Mobile technology and food safety

The Digital Revolution in Food Safety

By Manik Suri
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Mobile technology and food safety

News concerning the safety of food seems to be everywhere these days. On a daily basis there’s a story about a salmonella outbreak or a company initiating a product recall due to possible contamination. Why is this the case?

If you visit most food businesses, whether it’s a restaurant, grocery store, manufacturer or foodservice operator, chances are you’ll see the same thing: Employees using pen and paper checklists, forms and log books to manage their food safety operations.

The recent E. coli outbreak traced to Chipotle Mexican Grill infected more than 50 people and led the company to shut down several restaurants. The outbreak was also a PR disaster for the company and damaged its reputation as a reliable provider of safe meals. Chipotle lost out on potential revenue and probably spent a good amount of money on hiring outside food safety consultants to examine its safety standards.

Since starting the business, Chipotle has remained focused on a core mission: Make great-tasting food, and more recently, food that is not modified with GMOs. While its goal has not changed, running a food company is vastly different today than in the past.

Modern Food Safety Isn’t So Modern

For one thing, there is a lot more paper to manage in today’s world. Between time and temperature controls, HACCP and HARPC requirements, and a whole host of industry certifications and brand standards, food businesses implement several safety processes. Even with advancements in technology, food safety operations are often run manually and therefore are error-prone.

In the early 1990s, food companies could handle the volume of paperwork themselves. Today, they’re swamped. Visit a food business, and you’ll see the same thing everywhere: Stacks of documents that need to be typed up and sent to food agencies. As one quality assurance manager recently stated, “We can barely keep track of them all.”

Surrounded by stacks of paper in their office, quality assurance (QA) managers explain that much of the pileup is due to more rules and regulations related to food safety. Food companies must comply with a growing number of local, state and federal laws that regulate food safety. The focus of recent laws such as FSMA is toward prevention of foodborne illness, placing even more emphasis on internal audits and recordkeeping. In addition to these laws, food companies must compete with the wealth of information available to customers about how their food safety operations work. Especially in the realm of social media, as Taco Bell has learned, one photo of an employee playing with food can lead to a PR nightmare.

A Day in the Life of a QA Manager

Complying with food safety laws often falls on a company’s QA manager who supervises food safety. She walks through the facility several times a day with clipboard in hand, reviewing a list of safety and quality measures.

The QA manager will then manually key this data into a spreadsheet, create reports, and file the results with industry partners and government regulators. These seemingly routine and time-consuming compliance tasks matter. Failing to comply with the appropriate laws can lead to costly penalties, permitting delays, loss of business from industry partners (such as retailers with strict requirements), and even legal action.

The legal requirements are often complex, overlapping, and they change every couple of years. The laws are designed, of course, to ensure that food preparation and delivery is safe, thereby protecting consumers. But an expanding body of regulations and fear of litigation have increased the time, cost and stress that play into compliance.

Mobile technology and food safety
Mobile tools can help companies improve food safety processes.

Improve Food Safety with Technology

So how can companies improve their food safety operations? By using food safety technology, particularly mobile software tools, to improve their processes. Since food safety operations are still manual, they tend to be hard to standardize and difficult to track—especially at larger companies where employees are working in multiple shifts across dozens of locations. Mobile food safety software offers several major benefits:

  • No More Pen and Paper. Replacing paper-and-pencil clipboards with digital tools saves time and money. Digital audits and task-lists can be logged and tracked, ensuring that staff are performing tasks in real-time. Digital entries are more accountable; managers can confirm when and where tasks where conducted and completed (including requiring photos to be taken). And digital clipboards can be loaded with reference materials like images and training videos, which helps staff learn best practices and prepare for real inspections by government agencies.
  • Quality and Safety Checklists. Instead of letting employees complete tasks ad hoc and make notes on clipboards and log books, companies can use quality and safety checklists to ensure that key tasks are standardized across the organization. For example, data can be collected to show that a company is always forgetting to label produce with an expiration date. Digital food safety and quality checklists that are loaded on smartphones or tablets makes it easier to ensure that all employees are following brand standards and best practices.
  • Automated Reports. Instead of sifting through binders filled with audit logs, food safety software captures and stores data in a structured format, making it easy to search and analyze. Why waste hours at the end of every week or month sifting through binders full of paper, when software lets you generate insights with the click of a button?
  • Real-Time, Centralized Management. Food companies often have multiple locations in which employees are conducting food safety operations in their own way. For companies that have multiple locations, mobile software being used by employees at each location can help corporate managers track performance by location, provide critical alerts, and give employees real-time feedback to help standardize food safety operations.

Here’s an example of a QA manager running a food safety audit using mobile software. During a random spot check, the manager shows up on the line with a smartphone in hand. As she walks around, she pulls up a food safety application and answers a series of pre-set multiple choices questions that cover key criteria, dictates comments into the device using the built-in voice recognition, and takes high-resolution color photos of several problematic issues. If a QA manager is unsure about food safety requirements, she can use her mobile device to quickly pull up a reference document (or even the official code citation) from state, FDA, USDA or other agencies.

After running a digital audit with food safety software, the QA manager can immediately print or e-mail a report that shows all of the items out of compliance, creating actionable intelligence for her team. The QA manager can then share this with line workers during their weekly team meeting, which help to train staff on best practices in food safety.

The data the QA manager collected through her mobile device is immediately stored in the cloud. From there it can be easily accessed by a colleague (i.e., her manager at corporate headquarters) at any time. Over time, the data from each of these spot checks is stored in a central database that a manager can analyze, looking for trends in performance, issues that keep arising, or locations that may need extra training and attention. Mobile software makes it easier to generate insights that can drive major improvements in an organization’s safety and performance.

By using software to help manage food safety audits, logs and line checks, businesses can save time and money on compliance, train staff on best practices, and most importantly, keep customers safe and satisfied.

Today, food safety technology, especially mobile software, should be a critical part of any modern food company’s operations. Mobile audit and task-management software allows QA managers to streamline and standardize quality and safety operations across large teams and multiple locations, helping save valuable time and money. Whether you’re a mobile food vendor or a large-scale food processor, modern software tools can help food businesses of all sizes effectively manage time-consuming tasks around food safety and compliance, from digitizing audit logs for analysis to created automated filings for supply chain partners.

How Automated Inventory Tracking Systems Contribute to Food Safety

By Ryan Hardy
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When a business decides to invest in technology, the primary driver is usually to save money over the long term. As with most automated systems, inventory management tools can reduce costs by saving time and resources used to manage inventory.

But the benefits that automated inventory tracking can provide through traceability (of lots, batches, and even individual items) go beyond the financial. These systems can also be used in every aspect of your food safety program from helping with compliance, to improving your quality controls.

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In a nutshell, having an automated system that allows full visibility into the supply chain—that is, one that identifies in real time where items are being used and where they are sent, while retaining a historical record of that flow through the chain—makes it much simpler and faster to implement procedures to ensure the safety of the food you produce.

All about Accuracy and Speed

Speed and accuracy make a huge difference when it comes to dealing with potentially contaminated food. Being faster and more accurate than a manual inventory method is the most immediate benefit that an automated system brings to your food safety program.

