Tag Archives: FSMA

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Translating the Talk into Action

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

With a little less than two months under my belt as an editor in the food safety industry, I have already started to become a bad dinner date and my hands beg for mercy as a result of my newfound obsession with soap and water.

Quirks aside, I am seeing some common threads in this industry, although they are themes we see in any highly regulated industry. Partnerships. Collaboration. Transparency. Alignment. Accountability. Now more than ever, these words mean something. FSMA has forced the issue of food safety to the forefront. Yet, we’ve barely begun and I’m already hearing the phrase “FSMA Fatigue”.

For the folks who have been involved in preparing for FSMA from the start, they probably are a bit fatigued. There have been many meetings, and there’s been a lot of talking surrounding what’s going to happen, what needs to be done, and what challenges we’ll face (in many cases, together). But let’s not forget that not everyone is as well versed on the nuances of the regulation. I admit, I am raising my hand here… for now.

Now let’s back up a couple of sentences. “There’s been a lot of talk…” Yes, there has been. While these are enthusiastic discussions about what we as regulators, food processors, retailers, suppliers, scientists and everyone in between should be anticipating with FSMA rules and the consequent implementation, HOW are we going to navigate this new frontier?

Let’s start this conversation now.

You’ll see a lot of changes to Food Safety Tech this year. We’ve already started the information exchange with industry stakeholders about how we’re going to work together to get through FSMA implementation and the tools we need to arm our audience with to help them along this journey. We also just announced our Call for Abstracts for the Food Safety Consortium Conference in November.  The Consortium will bring together leaders and regulators in this industry and facilitate a forum for that candid “how” discussion. Food Safety Culture will receive strong attention, and key players will be presenting a case history of how to apply metrics to food safety culture within organizations.

I’m excited to join this industry, and thank you to those who have already extended a warm welcome. And for the many who I have yet to meet, please drop me a note as you encounter challenges or have ideas about critical food safety topics. Our job at Food Safety Tech is to provide a platform through which we can enable a constructive dialogue about overcoming challenges, working together effectively, and navigating this journey into the future of food safety.

Maria Fontanazza
Editor-in-Chief

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.

A Supply Chain Or a Growing Spider Web?

By Maria Fontanazza
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The biggest risk faced by the food and beverage industry could be the supply chain itself.

Two proposed FSMA rules, Risk-Based Preventative Controls for Human Food and the Foreign Supplier Verification Program (FSVP), place high expectations on companies surrounding their supplier controls.

During a recent Tech Talk, “Tackling FSMA Compliance”, Melanie Neumann, executive vice president and CFO of The Acheson Group, offered advice on how companies can use technology to execute on the challenges they will face under FSMA.

Game-Changing Challenges

Globalization.  “We as an industry are sourcing more ingredients than ever before—more by volume, more by way of uniqueness, and more by way of more countries,” says Neumann. “We have more companies that are playing in the global supply chain, and arguably, it’s a growing spider web versus a chain.”

Importer of Record. These days, companies have to keep track of more information than ever. “That’s where technology can come into play,” says Neumann. “We have other challenges like trying to understand who really is the importer of record, because there’s some regulatory vagueness with respect to that definition.”  Variations, such as how the Bioterrism Act and the FSVP define importer of record, can also cause confusion. “We need to take a deep dive within our organizations and ask, ‘Am I the importer of record? Do I need to comply with foreign supplier verification?’”

Foreign supplier awareness.  Some companies can’t name all the foreign suppliers present in their supply chain, and this is compounded by the reality that some foreign suppliers doesn’t understand FSMA. “Some foreign suppliers haven’t heard of FSMA, and we have a very short period of time to compliance to get them ready if you still want to source from them,” says Neumann. “Technology can help us track back and keep record of the supply chain.”

