Tag Archives: training

Laboratory Information Management System

How LIMS Facilitates ISO 17025 Certification in Food Testing Labs

By Dr. Christine Paszko
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Laboratory Information Management System

In order to ensure that a food testing laboratory maintains a quality management system that effectively manages all aspects of laboratory operations that affect quality, there are numerous records, reports and data that must be recorded, documented and managed.

Gathering, organizing and controlling all the data that is generated, managed and stored by food testing laboratories can be challenging to say the least. As the ISO Standards and regulatory requirements for food testing laboratories evolve, so does the need for improved quality data management systems. Historical systems that were very efficient and effective 10 years ago, may no longer meet the demanding requirements for ISO 17025 certification. One way to meet the challenge is to turn to automated solutions that eliminate many of the mundane tasks that utilize valuable resources.

There are many reasons for laboratories to seek this certification, including to enhance reputation, gain a competitive advantage, reduce operational costs, and meet regulatory compliance goals. A major advantage for food testing laboratories to obtain ISO 17025 Certification is that is tells prospective clients that the laboratory has a strong commitment to quality, and they hold the certification to prove it. This certification not only boosts a laboratory’s reputation, but it also demonstrates an organization’s commitment to quality, operational efficiency and management practices. Proof of ISO 17025 Certification eliminates the need for independent supplier audits, because the quality, capability and expertise of the laboratory have been verified by external auditors. Many ISO Certified laboratories will only buy products (raw materials, supplies and software) and services from other ISO-certified firms so that they do not need to do additional work in qualifying the vendor or the products.

There are many areas in which a LIMS supports and promotes ISO 17025 compliance. Laboratories are required to manage and maintain SOPs (standard operating procedures) that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, managing all test methods, and managing all documents pertaining to quality. In addition, all contact with clients and their testing instructions should be recorded and kept with the job/project documentation for access by the staff performing the tests/calibrations. With a computerized LIMS, laboratory staff can scan in all paper forms that arrive with the samples (special instructions, chain of custody (CoC), or any other documentation). This can be linked to the work order and is easy assessable by anyone who has  the appropriate permissions. The LIMS provides extensive options for tracking and maintaining all correspondence, the ability to attach electronic files, scanned documents, create locked PDFs of final reports, COAs (Certificate of Analysis), and CoCs.

Sample Handling and Acceptance

Laboratories are required to have a procedure that defines all processes that a sample is subjected to while in the possession of the laboratory. Some of these procedures will relate to sample preservation, holding time requirements, and the type of container in which the sample is collected or stored. Other information that must be tracked includes sample identification and receipt procedures, along with acceptance or rejection criteria at log-in. Sample log-in begins and defines the entire analysis and disposal process, therefore it is important that all sample storage, tracking and shipping receipts as well as sample transmittal forms (CoC) are stored, managed and maintained throughout the sample’s analysis to final disposal. To summarize, the laboratory should have written procedures around the following related to sample preservation:

  • Preservation
  • Sample identification
  • Sample acceptance conditions
  • Holding timesShipping informationStorage
  • Results and Reporting
  • Disposal

The LIMS must allow capture and tracking of data throughout the sample’s active lifetime. In addition, laboratories are also required to document, manage and maintain essential information associated with the analytical analysis, such as incubator and refrigerator temperature charts, and instrument run files/logs. Also important is capturing data from any log books, which would include the unique sample identifier, and the date and time of the analysis, along with if the holding time is 72 hours or less or when time critical steps are included in the analysis, such as sample preparations, extractions, or incubations. Capturing the temperature data can be automated such that the data can be directly imported into the LIMS. If there is an issue with the temperature falling outside of a range, an email can automatically be spawned or a message sent to a cell phone to alert the responsible party. Automation saves time and money, and can prevent many potential problems via the LIMS ability to import and act on real-time data.

