The Lewiston, Maine, city council has voted to keep its local restaurant inspection program following a three-month saga that saw the ouster of the town’s code enforcement director and threats to eliminate its restaurant health inspector position following the temporary closure of a popular local restaurant due to a cockroach infestation.
The events in Lewiston have brought back not so pleasant memories for others who have faced retaliation and ostracism for doing their jobs. On the most recent episode of the “Don’t Eat Poop” Podcast, entitled “Good Job! You’re Fired,” co-host Francine Shaw recounted her own experience as she and Matt Regusci shared why this hits so close to home for many inspectors and auditors.
Earlier in her career, Shaw served as a health inspector in a small town, where she was called before the city council after closing a local restaurant for multiple violations. “The owner had friends on city council, and I got called in front of the council to defend myself,” said Shaw. “I went with all kinds of documentation including the inspection reports, images of the violations and documentation about what could happen based on the violations I found.”
As she described the violations and shared images of the cockroach infestation, mold in the ice trays and more, she saw the faces of the angry councilors, several of whom were regular patrons of the restaurant, change. “When I was finished, the council and the general public that came to defend this restaurant and attack me, there was nothing for them to say,” Shaw said.
While the council ultimately supported her decision, as they did in Lewiston (thanks to several restaurants who came out to support the inspector), situations like these are not unknown to inspectors and auditors. They also highlight the importance of proper documentation for all audits or inspections. “I’ve been threatened with lawsuits, but we do third-party auditing, so these are not publicly available documents,” said Regusci. “We investigate, and if the auditor was correct we say, ‘We are not settling, we are going to court and then all these auditing reports will become public.’”
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image credit: Susanne Kuehne.
Seafood fraud is still on an almost unchanged high level in Canada. Based on a 2021 investigation by Oceana Canada, 46% of 94 DNA tested seafood samples were not what the label claimed them to be. The Oceana report describes seafood traceability in Canada, the 2021 seafood fraud investigation and results, what consumers can do, and suggestions for the federal government on how to mitigate seafood fraud. These recommendations include setting up a traceability system, labeling standards, improving testing standards and better documentation in the supply chain.
Food waste is a massive global problem led by the United States. According to the USDA, an estimated 30–40% of the country’s food supply ends up in landfills—most of it at the retail and consumer levels. This amounted to approximately 133 billion pounds and $161 billion worth of food wasted in 2010 alone, which prompted the USDA and the Environmental Protection Agency to launch the U.S. Food Loss and Waste 2030 Champions initiative in 2016. Businesses and other organizations can join the ranks as champions by committing to a 50% reduction of food loss and waste by 2030.
That’s a noble goal, but those businesses will only be able to achieve their objective with technologies that reduce food waste in production and the supply chain. Food lost in this medium is hardly insignificant. At least 10%—or billions of pounds of food—is wasted in acts as small as over-ordering or in transport. This is, in short, the result of errors in resource planning.
After an extremely difficult year, food process manufacturers can no longer afford to generate that level of waste. Fortunately, technologies already exist to help the industry regain control of its production, storage and forecasting, and can facilitate leaner businesses and less waste.
Eliminate Human Error and System Inconsistencies
There have been a lot of changes in the way food is grown, harvested, delivered and sold over the last few decades, yet little progress has been made when it comes to unnecessary waste. The Commission for Environmental Cooperation reports that food loss and waste can occur post-harvest due to inaccurate supply and demand forecasting, grade standards for size and quality, and deficiencies in refrigeration. Even the packaging can cause problems if it is inefficient or ineffective.
These and other problems lead to waste—some up front before the product is ever sold to consumers, others down the line after an item has been purchased, leading to a recall. If inventory records are anything less than 100% accurate from formulation through shipment, additional challenges will follow. Though it is not heavily considered in an FDA audit, manufacturers still need the ability to instantaneously report on any aspect of their inventory history, regardless of the ERP software from which data is pulled. ERP systems with bolt-on modules often fail in this regard. If functionalities of the sub-systems are not designed for strict lot tracking, or if those sub-systems are not designed exactly the same, errors are inevitable.
Workarounds can be implemented, but they cannot account for processes that still need to be performed manually, which increases the likelihood that lot tracking accuracy will fall short. Inefficiencies are further exacerbated by sub-systems that handle actions differently, but the challenges don’t end there.
Problems can also develop when data has to be shared across more than one module, database or even system, which may inspire the use of outside solutions, such as an Excel spreadsheet, compounding the issues at hand. Makeshift solutions increase the risk that an incorrect lot number will be entered or that someone will forget to delete a number after a lot was de-issued and re-issued. Any of these cracks in the operational foundation will inevitably deduct from the 100% inventory accuracy that’s necessary for a smooth recall process—anything less will lead to a greater impact on the business.
The only real solution is to eliminate the potential for human error and system inconsistencies altogether—and that can only be accomplished with a configurable ERP solution that handles all business processes from one system and one database and can easily adapt to changing regulation and recipes. Without it, true strict lot control—meaning 100% inventory accuracy with perfect record keeping and the ability to instantly report on any aspect of the inventory history—cannot be achieved.
Reduce Inventory Variance and Grow without Unnecessary Expansions
There are aspects of food waste that can be controlled, including inventory variance, which occurs when items are lost, misplaced or miscounted. This is particularly problematic for packaging and ingredients, causing issues at the production level—finished products cannot be made if there aren’t enough items to complete the process, which is also bad for the bottom line. Inventory variance may occur if deliveries are not verified to confirm that ordered ingredients were actually received or may happen if items are entered incorrectly or simply misidentified.
Variance is more than a nuisance—it can be quite costly. For example, Silver Spring Foods encountered this firsthand when it discovered that its inventory variance commonly reached between $250,000 and $300,000. The company, which debuted in 1929 when founder Ellis Huntsinger started growing horseradish and other vegetable crops, now produces the number-one horseradish retail brand in the United States. With more than 9,000 acres of prime Wisconsin and Minnesota farmland, Silver Spring realized that it had outgrown its outdated ERP solution.
