Paul Damaren

The New Era of Quality Management Solutions

By Paul Damaren
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Paul Damaren

Food businesses must prioritize safety and quality by taking every known precaution to protect their foods, customers, employees, and businesses. The most effective way for food brands to ensure safety, quality, and compliance is to use technology to elevate their quality management programs.

Technology, including artificial intelligence (AI), the Internet of Things (IoT), blockchain, and machine learning, can make food significantly safer by improving food safety protocols, quality control, compliance, and supply chain management.

The Importance of Quality Management

Whether you’re a processor, manufacturer, distributor, retailer, or other food business, you must ensure that your safety and quality practices are consistent and properly maintained. And you must confirm that all employees follow gold standard safety protocols to minimize risks and maximize safety. But that isn’t enough on its own. You must also manage your entire supply chain to be certain that foods are safe and proper protocols are followed through every step of the journey.

Businesses need to maintain high-quality standards while also scaling production, introducing new products, providing exceptional customer service, and meeting evolving consumer demands. That’s no small feat! Fortunately, several tech tools now exist that can help food brands elevate their quality management programs and safety efforts.

Quality Management Tools Have Improved Dramatically

The way that organizations manage their food safety and quality programs has improved significantly over the years. Savvy food businesses have ditched their manual paper systems due to drawbacks such as being unable to provide real-time, integrated data across an enterprise. Manual systems also come with compliance risks, as employees could do sloppy or incomplete work on inspections, audits, and safety checks — or skip them altogether. Tech solutions offer more efficient and accurate ways to conduct and track quality management programs.

Food businesses should rely on digital quality management solutions that:

  • Are made specifically for the food sector, addressing food brands’ unique challenges and needs.
  • Are comprehensive, offering audit management, compliance tracking, risk assessment, supplier quality management, and quality control in one easy-to-use solution.
  • Include mobile auditing features to enhance on-site inspection efficiency, which is crucial for maintaining quality in fast-paced environments.
  • Feature compliance and reporting capabilities to ensure adherence to the latest regulatory requirements.
  • Allow brands to manage their suppliers, ensuring everyone is committed to the highest safety and quality standards, as any weak link in the supply chain can jeopardize the integrity of the food, leaving end-users vulnerable.

Technologies To Elevate Quality Programs

The integration of technology in the food sector has been exciting, and we have learned much about which technologies offer the greatest benefit. Some of the most valuable solutions include:

  • Busy food brands can leverage automation to reduce administrative burdens and time-consuming tasks and improve efficiency, consistency, accuracy, and productivity.
  • AI and machine learning. These solutions offer predictive maintenance of equipment, quality control, and yield optimization, and give business owners critical, real-time data to drive more informed decision-making. Additionally, machine learning algorithms can predict food safety risks based on various parameters, such as storage conditions and handling.
  • IoT devices monitor safety and quality parameters, including temperature, humidity, and vibration to identify and either resolve or alert companies to safety and quality risks. IoT provides constant feedback, so food brands can quickly prevent (or remediate) safety breaches and quality degradation.
  • Blockchain can provide food authentication through increased transparency and enhanced food traceability. Food brands can leverage blockchain technology to ensure the food they’re getting is safe, authentic, and high-quality. Blockchain can trace food back to its source to prevent food fraud, increase food safety, and improve recalls in the event of a safety breach.

A New Era of Food Safety & Quality Software

As these technologies have made their way into the food industry, we are seeing continuous improvement in quality management tools, including:

  • More comprehensive functions. When multiple functions are packaged together in a single intuitive solution, it allows food brands to streamline their quality management processes, aligning with industry-specific requirements.
  • More robust compliance management. Additional compliance management features help brands better understand ever-evolving regulations and adhere to stringent safety standards. And that’s reassuring for customers and end-users, including the retailers that sell the products, the restaurants that serve them, and the consumers that eat them.
  • Focus on supply chain management. Supply chain management has seen a technological overhaul around quality assurance, providing more transparency and traceability from farm to fork. Focusing on every point across the supply chain is crucial in an industry where the quality of the end product is directly influenced by the quality of the sourced materials.
  • Mobile auditing. Mobile auditing solutions within quality monitoring programs allow organizations to facilitate real-time data collection and reporting, a critical factor for onsite inspections in food production, processing, manufacturing, and retail environments.
  • Accessible for all. As tech solutions have become more affordable, accessible, scalable, and user-friendly, they have become more attainable for food businesses of all sizes and budgets. While some brands may worry that digital quality management solutions require significant investment, think of the ROI you’ll receive by avoiding brand damaging and expensive safety and quality breaches.

Digital quality management solutions have become essential for every food business, allowing brands to avoid costly, damaging breaches. Food businesses would be wise to adopt and embrace this new era of quality management solutions to maximize safety, minimize risks, and demonstrate their commitment to quality and compliance.

Emily Newton, Revolutionized Magazine

Technologies To Prevent Microbial Contamination in Dairy Production

By Emily Newton
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Emily Newton, Revolutionized Magazine

Although milk is among the most regulated food products in the nation, microbial contamination remains a long-standing pain point. Milk products can become tainted at every stage in the production process. Microbial contamination renders farmers’ yields worthless, sharply increases production facilities’ financial losses, and backs up production.

Early spoilage is likely if microorganisms such as Pseudomonas fluorescens and Streptococcus aren’t caught in time. Illnesses caused by Listeria monocytogenes, E. coli and Campylobacter will occur if timely recalls are not issued. In the event of a recall or contamination event, the brand’s reputations and relationships with manufacturers will be damaged, and affected consumers may seek legal or regulatory action. Fortunately, emerging dairy industry technologies can help prevent microbial contamination in novel ways.

Common Microbial Contaminants in Dairy Production

Microbial contaminants take many forms in the dairy industry, as milk’s complex biology can conceal pathogenic molds, bacteria, and yeasts. Listeria monocytogenes, E. coli, Campylobacter and Pseudomonas fluorescens are some of the most common microorganisms present in dairy products.

Biofilms — microbial cells that adhere to a surface to reproduce — are a relatively overlooked source of contamination. Biofilms can persist on equipment throughout the processing chain and lead to continuous contamination, if left unchecked, highlighting the importance of proactive cleaning and maintenance.

Sources of Microbial Contamination in Dairy Production

Microbial contamination can come from dairy cattle, transport, equipment, and production staff. Virtually every stage in the process — from farmer to consumer — offers opportunities to introduce a potentially lethal contaminant.

Water used during handling and processing is one of the most prominent sources of microbial contamination. Microorganisms present in the water can contaminate food manufacturers’ equipment, tainting every product in a batch. Additionally, dairy cattle may drink from sources with high bacterial loads and produce unclean milk. Dairy cattle can consume or interact with microorganisms that cause infections and diseases. Mastitis — often caused by E. coli, Streptococcus dysgalactiae and Streptococcus uberis — is a common disease in dairy cows that can lead to production of tainted milk.

Dairy farmers who attempt to remedy dairy cattle’s ailments could cause further issues. While labs often catch and reject antibiotic-resistant bacteria, their methods are not 100% accurate. These failures highlight the need for thorough detection and treatment methods.

If milk makes it to a facility untainted, poor facility management can lead to contamination. Equipment covered in biofilm or immersed in liquids with high bacterial loads will taint the product on the production line. Poor or inadequate hygiene practices among production staff, such as wearing contaminated shoes or forgetting to wash their hands, can also lead to contamination of milk products.

