Tag Archives: GFSI

Which GFSI Standard is Right for Me, and How Do I Prepare For The Audit?

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So your company has decided to pursue certification against a GFSI benchmarked standard. How do you go about choosing the right standard for you, and how can you prepare for your first audit? This article offers some advice.

One of the most important questions to ask before researching and deciding upon a standard for GFSI certification is, “Do any of my company’s current or prospective customers require GFSI certification to a particular standard?

Some customers do require their suppliers to achieve certification to a particular GFSI benchmarked standard and it is worth investigating customer requirements upfront before investing time and resources in the development of a standard specific food safety management system, which is not recognized by a particular customer.

While GFSI benchmarked standards are similar to each other in the core criteria of a supplier’s food safety management system, there are subtle differences with respect to the level of prescriptiveness and certification cycles required by each standard. While GFSI’s motto is “One Certified, Accepted Everywhere,” the reality is that retailers and manufacturers have unique requirements for their suppliers to support organizational initiatives and it is in the best interest of suppliers to understand such requirements for increased market access of their company’s food products.

Identify your company’s preparation profile

Once customer requirements for GFSI certification are evaluated, the next step is to assess management objectives for GFSI certification as commitment and resource requirements maybe different depending on which standard is adopted for certification.

At their most basic level, all GFSI benchmarked standards require the development and implementation of a food safety management system (FSMS) for certification. However, some schemes extend the scope of certification beyond food safety requirements and offer certification of both a food safety and quality management system (FSQMS) such as BRC Global Standard for Food Safety or SQF Code Level 3.

Distinguishing between implementation of these two types of management systems is critical for determining management commitment, resource requirements, implementation of timelines, and maintenance (certification) of the system.

Attributes to consider and evaluate against the different GFSI benchmarked standards when deciding which GFSI standard to implement may include consideration of the following:

  • Type of operation
  • Number of locations
  • Physical size of the facility
  • Number of employees
  • High or low-risk product
  • Number of HACCPs
  • Product category(ies) to be included in scope of certification
  • Ability of management and staff to submit to required unannounced audit during certification cycles.

Developing, implementing, and maintaining a food safety management system is a financial commitment on the part of the company seeking certification with immediate and long term benefits as previously discussed. As such, budgeting for the initial development and implementation as well as continued maintenance of the system is necessary. Consideration should be given to the need for initial training of key management and staff to the selected standard, consultancy, allocation of management and staff time, and initial audit costs. Maintenance of the system should consider continued training needs as new editions of the standards are issued, annual review, revision, and verification of the system, and annual recertification costs.

How to prepare for the audit

In preparation of the audit, it’s helpful to prepare an Internal Preparing Checklist, covering the following aspects:

  • GFSI Standard: Have you determined which GFSI standard best fits your company culture and acquired the current version of the standard?
  • Commitment: Is senior management fully committed to implementation and maintenance of the selected standard’s requirements?
  • Food Safety Management Team: Do you have a qualified HACCP team leader, inter-departmental HACCP team, and designated individual(s) to lead the development and implementation of the food safety management system?
  • Training: Are the company’s designated HACCP and food safety management leads trained in the requirements of the current version of the standard?
  • Readiness: Does the company have a well developed, implemented, and documented HACCP system with core prerequisite programs included allergen management, internal audit, GMPs, process and product segregation, SSOPs, specification approval, supplier approval, recall plan, traceability and training?
  • Timeline: Has senior management set a target date for certification?
  • Consultancy: Do company resources lend itself to successful development of a documented food safety management system, which meets all requirements of the standard, or is there a need for a standard specific consultancy?
  • Internal Audit (Gap Assessment): Has the food safety management team conducted an internal audit of its system against the requirements of the standard? Are “Gaps” or a reason of non-conformance to standard requirements identified with a correction action plan?
  • Third Party Assessment: Is there a need for a third-party (certification body) to conduct a pre-assessment audit of the company’s system against standard requirements? Third party pre-assessments provide objective and competent evaluation of the system by a trained auditor in preparation for the planned certification audit.