If any instrumentation is used in the analysis, the following information must also be recorded in the instrument identification (to ensure that it is in calibration, and all maintenance and calibration records are current), operating conditions/parameters, analysis type, any calculations, and analyst identification. In addition to analyst identification, laboratories must also keep track of analyst training as it relates to their laboratory functions. For example, if an analyst has not been trained on a particular method or if their certification has expired, the LIMS will not allow them to enter any result into the LIMS for the method(s) that they have not been trained/certified to perform. The LIMS can also send automated alerts when the training is about to expire. Figure 1 shows a screen in the LIMS that manages training completed, scheduled, tests scores, and expiration dates of the training, along with the ability to attach any training certificates, exams, or any other relevant documentation. Laboratory managers can also leverage the LIMS to pull reports that compare analyst work quality via an audit report. If they determine that one analyst has a significant amount of samples that require auditing, they can then investigate if there is a possible training issue. Having immediate access to data allows managers to more rapidly identify and mitigate potential problems.

Laboratory Information Management System
LIMS manages a variety of aspects in training, including when it has been completed, scheduled, tests scores, and expiration dates. (Click to enlarge)

Another major area that a LIMS can provide significant benefit is around data integrity. There are four main elements of data integrity:

  1. Documentation in the quality management system that defines the data integrity procedure, which is approved (signed/dated) by senior management.
  2. Data integrity training for the entire laboratory. Ensures that the database is secure and locked and operates under referential integrity.
  3. Detailed, regular monitoring of data integrity. Includes reviewing the audit trail reports and analyzing logs for any suspicious behavior on the system.
  4. Signed data integrity documentation for all laboratory employees indicating that they have read and understand the processes and procedures that have been defined.

The LIMS will enhance the ability to track and manage data integrity training (along with all training). The LIMS will provide a definition of the training, the date, time, and topic (description); instructor(s); timeframe in which the training is relevant, reminders on when it needs to be repeated; along with  certifications, quiz scores, copies of quizzes, and more. With many tasks, the LIMS can provide managers with automated reports that are sent out at regular time intervals, schedule training for specific staff, provide them with automatic notification, schedule data integrity audits, and to facilitate FDA’s CFR 21 part 11 compliance (electronic signatures). The LIMS can also be configured to automatically have reports signed and delivered via fax or email, or to a web server. The LIMS manages permissions and privileges to all staff members that require access to specific data and have the ability to access that data, along with providing a secure document control mechanism.

Laboratories are also required to maintain SOPs that accurately reflect all phases of current laboratory operations such as assessing data integrity test methods, corrective actions and handling customer complaints. Most commercial LIMS provide the ability to link SOPs to the analytical methods such that analysts can pull down the SOP as they are doing the procedure to help ensure that no steps are omitted. Having the SOPs online ensures that everyone is using the same version of the locked SOPs, which are readily available and secure.

Administrative Records, Demonstration of Capability

Laboratories are required to manage and maintain the following information on an analyst working in the laboratory: Personal qualifications and experience and training records (degree certificates, CV’s), along with records of demonstration of capability for each analyst and a list of names (along with initials and signatures) for all staff that hold the responsibility to sign or initial any laboratory record. Most commercial LIMS will easily and securely track and manage all the required personnel records. Individuals responsible for signing off on laboratory records can be configured in the LIMS to not only document the assignment of responsibility but also to enforce it.

Reference Standards and Materials

Because the references and standards that laboratories use in their analytical measurements affect the correctness of the result, laboratories must have a system and procedures to manage and track the calibration of their reference standards. Documentation that calibration standards were calibrated by a body that can prove traceability must be provided. Although most standards are purchased from companies that specialize in the creation of reference standards, there are some standards that laboratories create internally that can also be traced and tracked in the LIMS. Most commercial LIMS will also allow for the creation, receipt, tracking, and management of all supplies in an inventory module, such that they document the reference material identification, lot numbers, expiration date, supplier, and vendor, and link the standard to all tests to which it was linked.

The ISO 17025 Standard identifies the high technical competence and management system requirements that guarantee your test results and calibrations are consistently accurate. The LIMS securely manages and maintains all the data that supports the Quality Management System.

