Tag Archives: FSMA

Chelle Hartzer, Orkin
Bug Bytes

Don’t Let Pests Wreck Your Supply Chain

By Chelle Hartzer
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Chelle Hartzer, Orkin

In today’s global marketplace, it has become necessary for facility managers to implement more detailed inspection and documentation policies for incoming shipments as part of the larger food safety plan. But plan as you might, pests are adept at infiltrating food products and contaminating shipments. Their resilience and persistence will make you pay, literally, if you’re not paying close attention.

Pest management is a key component of any facility manager’s food safety plan, but understanding how best to prevent pests from compromising shipments—and by extension the supply chain—takes diligence. An integrated pest management (IPM) program is the best way to ensure that insects and rodents are kept away from processing, packaging and storing food products. Again, this information shouldn’t be anything new if you’re a food processing facility manager, but it’s important to note that IPM focuses on proactive prevention of pests, to align with FSMA’s Hazard Analysis and Risk-Based Preventive Control (HARPC) regulations. These newer regulations shift the focus from reacting to potential contamination concerns to preventing as many issues as possible. Being proactive is a must.

Aside from the legal backlash a facility could face if found if violating these rules, pest issues can also have a major negative impact on a business’ bottom line. Imagine the cost of even one of your outgoing shipments being contaminated by cockroaches or stored product pests. Now, imagine the impact on your business from consumer backlash if the pest-ridden shipment travels further down the line. Simply put, it’s never good if the pest problems are traced back to your facility.

So, what’s the best way to protect your supply chain from potential pest issues and remain compliant under FSMA and HARPC?

All food safety plans should have considerations in place based on a review from a Preventive Controls Qualified Individual (PCQI). This individual is responsible for preparing the document, with the input of as many departments and people as possible, such as QA/QC, maintenance, production teams, and more. Since pests are a common potential hazard, a pest management program should be included in the plan.

That being said, it’s important to inspect all incoming shipments. Even if suppliers have implemented measures to help keep pests away from their sites and products, pests are tough to entirely prevent and it’s always a possibility some have slipped through the cracks (literally!). Pests are attracted by food, water and shelter, so a truck transporting products to your facility is going to be chock-full of attractants! Carefully inspecting incoming shipments will not only help ensure pests don’t enter your facility, but it will help you and your supply chain partners target exactly where problems may be occurring. Forming good relationships with your suppliers, and keeping communication open can help to manage any issues that may pop up.

The faster pest issues are detected, the better. It’s easier to address a pest problem and more accurately pinpoint where it originated if it can be caught early. Otherwise, pests can reproduce quickly and spread, making it harder to pin down the source of an infestation and to treat it. It’s tough to overstate the importance of open lines of communicated between supply chain partners!

To avoid allowing pests into your facility or sending them to a supply chain partner, implement the following processes:

  • Inspect shipments for pest activity, especially incoming shipments. Some common signs include live or dead insects, droppings and damage to the product and packaging.
  • Ensure packaged products are properly sealed and undamaged before transport, and then check the transportation vehicle before loading product for shipping.
  • If there is a pest sighting, remove any compromised product to avoid allowing pests to spread to other goods or find a way into the facility. If it can’t be removed from the facility, isolate it in a contained area and call your pest management provider immediately.
  • Empower employees to call out pest issues as well by implementing a “see something, say something” policy. Don’t forget to have a pest sighting log, and let the employees know where it is and what to record.
  • Use monitoring devices to detect pest activity levels. Devices like insect light traps, pheromone monitors, and glue boards can be easily placed in shipping and receiving areas as an early warning sign of pest activity.

With an untrained eye, pest issues can be difficult to notice. Ask your pest control professional about a free training session for employees. Most pest management companies offer this service free of charge, and it can be a big help. There’s no reason you shouldn’t take advantage.

The pest pressure a facility faces is dependent on a variety of factors including location, geography and the type of product being produced and stored. No two facilities are the same, which is why every pest management program should be customized to meet the needs of the business.

As a start, the following pests are the most common to find in the food processing industry.