Stay on top of risk instead of letting risk catch up with you

Keeping track of mountains of information while controlling risks within a paper-based environment is quickly becoming obsolete and potentially dangerous. Having the electronic documentation will help prove compliance with requirements. “Gone are the days where we can manage all these requirements in a filing cabinet. The technological solutions out there can help you put everything in an electronic format that is searchable and at your fingertips in minutes. By regulation, you’ll need the information within hours,” says Neumann. “These systems are building in mechanisms to auto-alert you, so if something looks like it is becoming out of spec or compliance, it will raise an electronic hand.  It also helps you keep and meet the record keeping compliance requirement from both a foreign and domestic supplier management perspective.”

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FSMA Fridays: Everything You’ve Wanted to Know About FSMA but Were Afraid to Ask

The Struggles of Managing Supplier Documentation

By Food Safety Tech Staff
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Providing customers with updated certificates and audit documents, and migrating to digital platforms are steps suppliers can take to conquer document management.

In its annual Food Safety & Quality Assurance (FSQA) Professional Survey, TraceGains polled professionals in food manufacturing, processing and distribution on the challenges they face at various levels of the supply chain. Rajan Gupta, vice president of Customer Success at TraceGains discusses the importance they place on supplier document management.
 
Food Safety Tech: Companies understand the importance of document management. How do they struggle when collecting and managing supplier documentation?

Rajan Gupta: The greatest challenge to document management is that there is a complicated web of requirements that companies need to maintain for compliance, safety and business growth. For example, companies are required to maintain documentation proving compliance with rules and regulations such as the Food Safety Modernization Act (FSMA), labeling, allergen control programs, Hazard Analysis and Critical Control Points (HACCP), Global Food Safety Initiative (GFSI), as well as FDA and third-party audits, just to name a few. With each entity, rule or regulation, companies are faced with a different set of required documentation that they must maintain and furnish upon request. Obviously, this poses a challenge for companies to not only remain abreast of new rules and regulations, but also know exactly where they stand.
 
FST: How often do manufacturers need to monitor supplier documents to ensure they are up to date?

Gupta: Despite the common misconception that safety and compliance documents should be updated every year, this is not always the case.  Certain documents, such as Kosher certificates and third-party audits, should be updated annually; however, other documents only need to be updated when something changes. To complicate matters, the industry is so far behind that catching up is becoming difficult. Often, suppliers do not proactively send updated documents to their customers, thus forcing them to require new documents each year and further complicating the company’s ability to confidently know where they stand with compliance and safety rules and regulations.

FSQ_InfoGraphic_Final
Credit: 2015 Annual TraceGains FSQA Professional Survey

 
FST: What’s the biggest tip you can offer manufacturers when it comes to ensuring documentation is in place, especially when considering the requirements of an audit?

Gupta: The key to documentation success is actively working with suppliers to minimize the “noise” of unorganized information sharing. Companies should make it a priority to take steps towards digital information sharing, thereby enabling efficiency in an otherwise very inefficient environment.  Such small steps require vision, leadership, and an inclination towards entrepreneurship.

Poll: Food Manufacturers Challenged with Limited Resources, FSMA, Staff Training, and Information Overload

By Food Safety Tech Staff
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In the age of increasingly fewer resources and less time, companies are challenged to effectively train staff and meet ever-changing regulatory requirements, while successfully managing their suppliers and customer expectations.

In its annual Food Safety & Quality Assurance (FSQA) Professional Survey, TraceGains polled professionals in food manufacturing, processing and distribution on their top priorities, challenges and predictions for 2015.  “Quality isn’t suffering, but not having enough resources—which typically means money, leads to non-optimal staffing—does have a negative effect on the workforce,” says Gary Nowacki, CEO of TraceGains. Nowacki tells Food Safety Tech how companies are managing these challenges.

Food Safety Tech: How are companies managing the lack of resources? Is it negatively affecting how they operate from a safety and quality perspective?

Gary Nowacki: People have to work more hours or do more jobs. They often cannot advance in their careers because there is no skill redundancy, and [they] cannot do much of the proactive work they’d rather be performing to help their company excel. This is especially true as the number of audits has increased rather than decreased as has been promised, which command a strong resource commitment from a limited pool.
 
FST: How are firms preparing for the changing regulatory and compliance requirements, especially regarding final FSMA rules?

