Auditing/Validation Archives - Food Quality & Safety https://www.foodqualityandsafety.com/category/safety/auditingvalidation/ Farm to Fork Safety Tue, 12 Apr 2022 23:38:41 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 180523520 Food Companies Should Run Internal Audits Now https://www.foodqualityandsafety.com/article/food-companies-should-run-internal-audits-now/ https://www.foodqualityandsafety.com/article/food-companies-should-run-internal-audits-now/#respond Tue, 12 Apr 2022 23:08:54 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=36890 Now is the time to revisit your audit documents and personnel trainings to be prepared for your next inspection.

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This is the time to prepare for a year that’s quite different from the last two. Let’s face it; food safety teams have been distracted for some time and it’s easy for small things to slip in the crunch of a crisis. When the crisis lasts more than two years, a lot of small slips can add up quickly.

A great place to start is with a solid GMP internal audit, and an audit is only as good as the documents used to record its findings. Take the time to update your GMP internal audit documents before performing any physical audit activities, and make sure all related forms have been updated for any COVID-19-related practices and processes that have been added or procedures that were modified during the pandemic.

Now is also a good time to verify that all personnel trainings are current and identify any topics that need to be addressed with updated or new training sessions. Make sure these are covered in new hire orientations where needed. This should provide the foundation for an annual training plan that eliminates knowledge gaps or ensures that all groups of personnel receive the necessary training.

Once the audit documents are updated, schedule the actual audit as quickly as possible. Inspections are ramping up, as are third-party audits, so getting the audit completed takes on a new urgency.

The amount of time to complete corrective actions will vary from facility to facility, but each finding should have a deadline established when assigned to personnel for completion. Any findings that require extended correction time should be documented carefully and tracked to ensure they are effectively handled in a timely manner. Now is the time to catch up on any other items such that were postponed due to the pandemic, and that list may be bigger than normal.

It sounds simple enough: Update a few forms and perform the usual walk through, right? Under these extreme circumstances, this process could take far more time than expected, so build in some flexibility to help smooth out the bumps as things return to normal.

Given the supply chain issues, this is an area that could also be included in the internal audit. While supply chain issues may or may not be a regular component of a routine audit, if there have been instances of emergency sourcing or interrupted supplies, this would be a good time to check procedures and documentation to make sure they’re complete and up to date. In fact, this may need to be one of the first areas looked at since, an audit may be required for new suppliers of certain high-risk products, and getting audits completed on short notice these days can still be difficult.

The good news is these steps should put you well on your way to being ready for your next inspection or audit.

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GFSI Sets First Benchmarking Requirements for Food Safety Auditor Training https://www.foodqualityandsafety.com/article/gfsi-sets-first-benchmarking-requirements-for-food-safety-auditor-training/ https://www.foodqualityandsafety.com/article/gfsi-sets-first-benchmarking-requirements-for-food-safety-auditor-training/#respond Fri, 05 Nov 2021 16:39:59 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=36425 The initiative is intended to help recruit and retain auditors.

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The Global Food Safety Initiative (GFSI), a coalition of the Consumer Goods Forum, has launched the first-ever set of benchmarking requirements for food safety auditor professional recognition bodies. By raising the profile of the profession of auditing and focusing entry requirements on competence, the aim is to attract and retain talents into this profession.

Over the years, the industry has faced mounting difficulties in recruiting and retaining auditors, putting a strain on the certification bodies’ ability to cater to the increasing demand in food safety audits. GFSI says situation has worsened due to increasingly complex and duplicated requirements applying to new and existing auditors, including the increasing GFSI benchmarking requirements for certification program owners on auditors.

To combat this, GFSI has now developed a new recognition program for professional recognition bodies in the food safety sector, setting them up as responsible for validating common competencies in a food safety auditor for all GFSI-recognized certification program owners. The move also means that the food industry can rely on this registration and validation to verify the competency of the auditor.

“The current qualifications and industry experience required for a food safety auditing career are stringent and specific, which narrows the field of potential recruits dramatically,” says Erica Sheward, director of GFSI. “By harmonizing training and professional development across the industry, we can make food safety auditing an accessible, attainable, and desirable profession for many more people, helping to safeguard the future of an essential component of the food safety ecosystem.”

GFSI says that this initiative forms part of the larger GFSI Race to the Top framework, which works to improve trust, transparency, and confidence in GFSI-recognized certification and audit outcomes. For more information, access the benchmarking requirements on the GFSI website.

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Understanding ISO 22000: A U.S. Perspective on Certification Requirements https://www.foodqualityandsafety.com/article/understanding-iso-22000-a-u-s-perspective-on-certification-requirements/ https://www.foodqualityandsafety.com/article/understanding-iso-22000-a-u-s-perspective-on-certification-requirements/#respond Mon, 16 Aug 2021 11:18:12 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=36124 We explain how the International Organization for Standardization is structured and how the U.S. interacts with it to better understand ISO 22000.

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The ISO 22000:2018 food safety management system is a set of requirements for any organization in the food chain that describes what a processor must do to show that it can control food safety issues and assure that the food produced is safe. It can be applied to organizations of any size and at any place in the food production or processing chain. The basic approach contained in this document to developing and implementing a food safety management system is based on risk analysis, which includes the probability of the occurrence of a hazard and the severity of the outcome of the hazard if it occurs. The ISO document includes a cross reference section to the Codex Alimentarius Hazard Analysis and Critical Control Points (HACCP) document, which further emphasizes the need for hazard (risk) analysis.

To understand ISO 22000, it is helpful to recognize how the International Organization for Standardization (ISO) is structured and how the United States interacts with it. ISO is a global organization established in 1947 that provides standards for many different operations and manufacturing processes. It is a non-governmental organization that is linked to national standards institutes of member countries. There are approximately 165 member countries, and the U.S. representative is the American National Standards Institute (ANSI).

ISO is managed by a central secretariat, located in Geneva, Switzerland. The secretariat handles the operations and management of the organization. The general assembly is the final authority of the organization for statutory decisions, and all member nations and ISO officers participate in it. ISO is governed by a council that consists of six permanent members and 14 rotating members who address strategic, financial, commercial, and external relations issues. ANSI is one of the six permanent members, and the council reports directly to the general assembly. As the U.S. representative, ANSI also has a vote in the general assembly. The management of the preparation and revision of standards is addressed by the technical management board, which reports to the governing council. This board oversees the technical committees that develop and revise the standards.

ISO has a standardized procedure for the development of a new standard. To initiate a new standard, a preliminary work item may be developed for the initial study of a subject before starting actual standards development, but this is not required. A formal proposal (a new work item) is developed for ISO members to vote on, and, if approved, actual standards development begins on a working draft. If the proposed project does not appear to relate to an existing committee, the technical management board will assign the project to an existing committee, or a new committee will be created. The committee will then develop a working draft to be issued eventually as a draft international standard for formal voting, after which it may be issued as a final draft international standard. The final draft will undergo further review and approval by ISO members. Once approved, the new or revised international standard is published.

The United States has many technical advisory groups (TAGs) to represent the U.S. position on various ISO standards. These TAGs address all aspects of the ISO process, from the development of new work to determining the U.S. position on draft international standards. The TAGs are managed by a U.S. administrator who serves a similar function to a standards development committee secretary by managing the day-to-day administrative activities of the groups.