Key advantages of food testing laboratories that have achieved ISO 17025 Certification with a computerized LIMS that securely and accurately stores all the pertinent data and information:

  • Proof of ISO 17025 Certification eliminates the need for supplier audits, because the quality, capability and expertise of the laboratory have been demonstrated by the certification.
  • Knowledge that there has been an evaluation of the staff, methods, instrumentation and equipment, calibration records and reporting to ensure test results are valid.
  • Verification of operational efficiency by external auditors that have validated the quality, capability and expertise of the laboratory.
  • Defines robust quality controls for the selection and authentication of methods, analyzing statistics, controlling and securing data.
  • Clearly defines each employee’s roles, responsibilities and accountability.
  • Confidence that the regulatory and safety requirements are effectively managed and met in a cost efficient-manner.
FDA

FDA Awards $600,000 for FSMA Training Center

By Food Safety Tech Staff
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FDA

Today FDA announced its strategy for training the food industry as part of the successful implementation of FSMA. This included awarding a $600,000 grant to the International Food Protection Training Institute (IFPTI) to establish a National Coordination Center. This center will serve an important function in the training process for the food industry.

“One size won’t fit all when it comes to training,” according to an FDA release. “The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements.” The agency indicated that there will be different options and delivery formats for the training, but wants all hands on deck—domestic and international stakeholders from government, industry and academia—to work with FDA on developing and delivering the training to food suppliers.

The major components of the FSMA Training Strategy include:

  • Crafting the FSMA alliance curricula
    • The alliances include the Produce Safety Alliance, the Food Safety Preventive Controls Alliance and the Sprout Safety Alliance
  • Alternate training options
  • Cooperative agreements, including a five-year agreement with the National Association of State Departments of Agriculture
  • Establishing the National Coordination and Regional Centers to support training delivery
  • Delivering the training
    • The three above alliances are developing a Train-the-Trainer program to provide training via an established process. A range of partners will be involved, including the Association of Food and Drug Officials, the Association of Public Health Laboratories, and the Association of American Feed Control Officials
  • A FSMA collaborative training forum co-chaired by FDA and USDA
Timothy Ahn, LRQA
FST Soapbox

Tackling the “Why” of Food Safety

By Timothy Ahn
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Timothy Ahn, LRQA

Food safety training has traditionally focused on foundational topics such as Hazard Analysis Critical Control Points (HACCP) and Good Manufacturing Practices (GMPs). While these topics are essential in defining and implementing Food Safety Prerequisite Programs, they define the What and How, but not the Why of Food Safety. In order to address the Why of Food Safety, training programs need to address food safety culture, and the role of a food safety management system in establishing that culture.

A session during the 2015 Food Safety Consortium Conference will discuss advancing food safety and harmonization through educating employees. | November 17-20, Schaumburg, IL| REGISTER NOWCreating a food safety culture needs to start at the top. It must be known that food safety is a top priority to upper management. In order for training programs to support a food safety culture, they need to be delivered in a format that enables employees to contribute to the organization’s business strategy and food safety objectives while simultaneously reinforcing employee skills, attitudes and behaviors. Studies have shown that during training, one should consider manufacturing as a whole—not bits and pieces—and that the correct and most effective approach to training should look at collective knowledge requirements rather than any single requirement. A good starting point is to understand how a well-planned management system can help bring focus on a holistic approach that transforms the culture. A company’s ability to adopt a culture of food safety is dependent on its ability to take a holistic approach to manage food safety risk and incorporate all components of a food safety culture.

The second area of focus is having an effective FSMS in place. The International Organization for Standardization (ISO) defines a system as “a set of interrelated or interactive elements” and a management system as “a system to establish policy and objectives and to achieve these objectives.”  In order for the FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the whole organization.  A food management system is most effective when it benchmarked against a proven standard and independently verified. Having an effective FSMS in place provides a vote of confidence in your organization—a statement that your organization takes safety and quality seriously and has made the right moves to help protect your brand reputation and consumers by addressing the complexity of risks, up and down your supply chain, and assuring food safety and sustainability.

By following these pragmatic guidelines your organization can raise the level of food safety around the world by creating more effective food safety solutions not only for today, but also tomorrow.

Laura Nelson, Alchemy, Food Safety Tech

From the Top Down, Gaining Management Support

By Maria Fontanazza
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Laura Nelson, Alchemy, Food Safety Tech

The importance of accountability at the employee level should not be underestimated. Food safety professionals recognize this, and gaining support from management is key. In this video interview from the 2015 IAFP conference, Laura Nelson, vice president of business development at Alchemy, shares her thoughts on how companies should not only train their employees but also track the effectiveness of that training.