Nowacki: We’ve seen two approaches prevail: Being extremely proactive now or purposely waiting until the last minute to push off any potential expenses associated with compliance. The lengthy rollout of the Food Safety Modernization Act hasn’t helped spurn companies into action. Considering that food processing and manufacturing is a very low-margin business, it is understandable that many companies wish to have full clarity before committing the required resources. We haven’t found anyone who does not wish to be complying with FSMA—there is great respect for the purpose of the law, and all companies that we have encountered practice food safety first.

Credit: 2015 Annual TraceGains FSQA Professional Survey
Credit: 2015 Annual TraceGains FSQA Professional Survey

 

FST: How is information overload affecting how companies operate? What advice can you offer firms?

Nowacki: Information overload goes hand-in-hand with limited resources. Ever-increasing upstream requirements, be they regulatory or industry driven, command ever-increasing downstream requirements. This, coupled with the fact that most organizations still operate in siloed departments, puts increasing strain on data collection, analysis, and retention requirements. Automation, specifically software-based automation, can help companies accomplish more, but we don’t advocate “with less”.

Further, automation can help break down those department and information silos, as decisions can then be easily made from shared data. One of the things we often sense first is that automation is expected to replace people—that has been very true globally in manufacturing—so there is a great deal of fear or uncertainty involved. Our experience has been that automation helps the limited human resources be more productive and, more importantly, more proactive. Automation helps move people from clerical, error-prone tasks to higher-level and more strategically important tasks, as the overwhelming amounts of data are being handled digitally.

FSMA to Expand Lab Responsibilities, Partnerships Essential

By Maria Fontanazza
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Partnerships between research and regulatory labs should strive to bridge information gaps with the goal of harmonizing standards, integrating lab networks, and expanding surveillance programs.

FSMA will add more responsibility to a laboratory’s plate, stressing the need to maximize research and develop an integrated approach to prioritizing risks. Under its general requirements, research and regulatory labs will be expected to examine performance standards, cooperate with federal partners within HHS and the Department of Homeland Security, and build a domestic capacity that encompasses federal, state and international partners.

Partnerships between research and regulatory labs should strive to bridge information gaps with the goal of harmonizing standards, integrating lab networks, and expanding surveillance programs. During the Food Labs Conference in March, Palmer A. Orlandi, PhD, CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, discussed how partnerships in the era of FSMA are crucial to facilitate innovation. “We’re not necessarily looking for someone to take our responsibilities, but we’re looking for someone to walk with us to do this,” said Orlandi.

For research and regulatory analytical capabilities to move forward, several needs and goals must be addressed:

Needs

•    Burden sharing
•    Expansion of the scope of testing programs (and the methods to support them)
•    Development of sampling strategies
•    Risk-informed prioritization strategy

Goals

•    Capacity building
•    Methods that are rapid, sensitive, specific, easy to use, robust and portable
•    Ability to test at the source
•    Database of information that shows susceptibility for contamination and root cause, while also providing solutions for prevention
•    Targeted and statistically significant surveillance, with the ability for sharing

Examples of capacity-building partnerships include the Food Emergency Response Network (FERN), which is run by FDA and USDA. FERN is comprised of more than 170 state and federal labs, and has gone beyond its roots in emergency capacity, expanding into a food safety network that also participates in large-scale surveillance. The Integrated Food Safety System incorporates a Lab Task Group with seven subcommittees to develop standards in areas that include accreditation, methods, regulatory requirements, reporting, and sampling. International partnerships are currently being forged in Mexico and Canada.

View excerpt from Palmer Orlandi’s presentation about Partnerships & Innovation at the Food Labs Conference

 

What’s Next: Innovation, Technology and the Possibilities

Portable technology: A user-friendly, handheld rapid-screening instrument that requires minimal sample prep and is cost effective. Think Tricorder. Will it be possible to wave an instrument over a head of lettuce and detect bacterial contamination? What about detecting a spectrum of approved or unapproved pesticides or active pharmaceutical ingredients?

“This is where we would like to go,” said Orlandi. “Is it pie in the sky? Absolutely.  But if you don’t ask the big questions, if you only take the incremental steps, you’re only going to get so far.”