Technologies That Combat Contamination

Research teams and industry experts have been working hard to develop new technologies to reduce the risk of microbial contamination. Following are some of the novel dairy industry technologies that are making products safer from farm to fork.

Ultrasonication. Ultrasonication cavitation is an emerging technology that can help to prevent microbial contamination. This noninvasive treatment method is cost-effective and environmentally safe to deploy. It can measure microorganisms in milk products, destroy microbials, reduce allergens, and improve enzyme inactivation. 

Thermal Biosensors. Researchers recently developed a thermal biosensor capable of onsite microbial detection. They describe it as an easily scalable, cost-effective prescreening tool. The sensor identifies high bacterial loads including Klebsiella pneumoniae and Staphylococcus aureus. It is most effective when used in tangent with other methods and technologies.

Pulsed Electric Fields. A pulsed electric field (PEF) is a nonthermal treatment that disrupts microbial growth. It uses irreversible electroporation to target and interrupt microorganisms’ reproduction while preserving milk products’ nutritional and sensory characteristics. However, researchers note that PEF-treated dairy might have a shorter shelf life.

Cold Plasma. Cold plasma is a coating technology that inhibits biofilm formation and repels microorganisms. It can detect toxins and improve enzyme inactivation. One case involving sheep’s milk resulted in a 94.2% reduction in bacterial count. Dairy production facilities can also use it to decontaminate and sterilize equipment. Notably, it causes less degradation over time than wet chemical treatments.

Emerging Technologies Entering the Dairy Industry

In addition to the technologies mentioned above, there are two emerging technologies that may reshape how the dairy industry addresses risks of microbial contamination:

Patch-Based Biosensors. Researchers have developed a new patch-based device to prevent microbial contamination. All food manufacturers must do is place this tasteless, food-safe sticker inside their containers. An internal biosensor then detects and repels unwanted microorganisms automatically. This technology can be modified for specific pathogens.

While this technology is still in development, multiple peer-reviewed studies have highlighted its capabilities. Some variants of the patch-based biosensor can react to bacterial growth within 72 hours or less. Various research teams have created mechanical, electrochemical and bioluminescent sensors to explore this technology’s full potential.

Electron Beam Irradiation. Electron beam irradiation (EBI) is a nonthermal treatment that has numerous advantages over traditional thermal decontamination methods. It is faster, more environmentally friendly and has a lesser impact on milk products’ nutritional values.

Although EBI is new to the dairy industry, it has a long history as a food production and agriculture sterilization tool. The FDA evaluated it for three decades and deemed it safe, approving it for numerous applications. With further testing, milk products will soon follow suit.

EBI decreases contamination in raw milk samples by inactivating potentially harmful pathogenic bacteria. It reduces microbial infection risks to fewer than one out of 9.7 million people when processing at a 2 kGy dose. It leaves no chemical residues and does not alter products.

This technology has the potential to drastically reduce the microbial load in milk products while maintaining desired characteristics. Although EBI lowers the vitamin B2 content of pasteurized milk by about 32%, it remains within the USDA’s nutritional guidelines. EBI’s effectiveness increases substantially if production facilities combine it with other tools.

Most professionals understand new, advanced tools are essential. Realistically, conventional methods are quickly becoming outdated and pose significant safety gaps. Production facilities that leverage the latest dairy industry technology can prevent microbial contamination to deliver safer products to processors and consumers

Olvia Pitts

Internal Audit Planning: The Key to a Successful Audit Program

By Olivia Pitts
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Olvia Pitts

The first step in internal audit planning is to understand the process and the available resources. The format and structure of the internal audit program will vary between organizations. Factors such as company size, culture, and staffing play a significant role in the development of the program structure. Auditing requires time and commitment to be effective. Top management should be involved in this process to ensure there is a clear understanding of the level of commitment needed across the site. This activity can be incorporated into annual strategic planning meetings or through the management review process. Participants should include members of top management and relevant support staff.

Once the team is gathered, discuss the options and identify the preferred structure. This is a great time to discuss needed resources and identify a point person to oversee the program. Though not a standard requirement, identifying someone to manage the program provides high-level visibility of the overall effectiveness. Responsibilities may include oversight of internal audit scheduling, auditor training, and maintenance of records. Having someone dedicated this role will help to ensure that the program is being managed as expected.

Continuing education around the process is vital to ensure everyone is in alignment. This includes education for both top management and plant staff. All employees should be aware of the audit program activities regardless of their level within the organization. Developing a format for driving awareness helps to reduce any fears around participation in audits as an auditee. Individuals who are unaware of the format and structure will often avoid being interviewed for fear of saying the wrong thing. These types of issues can be resolved by sharing the message that internal audits are a way to improve current processes and procedures. They are not intended to be a fault-finding activity but rather a way to grow.

Business is constantly changing thus resulting in events that may impact the internal audit program. A process review is not a one-time activity. Be sure to set aside time, at least annually, to review the overall format and structure of the program. Identify areas that need improvement and celebrate areas of success. Remember the program needs to work for each individual organization. Adapting and changing to fit the needs of the team should be expected, especially in the early days of the internal audit program.

Utilize Auditing Tools

The proper adoption of auditing tools will provide significant benefit across the auditing program. Tools often used in auditing include the sitewide audit schedule, audit plans, and audit checklists. By implementing these tools, the audit program becomes streamlined reducing confusion and driving the program to success.

Audit scheduling is made up of two parts. It includes the overall schedule for the entire organization and the individual audit schedule otherwise known as the audit plan. The sitewide audit schedule should encompass each functional area within the scope of the management system, while the individual audit plan should detail the specific areas being audited. Developing these two documents requires input from the entire management team. This should not be a task that is undertaken alone. Involving team members aids in spreading awareness of the needs and expectations around the audit program. The management team should be provided with clear expectations around the timing needed for each audit. This information not only allows the plant staff to prepare for visitors within their areas but also establishes a collaborative approach to internal auditing. When determining the timing for each of the audits, the team should provide an overview of what processes and records will be reviewed and the number of interviews needed. This information provides an outline for time and resources needed for each audit. Considerations should be made for unexpected delays or the need for special accommodation requirements due to production demands. This may require scheduling during specific times or bringing in additional support staff to support the production lines during the audit. By taking time to review potential issues upfront, the risk of audits being cancelled or delayed is greatly reduced.

For those areas identified as potentially challenging it’s a good idea to build the sitewide schedule so that it allows for flexibility. This may include scheduling higher risk audits earlier in the year to build in more time, or allowing the department manager to provide the preferred audit dates. When developing the schedule be careful not to overload with an extensive number of audits. There should be an adequate balance to avoid potential issues. The auditing structure can be set up in a variety of formats. Some organizations choose to audit by department, while others prefer reviewing by process to capture a cross-functional view. Both formats can be used to confirm conformance to established requirements. Identify the requirements and the records needing review to determine the logical format for the organization. The key is to allow ample time to cover the entire scope of the individual audit. Keep in mind additional time may need to be built into areas that require lengthy transit times to arrive in the audit area.

Once the overall audit schedule has been established, the next step is developing an audit plan. This critical step is often overlooked to save time; however, having an audit plan is the true time saver. It helps to set the framework for the audit and aids the auditor in developing a clear understanding of what needs to be reviewed. A well-developed audit plan will include a timeline, processes being audited, auditee and applicable standard or internal documentation references. By outlining this information, the auditor will develop a clear path for the audit. The audit plan can also be shared with auditees to provide communication around expectations and requirements going into the audit.

