Tag Archives: FSMA

Bug Bytes

Tis the Season for Mosquitoes. Take Preventative Action to Protect Your Facility

By Maria Fontanazza
No Comments

With the heat of summer quickly upon us, food processors should take measures to keep their facilities free of pests that can both harm workers and lead to contamination.

Memorial Day is the unofficial start of summer, a time when we can look forward to more relaxing days sitting by the pool, just enjoying life. But the season also welcomes the unwelcome: more bugs and other little critters.  It is during this time of year that food processers should be extra vigilant about inspecting their facilities to ensure that pests do not become a problem.

While small in size, mosquitoes can be big in nuisance. Ron Harrison, Ph.D., director of technical services at Orkin, LLC, offers a few steps that companies should take to prepare for the season to both protect workers from potentially serious disease transmission such as West Nile Virus or chikungunya virus, and keep mosquitoes from contaminating a food processing facility.

1.    Inspection. Conduct a thorough survey of the perimeter or outside of your building. Have your pest control professional or entomologist look for the presence of natural breeding sites and how they can be eliminated. For example, if there is standing water, how can it be drained? Can it be moved as opposed to remain standing? Growth regulators can also be used to inhibit the developing larvae.

2.    Secure your building. Make sure all screens are in place and that your heating and air system is in proper working order. Check the pressure of your building. If you have positive air pressure with a door open, it pushes air out; if you have negative air pressure, it sucks air in, so a mosquito or any type of bug could be sitting on the outside and get sucked inside.

3.    Use residual products. Mosquitos can be blown in from long distances. Using good residual products on vegetation and shrubs on the outside of your building can help reduce the population. In addition, make sure any dense landscaping is pruned to reduce the harboring sites where mosquitoes might live.

Harrison adds that the prevalence of mosquitos tends to be worse based on the location of a facility. This is where making sure your building is tightly sealed, from the cracks to the positive air pressure in entranceways, is important. “The biggest reason we struggle is that the building or processing plant is built in a swampy area, which is a haven for bugs,” he says. Other factors, including the color of the building (light-colored buildings) and the presence of excessive lighting, can attract more insects.
 
Now is the time for food processing facility managers to take action and inspect their facility. “Mosquitos are just now starting. In another two or three weeks, it’s going to get serious,” says Harrison. “Preventative activity means that later on in the season when they are bad, your processing plant won’t have problems because you took proactive steps.”

The Accountability Factor in Food Safety Culture

By Maria Fontanazza
No Comments

To build an organizational culture that embraces true food safety preventive controls, give employees the autonomy to make critical decisions.

Strengthening food safety culture within a company goes beyond the quality function in raising the banner for food safety: Engagement across an organization, from human resources to maintenance to operations are essential. In a recent Q&A with Food Safety Tech, Laura Nelson, vice president of business development and professional services at Alchemy Systems, discusses how companies can train employees working on the plant floor to help them attain a level of empowerment to take an active, preventative role in food safety, as well as how to engage executive leadership in sharing and evaluating metrics.

Food Safety Tech: How does the accountability of employees play into FSMA implementation?

Laura Nelson: FSMA is going to be additive to what [companies] are doing now in some ways. When you look at FSMA, I think about formalized programs for some companies that may not have a full-blown environmental program that is managed as a preventive control. There’s a lot of training [involved], not only in executing the environmental program, but also in how you maintain your environment to prevent those microbial niches. You start to drill back from the actual protocol of environmental monitoring, and what you do when you receive a positive listeria. How can we start educating employees to be able to recognize the niche? [For example,] is it a cramped pushcart, or damage to [something] holding product where it can’t be properly cleaned? You start educating employees at the level that they can play a more preventative role [in recognizing] they need to take equipment out of commission or send it to maintenance because it can’t be cleaned. This is when we start to see a real change in the culture of a plant. People move beyond these SOPs and requirements to a much more facilitative and educational role to drive the support of some of the FSMA requirements.

The other thing I see is record keeping: There’s a big criticality in maintaining records. People maintain a lot of data now, and there’s a lot of ancillary information included. We just haven’t had the scrutiny on record keeping. The auditors will look through it and find the information they need, but it will be a different [level of] scrutiny when FDA inspectors start to look at the data out there. I think that provides a big opportunity for industry to look at how they maintain records, what they use, and how to capture it. Again, it rolls down to employees—educating them on what is a proper record.

FST: Is facilitating employee awareness and training a challenge faced by more smaller companies versus larger organizations?

Nelson: I think large and small companies face the same challenge, and that is to elevate the knowledge of their employees (they are the eyes and ears) to help them maintain your food safety programs. It goes beyond an SOP on how to clean a piece of equipment or wash their hands. It’s more of understanding the “whys” behind it so they can be line-of-sight. They’re [on the floor] 24/7; they’re the ones who see equipment getting damaged, or drips and leaks. For them to understand and recognize what kind of risk that introduces into a plant [enables them] to raise their hand to prompt some corrective action.

There are food companies out there that are looking to achieve that level of autonomy of giving employees the ability to stop a line because there’s a food safety issue. These are hourly workers that have the autonomy to do that. That’s a huge thing. If you’re able to do that, you’ve far surpassed the basic compliance of any kind of training or education. You’re really looking at an organizational culture that has embraced true food safety preventative controls program.

FST: Food Safety Culture makes the connection between employee behavior and accountability, and establishing metrics. What are your thoughts on Food Safety Culture moving forward?

Nelson: It’s very hard to monitor behaviors. It’s easier to do classroom training and check that box. [It’s the] “how-to”: How do you do that? How do you mature your food safety culture to a point where you get to that autonomy point? We know that you need to go beyond letting employees read SOPs and sign-in [sheets], and say they understand it and move on. You have to move beyond classroom training where you’re giving employees what they need to know and telling them the requirements. You have to connect those behaviors, and then monitor and observe those behaviors, and validate that you’re executing on them. Then it’s applied onto the plant floor.