The management of the food safety activities of ISO is addressed by the ISO Technical Committee 34, Sub-committee 17. The scope of this committee is defined as “standardization in the field of food safety management systems, covering the food supply chain from primary production to consumption, human and animal foodstuffs, as well as animal and vegetable propagation materials.”

This subcommittee, coordinated by the American Society of Agricultural and Biological Engineers, consists of approximately 30 members from the food industry, government agencies, and academia. It provides a U.S. perspective on matters related to food safety, primarily ISO 22000.

The ISO 22000 standard was finalized in 2005, hence the original designation ISO 22000:2005. The standard was the result of the labors of Technical Committee 34. The first meetings of the committee were hosted by the Danish Standards Association in Charlottenlund, Denmark. Among the driving forces behind the establishment of the group that was convened for the development of this standard was the desire for certification of HACCP programs, which required the establishment of an auditable international standard for food safety management systems. Another element was a desire to harmonize the current national food safety management standards. For example, there were and are currently many private food safety standards that have been established globally. ISO 22000 became a global standard. Now, there is the Codex Committee on Food Hygiene document that defines the basic HACCP principles and prerequisite programs. Although this document, along with ISO 9000, served as a reference in developing the ISO 22000 standard, it’s not an auditable standard by itself.

ISO 22000:2018

The latest version of ISO 22000 was published in 2018. ISO 22000:2018 is organized by sections, with the first being the “context” of a food processing organization. This means that the organization should consider all of the potential areas that could affect food safety, both within the company and outside of it. These could include the role of raw material suppliers in the manufacturing process and process variation within the operations, as well as the end use of the product by the consumer—whether the consumer is another business or an individual.

The next sections focus on leadership, planning, and support within the company, followed by operations, performance, and improvement. One of the strengths of the ISO 22000 standard is its focus on leadership. The plant manager, CEO, or whoever is ultimately responsible for managing the processor is also ultimately responsible for the food safety management system. This includes setting policies, assigning responsibilities, managing continual improvement through management review meetings, and handling internal and external communication. The standard presents a logical approach to developing and implementing a food safety plan, and the concepts are fully compatible with both HACCP and the preventive controls described within the Food Safety Modernization Act. All of these programs focus on risk management by mitigation at appropriate steps in the process.

Table 1

As with all ISO standards, ISO 22000 is periodically reviewed to assure that it represents the current thought processes for food safety. One of the reasons behind the revision of the standard was to bring the standard into line with other ISO standards by incorporating elements of the high-level structure (HLS). This ensured that language and standard format were uniform. Among the changes incorporated into ISO 22000:2018 is wording that more closely conforms to the Codex HACCP document and also emphasizes the difference between operational risk (i.e., traditional HACCP) and overall organizational risk (i.e., management decisions to avoid risk). In addition, the 2018 version introduces the concept of operational prerequisite programs and requires that a company demonstrate that it is effectively using the results from monitoring and verification activities. A summary of the organizational structure of ISO 22000:2018 is given in Table 1.

The most recent development for ISO 22000 was the publication of a document entitled “ISO 22000:2018–Food Safety Management Systems–A Practical Guide,” which was published jointly by ISO and the United Nations Industrial Development Organization. As the name implies, this publication provides practical information about and examples of how to implement ISO 22000:2018 and is a valuable addition not only for those who are interested in implementing 22000, but also for those who are currently certified. Other recent developments include the establishment of a committee draft on the requirements for bodies providing audits of food safety management system elements, ISO/CD 22003, parts 1 and 2. These will be an update of the existing ISO/TS 22003:2013 Food Safety Management Systems–Requirements for bodies providing audit and certification of food safety management systems.

ISO 22000 versus FSSC 22000

The Global Food Safety Initiative (GFSI) has been in place for more than 20 years, and many of the major food retailers are requiring that processors be GFSI certified. In this context, there has been some discussion about the difference between ISO 22000 and FSSC 22000, as sometimes these terms are used interchangeably. FSSC 22000 incorporates ISO 22000, 22002, and 22003, as well as other technical specifications. The primary difference is that FSSC 22000 has more extensive requirements for infrastructure and prerequisite programs than ISO 22000. Of importance to many is the fact that FSSC 22000 is one of the GFSI-recognized food safety management systems, while ISO 22000, by itself, is not. The FSSC 22000 audit scheme, which includes prerequisite guidelines described in TS 22002-1:2009 (formerly PAS 220), incorporates the ISO 22000 standard. The feeling at GFSI was that the ISO 22000 standard did not specifically address prerequisite programs in sufficient detail, hence the development of PAS (Publicly Available Standard) by the British Standards Institute (BSI), which eventually became Technical Standard (TS) 22002-1:2009.

The ISO 22000 standard has been very well received and has been adopted globally, especially in Europe and Asia, with more than 25,000 companies certified worldwide. However, these figures do not reflect companies that have adopted FSSC 22000 principles and would probably meet the necessary audit requirements. These companies are, for all intents and purposes, following ISO 22000 to the letter. In the future, ISO 22000 may continue to grow, although there have been some growing pains associated with the revised standard. As noted, the overall data show greater acceptance of the ISO 22000 standard in Europe and Asia, but many multi-nationals based in the United States have elected to adopt the FSSC 22000 audit scheme. Among their reasons are the lack of prescription and an emphasis that is not just on whether a processor has established a procedure, but also on whether the protocol is truly effective. This is the ultimate goal of third-party audits. Another benefit that has been seen by companies of all sizes is that the adoption of FSSC 22000 has provided a management system that allows the company to grow and improve.

ISO 22000:2018 certification is a well-defined process. The company applies to an ISO certification organization and defines the overall scope of the certification. There is an initial review that verifies that the basic components are in place, followed by a certification audit. After all non-conformities are resolved, the company is certified, subject to surveillance audits and re-certification every three years. As part of the preparation for the certification process, the company should follow the standard and be sure that they have all of the components of the food safety management program established, documented, and up to date.

Future revisions of ISO 22000 may focus on closing the gap between FSSC and ISO 22000 and, perhaps, ultimately eliminating the need for two separate programs.


The authors gratefully acknowledge the comments and suggestions of Steve Cornish at the American National Standards Institute.

Stier, industry co-editor of Food Quality & Safety, is a consulting food scientist with international experience. Reach him at rickstier4@aol.com. Dr. Dickson is a professor in the department of animal science at Iowa State University in Ames and a member of the Food Quality & Safety editorial advisory board. Reach him at jdickson@iastate.edu.

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USDA Offers Grants to Improve Meat and Poultry Inspection Operations https://www.foodqualityandsafety.com/article/usda-offers-grants-to-improve-meat-and-poultry-inspection-operations/ https://www.foodqualityandsafety.com/article/usda-offers-grants-to-improve-meat-and-poultry-inspection-operations/#respond Thu, 24 Jun 2021 19:58:14 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=35927 More than $55 million is available for small and mid-sized meat processors to expand capacity or improve facilities to operate under federal meat inspection

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USDA has announced $55.2 million in competitive grant funding available through the new Meat and Poultry Inspection Readiness Grant (MPIRG) program. The new program is funded by the Consolidated Appropriations Act of 2021.

This announcement is part of the Build Back Better initiative, a commitment to invest more than $4 billion to strengthen the food system, support food production, improved processing, investments in distribution and aggregation, and market opportunities.