The audit checklist is another valuable tool available to the auditor. A checklist should include such details as the scope, objectives, focus area and questions for the auditee. This tool helps the auditor stay focused and remain on track throughout the audit. Once developed, audit checklists can be reused and adapted for future audits. The checklist should be written to focus on the overall process being audited. Be sure to include both standard requirements and requirements related to internal processes and procedures of the organization. A well-developed checklist contains a mix of process specific and high-level management system questions focused on the overall system. The high-level questions can target such areas as quality policy, quality objectives document control and continual improvement. By creating and reviewing the audit checklist prior to the audit the auditor will be prepared and efficiently utilize their time.

Support the Audit Team

The most effective way to support the audit team is to ensure top management finds the audit program beneficial to the organization. Strong support from top management will empower the audit team and encourage them to drive change. When developing a new internal audit program ensure that the top management team is aware of the resources needed to develop the program. Help them to understand the time commitment and explain any disruptions the audits may cause in the daily activities. By communicating this information up front the risk of audits being delayed due to constraints related to management will be significantly reduced. As the program progresses, provide updates on status of the audits and actions implemented. This will help to reinforce the continuous improvement mentality and demonstrate the value of the program.

Holding frequent meetings with the audit team will help to drive the importance of the audit program. It will also help to identify potential issues with scheduling and clarify any misunderstandings. These meetings can also be used to educate auditors about the standard or internal requirements. Limit the meeting to an hour or less to maintain the interest of the audience. As auditors work through the audit process, they may need additional help preparing audit plans and audit checklists. Encourage the team members to work together and learn from each other. Becoming a skilled auditor takes practice. Encourage the audit team at a minimum to participate in audits quarterly. As the team grows, provide feedback on their progress and achievements that have been accomplished. Feedback is crucial in building the confidence of internal auditors and the overall audit program.

Providing communication and awareness to the entire organization around the audit program is an important element of supporting the team. Many employees know little about the program unless directly as a part of their role. Auditing requires an extensive amount of work and time commitment. Often the role is voluntary or an addition to the employee’s current role. It’s imperative that the management team acknowledge the workload required of those asked to conduct and participate in audits. This will provide the auditors and auditees with a sense of appreciation for their efforts, thus resulting in a workforce with a committed focus on continual improvement.

Be Consistent

Developing a strong internal audit program does not happen overnight. Instilling audit planning into the internal audit program will provide organization-wide success. Ensure that the team has a full understanding of the process and encourage the use of auditing tools across the organization. When issues occur be willing to change course and adapt as needed. Internal audit programs are ever changing and will need consistent maintenance to be the most effective. Through the support of top management and the utilization of these valuable concepts a strong foundation can be established. Be consistent and positive results will follow.

Liz Figueredo

Preparing for the USDA Strengthening Organic Enforcement Rule’s Implementation

By Liz Figueredo
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Liz Figueredo

Businesses in the organic food supply chain have just weeks to prepare for the upcoming implementation of the United States Department of Agriculture (USDA)’s Strengthening Organic Enforcement (SOE) Rule. This updating regulation, which goes into effect on March 19, 2024, aims to fortify the integrity of USDA organic products. From manufacturers to retailers, businesses across the supply chain must adjust their procedures and practices to comply with the updated rule.

The SOE Rule calls for the implementation of more rigorous certification practices for various types of businesses, including key links in the organic supply chain such as importers, exporters, brokers, traders and storage facilities. Because these organizations have not historically been required to be certified, it’s likely there will be an increase in last-minute organic certification applications. To accommodate the incorporation of these new entities, USDA-accredited certifying agents are now offering expanded services, including on-site inspections with enhanced authority to prevent fraud and non-compliance.

Changes Throughout the Supply Chain

Business activities that encompass any form of aggregating, culling, packaging, repackaging, storing or related processes of USDA organic products are now required to obtain certified organic status. In addition to a broader spectrum of handlers throughout the supply chain requiring certification, low-risk businesses in the exempt category must still adhere to stringent contamination prevention protocols and maintain meticulous records. This underscores the integral role of record-keeping and anti-fraud systems throughout the supply chain. To find out if your business should seek organic certification, try NSF’s interactive online decision tree tool.

Next Steps to Compliance

The USDA estimates that 1,000 domestic businesses will need to achieve organic certification prior to the Rule going into effect. Businesses must work with an independent, third-party certification body that is accredited by the USDA, such as Quality Assurance International (QAI), an NSF company, to secure certification. Once certified, labels—including non-retail and bulk labels—must be updated to demonstrate compliance.

The organic certification process involves completing an application, submitting documentation, an on-site inspection and technical review. To achieve certification, the applying business must resolve any noncompliances in a timely manner. After successfully completing the inspection and technical review process, the business will receive an official, numbered certificate and can then use the organic mark on its product labels. The certificate will also be added to the Organic Integrity Database and will be downloadable by the public. Each certificate includes a Scope and Product Summary Addendum.

The SOE Rule also calls for a mandatory electronic National Organic Program (NOP) Import Certificate for any organic product entering the US, regardless of the country of origin.

A crucial component of compliance with the Rule is creating or updating an Organic Systems Plan (OSP). An OSP acts as both an economic management tool and a contract between certifiers and certified operations and comprises a description of practices, list of substances, monitoring practices, recordkeeping systems, contamination prevention plans and specific information pertaining to an operation. This document safeguards organizations through supply chain traceability and organic fraud prevention procedures and is required for organic certification.

In addition to the requirements for businesses under the SOE Rule, USDA–accredited certifiers will provide enhanced oversight through possible unannounced inspections, inspector training, trace-back and mass balance audits, and new rules specifically for grower groups.

QAI and NSF offer a free SOE Rule toolkit to support organizations across the supply chain. The toolkit includes an interactive decision tree, FAQs, readiness checklist and links to educational webinars.

Jennifer Allen

Consumers: A New Food Labeling Authority

By Jennifer Allen
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Jennifer Allen

Pop quiz. Who regulates food? You’re probably going through an alphabet soup of agencies in your head right now, and you wouldn’t be wrong. FDA, USDA, FTC, state and local agencies, all play a role in regulating the food we eat. But how many of you thought of the consumer? In recent years, consumers have increasingly become a de facto regulatory agency by harnessing the power of the courts. Statements on your labels that may pass muster with FDA and other agencies are falling afoul of consumer expectations, and consumers are seeking, and sometimes obtaining, redress in the courts. Although there have been some more promising rulings lately suggesting that some courts at least are beginning to rein in these types of claims, food manufacturers should nevertheless be vigilant.

Take, for example, the case of Mantikas v. Kellogg Company. There, a group of consumers sued the manufacturer of Cheez-It crackers. The crackers were available in a version that contained the language “Whole Grain” in large font in the middle of the principal display panel, with smaller language stating “Made with 8G of whole grain per serving” in the corner. But the ingredients panel showed that enriched white flour was the primary ingredient. The Second Circuit Court of Appeals held that the consumers had stated a claim under their states’ consumer protection laws. Even though the product did in fact contain 8 grams of whole grains, and even though the consumer could look to the ingredient panel to learn that the primary ingredient was white flour, the court explained that the purpose of the back and side panels is to offer more detailed information than that on the front panel, not to correct a misconception caused by a misleading representation on the front panel. The “whole grain” representation was clearly intended to mislead the consumer into believing that the product was made predominantly or entirely with whole grains when that was not in fact true. The fact that the consumer could figure that out by reading the ingredients panel was not enough to satisfy the court.

