Tag Archives: risk

TraQtion dashboard

New Software Warns of Out-of-Compliance Suppliers and Products

By Food Safety Tech Staff
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TraQtion dashboard
TraQtion dashboard
Screenshot of TraQtion dashboard. Click to enlarge (Courtesy of NSF International)

TraQtion has announced new software that is designed to help companies better manage supply chain risks. By scanning, evaluating and interpreting data, the upgraded cloud-based software is able to anticipate potential issues and whether corrective measure must be taken immediately, and alerts clients to suppliers, products and sites that pose a higher risk. Its intelligent compliance engine runs an algorithm in the background to provide visibility to problem areas and prioritizes responses across a company’s locations accordingly. A product inspection module automatically identifies in-spec and out-of-spec products through testing and inspection. A dashboard gives users an overview of the company’s quality and compliance program, and uses a color-coding system to rate suppliers, products and sites.

TraQtion is a wholly owned subsidiary of NSF International.

Risk, food safety

Seven Threats to the Food Supply Chain

By Food Safety Tech Staff
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Risk, food safety

Food businesses face a range of risks, from lack of consumer confidence to supply chain security. As FSMA regulations and issues such as climate change rise to the top of the list of priorities of global governments and regulators, food companies need to secure the reins on their businesses to ensure they can face these seven emerging risks in 2016 and beyond.

SevenEmergingRisks_FoodSupply
Infographic courtesy of EtQ, Inc.

 

FST Soapbox

Risk in Our Supply Chain: Where Do We Start?

By Traci Slowinski
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FSMA has arrived with the launch of the first two preventive control rules – Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food (or cGMP and HARPC, for short). With these new FSMA rules, the food and beverage industry will now be held accountable for being more proactive versus reactive, and will be responsible for identifying and managing risk throughout their supply chain. Of course, this emphasis on risk can also be seen in other sectors of the industry (i.e., GFSI and ISO), and risk has become the focal point for a number of compliance initiatives.

Supply chain challenges in food safety
Supply chain challenges in food safety (Click to enlarge)

These days a number of supply chain challenges are driving risk. Continued global expansion of the industry is resulting in more import and export activities. We are seeing consumer food trends shift toward riskier food/preparation options. Regulatory agencies continue to work on improving their food safety requirements. And the growing population is putting more demands on our current resources. All of these factors equates to great risk within all stages of the supply chain.

Therefore, it will be important that you understand what risk management entails and have the right tools to identify, assess and control the risks that you find throughout your supply chain.

So where do we start looking for risk? Here are a few examples of where your risk assessments should be performed:

External Partners. You need to build strategic relationships with your external partners (suppliers, contract manufacturers/co-packers, service providers, carriers, etc.) across the supply chain. Building trust through good communication and collaboration is essential to ensure that you can rely on your partners to do the right thing for both parties.

RiskAssessmentSupplyChainRaw Materials. Many hazards can be introduced into a facility through raw materials—whether we are talking about raw ingredients, packaging materials, chemicals, or other components used to produce your product. Some hazards to assess include pathogens, allergens, chemical residues, pests and foreign material.

Storage and Handling. When looking at risk during storage and handling, it is important to address several hazards including allergen control, temperature control, foreign material control, proper segregation and product flow.

Processing. A number of areas in processing can introduce hazards and therefore should be included in your risk assessment. These include improper sanitation, cross contamination/contact potential, foreign material contamination, critical control point deviations, pre-requisite program failures and mislabeling.

Shipping and Transport. Lastly, you must safeguard your shipping and transportation procedures in order to account for any potential risk once the product has left your facility. Areas to consider during your risk assessment include temperature control, condition and sanitation of truck and storage units, loading/unloading practices, security/tampering potential, accident/emergency recovery, and traceability.

For more information on risk management within the food and beverage supply chain, register to attend the free webinar “Supply Chain Management: Does What I Eat Put Me at Risk” on October 28, 2015. Speakers will discuss risk throughout the supply chain, focusing on supplier management and some of the new FSMA requirements. They will provide an overview of risk management and some of the tools that can be used to identify and assess risk. In addition, they will discuss how technology can help companies meet FSMA requirements.
Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

Final Preventive Controls Rules – Devil in the Details?