The above article has been adapted from a white paper published by CERT-ID, which has over 15 years’ experience in providing certification services globally. For more information, visit www.cert-id.com.

NSF International Strengthens Global Food Division’s European Team

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Global public health organization NSF International has appointed Kevin Swoffer as Technical Director of its Global Food Safety Division. Additionally, NSF promoted Stephen Cox to Global Managing Director, NSF Agriculture and Grace O’Dwyer to Director of Operations for NSF’s Europe Middle East and Africa (EMEA) region.

With nearly 40 years of experience in the food retail and manufacturing sectors, Swoffer has held a number of senior executive positions, including Head of Technical Services at British Retail Consortium, where he was instrumental in developing the BRC series of standards and the Safe and Local Supplier Approval scheme (SALSA). He has also worked at Nestlé UK and Safeway UK in several technical roles, and most recently served as a consultant to a number of global organisations.

“Kevin, Stephen and Grace have a great deal of technical experience in the industry,” said David Richardson, Vice President of NSF International’s Global Food Division’s EMEA region. “I have no doubt our clients will benefit from the changes we have made to our senior management team, adding a unique level of expertise and experience to the services NSF International provides.”

“I have worked with NSF International over many years and welcomed their professional input into standards development and certification services. NSF International has also developed a number of unique solutions to food safety issues. I have long respected their leadership and approach within a very demanding industry,” said Swoffer. “I’m confident we will continue to bring innovative technical services to clients and further enhance our consulting proposition.”

In his role, working as a member of the NSF Technical Services and Consulting Leadership Group, Swoffer will be responsible for developing, implementing and continuously improving services consistent with corporate strategy and meeting the needs of NSF clients. He will provide technical support, advice and guidance to members of NSF teams in the EMEA region.

Swoffer has been involved with the development of food safety standards since 1993. He has authored a number of industry publications including editing the UK Industry Guide to Good Hygiene Practice: Retail Guide, 2nd Edition and writing BRC Product Recall Guidelines. He was appointed as an expert on food quality and safety private standards for UNIDO (United Nations Industrial Development Organization) in 2009 and as the Chairman of the Global Food Safety Initiative (GFSI) Technical Committee in December 2007. He was one of the founding members of the GFSI in 1999 and has been actively involved with GFSI development in recent years. He holds a degree in food science and is a Fellow of the Institute of Food Science and Technology.

Stephen Cox, formerly NSF Agriculture International Development Director, moves to Global Managing Director, NSF Agriculture. In this new role he is developing new services for traditional and emerging agricultural markets in addition to further developing the business’ role. In his earlier role as Business Development & Quality Director for NSF Certification, Cox and his team managed many of the technical and integrity issues for a variety of pre- and post-farm gate assurance standards in addition to liaising with the global network with specific responsibilities for the U.S., Spain, Italy and South Africa.

Grace O’Dwyer has been promoted to the role of Director of Operations EMEA from her previous position as Director of Operations for NSF Agriculture. In her new role, O’Dwyer will focus on developing the European infrastructure of offices, technical expertise and administration support across Europe, the Middle East and Africa. This includes putting in place innovative IT platforms and systems and strengthening operating processes and systems to provide best-in-class customer service support. With a background of technical services provision and business development in the agri-industry, O’Dwyer has significant experience developing customer-led solutions and operating practices in international supply networks.

To learn more about the NSF Global Food Division, visit the NSF Food Safety website.

GFSI Recognizes SQF Scope Extension for Storage and Distribution

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Scope J, Provision of Storage and Distribution Services, is the latest extension to the SQF scopes covered by the GFSI benchmarking requirements, and includes the management of safety schemes for storage facilities and the distribution vehicles for food and feed.