The most compelling reason for having accurate and readily accessible track-and-trace data is to handle food recalls and to comply with requests for documentation from government agencies such as the FDA. In cases where consumer health is at risk, that information needs to be delivered quickly to prevent further harm, and it must be accurate to enable investigators to move in the right direction. Responding to requests for detailed documentation within a 24-hour timeframe can be nearly impossible if you are not using an automated system.

Even when the situation doesn’t involve a federal investigation, once a situation in which possible contamination or mislabeling arises, the faster you have accurate and detailed data, the faster your internal processes can move forward.

If the issue is identified through your quality control process, you will be more likely to be able to prevent contaminated product from reaching the retail outlet and thus getting into the hands of the consumer. Having traceability built into your inventory management systems provides immediate knowledge about whether a product using ingredients from the same batch have entered the distribution chain, and if so, where they are going. This greatly improves the likelihood of limiting the cost and scope of a recall.

Depending on the specific technology you employ, an automated system can provide immediate access to the track and trace information for specific ingredients at least one step backward and one step forward, as required by the Bioterrorism Act of 2002. A supply chain that integrates the most sophisticated technology, such as DNA tracking, can trace an item all the way from the farm or border to the individual consumer or restaurant kitchen.

This traceability means that if an ingredient was already contaminated before it entered your production line, the inventory tracking system can identify all products using that ingredient from the contaminated lot and thus will help you define the scope of the problem. This automation can go a step further by identifying where the ingredient lot originated, and thus help trace the ingredient at least one step backward to the vendor. If the vendor (whether a distribution company or a direct supplier) has traceability in an automated system, or if you are using a system hosted by a distribution partner, tracing the source farther back than one step is possible.

Such information can help you respond more quickly to FDA requests for product information and support the agency’s efforts in product traceability.

Protect Your Reputation

Just as using tracing technology can help identify potential contamination sources quickly, it can also be used to eliminate sources more quickly and accurately, thereby speeding up investigations into food contamination incidents. The faster a company can be eliminated from an investigation, the less time is taken away from normal production. In addition, quick exclusion can protect a company’s reputation from harm.

Additional Benefits

Through their ability to store specific data that can be used to identify potential risks, automated track and trace systems contribute to many preventive food safety measures as well as to the following corrective responses:

  • For perishable products, automated traceability can identify how long specific perishables have been in supply chain. This allows you to avoid using ingredients close to spoilage and to remove overdue products from the distribution chain.
  • During mock recalls, automated tracking systems reduce the time spent away from regular production and allow you consistent information throughout the organization, eliminating wasted effort due to miscommunications.
  • Automated systems reduce the time needed for notifications both internally and externally in the case of an incident affecting food quality or safety. This leads to faster line clearance and faster isolation of the possibly contaminated product.
  • With more effective accounting for possibly affected batches, you can better identify where to apply cleanup measures in the production chain.

In short, automated tracking can improve implementation of preventive controls to stop the contaminated product from reaching the marketplace, and in cases in which corrective actions are required, the automated system can help you respond more quickly and can reduce the scope of risk.

Not just Foodstuffs

Although raw ingredients and food products obviously require traceability, they aren’t the only traceable inventory that can impact food safety. Automated lot tracking can enhance food safety efforts related to all inventory items used in food processing/manufacturing:

  • Packaging. A sub-standard packaging lot can allow incursion of harmful substances or the growth of harmful bacteria. Leakers can contaminate an entire batch of meat or poultry product. Automated lot tracking can help you rapidly isolate the bad lot and know which production lines have already used the sub-standard materials.
  • Labeling. If an inferior adhesive has been applied to a batch of labels, you can identify which product lots to pull from the distribution chain. You can do the same if your quality controls find a batch of inaccurate labels.
  • Protective equipment and clothing. Gloves, masks and other protective gear must function properly to ensure the safety of your workers and also to prevent contamination from being introduced on the production line. An inferior batch of protective gloves that tear during use, for example, could violate your food safety practices. Identifying the bad batch quickly and removing it from the operations area immediately can save potential contamination.
  • Cleaning solutions. Even a batch of cleaning solution can be sub-par. If tests show that cleaning has not eliminated the targeted bacteria, for example, you can more quickly take measures to determine whether the root cause of the problem was a procedural issue or a quality issue with the batch of cleaner.

Beyond the Production Line

The benefits of automated tracking systems to your food safety program extend beyond the production line. They can also enhance decision-making, vendor management and communications functions.

When it comes to potential contamination, decision making needs to be both timely and based on the best information available. Automated systems can provide you with accurate information quickly to help you answer these and other key questions, so that the decision on what actions to take can be based on good information:

  • How widespread is the potential contamination?
  • Where is the product in the production and distribution chains?
  • Have we already exposed consumers?

These systems can put the answers to these questions in front of the appropriate decision makers early in the process. The technology can be configured to allow access to the data via a browser, so if those who make the final decisions are located elsewhere, they can see in real time the same information that you are seeing in the plant. This makes communication about potential contamination more effective and clear, since everyone can see the same thing at the same time, and it can eliminate the potential for miscommunication up the chain of command.

By identifying where bad lots entered your supply chain, automated track-and-trace can enhance supplier accountability. You can accurately see if you have vendors with recurring issues in the quality of the supplies they are providing.

Automated Inventory Tracking Technologies

An automated inventory tracking system depends on three components:

  • A physical component, such as a label or tag, which contains detailed information identifying the specific lot or item.
  • A database, where each discrete data item is stored.
  • A reporting interface that allows people to access and use the identification information. This is the programming code that performs searches, retrieves the data, and formats the information in a formatted report, which is then presented on the screen, saved to a file, or sent to a printer.

The most common physical components used by automated inventory tracking systems rely on barcode or RFID technology, or a combination of both. The choice of which technology to use to integrate into the inventory management database layer of the system depends on a number of factors, but both have been proven extremely accurate (some sources say up to 99%). What is more important than the choice of tracking tools is the quality of the data encoded in them.

The latest in tracking technology uses an engineered DNA marker, in the form of an edible spray. When applied to produce, this DNA marker can track the individual item (i.e., an apple, head of lettuce or onion), along the entire food supply chain, identifying where it was farmed, the date it was picked, and where it was processed.

Whatever form of technology you employ, ensuring that your data is complete and accurate and can be integrated into both your supply and distribution chain is critical to realizing the benefits of that system in supporting your food safety efforts.

The WDS Food Safety Team also contributed to this article.

Food Safety and Social Media Crisis Communications

What Does a Social Media Crisis Communications Plan Have to Do with Food Safety?

By Ryan Hardy
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Food Safety and Social Media Crisis Communications

No one can contest the power of social media these days. As of August 2015, there were 2.2. billion users of social networks globally, with Facebook still by far the largest social network platform, at nearly 1.5 billion active users. Even if you aren’t on Twitter or Instagram, you have most likely heard or read about topics on them through other media. The influence of social networks to reach so many people makes them perhaps the most powerful communications tool available.