“We are building capacity and increasing economic opportunity for small and mid-sized meat and poultry processors and producers across the country,” says Tom Vilsack, the U.S. secretary of agriculture. “Through MPIRG, meat and poultry slaughter and processing facilities can cover the costs for necessary improvements to achieve a federal grant of inspection under the Federal Meat Inspection Act or the Poultry Products Inspection Act, or to operate under a state’s Cooperative Interstate Shipment program.”

USDA encourages grant applications that focus on improving meat and poultry slaughter and processing capacity and efficiency, developing new and expanding existing markets, increasing capacity and better meeting consumer and producer demand, maintaining strong inspection and food safety standards, obtaining a larger commercial presence, and increasing access to slaughter or processing facilities for smaller farms and ranches, new and beginning farmers and ranchers, socially disadvantaged producers, and veteran producers. Eligible meat and poultry slaughter and processing facilities include commercial businesses, cooperatives, and tribal enterprises.

Applications must be submitted electronically through www.grants.gov by 11:59 p.m. Eastern Time on Monday, August 2, 2021.

 

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FQ&S Blog: The Emotionally Intelligent Food Safety Professional https://www.foodqualityandsafety.com/article/fqs-blog-the-emotionally-intelligent-food-safety-professional/ https://www.foodqualityandsafety.com/article/fqs-blog-the-emotionally-intelligent-food-safety-professional/#comments Thu, 07 Jan 2021 23:11:13 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=35262 Food safety professionals have the ability to positively impact food safety culture through emotional intelligence.

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A fellow auditor once shared a candid remark that a client made: “You may be a food safety auditor, but what you really are is the food safety police.”

Oddly enough, it was not the first time I had heard something like that. In fact, I too was once told this, many moons ago. It did get me thinking and made me wonder whether auditors from other industries experienced the same thing as well. Having transitioned from being a food safety auditor to an organizational culture consultant, one thing is clear: One’s professional title defines professional authority and not their personal identity. However, in practice, we follow the opposite—we allow our title to become our identity and, at times, overstep our authority when it’s not acknowledged. For instance, think about how you introduced yourself to someone or vice versa. See the pattern there?

Food safety professionals have the ability to positively impact food safety culture through emotional intelligence. Emotional intelligence is often mistaken for emotion suppression. In fact, it’s the opposite. Emotional intelligence is being aware of the emotion that you’re feeling, understanding how it’s impacting you, and being aware of how that emotion is impacting others around you. Considering how the human brain is hard wired to be defensive, it’s easier to be reactive than it is to be reflective.

Here are a few ways food safety professionals can practice emotional intelligence, especially in the pandemic age.

Check In With Your Technical Team

If your organization is currently HACCP (or a similar standard) certified, then you’re familiar with the importance of cadence team meetings. As the team lead, you may be working with multi-disciplinary team members who do not report to you. Nevertheless, you still have the ability to keep things human, co-create an inclusive environment, and help your team members feel valued.

Something that I encourage HACCP teams to practice is pass-the-baton leadership, where team members take turns leading a HACCP meeting while practicing the underlying theme—checking in with their team members.

Align Your Emotional Intelligence With Your Values

It is possible to be compliant and ethical, if you choose to do so. Imagine being a plant supervisor who is able to motivate the bottom line to increase the facility’s output by compromising on their health and well-being (example, by pushing them to work overtime). Your ability to practice emotional intelligence correlates to what you value. While there are “good-intentioned” leaders who try to inspire and motivate their teams, it’s important for them to keep ethics at the forefront of how they make everyday decisions.

Implement an Open-Door Policy

One the best things about being a HACCP team leader is the ability to understand how other departments working alongside each other and what driving forces cause them to shift their priorities.

When I was the acting team lead for a manufacturing operation, I gained more visibility into why training needs were competing with operating needs. The human resource team would struggle to get the floor managers to commit to a training date, and the floor managers would struggle to gain flexible training options from human resources. Being the team lead meant acknowledging how both sides of the conversation felt and also helping them realize that they share a common goal.

Trust is the glue that binds us all, professionally and personally. Maintaining an open-door policy means that you are accessible to your team and that you are ready to hear them out. The more people feel comfortable communicating with you, the more you will be able to see the bigger picture.

Practice Self Care

Here’s a fun (and insightful) exercise. Ask your team members to list the five things they value most in their lives. While most of them may list their spouses, children, partners, pets, or cars, very rarely, will people list themselves. Whether you are a food safety team member or leader, your time and energy are both finite resources. To practice emotional intelligence, you need to first practice self care. Without navigating your own emotions, understanding what your triggers are, and what actions you can take to be fully present for your team (and family), it is hard to be emotionally intelligent.

Whether we realize it or not, emotional intelligence plays a strong role when it comes to food fraud investigations, product recalls, traceability, food safety inspections, and training professionals. Take a moment to think about ways we can make food safety purpose and value-driven through emotional intelligence.

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Unconscious Bias During an Audit https://www.foodqualityandsafety.com/article/unconscious-bias-during-an-audit/ https://www.foodqualityandsafety.com/article/unconscious-bias-during-an-audit/#respond Wed, 30 Sep 2020 23:55:40 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=34702 We are only scratching the surface when it comes to understanding our unconscious biases; there is much work to be done.

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Our perception of self and others is shaped by our life experiences. Anaïs Nin, the late French-Cuban American novelist, describes this astutely: “We don’t see things as they are. We see things as we are.” We rely heavily on our sense of familiarity to discern between opportunities and threats. In fact, we are hard-wired to anticipate a threat when faced with an unfamiliar scenario.

Although this bias served a critically adaptive function in the past (when humans were still evolving as a species and were predominantly hunters and gatherers), it is only recently that researchers have studied its impact on modern societies, and that we have begun trying to correct it.

Last year, we explored the impact of unconscious bias on food safety and quality auditing. This blog post is a deeper dive into the types of unconscious biases that surface during an audit. Although this post does not include a comprehensive list of biases, it does serve as a primer to explore the other types of biases that may manifest itself in the workplace.

Conformity Bias

Our natural inclination in a social setting is to fit in. Gaining a consensus within the group limits conflicts and promotes coherence. Solomon Asch devised the popular Conformity Experiment in 1951, which later paved the way for understanding how an individual’s judgement could be skewed under peer pressure. The objectivity of one auditor within a team audit setting may be influenced because of this bias. One way to overcome this would be to have auditors share their observations in writing, before discussing them as a group. Not only would this open the door to a more diverse viewpoint, but it would also encourage junior members on the audit team to vocalize their thoughts.

Gender Bias

Gender bias is when we think one gender is better suited for a role over another. In the early 2000s, the food safety and quality management industries were male-dominant ones. Even though there has been a significant improvement in closing the gender gap since then, studies have shown that the outcome of an audit can be impacted by the gender of the auditor. In fact, this bias affects both the auditor and the auditee.

Ageism

Ageism is the difference in behavior or attitude toward people solely based on age. Reverse ageism is the terminology popularly used to describe prejudiced behavior against the younger workforce. If left unchecked, ageism can get in the way of team problem solving, effective interpretation, and the communication of audit results.

Framing Bias

Framing bias, also known as the framing effect, is when an individual’s or a group’s decisions are influenced by how the information is presented or framed, using words or graphics. For example, “contains 5% fat” and “is 95% fat free” are technically the same thing. However, “fat free” paints a healthier picture and we may feel more inclined to choose it. This is the power of framing. Considering the effects of framing bias and being mindful of them are good tools to possess as an auditor.