The Global Food Safety Initiative Board of Directors is pleased to announce that SQF has achieved recognition against the Guidance Document Sixth Edition for the scope of Storage and Distribution (J). This is in addition to the scopes for which SQF has already achieved GFSI recognition (AI, BI, C, D, EI, EII, EIII, EIV, F, L and M). The GFSI Guidance Document’s Scope J, Provision of Storage and Distribution Services, is the latest extension to the scopes covered by the GFSI benchmarking requirements, and includes the management of safety schemes for storage facilities and the distribution vehicles for food and feed.

Scopes of Recognition

GSFI-SQF-Scope-Jan-2015The GFSI Benchmark Committee was led by Kevin Swoffer, director, KPS Resources Ltd with the support of Cloeann Durham, Sr. Director Quality ; CCBCC, The Coca-Cola Company and Bizhan Pourkomailian, Director Food Safety and Supplier Workplace Accountability, McDonald’s.

“The GFSI Board is delighted to recognize yet another food safety scheme against the GFSI requirements for storage and distribution activities. SQF now offers another option to companies looking for food safety management solutions in this part of the supply chain,” said Cenk Gurol, Aeon, Chairman of the GFSI Board.

“SQFI is pleased to announce the recognition and benchmarking of our Storage and Distribution of Food Products Program by GFSI. We are excited to offer these highly anticipated benchmarked modules to our stakeholders so they can be assured they are transporting and storing perishable and non-perishable food and feed products safely,” said LeAnn B Chuboff, Senior Technical Director, SQFI.

The Safe Quality Food (SQF) program is recognized by retailers and foodservice providers around the world as a rigorous, credible food safety management system. It is the only certification system recognized by the Global Food Safety Initiative (GFSI) that offers certificates for primary production, food manufacturing, distribution and agent/broker management. This enables suppliers to assure their customers that food has been produced, processed, prepared and handled according to the highest possible standards, at all levels of the supply chain.

The Global Food Safety Initiative (GFSI) is a business-driven initiative for the continuous improvement of food safety management systems to ensure confidence in the delivery of safe food to consumers worldwide. GFSI was launched in 2000 following a number of food safety crises when consumer confidence was at an all-time low. Its collaborative approach to food safety brings together international food safety experts from the entire food supply chain at technical working group and stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry.

The Global Food Safety Initiative (GFSI) was founded to deliver equivalence and convergence between effective food safety management systems through its benchmarking process and continues to flourish in doing so. Benchmarking is a “procedure by which a food safety‐related scheme is compared to the GFSI Guidance Document”. The benchmarking process determines equivalency against an internationally recognized set of food safety requirements, based on industry best practice and sound science. These requirements are developed through a consensus building process by key stakeholders in the food supply chain and can be found in the GFSI Guidance Document Sixth Edition, freely available for download on www.mygfsi.com.

FSMA: What to Expect in 2015

By Aaron G. Biros
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Companies should start preparing for FSMA immediately, caution two food safety experts. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines. So are you prepared?

Two experts from The Acheson Group – Dr. David Acheson, and Melanie Neumann, in a recent FSMA Friday webinar, discussed what companies should expect from the FDA in 2015 and how they can adjust to comply with new rules as the final deadlines approach. FoodSafetyTech presents some excerpts:

With the FSMA comment deadline closed, what can we expect from FDA in terms of finalizing FSMA?

With the agency still answering questions and conducting FSMA related activities such as dealing with deadlines and proposals, we can expect to see the agency go silent on that. We have gone through multiple comment periods already so we should expect them to stick to their timeline of implementing rules.

What is FDA ultimately seeking to achieve with these rules?

When we look at where FDA is going in 2015, we need to look at what we should be doing in the private sector under FSMA’s prevention scheme. FDA is trying to require companies to think about preventative controls. It is about understanding where your risks are and using the appropriate controls. The main issue surfaces when regulators and suppliers have different senses of what appropriate controls really are. So, thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or importer, is going to be key in planning for the future.

When is it anticipated that the FSMA rules will be finalized?