The company initially thought that it had reached capacity and could only grow further by physically expanding its building with an additional manufacturing line that would require new hires to come aboard. In reality, the company needed an ERP solution that could keep up with its impressive level of growth.
More specifically, Silver Spring Foods wanted an ERP system that could tie together several elements, including customer service, accounting, manufacturing, purchasing and shipping within a single tool. The company needed a solution that offered strong data mining and reporting functionality, as well as strong sales reporting, sustainable tech support capabilities and would not exceed ERP budget allocations. It was equally important to have an ERP solution that was configurable without customization, prioritizing speed and efficiency while offering predictable quality and cost of ongoing IT support and maintenance.
After upgrading to a solution that met all of its requirements, Silver Spring Foods was able to gather all data in one system that brought together multiple software integrations, including CRM. This allowed the firm to fine-tune its material purchases to match current production needs, sales forecasts and production schedules. More importantly, inventory variance was reduced to $90,000 during the first year and now falls within a range of just $1,800 to $2,500. By improving inventory management, unearthing new efficiencies and proving that Silver Spring had not yet reached capacity, the company was now able to grow without adding additional square footage.
Don’t Let Waste Cut into Productivity
Food growers, processors and supply chains cannot afford to let waste cut into their productivity or their bottom line. They need to be able to keep track of everything, achieving true strict lot control to limit the damage caused by a recall. They also need to be able to improve food management and reduce inventory variance. These and other advantages can only be attained with the right ERP technology, however, so businesses must choose wisely before making an investment.
Q: Why would a company think about changing auditing methods if their current process is working well?
Kari Hensien: Simply put, you don’t know what you don’t know. Many companies believe they have a strong auditing program because they have not yet seen a problem. However, that doesn’t mean that an unsafe or noncompliant behavior hasn’t happened, it only means that it hasn’t surfaced.
Problems may arise that are more difficult to catch in an audit. Factories are tired from repeating the same audit for multiple clients, auditors are exhausted from long days and doing the same work twice, and this type of audit fatigue can lead to audits being rushed or errors being introduced in data entry.
Companies have gotten comfortable with more manual auditing processes – clipboards, spreadsheets, binders – as they’ve evolved over several decades. Any change to the status quo will cause some degree of discomfort, so there’s an understandable reluctance to make a change without a major catalyst.
In this case though, the catalyst may not have been within a company, but rather changes to the industry the company operates in. Regulations are stronger than ever, supply chains have become more complex, and suppliers and brands are asking more questions about where their food comes from and how it’s processed. Further, standards bodies have begun the process of requiring digital audit submission for better tracking and that trend is likely to continue.
These changes are happening because manual or traditional auditing creates blind spots in the quality, safety, and risk management program.
Data collected manually is difficult to aggregate, which makes spotting trends difficult and delays catching potential issues before they become problems.
Manual audits create audit fatigue because results can’t be shared across certifying bodies or inspectors, and suppliers must complete the same audit for each customer.
Corrective actions become time consuming and difficult to track without automation.
Q: What options are available to strengthen audit programs?
Hensien: Companies should not have to give up an auditing program they like to adopt new technology. In fact, having a strong process is an advantage when looking to improve the process already in place. This means bringing in technology will be additive rather than disruptive.
Companies that are looking to modernize their quality and risk auditing programs have a variety of options. Digital auditing solutions run the gamut from simple online forms to full enterprise platforms. Here are some of the features companies may find in modern auditing solutions.
Digital auditing forms. These are one step above the manual process. Auditors can input data directly into the form and skip the step of then having to transcribe results.
Comprehensive reporting. Holistic, timely reporting is a key advantage of moving away from manual audits, and more enterprise quality management platforms will include it. A centralized data warehouse of audit data makes it easy for companies to have visibility into whatever matters most.
Data integration. For companies monitoring large supply chains, complex business structures, and external quality indicators, integrating multiple data sources gives a comprehensive look at the factors that contribute to quality and safety. Data integrations bring in information from partners, third-party auditors, and more to get a full view of critical information.
Automated corrective actions. Mistakes are inevitable, but how they are handled can make or break a business. Having corrective actions, and their follow up, automated when something is out of compliance takes the guesswork out of whether it’s been handled effectively.
What matters most is that any company looking to improve their existing model take the time to identify what risks exist and how new technology can help mitigate those. For example, not every company needs to bring in data from external sources. But if a standards body they work with recently began requiring digital audit submissions, then digital forms are a logical choice to avoid any audit-fatigue related errors when transcribing data into the submission portal.
Finding the capabilities available to reveal the blind spots that existed in the manual auditing process reduces the friction and fatigue in auditing. Administrators are able to better see and understand all parts of quality and safety management, auditors can spend more time thoughtfully working with those being auditing, and suppliers and factories can share digital audit results with multiple customers rather than repeating the same audit many times.
As president of RizePoint, Hensien is championing a new continuous quality initiative. Since travel and interpersonal interactions have been devastated by COVID-19, it’s been challenging for businesses to obtain regular third-party audits, which are integral to access and analyze key data and ensure safety compliance across the enterprise. Hensien is facilitating an increased self-assessment auditing model, where businesses and their locations can use RizePoint’s digital platform themselves, resulting in more frequent audits and broader visibility during the pandemic and beyond.
The immediate benefit for pest management professionals is clear: An electronic remote monitoring (ERM) system can increase service efficiency and save technicians time checking traps because they know exactly which traps have activity. But, how exactly does that benefit you?
The short answer: These technologies enable your service technician to receive real-time notifications of pest activity that is recorded with a time stamp. That means you receive a quicker response to resolve an active pest issue, allowing for more prompt corrective and preventive action. But, that’s just the tip of the iceberg.
Shifting From Trap Checking to Always-on Pest Control
No one wants a service technician who simply checks traps. When tasked with checking 100 traps week after week, a technician tends to go into “checknician” mode – simply going through the motion of checking traps. It’s human nature; they have a road map to follow, and they’ll follow that road map, missing those trouble spots, such as new evidence of pest activity, along the way. It also means they are only reacting to what they find versus proactively looking for opportunities to prevent pests.
By using ERM technology to essentially enable the traps to check themselves, the technician can do the job they were hired and trained to do. By freeing up their time from trap checking, technicians can proactively seek out issues that leave you vulnerable to pest problems.