When it comes to a food safety crisis—whether a product recall or a report that a consumer has found a foreign object in prepared food product—you have to assume that messages about it will show up on Facebook, Twitter, Instagram, and even YouTube. From there, it is likely to end up on TV through newscasts as well. If your company maintains silence on social media, the public is likely to assume that you have something to hide, that your company is out of touch with public concerns, or that you just don’t care.

For these reasons, it is important that your food safety program be integrated with a social media crisis communications plan. That does not mean that your food safety team has to create the plan or manage the communications. These responsibilities should fall to your designated communications and public relations personnel. But it does mean that when a food safety issue with potentially harmful effects on public health arises, your food safety team should be aware of the plan and coordinate with the public relations team in the overall response.

The Positive Side of Social Media in a Crisis

The most obvious benefits of using social networks for crisis communications are speed and the large number of people you can reach. In a situation with potential to impact a large number of people, getting accurate information out to the public quickly is important to lower the risk to public health.

Other benefits may not be as obvious. By presenting a consistent and accurate message to a broad audience, your communications can help prevent or counter misinformation. A well-crafted social media post should be clear and concise, and thus is less likely to be misunderstood. That clarity and concision may help to avoid your message being reported as a “sound bite” out of context. And your message is more likely to be transmitted and repeated accurately, as social media users can share it in full.

Studies have shown that frequent communications from a firm can increase consumers’ intentions to comply with a recall effort and, when well handled, actually enhance consumer perception of a company. Thus, a social media crisis communications plan can contribute to action on the part of consumers and to maintain your company’s reputation.

The Downside of Social Media in a Crisis

As with any communications platform, social network communications do have a downside. The social nature of the platforms means that anyone with an account can post a response, and the potential for inaccuracies and outright hostility is very real. How to respond appropriately, and when not to respond at all, takes training and experience. That is the reason that crisis communications need to be handled carefully by the communications experts in your organization.

However, even if you are not the one posting the communications, having an understanding of the plan will help you as you carry out your responsibilities as part of the coordinated response to a food safety incident.

The Basics of a Social Media Crisis Plan
Although each social media crisis communications plan should be tailored for the individual company, the following some common elements of a good plan:

  • Clear assignment of roles and responsibilities. Who should post/comment/tweet on behalf of the company? All others should avoid commenting about the situation, even if using their own accounts, to prevent confusion and promote consistency.
  • Identification of the primary social media channel to use during the crisis (and of secondary channels). For example, will you post all relevant information to the corporate website, on Twitter, or on the corporate Facebook page? Picking one channel helps control the messages and makes it possible to funnel users of other social networks to one central source.
  • Message templates. One template should be for an initial message, indicating that your company is aware of the situation and will be issuing an official statement shortly. Twitter is a good channel to use for this message, but it is also appropriate for your corporate Facebook page. It is also a good idea to include the platform you will be using as your primary channel for communications. For example, the initial message for a company intending to use Facebook as the primary social media communications channel could be “@Company is aware of the [brief description of the situation] and will be issuing an official response soon. For continuing updates, please visit our Facebook page [url].”
  • Internal contact information (including for after-hours). You should know whom to alert and how to contact them regardless of the time, and under what circumstances you should contact them. This is key information to include in your food safety plan.
  • Clear procedures and responsibility for cancelling scheduled social media posts. During a crisis, the company needs to prove that situation is their top priority. Pre-scheduled messages about products can send the wrong message.
  • Guidelines on the frequency and content of messages. For example, measures the company is undertaking and actions consumers can take to avoid the contaminated item(s) should be posted. However, prematurely stating that preliminary measures will completely address the problem should be avoided; otherwise, if you have to increase the scope of corrective measures, your company could lose consumer trust.
  • Message approval procedures. Identify any specific type of message that requires approval by senior management. However, be mindful that a lengthy approval process for all messages will defeat the purpose for communicating through social media. (That’s one reason why templates are an important part of the plan, as they can be vetted and approved ahead of time).
  • Message review procedures. On the other hand, all messages should be reviewed before being posted to verify technical accuracy and to ensure clarity and appropriateness. During a crisis situation, you must adhere to the highest standards of professionalism.
  • Procedures for coordination with regulatory agencies. In the case of a recall, the FDA, CDC and USDA post information on their consumer food safety site at FoodSafety.gov. It is critical that the information provided to these agencies is consistent with messages posted on your social network channel(s).

Coordinating Response and Communications

So what should a food safety professional do regarding a social media crisis plan? Here are some first steps to help with a coordinated response:

  1. Review your food safety procedures to see if procedures for crisis communications are included.
  2. If not, check with your corporate office to find out if there is already a social media crisis plan. Ask to see it, and then update your food safety procedures to include relevant steps to keep the designated contact information updated. If yes, be sure the information in your response plan is current.
  3. Make sure everyone is familiar with the plan and of specific roles and responsibilities. Ensure that employees are trained on what they should expect, and what they should and should not do, regarding social regarding social media during a crisis. Employees should understand that if they post information related to the crisis using their own social media accounts, it can lead to confusion and undermine efforts to protect the public health, as well as affect the company’s credibility.
  4. During a crisis, provide timely and accurate updates to the communications team as appropriate. Be sure to check the designated channels to remain aware of what the company is communicating publicly.

Can Social Listening Lead to Better Crisis Response?

Several major companies in the food industry have found that social listening—the monitoring of social networks for mention of their company and its products—can help them identify a potential problem early. If a consumer post describes finding a foreign object in a can of soda, for example, the manufacturer can quickly reach out to that person through social media to request that the individual contact the customer service department to provide details. That way, an investigation can get underway to determine the accuracy and extent of the potential issue, and the customer can have their situation addressed more quickly and appropriately.

Monitoring the company Facebook page, Twitter ID and hashtags for product names can be a component of proactive measures for averting a larger problem. Better that you find out that someone posted that they found a rat tail in their soup than for you to be blind-sided by a report about it in traditional media.

Public health agencies in New York City and Chicago are also studying the use of social media to identify potential outbreaks of foodborne illnesses in their jurisdictions. They are working to determine if searching restaurant reviews posted on Yelp can help them identify foodborne health issues that have a common source. Results suggest that online restaurant reviews might help to identify unreported outbreaks of foodborne illness and restaurants with deficiencies in food handling.

Don’t Wait Until a Crisis

It is better not to have to learn about the power of social media once a crisis has arisen. Having an understanding of social media’s role in communications and of how your company can use it effectively can help improve your crisis communications efforts.

If you want the public to trust what you say on social media during a food safety crisis, one of the best strategies is to build a reputation as a trustworthy source of food safety information before a crisis occurs. Consider a social campaign around food safety topics, such as how to prepare food products safely, the difference between a sell-by date, a best by date, and an expiration date, and other topics that tell the consumers that you are attuned to their concerns around food safety. If you are considered a trustworthy source of food safety information, your communications during a food safety crisis are more likely to be believed. As a result, you are more likely to be able to protect both public health and your reputation should a crisis arise.

In a future article, we will discuss specific ways to integrate a social media crisis communications plan into your food safety incident response plan.

The WDS Food Safety Team also contributed to this article.

Hand

Why Management Reviews and the SQF System Go Hand-in-Hand

By Clare Winkel
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SQF certification is an ongoing process; once you have attained it, you have effectively committed to a continuous improvement program for your business. Conducting regular, thorough and transparent management reviews will play a key role in ensuring that you continue to achieve your SQF goals.