We are only scratching the surface when it comes to understanding our unconscious biases. There is much work to be done in this area, and it will only get better with a learner’s mindset.

What are some biases that you have encountered as a food safety auditor or auditee?

 

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Audit Tips: How to Think Like an Auditor and Avoid Risks, Fines, Shutdowns https://www.foodqualityandsafety.com/article/audit-tips-avoid-risks-fines-shutdowns/ https://www.foodqualityandsafety.com/article/audit-tips-avoid-risks-fines-shutdowns/#respond Sun, 19 Jul 2020 11:44:12 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=33649 Anticipate how your facility could someday risk contamination or hazards before your audit to minimize your facility’s chance of FSMA infractions.

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A compliance audit is often an anxious time for a food and beverage facility manager. The last thing that manager wants is a shutdown, let alone one that could have been avoided by making a simple proactive coatings repair, for example. Yet, violations of the Food Safety Modernization Act (FSMA) flagged by a third-party compliance auditor are common and can lead to major operations interruptions if the problems cannot be remedied quickly.

The likelihood of flagged issues and stalled operations has risen in today’s environment of higher industry standards. This is evident in the amount of product flagged for contamination. Foreign-material contamination caused 23% of all recalls in 2018, up from 7% in 2015, according to a report published in The National Provisioner. Has the industry become more lax about allowing contaminants into food products? No; the more likely interpretation is that today’s stringent regulations lead auditors—and facilities themselves—to catch potential dangers previously left unchecked.

With companies of all sizes now in compliance with the more rigorous FSMA, the question becomes how well they can maintain these standards. That will be determined, in part, by company culture. In some companies, teams will do the minimum to remain compliant, making incremental updates just before an audit or emergency corrections thereafter to avoid a shutdown. This may be especially true for mid-sized companies, where a plant manager does not have the time or expertise to identify the optimal coatings products to fix specific conditions, for example. Most generalist facility managers will not know which floor coatings offer a fast return to service to minimize downtime or which wall coatings are the most durable against chemical washdowns.

However, in other companies, teams will adopt a more proactive approach. The facility manager will not wait for an auditor to point to a problem or learn on the fly how to repair an area. Instead, the manager will work with stakeholders and a third-party coatings expert, for example, to spot not just current violations, but also future vulnerabilities, and to develop proactive repair specs so the facility can address any deficiencies before they become an issue. As such parties anticipate how a facility could someday risk contamination or hazards, the facility manager will not only minimize the facility’s chance of FSMA infractions but will also create long-term peace of mind.

Four Key FSMA Audit Areas

One way for a facility manager to plan ahead is to take on the mindset, and even the checklist, of an auditor. By performing self-assessment walk-throughs that consider hazard analysis, sanitation, equipment preservation, and warehouse and distribution matters, the manager will mirror the checklist an auditor uses when visiting sites. This approach allows the manager not only to see current problems, but also to envision and create a strategy for future issues. By inviting a third-party coatings expert to participate in the assessment, the facility manager can better identify potential vulnerabilities, learn what products will enable fast returns to service and long maintenance intervals, and develop a proactive plan for making repairs.

1. Hazard Analysis & Controls

Personnel, hand carts, forklifts, and other machinery create heavy traffic throughout a facility, so one aim of a FSMA audit is to minimize the risk of employee injury. A coatings specialist can be especially helpful to a facility manager here by suggesting products that will limit injury risks related to slips from flooring hazards or burns from hot surfaces.

Slips and falls are among the primary hazards to employees. Although FSMA does not set any specific floor skid-resistance standards, a facility manager will want to work with a coatings specialist to determine what surface treatments can reduce the chance of unfortunate incidents, yet still meet other facility objectives. Skid-resistance options range from aluminum oxide to sand to a quick-texture system, a splatter coat created by a hopper gun. The latter is especially advantageous, as it establishes skid resistance, but without the pointy profiles that occur with other broadcast aggregates. The rounded, quick-texture profile allows better drainage following wash-downs and is potentially more durable, as pointier profiles created by other aggregates may break off over time.

Tripping hazards can develop when floor quarry tiles or dairy bricks—which are commonly found in food facilities—become uneven, in some instances because water has ponded beneath them and worked them loose, leaving bumps and voids in the flooring. Beyond contributing to falls, such voids can become harborage points for bacteria, and a facility may fail inspection if these areas are not corrected. A facility manager can mitigate both slipping and sanitation concerns by installing a seamless resinous flooring system at the outset of a flooring installation or on top of quarry tile or dairy brick. Such floors offer better drainage, provided the floor has a proper slope, and eliminate grout lines, which trap moisture and promote bacteria growth.

To minimize the risk of another hazard such as burns, a facility manager should look at any area where a worker may come into contact with a heated surface, from piping to tanks, and treat it with a heat-resistant insulative coating. Such coatings allow otherwise hot surfaces to remain cool to the touch without insulation applied, while also providing some insulative properties that will retain heat inside the pipe or vessel. Using coatings instead of insulation also removes the opportunity for corrosion to develop beneath insulation, which can be a hidden and potentially dangerous development.

2. Sanitary Facilities & Controls

Bacteria and allergens are a serious concern for any facility because they jeopardize food products with contamination and cross-contamination potential, respectively. An FSMA auditor tests extensively for these unwanted contaminants, knowing that, despite cleaning protocols, nut material, for example, can get lodged in walls and floors, and then days later, potentially dislodge and end up in another product. For a facility manager developing a preventive maintenance program, the aim should be to eliminate any risks from bacteria and allergens. The focus for both will be to ensure proper water management and eliminate porous surfaces

Facilities are washed down regularly, but how much of the water and chemicals, potentially loaded with bacteria and allergens, make their way to the drains? It is critical to prevent these fluids from ponding behind the walls or under the floor. A coatings specialist can suggest the right products to create seamless systems for these surfaces. In a facility with block walls, for instance, a specialist might suggest using block filler to reduce any divots where allergens can rest before applying a smooth topcoat material designed for washdowns.

Consider also the transition from walls to floors. The crevice of a 90-degree transition makes it easy for bacteria to lodge and remain there following cleaning processes. However, a cove or cant base, with its curved or 45-degree transition, respectively, from wall to floor, creates a seamless floor-to-wall transition and slope that enables more thorough draining and better hygiene following cleanings.

Of course, the end destination for cleaning water is the drain, which is why the floor must have a proper slope that allows fluids to drain away. A cove or cant base helps with this movement at the wall, as does the design of the drain itself. For example, many facilities are transitioning from trench to box drains because the former has more surface area where water and microbes can lodge and allow bacteria to proliferate. Installing a box drain will limit contamination; however, to ensure proper drainage, the floor surrounding the box drain must be re-pitched a quarter inch for every foot that fluids must fall from the edge of the wall.

3. Equipment Preservation

Food and beverage facilities are rife with steel—metal ceilings, railings, columns, and more—found above and near production lines and packaging operations. As steel wears, rust and paint chips can break loose and potentially drop into products. This is one reason why an FSMA auditor closely inspects any steel along a product’s path through a facility. A facility manager should also trace those paths, across every floor and up every stairwell, looking for exposure risks and treating the steel with proper coatings. Coated steel is not only better at resisting corrosion and rust, but also easier to clean.