Consumers are also on the attack against terms like “real,” “natural,” “good for you,” “pure,” and “wholesome,” terms that are not explicitly regulated by FDA. What each of these terms has in common is that they are vague and hard to prove or disprove. What does “real” even mean? Under one definition, all food is real unless it’s the plastic food in a child’s toy box. Cyanide is natural, and may even be pure, but we wouldn’t want to eat it. And almost everything we eat could be good for us in the sense that it helps stave off starvation. You see where I’m going with this. These terms are wildly open to interpretation, and the chances of you and your consumer interpreting them the same way are slim. Better to stick to narrower terms that you can substantiate. For example, you might say that your popsicles are flavored with the juice of real fruit, though, like Cheez-Its, beware of making that claim if the majority of the flavor is not from real fruit juice.

And consumer suits go way beyond the content of the product. Take, for example, the case of Broomfield v. Craft Brew Alliance, Inc. In that case, a group of consumers sued over labeling that deceived them into believing that Craft Brew’s beer was made in Hawaii. While the defendant did manufacture beer in Hawaii, the beer it sold on the mainland was made on the mainland. The court sided with the consumers. While pictures of surf boards and the phrase “Liquid Aloha” weren’t enough to make the case, Craft Brew went far beyond that, with a map of Hawaii depicting the location of its brewery, a Hawaiian address, and an invitation to visit the brewery when in Hawaii.

So what’s a manufacturer to do? When coming up with that enticing label, first, think like a consumer. What might that consumer believe or, at least, what might they be able to convince a court that they believed? Second, conduct a risk/benefit analysis. Is that “all natural” label expected to generate enough extra sales to justify the risk of a consumer lawsuit. Finally, ask your attorney to check on the existing legal landscape. Has another manufacturer run into legal problems using the very same language you want to use? If so, did the court suggest ways in which the manufacturer could have cured the problem? If in doubt, use specific, verifiable statements over vague pronouncements of “healthiness.” And above all, don’t play games with the consumer. If you’re trying to make your product look healthier than it is, there are plenty of plaintiffs’ lawyers ready and waiting to challenge you in court.

Bob Lijana

Checklists: Useful Tools or Traps?

By Bob Lijana
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Bob Lijana

Everyone knows a “checklist” when they see it: a systematized tool that lists things, components, steps or criteria whose presence or quantitative amount are essential to the performance of a specific task. The order of items in a checklist may or may not be critical in terms of the sequence of tasks which need to occur.

Checklists serve the wonderful purpose of identifying the important and critical steps needed to manufacture fresh food, fly a plane, perform a surgery or run a nuclear plant. They serve the purpose of helping to make sure that no important step is forgotten, and all critical steps are performed in the right order. Having a high “checklist intelligence” means that checklists are used proactively and dynamically, and that they drive continuous improvement in practices and procedures. And this occurs regardless of personal or organizational biases.

Let’s review some of the published literature on checklists.

A popular book on checklists is “The Checklist Manifesto” (Picador, 2009) by surgeon Atul Gawande. As noted in the book, checklists are very useful when there is a lot to get right, that is, when there is a high degree of complexity for certain actions. For example, commercial airplanes have “become too much airplane for one person to fly.” Hence, the industry uses a number of checklists, especially pre-flight, to address possible risks before the airplane takes to the air. Food manufacturing is similar, especially given its impact on public health.

A distinct disadvantage is that checklists can drive a tyranny of the urgent, i.e., simply checking a box to be done with it.

A distinct advantage of checklists is that they can be built by the “wisdom of a group” of experienced people, and therefore do not rely solely on a single individual’s memory or experience base. A distinct disadvantage is that checklists can drive a tyranny of the urgent, i.e., simply checking a box to be done with it.

Western Michigan University (2017) has an Evaluation Checklist Project with a number of excellent resources showing how to develop checklists for evaluating programs and projects. These include a “checklist for formatting checklists” and scholarly presentations on the logic behind checklists. Their suggestions can easily be re-applied to the food industry.

There are many published articles which address bias in decision making. For example, Ely et al. (2011)[1] studied the use of checklists to reduce diagnostic errors in hospitals, clinics and emergency rooms. Of note, the authors delve into cognitive processes to identify the inherent biases and reliance on intuition that often drive decision-making. They remind checklist developers to take into account “Type 1” thinking processes which are fast, reflexive and intuitive (and usually subconscious) and “Type 2” processes which are analytic, slow and deliberate (and usually take very focused attention).

Application of Checklists in the Food Industry

Checklists are widely used in the food industry. The USDA (2014) has a label submission checklist that helps companies avoid common labeling mistakes, and clarifies what is needed. The agency also has a guideline checklist for the cooking of meat and poultry products.

In 2020, FDA published an Employee Health and Food Safety Checklist in response to the COVID-19 pandemic. In 2001, the agency developed the Allergy Inspection Guide, a checklist for inspection of food companies which manufacture products potentially susceptible to contamination by allergenic ingredients, and now has a draft guidance/checklist for evaluating the public health importance of allergens.

Employees in factory

In the food manufacturing setting, companies often conduct their FSMA-related GMP audits by having employees walk around the plant using a checklist of equipment, documents and practices to look for. Companies making prepared foods have checklists that operators must follow to ensure that proper cooking and cooling procedures have been followed (these are also called SOPs, or Standard Operating Procedures, which are, in essence, checklists). Similarly, sanitation teams follow strict SOPs/checklists to ensure the right sanitizers are used in the right concentrations and for the right durations. Line changeovers often use checklists to prevent allergen cross-contamination. The same is true for pre-production equipment assembly. And product development/chef teams use checklists to ensure that the right ingredients are used, with proper consideration given to allergens, glutens, GMOs and organic product needs.

Finally, some of the most widely used checklists in the food industry are standards, including those developed by the Global Food Safety Initiative (GFSI), Safe Quality Foods (SQF) and the British Retail Consortium Global Standard (BRCGS).

Checklists as an Indicator of Food Safety Audit Maturity

Companies going through the GFSI certification process (e.g., SQF) often follow a three-phase audit maturation process that highlights how checklists can help or hinder food safty. In the first phase, the company is new to the process and therefore may not have systems in place to handle all of the requirements inherent to the standard. Thus, the company may “shotgun” their approach based on where they think they have gaps (by their own evaluation and/or with the help of third-party consultants). In this phase, the SQF Code may not be looked at in its totality nor in its intent, and certain requirements may be looked at as more important than others (with the insidious side effect of some requirements being missed).

In the second phase of the growth curve, the company recognizes that the food safety requirements are laid out in a very organized and helpful manner: the SQF Code. They realize that if they can match each requirement in the code with practices and procedures, then they can essentially use the code as a checklist. Many companies in this phase build their programs and their audit readiness exactly in the order of the code, and solely to meet the specific requirements detailed in each section of the Code. This ensures that when the SQF auditor comes in, the company will have addressed each and every requirement. This approach serves those companies well who are still in the learning phase of building a strong food safety plan and food safety culture, and generally helps most companies “pass” their food safety audit.