Going from reactive to proactive and preventative strategies is the essence of FSMA’s effect on shifting the regulatory scheme. Therefore we should expect preventative control rules to come out first. We must put together a monitoring program and corrective actions in our food safety plan proactively. The FDA really wants to get these rules rolled out and enforced before the administration changes in 2016 with the next presidential election so we can safely assume they will try to stick to their published timelines (most proposed rules have a deadline in Fall 2015 with the latest in the spring of 2016).

What will some of the biggest challenges be for food and beverage companies as they begin to consider FSMA compliance?

The biggest challenges will deal with how to properly manage, store, and retrieve documentation. All the traceability data, information, and production and supplier documentation that is key in a recall should be readily presentable. Having all this data and documentation, being able to produce it quickly and turn it over to the on demand is the biggest hurdle. Companies need to leverage technology to manage this risk in documentation and data organization.

What should companies be doing now to begin to prepare for FSMA as we wait for the final rules?

Companies should start preparing for FSMA immediately. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines.

Supply chain risk control and environmental monitoring are new and challenging ventures. The behavior of FDA in the past few years have shown that any company that needs to comply with preventative control rules should really pay attention to their environmental monitoring program.

HAACP systems are likely to be fairly robust and will translate quickly, but environmental monitoring could be considered the Achilles’ heel. The other Achilles’ heel is the supply chain. This was in the original statute giving FDA the authority to require supply chain risk assessments and controls. This has resurfaced in the re-proposals, which is very reflective of the foreign supplier verification program. Look at what you know about your supply chain. The expectation will be that you control those risks.

The other challenge is FDA is expecting you to look more than one step upstream. If you are buying your ingredients from a distributor, it is your responsibility to institute preventative controls in environmental monitoring Companies need an organized central repository of all upstream, internal, and downstream documentation and data.

GFSI standards compare to the preventative control rules. The standards might be highly robust but that does not necessarily mean you comply with food defense and foreign supplier verification programs. Keep all that in mind when looking strategically toward 2016.

Summarized by Aaron Biros

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

Top 10 Elements of a Successfully Certified GFSI Program

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

GFSIstandardsDec2014The Global Food Safety Initiative (GFSI) relies on a number of benchmarked schemes to establish food safety requirements, all are designed to ensure the quality and safety of a company’s products.

In order to become certified to one of these GFSI-recognized schemes, a company must undergo a third-party audit by a certified auditor. Kestrel’s experience conducting these audits has revealed that companies who successfully achieve certification demonstrate a number of common attributes—regardless of their chosen scheme:

  1. Corrective and preventive actions are up-to-date and current.
  2. Continuous improvement/root cause analysis process is in place to make ongoing improvements and to ensure final resolutions to all out-of-control issues or non-conformances to the Food Safety Program.
  3. Premises, facility, and building programs are established and operating, including controls, signage, direction, job training, and physical evidence of a fully implemented Food Safety Program.
  4. Preventive maintenance system links scheduled maintenance to Hazard Analysis & Critical Control Points (HACCP) critical equipment monitoring requirements.
  5. Approved materials and process specifications are managed and controlled.
  6. Product identification and traceability processes are in place, including complete records detailing all activities for the production of food product.
  7. Document management and control program is updated, validated, and maintained. Developing program management systems helps ensure compliance with document management and control.
  8. Food safety program updates and management are completed through annual and multi-year planning for maintaining the Food Safety Program, including management of change, management review, approvals, and internal audit.
  9. Records and verification management systems provide access to supporting data, as determined by FDA/FSMA and company programs.
  10. Data management of food safety records outlines processes for assuring prompt or immediate access to critical records, as needed, for audit, compliance, or regulatory purposes.

 

Gary Smith, Eurofins’ Food Safety Systems

Moving from GMP to GFSI Audits

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

Ask any one in the food safety and quality sectors of the F&B industry and they all talk about one uniform concern: Audits. The sheer number of audits, supplier audits, GFSI audits, FDA audits, unannounced audits, the work involved in preparing for these, and the possibility of still things not working as planned on the actual day of the audit.