The first and most important thing to understand about management reviews is that they don’t have to be a cost to your organization. In fact, when conducted correctly, these reviews should become the cornerstone of your continuous improvement program, assisting you in measuring company performance against documented objectives.

Once you’ve committed to a management review, it’s important to be aware of the fact that these reviews take significant preparation. The senior management team will be responsible for reviewing the SQF system, preparing for and documenting the review procedure in its entirety. As outlined in clause 2.1.2.4 of the SQF system, there are four key elements against which company performance must be reviewed:

  • The SQF policy manual
  • Internal and external audit findings
  • Corrective actions (investigation and resolution)
  • Customer complaints (investigation and resolution)
SQF Management Review Procedure
Click to enlarge this document on how to conduct a Management Review Procedure

The management team is required to make adequate resources available for food safety and quality objectives and to support the development, implementation and maintenance and ongoing improvement of the SQF system (clause 2.1.2.3). This team must also establish processes to improve the effectiveness of the SQF system in order to demonstrate continuous improvement (clause 2.1.2.9).

Keeping Good Records

One cannot overstate the importance of thorough and effective documentation of the review, so remember the mantra: If you don’t write it down, it didn’t happen.

Every aspect of your review must be clearly and thoroughly documented. These records are important documents in the SQF audit process and also as benchmarks against which company performance and subsequent reviews can be measured.

Management Review Process

The management review process comprises four key stages:

  • Identifying objectives
  • Collecting and analyzing data
  • Management review meeting
  • Disseminating results

1. Identifying Objectives

Identifying objectives should be your first step. You cannot start collating data before you know what you’ll be measuring it against. Objectives are essentially short statements that outline what you want your company to achieve in specific business areas. They should encompass a whole-of-company approach in that they should contribute to overarching company goals rather than delivering a one-sided or fragmented approach to continuous improvement. It is important to note that objectives are neither mission statements nor warm and fuzzy statements.

As a general rule of thumb, objectives should be:

  • Measurable. They should outline specific quantities and quotas for what you are trying to achieve.
  • Business-specific. Objectives should be relevant to the future of your business and to the individual business improvement process. Don’t worry about what your competitors are doing.
  • Relevant. Make sure the objectives will have a significant and lasting impact on your business once they are achieved. This might mean choosing complex objectives versus taking the easy way out.
  • Linked to a key performance indicator. Every objective should contribute to the company’s KPIs and be part of its broader strategic goals..
  • Clearly defined. Be clear about what you are trying to achieve and how you plan to achieve it.
  • Documented. Write your objectives down! The review process, future audits and your ongoing improvement efforts will be measured against them, so it is important to accurately capture the details.
  • Communicated across the breadth of the organization. Don’t make the mistake of keeping them in a filing cabinet somewhere. Put them in the lunchroom, put them in induction packs, hand them out during annual updates—share them with your team so that everybody understands the goals.

2. Collecting and Analyzing Data

Data collection is one of the most time consuming components of the management review process, so have a clear game plan ready before starting. Ask the following questions:

a.    What information must be extracted from company records?

Determining the sort of data you need depends largely on your management review objectives. Your data should deliver insights on company performance and provide an evidence base for changes you make to your business processes. As a food company, your SQF systems should monitor and collect data on a wide range of business activities, including:

  • Preventative maintenance result reports
  • Equipment breakdown reports
  • Goods inwards records
  • Verification results (i.e., swab results, lab results)
  • Cleaning records
  • Corrective action reports
  • Near miss incident records
  • Pest control records
  • Swab and microbiological results from cleaning processes
  • Microbiological results from water supply and product testing, or raw material testing
  • Insurance and credit claims
  • Chemical product results
  • Mock recall tests
  • Product traceability tests

Think about the data sources that respond directly to the objectives you developed for your review. You should be leveraging the systems you already have to collate information, with a view to feeding the information back into work practices to create a loop of continuous improvement.

b.    What format is the data in and how can you make it accessible?

Like most food companies, your company is likely to be home to a mix of paper-based and electronic data. Different data types throw up different challenges when it comes to data acquisition. Paper forms are easy for staff to use and easy for management to collect, but they require double handling in order to translate relevant data into a format that can be analyzed with any degree of depth. Electronic data collection is more useful when it comes to number crunching, but you need access to specific expertise when it comes to data extraction if you want your data to work effectively for you. Newer, more sophisticated data management systems will help automate data collection activities and will also ensure that your database systems can communicate with each other to share relevant information.

Data access is another issue to think about early in the process. Who is responsible for all the different data sets that must be accessed for the review? Is he or she the right person to manage that data? Will he or she be available at the time you need to access the data before the review?

c.     Who will analyze the data, and do you have the requisite skills in-house?

Another important element of the pre-planning process is the question of who will analyze the data once it has been extracted from your systems. Does your staff have the skills and time required to conduct effective statistical analysis? Do you have suitable software systems to support the analysis process? If so, you’ll need to allocate each data analysis task to a staff member, making roles, responsibilities and timelines for the analysis process clear. In addition, ensure that all managers have access to (and an understanding of) the previously identified management review objectives so they can target their analysis appropriately.

If you don’t have the requisite data management skills in-house, you need to think through potential solutions during the pre-planning stage, whether it involves providing training for staff or bringing in outside expertise.

Prior to the data analysis process, you should also be looking at your raw data and reviewing data outliers (that is, data that lies above or below the mode)—these can sometimes provide interesting insights about your processes and procedures. It’s important to have an experienced quality assurance team on board before you start assessing your outliers; your QA team should already understand the variables within your processes and procedures, and will therefore be able to identify whether the outliers are one-off data spikes or trends requiring further investigation.

3. Management Review Meeting

a. Meeting preparation

Meticulous preparation is key to a successful management review meeting. Ensuring all meeting attendees are on board with the agenda and meeting outcomes is a good way to get started. First, develop a written agenda and timeline for the review. Think about the timing of your meeting in conjunction with your unannounced SQF audit. Set the date of the meeting with enough time to ensure close off of the corrective actions issued as a result of the meeting. Yes, if you’re doing it properly, you should have corrective actions issued.

Next, you’ll need to get all participating staff members up to speed with the review process. Pull together the requirements of the review, the relevant SQF clauses, customer requirements and company objectives, and put them into a document that can be circulated well in advance of the meeting. Identify the individual managers who will be involved with the review—that is, the managers whose business areas will make a contribution to, or be impacted by, the review process itself. Ask participating managers to prepare the data that is relevant to their key performance areas and to the management review objectives you’ve identified, as this will be distributed at the meeting.

b. At the meeting

Good record keeping is particularly important during the management review meeting itself. Poor documentation can undermine the review and its subsequent outcomes, not to mention the SQF auditing process. As such, it’s important to capture the details of the discussion that occurs at the meeting—you need more than just a few scribbled notes. Nominate a scribe whose sole responsibility is to take notes at the meeting. Ensure they capture (at a minimum) the following:

  • Meeting date and time
  • Meeting attendees and no-shows
  • Discussion of each agenda topic
    • Key items
    • Outcomes
    • Conclusions
    • Action points
    • Objectives. Were they met? If not, why not? Do they need to be modified for next year? If so, why, and to what?
  • Action points, role responsibilities and verification of actions being undertaken
  • Conclusions

The scribe should also be responsible for compiling all supporting documentation from the meeting for audit purposes and for review prior to future management review meetings.