FDA sets specific standards for which coatings may be applied to steel, and those conditions vary based on whether the steel has direct or indirect contact with food products. For example, grain elevators and storage silos, which store dry goods, must comply with the 21 CFR 175.300 standard. While a facility manager might not be familiar with the entirety of FDA regulations on these matters, a third-party coatings expert will be able to supply that knowledge and recommend appropriate products.

4. Warehouse & Distribution

At most food and beverage facilities, ingredients and finished products sit in a warehouse where high traffic and outdoor access might invite some undesirable agents such as dust mites, bugs, and rodents. In such areas, the right surfaces can help to stave off critters or identify their presence. For instance, sealer placed on a concrete floor makes the surface more cleanable, so dust comes up during washing, which minimizes mites. A run identification strip, a set of white lines painted on the floor around the perimeter of a warehouse, creates contrast so that workers can spot rodent droppings against the light floor surface. In addition, seamless flooring systems reduce the cracks and crevices that bugs nestle within. For each of these matters, a coatings specialist can recommend ideal solutions.

In cold storage and processing areas, a facility manager needs to be concerned about contamination from insulated metal panels (IMPs), as their factory-applied finish may flake off over time. One way to protect this material is to apply polyurea, a chemical-resistant waterproofing membrane that fills cracks and joints and limits flaking. However, not all contactors have the plural-component equipment needed to spray such coatings. A coatings specialist can help facilities identify contractors for the project, which can be completed in one weekend, even at low temperatures.

Establish a Proactive Plan

With so many ways to prepare ahead, there is no reason a facility manager should let an auditor’s visit become a nail-biting experience. Instead, a manager can work directly with a coatings specialist to walk through the facility together, identify any areas of current and future concern, and create a proactive plan to rapidly address repairs as needs arise, especially if an auditor raises an issue. The proactive approach of thinking like an auditor will help the facility maintain compliance and avoid costly fines and shutdowns.


Ball is global market director for Sherwin-Williams High Performance Flooring. He can be reached at casey.a.ball@sherwin.com.

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View Food Safety Audits as Tools for Continuous Improvement https://www.foodqualityandsafety.com/article/view-food-safety-audits-as-tools-for-continuous-improvement/ https://www.foodqualityandsafety.com/article/view-food-safety-audits-as-tools-for-continuous-improvement/#respond Wed, 13 May 2020 17:46:05 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=33612 An audit defines your establishment’s food safety culture, and this must be evident in your daily operations and the products you manufacture.

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“I can’t talk now. We’re preparing for a third-party audit next week.”

“I have a third-party audit in two days and we’d like to get a very high score again!”

“Can you come to our facility tomorrow and help us prepare for an audit scheduled in two weeks?”

Have you heard these statements before? Audits seem to bring on anxiety and fear, and, in some cases, the auditees challenge themselves to obtain the highest audit scores in the community. They can cause stress for food businesses that allow (and pay for) audits in order to sell their products. Viewing an audit as a tool for food quality and safety rather than as an endpoint may correct some of these misperceptions and relieve some anxiety.

Audits verify that the appropriate activities a food processor is using are written and properly followed to control the hazards of the food, facility, and supplier. Audits consist of the verification of records reviews, key personnel interviews, and onsite observations evaluated against a set standard or a checklist. The potential areas of verification include the process, sanitation, supply chain, allergens, and system. Audits are conducted by a food regulator, such as FDA, USDA, or their equivalents in other countries; by a buyer/vendor, such as a food manufacturer, the military or government, or a retail food chain; or by a third party.

The auditor verifies that the processor has written food safety plans that describe what is to be done to keep food safe. For example, if the processor states that product temperatures are obtained with a calibrated temperature indicating device (TID), the processor must have procedures demonstrating that someone in the facility is trained to use a calibrated TID to obtain the necessary data and that a trained staff member knows how to calibrate the TID. If the procedures are not properly done or followed, that processor’s performance will be reflected in the audit results.

Auditors are also different from one another; they can interpret the same auditing guidelines differently. Additionally, auditing guidelines and standards are different for different schemes. Thus, when a food processor does not address all the audit elements that a specific auditor has on its prescripted checklist, such omissions may result in audit score deductions. But is a low or even failed audit score a reflection of a poorly run operation? Conversely, is a high audit score a reflection of a superbly run operation? The answer to both questions is no.

Define Your Goal

A critical requirement of an audit is to define your audit goal. Is the goal to obtain a very high score that gives you bragging rights? Is it to obtain an impressive-looking certificate to hang in your reception area? Or, is it to control food hazards and risks and then learn from the results in order to improve the operations? Defining your audit goal is a critical issue that must be addressed.

When your audit goal has been defined, your company leadership then sets the tone for the rest of the staff to achieve this goal. An audit is not like an exam that you study for, take, and then shelve until another exam is scheduled; an audit defines your establishment’s food safety culture, and this must be evident in your daily operations and the products you manufacture. The establishment culture states your belief that food safety is your first and foremost objective. If a food is not safe, it is not a food and will not be sold.

Auditing Services and Standards

To maintain grocery shelf space, diversify product offerings, and potentially increase revenue, processors continue to improve existing products and develop new ones. But, as improved and new food products are introduced to the marketplace, their safety must be verified. Food regulators often require safety verification at least one step back (to vendors) and, at times, one step forward (to users). Processors meet this verification requirement either by themselves or through the assistance of auditing services and consultants.

Many auditors share an audit plan before the audit is conducted to help the auditee prepare for the focus areas and audit timelines defined by the auditor. If the auditor is a state or federal or foreign regulator, their audit standards (i.e., audit plans) are known. If the auditor is the buyer or vendor, they will have their own proprietary audit standards that are made known to the auditee. If it is a third-party auditor, standards may be made known to the auditee, but these standards also can vary—not widely, but they do vary.

There are true standards such as those set by International Organization for Standardization (ISO) that address food safety, quality, and environmental concerns. There are industry standards, such as the Global Food Safety Initiative (GFSI), formed by a consortium of major market chains to codify food safety, quality, and ethical practices. Other schemes benchmarked against GFSI have emerged, such as the British Retail Consortium (BRC), International Food Standard (IFS), Safe Quality Food (SQF), Dutch HACCP, and FSSC 22000. Many food processors are most familiar with the standards, requirements, or expectations created by a number of private or company auditing services, such as AIB International, ASI LLC, Steritech, Merieux NutriSciences, Primus Auditing Ops, McDonalds, and NSF International.

Thus, the processor is faced with many auditing services operating under many and different audit standards. Fortunately, most of the elements in any audit system are the same, or at least very similar to one another, starting with what are known, in the U.S. and other countries, as the Good Manufacturing Practice or GMP (21 CFR 117 Subpart B previously found in 21 CFR 110). GMPs comprise the basic food safety laws and cover eight key sanitation areas (i.e., safety of the water; condition and cleanliness of food contact surfaces; prevention of cross-contamination; handwashing/sanitizing and toilet facilities; protection from adulteration; labeling, storage, and use of toxic chemicals; employee health conditions; and exclusion of pests). Everyone involved in the handling of food must comply with the GMPs.