The right culture drives the right entries on the checklists. Not the other way around.

All is well until there is a food safety incident, trade withdrawal or public recall, which can happen in spite of a company checking every box on the SQF “checklist.” A major negative event, or even the recognition that such an event could happen, can therefore rightly push a company into the third phase of using the SQF Code.
In the third phase, a company uses and views checklists as valuable tools (and likely still structures its audit readiness in the same order as the SQF Code). However, the company has critically realized that it needs to go beyond checklists to drive the right food safety culture in the organization. Additional practices, procedures, documentation and systems are put in place to drive the right culture. These in turn make sure that the checklists get checked. Said another way, the right culture drives the right entries on the checklists. Not the other way around.

A Checklist for Checklists

Let’s consider creating a checklist for checklists. Each of the following provides perspective on the value, and the warnings, of using checklists to drive and improve an organization’s food safety culture and therefore its “checklist intelligence.”

Checklists Can Speak the Truth. If the results from a completed checklist are pointing out significant issues, then at the basic level the checklist is working. This is not a time to alter the checklist, which can happen in low-maturity organizations as a way to hide an issue, or an excuse to fill out the checklist incompletely. Rather, complete results should be heralded as validation that the checklist is performing as it should.

Learn From Failures. Something going wrong despite the use of a checklist is a good clue that the wrong things are being checked or that something is missing. This should be discussed broadly and cross-functionally and drive a root-cause analysis, which can markedly point out what got missed, which in turn allows for continual improvement of the checklist.

There Is No “One-Off.” All experienced auditors have heard “this is the first time that this has happened.” Or “there are many unusual things going on at the same time, and this caused the issue; it won’t happen again.” There is no one-off! A root cause analysis should be performed. Checklists must be able to help the organization identify and diagnose root causes.

Check the Checker. Is the person filling out the checklist being driven by the checklist to look for the right food safety behaviors, or is the person merely checking the boxes since that’s the job? Perhaps more insidious, employees might follow a checklist quite diligently—observing just those tasks which are on the list—yet miss faulty or risky behaviors. This may not be the fault of the checklist, but it is certainly the fault of the organization and its training. Relying solely on a checklist can still allow egregious and unwanted behaviors. If the employees are trained only to follow the checklist and make sure it gets filled out, significant untoward behaviors get missed. In this regard, checklists become shackles.

Checklist

Check the Documents. Critical to some checklists are documents which are meant to substantiate that a particular task on the checklist was taken care of. The utility of these documents is only as good as the value of having them on the checklist to begin with. Time must be taken to identify which procedures or cooking logs, for example, need to be checked as part of a checklist. This is independent of having these documented as part of the organization’s food safety plan.

Honor the System. Checklists are just that: lists. They are not roadmaps, graphs or linkages to knowledge bases. They are static, rather than dynamic systems that drive action and resolution of issues. In general, checklists can be ill-equipped to capture systemic behaviors and the culture of an organization. This is especially true if the checklists are from a third-party and/or have not been adapted to specific organizations and facilities. Hence, checklists should be used for what they can bring—no more, no less.

The Law of Unintended Consequences. An oft-quoted phrase is “you get what you measure.” And this is certainly in play for checklists. If the item on the checklist is wrong, or is directing the wrong behavior, measuring it regularly could serve the unwanted purpose of instilling that behavior as “correct.”

Defeating the Checklist

By now you realize that checklists in the food industry can serve as a crutch or as a divining-rod for continuous improvement of food safety practices and procedures. Following are some indicators that a checklist is not working or is not as effective as it should be.

Too burdensome. A very common checklist used in food manufacturing is the “GMP audit checklist.” This is typically a long list of behaviors and practices which the organization believes it should be engaging in to meet the GMP regulations and produce safe food. Most organizations commit to conducting such audit checklists as part of their promises to the auditing organization. The list gets longer and gets spread across more functions, and all of this work becomes quite burdensome. When it is time for the GFSI audit, missing or incomplete checklists may get pencil-whipped, leading the auditor to believe that the company has been using the checklists regularly.

Pencil-Whipping. As much as putting false entries on a form is unethical, and usually illegal, it can still occur under the right stressors or employee attitudes. Simply checking the boxes on a checklist does no one any favors and can provide a false sense of security.

Complacency. Organizations that rely on the data from checklists could develop a false sense of security and become complacent about corrective actions. Although not necessarily unethical or illegal, someone checking a box as “complete” just because it always has been in the past is misleading (if not outright wrong) if the checker really did not check. Understanding this risk can help define the items in the checklist, including those things needed to ensure that the checklist checker is focused and paying attention.

Pressure to “get back to work” can be one of the quickest means to defeat a checklist.

Inaccurate documents. Practices and procedures change over time, and often the documents that go along with them do not get updated on the production floor. Continual vigilance is needed to ensure that the most up to date documents are aligned with current practices and the details on the checklist. In fact, one of the items on a checklist might be checking the issue dates of key documents being used by operators.

Stress. Pressure to “get back to work” can be one of the quickest means to defeat a checklist. This could be due to senior management’s communications, a team’s own leadership or individuals believing they need to hurry up so that they can resume their “real job.”

The End-Game: A Game of Checkers

To win at the game of checkers (or draughts), there are a number of strategies which experts often espouse, most of which apply to checklists in the food industry.

Control the center: Focus on the stuff that counts, not the stuff on the edges.

Play offense, not defense: Attack the issues that strive to undermine the food safety program.

The goal is to get to the end of the board: The checklist must be completed in its entirety.

Checker Board

Be willing to sacrifice: If an item on the checklist is not working, take it off.

Advance as a group: Don’t just leave checklists to one group (e.g., QA); build and use them based on input from experts from all functions.

Realizing the value of checklists requires the right culture, rules and execution as well as recognition that checklists are tools to maximize risk identification and risk management. Building your organization’s “checklist intelligence” will help in the development of the checklists, the effectiveness of those checking the checklists and in increasing the assurance of those checking the checkers.

The game never ends, which means that with the right strategy you can win all the time.

References:

[1] Ely, John, Graber, Mark, and Croskeey, Pat (2011): Checklists to Reduce Diagnostic Errors, Academic Medicine, 86:307.

 

Prasant Prusty and Arundhathy Shabu

Know Your Supplier for Better Ingredient Hazard Control and Risk Mitigation

By Arundhathy Shabu, Prasant Prusty
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Prasant Prusty and Arundhathy Shabu

In 2022, more than 80% of businesses encountered at least one major supply chain disruption, while half experienced three or more, and supply chain disruption is anticipated to continue. Supplier management systems are instrumental in minimizing the frequency of disruptions through proactive risk assessment, streamlined communication and robust contingency planning, allowing organizations to maintain operational resilience and continuity in the face of unforeseen challenges. One of the key components of a supplier management system is the supplier qualification program.

A supplier qualification program helps ensure that suppliers adhere to stringent standards and criteria, effectively controlling hazards and mitigating risks tied to subpar product quality, unreliable deliveries and lack of regulatory compliance. These programs foster consistency, reliability and excellence across the entire supply chain by meticulously evaluating and approving suppliers. In this article, we look at some prominent challenges in setting up supplier qualification systems, key facets of supplier management and the future of modern procurement.