By Dr. David Acheson, Melanie J. Neumann
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Dr. David Acheson is the Founder and CEO of The Acheson Group

As we review the general applications and requirements for the first two final rules of FSMA (Preventive Controls for Human Food and Preventive Controls for Animal Food), we’re not seeing a big departure from the proposed preventive controls. But with nearly 1,600 pages of reading, we may not have found all the changes yet. Areas of note include: For the first time in history, training is now a regulatory requirement; and a new definition for a “preventive controls qualified individual” that is separate and distinct from the “qualified individual” under the proposed rule. With further analysis of the rule to come, we fully anticipate the devil to be in the details.

In this first article on the final rules, we are pulling out the key points, providing a general perspective of the Preventive Controls for Human Food, and main elements and compliance dates for both Preventive Controls rules.

The Human Food Rule

FDA has emphasized that it has built more flexibility into key requirements of the Human Food rule, including giving facilities the flexibility to consider the nature of the preventive control, the facility, and the its food safety system when establishing the appropriate preventive control management strategies (e.g. monitoring, verification, validation, corrective action).  In addition, the definition of farms, which are exempt from these regulations, has significantly changed to reflect modern farming practices.

The agency views the rule as better protecting public health by adopting a modern, preventive, and risk-based approach to food safety regulation for the future in three key ways:

  1. It creates new requirements for facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
  2. It modernizes FDA’s long-standing CGMP regulations, updating, revising, and otherwise clarifying certain CGMP requirements, which were last updated in 1986.
  3. It clarifies the scope of the exemption for “farms” and makes corresponding revisions to regulations for the establishment, maintenance and availability of records.

The rules generally apply to establishments that are required to register with FDA. Key elements of the rule are as follows:

  1. Facilities must implement a food safety system that includes an analysis of hazards and risk-based preventive controls, including a written food safety plan that integrates hazard analysis of known or reasonably foreseeable biological, chemical, and physical hazards; preventive controls for processes, food allergens, and sanitation, supply-chain controls and a recall plan; and oversight and management of preventive controls to include monitoring, corrective actions/corrections, and verification.
  2. The definition of a “farm” is clarified to cover two types of farm operations not subject to the preventive controls rule (however, farms that conduct activities covered by the Produce Safety rule are subject to that rule):
    • Primary Production Farm. An operation under one management in one general, but not necessarily contiguous, location devoted to the growing or harvesting of crops, the raising of animals (including seafood), or both. The final rule expands the definition to include facilities that pack or hold raw agricultural commodities grown on a farm under different ownership, and to those that solely harvest crops from farms.
    • Secondary Activities Farm. The operation is majority owned by the primary production farm but located separately and is devoted to harvesting, packing and/or holding raw agricultural commodities.
  3. A flexible supply-chain program with separate compliance dates. In general, a manufacturing/processing facility must implement a risk-based supply chain program for raw materials/ingredients for which it has identified a hazard requiring a supply-chain applied control – unless it or its customer controls the hazard using preventive controls according to the preventive controls rules.
  4. Updated and clarified Current Good Manufacturing Practices (CGMPs). In addition, some previously nonbinding provisions have become binding rules.
  5. A new “Qualified Individual” aka the “preventive controls qualified Individual.” This is a more highly qualified position/level in the organization with responsibility to perform the hazard analysis and assign preventive controls, defined under the rule as “a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA or is otherwise qualified through job experience to develop and apply a food safety system.” The qualified individual is based on education/training as applied to the individual’s assigned job duties—with the assumption that each individual will be a “qualified individual” for his/her assigned role.
  6. Training is a requirement. Foremost is the training required for the preventive controls qualified individual and qualified individuals. Further training may be required under Proposed §117.135(c)(6)–Other Controls, which proposes that preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of §117.135(a).

The Animal Food Rule

In addition to key elements similar to #1–3 of Human Food (above), this rule:

  1. Establishes CGMPs for animal food production by which facilities that further process a by-product for use as animal food must do so in compliance with CGMPs, but can follow either the human food or animal food CGMPs.
  2. Does not apply to feed mills associated with fully vertically integrated farming operations that generally meet the definition of a farm. However, because FDA expressed concern that this leaves a food safety gap, it plans to publish a proposed rule in the future to require that some feed mill operations implement the CGMPs established by the Preventive Controls for Animal Food rule.

Complacency Kills. What To Do Before a Recall

By Maria Fontanazza
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A control point breakdown can lead to a food safety recall. Here’s what to expect, what to do, and how to move forward. But most importantly, this discussion with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, will focus on prevention and re-evaluating whether your company’s current plans will be effective in the wake of a recall.