The other common audit elements are also related to the GMPs and include allergen controls, good laboratory practices, food defense and intentional adulteration, shipping and receiving, purchasing and vendor approval, document control, recall and traceability, weight control, specifications (of ingredients, finished products, packaging, equipment, and controls), written assurances, consumer complaint program, corrective and preventive actions, calibration, and education and training. Quality systems are also included by several third-party auditors. Thus, there are guidelines to meet audit standards, and many of these guidelines are known.

It is short sighted and a waste of resources to view these preparatory activities as being only for a short-term purpose, i.e., solely for the upcoming audit. These activities should be managed as tools for continuous improvement of food safety, quality, sanitation, and security that align all operations, facilities, and personnel for a long-term strengthening of your food safety culture. Relying on the strength of your food safety systems instead of aiming for high audit scores or obtaining an audit certificate is a truer indication of success. It must be noted that a food processor that obtained a lower audit score than another may still be selling its product. Additionally, within the past two decades, there have been several high-profile cases in which food processors given very high audit scores eventually went out of business due to breaches in food safety that resulted in recalls.

Some processors pass audits, and other processors fail audits. What remains critical to the integrity of a food business is to identify the root cause of deficiencies and prevent them from recurring.

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Avoid These Common Mistakes When Preparing a FSMA-Compliant Food Safety Plan https://www.foodqualityandsafety.com/article/avoid-these-common-mistakes-when-preparing-a-fsma-compliant-food-safety-plan/ https://www.foodqualityandsafety.com/article/avoid-these-common-mistakes-when-preparing-a-fsma-compliant-food-safety-plan/#respond Tue, 21 Jan 2020 12:11:54 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=32629 Read these tips before preparing your food safety plan.

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Since the Food Safety and Modernization Act (FSMA) went into effect in 2011, U.S. companies have had to take their food safety practices to a new level. The law introduced substantial changes, such as a stronger focus on prevention, new hazards to consider (radiological, allergen control, and economically motivated adulteration), more transparency and accountability, and a closer inspection of the supply chain.

Adapting to these provisions means new challenges for food businesses, especially when it comes to preparing the food safety plan, the written document or set of documents in which companies must explain how they prevent food safety incidents from happening and how they’ll manage an emergency if one does happen.

Prevention’s Biggest Enemy: Complacency

The authors of the FSMA greatly reduced the application of Hazard Analysis and Critical Control Points (HACCP) in favor of a framework called Hazard Analysis Risk-Based Preventive Controls (HARPC). Compared to HACCP, HARPC is more proactive, less reactive, and has a stronger focus on risk-based prevention. For food companies, one of the practical consequences of this shift is that steps and procedures that were part of HACCP’s Prerequisite Programs are mandatory in HARPC.

Although this is a significant change, according to Nancy Scharlach, president and chief technical director at FSMA International, many operators tend to think that preventive controls are just HACCP with a different name. “A lot of companies are too complacent, still in the mindset that they only have to make a few tweaks to their HACCP plan in order to be FSMA compliant,” she says. “In fact, we’ve grown beyond HACCP. The FDA felt that it didn’t cover all of the critical recall subject matters like allergens, environmental pathogens on ready-to-eat food, and food fraud from within the supply chain.”

The other risk of a complacent attitude is to have a false sense of security. “When companies use their HACCP plan as a reference to build their FSMA food safety plan, sometimes they don’t carry risks over,” says Mathew Suri, president of Essential Food Safety Consulting. “If they identified a hazard in their HACCP plan but never experienced a problem with that hazard, they just might not include it in their risk assessment, when in fact they still need to keep track of it as a potential hazard.”

Another common mistake is not being specific enough. “Many food safety plans that we review worldwide are too generic,” says Scharlach. “You’ll see a hazard analysis that simply says: ‘biological hazard,’ ‘pathogens,’ or ‘allergens.’ But you need to know which allergens or pathogens are unique to your production line.”

For Brian Perry, senior vice president of food safety and quality at TreeHouse Foods, a manufacturer and distributor of private-label packaged foods and beverages, conducting a correct hazard analysis was one of the main challenges to making his company’s food safety plan FSMA compliant. “One of the things that we worked to improve upon across the board was making sure that we’re looking at all the inputs from the supply chain and at our risk assessment in a broad sense. We tend to focus very much on microbiological hazards because of the public health elements, but we can’t ignore radiological, chemical, and physical hazards.”

Finding the Right Resources

What complicates things further for food companies is that they don’t always know where to find resources and guidance to put together a food safety plan, making the mistake of falling back into what they already know.

According to Perry, companies shouldn’t be insular in their risk assessment. They should actively seek expert opinions and use all the materials provided by the FDA and other food safety institutions.

Kevin Byrne, senior consultant at Essential Food Safety Consulting, says most companies don’t do enough research. “Especially if you’re a smaller company with little time to look at what’s out there, you may not be aware that other hazards exist, so you can’t complete a thorough assessment of your ingredients, process steps or finished products. For example, something that a lot of people don’t even realize is that the FDA put out an appendix to the draft guidance on the food safety plan, which covers all of the biological and chemical hazards that you would expect to encounter with different ingredients based on their category. It’s a huge reference, but not a lot of people are aware that it even exists.”

Make Your Food Safety Plan Crisis Ready

Managing a food safety emergency requires a lot of intense decision making, including knowing when to issue a recall or not. “There are a lot of layers involved, but if there’s even a chance that misbranding or adulteration occurred and you can’t prove that it didn’t, you still have to initiate a recall,” Scharlach says.

According to Byrne, the first step is obviously to assess the impact by identifying which customers the product was sold to and then to take care of the regulatory aspects by contacting the appropriate people.

The part of the food safety plan about crisis management should be a tool that helps quality and safety teams make the right decisions quickly. Unpredictability is an objective limit here: When prevention fails, there are an infinite number of things that can go wrong, and it would be impossible to include all of them in the recall plan—in fact, this isn’t what the FDA expects. “What the FDA wants to see in your recall plan isn’t necessarily the hundred different scenarios that could happen. What they want to see is that you have a list of key contacts, both internal and external, and a step-by-step protocol that the recall team will follow in order to decide on, initiate, and follow through with the recall process,” Scharlach says.

Do Mock Recalls, but Do Them Right

A good way to bridge this gap as much as possible is by conducting mock recalls, but they need to be done the right way.

“A lot of businesses do mock recalls, but once they know which customers are being affected and they can account for everything, they stop the exercise,” Byrne says. He suggests companies add more specific steps to their mock recalls, such as root cause analysis and the drafting of a press release.

“You may think you’re doing a mock recall, but all you’re really doing is a traceability exercise,” adds Suri. “That’s only one aspect of a mock recall, though. There are several other things that have to be done, sometimes concurrently,” says Suri.

Mock recalls aren’t just for rehearsing for an emergency, but also to find out if there are any gaps in your recall plan. “[Businesses] put a plan together that looks like it should hold up procedurally, but practically they’ve missed steps because they’ve never really mocked the process the whole way through. So when an actual recall shows up, they’re lost,” Suri says. “You might not be able to role play every potential situation, but we encourage our clients to pick a different scenario each time and role play it out fully twice a year. That way, you wind up gaining experience with a wide gamut of issues.”

Byrne also warns food companies away from taking a superficial approach toward corrective action through a lack of monitoring. “We see a lot of companies identify the problem and what the corrective action is or should be, and document that it’s being done. But then they don’t monitor it to make sure that the corrective action is continuing to prevent the problem from reoccurring. I think the main challenge is in making sure that corrective actions go far enough and that you’re not looking at them just as a Band Aid.”