Current Challenges in Supplier Qualification Models

In today’s rapidly progressing world, industries operate within a globalized framework, intertwining trade and technology to produce an unprecedented level of connectivity and interdependence that transcends geographical limitations through a harmonious exchange of goods, services and ideas across borders. This global network, however, poses challenges to food processors and distributors, as it requires them to identify and track large numbers of suppliers from greater distances. As a result, there is a new imperative for industries to be able to qualify suppliers that align with their supplier qualification goals on a global scale.

Following are some of the key considerations and challenges facing food companies:

Supply Chain Disruptions. Factors such as natural disasters, global pandemics and escalation of geopolitical tensions may lead to restricted access to vital materials or the closure of significant trade routes, resulting in supply chain disruptions that create limitations, making it difficult to evaluate the credibility of the suppliers.

Supplier Diversity. Supplier diversity refers to actively engaging suppliers owned and operated by individuals from underrepresented groups, such as women, minorities, veterans and individuals with disabilities, with the goal of promoting economic opportunities and cultivating inclusivity in the supply chain. It can present challenges for the supplier qualification process due to the limited pool of qualified diverse suppliers, competitive pricing, bias or skepticism, and equal support for all suppliers.

Regulatory Compliance. Organizations must navigate a complex terrain of regulations and standards that differ across industries and regions to achieve regulatory compliance within supplier qualification models. Compliance obligations encompass various areas, including labor practices, environmental regulations, data privacy and product safety. The continuous challenge lies in adapting qualification models that encompass evolving compliance standards and diligently observing supplier compliance on an ongoing basis.

Supplier Information. The multiple challenges related to supplier data management include the use of different technologies, procedural variations, employee training gaps in handling supplier information, monitoring difficulties, communication limitations and averting risks, such as intellectual property infringement and regulatory and legal compliance issues. Supply managers confront the dual challenge of meeting the growing demand for sharing sensitive data while protecting that data and ensuring a secure system for managing and updating supplier information.

Optimizing Supplier Performance. Once suppliers are qualified, supplier performance management is necessary to ensure compliance and maintain quality standards. There is often a lack of standardization in how suppliers are evaluated, making it tedious to define appropriate performance metrics, collect relevant data and consistently analyze supplier performance. This also makes it challenging to enable objective evaluation, facilitate ongoing supplier supervision and identify which suppliers are underperforming.

Communication & Collaboration. Effective communication is a reciprocal process that requires regular contact and engagement with suppliers at every project stage. Procurement professionals often overlook the importance of building strong supplier relationships and encouraging open lines of communication, which is essential for cultivating sustainable and successful supplier qualification models.

Data Management & Visibility. Controlling data use and distribution becomes challenging when information is dispersed across multiple supplier locations or sub-tiers of the supply base. Consequently, accessing and maintaining a single source of truth regarding supplier information, along with data accuracy, integrity and security is an important, though complex, need.

Scalability. For companies operating in varied markets and dealing with a large number of suppliers, the scalability of their suppliers is critical. A supplier who cannot scale production in response to the buyer’s production cycles and maintain corresponding quality control measures can become a challenge for the buyer.

The Key Elements of Supplier Pre-Qualification

Supplier pre-qualification is a formal process of pre-screening and assessing potential suppliers against a predetermined set of criteria to ensure they have the baseline qualifications to provide a service or product before being accepted as a customer’s supplier and initiating procurement procedures. Only suppliers who meet established criteria are invited to tender. The process also helps in evaluating financial stability, mitigating supply chain risks, keeping an eye on environmental credentials, ensuring sustainability practices and complying with diverse regulations and quality standards.

To adequately pre-qualify a supplier, buyers must consider the following:

Supplier Evaluation Criteria. Organizations must establish benchmarks or specific requirements that suppliers must meet to qualify for participation. These criteria can vary depending on the nature of the procurement, but they commonly include factors such as experience, technical capabilities, financial resources, legal compliance, quality management systems and past performance.

Supplier Documentation and Information. Suppliers must submit documentation and information that provide evidence of their qualifications. These may include company profiles, financial statements, licenses and certifications, regulatory documents, references, product samples and other relevant information demonstrating their ability to meet the organization’s needs.

Supplier Auditing. Submitted documentation and information should be reviewed through supplier auditing as part of pre-assessment or continuous evaluation procedures to assess the suitability of each supplier. This evaluation may involve a review of financial records, conducting site visits, interviewing key personnel and analyzing past performance records. The goal is to gather as much information as possible to determine the supplier’s capabilities, trustworthiness and overall suitability for the procurement.

Risk Assessment. As part of the pre-qualification process, organizations often conduct risk assessments to evaluate the potential risks of engaging each supplier. This assessment may consider factors such as financial risks, legal compliance risks, operational risks and reputational risks. The purpose is to identify and mitigate potential risks of working with a particular supplier.

Supplier Onboarding. Based on the evaluation, the organization shortlists suppliers that meet the predetermined criteria and have demonstrated the necessary capabilities. These suppliers are considered eligible to participate in the subsequent procurement process and are onboarded.

Emergency Supplier Approval. There must be a provision to address and handle emergency supplier qualification in situations where there is the absence of an established supplier approval process. This step should propose workaround measures or solutions that can be implemented to minimize or mitigate risks and manage critical supply requirements.

Supplier Performance Monitoring. The pre-qualification process may also involve monitoring the performance of existing suppliers to ensure they continue to meet the organization’s requirements and standards. This ongoing evaluation helps maintain a pool of qualified and reputable suppliers for future procurement needs.

How Tech-Enabled Solutions Optimize Supplier Management

As the age of modern procurement practices commences, tech-enabled supplier management solutions and digital software will play an increasingly pivotal part in supplier qualification systems. Supplier pre-qualification and performance assessment through digital processes and forms offer numerous advantages to businesses, including:

Efficiency and Time Savings. By automating manual tasks such as documentation collection, verification and approval, the entire supplier management process, from onboarding to continuous monitoring of suppliers, can be simplified and expedited. Digital features such as supplier performance tracking, compliance monitoring and alerts for contract renewals or expirations drive business continuity. It further streamlines organizing and analyzing supplier data, lowering administrative burdens related to paperwork collection, enabling faster decision-making and helping to nurture a culture of safety with significant cost benefits as well.

Enhanced Data Accuracy. Digitizing supplier qualification models can help organizations maintain more reliable supplier information and reduce the risk of incorrect or outdated data by minimizing human error and ensuring accurate and consistent data entry. Implementing stable data management systems and technologies, such as supplier management software, can also aid in identifying and managing supplier risks through early identification of issues and timely mitigation to minimize supply chain disruptions.

Centralized Data Repository. Digital supplier management tools offer a centralized repository to store all supplier-related information, such as qualification documents, certifications, performance metrics and contracts. This allows for easy access, retrieval and sharing of information across departments or teams, fostering collaboration and eliminating data silos. Data centralization can also provide comprehensive data analytics and reporting.

Streamlined Qualification Process. Standardized workflows and pre-defined criteria brought about by digital tools for supplier qualification enable a more structured and efficient process. They often include automated screening mechanisms, such as compliance checks and risk assessments, which help evaluate suppliers against specific requirements and filter out unqualified candidates.

Supplier Visibility through Trend Analysis. Tech-enabled solutions often encompass reporting and analytics capabilities that enable stakeholders to acquire valuable insights into supplier performance, cost structures and trends by tracking and reviewing key performance indicators (KPIs) based on predefined metrics. Organizations can leverage this data to identify opportunities for cost savings, process improvements and strategic sourcing decisions. This results in real-time visibility into supplier performance, capabilities and compliance status, based on precise and up-to-date information.