4. Disseminating Results

Once the review process is completed, any processes and procedures identified as requiring modification must be updated. This is also the time to follow up on action items—your meeting documentation should clearly show who is responsible for each item and their respective tasks. Engage with the staff members responsible for each item at regular intervals to chart their progress, and follow up again at subsequent management meetings to ensure that all actions have been completed.

Communicating review outcomes is very important. Charting a specific course requires an understanding of, and commitment to, that course by everyone involved in the navigation process—and you need your team to understand where you’re going so that they can help you get there. This means communicating all the outcomes, both good and bad, to all relevant personnel, and taking the time to thank and congratulate staff who were instrumental in achieving positive results.

The last step of the review process is to share your success—don’t let your hard work go unnoticed! Communicate the value of the review both to your team and your superiors, and demonstrate the link between the review itself and the achievement of individual, team and company KPIs.

Conclusion

A completed management review will deliver significant benefit to your company in the form of documented, measurable and communicated objectives that are reviewed on an annual basis. Additional benefits include:

  • Increased business value
  • Enhanced safety (for staff) and quality of product (for clients)
  • A more targeted approach to business strategy
  • Reduced financial risk and increased profitability
Laboratory Information Management System

How LIMS Facilitates ISO 17025 Certification in Food Testing Labs

By Dr. Christine Paszko
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Laboratory Information Management System

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

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

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

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

Sample Handling and Acceptance

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

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

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

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

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

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

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

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

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

Administrative Records, Demonstration of Capability

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

Reference Standards and Materials

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

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

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

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

If You Aren’t Color Coding Yet, You’re Way Behind

By Bob Serfas
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Color coding to enable allergen and potential contamination distinction

Since the introduction of FSMA, food safety has been under a much-needed magnifying glass. Standards for hygiene and accountability are increasing, and companies are implementing more measures to keep consumers safe. One of the ways in which businesses are being proactive is through implementing color-coding plans. If you have not heard of this type of plan yet, it’s time to get schooled; and if you have, this article will provide a quick refresher on why companies are expanding their spectrum on contamination prevention—by literally implementing the color spectrum in their plants and businesses. 

What Is A Color-Coded Plan?

A strategy for a plant or business that designates certain colors for a specific area or purpose designed to promote safety and cleanliness.

Example Plans. Although color-coding plans vary by the needs and demands of each plant, the following are the most popular types of color-coding plans currently being practiced in food manufacturing.

Color coding to enable allergen and potential contamination distinction
Color coding a cleaning brush can help employees make the distinction when dealing with allergens and potential contamination. All images courtesy of Remco/Vikan

Allergen/Potential Contaminant Distinction

Food Processors and manufactures usually have identified potential allergens and contaminants that pose a risk to the production process. Color distinction for equipment or instruments that come into contact with these potential contaminants is an ideal tool for food safety. Determining the amount of items that fall into this category within your facility is the first step to selecting the appropriate amount of colors to implement. The most basic color-coding plan for this purpose would be to select one color to represent tools that come into contact with a particular risk agent and one color to represent those tools that may be used elsewhere. If a plant has more than one risk agent, this plan may be expanded to include several colors. It is important to remember, however, that simplicity is key in color coding and that additional colors should be implemented strictly on an as-needed basis.

Zone Distinction

Many plants already have identified zones in place based on what is produced in each zone or simply due to operating a large plant. This presents an ideal opportunity to color code zones to keep tools in their proper place.  

Shift Distinction

Certain plants that have a large number of employees working different shift times should also consider color coding. Color coding by shift can hold each shift responsible for proper tool use and storage. This approach also allows management to see where work habits may be falling short and where the cost of tool replacement is highest. 

Assembly Process Distinction

Plants that have assembly line-like processes can implement color coding if necessary to differentiate tools that belong to each step. For example, this becomes particularly important in plants that deal with products such as meat; obviously you do not want to use the same tools with raw and processed meat. Color coding eliminates the question of whether or not a tool is meant for each step in the process.

Color coding for cleaning purpose distinction
Implement a two-color-coding plan to distinguish between tools used for cleaning versus sanitation.

Cleaning Purpose Distinction

For many food plants, cleaning and sanitizing are processes that are considered different in purpose and practice. Often, there is a specific list for cleaning and then a separate plan for sanitizing. Implementing a two color-coding plan can distinguish tools that are meant for each process.

Why You Need A Color-Coded Plan

It helps meet FSMA requirements. A major part of complying with FSMA regulations is having proper documentation to prove safety measures. Color-coding plans do exactly that, and most providers of these products can provide you with the necessary documentation.

It reduces pathogens and allergens contamination. For food producers, this is the most important reason to implement color coding. There is nothing worse for a company than experiencing product contamination or a recall; this is one step that may prevent such events from occurring. 

It is easy to understand. Color coding works so well because it is so simple. All employees, even those who may not speak the same language or are unable to read posters and manuals that dictate proper procedures, can easily comprehend it.

It creates a culture that holds employees accountable. Managers enjoy color-coding practice because it is a simple measure that really works to hold employees accountable in the proper use of tools. It becomes much more obvious when a brightly colored tool is out of place, and thus workers are more likely to follow proper procedure.

Thermo Scientific's Integrated Informatics LIMS

How Integrated Informatics Benefit Regulatory Compliance, Defensible Data, Traceability and Brand Protection

By Trish Meek
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Thermo Scientific's Integrated Informatics LIMS

To understand why an integrated informatics solution is important to manufacturers in the food and beverage industry, it helps to first consider the unique challenges this industry faces. Simply put, food production has scaled into a global business so rapidly that oversight has hardly kept pace. Even the stricter regulatory stances taken by the FDA and the European Union in the past decade are effectively catch-up efforts.

The broader food industry, which for purposes of this article will also comprise the beverage industry, has globalized quickly and, many would argue, haphazardly. It actually wasn’t that long ago that the products we purchased in our local food store were produced locally or regionally. Seasons determined selections as well—if you wanted a tomato in November, you would pay a premium for that indulgence.

Seasons and geography no longer constrain what we can buy and when. By far the world’s largest industry—with a combined revenue of more than $4 trillion, the food industry has used its massive scale to overcome historical limitations. We now take for granted that our grocery carts can be filled with fresh products that may come from thousands of miles away. And those products may have been grown, processed and shipped in multiple countries before they reach our local grocer.

The complexity and scale of this modern food supply chain is the industry’s greatest challenge and regulators’ greatest worry (on consumers’ behalf). How can growers, producers, processors, packagers, shippers and others in the global supply chain secure a food chain that’s so distributed? How can regulators ensure safety without restricting choice or inflating prices?

The Bits and “Bytes” of Food Safety

The food industry—and its regulators—would likely agree on one thing: A system this massive cannot operate on trust alone, as it once did. The grower with generations of experience on the land, for example, is now too far removed from end consumers. A finished product may contain one farmer’s product and those from five others, all from different regions worldwide.