Food Safety Tech: What is the role of the crisis management plan as it relates to a company’s food safety program?

Alan Baumfalk: The crisis management plan is an interwoven topic. Some people use crisis management or business continuity interchangeably, but they tend to have a bit of a different focus.

First of all, a crisis management plan usually goes together with a food safety plan, and in some cases, it is part of a food safety plan. We are all familiar with the food safety plan, which includes a HACCP plan (Hazard Analysis and Critical Control Points). HACCP consists of seven principles. We’re all involved in HACCP everyday; it’s related to everything we do. We identify the hazards that might be involved in the food we’re producing; we identify the hazards that might be involved in our daily lives (for example, we choose no to drive in rush hour traffic because of the potential hazards that might be involved).

This all fits into our food safety program where we try to eliminate risk through risk assessment. We establish critical limits of what we will and will not accept, and then we monitor and verify them. We take corrective actions when something we monitor is not within that critical limit. Verification involves verifying that what we’re monitoring is indeed being monitored, and finally, there is record keeping.

The crisis management team wants to prevent a recall, which is a crisis to the business, to the brand, and to the health and welfare to the public. No one wants to have a recall. When putting together this plan, you need to make sure you have a multidisciplinary team. It cannot consist of all sales people, nor can it be solely quality control people. You have to bring in people with certain expertise: Include people that are from legal, media/communications, and the business group.

FST: In preparing for a crisis, where does business continuity planning fit into the picture?

Baumfalk: Crisis management has two additional components—the business continuity plan and the food defense plan. They are not exactly the same, and they are not necessarily interchangeable. The business continuity plan is related to how you are going to continue your business if you have a situation that occurs. It can be a crisis that involves a buyer, an environmental hazard, or a physical hazard, for example.

Sometimes people will consider what is happening in the media right now. What happens if there’s an incidence at the local school and your employees have children there. What are you going to do and how will you respond? How will you continue to do business in a safe way?

When putting together a business continuity plan, you need to ask yourself, how are you going to cope with the business crisis and continue doing business.

  • Designate a senior manager who is in control of handling the organization and making the necessary decisions.
  • Identify a multidisciplinary crisis management team. Each person should have a specific responsibility (i.e., medical, regulatory services, contacting customers, suppliers and internal/external communications). Each team member should be prepared to respond to food safety issues.
  • Develop a contact list that includes legal and various experts in the industry.
  • Train employees.
  • Devise a worst-case scenario and practice, practice, practice. The plan should be tested rigorously and on an annual basis.

When we talk about a mock recall, one of the biggest deficiencies is that people don’t rigorously test it. The number one priority should be to have the plans in place and test them, and identify the weaknesses that you can correct. One of the biggest problems that may eventually cause a recall is complacency. The employees think they got it all covered. It’s important to note that an ounce of prevention is worth a pound of cure.

In Part II of this series, Baumfalk will make the connection between crisis management planning and food defense.

Prepare Your Food Safety Plan for the Preventive Controls Rule

By Maria Fontanazza
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As FDA prepares to issue its next final FSMA rule, Preventive Controls for Human Food, companies should already be laying the groundwork for training staff.

With the August 31 deadline for the Preventive Controls for Human Food rule only months away, careful attention must be paid to training, metrics and collaboration between larger and smaller players to prepare for implementation.

Training surrounds all aspects of a food safety plan, from understanding validation and verification to proper recordkeeping. “Regardless of what happens, training is critical and imperative,” said Donna Garren, Ph.D., American Frozen Food Institute, at the Food Safety Summit last week in Baltimore. “FDA is measuring food safety culture in an operation, and training must be ongoing.”  Garren pointed to the FDA-funded Food Safety Preventive Control Alliance (FSPCA), which was established to develop standardized curriculum and help companies, especially those small and mid-sized, with training programs to meet requirements of the preventive controls regulation. The FSPCA curriculum is fairly broad and includes content that addresses an overview of food safety plans and GMPs, preventive controls related to allergens, sanitation, and suppliers, recall plans and record-keeping procedures. FSPCA has planned its pilot sessions for April, May and June of this year, with a train-the-trainer course planned for the fall.

