Tag Archives: GFSI

Ask the Expert: What do processors need for rapid Salmonella detection methods?

By Food Safety Tech Staff
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Rapid technologies address the trend toward environmental testing versus finished product testing.

During the past decade, incidences of Salmonella have failed to drop, and the pathogen continues to pose a serious problem to the food supply. Meredith Sutzko, Product Manager, Food Pathogens at Romer Labs North America discusses current technology needs for the food industry.

Q: What are processors looking for in Salmonella detection methods?

Sutzko: I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing. Instead of waiting to test finished products at the end of a production cycle, we’re finding that processors are taking a lot of environmental samples from the production line in different areas in order to find contamination further upstream so that when they get to the product testing, they have a lot of confidence that the product is going to be pathogen-free.

Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results. By using test methods on-site, they can immediately take action upon getting the test result.

Q: How is RapidChek® differentiated from other rapid methods currently available?

Sutzko: The RapidChek method is an innovative, simple and easy-to-use test. With this test, we typically focus on the enrichment portion of the rapid method, because if salmonella is present in the environment, it’s going to be present at very low levels. The enrichment portion (or the growth phase), is important to get that pathogen to higher concentrations for detection.

We use innovative bacteriophage technology in our enrichment media. The bacteriophage act as selective agents during enrichment to inhibit the growth of competing microorganisms, which could be present. The phages allow an optimal growth environment for Salmonella, if it’s present, by reducing the growth of these other competitors. It helps to provide a fast time to result. Then we combine the enrichment media with a state-of-the art-lateral flow test, which uses highly purified antibodies that have been optimized for the sensitive and specific detection of Salmonella.

The technology is simple and easy to use. The end user doesn’t need any expensive equipment to run it. The method comes all-inclusive with everything necessary to run it, so there are no additional expenditures on consumables. Producers are able to do a lot more testing using the RapidChek, because it’s so cost effective. If they find contamination or a growth-niche, they can sanitize, take action and do more testing to make sure they’ve gotten rid of the pathogen.

Q: What’s the significance of Salmonella detection right now as it relates to the risk that the pathogen poses to the food supply?

Sutzko: Historically, Salmonella has been associated with meat and poultry. Recently we’ve seen a lot more outbreaks in different types of food products and matrices that historically have not been associated with Salmonella. Also, the food supply is being globalized. We’re receiving a lot of foods from different countries, possibly where their food safety standards are not as stringent as we have in the United States. We’re seeing an increased level of awareness by producers. They look at their suppliers and their raw materials to make sure they’re testing the materials before they put it into their supply chain.

Also with regulations like FSMA, we see retailers driving food safety and quality systems through third-party certification bodies such as GFSI. Retailers are requiring their suppliers to have effective food safety quality management systems in place in order to do business.  These practices will help to ensure safe food is being supplied to the consumer from farm-to-fork.   

Animal Feed Industry: Steps to Success to Meet FSMA Requirements

By Maria Fontanazza
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As industry awaits next month’s final rule on preventive controls for animal food, companies in the animal feed business must be prepared for the changes, especially as it relates to having an aligned system with HACCP principles. In a Q&A with Food Safety Tech, Victor Muliyil, food technical project manager at SGS SSC North America, and Mary Williams, a quality assurance and regulatory affairs expert at Land O’Lakes, Inc, discuss where companies should be looking for gaps in their systems.

Food Safety Tech: What critical changes does FSMA introduce to the animal feed industry?

Victor Muliyil: FSMA introduces the primary change that all feed manufacturers must have a feed safety hazard control program that is in line with HACCP principles. Hazards likely to occur must be identified and controls implemented; and [although] hazards related to medications and prohibited material must still be controlled, the responsibility is on the manufacturer to identify all hazards and controls. The focus is on prerequisite programs, not just on critical control points.

In addition, feed industry recalls can now be mandated by FDA, not just recommended. HACCP certification is not mandated by FDA, but several feed and food industry customers are looking for competent independent audit and certification of feed safety control programs. Trained internal auditors are required to verify the system. Traceability is required to the next level of distribution, as well as backward to key ingredients such as medications.