Orlandi pointed to X-ray fluorescence, which takes less than two minutes to perform sample analysis and ion mobility spectrometry, which can detect a small range of selected compounds in just 30 seconds, as technologies that have future potential.

FDA has a goal of bringing such innovative technologies to bear through its Broad Agency Announcements, a program that provides funding from $200,000 to $50 million to harness new technologies.

Orlandi also cited the Whole Genome Sequencing (WSGS) Collaborative as the next big technology. The GenomeTrakr is a federal and state network of 24 labs that collect and share genomic data from foodborne pathogens. This enormous data flow provides the ability to sequence and transmit and store data, involving domestic and international partners. One application example includes identifying antimicrobial resistance markers.

As FSMA increases industry requirements, “partnerships are going to spawn our capabilities to harmonize standards that will involve, then leads to mutual reliance,” said Orlandi. “We rely our partners’ data and their processes. This will lead to greater capabilities for surveillance and data sharing. All of these combined will lead to a greater food safety network.”

Related Content: Five Questions with Palmer Orlandi

CAPA and Root Cause Analysis for the Food Industry

By Dr. Bob Strong
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A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.

Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.

Who should perform the RCA?

Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan

CAPA: The process unpacked

A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:

  1. Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
  2. Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
  3. Investigate: Make a plan to research the problem.
  4. Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
  5. The Action Plan: Narrow the list of possible causes.
  6. Implement: Execute the action plan
  7. Review: Verify and assess effectiveness

CAPA benefits

A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.

This article is an excerpt from a white paper prepared by SAI Global Assurance Services, and has been published in Food Safety Tech with permission. Click here to download the white paper in its entirety.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

What to do Now to Migrate from HACCP to HARPC

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

There is much talk about HARPC – Hazard analysis and risk-based preventive controls – and how food companies need to either elevate their existing Hazard Analysis at Critical Control Points (HACCP) program, or formulate a new HARPC-based food safety plan, in order to comply with proposed rules under the U.S. Food Safety Modernization Act in the

In a recent FSMA Fridays discussion, Dr. David Acheson and Melanie Neumann of The Acheson Group elaborated along with SafetyChain Software’s Barbara Levin, how HARPC differs from HACCP and what companies can start doing now to be prepared. We present below some excerpts.

How are HACCP and HARPC different?

The key term is that HARPC is risk –based. While HACCCP is more prescriptive, based on the seven-step process, the risk-based analysis requires moving outside of those seven steps to think of how else can I manage risk. Also, under HARPC, it’s no longer deemed sufficient to have a HACCP plan – you need to have a more exhaustive food safety plan.

How should F&B companies approach migrating HACCP to HARPC plans?

In the proposed FSMA rules, FDA has changed the language of defining how and which products should be monitored from ‘reasonably likely to occur,’ which is HACCP type terminology, to ‘significant.’ FDA is doing this in an attempt to differentiate the required HARPC-based food safety plan from traditional HACCP plans. This requires food companies to look at hazards along the whole supply chain – from when we are receiving food to when we are shipping it out (and not just at control points). For instance, environmental controls in a ready-to-eat foods processing area is covered now, which is beyond the traditional HACCP area. So look at those risks in the processing facility and ask if they are significant risks.

Who is the Qualified Individual and how does this impact the HARPC approach?

This is the million dollar question! FDA hasn’t come out with a clear definition yet – only vaguely referring to this person as ‘qualified by training or experience.’ However, this person has a lot of responsibility on their plate – they are responsible for preparing a robust food safety plan that identifies and controls risks, for putting in place corrective actions and validate these, and for doing a reanalysis of the food safety plan as needed. F&B companies need to ask if they have the right person driving this bus. You do need somebody in your business who is capable and qualified to do this, or FDA allows you to use an outside expert as the Qualified Individual.

What will FDA expect to see with HARPC when they come in to see FSMA being enforced?

Once FSMA is implemented (possibly) by August 2016, FDA inspectors can come into F&B facilities and ask to see food safety plans, and details of the HARPC plans. They would want to understand what the process is, what the hazards are, and how and if you are controlling these, and if you are thinking of these hazards from a risk-based preventive controls strategy.