Formed in January, the FSMA training workgroup has been working to develop training curriculum specifically for regulators on how to evaluate a facility against the preventive controls requirements. According to Priya Rathnam, supervisory consumer safety officer, Division of Enforcement/Office of Compliance at CFSAN/FDA, the agency plans to take a staggered approach to training based on deadlines, beginning with larger companies, as it is not practical to train all safety staff at once.

FDA’s Preventive Controls Phase 2 Workgroup is developing a metrics plan to measure progress (specifically measures that directly tie in with public health outcomes) and track trends, making adjustments as necessary. The agency plans to issue a guidance document to help industry and food and feed safety staff identify significant hazards and implement preventive control strategies. An internal technical assistance network is also planned to assist in consistent implementation in the field.

Start the journey now

While many in the industry may suffer from “FSMA fatigue”, discussing the implications of FSMA day in and day out, a lot of education and outreach still remains. Not everyone within an organization is aware of the intricacies of the regulation. “[We] need to make sure others have the same level of insight that we do,” said Tim Jackson, Ph.D., director of food safety at Nestlé North America.  In addition, the bigger industry players need to work with smaller suppliers and manufacturers that don’t have the resources.

When developing an implementation approach, a company should standardize an internal approach now, rather than wait until the rule comes out in August. This begins with establishing a FSMA team. Jackson advises that this specialized team perform a detailed review of the preventive controls rule requirements and conduct a face-to-face workshop to confirm a rollout strategy and action plan. “We’re looking at our own HACCP plan,” Jackson says of Nestle, adding that they are reviewing validation of control measures and the company’s documentation system, challenging whether it’s “good enough,” and enhancing its early warning system.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA Fridays: Concerns Around High-Risk Food Methodology

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

In February 2014, FDA published a Draft Approach for Designating High-Risk Foods under the Food Safety Modernization Act, with the purpose to identify high-risk foods based on specific parameters for additional recordkeeping requirements to enable rapid, effective tracking in the event of foodborne illness outbreak.

What are the factors by which a food is designated as ‘high-risk?” will FDA do such an analysis for every single food product? And what are concerns about this approach?

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on this topic.

What will the high-risk foods list be used for?

Dr. David Acheson: What FDA wants to do with the high-risk foods list is to mainly leverage this for better product tracking. FDA will also have greater authority to ask for more information and keep more records for these high-risk foods, though the agency hasn’t clearly specified what information yet. Also the frequency of routine inspections for high-risk foods will be greater: once every three years, compared to once in every five years for non-high risk foods. One area which FDA hasn’t elaborated on is importers needing certificates for high-risk foods entering the U.S. Initially, the agency had considered this, but didn’t have a system in place to require this. Now the requirements are proposed in the FSMA rules and third-party audits can support this.

What are factors that will determine if a food is high risk?

Jennifer McIntyre: FDA considered several areas and has finalized a detailed methodology to identify high-risk foods based on the following parameters:

  • Frequency of outbreak and occurrence of illness associated with that food since 1998;
  • Severity of those illnesses;
  • Likelihood of contamination;
  • Growth potential of that food;
  • Is there an opportunity during processing for that product to become contaminated;
  • Consumption of that food product; and
  • Economic impact associated with that food product in case there’s an outbreak or recall.

This approach is based on an evaluation of chemical and microbial hazards combined with foods using criteria that encompass the FSMA-required factors.

How will each food be scored and is there a distinguishing line between high-risk and non-high risk foods?

McEntire: Food will be rated on a 1 to 9 scale, with 1 being low, 3 being medium, and 9 being high. Companies have these three options to choose from. There’s no clear line the agency has proposed to determine what foods are on the list and what aren’t.

Is FDA going to do this analysis for every single food product? Where will they get the data from?

Acheson: There’s no way the agency can do this for every single food product. They are looking at a lot of parameters to consider. What they might do, and they are already doing, is try to bunch food products and commodities together, so there will be buckets of food identified as high-risk and non high-risk. Getting all that data will prove to be a challenge, considering that what’s available is quite thin. Private sector may have data that could help the agency, but then there’s the concern that if you share the data voluntarily, you have a risk of your product being classified as high-risk.

Are there any concerns being expressed in the industry about this approach?

McEntire: There are many concerns that industry is expressing right now, such as, given the limited data, how do you choose which foods to look at? How do you make sure that the analysis of one food can be applied to another food? How can we factor differences in processing and facilities? How will all the data be used? The parameters specify considering outbreaks going back to 1998 – some of this information has changed tremendously, and this will not factor in new regulations under FSMA.

