will be led by Kestrel Management’s Roberto Bellavia, Food Safety Lead, and Senior Consultant, and Frank Ferko, Senior Consultant.
Kestrel Management’s Food Safety division helps companies achieve compliance with regulatory and food safety certification requirements, including GFSI and FSMA. Led by senior consultants averaging over 25 years of experience, team members are certified in FSSC 22000, BRC, IFS, and HACCP training/development, and share expertise that integrates quality, environment, safety, and security.
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
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.
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.
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.
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:
- 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.
- 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.
- 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.
- Review all records to maintain verification requirements for FSMA, as required by Section 117. Ensure that all records are complete, validated, and verified.
- 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.
- Ensure compliance with all other regulatory requirements, including FSMA Sanitary Transportation, Foreign Supplier Verification, site registration, and any other related regulatory requirements.
- 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.
- 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.
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.
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.
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.