 

This year’s Food Safety Consortium Conference (November 17-20, 2015 in Schaumburg, IL) features sessions on employee engagement and involvement in Food Safety Culture. Register now.

Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

Food Safety Testing Must Live Up to Higher Expectations

By Maria Fontanazza
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Sample6 executives, Tim Curran, Jim Godsey and Mike Koeris

From sanitation and processing to testing and analysis to transportation and imports, government requirements of companies in the food industry are changing. Many companies are already prepared for the transformation that FSMA will bring. Within food testing and analysis, expectations will be higher than ever. Companies should be able to more accurately and rapidly identify contamination in order to take immediate action. What are some of the biggest concerns in testing and analysis? What changes can we expect? In a roundtable discussion with Sample6 executives, Michael Koeris, Ph.D., founder and vice president of operations, Tim Curran, CEO, and Jim Godsey, vice president of research & development, share their perspective on the hurdles that industry is facing and how innovative technology plays an important role in the future of food safety.

Key trends:

  • Focus in testing shifts from not just testing and recording data, but also analyzing and communicating results. Having data analysis and reporting skills will be a critical function for the next generation of food safety professionals.
  • Be proactive, not reactive. If you’re finding problems at the finished product level, it’s too late.
  • The need for stronger partnerships between industry and government, especially relating to providing industry with the tools to effectively gather and analyze data in a timely manner.

Food Safety Tech: What are the current industry challenges, especially related to advances in pathogen detection technology?

Tim Curran, CEO of Sample6, pathogen detection
Tim Curran, CEO of Sample6

Tim Curran: When I look at food companies and food safety managers, [their jobs] have become harder to do well, instead of easier. The environment in which they’re working is more challenging, and the pressures are increasing. There’s more regulatory scrutiny, whether we talk about FSMA or the regulatory environment [in general], and there are more testing and inspection [expectations].

Second, the nature of the foods that we need make for the U.S. population (and I think it is a trend around the world): Ready-to-eat products. We’re producing products that are more convenient for families where they won’t necessarily have a cook step down the road. The kinds of foods in demand have a higher risk profile.

Third is the globalization of food supplies. Raw materials are coming in from all different directions, and there is an increasing number of shipping points. That creates more pressure, and from a food safety perspective, that is a bad thing.

“It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there.” -Michael KoerisFinally, there’s social media. There’s a lot of scrutiny from the public. Information around any kind of fear or recall is rapidly disseminated.

These factors add up to higher pressure, a higher bar, and a harder job to accomplish—and the tools and methods available to keep the plant safe and food safe are not keeping pace.

Although I think food plants want to test more at the point of contamination, it’s just not possible. Unless they have a sophisticated lab, most food companies ship out samples because enrichment is required. As a result, they’re getting feedback on the safety of their plant and food in two, three, or four days, depending on where they fall as a priority to that outside lab.

Jim Godsey: With FSMA, testing is decentralizing from the larger lab, which is typically staffed with experienced personnel, to the facility where those personnel don’t exist. Having a test with a workflow that can be easily accommodated by someone with a high school education is absolutely critical for the field.

Michael Koeris, Ph.D., founder and vice president of operations, Sample6, pathogen detection
Michael Koeris, Ph.D., founder and vice president of operations

Michael Koeris: Visibility of data is generally extremely poor, because many people touch individual data points or pockets of data. The hand-off between the different groups is usually shaky, and the timeliness of delivering data to the operators has been a huge issue. This has been an opportunity for us: Our control offering is an operating system for environmental control. It’s an open system, so it accepts both our data and other people’s data, enabling visibility across an entire corporate infrastructure. Plant managers and other [users] of these systems can generate timely reports so they can see what is happening on a daily basis.

FST: In considering professional development, what skills are necessary to ensure that employees will be well equipped to address the issues discussed here?

Godsey: The role of the food safety manager becomes a much more critical and challenging role. To support that, they need better tools; they need to know with a high degree of confidence that their facility has been tested, that the testing was done at the proper times and intervals, and that the data has been analyzed in a timely manner. It’s not just assay/analysis [or] reporting results anymore; it’s the holistic review of those results and translating that [information] into whether or not the plant is safe at that point in time.