Dispelling some of these concerns, Gary Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, spoke to Food Safety Tech about how companies can be better prepared; challenges in moving from traditional GMP audits to GFSI recognized certification audits; role of management; and what do you if you disagree with the auditor.

Food Safety Tech: What is the biggest challenge for a company moving forward from traditional GMP audits to GFSI recognized food safety certification audits?

Smith: A good GMP audit program has probably got about 80 percent of the full GFSI scheme. It’s a great precursor. But there are some aspects that are not addressed in GMP audits which are facility-specific, such as would we know if the floor is in bad shape etc.? With GFSI you can’t have any non-conformance. Internal audit programs, corrective action management, root cause analysis, all of these are a must for GFSI. So it’s much more advanced than what’s required in GMP.

The audits are also difference from a validation stand point. For instance, with GMP audits, you need to have six elements of a Pest Control program and a facility can say, I have all six, so I am set. But with GFSI certification programs, you need to have these six elements, but you also have to prove that these are effective.

GMP audits provide a snapshot in time, a look behind the curtain to make sure you are following all the requirements. With certification, it’s a more consistent and continuous process – you are always looking for ways for improvement, and ensuring the standards and systems are working the way they are supposed to.

FST: What is the role of management in the audit process – whether GMP or GFSI?

Smith: There’s a big difference when it comes to management participation with both these sets of audits. Management needs to understand that with GFSI certification, management is required to have a culture of continuous improvement, where they are constantly looking for issues to manage and ways to get better. Leadership has to drive that change and a lot of folks struggle with this. QA managers should focus on training them to bring managers to embrace and communicate that culture.

FST: For companies first looking into certification services, what criteria should they be using while selecting a certification body?

Smith: The most basic requirement according to me is auditor availability. You need to identify a certification body that has more than one or two certified auditors. While price should be a consideration, it shouldn’t be the top priority.

As companies move to certification versus auditing, it is also important to look for a food safety partner, one who can service many of your foods safety needs such as testing, consulting, training etc., versus just auditing. For instance, can you call the Certified Body in case you have a recall or a food safety incident, and can the CB help you minimize the issue and solve the problem? Of course, customer service is an important consideration; the auditor and the team have to be responsive and polite.

FST: What steps can a company take prior to an audit to give themselves the best chance for success on the audit?

Smith: Training is critical. The facility and the personnel concerned with the audit process need to thoroughly understand the standard against which they are being audited, what will be asked and assessed for. Companies need to be harder on themselves than the auditor will be. Get others in maintenance and product involved in the facility and ask them questions that an auditor may ask. Train them to answer those questions.

Have strong internal auditing programs so you are prepared. You should know your issues and some auditor shouldn’t be telling you what the gaps are. All this is time and energy consuming, but it’s worth it.

Taking pictures both internal and external can also help, and can be a great training tool. When you have actual pictures from the facility and the processes, there can’t be too much room for debate.

FST: If the company disagrees with an auditor or the audit findings, what should they do?

Smith: The first thing I would say is don’t be afraid to ask the auditor questions. It is okay to say, ‘show me in the standard where it says this is a nonconformance.’ Remember to ask them before they leave. In most cases, asking such questions can help solve 75 percent of the issues.

Auditors can help describe why something is a nonconformance. If as a facility there’s still disagreement, you can go to the CB and provide a written description with as much information as you can, specific to the standard, about why you disagree with the audit. You can do an investigation and in many cases, probably 40 percent of the time, the auditor could have made an error, and gone beyond the standard. Remember that for the CB also, it’s important for them to get it right. So sites shouldn’t be worried about asking auditors questions, and CBs should respond to them – all in the process of continuous improvement.

Unfortunately, in some instances, it gets escalated beyond the CB to the standard owner. Though it’s a really drastic step, it has happened with SQF. As the final step, the site can still contact the Accreditation body, the American National Standards Institute.