Integrated informatics may seem like an unlikely fix for modernizing a highly distributed food chain, but it’s actually perfectly suited. An integrated informatics platform provides access to massive amounts of information in a timely fashion, dramatically improving decision-making. It does this by making information rapidly available to many stakeholders and by ensuring that it’s reliable.

Consider this example. A hypothetical lab uses an analytical instrument to detect pesticides in barley, and regulation dictates that this data be compared to allowable maximum residue limits (MRLs). If the barley sample exceeds allowable MRLs, the manufacturer must identify everywhere that ingredient is being used, quarantine it and determine who produced it. All this must happen quickly and according to strict procedures.

Procedures are critical. Not only must the lab have a process for checking against current limits for a pesticide, for example, but also that analytical information must be carefully tracked with the appropriate sample, and the method used to deliver the result must be consistent between different samples and users. Without an integrated informatics solution, adhering to these procedures, defending the quality of the data, and making it usable would be nearly impossible.

The Role of Informatics in Compliance

Gathering the bits and bytes of data, following procedures and making the data useful enterprise-wide is important, but regulatory compliance is where most industry attention is focused today. This is another area where integrated informatics provides significant benefits.

As mentioned above, food industry growth significantly outpaced regulatory oversight in the past decade. Globalization was rapid and inevitable, but so too were food safety breaches, and with progress came stories of tainted fruits, vegetables, meats, cereals, nut butters and much more. Suddenly we had a trust issue. With a food chain that’s distributed across many borders and jurisdictions, how is the public’s trust best protected and by whom?

From the Food Safety Modernization Act (FSMA) to EU Regulation No. 178/2002, we’ve seen a heightened regulatory focus, and the most common themes are traceability, authenticity and risk-based approaches. The common denominator here is food chain security.

So what does all of this mean for multinational food and beverage producers? It means having to conform to multiple regulatory requirements for each distribution market, and there are often many. And this is a data management and reporting headache. Fortunately, however, common standards such as ISO 22000 exist that enable companies to standardize their processes enterprise-wide, achieving levels of operational rigor and quality that satisfy multiple regulatory authorities at once.

So where do informatics fit into this regulatory compliance landscape? In a typical multinational food producer, a significant amount of the quality data is delivered by the laboratory. Raw materials are analysed for pesticides, herbicides, nutritional content and so on. Packaged products are monitored for shelf-life compliance. Plant hygiene is monitored using microbiological samples taken from across the facility. Records from all of these distinct, but interrelated activities are critical for demonstrating compliance.

Defending Data

The shift in recent years has been toward prevention instead of crisis response. Regulators now focus on auditing food and beverage producers to assess their practices prior to any adverse event. For companies with good systems in place, time-consuming audits will be less frequent, so it pays to have systems in place that demonstrate that data is reliable and defensible.

Audits can be daunting. The producer must prove that activities were carried out correctly, that records are properly collected and that supporting information is accurate. Auditors typically pick a starting point in a process and follow the trail. They may start by looking at the data associated with a released batch of product; perhaps quality assurance samples; follow the trail to cleaning validation, and then review individual laboratory results, including entire methods, instrument calibration, user training, etc. At each point of the audit, producers must show evidence of compliance—even the smallest details.

With an integrated informatics solution, all evidence resides in a single platform. Hierarchies and relationships within the data records are automatically recorded and retained. Everything—from relationships between lots or batches of material; the connection between methods, specifications and results; the history of an instrument configuration, maintenance and calibration; and user training records—is in one place for easy retrieval and reporting.

Having one system of record not only codifies data capture, it also helps labs create standard operating procedures (SOPs). Establishing SOPs does several important things:

  • It ensures that all lab users are following the same process—no personal preferences for carrying out a specific test.
  • It makes sure that all necessary data is collected—by enforcing a series of data entry steps, labs can prevent a method from being marked complete until everything has been entered.
  • Labs can roll out updates to their processes by updating the method for all users at the same time.

Managing lab execution activities in this way means that data is more consistent; it is being collected in the same way for all users. It is also prone to fewer errors because users move stepwise through each stage of the measurement process, and they can stop a test whenever they encounter a problem.

Achieving Traceability

Traceability, the ability to verify the history, location or application of an item using documented information, has become increasingly more important for the food industry. And traceability is closely linked to compliance and data defensibility. Fortunately, traceability is another strength of an integrated informatics solution.

In practical terms, to demonstrate traceability we must be able to go either backwards or forwards within a set of process items and understand the complicated relationships. An integrated informatics solution lets us map relationships between “child” and “parent” batches, information that can also come from integrating ERP or process or production information management (PIMS) systems. By integrating all this information, manufacturers can trace a product back through intermediate products and raw materials and then forward again to any resultant batches that may be contaminated. In other words, with an integrated informatics solution, traceability is built in.

Brand Protection

Because of its size and fragmentation, the global food and beverage industry is a target for adulteration and counterfeiting. The Grocery Manufacturers Association estimates that these activities cost the industry $10–15 billion each year.

While the risk to consumers of adulteration can be deadly, as in the case of milk solids adulterated with melamine in China, much of the impact comes in the form of trust erosion and fraud. An example is Manuka honey, a premium product with purported health benefits that commands a high price. The entry of fraudulent producers into the market affects legitimate producers by creating uncertainly about all products, depressing sales and lowering prices.

Thermo Scientific's Integrated Informatics LIMS
Having access to data from all critical points in the food production chain is the most important safeguard against product recalls and loss of revenue for food manufacturers. Having an integrated informatics solution in place provides data when it is needed for quality checks in the production process, for management metrics reporting or to adhere to regulatory requirements. (Click to enlarge)

This is only one example, but it illustrates the larger problem: Once consumer trust erodes, it’s hard to regain. As it happens, however, honey has unique chemical markers that can be used to determine whether it has been adulterated. But isolating these markers involves complex analysis, including ultra- high-performance liquid chromatography (UHPLC), and methods that are highly specific, consistent and defensible.

Consistency and defensibility are hallmarks of an integrated informatics solution. For the honey producers, an informatics solutions, such a LIMS, can automate processes so that no non-conforming product is missed, establish compliance rules and checks for instrument calibration so that results are defensible, and standardize methods through built-in laboratory execution system (LES) capability.

Conclusion

An integrated informatics solutions is designed to address multiple business needs in the food and beverage industry, from compliance and data defensibility to traceability and brand protection. The complexity and scale of the modern food supply chain demands it.

Growers, producers, processers, packagers, shippers and others in the global supply chain are now interdependent, but not necessarily integrated. The only way to protect consumers, however, is to achieve this integration through a combination of voluntary and imposed compliance. And to achieve this compliance without undue burden on the industry and imposing higher costs on consumers, we need technology that is built for integration at scale—and informatics solutions have proven they are more than capable.