In addition to checking traps with activity alerts, service technicians can spend their time reviewing pest sighting logs, looking for signs of pest activity and seeking out its source, as well as identifying conditions favorable for pests. This proactive and strategic inspection ultimately results in more detailed documentation and reporting of their findings for further root cause analysis, corrective action and overall prevention.
Audit-Ready Elevated Documentation
Another benefit is the documentation that ERM systems can provide. For instance, pinpointed, time-stamped data some of these systems deliver fits right in with the trending and active hot spot data most auditors are looking for when they visit a plant.
Auditors understand that you’re going to have a mouse from time to time, but what they truly want to know is: What did you do about it, how did you protect your product and how will you prevent the problem from happening again. ERM systems make that data readily available.
Data Is Meaningless Without Expertise
There’s no point in collecting data if you aren’t going to put it to use and to do so, you need a strong partner in your pest control service provider. Your service provider’s expertise stretches far beyond killing pests. ERM systems allow your technician the time to apply that expertise while on-site, while also supplying the pinpointed data they need to get ahead of pest issues.
Without that strong partnership, it’s like hiring a heart doctor because you had a heart attack, but you do nothing else to help your heart condition. It’s no different when a food processor suffers a rodent infestation and an auditor finds a problem with their program or there’s a customer complaint. Often, the first reaction is to blame the pest control company. In actuality, pest management success is rooted in a strong partnership between the pest control provider and the facility management.
A pest management program with ERM technology is just one piece of the larger pest prevention puzzle. Knowing where pest activity is happening and identifying the root cause only goes so far in resolving the problem. The preventive steps, such as fixing a damaged door sweep or improving sanitation, is a shared responsibility with facility management.
Investing in Data-driven Pest Control
Everyone likes to save a little money, but your pest prevention program isn’t the place for penny-pinching. Like all new technologies, adopting an ERM system may mean additional costs, but it’s important to realize that no amount of cost cutting is worth it if there’s a recall or a disgruntled customer.
When you hire a pest control company, it’s an insurance policy for pests and an investment in your food protection program. By using ERM technology, you enable your service technician to monitor rodent activity in real time so they can provide a quicker response for corrective and preventive action. That data-driven approach to prevention aligns directly with FSMA and GFSI standards, ensuring not only your compliance, but also that your facility and your product is better-protected in the long-term.
In today’s digital-first world, it might be surprising for those outside of the food manufacturing industry to learn that paper and pen are still considered state-of-the-art documentation tools. Answering food safety and quality questions such as: “What was the underlying cause of this customer complaint?” or “What caused the production halt this morning?” still require hours of research across paper documents, emails and spreadsheets. Maybe even the odd phone call or text message.
The good news is that many food safety and quality problems can be solved by leveraging modern-day technology. The challenge is taking that first step. By applying the following best practices, organizations can take small steps that lead to substantial benefits, including optimized food safety and quality programs, happier employees and safer operations.
Digital Transformation Best Practices
What if all the information food safety professionals require could be accessible through one unified interface and could proactively point to actions that should be taken? It can, with the right mindset and the right strategy.
While there is no “flip of a switch” to become digitally empowered, best practices exist for where to start. And, early adopters are injecting innovation into food safety programs with simple, but powerful technology.
Look Inward
Too often, food safety professionals push forward on a path to digital transformation by evaluating software and business applications against features and/or cost. But before taking this approach, it is important to look at existing food safety programs, identify where incremental improvements can be made and determine the potential return on a new technology investment.
Self-awareness is a beneficial leadership skill, but it’s also the key driver in understanding an organization’s business needs for food safety. Food safety professionals need to get real about common pain points, such as inconsistent or insufficient data, non-standardized practices, and delayed reporting. This is not the time to gloss over problems with processes or tools. Only by clearly documenting the challenges upfront will organizations be able to find the best solutions.
As one example, a common pain point is managing different formats and timing of reporting across facilities. See if this sounds familiar: “Well, Dallas sends an Excel spreadsheet every week, but Toledo only sends it on a monthly basis, while Wichita sends it monthly most of the time, but it’s never in the same format.”
Start out by identifying similar problems to help define the business objective, which will help determine how technology can be most effectively applied.
Eat, Sleep, Food Safety, Repeat
Food safety processes should constantly evolve to enable continued improvements in food safety outcomes. With that in mind, it’s helpful to dust off the corporate SOP and review it, especially if an organization is moving to a digital program. A common mistake many food manufacturers make is asking technology providers to configure an application based solely off the corporate protocol, only to discover at go-live that users don’t follow that protocol.
To avoid this situation, consider the following questions:
Why are food safety professionals not completing processes by the book?
Is that similar with every site?
Why has it been that way for so long?
Why did food safety professionals start to stray?
By locking down processes and identifying the desired way forward, leaders can configure a new application with the latest information and updated decisions. At a minimum, this step will help identify current issues that should be addressed, which can become measurable goals for the use of the new technology, ideally emphasizing the most pressing problems.
Less is More
Digital transformation doesn’t always need to become a “fix-all” project. Instead, it may revolve around a single operational initiative or business decision. For example, food safety professionals often maintain a spreadsheet with usernames and passwords for countless applications, some of which overlap in functionality and/or require a separate login for each facility. This is not only a safety concern, it’s an easy entry point when moving to a digital approach.
Consolidation of applications is a natural step from the standpoint of feasibility and fiscal responsibility. So, look for digital transformation opportunities that result in fewer applications and more consolidation.
Don’t Rush It
While digital transformation is inevitable, Rome wasn’t built in a day and neither should be an organization’s digital strategy. Unfortunately, the decision to go digital is often made, and a go-live date chosen, before determining what transformation requires, which is a clear-cut recipe for failure.
Technical vendors should play a key role in developing an effective implementation strategy, including sharing onboarding, planning, configuration and go-live best practices.
While technology is here to help the world become smarter about food safety, it is not here to replace human experience. Food safety leaders should continue to augment processes through supplemental technologies, rather than view technology as a full takeover of current approaches.