What are top three things that companies should be doing to comply today?

As described often, HARPC is an evolution of HACCP or HACCP on steroids. The first thing you need to do is understand what you are being asked to do with HARPC. Make sure you get the strategy here. Step two, is to get together a team to do this to figure out where your risks are, if they are significant, and build these into food safety plan. Step 3 is look at your current systems and structure. Do you have these now identified significant risks controlled? Have you determined what the controlling steps are, and put in place these preventive controls? Ask yourself if you are controlling these risks, monitoring them, putting in place corrective actions and validating them?

Final point: we often hear people saying, ‘I am going to wait. We are going sit out and watch how the rules evolve.’ But our advice is Do Not Wait! We have a lot of insight on how the final rules are going to pan out and what the compliance requirements will be. So start working now.

For more on this discussion, click here.

Lessons Learned from the Implementation of Seafood HACCP for FSMA

By Tim Hansen
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While HACCP has been highly successful and truly promoted seafood safety and consumer confidence in these products, there are several useful lessons that may make your transition to FSMA compliance easier.

One of the tenets of FSMA is the requirement for preventive systems (AKA HACCP) for all food groups regulated by FDA. Up to the time of passage of FSMA, FDA wanted preventive systems only for seafood, fruit and vegetable juices and low-acid canned foods.

Since the requirement for preventive controls is about to be extended to all foods regulated by FDA, it may be instructive for affected food firms to consider some of the common problems experienced by the seafood industry during the implementation of HACCP. This regulation has been highly successful and truly promoted seafood safety and consumer confidence in these products. There are several useful lessons that may make your transition to compliance easier.

1. Unnecessary CCPs. Implementation of the Seafood HACCP regulation came with a great deal of uncertainty for the industry. Their response was to include a hazard as a CCP even when it did not meet the FDA “reasonably likely to occur” standard. This resulted in some cases overly complicated HACCP plans. Firms can avoid this problem through rigorous hazard analysis and following agency guidance for the commodity being processed.

2. Mixing sanitation controls with HACCP controls. The Seafood HACCP Regulation requires that certain aspects of sanitation be properly controlled, monitored and documented through records. While it is feasible to include these controls within the HACCP plan it is much simpler keep sanitation controls separate from HACCP controls. A sanitation SOP is highly recommended that show how sanitation is controlled, monitored and recorded.

3. Monitoring need to be available in their original form in an organized fashion. Inadequate or poorly organized monitoring records were a big problem. Ideally, records should not be rewritten unless absolutely necessary. Rewritten records are a red flag to FDA investigators. If records are missing do not falsify information to fill the gaps. This could be the basis for a severe regulatory action. It is much better to perform a verification review and corrective action that is available to the investigator.

4. If a new product is introduced to your processing operation the HACCP plan should be amended immediately. Do not wait until a convenient time as a regulator could show up at any time. Also, do not assume that the hazard analysis and HACCP plan for a similar product will be the same. Either can result in a finding of failure to have a HACCP plan. You should start at the beginning with a proper hazard analysis and develop the plan for that product in accordance with the hazards you identify.

5. Scientific studies used to establish a critical limit for a CCP should be readily available to the investigator. For example, a study to show the necessary heat penetration time-temperature parameters of a cooked product to achieve sufficient bacterial kill or the proper mix of salt, water and exposure time to achieve a proper level of water phase salts in a cold smoked fish products are important information for the investigator to evaluate whether the critical limit of a CCP is adequate to control the hazard.

6. Generic HACCP plans should not be used. In the past some operations adopted a generic HACCP plan to cover their processing without performing a hazard analysis. This often resulted in hazards being missed and a faulty plan. FDA expects that each firm will conduct a hazard analysis. Not doing so could result in a serious charge.

This article originally appeared in EAS-e-News, March 2015 edition. 

 

Getting Ready for FSMA: How a Laboratory Information Management System Can Help

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Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit: www.thermoscientific.com/foodsafetyresources.