Company Culture Is Key

For Perry, the effort that FSMA has required from food manufacturers has definitely improved food safety standards. “It’s been like a tide that raises the waterline for all boats. The focus on prevention brought a clear improvement and probably helped to weed out some bad actors,” he says.

This higher level of effort puts different challenges in front of both small and large enterprises, requiring them to allocate more time, knowledge and people to their food safety program. “Small companies may have a hard time getting people trained properly, creating bigger budgets around food safety, and understanding how to comply with each element of the law,” Scharlach says.

Larger companies face different issues. “The challenge for us has been to manage a very complex portfolio and still make our food safety plan as simple as possible,” says Perry. “The main difference has been the level of validation, verification, and transparency that we have with our agency partners. As the FDA comes in and reviews our food safety plans, we know that our record keeping must prove that we did what we said we would do.”

Despite all difficulties and misconceptions, there’s no escaping this adaptation to FSMA requirements, no matter how large or small the business. “It’s a matter of sitting down, doing it correctly, rewriting everything properly, and retraining everybody,” Scharlach says. “That takes time, effort, energy, and culture change.”

The key to this culture change is a top-down approach to food safety culture, where companies’ executives are directly involved in the implementation of the food safety plan. One example is TreeHouse’s steering committee, where, Perry explains, the C-suite and the presidents of the divisions meet monthly to review food safety objectives and challenges, and make sure they have visibility and alignment.

By contrast, when all responsibilities are left entirely to employees, the level of food safety culture is often poor. “If the project is dumped on the already overburdened food safety lead or QI-practitioner, then the workforce will resist change resulting in an ineffective plan,” says Jocelyn Lee, consultant at Superior Food Safety. “When food safety culture is embedded from the top down, the preparation of a food safety plan is likely to be smooth, comprehensive, effective, and implementable.”


Tolu is freelance writer who specializes in covering the food industry. Reach him at andrea@andreatolu.com.

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Food Safety Auditing: An Industry in Transition https://www.foodqualityandsafety.com/article/food-safety-auditing-an-industry-in-transition/ https://www.foodqualityandsafety.com/article/food-safety-auditing-an-industry-in-transition/#respond Sun, 18 Aug 2019 12:40:41 +0000 https://www.foodqualityandsafety.com/?post_type=article&p=31656 Attempting to efficiently integrate FSMA requirements into existing food safety management systems with a shortage of qualified auditors.

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With the passage of the Food Safety Modernization Act (FSMA) in 2011, the food industry overseen by FDA experienced the most extensive regulatory overhaul in the last 70 years. In the years since, auditing, which is used to both evaluate whether a food safety system is appropriate and effective, and to verify whether it is in compliance with certain industry or government standards, is also in a whirlwind of transition.

For instance, in 2010, the year before FSMA was signed into law, a cut green bean processor in the U.S. would have undergone regulatory inspections as well as several customer audits, either via first-party audits performed by the customer’s staff or third-party audits conducted by an outside company. As a condition of supplying a major retailer such as Walmart, the processor would also have been required to participate in a third-party audit for one of the Global Food Safety Initiative (GFSI) certifications, which is a food safety auditing platform that established a standardized level of global food safety requirements almost two decades ago.

However, in 2019 under new FSMA regulations, the farm supplying green beans to that processor is now also experiencing its first round of regulatory inspections on the federal level. What’s more, certain segments of its supply chain that were somewhat overlooked in the past (e.g., harvesters, packing facilities, etc.) are now also subject to regulatory inspections and may opt to seek out third-party auditing to confirm that their food safety management systems address all FSMA requirements.

In the current food safety auditing climate, that means that more than half of U.S. food facilities have five or fewer audits a year while a third have anywhere from six to 20 audits annually, according to a spring 2019 poll of U.S. food businesses by Lloyd’s Register.

“It remains to be seen if the volume of customer audits and request or requirements for GFSI third-party audits will decrease as FSMA implementation and regulatory inspections ramp up over in the coming years,” says Willette Crawford, principal, Food Safety and Regulatory Compliance at Katalyst Consulting. Yet regardless of what’s coming in the future, the food safety auditing industry is currently straddling two approaches as it attempts to efficiently integrate FSMA requirements into existing food safety management systems.

What’s Changed

Prior to FSMA, although FDA required Hazard Analysis and Critical Control Points (HACCP) for seafood and juices, it was not required for the bulk of FDA-regulated products. In fact, the Federal Food, Drug, and Cosmetic Act of 1938 was the last major federal legislation passed to improve food safety for FDA-regulated facilities in the U.S.

To fill this gap in regulation and streamline auditing, a group of major retailers came together in 2005 to create GFSI, an auditing platform that made HACCP a fundamental food safety requirement for a scheme to be recognized by GFSI, setting the baseline above FDA’s regulatory requirements at that time. Individual GFSI schemes include FSSC 2200, SQF, and BRC, all of which have been widely used by industry and executed by third-party auditors internationally for the last 15 years.

A series of high-profile and deadly foodborne illness outbreaks, many tied to imported foods, prompted Congressional action. Signed into law in 2011, FSMA directed FDA to develop U.S. food safety regulations focused on prevention across the entire supply chain. Under one of FSMA’s seven rules, the Preventive Controls Rule for Human Food, FDA’s regulations now require that domestic food facilities and those importing to the U.S. develop, document, implement, validate, and keep records of a food safety plan. This food safety plan must identify food safety hazards and adulteration risks associated with the specific foods and processes involved, assess the level of risk involved, and implement controls to minimize those risks. The plan must verify that the controls used are effective, and define the corrective actions necessary to address deviations from applied controls. FSMA includes a similar rule for animal foods, and a Produce Safety Rule that addresses farm food safety.

FSMA’s Preventive Controls rules also require that food companies verify their supply chain for raw materials and ingredients, and require an audit of any supplier that controls a serious hazard not otherwise controlled downstream in the supply chain. FSMA dictates that the audit must cover the applicable regulations, be performed by a “qualified auditor,” and verify that the suppliers’ controls for the hazard identified are effective and used consistently. This also applies to imported foods under FSMA’s Foreign Supplier Verification Program (FSVP) rule. As supplier verification audits must cover all regulations applicable to the suppliers’ products, this process can involve using more than one type of audit document.

“A great deal of confusion seems to persist regarding the difference between HACCP and Preventive Controls despite FDA’s education and outreach efforts,” says Crawford. While FSMA’s preventive controls approach to controlling hazards incorporates the use of risk-based HACCP principles in its development, it goes further in many regards such as requiring a recall plan for each product for which a hazard requiring a preventive control has been identified.

Crawford also stresses that by this September, most of the FSMA compliance deadlines, which were staggered over a series of years based on risk and operation size, will have passed. And while she says FDA has used its discretion on what to enforce while the industry becomes more familiar with the new requirements, inspections and enforcement of FSMA rules such as preventive controls, FSVP, and produce safety have already begun.

“At this point, industry should already be complying and analyzing their food safety program and documentation for gaps in compliance, as well as identifying and mitigating weak points in their supply chain,” says Crawford.

Auditing Gets a New Role

While auditing has always served to assist food companies with identifying and correcting gaps in their safety practices, third-party auditing now has a new role. Designed to help FDA expand its regulatory reach on imported foods, FSMA’s Accredited Third-Party Certification rule outlines that third-party certification bodies that meet FDA’s accreditation criteria can conduct audits and issue certifications on foreign suppliers of FDA-designated high-risk foods.