Barriers to entry for digital transformation are being lowered, as the ease of adoption of the underlying technologies continues to advance and access via cloud-based applications improves.
What to Do With All This Data? 5 Outcomes Food Manufacturers Can Achieve
Food manufacturers have benefited from digitally transforming environmental monitoring programs (EMPs) using workflow and analytics tools in a variety of ways. In the end, what matters is that the resulting data access and usability enables new insights and accelerates decisions that result in reduced risk and improved quality. Keep in mind these key outcomes that food manufacturers can achieve from digital transformation.
Enhancing an internal audit framework with digital tools will greatly reduce the burden of ensuring compliance for schemes such as BRC, SQF and FSSC food safety standards. Flexible report formats and filtering capabilities empower users with the right information at the right time.
Imagine, no more sifting manually through binders of CoA’s and test records to find a needle in a haystack. Exposing teams to a digital means of performing internal audits will not only boost confidence to handle requests from an auditor but will also help drive continuous improvement by providing easier access to insights about the effectiveness of internal policies. At the same time, digital tools will help ensure that only the required information is shared, reducing confusion and uncertainty as well as audit time and cost.
Outcome #2: Proactive Alerting and Automated Reporting
Threshold-based report alerts are an excellent way to reduce the noise often associated with notification systems. Providing quality and safety managers with automated alerts of scheduled maintenance or pending test counts can help them focus on activities that need attention, without distractions.
The benefit of threshold-based reporting is that it is a “set it and forget it” method. While regular “Monday Reports” are still a necessity, alerts and reports can be generated only when attention is needed for anomalies. A great example of this is being able to set proactive alerts for test counts in a facility that are approaching nonconformance levels. Understanding the corrective action requirements needed to control an environmental issue before it impacts quality, production and unplanned sanitation measures is a critical component of risk management and brand protection. In addition, reports can be automatically generated and delivered on a regular schedule to help meet reporting needs without spending time collecting data.
In other words—imagine a world where data comes and finds users when needed, rather than having to search for it in a binder or spreadsheet. Digital tools can provide email reports showing that a threshold has (or has not) been met and link the user directly to the information needed to take action. This is called “actionable information” and is something to consider when deploying technology within an organization’s food safety program processes.
Outcome #3: Optimize Performance with Tracking, Trending and Drilling
The Pareto Principle specifies that for many outcomes, about 80% of consequences come from 20% of causes. Historical data that is digitized can be used to quickly identify the root cause of top failures in a facility in order to drive process improvements. Knowing where to invest money will help avoid the cost of failure and aid in the prevention of a recall situation.
Dashboards are a powerful tool that organizations can use to understand the risk level across facilities to make better, data-driven decisions. Reports can be configured through a thoughtful dashboard setup that enables users to easily identify hot spots and trends, drill down to specific test locations, and enable clear communication to stakeholders. Figure 1 provides an example of a heat map that can be used to speed response and take corrective actions when needed.
Figure 1. Pathogen Positives by Zone and Location Heat
Outcome #4: Simplified Data Governance and Interoperability
Smarter food safety will drive standardization of data formats, which allows information to flow seamlessly between internal and external systems. One of the major benefits of shifting away from paper-based solutions is the ability to be proactive to reduce risk and cost. FSQA managers, within and across facilities, can benefit from a 360-degree operational view that reveals hidden connections between information silos that exist in the plant and across the organization. This includes:
Product tracing through product testing to environment monitoring and sanitation efforts
Tracing back a product quality issue reported from a customer to the sanitation efforts
Understanding why compliance is on track but quality results aren’t correcting
Outcome #5: Reduce the Cost of High Turnover
Successful GMPs, SSOPs and a HACCP program require leaders that continually ensure that employees are properly trained, which can be difficult with high turnover rates. To address this challenge, digital tools can aid in providing easily accessible documentation to empower users and reduce the cost, time and risk associated with having to re-train new employees on the EMP process. While training cannot be replaced with technology, it can be accelerated.
For example, testing locations within facilities can be documented with images and related information enabling new employees to visually see the floorplan and relevant testing protocols with accompanying video and click-through visualization of underlying data. Additionally, corrective action protocols can be enhanced with videos and standardized form inputs to ensure proper data is being collected at all times.
The Path Ahead
As the digital transformation of the food safety industry continues, food manufacturers should seek out and apply proven best practices to make the process as efficient and effective for their organization as possible. By avoiding common pitfalls, companies can achieve transformation objectives and realize substantial benefits from more easily accessible and actionable food safety data.
Managing the complexities of a management system is challenging for any food and beverage company, particularly for the team tasked with implementing the system throughout the organization. That is because every regulatory agency (e.g., FDA, USDA, OSHA, EPA) and voluntary certification (e.g., GFSI-benchmarked standards, gluten-free, organic, ISO) calls for companies to fulfill compliance requirements—many of which overlap. Supply chain and internal requirements can create further complications and confusion.
In today’s “New Era of Smarter Food Safety,” having a common system to organize, manage and track compliance offers an ideal solution. Dynamic tools are becoming available—systems that can manage employee training, pest control, laboratory testing, supply chain management tools, regulatory compliance and certification requirements, etc.
Unfortunately, these systems are often not set up to “talk” to each other, leaving company representatives to navigate many systems, databases, folders, and documents housed in many different locations.
The Solution: Compliance Management Systems
An integrated compliance management system (CMS) is intended to bring all these tools together to create one system that effectively manages compliance requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data that is collected daily by the team charged with implementation.
A CMS is used to coordinate, organize, control, analyze and visualize information to help organizations remain in compliance and operate efficiently. A successful CMS thinks beyond just access to documents; it manages the processes, knowledge and work that is critical to helping identify and control business risks. That may include the following:
Ensuring only authorized employees can access the right information.
Consolidating documents and records in a centralized location to provide easy access
Setting up formal business practices, processes and procedures
Implementing compliance and certification programs
Monitoring and measuring performance
Supporting continuous improvements
Documenting decisions and how they are made
Capturing institutional knowledge and transferring that into a sustainable system
Using task management and tracking tools to understand how people are doing their work
Enabling data trending and predictive analytics
CMS Case Study: Boston Sword and Tuna
In early 2019, Boston Sword and Tuna (BST) began the process of achieving SQF food safety certification. We initially started working with BST on the development, training and implementation of the program requirements to the SQF code for certification—including developing guidance documents for a new site under construction.