One major concern is how can I get off the list? If you are considered a high-risk food now, but change your methodologies etc., can you get off the list? We need to see another iteration of this proposed rule from FDA to see if this rule can evolve and address some of these concerns.

What are some next steps for high-risk food methodology and what should industry do to prepare?

Acheson: Determining whether a food is high-risk or low risk will depend on the type of data being collected. The agency’s authority to increase demand for data for purposes of better tracking will require more robust data collection on the part of industry. Food companies will need to assess the data sets they are collecting now, and their product tracking system. Consider the IFT report and its recommendations to learn specifically what data should be collected. If a company determines that some of its products are going to be designated as high-risk, then they need to consider what the criteria will be for gaining that import certificate. Is that food being produced according to the standards that FDA is expecting? Pay attention to your foreign suppliers and ensure that they understand the need to be compliant with FSMA rules, and have sound food safety programs in place.

If this rule is a one-way street, where a food can only be moved from low-risk to being designated as ‘high-risk,’ then that would be disappointing and would detract from seeking improvement and rewarding behavior. The rule needs to consider situations when a company puts in specific mitigation steps in place, so can the food then be categorized as low risk?

For more details and to access FSMA Fridays webinars, please click here.

How can Food Safety Management Systems Improve Compliance and Reduce Risk?

By Food Safety Tech Staff
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LeAnn Chuboff, Senior Technical Director, SQFI, talks about using data within the food safety management system to prioritize and address food safety risks within the organization.

Food safety regulations are driving organizations to seek more methods of enhancing visibility into their quality and safety operations to increase compliance and reduce risk. As this need evolves, the tools inherent in the Food Safety Management System are crucial in helping an organization take a proactive approach to preventing food safety risks.  

LeAnn Chuboff, Senior Technical Director, SQFIWhat lessons can you learn by looking at and analyzing your non-conformance reports and how can you use these to better your food safety management programs?

LeAnn Chuboff, Senior Technical Director, SQFI, talked about using data within the food safety management system to prioritize food safety risks within your organization.

Speaking recently on the topic of How can Food Safety Management Systems Improve Compliance and Reduce Risk, Chuboff discussed the example of SQF analyzing a year’s worth of audit reports and non-conformances. Below are some excerpts. 

“We asked ourselves the following questions: What area has the greatest impact to food safety – is this impact overall, major, minor or critical? What is one of the main reasons for recalls? What is the top major or critical non-conformances? And what is the frequently missed element? And we identified allergen management as the top area.”

Chuboff listed the key requirements for an allergen management program:

  • The facility needs to have an allergen management program in place;
  • The program should have cleaning and validation requirements in place;
  • There should be a register of list of allergens maintained;
  • And the allergen management program should be thoroughly addressed in the facility’s food safety plan.

On further analysis, SQF found that 84 percent of the facilities were missing an allergen program; 13 percent of the non-conformances were due to improper storage of the food products; the next issue was that facilities have improper labeling in place – 2 percent of non-conformances were due to labeling issues. And another problem was inadequately addressing rework. 

So what can a supplier do in terms of corrective actions to address these non-conformances: 

  • Conduct validation study for SSOPs (validate it, test it, revalidate it) – if you don’t have in-house expertise, bring them in from outside; 
  • Identify ingredients as allergens at receiving, in process and rework – do a complete reassessment of the labeling program; 
  • Establish label inspection program at receipt and in packaging – work with raw material suppliers to ascertain that the labels are clearly specified, taking into account requirements of both the country that it’s produced in and the country it’s being shipped to; 
  • Include allergens in the facility’s HACCP plan; and  
  • Have a strong internal audit program – this will help you engage your employees, identify problems, and address them successfully. 

What can auditors and scheme owners do? 

  • Support additional research for effective allergen control;  
  • Training and guidance for auditors and suppliers is needed for this sensitive area; and 
  • Work on providing stronger GFSI guidance? 

In summary, Chuboff added that companies need to gather the right data, use the data available to identify areas of opportunity and establish KPIs; conduct a root cause analysis and use the tools available and work with all members on the team to develop a solution; avoid settling on simple solutions and immediate corrections and instead plan to get to the root; establish a preventive action plan for long-term control; and finally, repeat all the above! 

To listen to Leann Chuboff talk more on this topic, click here.