Mary Williams: Food industry leaders must now show they have “planned to work safely,” and this plan must be written down with documented evidence of training. This is a fundamental shift in approach, as FSMA indicates that all feed manufacturers must control feed safety hazards consistent with principles many of us have learned in HACCP. This speaks to prevention vs. reaction, so the prerequisite programs as a foundation must be in place first. This is a time of unprecedented change in the U.S. Food/Feed industry plus global supply chains that are expanding. While it is widely accepted that zero risk is unattainable, the approach that companies take to prevent having an issue, and to prepare for efficient and effective response in the event of a problem is seen as critical.

Product Safety Culture must be leadership driven and reinforced and furthermore, a strong product safety culture is a “choice”.  Leaders of an organization set the tone and must proactively reinforce the expected outcome because it’s the right thing to do, not just because it is the newest food safety law.

While many feed companies are moving toward HACCP certification, it is not mandated by the FDA.  Regardless of whether you build a HACCP plan or a Food Safety Plan, it is important for feed/food companies to start now. The cGMPs, new GMPs and most FSMA requirements are generally understood thus having more time to live and practice the programs implemented allows time for adjustments.

FST: Regarding GFSI certification, in what areas are companies in the animal feed industry the most under-prepared?

Muliyil:  Management commitment, understanding and communication are key. Better training is needed to understand feed industry specific hazards and realistic controls. Currently, internal auditing is not very thorough and must be more structured. Corrective actions are not followed through to gauge effectiveness and are often not documented in adequate detail. Finally, validation is not well understood, nor is there specific guidance on this topic.

Williams: Management does not always clearly understand the need and requirements of “Management Commitment”.  It requires active and visible participation at all levels of management. Managers must “walk the walk” and “talk the talk”.  It may also require an investment in resources such as staffing, capital improvements, and training, to name a few. Management commitment is essential to support the development of a strong product safety culture. Failures in product safety culture increase the potential risk of outbreaks and deaths from foodborne illness.

The skills needed in the industry to meet these new expectations are different than what we needed before. It is not enough to just adopt new standards.  We have to train and educate those who implement them.

We need to train for behavior – what do we want the trainee to be able to do? The training needs to be clear and practical. In addition, we need to educate for increased knowledge across the employee base.  Don’t just send the managers and supervisors to HACCP class or auditor training, make sure we educate a multi-disciplined team including production employees.

Continuous improvement is an everyday concept and involves having a strong corrective action/preventive action program. Often deficiencies are corrected quickly, but not prevented over the long term, and this requires increased due diligence.

FST: Are companies with FSSC 22000 certification more prepared for the preventive controls rule?

Muliyil: FSSC 22000 is one of the GFSI benchmarked schemes that offer effective integrated food safety management, covering:

  • Specific controls and scheme criteria for animal feed and pet food
  • Global buy-in and adoption by many of the world’s leading feed and food manufacturing companies
  • A top-down focus, including defined roles for management, requirements for policies and regular management review
  • Prerequisite programs focused on hazard control, in line with HARPC and FSMA
  • The HACCP system approach to structured food safety control, focused on medications & prohibited material control
  • Traceability from suppliers through to customers
  • Communication:External: Consumers, customers, service providers, suppliers, associations and regulators.
    • Internal: Within a company and between all elements of the system
    • Internal audit of the entire food safety management system and follow up
  • Regular system updating to maintain rigor

Williams: A company certified in FSSC 22000 or one of the other GFSI benchmarked standards has implemented Codex HACCP and hygiene principles in their foundation programs. These same HACCP and foundation programs overlap with the requirements in the preventive controls rule and will support compliance to FSMA.  It will be important to review all the FSMA requirements to ensure all elements are effectively covered in the current company program.

FSSC 22000 requires annual recertification and an annual self-audit. These two elements of review ensure that internal and external eyes are always looking for program compliance before a failure occurs.  These are solid “prevention” elements that support FSMA compliance as well.

FSMA Final Rules Almost Here, Guide to GFSI

By Food Safety Tech Staff
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With a host of mandatory requirements under FSMA means, businesses may want to consider GFSI certification.