FST: What are some other concerns regarding audits against the backdrop of FSMA proposed rules and GFSI?

Smith: As the industry is still waiting for final FSMA rules, one requirement that is causing some concern is auditors having to inform FDA when they see a nonconformance during a consultative audit. There is some concern that such a requirement would discourage people to try and get better. Industry is also waiting to see how FDA views certification audits. Can this be a process to ease imports, or, for domestic suppliers, be a risk-reduction tool? For instance, if there are two food facilities that make the same product, one that uses a GFSI scheme and one that doesn’t, can the one that uses be considered lower risk and not require as much resources to assess risk? Can inspections be done less frequently for such a facility? Will FDA accept such factors in the final requirements?

Ultimately, we need to remember that certification in the food industry in the U.S. is only about six years old. We all need to collectively continue to drive the process forward.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA and GFSI: Alignment and Gaps

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

A recent FSMA Fridays webinar, presented by SafetyChain and The Acheson Group, focused on the interesting topic of FSMA and GFSI: Alignment and Gaps. The discussion covered questions such as did FDA reinvent the wheel with FSMA, given GFSI? If you are GFSI certified, will you comply with all FSMA rules? What do you need to do in addition? Will FDA accept GFSI certification in lieu of an inspection?

David Acheson, M.D., and Jennifer McEntire, Ph.D., of The Acheson Group gave their perspective on where the rules and guidance shaping food safety programs in the industry are similar, and how they differ. We present below some excerpts.

Did FDA reinvent the wheel with FSMA, with GFSI already there?

Dr. Acheson: At a very fundamental level, GFSI is global and FSMA is more U.S.-centric, focused on protecting the American consumer. If you look back a few years, to the time when FSMA rules were being put together, there wasn’t clear understanding about the impact of GFSI and what it could accomplish. GFSI has evolved substantially since then, both in terms of the various standards, and in terms of the execution (preparing companies for audits and doing the actual audits). While there is a lot of alignment between FSMA proposed rules and the various GFSI guidance documents, I don’t think FDA reinvented the wheel with FSMA, which is more detailed, more prescriptive and U.S.-centric.

Which proposed rules are most similar to the GFSI guidance document, and which are different?

McEntire: If we consider the seven proposed rules under GFSI so far, and compare it with the different ‘scopes’ under GFSI, you can see within one scope several elements of FSMA rule:

Produce rule: In some areas what FDA is looking for is more prescriptive, more stringent than what GFSI has in their books, and in other areas, GFSI standard is more detailed. We need to remember that these are still ‘proposed’ rules, so it is hard to predict where FDA will land eventually.

Preventive controls: There is fairly strong alignment between this rule and GFSI. There is some minor differences, but the approach is quite similar.

Food defense: With this rule, you can see of the greater differences. Under FSMA, there’s a whole new rule, compared to just a few lines under GFSI for food defense. So FDA is more specific in what they are looking for and will expect food companies to do more work, over the GFSI scheme.

Sanitary transportation: FDA said they wanted to align with industry practices, and GFSI Logistics guidance for this rule. So broadly the requirements are consistent.

Foreign Supplier Verification Program: This is an interesting one, because there’s no GFSI call out for international versus domestic supplier. FDA is taking a more specific approach in what needs to be done to evaluate and verify foreign suppliers. In our mind, GFSI is taking a more appropriate approach, which FDA will need to consider, to include all suppliers, global or domestic.

There are other elements of GFSI that FDA has not issued rules such as traceability, but overall there’s general alignment between the two sets of food safety requirements.

When you look at some key differences, again, GFSI is global. FSMA more US focused. GFSI is more guidance documents and broad scope, while FSMA is actual rules.

When it comes to rule-specific differences, if you consider Preventive Controls, the proposed rule looks at it pretty comprehensively, not just at critical points. So while it’s aligned with HACCP principles, it builds on it, and goes beyond HACCP.