  • Rodents: Rats and mice can carry disease-causing pathogens that can be deposited onto other surfaces by simply making contact with equipment or products. Both are capable of fitting through tiny gaps (mice can fit through a hole the size of a dime, while rats can fit through a hole the size of a quarter), meaning any openings on the exterior of a building serve as a welcome mat to a curious rodent. To spot the signs of rodent activity, look for droppings and yellowish-brown grease marks around corners and along baseboards, as these marks can be caused as a rodent rubs against these areas. In addition, look for gnaw marks around any gaps or openings in walls and on products.
  • Cockroaches: Able to squeeze their bodies through miniscule gaps, cockroaches will feed on just about anything. With a good food source, they can reproduce quickly. A couple cockroaches can become an infestation in a matter of months, especially with an abundant food supply. Cockroaches are most active at night, so if you see one during the day it’s a good sign that it’s time to act quickly!
  • Flies: While less likely to find their way into packaged products, flies can spread dangerous, potentially disease-spreading pathogens on everything they touch. They usually don’t travel too far from their larval food source, but their ability to reproduce quickly can make them a nightmare to get rid of if steps aren’t taken to remove them immediately.
  • Stored Product Pests: There are numerous kinds of stored product pests, but all are adept at thriving in and around products undetected. The Indian meal moth, for example, is a moth with small, cream colored larvae that will eat just about anything. Stored product pests are some of the most likely pests you’ll find on incoming shipments and in storage areas, as they’re right at home breaking into and surviving within product packaging.

Keep these pests on the radar, and make sure to take note of where pests are found and how many are spotted. The more information, the better, as it helps pest management professionals get to the root of pest problems.

Documentation is always a major key. It shows an auditor that careful planning and proactive prevention are points of emphasis, which will be important. Although there are numerous documents to keep on hand, add the following to your list in order to more easily demonstrate compliance with pest related FSMA regulations:

  1. Supply chain program, including suppliers and ingredients.
  2. Receiving procedures, including the pest management program that helps prevent pests from entering the facility on products or through loading areas.
  3. Receiving records, or, in other words, documentation of shipments received from suppliers.
  4. Monitoring records of any captured pests in or around the facility and any corrective actions.
  5. Application records for treatments used in and around the facility.

If suppliers are located in another country, note the requirements differ from facilities located in the United States. The FDA breaks this down on their website, but importing products from another country means a facility must follow the Foreign Supplier Verification Program. This comes with a different set of compliance documents and means the importing facility must monitor foreign suppliers’ food safety plans.

Remember: Preventing pests needs to be a proactive process included in the food safety plan. If you want your supply chain to remain pest free, partner with a pest management company and talk to your supply partners to establish standards for documentation and communication. All will benefit, as you’ll be able to catch problems early and have a better chance of keeping pests from wrecking your supply chain.

Read on for more articles by Chelle Hartzer.

How to Prepare for an Audit at Any Time

Minimize the Risk of Pests by Maximizing Your Staff

 

FDA

ANSI Names First Certification Body Under FDA’s Accredited Third-Party Certification Program

By Food Safety Tech Staff
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FDA

The American National Standards Institute (ANSI) has accredited Perry Johnson Registrars Food Safety, Inc. under FDA’s Accredited Third-Party Certification Program. The firm is the first certification body (CB) to be accredited under the program for the scopes of Produce Safety, Preventive Controls for Human Food, Juice HACCP and Seafood HACCP. Under the voluntary program CBs can conduct food safety audits and issue certifications of foreign food facilities.

Once an accredited CB issues a certification through this program, importers can use it to establish eligibility to participate in the Voluntary Qualified Importer Program.

TraceGains Sponsored Content

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Melody Ge, Kestrel Management
FST Soapbox

Supply Chain Management 101

By Melody Ge
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Melody Ge, Kestrel Management

Supply chain management is becoming more and more relevant to small and entrepreneurial food businesses, particularly related to FSMA requirements that are required to be fully implemented by this September. To meet these requirements, it is important for small businesses to understand:

  • Applicable FSMA requirements
  • How to develop a supplier approval program
  • What challenges companies may encounter and tips to overcome them
  • How to find an appropriate starting point to develop a supply chain management program

Supply Chain Management Program

1. Receiving facility: A facility that is subject to preventive controls and supply-chain program and that manufacturers/processes raw materials or ingredients that it receives from a supplier.
2. Supplier: The establishment that manufacturers/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.Food manufacturers need to develop and implement a supply chain management program, including supply chain preventive control, to control those potential hazards identified that shall be controlled by the suppliers when receiving all raw materials and ingredients. As defined in the actual FDA regulation, a supply management program will only be considered as a preventive control when it is linked to a potential food safety hazard in the raw materials and incoming ingredients. It is the supply-chain-applied control (21 CFR 117.3). As a receiving facility, you have the right to ask your suppliers for all related information associated with the food safety hazards that you identified from your own food safety plan.

What should be in your supply chain management program or supply-chain-applied control?