Granulated sugar with dark foreign particles

Food Investigations: Microanalytical Methods Find Foreign Matter in Granular Food Products

By Mary Stellmack
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Granulated sugar with dark foreign particles

The upcoming implementation of FSMA will likely result in increased scrutiny of contaminants in food products. If the foreign matter can be identified, steps can be taken to eliminate the source of contamination and avoid future losses of product. Small foreign particles are sometimes observed in drums of bulk granular or powdered raw materials. While these foreign particles may be seen as dark specks in the product, they are often too small for standard QA/QC methods of analysis. Microanalytical techniques, however, can be used to isolate and identify the specks. This article describes a case study of dark particles in a granulated sugar sample.

Microscope Exam

Ideally, when conducting contaminant analysis, all sample manipulations take place in a cleanroom to eliminate the chance for contamination by extraneous environmental debris. This is especially important when working with small contaminant particles, which may consist of environmental debris such as metal particles, fibers and other types of dirt. If the unknown particles are identified as common environmental debris, the analyst must be certain that he or she did not introduce any debris while handling the unknown sample.

Granulated sugar with dark foreign particles
Figure 1. Granulated sugar with dark foreign particles, 13X (Click to enlarge)

The first step in the identification process involves examination of the sample under a stereomicroscope. Figure 1 is a photomicrograph of dark brown particles, less than 1 mm in size, in the sugar sample. Particles of this size must be isolated from the bulk product prior to analysis in order to correctly identify them.

Since all of the dark particles are visually similar, only a few representative particles need to be isolated. The contaminants can be isolated by removing a small glob of tacky adhesive (50 µm or smaller) from a piece of tape with the pointed tip of a fine tungsten needle. The adhesive-coated needle tip is gently touched to the surface of one of the dark particles, causing the particle to adhere to the needle, and the particle is transferred to a glass slide or other substrate for further examination.

Isolated dark foreign particles
Figure 2. Isolated dark foreign particles, 63X. (Click to enlarge)

Figure 2 is a photomicrograph of three dark particles, isolated from the sugar granulation. The dark brown particles have a smooth, shiny appearance with conchoidal (shell-shaped) fracture surfaces, and are visually consistent with glass. However, when probed with the tungsten needle, the particles are found to be brittle and fragile, and this texture is not consistent with glass. Therefore, chemical analysis is needed to identify the brown particles.

Micro-FTIR Analysis to Identify Organic Components

Most organic compounds (and some inorganic materials) can be identified by Fourier transform infrared (FTIR) spectroscopy. For the analysis of small particles, a microscope is coupled with a standard FTIR system; this method of analysis is known as micro-FTIR analysis. The micro-FTIR system passes a beam of infrared radiation through the sample and records the different frequencies at which the sample absorbs the light, producing a unique infrared spectrum, which is a chemical fingerprint of the material. By comparing the spectrum of the sample with spectra of known compounds from a reference library through an automated computer search, the sample can often be identified.

In order for the FTIR analysis to work, the sample must be transparent, or thin enough to transmit light. In the case of the particles from this case study, this is achieved by applying pressure to a ~50 µm portion of the sample until it forms a thin transparent film. This film is placed on a salt crystal for micro-FTIR analysis.

An FTIR spectrum of crystalline sugar is shown in Figure 3, and a spectrum of a brown particle is shown in Figure 4. The spectrum of the brown particle has some similarities to sugar, but there are fewer peaks, and the remaining peaks are rounded, consistent with a loss of crystallinity. The loss of crystallinity, coupled with the brown color of the particles, suggests charred sugar.

FTIR spectrum of granulated sugar
Figure 3. FTIR spectrum of granulated sugar. (Click to enlarge)

Figure 4. FTIR spectrum of a dark foreign particle, microanalysis
Figure 4. FTIR spectrum of a dark foreign particle. (Click to enlarge)

SEM/EDS to Identify Inorganic Compounds

The FTIR method does not provide complete information about the presence or absence of inorganic materials in the contaminant. To complete the analysis of the brown particles, scanning electron microscopy (SEM) combined with an energy dispersive X-ray spectrometer (EDS) detector is needed. Using the SEM/EDS method, two types of information are obtained: SEM provides images of the sample, and the EDS identifies the elements that are present.

SEM/EDS analysis of a dark foreign particle
Figure 5. SEM/EDS analysis of a dark foreign particle

A brown particle was mounted on a beryllium stub with a small amount of adhesive, and submitted for SEM/EDS analysis. Figure 5 includes an SEM image of the particle, and a table of EDS data. The SEM image provides some information about the composition of the particle. This image was acquired using backscattered electron mode, in which heavier elements appear lighter in color. The image displays light colored specks scattered across the surface of the particle, indicating that more than one type of material is present. The light-colored circle on the SEM image shows the area that was included in the EDS analysis (the entire particle was analyzed). Looking at the column in the table for weight percent (Wt%), the particle consists primarily of carbon and oxygen, with small amounts of chlorine and iron. Carbon and oxygen are chemical constituents of sugar, but chlorine and iron are not.

SEM/EDS analysis of specks on a dark foreign particle
Figure 6. SEM/EDS analysis of specks on a dark foreign particle

The EDS system can also be used to focus on individual small areas on the particle. Figure 6 includes EDS data from five specific light-colored specks on the surface of the brown particle. The specks contain major amounts of iron with small amounts of chlorine, and sometimes chromium and silicon, plus contributions from carbon and oxygen from the surrounding sugar matrix. The composition of the specks indicates steel corrosion, likely from low alloy steel. The presence of chlorine suggests that a chlorinated substance was the initiator for the corrosion process.

In some cases, steel corrosion can be the sole cause of brown or dark discoloration of small particles. In the case of this brown particle, the SEM image shows that the iron-rich particles are not evenly distributed throughout the particle, but are only scattered on the surface. Charring is the most likely cause of the overall brown color of the particle.

Conclusion

When examined under the microscope, the dark particles in the sugar sample had the visual appearance of glass. However, chemical microanalysis of the particles revealed that they were not glass at all, highlighting the importance of microanalytical methods in determining the identity of the foreign matter. The brown particles were ultimately identified as charred sugar particles with scattered specks of steel corrosion (likely from low alloy steel) on the surface. This information can be used to narrow down the search for possible sources of the brown particles in the bulk sugar sample. As part of a root cause investigation, samples of dark particles from various locations in the manufacturing and packaging processes can be studied by the same techniques to look for a match.

More information about FTIR analysis is available in the webinar, Preparation of Polymer Samples for Microspectroscopy

Food processing and sanitation

Seize the Competition by Improving Sanitation

By Tim Tancred
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Food processing and sanitation

For consumers and manufacturers, product quality and cleanliness are a preeminent priority. Product recalls resulting from manufacturing errors in sanitation often warrant national headlines and cause widespread mistrust and panic among consumers.

After a tumultuous spring and summer, Blue Bell Creameries, a Texas-based ice cream manufacturer, will be restocking its products in select grocery store freezers in five phases. The popular brand was forced to recall its products due to Listeria contamination, which has been blamed for the deaths of three people.

Learning from these instances can greatly reduce the number of sanitation-related issues in the future. Investing in sanitation not only increases safety but does wonders for performance and efficiency.

How can sanitation be a competitive advantage and not a troublesome necessity? It’s all about OEE.