The process of attaining SQF certification included the development of a register of SQF requirements in Microsoft SharePoint, which has since evolved into a more comprehensive approach to overall data and compliance management. “We didn’t plan to build a paperless food safety management system,” explains BST President Larry Dore, “until we implemented our SQF food safety management program and realized that we needed a better way to manage data.”
We worked with BST to structure the company’s SharePoint CMS according to existing BST food safety management processes to support its certification requirements and overall food safety management program. This has included developing a number of modules/tools to support ongoing compliance efforts and providing online/remote training in the management of the site and a paperless data collection module.
The BST CMS has been designed to support daily task activities with reminders and specific workflows that ensure proper records verifications are carried out as required. The system houses tools and forms, standards/regulatory registers, and calendars for tracking action items, including the following:
Ambient Temperature
Corrective and Preventive Action (CAPA)
Chemical Inventory/Safety Data Sheets (SDS)
Compliance Management
Customer Complaints
Document Control
Employee Health Check
Food Safety Meetings Management Program
Forklift Inspections
Good Manufacturing Practices (GMP) Audit
SQF Register
Maintenance (requests/work orders/assets/repairs)
Nightly Cleaning Inspections
Operational/Pre-Operational Inspections
Sanitation Pre-Op Inspections
Scale Calibration
Sharp/Knife Inspections
Shipping/Receiving Logs
Thawing Temperature Log
Thermometer Calibration
Key Considerations for Designing a Successful CMS
An effective CMS requires an understanding of technology, operational needs, regulatory compliance obligations and certification requirements, as well as the bigger picture of the company’s overall strategy. There are several key considerations that can help ensure companies end up with the right CMS and efficiency tools to provide an integrated system that supports the organization for the long term.
Before design can even begin, it is important to first determine where you are starting by conducting an inventory of existing systems. This includes not only identifying how you are currently managing your compliance and certification requirements, but also assessing how well those current systems (or parts of them) are working for the organization.
As with many projects, design should begin with the end in mind. What are the business drivers that are guiding your system? What are the outcomes you want to achieve through your system (e.g., create efficiencies, provide remote access, reduce duplication of effort, produce real-time reports, respond to regulatory requirements, foster teamwork and communication)? Assuming that managing compliance and certification requirements is a fundamental objective of the CMS, having a solid understanding of those requirements is key to building the system. These requirements should be documented so they can be built into the CMS for efficient tracking and management.
While you may not build everything from the start, defining the ultimate desired end state will allow for development to proceed so every module is aligned under the CMS. Understand that building a CMS is a process, and different organizations will be comfortable with different paces and budgets. Establish priorities (i.e., the most important items on your list), schedule and budget. Doing so will allow you to determine whether to tackle the full system at once or develop one module at a time. For many, it makes sense to start with existing processes that work well and transition those first. Priorities should be set based on ease of implementation, compliance risk, business improvement and value to the company.
Finally, the CMS will not work well without getting the right people involved—and that can include many different people at various points in the process (e.g., end user entering data in the plant, management reviewing reports and metrics, system administrator, office staff). The system should be designed to reflect the daily routines of those employees who will be using it. Modules should build off existing routines, tasks, and activities to create familiarity and encourage adoption. A truly user-friendly system will be something that meets the needs of all parties.
Driving Value and Compliance Efficiency
When thoughtfully designed, a CMS can provide significant value by creating compliance efficiencies that improve the company’s ability to create consistent and reliable compliance performance. “Our system is allowing us to actually use data analytics for decision making and continuous opportunity,” said Dore. “Plus, it is making remote activities much more practical and efficient”.
For BST, the CMS also:
Provides central management of inspection schedules, forms, and other requirements.
Increases productivity through reductions in prep time and redundant/manual data entry.
Improves data access/availability for reporting and planning purposes.
Effectively monitors operational activities to ensure compliance and certifications standards are met.
Allows data to be submitted directly and immediately into SharePoint so it can be reviewed, analyzed, etc. in real time.
Creates workflow and process automation, including automated notifications to allow for real-time improvements.
Allows follow-up actions to be assigned and sent to those who need them.
All these things work together to help the company reduce compliance risk, create efficiencies, provide operational flexibility, and generate business improvement and value.
The coronavirus pandemic has impacted the food industry on several fronts from production to consumer purchasing habits to in-restaurant dining adjustments. While facility operations might look different, the demand for product is certainly still high, so operations should be tighter than ever.
Unfortunately, pest activity has not slowed down during the pandemic. From rodents and cockroaches to stored product pests and birds, your facility is susceptible to pest disruptions. With shipments coming and going and limited staffing, it’s also highly likely you don’t have time to prioritize your pest management program. An unchecked, contaminated shipment leaving your facility and making it into the homes of consumers is all it takes to wreak havoc on your business.
Your goal, and the goal of your pest control partner, should be that your facility is ready for an audit at any time. (Image courtesy of Orkin)
If you already have an integrated pest management (IPM) program in place, you’re heading in the right direction with securing your facility. IPM programs help food processing facilities keep pests from entering and destroying your product by applying preventive measures such as identifying potential and existing sanitation opportunities and regularly evaluating the state of facility maintenance.
The last thing you need right now is a failed audit due to preventable pest issues. Failing a first, second or third-party audit can lead to many consequences such as a damaged reputation, reduced profits and worst of all, lost customers. With most regulators resuming on-site audits, offering remote options or a hybrid of the two, ensuring your facility stays within regulations is still possible, and highly encouraged. After all, pest control plays a significant role in all major food safety audits and can account for up to 20% of your score.
Food Safety Audits during the Pandemic and New Changes
Not only do facility managers have to regulate operations during a pandemic, but they also must maintain strict food safety standards to ensure that the food supply chain stays healthy. With the arrival of COVID-19 vaccines, there is some hope that the pandemic may be under control soon, but it is not over yet, and food safety audits should not be avoided because of a pandemic. To accommodate, many auditors implemented new measures such as remote and hybrid audits for food processing facilities, in addition to on-site audits.