Supplier Collaboration and Engagement. Some tech-enabled solutions help secure supplier communication channels and provide real-time collaborative platforms, which promote transparency and accountability in supplier-procurer relationships. These may include features such as supplier portals or online platforms that enable document sharing, bid submissions and performance feedback, fostering better engagement and long-term relationships.

Future Advances in Supplier Management

Looking ahead, digital solutions for supplier management are poised to transform the supplier-procurement paradigm for businesses. By utilizing artificial intelligence (AI) algorithms, the supplier management process will become more efficient, reducing validation steps and communication requirements, and encouraging greater supplier participation. AI’s data-gathering capabilities and predictive modeling can accurately predict foodborne illness outbreaks that may occur by analyzing supplier data from various sources including environmental factors, ingredient quality and contamination history.

Similarly, Internet of Things (IoT)  data allows companies to monitor and optimize the movement of goods and services throughout the supply chain, establishing better traceability in the procurement process. With blockchain, companies can effortlessly verify supply chain integrity and product authenticity without human intervention, which further refines supplier auditability, addressing the complexities and delays in information flow between intermediaries and suppliers.

The integration of these state-of-the-art technologies will propel increasingly accurate and dynamic supplier management software, bringing forth a safer food supply chain for the future.

Emily Newton, Revolutionized Magazine

The Benefits of Modularization in Food Processing

By Emily Newton
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Emily Newton, Revolutionized Magazine

The food industry’s fast pace coupled with fluctuating consumer demands require food companies to be adaptable and responsive to changes. Food processing modularization supports these aims by allowing facilities to buy specialty equipment that is easy to install and supports a company’s growth. This includes modular automation systems that allow food processors explore new and feasible ways to streamline critical processes.

Modularization in food processing involves separating your hardware and processing lines into modular systems that can be adapted to expand operations or meet shifting demands. When the COVID-19 pandemic caused a goat meat processor to reevaluate its business model, the founder contacted a modular building supplier to learn about solutions. He decided to install a modular butchery unit that allowed the company to serve online customers, whereas it previously worked primarily with physical restaurants. The building company took less than six months to create a fully functional unit. The prefabricated pieces increased flexibility without the need for on-site construction or expansion to a larger facility.

The chosen solution allows the business to add up to three more modules, if needed, as it grows. The company has hired two additional butchers since launching the modular unit and can double that capacity when needed.

Meet Rising Demands with Modular Automation Systems

Decision-makers from a Dutch company invested in a modular extrusion machine that offers quick changeovers and individualized customization for products ranging from cookie pieces to protein chips. The extruder offers a screw speed topping 1,800 rotations per minute, providing an estimated 8,000-ton boost to the company’s annual capacity. This investment allowed the company to produce both new and existing products to the same high standards offered through its previous equipment. And the new extruder also has a hygienic design that minimizes downtime for cleaning.

Modular automation systems can support company goals to earn food certifications and cater to new market segments. For instance, businesses with equipment that allows quick changeovers and thorough, efficient cleaning can more easily meet the requirements of customers with specific dietary preferences.

Alter Production Capabilities to Meet Market Needs

Consumer tastes change, and companies that frequently offer new products, flavors or formats have a competitive edge. Food processing modularization supports this flexibility and innovation by making it easier for manufacturers to adapt. Modular automation systems let companies quickly and strategically reprioritize operations according to marketplace trends or business goals. A modular type package (MTP) can save up to 40% on production costs by increasing flexibility. For example, MTPs allow companies to reserve specific days of the week for production of particular items, enabling shorter production runs and greater product diversity.

Decision-makers at candy brand Hershey’s installed modular systems that use robotics and automation and allow for smaller production runs and shorter changeover times. These efforts were part of a larger overhaul to enhance the company’s supply chain and tackle seasonal slowdowns.

Plan for Profitable Futures

Success in the food processing industry requires companies to stay one step ahead of competitors by choosing the best times to scale up or shift to meet future needs. Baking industry professionals explain that speed is only one element of future-proofing a processing line. People must also explore how to make more items out of the same dough.

Some companies sell modular equipment and tools that enable employees working at baking facilities to make rounded items out of square sheets, for example. Besides reducing waste by increasing the amount of usable material, such equipment can help companies introduce new products faster by creating more products on the same lines. These advances enable bakery leaders and other food processing decision-makers to adopt future-oriented mindsets rather than only addressing immediate needs, which boosts the bottom line and helps companies stay competitive and current.

Enjoy the Benefits of Food Processing Modularization

Budgeting for food processing modularization systems is an excellent way to focus on growth, worker productivity and scalability at an industrial facility while maintaining efficient changeover times and sanitation requirements.

Companies interested in purchasing these solutions should consider which challenges they want to solve and how the upgrades fit into overarching business goals. Such considerations will give you the best opportunity to achieve desired gains. One of the biggest advantages of modular products is their flexibility, which helps companies meet their needs in shorter time frames and without moving to new facilities.

Olvia Pitts

Tips for Building a Robust Internal Audit Program

By Olivia Pitts
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Olvia Pitts

Developing an internal audit program does not have to be a dauting task. With a small amount of work upfront a program can be developed and implemented in a matter of weeks. In this article we discuss the key elements of a successful program and provide guidance to ensure that audits add value to the daily operations across the facility.

Have a Plan in Mind

The first step in any successful audit program is to identify the overall structure and format. Audit programs can be set up in a variety of ways ranging from an annual full system audit to monthly departmental audits. The format and structure should be unique to each individual organization. Determine what works best for the organization and stick with it.

Developing a concise schedule will help to ensure expectations are clear. This schedule should be communicated with team members via appropriate channels. Identifying a point person to routinely follow up on the progress of the audits will ensure the program is being managed as expected. Considerations should be made for potential scheduling challenges. Build in additional time for those areas that are known to encounter delays.

Staying consistent with the maintenance and review of the program will ensure all audit activities are conducted within the expected timeframe. This can be accomplished by establishing a routine review of the program. Monthly review meetings can be established to review the audit schedule, results of audits and pending action items. During this time necessary adjustments can be made as needed and communication plans can be established. This helps to drive engagement across the organization around the entire audit program.

Accurate maintenance of audit records is a crucial step in maintaining a successful program. Ensure all records are properly filed and protected by establishing a designated filing system. Developing an organized file structure aids in keeping files in one place and reduces frustrations around locating documentation in the future. Be sure to include records for both internal and external audits as they are a required input to management review and may be needed for future assessments.

Build a Strong Audit Team  

Having a good pool of auditors to pull from is critical. The number of auditors needed will vary based upon the size of the business and complexity of the processes. When considering the format of your team consider the backgrounds of the team members selected. There should be a good mix of experienced and new auditors to provide balance among the group. When assigning auditors to specific areas consider technical knowledge for those complex processes that may require a deeper understanding. Pairing auditors together is a great way for auditors to learn from each other as they work through the review of the data.

Auditing is often a required responsibility for QA/RA. Recruiting internal auditors from departments outside of QA/RA is beneficial, as they bring a different perspective and may ask questions that seem obvious to QA/RA professionals. All of the standards require auditors to be trained and/or competent in the auditing process. Training can be done externally or internally, and companies must show proof of training.