Sanitation efficiency
Investing in sanitation efficiency now will pay off later. Image courtesy of Myrtle Consulting Group

While not investing in sanitation may save you a little money in the short-run, neglecting it can cause exponentially larger costs down the road, including elevated food scrap, equipment reliability failures, excessive non-value adding to production time, expensive recalls, remediation costs, potential legal liability, and destroyed consumer trust.

A focus on Overall Equipment Effectiveness (OEE) will increase capacity without investment or additional resources, and it does not need to be overly difficult or expensive. However, OEE management does require detailed process analysis, process rethinking, reconstructing of resource assignments, and installation of management control and reporting systems. When equipment is scheduled to run, it’s running at the correct rate, using the right number of resources and at the right level of quality. This will not only boost the efficiency of your operation, but the safety and quality of it as well.

An Important Piece of the Puzzle

Adopting lean techniques into your sanitation plan is an effective and efficient way to improve process time. With this approach, you can determine:

  • How to best execute work
  • How much time it should take
  • Who should do it
  • What specific equipment or tools are needed
  • Which materials and PPE (Personal Protective Equipment) are necessary
  • What testing is required

Using LEAN will allow you focus in on three essential areas: the elimination of waste, reduction in variability and reduction of inflexibility. When these factors come together, work can be completed in a standardized, efficient and sanitary manner.

Study. Streamline. Standardize.

Food processing and sanitation
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers. Image courtesy of Myrtle Consulting Group

Study. To incorporate, improve or ensure sanitation, the first step is to evaluate what you’re working with. Take the time to examine existing protocols and contracts. Conducting a detailed study of the current processes can help you define the areas that need work, which may include equipment effectiveness, supervisory staff and materials used.

Streamline. Once you obtain the initial result of the study, goals and plans can be determined to streamline the process and make everything run more efficiently. It is not unusual to discover at least 30% of non-valued time within the existing process, mainly due to poor planning, poor coordination or the use of overly cumbersome methods.

Standardize. After creating a plan to improve effectiveness and sanitation, swift and certain implementation of these ideas are critical to maintain commitment and realize results. With a detailed plan, sanitation of machines and other supplies can be executed in an exact, timely fashion.

Placing Sanitation Operation First

One of the biggest mistakes that can be made in manufacturing is viewing sanitation operations as secondary in importance. This attitude can lead to all kinds of oversight and carelessness, which can cause costly mistakes. Clear expectations, clear roles and responsibilities, and measured performance are the hallmarks of well-executed operations and an effective way to make sanitation a priority.

Dramatic Improvements, Significant Savings

Making these changes to increase efficiency and sanitation have yielded dramatic improvements for manufacturers. A large U.S. food manufacturer installed this system in five of their plants and quickly cut costs while boosting productivity. One of the plants was able to repatriate production outsourced to a co-manufacturer at a savings of approximately $500,000. Another replaced its entire 50+ person sanitation crew with a subcontract cleaning crew, reducing its labor cost from $22 to $11.47 an hour, while at the same time increasing the work effectiveness of the crew and performing 15% more sanitation work within the same time frame.

Manufacturing isn’t only about quantity; it involves ensuring a level of quality that builds consumer loyalty and efficiency. When your product potentially poses risk for the consumer, it also poses a danger to your business and its success. Remember, you don’t have to risk using unsanitary methods for the sake of saving money or increasing efficiency. In fact, sanitation and efficiency are easily attainable when they are brought together in a strategic plan. Putting in the time and dedication to create an effective sanitation plan will help you avoid negative consequences and bring you to the top of your game. Stay clean.

Cannabis Labs: The Need For Standardized Analytics

By Aaron G. Biros
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Laboratory testing is an integral part of the cannabis industry for the same reasons it is important in the food industry. To ensure the consumer is ingesting a safe product, accurate testing should be required for microbials, pathogens, pesticides, heavy metals, and perhaps most importantly dosage. Unfortunately, however, the problem is that testing requirements are not quite there yet in the handful of states that have legalized marijuana for recreational or medical purposes. This creates a degree of uncertainty in the marketplace, which is detrimental to the growth of the industry as a whole.

Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.
Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.

Lauren Finesilver, Executive Chef at Sweet Grass Kitchen, sits on a counsel for compliance with C4 (Colorado Cannabis Chamber of Commerce). Finesilver believes “We are a food manufacturer first and foremost so we need to ensure we sell a final product that is safe for the public and [one] that consumers know is coming from a responsible manufacturer.” Ahead of marijuana rule changes that are soon to come, Colorado’s Marijuana Enforcement Division (MED) announced five new rulemaking working groups, one of which will address testing, packaging, and labeling.

Some states, including Colorado and Nevada, have made impressive strides in implementing proper testing regulations.

“Nevada has done a really good job from the start in designing a program where they have at least addressed some of the issues with product quality including testing, labeling, and potency requirements,” says Tobias Paquet, Chief Scientific Officer of C3 Labs, LLC (Cannabis Chemistry Consulting).

Paquet, who previously worked at Waters Corporation as a field chemistry specialist, cites potential contamination at almost every step of the cannabis supply chain from seed to sale. “Some of the biggest concerns with contamination during cultivation or extraction are pesticides, heavy metals, and microbial contamination,” he says, adding that he is most concerned about two microbial carcinogens—mycotoxin and aflatoxins.

“We aim to provide reliable and consistent labeling that is accurate and reflects the contents of that product,” says Paquet. “This comes with a validated method on qualified instruments and laboratory accreditation.”

Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.
Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.

Much like the food industry, accurate testing across the board is needed for consumers to feel safe ingesting edibles containing marijuana. Laboratories that operate in states where marijuana is already legal need to utilize good laboratory practices and standards to ensure consistency.

“We have been working to create an accreditation process that is accepted on a national level,” says Roger Brauninger, biosafety program manager at the American Association for Laboratory Accreditation (A2LA). “Without firm state laboratory accreditation regulatory requirements in place, the possibility exists that people may shop laboratories to get the results they want. So if applied across the board, ISO 17025 accreditation would help reduce that, thereby helping to create greater consistency of tests results between laboratories, ultimately helping to reduce marketplace confusion.”

The cannabis industry has the momentum to become a safe and regulated marketplace as state reforms continue, with testing and analytics acting as the wind behind its sails.

Matt Karnes, founder and managing partner of GreenWave Advisors, LLC, suggests that by 2020, assuming full legalization occurs in all 50 states and D.C., the lab testing industry could easily reach $850 million (this figure includes testing, data analytics and consulting services). The firm provides an analysis of each state’s potential market size which is predicated on its U.S. retail marijuana forecast of $35 billion (again, assuming full legalization by 2020). Karnes was recently cited in a Forbes article suggesting that cannabis testing is one of a handful of top new technology investment opportunities.

Karnes’ predictions echo that of many when discussing the cannabis analytics space. “More states are becoming focused on standardized laboratory testing requirements,” he says. “There is really no consistency, which is something that needs to be worked out.”

While a handful of states work toward achieving good laboratory standards, players in the cannabis industry, including laboratories, dispensaries, and cultivators, continue to self-regulate when it comes to safety and quality.

CannabisIndustryJournal.com, our newest publication, will be launched in late September. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!