The first FSMA deadlines are now two months away, and manufacturers may wonder how and where GFSI certification ties into increased regulation. First, what are some of the main differences between GFSI and FSMA? GFSI is seen as more global, while FSMA is more US-focused. Of course, the final FSMA rules will require mandatory compliance, and GFSI is voluntary. However, GFSI certification is recognized among major domestic and international retailers, so compliance with a GFSI-recognized scheme is an important part of a company’s food safety program.

The Food Safety Consortium Conference features a GFSI Services & Compliance track. With increased regulatory demands under FSMA, speakers will discuss the role of food safety certification systems. A GFSI-certified facility is one step closer to compliance with FSMA and may be held in higher regard by FDA from an auditing and inspection standpoint versus a business that has not opted to obtain certification.

Obtaining GFSI certification provides several benefits to the food industry, according to a recent TraceGains blog about the GFSI journey, including:

  • Reducing duplication of audits
  • Creating a comparable audit approach and outcomes
  • Enabling continuous improvement and customer opportunity for GFSI-benchmarked companies
  • Enhancing trade opportunities
  • Gaining cost efficiencies throughout the supply chain
  • Increasing competitiveness in the global market

Several food safety management schemes are recognized by GFSI. Among them is FSSC 22000, which touts the certification of more than 10,000 businesses worldwide. This year’s Food Safety Consortium also includes the first FSSC 22000 North American Harmonization Day on Tuesday, November 18. The meeting will provide a technical update of FSSC 22000, along with current scheme and future plans for expanding scopes and preparing for GFSI benchmarking.

Unleashing the power of the cloud on Food Safety and Food Quality

By Food Safety Tech Staff
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SafetyChain’s FSQA Tech Talk conversation continues next week with a discussion on why cloud and mobile technologies are becoming a game changer for food safety and quality assurance (FSQA).

As part of an ongoing series that focuses on how technology is being leveraged to solve FSQA execution challenges, the next FSQA Tech Talk session’s special guest speaker will be Michele Eddy, Corporate QA Manager with UniSea.  Eddy will be sharing her experience and insight as to how realtime FSQA data, which is  available, anywhere, and at anytime, is helping to provide sales with immediate quality gradings, better manage HACCP, CAPA, and direct observations for UniSea’s pillars of sanitation,  and how the cloud is making it easier for participants in their supply chain to work together.  Eddy will also discuss use and employee adoption of mobile devices.

The session will start with SafetyChain’s Director of Technical Solutions who will discuss key benefits of the cloud on FSQA, including the ability to have realtime data proactively pushed out and acted upon,  as well as how cloud and mobile devices support FSQA transparency and visibility across the value chain. Also discussed will be common cloud misperceptions including security and employee adoption.

The speakers will be taking questions live from the audience, and FSQA attendees are encouraged to bring their IT folks to participate. Attendees who would like to see what the cloud and mobile FSQA apps look like in action, are invited to stay online after the Tech Talk for a 15 minute demo of SafetyChain’s cloud and mobile solutions. The session is being held on Tuesday, May 19 at 10:00 am PDT, and those interested in attending can visit here for more information and to register.

The FSQA Tech Talks are a part of SafetyChain’s 2015 FSQA Technology Series: “Enabling Technologies – The Food Safety & Quality Assurance Game Changer” – which includes Leadership Forums, FSQA Tech Talks and Executive Briefs. Jill Bender, SafetyChain Vice President of Marketing Communications, said, “SafetyChain has been very proactive these past several years in educating industry on key FSQA challenges such as FSMA, GFSI, cost of quality and more. Input from the thousands of people who have attended our webinar forums was that they’d also like to learn more about how their peer companies are leveraging technology to execute on these challenges – and so the 2015 FSQA Technology Series was born!” “So far more than 1,500 hundred FSQA and food company IT folks have participated in the series, and we’re very excited to continue with fabulous speakers such as Michele Eddy,” Bender continued.

To learn more about SafetyChain’s FSQA Technology series visit www.safetychain.com/2015techseries.

Upcoming FSQA Tech Talks Include:
June 23: Harnessing Cost of Quality
July 21: Conquering HACCP, HARPC and Food Safety Plan Management
Participants of this series need only sign-up once and will automatically receive notice of the next topic and login/call information.  Register here for this complimentary series.

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.