These third-party certification audits fall into two categories: consultative and regulatory. Consultative audits can serve as readiness audits that assist foreign companies in understanding gaps in practice that need to be addressed to become compliant with the appropriate FSMA regulations. A regulatory audit of foreign facilities is required for FDA certification, and can also be used for verifying compliance of a company’s supply chain under FSVP. These certification audits are the basis for participating in FSMA’s Voluntary Qualified Importer Program (VQIP), which offers importers expedited review and entry of food into the U.S.

In addition to the new auditing opportunities that FSMA presents, third-party auditors continue to audit food facilities against safety program schemes such as GFSI, which are still recognized internationally and are required by some retailers. “It isn’t that GFSI audits weren’t comprehensive, in fact they have made tremendous strides in improving food safety, but they lack a required reporting feature that documents the detail that FDA wants to see,” says Patricia “Trish” A. Wester, CEO, The Association for Food Safety Auditing Professionals (AFSAP).

In fact many in the industry recommend companies striving to be FSMA compliant make sure they are GFSI certified, which will get their operation 80 percent of the way there. “Regulators all over the world, not just in the U.S., are struggling with implementation of regulation,” says Véronique Discours-Buhot, the director of GFSI. “We are all short on resources and an organization like GFSI can be part of the solution.”

In the meantime, FSMA compliance is creeping its way into the existing GFSI food safety standards. “What we’re seeing as a certification body is that when, for instance, FSSC 2200 was last updated, it now encompasses many of the FSMA requirements,” says Jennifer Lott, senior food safety auditor at SGS. “So in the new version of FSSC, you now have to look at vulnerability assessments, food defense, and how you’re meeting all those extra requirements of the FSMA law and all of its regulations.”

While existing food safety plans may encompass some of FSMA, they are not interchangeable as an FDA certification audit goes beyond the traditional food safety elements and focuses on compliance with specific regulations. “Food safety auditors are currently in a transition from these bigger, broader, every-question-you-can-think-of-food-safety-event type of audits such as GFSI,” says Wester, “to very specific FSMA audits that say, ‘Look at this cook step and this regulation. Are they doing it right?’ We are not accustomed to reporting that level of detail on a specific hazard or regulation.”

An Increasing Number of Audits

While FSMA is, at least for the time being, increasing the number of third-party audits, SGS’s Lott says she’s noticed another reason for the growing number of audits. “Walmart tells a supplier, ‘If you want to sell your product in our store, you have to be GFSI certified,’ a company gets that certification, then looks at all their raw material suppliers and says, ‘Why don’t we get all them GFSI certified as well?’” she says. This trickle-down effect has even reached packagers in a supply chain as their product includes a surface that has contact with food, she says, which buyers want to get GFSI certified as well.

In addition, the journey from farm to fork has become increasingly complex, says Stuart Kelly, head of Commercial at Lloyd’s Register. “Fifty years ago, the average supermarket stocked 200 items, 70 percent of which were processed within 100 miles,” he says. “Today, supermarkets stock around 39,000 items, and on average these items have travelled 1,500 miles before they’re consumed.” He adds that the more complex the supply chain, the higher the risk of foodborne illness hazards. “This complicates auditing but also makes it more important than ever to ensure safe, sustainable, and responsibly sourced food,” he says.

Personnel Challenge

As FDA increases regulatory inspections under FSMA and third-party auditors are beginning to issue FDA certifications, the food safety auditing industry is going to be under a lot of pressure. “This industry is going to grow tremendously,” says SGS’s Lott. “And auditors are an aging population. We need to focus on how we can get young people qualified faster to answer that demand.”

Lack of qualified auditors has always plagued the industry, even before FSMA and the recent uptick of audits. “Auditors are typically independent contractors who often do two or three audits a week, spending Monday to Friday on the road,” says Wester. “How does one maintain a life or a family—let alone write their audit reports—with that kind of schedule? We don’t have enough auditors, and the ones we do have burn out too quickly.”

What’s more, many job postings for auditors require so many years of auditing experience or specialized knowledge in a specific food sector or certification scheme that it filters out most new job seekers. “We need to work out entry-level positions for auditors,” says Wester, who helped start an association to represent those in the auditing industry. “Let them start at low-risk foods and then climb up to high-risk and reward them with pay increases.”

Meanwhile Martin Fowell, director of Auditing Operations at Mérieux NutriSciences, says that they have been working with the U.S. Department of Labor on an apprenticeship program to help alleviate some of the pressures they’re seeing on auditor capacity.

But it isn’t just auditor capacity that’s a challenge—it’s auditor competency as well. GFSI recently created “knowledge exams,” also known as GFSI Auditor Exams, to offer a consistent method to assess auditor knowledge across a range of relevant skills for all GFSI-recognized programs, as well as cover HACCP and Good Manufacturing Practice (GMP) requirements, and standard auditing skills such as sampling and evidence gathering.

While this exam well help ensure a baseline of expertise, GFSI’s Discours-Buhot also says that the challenge of auditor competence stems from the fact that a good auditor does a lot more than check off boxes. “We need auditors who have not just technical but human skills,” she says, “to be able to investigate, but also be able to chat with the employees in their own language.”

Aligning Expectations

Whether an audit is being done for internal assessment, toward certification, or to comply with regulation, those in the field say food companies often have an unrealistic expectation of what an audit can accomplish. “Some view these certification audits as a kind of zero-risk insurance when in fact, the auditor is taking only a snapshot of one moment in time,” says Discours-Buhot. “As an industry, we need to better communicate that the certificate is only one of the tools used to mitigate risk when it comes to foodborne illness.”

Food safety is everyone’s business, according to Wester, not just the auditor. “Every person on every line plays a critical role in producing safe food,” she says. “They are the ones who see everything and should be empowered to act when necessary. Because even the best auditor is in a facility for only a couple of days.”

 

Guidelines for the Fresh Tomato Supply Chain

United Fresh Produce Association recently released the updated version of the Food Safety Programs & Auditing Protocol for the Fresh Tomato Supply Chain, commonly known as the “Tomato Metrics.” These metrics were initially developed in 2009, endeavoring to harmonize food safety audit standards for the fresh tomato supply chain. It was this original effort that led to the development of the Produce GAPs Harmonized Standard.

The Tomato Working Group recommended a new structure for the Tomato Metrics in which tomato operations will use the Harmonized Standard (or other similar GAP audit) as the base food safety protocol, with the Tomato Metrics added as an industry-specific addendum. With the revision, the Tomato Metrics are limited to areas that are either unique to the tomato industry, or not necessarily unique, but not currently in the Harmonized Standards.

This update of the Tomato Metrics corresponds with the September 2018 publication of the Tomato Guidelines, 3rd ed. Together, these resources provide in-depth information and auditing protocols for the recommended food safety practices intended to minimize the microbiological hazards associated with fresh and fresh-cut tomato products.

“We hope that the new format of these metrics will encourage continued use of these standards, achieving our ultimate goal of food safety standard harmonization, and reduced audit fatigue among produce growing and handling operations,” says Emily Griep, manager of food safety, United Fresh.

The Tomato Guidelines can be downloaded for free by visiting www.unitedfresh.org.FQ&S

 

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