Also, there are some terminology differences: FDA calls the point person a ‘qualified individual.’ Each scheme has their own term for this person. Some standards require a team to evaluate – not just one individual.

Will FDA accept a certificate from one of the GFSI schemes instead of an inspection?

Dr. Acheson: This is a million dollar question and often asked. I feel if it is a full course inspection (based on a compliant, an RFR etc.), then no. FDA will want to do the inspection in order to do their regulatory job, as they are supposed to. Remember, there’s a lot of alignment between GFSI and FSMA, though it’s not a 100 percent. So will they accept a certificate in lieu of an inspection? Right now, no. but there will be a point, where FDA will take a certificate as recognition that a company is certified to a GFSI standard – and factor this in to a certain level, for instance, to determine who will get inspected this week versus next month. As the schemes evolve, and as GFSI becomes more aligned with FDA, keeping in mind that GFSI is intended to be more global than U.S. focused, if a company is certified against a GFSI standard, I think it’s likely that FDA will take it seriously.

McEntire: If a company is certified to a GFSI scheme, and is willing to share information of that certification process with FDA, it will go a long way in establishing credibility of the food safety and quality program. Of course, you need to keep in mind that the certificate is limited to that audit, which at best, is a snap shot of the company’s food safety management program a given time. Also, note that GFSI audits are currently announced, versus FDA inspections which are unannounced, where an inspector show s up at your door.

Broadly, if you are certified to a GFSI standard, you are in a good place to comply with FSMA rules, and in better shape than other companies who are not certified. But you need to read the rules, understand the rules, and see what additional things you need to do to be compliant.

Hear more about FSMA and GFSI – Alignment and Gaps, and what you need to do by clicking here.Next FSMA Fridays, on October 31, will cover Foreign Supplier Verification, Produce, Human and Animal Rules – 2nd Review Cycle – Part 2.

Gary Nowacki, CEO, TraceGains, Inc.

How Can You Improve Your Supplier Qualification and Management?

By Food Safety Tech Staff
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Gary Nowacki, CEO, TraceGains, Inc.

Proposed rules under Food Safety Modernization Act are putting new demands on food and beverage companies for prevention-based risk controls. FSMA specifically addresses issues related to this for both foreign and domestic suppliers. This is going to mean either allocating more people and more time or coming up with modern ways to address these increasing and emerging demands.

Gary Nowacki, CEO at TraceGains, Inc. will address the topic of Supplier Qualification and Management at Food Safety Tech’s Food Safety Consortium to be held next month in Chicago. He will speak about how companies are struggling with managing up-stream supplier and ingredient risk and how they can both save time and be more in control of these challenges by using powerful tools and techniques.

Nowacki says that often companies have partial information on necessary documents: “Previously, companies might have felt ok about having at least certain data on their suppliers. That’s not enough under FSMA and the increasing demands of GFSI schemes, audits, and auditors.” By automating tasks that free up valuable human resources to focus on more complex issues, says Nowacki.

Giving an example, he says think about automatically sending out notices to suppliers who are non-compliant on certain information or documents so that a valuable resource doesn’t have to waste time calling or emailing the suppliers.

The role of desk audits

Another way to strengthen supplier relationships is by doing desk audits, the topic that Chris Petrlik-Siegel, Supplier Quality Manager at TIC Gums, will address at the Food Safety Consortium.

In a desk audit, the auditor checks to see if a supplier’s system as documented meets the requirements of the GFSI code under which they are certified. It also confirms if the concerned person has validated and verified the Food Safety Plans and Food Quality Plans. The Desk Audit can be conducted as an off-site or on-site activity and issues found during the Desk Audit will be documented as non-conformities. Depending on the number and type of non-conformities documented, the audit will move to the next phase – the Facility Audit – or not move forward until and critical and major non-conformities identified are properly corrected and corrective action is verified.