If your facility is still unable to conduct on-site audits at this time, special accommodations can be made. The following auditors have made updates to their food safety audits amid the pandemic:
BRCGS: In addition to blended audits, BRCGS is offering certificate extensions for up to six months with a risk assessment and review. Although not benchmarked by GFSI, remote assessments are also available and involve a video audit of your facility’s storage and production areas in additional to reviewing internal audit results and documentation.
SQFI: SQFI is postponing certifications for extenuating circumstances and implemented additional processes for risk assessments. Certifying bodies will have to conduct risk assessments to determine whether a certificate extension is needed.
FDA: After temporarily suspending all facility inspections last March, the FDA has resumed domestic inspections on a case-by-case basis when safe to execute. Foreign inspections have not yet resumed so, take extra care if your facility regularly receives foreign shipments.
FSIS: Inspections of meat, poultry and egg facilities continued through the pandemic. These regulated facilities continue to require sanitation SOPs to help maintain food safety and prevent the spread of diseases.
Whether your facility is able to resume onsite audits or needs to switch to a remote or hybrid option, pests will still be trying to take advantage. Working with your pest control provider to ensure your documentation and pest management measures are in order is one of the best ways to ensure any audit or risk assessment goes smoothly. While each auditor has specific requirements, here are some key considerations for your next third-party inspection.
Implement an IPM Program
We cannot stress enough the importance of a proactive pest management program for food processing facilities. The best way to reduce pest issues is to build them out. Your pest control partner will identify and communicate to you on ways to reduce, or in some cases even eliminate food, water and harborage for pests. Ensure your contract specifies the roles and responsibilities of your pest control partner and you, the scope of service and a risk assessment plan. If you’re unsure of what your contract entails, now is the time to get in touch with your pest control partner.
Invest in Your Employees
Train your staff to spot and record signs of pest activity so you can address them immediately with your pest control partner. This is particularly important if you had to adjust employee schedules during the pandemic to enforce proper social distancing. Fewer staff means fewer opportunities to spot pest issues, so making sure all employees are trained can help you in the long run.
Keep Up with Documentation
Your documentation is an integral part of your audit process because it shows third-party auditors that you can verify that you have an effective pest management plan in place. Three types of documents are needed for your audit: Proof of training and certification, pesticide documentation and general facility documentation. Most pest control providers now maintain digital documentation for their partners which makes it easier to track and monitor for pest trends, treatments and updates to your plan. Even with a proper pest management program in place, facilities can still lose points for not having proper documentation so don’t overlook this part.
Hold Practice Runs
A good pest control partner will encourage test audits to ensure you’re prepared for the real deal. An annual assessment is one of the best ways to make sure your pest management program is still working and to address any gaps if it isn’t. Don’t forget to review your documentation during test audits in addition to joining your pest control partner for a physical inspection of your facility (socially distanced, of course).
Prepare your Facility
Your goal, and the goal of your pest control partner, should be that your facility is ready for an audit at any time. However, if you have an upcoming scheduled audit, a week before your audit, work with your pest control partner to conduct interior and exterior inspections as well as a documents review. Make sure you are familiar with how to access your customer web portal so that you can access data if requested. During these inspections, make sure any monitoring devices meet auditor requirements and are properly placed and maintained. The day before your audit, make another run through the facility to be sure your facility is ready. You don’t want your auditor finding cobwebs in your storage room or debris showing up in the background of a video audit.
Food safety should be a top priority for your business—your reputation depends on it after all. As the food industry continues to navigate operating in a post-pandemic climate, maintaining a successful pest management program and updated records will give you a head start when it comes to audits no matter the format. With public health concerns at an all-time high, consumers and suppliers alike will be grateful for your increased attention to maintaining industry regulations.
“Food safety plan” is a term often used in the food industry to define an operation’s plan to prevent or reduce potential food safety issues that can lead to a serious adverse health consequence or death to humans and animals to an acceptable level. However, depending on the facility, their customers, and or regulatory requirements, the definition and specific requirements for food safety plans can be very different. To ensure food safety, it’s important that the industry finds consensus in a plan that is vetted and has worked for decades.
One of the first true food safety plans was HACCP. Developed in 1959 for NASA with the assistance of the food industry, its goal was to ensure food produced for astronauts was safe and would not create illness or injury while they were in space. This type of food safety plan requires twelve steps, the first five of which are considered the preliminary tasks.
Assemble a HACCP team
Describe the finished product
Define intended use and consumer
Create process and flow diagram
Verify process and flow diagrams
This is followed by the seven principles of HACCP.
Conduct the hazard analysis
Identify critical control points
Establish critical limits
Establish monitoring requirements
Establish corrective actions for deviations
Procedures for verification of the HACCP plan
Record keeping documenting the HACCP system
HACCP is accompanied by several prerequisites that support the food safety plan, which can include a chemical control program, glass and brittle plastics program, Good Manufacturing Practices (GMPs), allergen control program, and many others. With these requirements and support, HACCP is the most utilized form of a food safety plan in the world.
When conducting the hazard analysis (the first principle of HACCP), facilities are required to assess all products and processing steps to identify known or potential biological, chemical and physical hazards. Once identified, if it is determined that the hazard has a likelihood of occurring and the severity of the hazard would be great, then facilities are required to implement Critical Control Points (CCP) to eliminate or significantly reduce that identified hazard. Once a CCP is implemented, it must be monitored, corrective actions developed if a deviation in the CCP is identified and each of these are required to be verified. Records then also need to be maintained to demonstrate the plan is being followed and that food safety issues are minimized and controlled.
HACCP is, for the most part, the standard food safety plan used to meet the Global Food Safety Initiative (GFSI) standards. This is utilized in various third-party audit and customer requirements such as FSSC 22000, SQF, BRC, IFS and others. These audit standards that many facilities use and comply with also require the development of a food safety management system, which includes a food safety plan.
Further, HACCP is often used to demonstrate that potential food safety issues are identified and addressed. FDA has adopted and requires a regulated HACCP plan for both 100% juice and seafood processing facilities. USDA also requires the regulated development of HACCP for meat processing and other types of facilities to minimize potential food safety issues.