Koeris: The persona of the food safety manager is changing. They need to see themselves as the brand protection manager. If you have food safety issues, your brand is at risk. We need to empower the food safety manager at the local level to act, remediate and change processes.

Jim Godsey, vice president of research & development, Sample6, pathogen detection
Jim Godsey, vice president of research & development

There also has to be fundamental change in the industry in how results are viewed. Not all tests are created equal. It is okay to find positives for Listeria or Salmonella in the appropriate zones that are far away from food contact surfaces. It is inconceivable to have a plant that has no actual bacterial organisms living there. This is not a pharmaceutical production facility. Setting the wrong goals at the corporate level of zero positives disincentivizes operators to not look hard enough. You have to actually understand the plant and then make sure that you’re safe with regards to your control plan.

FST: How do you expect the final FSMA rules and implementation process will impact industry?

Koeris: Most of the larger food players are already doing what FSMA mandates or will mandate. The medium and smaller processors will have to adapt and change. They have to implement better standards and more standards, more surveillance, and implement more rigorous processes. The [key] is to help them do this on a tight budget.

FSMA has increased awareness of food safety across the supply chain. It is still focused on the processors, but we know it doesn’t stop there; it doesn’t stop at the distributor or the retailer. Food safety has to be throughout that supply chain.

Having an understanding and awareness of all of the challenges that exist downstream—that will [lead to] the real innovation and increase in foods safety.

Empower Employees to Make Decisions

By Maria Fontanazza
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At this year’s IAFP 2015 conference, there was a lot of buzz surrounding food safety culture and employee behavior. Laura Nelson, vice president of business development at Alchemy, shares her insights on the importance of empowering employees. This is achieved through providing training that gives them the confidence to make immediate decisions on the facility floor.

“We have to own the fact that employees are the key. They are exposed to the product and they’re really the ones touching our food every day,” says Nelson. “And yet, we don’t do a really good job at training and measuring that effectiveness in their execution of the behaviors that we train them on, on the plant floor.”

In the following video, Nelson talks about what industry is doing right in food safety culture, and the areas in which improvement is needed moving forward.

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

Who Will Carry the Food Safety Torch?

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

Each and every business in the food industry is facing a growing and daunting task: not just succession planning but also preparing for what could be an absence of qualified millennials entering the food safety profession.

At this year’s IAFP conference, the concern over professional development in this industry was at the forefront. “If we’re going to fill our shoes, where are the shoes walking?” asked Brian Bedard, executive director of the Grocery Manufacturers Association’s Science and Education Foundation. “How do we get young people excited about this profession? What are the programs we can get involved in to expose young people to this at a very young age?”

The question of how we are going to find passionate people to work in the food safety space, especially regarding the recruitment and training of millennials, is a big one. We need to make sure we are prepared to have the resources that will help build future success in food safety. In order to recruit those resources, we need to create more enthusiasm surrounding the field and make it a profession that people aspire to be a part of when they “grow up”.

“If we’re talking about the future…we need to get to the core of where people are making their life decisions and not waiting,” said Bedard. Yes, we need people with a Masters of Science degree in food science or nutrition, or expertise in microbiology and the like, but we also need people who know how a manufacturing or processing plant operates; we need people with knowledge about sanitary engineering and sanitary design, pointed out Bedard. With the changing landscape that we will experience with FSMA implementation, do you think we are armed with the resources to handle this paradigm shift as we look to the future?

Are we being proactive enough? How is your company working to invigorate the younger generation to become involved in this industry?  

The Accountability Factor in Food Safety Culture

By Maria Fontanazza
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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

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

By Maria Fontanazza
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Experts cited management buy-in, employee satisfaction, and information sharing as the critical factors for success.

Food safety culture is not a program that is implemented at a company. It’s a living organism that’s either strengthened or weakened by the actions taken by an organization. “There’s no on/off switch,” said Lone Jespersen, director, Food Safety and Operations Learning at Maple Leaf Foods, at the GMA Science Forum held this week in National Harbor, MD.

Product safety and quality is a shared responsibility. However, fostering a positive environment in which employees embrace accountability starts at the top. “You need to have management commitment; then employee buy-in follows,” said Joseph Levitt, partner at Hogan Lovells US, LLP. “It’s a message people want to embrace.”