“Desk audits are a great way to check how ready you are to be audited. These take a lot less time than an on-site audit, and really help in preparing for the actual audit. Desk audits are more to establish or strengthen the partnership with the supplier rather than to work on an audit for the purpose of complying with regulations,” says Petrlik-Siegel.

She explains that many times, a food company visits a supplier to do an audit, and realizes that it’s a waste of time due to lack of preparedness of the supplier. “Now due to new rules being proposed under FSMA, as an end product supplier, we are responsible for the ingredients in the products, and all the products we are importing from foreign suppliers. So we rely on in-depth audits to ensure that our suppliers have robust systems and procedures in place, in addition to what we follow in-house,” describes Petrlik-Siegel.

So with 70 suppliers, each on an average supplying about 10 ingredients, the Quality Manager stresses on the importance of desk audits preparing you for the final site audits, and also for better compliance with FSMA rules. It’s often overwhelming to do a thorough audit in a matter of one or two days, so it helps to look at documentation and identify any gaps ahead of time, Petrlik-Siegel adds.

Listen to Nowacki and Petrlik-Siegel speak about Supplier Qualification and Management at the Food Safety Consortium. Click here for more information and to register.

John Kukoly of BRC Global Standards

Where BRC is Going, and How Can You Get There?

By Sangita Viswanathan
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John Kukoly of BRC Global Standards

Food Safety Tech (FST): We’re very excited to have you participate in the SafetyChain/ FoodSafetyTech’s GFSI Leadership Webcast Series with the October 24 BRC – The Road Ahead webcast. We know that you’ll first be addressing what is new with BRC today. What are some of the things you’ll be talking about in terms of current changes?

Kukoly: We are just on the cusp of releasing Issue 7 for BRC. This is scheduled to be released in January 2015. With this, there will be some changes made to how food companies and facilities can obtain the BRC standard. We have a really unique system, termed BRC Participate, that we propose to unveil during this time, which I will talk about more during the webinar.

FST: We know that audits will be a topic of many questions. Is BRC planning changes to the way it does audits? What are some of audit-related topics you’ll be addressing in the webinar?

Kukoly: One of the changes I will be talking about is the auditor-competency program. Other topics will include expansion of our unannounced audit program. BRC is currently the leader in this area, and Wal-Mart has specifically asked us about this. We have done such audits in over 600 sites already, and are currently the go-to people for unannounced audits now. We are also forming BRC Global Markets, which will help small and less developed companies to get ready for certification.

FST: You will also be talking about the direction of BRC in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to BRC?

Kukoly: In my opinion, the two most critical areas of focus for the food industry right now are risk management and supplier management. These are the two main key elements being covered in all new regulations under development, and if a food facility has these covered, then they are in a good place. These are the two specific drivers that are shaping future changes to the BRC standard.

FST: While we all know that while change is important, it’s not always easy to get already-burdened food safety organizations to embrace change. What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of BRC certification?

Kukoly: I don’t think ‘why’ should be the right question. We should focus on ‘HOW’ to go about this. And I think we need to talk about food safety culture and change management. These are the areas that are key to success and embracing change.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s BRC. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Kukoly: One of the topics I will be addressing is training, not necessarily for BRC, but for obtaining the right skill sets such as risk assessment or HACCP. These are necessary for any food manufacturing organization to prepare for tomorrow’s BRC, and to have robust systems and processes in place.

FST: It has been said that GFSI certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance and alignment with BRC?

Kukoly: If you look at FSMA expectations, they are very well aligned with requirements of BRC standards, whether it be supplier management and verification requirements, or risk assessment etc. Beyond that, it is about strength of traceability procedures, knowledge of FSMA within the facility and its qualified individual. The focus is primarily on robust supplier management programs and implementation. If all these are in place, then you are in a very good starting place for FSMA compliance.

Listen to John Kukoly talk more on these topics and take your questions live in the BRC – The Road Ahead webinar on Friday, October 24, 2014 at 10:00 PT/ 1:00 ET. Click here to register. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.