For facilities required to register with the FDA—unless that facility is exempt or required to comply with regulated HACCP—there is a new type of food safety plan that is required. This type of plan builds upon HACCP principles and its steps but goes beyond what HACCP requires. Under 21 CFR 117, specific additions assist in identifying and controlling additional food safety hazards that are on the rise. This includes undeclared allergen recalls, which constituted 47% of recalls in the last reportable food registry report published by FDA.
Prior to developing this plan, FDA provided recommendations for preliminary steps that can be completed and are essential in development of a robust food safety plan but are not a regulatory requirement. The steps are very similar to the preliminary tasks required by HACCP, including the following:
Assemble a food safety team
Describe the product and its distribution
Describe the intended use and consumers of the food
Develop a flow diagram and describe the process
Verify the flow diagram on-site
Their recommended plan also requires a number of additional steps, including:
A written hazard analysis. Conducted by or overseen by a Preventive Controls Qualified Individual (PCQI). However, this hazard analysis requires assessing for any known or reasonably foreseeable biological, chemical, physical, radiological, or economically motivated adulteration (food fraud that historically leads to a food safety issue only). You may note that two additional hazards—radiological and EMA—have been added to what HACCP calls for in the assessment.
Written preventive controls if significant hazards are identified. However, similar preventive controls are different than a CCP. There are potentially four types of preventive controls that may be utilized for potential hazards, including Process Preventive Controls (the same as CCP), Allergen Preventive Controls, Sanitation Preventive Controls, Supply Chain Preventive Controls and Others if identified.
A written supply chain program if a Supply Chain Preventive Control is identified. This includes having an approved supplier program and verification process for that program.
A written recall plan if a facility identified a Preventive Control.
Written monitoring procedures for any identified Preventive Control that includes the frequency of the monitoring what is required to do and documenting that monitoring event.
Written corrective actions for identified Preventive Controls in case of deviations during monitoring. Corrective actions must be documented if they occur.
Written verification procedures as required. This could include how monitoring and corrective actions are verified, procedures themselves are verified, and calibration of equipment as required. Also required is training, including a Preventive Control Qualified Individual. Additional training is required for those individuals responsible for performing monitoring, implementing corrective actions, and verification of Preventive Controls. Further, all personnel need to have basic food safety training and all training needs to be documented.
While the term “food safety plan” is used widely, it’s important that operations don’t just use the term, but enact a plan that is vetted, proven to work, and encompasses the principles of HACCP. Doing so will help ensure that their facility is producing foods that customers and consumers will know is safe.
With the increasing globalization of the food industry, ensuring that products reaching consumers are safe has never been more important. Local, state and federal regulatory agencies are increasing their emphasis on the need for food and beverage laboratories to be accredited to ISO/IEC 17025 compliance. This complicated process can be simplified and streamlined through the adoption of LIMS, making accreditation an achievable goal for all food and beverage laboratories.
With a global marketplace and complex supply chain, the food industry continues to face increasing risks for both unintentional and intentional food contamination or adulteration.1 To mitigate the risk of contaminated products reaching consumers, the International Organization for Standardization (ISO), using a consensus-based approval process, developed the first global laboratory standard in 1999 (ISO/IEC 17025:1999). Since publication, the standard has been updated twice, once in 2005 and most recently in 2017, and provides general requirements for the competence of testing and calibration laboratories.2
In the recent revision, four key updates were identified:
A revision to the scope to include testing, calibration and sampling associated with subsequent calibration and testing performed by a laboratory.3
An emphasis on the results of a process instead of focusing on prescriptive procedures and policies.4
The introduction of the concept of a risk-based approach used in production quality management systems.2
A stronger focus on information technologies/management systems, specifically Laboratory Information Management System (LIMS).4
As modern-day laboratories reduce their reliance on hard copy documents and transition to electronic records, additional emphasis and guidance for ISO 17025 accreditation in food testing labs using LIMS was greatly needed. Food testing laboratories have increased reliance on LIMS to successfully meet the requirements of accreditation. Food and beverage LIMS has evolved to increase a laboratory’s ability to meet all aspects of ISO 17025.
Figure 1. A schematic representation of some of the requirements of ISO/IEC 17025:2017 compliance. (Figure courtesy CloudLIMS)
Traceability
Chain of Custody
A key element for ISO 17025 accredited laboratories is the traceability of samples from accession to disposal.5 Sometimes referred to as chain of custody, properly documented traceability allows a laboratory to tell the story of each sample from the time it arrives until the time it is disposed of.
LIMS software allows for seamless tracking of samples by employing unique sample accession numbers through barcoding processes. At each step of sample analysis, a laboratory technician updates data in a LIMS by scanning the sample barcode, establishing time and date signatures for the analysis. During an ISO 17025 audit, this information can be quickly obtained for review by the auditor.
Procurement and Laboratory Supplies
ISO 17025 requires the traceability of all supplies or inventory items from purchase to usage.6 This includes using approved vendors, documentation of receipt, traceability of supply usage to an associated sample, and for certain products, preparation of supply to working conditions within the laboratory. Supply traceability impacts multiple departments and coordinating this process can be overwhelming. A LIMS for food testing labs helps manage laboratory inventory, track usage of inventory items, and automatically alerts laboratory managers to restock inventory once the quantity falls below a threshold level.
A food LIMS can ensure that materials are ordered from approved vendors only, flagging items purchased outside this group. As supplies are inventoried into LIMS, the barcoding process can ensure accurate storage. A LIMS can track the supply through its usage and associate it with specific analytical tests for which inventory items are utilized. As products begin to expire, a LIMS can notify technicians to discard the obsolete products.
One unique advantage of a fully integrated LIMS software is the preparation and traceability of working laboratory standards. A software solution for food labs can assist a technician in preparing standards by determining the concentration of solvents needed based on the input weight from a balance. Once prepared, LIMS prints out a label with barcodes and begins the supply traceability process as previously discussed.