Embrace the culture of helping each other. Once you’ve achieved this: if your employees are executing when you’re not looking, that’s culture. It’s integrated and something that people embrace.

We did some research on the topic and developed an iPad coaching tool that allows people to systematically gather the data, to capture and automate it. We found that supervisors appreciated it because they had something that was clear and gives them dialogue on what to say in the event that something was missed.

FST: Where should companies focus when training and educating employees to reach a stage of empowerment?

Nelson: The training needs to be at the [appropriate] education level; it needs to be in the language they that understand. [For example,] companies may be able to do a lot more with pictures to accommodate non-English speaking folks in their plant.

Employees need to be challenged and quizzed to make sure they understand the information. The training itself needs to be tied to metrics:  What are you trying to achieve as a plant and therefore [need] to train people on? This should be tied into factors such as customer complaints, quality issues, and what has a direct impact on what employees are doing or not doing, as this [leads to] much more accountability. That’s where the role of the frontline supervisor is critical. That position is absolutely key to the success of driving food safety program compliance. We have to recognize that our frontline supervisors need the skills to motivate employees and communicate effectively with them, including discussing the challenges in conflict resolution.

Elevating food safety so employees as are aware. Awareness programs have a documented advance to people trying to drive specific requirements. We’ve seen a lot of people develop awareness programs around food safety and provide the focus in the plant on key elements that people struggle with. That way, they’re able to have multiple touch points (posters, digital signage, huddle guides). This is absolutely key as we move forward: not just training, but ongoing awareness.

FST: How can companies further educate management to understand the value of food safety culture and reach a point of alignment?

Nelson: There is and can be a pretty big disconnect between executive leadership and what is going on related to food safety. When you talk about the collaboration of the team and those within the plant, you have to include your executive management team. They should understand the different activities and efforts that go into driving a food safety program in a plant. When talking about metrics and evaluating effectiveness, that data should be shared with the executive team on a routine basis so that everyone is clear on what is happening in the plant as well as the results. If the results aren’t where we want them to be, and we’re not in a continuous improvement mode, then what is it going to take to get there? That dialogue should be had.

If you don’t continue to educate your executive team on what issues you’re seeing, then you start creating a divide within the organization. That’s part of what stems from people struggling with a lack of resources and time; this disproportionate disconnect is between other activities within a plant. Communication needs to be routine; people need to be held accountable for metrics so that you’re actually tracking to them. And if you need [more] resources, it’s the perfect way to start building a case for getting additional sales, technology, programs or procedures.

Food Safety Tech’s Food Safety Culture Series

Embed Food Safety Culture. There’s No On/Off Switch

Food Safety Culture: Measure What You Treasure

Randy Fields, Repositrak
FST Soapbox

The Silver Lining of FSMA Compliance: Leverage the Cloud to Mitigate Risk

By Randy Fields
No Comments
Randy Fields, Repositrak

It may seem counter-intuitive that any government regulation could generate an opportunity for food industry manufacturers, processors and marketers. But that is exactly the case with the Food Safety Modernization Act (FSMA). Manufacturers as well as your suppliers and customers need to invest in and change some business practices to comply with FSMA regulations, and doing so will enable them to bolster other processes and technologies to further cut costs and help mitigate risks not directly associated with food safety.

FSMA requires food manufacturers and your trading partners (both upstream and downstream) to have the documentation for regulatory compliance readily accessible for government inspection, with specific records required for companies that transport food or are deemed to be the procurer of foreign products. When you add these records to the business relationship records that food manufacturers, your suppliers and customers should already be maintaining (such as indemnifications and certificates of insurance that help manage brand risk), the databases start to become very large, very quickly.

The easy part of FSMA compliance for food manufacturers is with your largest customers and suppliers, because they likely have the processes and technologies in place to ensure both companies have the proper documentation. It’s really the group of smaller customers and ingredient providers, which can represent thousands of companies, that may not have the sophistication to supply the data points required under the law. Collecting and managing the information from these firms can be costly and labor intensive.

The good news is that cloud-based technology now exists to help all trading partners in the food supply chain meet FSMA requirements while working to prevent outbreaks and quickly limiting situations when they occur. This technology goes beyond just storing digital copies of documents—it helps to manage compliance with exception-based alerts for expired, missing or inaccurate records. It can also be the basis of an approval process for new vendors that incorporate record compliance. By linking and automating the management of compliance documentation and new vendor approvals, companies save time and allow for redeployment of resources to more productive activities. 

If you are serious about reducing brand risk, linking compliance management data with your purchase order system will swiftly and effectively accomplish that goal. Holding a purchase order for a non-compliant vendor protects the retailer, manufacturers and the consumer, and communicates a commitment to food safety within the entire supply chain. 

So, complying with government regulations such as FSMA doesn’t have to represent a significant one-time investment in technology and ongoing upkeep. Look to cloud-based technology with an eye for streamlining current processes, reducing overhead and supporting new customer or regulatory requirements.  And, being proactive to ensure the safety of your company and your customers will put you in a position to sell more and grow your market share. 

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

By Food Safety Tech Staff
No Comments

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

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

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

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

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

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

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

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

Translating the Talk into Action

By Maria Fontanazza
No Comments
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
No Comments

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
No Comments

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.”

Listen to the entire SafetyChain FSQA Tech Talk


Upcoming SafetyChain Webcasts Friday, April 24

Register to attend the Leadership Forum, “Food Supply Chain Risk Management and Operational Best Practices”

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
No Comments

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
No Comments

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
No Comments

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