  1. There needs to be a series of credentials for approval. This can be determined by you, depending on the hazards and product risks. For example, a third-party audit result or a certification from a reliable audit can serve this purpose.A few questions can be considered, including whether suppliers have a recall plan, whether suppliers have an existing food safety plan to control hazards, or whether suppliers have a non-conforming products control plan. Often these can be checked and verified when a third-party audit or third-party accredited audit is conducted. Once a supply chain management program becomes a preventive control, the raw materials can only be supplied by an approved supplier.
  2. Monitoring activities and verifications should be applied to those approved suppliers in your supply chain. This can be done throughout the business history and supplier performance. You need to demonstrate how you continue monitoring the supplier approval status, and suppliers must demonstrate how their products remain guaranteed. Public records (e.g., warning letters), sample testing incoming goods, and customer audits are commonly utilized in the industry. However, in FSMA, when an approved supplier is supplying a high-risk raw material, such as one with SAHCODHA (Serious Adverse Health Consequences or Death to Humans or Animal) risks, an onsite (your own audit or third-party (accredited) audit) is required to be conducted as the verification activity. This must be completed annually unless you can provide a risk-based justification of other types validated verification activities.
  3. Afterwards, as a receiving facility, you need to consider and develop procedures for non-conforming suppliers:
  • How do you require your suppliers maintain their “approval” status in your supply chain management program throughout the business years?
  • When one approved supplier is unapproved or experiencing unexpected incidents, how do you manage back-up suppliers?
  • What criteria do back-up suppliers need to meet prior to supplying the product(s)/ingredient(s)?

Melody Ge will be presenting “What Have We Learned After FSMA Implementation?” at the 2018 Food Safety ConsortiumDifferent products will have different approaches based on facility business operations. However, one thing remains the same. The justification must ensure that potential hazards identified from the original approved supplier are controlled when a back up supplier is used.

4. Last but not least, just like all other programs and controls, records and documentation are important! Records must be kept for all parts of the supply chain management program, including plan, monitoring, verification and any corrective actions that have been conducted. These data are precious to your facility over time, as supplier performance and trending could be a strong reference to see whether adjustment or modifications should be applied to your supply chain management.

There may be challenges collecting information or approving suppliers, but never forget the intention of a supply chain management program—to control the food safety hazards of incoming goods. Your supply chain management program will allow you to demonstrate that you have made all efforts to control the hazards that could potentially arise from your supply chain.

Resource

  1. FDA FSMA Preventive Controls to Human Foods. Retrieved from https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm
Deirdre Schlunegger, Stop Foodborne Illness
Food Safety Culture Club

How We Use the Word ‘Recall’ Matters

By Deirdre Schlunegger
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Deirdre Schlunegger, Stop Foodborne Illness

“Recalls”. This topic got me thinking, what is the literal meaning of recall? So, I looked it up:

Verb

  1. Bring (a fact, event or situation) back into one’s mind, especially so as to recount it to others, remember.
    “I can still vaguely recall being taken to the hospital”
  2. Officially order (someone) to return to a place
    “the Panamanian ambassador was recalled from Peru”

Noun

  1. An act or instance of officially recalling someone or something
    “the recall of the ambassador”
  2. The action or faculty of remembering something learned or experienced.
    “their recall of dreams”

Many people think of FDA when hearing the word “recall”, and many consumers believe that the FDA often or even always orders recalls. In fact, the FDA relies on responsible parties to voluntarily recall food products when a threat exists, but FSMA’s mandatory recall authority allows FDA to mandate a recall only when the criteria under section 423 of the FD&C Act are met.

For most, the word “recall” is all too familiar. We hear it so often that I wonder if we are becoming desensitized to it. Almost daily we hear this item or that item has been recalled due to XXX, allergy, Salmonella, Listeria, foreign matter, and the list goes on. I counted 45 human and three pet food-related recalls just since May 1, 2018—that’s in just 84 days as I write this. So, for consumers (and we are all consumers), how do we hear the word recall and what is our visceral reaction when we hear the word? What actions if any do we take? Does it become too overwhelming? Are we becoming immune from the word? We are required to eat for survival sake and we don’t know if there is a problem with the food we are eating until after it has been recalled. At Stop Foodborne Illness, we send out recall notices every time there is a recall announced, which is typically a few times a week. Recently, a friend asked, “So, do I just quit eating to avoid contamination?”

I wonder if we can start a conversation about the term, how we use it and how to use the word and related action effectively. What does it mean for consumers? Is it only meaningful after the fact? The word and action of the word “prevention” is so much more powerful. Just “food” for thought.