Selecting auditors from varying backgrounds is a great way to incorporate diversity within the team. Each auditor brings their unique experience to the group which builds a richer audit. Varying viewpoints helps to push the team to dig deeper to identify issues that may otherwise go unnoticed. Encourage the audit team to work together to build audit checklists that are specific to the area being audited. Conducting a review of the process and supporting documentation prior to the audit will enable the team to gain an understanding of the area under review. Encourage auditors to not become locked into the checklist but rather think of it as a guide. If audit trails within the scope of the audit arise during the audit be all means explore if time allows. This approach helps to empower the audit team by providing a sense of autonomy over their work.

When building the audit team, management should be mindful of the workload. For the program to be successful you want to ensure that audit team members are not overloaded. Often audits will be delayed due to competing responsibilities of auditors. To mitigate this issue, develop the audit schedule so there is a balance across the assigned audits. Ensuring that the auditor has plenty of time to conduct the audits within the specified timeframe. Overall, the audit team should feel supported and appreciated for their efforts and not be overwhelmed and burdened with the task. A poorly balanced workload only leads to a lack of interest and a disengagement among the audit team.

Provide Opportunities for Education

Providing an understanding of quality management systems and the standard being audited is imperative to the success of any audit program. There are two groups that require education. Education for the auditors and those that are participating in the audits. The auditors need an in-depth understanding of the standard and the requirements which they are auditing against. While the employees need awareness of how the management system is structured and their role in supporting it.

These educational goals can be accomplished both formally and informally across the organization. Auditors will need a more formalized structured training program that focuses on the details of the standard and auditing principles. While employee training can be incorporated into departmental meetings or shared through one-point lessons. Building education programs into existing activities is a great way of incorporating the audit program into the organizational culture. This helps to educate as well as share information with those in the organization who may otherwise not have awareness. This could be conducted via training sessions around processes and their linkage to the standard in which the organization is certified. Providing an understanding of the connections between the departments helps build collaboration between working groups. Employees gain exposure to what others in adjacent departments are doing and obtain a sense of understanding of challenges that may be faced by those groups. This in turn results in a collaborative team approach to the management of the overall system.

Involving employees from all parts of the business helps to drive the message that the system cannot operate in one department alone. Through education, employees will be able to understand their role in the system. This will lead to more engagement in the internal audit program. Employees will become excited to aid in audit activities and improvement initiatives because they will see positive results. They will gain understanding of the impact of their actions and how it impacts the overall system. This value-added approach will result in a favorable outcome for both the organization and the individual employees.

Promote Continuous Improvement

The support of top management is a very important element in the success of any audit program. Establishing a culture of continuous improvement will motivate the team and build engagement across the organization. This can be accomplished by frequently sharing status updates around the management system activities. A simple 15-minute update during sitewide meetings goes a long way. It demonstrates a commitment to the program and growth of the organization and its people.

Develop a format of communicating the details around the management system and any upcoming activities. This can be done by having a specific time each month when updates are provided. Putting this on the calendar will ensure that information is effectively communicated. Details should include both the negative and positive outcomes of internal and external audits. Include specifics around the audit findings and actions taken to address concerns. This will communicate to employees that the organization is serious about growing and is focused on improvement.

Sharing information helps to engage employees by bringing them into the improvement efforts rather than just being bystanders. These seemingly small actions can help drive excitement for the overall program and build a culture of quality. Lastly, be sure to celebrate the wins and ensure that team members are appreciated for their efforts. Building a successful internal audit program is a lot of work. Celebrating and acknowledging the efforts of the team is imperative.

Accomplish the Mission  

There are many ways to build a successful internal audit program. Taking the time and effort to think through the process of identifying the format, structure and team members is critical. By reviewing these items upfront roadblocks can be identified early on. There will always be unforeseen challenges yet having a plan is key to developing a successful program. With a strong commitment from top management and a mindset of continuous improvement an organization can establish a robust internal audit program that exceeds expectations.

Josh Smart

Tips to Stay Profitable in 2024

By Josh Smart
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Josh Smart

Staying profitable in 2024 could be a challenge for the agribusiness and food/beverage industries due to increases in insurance, labor and farm input costs. The labor shortage will also continue to be a factor. Proactively addressing risks and shoring up the right insurance coverage can help organizations address these challenges. Here’s how:

Offer Personalized Benefits

The labor shortage in the U.S. will continue in 2024 across the food, beverage and agriculture industry. Many organizations are struggling to hire new employees and maintain necessary staffing levels, which is impacting their ability to keep operations running smoothly.

The answer for many has been to harness automation, but this solution is not a cure-all. Some organizations have gone back to using traditional labor to address automation issues and reduce product defects, costs and issues with lower overall production.

Creative benefits solutions are one way to address the industry’s labor gap. Businesses that offer personalized benefits informed by data analytics are more likely to see better results in employee recruitment and retention. Personalized benefits programs are designed to provide quality employee experiences to attract workers and increase employee loyalty. These benefits can help improve employee safety, well-being and health while enhancing retention and hiring efforts.

Re-evaluate Insurance Coverage

Catastrophic weather events, high interest rates, increased insurance premiums and input costs, along with the lack of available labor will continue to impact businesses across the industry.

Interest rates, weather-related events and input costs are difficult to combat since organizations cannot control those factors. However, those that take on more risk and harness alternative risk transfer vehicles should be able to lower insurance costs and address lack of coverage to better protect profit margins.

Options to consider include:

  • Modifying limits, deductibles and retentions in existing policies
  • Carefully evaluating your business interruption coverages to ensure they meet your continuity objectives
  • Analyzing your layered insurance program for avoidable costs
  • Looking into captives or self-funded programs

Emerging risk transfer solutions can help the food and agribusiness sectors stay resilient. For example, parametric insurance policies are designed to compensate organizations after a qualified weather event, whether or not the insured actually sustains damage.

Mitigate Risks

There is an array of risks to contend with in the food industry, including product recalls, work safety, supply chain woes, manufacturing plant maintenance, cybercrime and, of course, weather-related risks. Taking a thoughtful approach to implementing risk management practices can help those in the food, beverage and agribusiness mitigate these challenges in 2024.

For example, to better develop business continuity and risk management plans, agribusinesses should undergo catastrophe modeling to simulate the impacts of possible catastrophic events that could occur in one’s geographic area. Factoring in the types of weather-related events by region to better determine how to address them also can help. Consider organizations impacted by drought: Establishing improved resource management plans can curb the impact of this type of weather event. For facilities and employees in geographic areas prone to wildfires, implementing improved safety measures can protect both.

For those in food production, contamination-related recalls and product withdrawal events are an ever-present threat. Take the issue of allergens in food, for example. Organizations that implement strong product oversight measures that include periodic audits can reduce the threat of recalls.

With the increased dependence on technology to improve production, particularly in the food and beverage industries, combating the threat of cybercrime has become particularly important. Training and educating employees on cyber threats can make them more aware of this potential crime and help to better maintain a safe work environment. In addition, implementing protective measures such as multi-factor authentication and endpoint detection and response systems can reduce the risk of cyberattacks.

The issues that the food, beverage and agriculture industries must contend with in 2024 do not differ greatly from what they’ve been dealing with the past three years. But those organizations that implement better risk management practices, analyze their insurance coverage and look at alternative risk transfer vehicles to reduce costs and improve employee well-being with enhanced benefits can remain profitable going forward.