Quality Assurance of Test and Calibration Data
This section of ISO 17025 pertains to the validity of a laboratory’s quality system including demonstrating that appropriate tests were performed, testing was conducted on properly maintained and calibrated equipment by qualified personnel, and with appropriate quality control checks.
Laboratory Personnel Competency
Laboratory personnel are assigned to a specific scope of work based upon qualifications (education, training and experience) and with clearly defined duties.7 This process adds another layer to the validity of data generated during analysis by ensuring only appropriate personnel are performing the testing. However, training within a laboratory can be one of the most difficult components of the accreditation process to capture due to the rapid nature in which laboratories operate.
With a food LIMS, management can ensure employees meet requirements (qualifications, competency) as specified in job descriptions, have up-to-date training records (both onboarding and ongoing), and verify that only qualified, trained individuals are performing certain tests.
Calibration and Maintenance of Equipment
Within the scope of ISO 17025, food testing laboratories must ensure that data obtained from analytical instruments is reliable and valid.5 Facilities must maintain that instruments are in correct operating condition and that calibration data (whether performed daily, weekly, or monthly) is valid. As with laboratory personnel requirements, this element to the standard adds an additional layer of credibility that sample data is precise, accurate, and valid.
A fully integrated software solution for food labs sends a notification when instrument calibration is out of specification or expired and can keep track of both routine internal and external maintenance on instruments, ensuring that instruments are calibrated and maintained regularly. Auditors often ask for instrument maintenance and calibration records upon the initiation of an audit, and LIMS can swiftly provide this information with minimal effort.
Figure 2. A preconfigured food LIMS to manage instrument calibration and maintenance data. (Figure courtesy of CloudLIMS)
Measurement of Uncertainty (UM)
Accredited food testing laboratories must measure and report the uncertainty associated with each test result.8 This is accomplished by using certified reference materials (CRM), or known spiked blanks. UM data is trended using control charts, which can be prepared using labor-intensive manual input or performed automatically using LIMS software. A fully integrated food LIMS can populate control data from the instrument into the control chart and determine if sample data analyzed in that batch can be approved for release.
Valid Test Methods and Results
Accurate test and calibration results can only be obtained with methods that are validated for the intended use.5 Accredited food laboratories should use test methods that are current and contain embedded quality control standards.
A LIMS for food testing labs can ensure correct method selection by technicians by comparing data from the sample accession input with the test method selected for analysis. Specific product identifiers can indicate if methods have been validated. As testing is performed, a LIMS can track time signatures to ensure protocols are properly performed. At the end of the analysis, results of the quality control samples are linked to the test samples to ensure only valid results are available for clients. Instilling checks at each step of the process allows a LIMS to auto-generate Certificates of Analysis (CoA) knowing that the testing was performed accurately.
Data Integrity
The foundation of a laboratory’s reputation is based on its ability to provide reliable and accurate data. ISO 17025:2017 includes specific references to data protection and integrity.10 Laboratories often claim within their quality manuals that they ensure the integrity of their data but provide limited details on how it is accomplished making this a high priority review for auditors. Data integrity is easily captured in laboratories that have fully integrated their instrumentation into LIMS software. Through the integration process, data is automatically populated from analytical instruments into a LIMS. This eliminates unintentional transcription errors or potential intentional data manipulation. A LIMS for food testing labs restricts access to changing or modifying data, allowing only those with high-level access this ability. To control data manipulation even further, changes to data auto-populated in LIMS by integrated instrumentation are tracked with date, time, and user signatures. This allows an auditor to review any changes made to data within LIMS and determine if appropriate documentation was included on why the change was made.
Sampling
ISO 17025:2017 requires all food testing laboratories to have a documented sampling plan for the preparation of test portions prior to analysis. Within the plan, the laboratory must determine if factors are addressed that will ensure the validity of the testing, ensure that the sampling plan is available to the laboratory (or the site where sampling is performed), and identify any preparation or pre-treatment of samples prior to analysis. This can include storage, homogenization (grinding/blending) or chemical treatments.9
As sample information is entered into LIMS, the software can specify the correct sampling method to be performed, indicate appropriate sample storage conditions, restrict the testing to approved personnel and provide electronic signatures for each step.
Monitoring and Maintenance of the Quality System
Organization within a laboratory’s quality system is a key indicator to assessors during the audit process that the facility is prepared to handle the rigors that come with accreditation.10 Assessors are keenly aware of the benefits that a food LIMS provides to operators as a single, well-organized source for quality and technical documents.
Document Control
An ISO 17025 accredited laboratory must demonstrate document control throughout its facility.6 Only approved documents are available for use in the testing facility, and the access to these documents is restricted through quality control. This reduces the risk of document access or modification by unauthorized personnel.
LIMS software efficiently facilitates this process in several ways. A food LIMS can restrict access to controlled documents (both electronic and paper) and require electronic signatures each time approved personnel access, modify or print them. This digital signature provides a chain of custody to the document, ensuring that only approved controlled documents are used during analyses and that these documents are not modified.
Figure 3. A software solution for food labs helps manage documents, track their revision history, and ensure document control. (Figure courtesy of CloudLIMS)
Corrective Actions/Non-Conforming Work
A fundamental requirement for quality systems is the documentation of non-conforming work, and subsequent corrective action plans established to reduce their future occurrence.5
A software solution for food labs can automatically maintain electronic records of deviations in testing, flagging them for review by quality departments or management. After a corrective action plan has been established, LIMS software can monitor the effectiveness of the corrective action by identifying similar non-conforming work items.
Conclusion
Food and beverage testing laboratories are increasingly becoming accredited to ISO 17025. With recent changes to ISO 17025, the importance of LIMS for the food and beverage industry has only amplified. A software solution for food labs can integrate all parts of the accreditation process from personnel qualification, equipment calibration and maintenance, to testing and methodologies.11 Fully automated LIMS increases laboratory efficiency, productivity, and is an indispensable tool for achieving and maintaining ISO 17025 accreditation.
Perry Johnson Laboratory Accreditation (2019). An Overview of Changes Between 17025:2005 and 17025:2017. ISO/IEC 17025:2017 Transition. https://www.pjlabs.com/downloads/17025-Transition-Book.pdf
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