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
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Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

Mike Robach

The Future of Food Safety: A Q&A with Cargill’s Mike Robach

By Mahni Ghorashi
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Mike Robach

Continuing on our journey to bring you the successes, best practices, challenges and accomplishments from the very best in this industry, this month I had the pleasure of interviewing Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill. Mike joined Cargill in January 2004 to lead the company’s corporate food safety and regulatory affairs programs. In this role, he helps partners innovate and manage risk so they can feel empowered to nourish the world

Mike Robach
Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill

Mike has also worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. He serves as chairman of the board of directors of the Global Food Safety Initiative (GFSI) and is a member of the Institute of Food Technologists and the International Association of Food Protection, among many other organizations dedicated to ensuring safe food and bringing innovative technology into the agricultural industry. He has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health and food safety standards.

Mahni Ghorashi: What are the biggest risks to our food safety infrastructure in 2018? What’s keeping you up at night?

Mike Robach: The biggest risks I see have to do with supply chain integrity and how companies implement their systems. Too often we do not have line-of-sight to the origin of the commodities and ingredients that make up our products. With global supply networks it’s important to understand where and from whom you are getting your inputs. There is also a need for food safety capacity building throughout the global food system. Many small and medium companies, along with some large companies, do not have the proper training for their employees to manage a food safety program. We also have an issue with constantly changing regulations that are not uniform from country to country, adding risk to our business.

Ghorashi: What are you most excited about? What’s changing in a good way in the food safety sector?

Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace. Blockchain technology gives us the chance to drive greater transparency throughout the supply chain.

Ghorashi: Let’s talk about regulation. How is the implementation of FSMA going? Do you foresee any challenges with the next phase of implementation?

Check out last month’s Q&A with Frank Yiannas of WalmartRobach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

Ghorashi: If you take a look at the homepage of Food Safety News, all you see is recall after recall. Are transparency and technological advancement bringing more risks to light and are things generally trending towards improvement?

Robach: I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Ghorashi: What is the number one challenge of securing global supply chains for 2018?

Robach: Knowing and understanding the integrated supply chain. Having knowledge and control of the process from origination to consumption would be ideal. We need the implementation of risk-based, harmonized food safety management systems based on the principles of Codex. Assuring the application of these systems along with properly trained employees to implement these programs would be the first step towards a secure, safe global food system.

Ghorashi: How do international trade deals and the stance of the current administration affect the future of food safety policy?

Robach: International trade deals such as the Trans Pacific Partnership and NAFTA can do a lot for the assurance of safe food around the world and within regions. Making sure that food safety provisions are included in these trade deals can drive the implementation of food safety management systems that will ensure safe food for consumers everywhere. These types of deals should allow us to remove technical barriers to trade by basing the requirements on Codex principles and adhering to the WTO SPS agreement.

Ghorashi: What role is blockchain technology playing in food safety? What are the prospects for the future?

Robach: Blockchain has a role to play in driving more transparency across the integrated supply chain. It can allow companies to show consumers where their food comes from. It can also be used to quickly trace back product in the event of a food safety problem. Still, it’s an enabling technology, not a solution.

Ghorashi: What about CRISPR? How is the food industry starting to respond to this technology from both a policy and GMO screening?

Robach: Gene editing holds great promise and many companies are looking at its potential benefits. However, there is always the policy question on whether or not the use of this type of technology should be labeled. I think the food industry has not done enough to promote the use of technology and how food production has improved over the years. We should let consumers know how we apply science to making food safer, more nutritious and more sustainable. At Cargill we have the vision of being the leader in nourishing the world in a safe, responsible and sustainable way.

Ghorashi: What trends are you seeing in food safety processes within food companies? Are they becoming more decentralized? Less? How are they balancing innovation with decades-old food safety practices?

Robach: Through the Global Food Safety Initiative, we have promoted harmonized, risk-based food safety management systems. The GFSI-benchmarked certification programs provide an opportunity for companies to implement consistent food safety programs regardless of where they are in the world. Through the GFSI Global Market Program there’s a tool kit that less sophisticated companies can use as a pathway towards full certification. We are constantly updating the benchmarking requirements to assure they are keeping up with changing science and technology.

2018 Food Safety Supply Chain Conference, Blockchain

Beyond Supply Chain Trends: Blockchain, FSMA, Food Fraud, Audits and More

By Maria Fontanazza
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2018 Food Safety Supply Chain Conference, Blockchain
Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew Seaborn Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA

How well do you know your suppliers? Can you trust your supplier’s suppliers? What kind of technology are you using to assess and ensure your suppliers are in compliance with regulatory requirements? These are common questions food companies must ask themselves on a regular basis. These and more were addressed at the 2018 Food Safety Supply Chain Conference, held last week at USP in Rockville, MD. Stay tuned for coverage of the event in upcoming articles. In the meantime, here are some top insights shared by FDA and others in industry.