At Land O’Lakes, the company took a four-pronged approach to its food safety culture, focusing on a clear quality message and mindset, employee education and training, active leadership alignment and participation, and establishing effective metrics and objectives. Most significant to the company’s success was its ability to involve senior management and get their commitment to taking a product safety 101 course. Sara Mortimore, vice president, Product Safety, QA & Regulatory Affairs at Land O’ Lakes, advised the audience to take a one-on-one tactic when talking to senior management versus putting everyone together in the boardroom. Having that individual interaction with management members forces each person to commit to sharing perspectives.

Companies must focus on monitoring employee behavior and ensuring that employees feel motivated to have a positive impact on product safety and quality. It involves having a continuous improvement mindset versus complacency. Jespersen cited the antecedent-behavior-consequences model as a means to establish goals and metrics, define critical behaviors, and determine positive or negative consequences. Most important to the process is that a company keeps it foot on the pedal when improvements are being made, as a lack of consistency is what causes lapses in progress forward. She also pointed to the Food Maturity Model, a method she developed with industry stakeholders, as a guide for companies to measure employee behavior as it relates to food safety culture across an organization.

Gary Smith, Eurofins’ Food Safety Systems

Why Food Safety Training Fails, and What Can be Done?

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

The food industry has multiple levels of people involved, ranging from leadership and supervisors, all the way to line and front-end workers. Training, thus, has to not just give directions, but also provide better understanding of why we do what we are supposed to, says Gary Smith at Eurofins.

Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, says that “training for supervisors and leadership usually works well. But training workers is fraught with challenges. General training is focused more on giving directions, but not so much on providing understanding. People often skirt this rationale with the line workers, or it’s lost in translation, or missed out due to time constraints, turnover, vacation days etc. That’s where training fails.”

What would happen if we don’t spend this time address the ‘why’ behind training? People then get busy, and then miss out on steps and processes, and that causes problems, Smith replies. “It’s also critical to aim to strike a balance, for instance with line workers training – you have to ensure they understand the importance of what you are training them on, but at the same time, you cannot go too deep into the training, that would be either unnecessary or redundant.”

So what kind of training will continue to be the focus for the industry? The usual ones will continue to be important, according to Smith: Regulatory requirements for seafood, specific HACCP requirements for meat, HACCP training for employees directly responsible for food safety and quality, standards training; training for audits… For line workers, training also needs to cover specifics of their jobs, employee hygiene practices (for instance, why it’s important to wear gloves, hairnets etc.), and how to handle customer complaints.

Proposed rules under the Food Safety Modernization Act are having a positive impact on training needs, says Smith. “Everyone is now waiting for the final set of rules to be announced and implemented. A lot of good things are coming out of it, such focus on risk management and process control, understanding which products are high risk and low risk. FSMA has brought back HACCP for those industries that haven’t really had strict regulatory requirements for food safety – such as seafood, fresh produce, juice etc., or ready-to-eat products that may have escaped regulatory scrutiny in the past, such as fresh produce, and bakery products. Now the industry as a whole needs to focus on FSMA implementation, by companies helping its employees understand where the food safety risks are, how to manage them, document them, and mitigate them.

How can training help companies towards certification? When training leaders that are going to be implementing the food safety standards within their facility, it’s important to be comprehensive about understanding the specific standard. There is also the opportunity to focus on common non-conformances and say ‘this is where others have struggled and this is what you can do to avoid those non-conformances.’ Training can provide lessons, solutions and ideas to address common problems to addresses non-conformances before an audit. It can help drive continuous improvement, and help secure management commitment.

What are some of the common training themes that have resonated with Smith? He says that mostly employees bring up the issue of getting management to understand the need to focus on food safety training and procedures. “People who have attended my classes are usually struggling with getting management commitment. They are often told they need to be certified to a particular standard by end of the year, and so figure it out, but there’s no skin in the game from management. I help these trainees walk through the various steps that they can take to secure that commitment, how to talking their language in terms of more efficient production, and higher dollar savings etc.,” Smith describes.

Some challenges that he has observed in his years of training? Smith says that often times the trainers are great auditors, but poor trainers. “They will quote standards, and regulations. They are too black and white, and objective. However, training can have successful outcomes only when it’s practical and linked to real situations and ideas.”