“We’ve issued a limited number of warning letters (two), and they were due to really egregious issues. Where there were previously warning letters issued, we’re seeing a lot more ‘regulatory meetings’.” – Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN, on FDA’s enforcement this fiscal year.

Criteria for FSMA auditors also includes the “soft skills”, aka ISO 19011, auditor personal attributes. –Josh Grauso, Senior Manager, Food Safety & Quality System Audits, UL

Fabien Robert, Nestle 2018 Food Safety Supply Chain Conference
Food fraud costs the industry up to $15 billion annually. – Fabien Robert, Ph.D., Director, Nestle Zone America

It’s concerning that so many QA managers (and other pros) today don’t know extent of risk assessment they need to carry out. – Chris Domenico, Safefood360, Territory Manager for North America

“Blockchain is more than a buzzword at the moment.”- Simon Batters, Vice President of Technology Solutions, Lloyd’s Register

2018 Food Safety Supply Chain Conference, Blockchain
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV Business Assurance; Simon Batters,Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Sometimes food safety doesn’t win; sometimes you need the business acumen to show that implementing supply chain efficiencies will create the win. – Gina Kramer, Executive Director, Savour Food Safety International

Bryan Cohn, 2018 Food Safety Supply Chain Conference
Building a robust & smart supply chain = reduce food miles, shrink carbon footprint, and save food waste to increase revenue/acre. – Bryan Cohn, Vice President of Operations, Seal the Seasons

The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group

FSMA

FDA Issues Draft Guidance on Supply Chain Program for PC Animal Food

By Food Safety Tech Staff
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FSMA

Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.

According to an agency news release, the draft guidance will help facilities in the following areas:

  • “Determine whether they need a supply-chain program;
  • Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish frequency of supplier verification activities;
  • Meet documentation and recordkeeping requirements; and
  • Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”

In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.

The FDA is accepting public comments on the draft for the next 180 days.

Audit

First Audit Stakeholders Meeting to Take Place at Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Audit

The Association for Food Safety Auditing Professionals (AFSAP) announces the selection of the Food Safety Supply Chain Conference as the site for the first Audit Stakeholders meeting on June 13 in Rockville, MD. This historic event will bring together FDA, accreditation bodies (ABs), certification bodies (CBs) and other interested parties to outline the requirements for FDA’s Accredited Certification to better understand the AB/CB roles in FSMA’s use of audits to protect the U.S. food supply.

There are two objectives for this meeting: First, the gaps in the current program must be explained so that all understand the challenges ahead. Second, and even more critical, will be to explore solutions such as creating a Voluntary Scheme Owner that will address those gaps.

Patricia Wester, PA Wester Consulting
Patricia Wester, AFSAP founder, will lead the groundbreaking audit panel at the 2018 Food Safety Supply Chain conference.

AFSAP’s founder, Patricia Wester, spearheaded the meeting to address critical questions regarding implementation of FDA’s Third-Party Audit program and provide a platform to discuss potential solutions.

“FDA’s program involves certification of regulatory compliance, which is an entirely new approach for CB’s currently involved in the GFSI system,” says Wester. “As currently structured, the individual CB’s responsibilities will include activities such as audit checklist development and auditor training requirements that will negatively impact audit consistency and dramatically increase audit costs. Another key concern is maintaining the audit documents, because regulations do not change on a regular cycle like GFSI, further adding costs and variability to the program.”

Supported by AFSAP’s food safety partners, NEHA and ANSI, long-time supporters of AFSAP’s efforts to raise awareness of FSMA’s use of audits, the Food Safety Supply Chain event provided the ideal venue to hold the discussion.

About AFSAP

The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.

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FDA

FDA’s Data Dashboard Helps Companies Meet FSMA Supply Chain Requirements

By Food Safety Tech Staff
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FDA

FDA has launched a new section of its Data Dashboard to help food importers, manufacturers and processors meet supply chain requirements put forth by FSMA (specifically FSVP, and the PC rules). The dashboard provides ease in finding compliance and enforcement information related to companies.

Do you trust your suppliers? What about your supplier’s suppliers? | Food Safety Supply Chain Conference | June 12–13, 2018 | Learn more“The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.” – FDA

The agency also made improvements to its supplier evaluation resources page and added it to the dashboard so that companies can simultaneously search several databases. Users can search for information about warning letters, import refusal and import alerts.