Tag Archives: Focus Article

Timothy Ahn, LRQA
FST Soapbox

The Real Cost of Not Having an Effective Food Safety Management System

By Timothy Ahn
2 Comments
Timothy Ahn, LRQA

If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.

Consumers and Foodborne Illness
An estimated 1 in 6 Americans fall victim to a foodborne illness annually.

While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.

We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.

In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.

In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.

Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.

Does your leadership recognize the importance of your FSMS?
Does your leadership recognize the importance of your FSMS? An effective FSMS should be established before a product incident or recall occurs.

Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.

Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.

The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.

At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.

For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.

Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.

The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.

Auditing and FSMS
A thorough auditor won’t look the other way and will find the problems. Call it as you see it–don’t be too soft when getting an assessment.

Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.

At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.

A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.

With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.

If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.

We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.

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.
Jim Hammel, vice president, customer success at Sample6
In the Food Lab

Using Software for Environmental Tracking and Data Visibility

By Jim Hammel
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Jim Hammel, vice president, customer success at Sample6

There is growing evidence that a strong environmental program is critical to identifying potential issues before they threaten product. This data must be captured regularly based on a robust environmental sampling plan and then analyzed in order to take advantage of the results. However, without the proper tools, this is challenging, time consuming and ineffective.

How Software Strengthens a Sampling Program

The most critical component of an environmental sampling plan is zone coverage. Many sampling plans exclude zone 1, direct food contact, because this implicates the finished product and may lead to a test-and-hold situation. However, at minimum, zones 2-4 should be covered in a sampling plan. In addition, it is important to randomize test points and schedules. Sanitation crews are held to rigorous standards, but it is human nature to complete repetitive tasks in the same manner. By randomizing which test points are tested—by day, time and operator—quality teams are more likely to identify potential areas of concern. Randomization is a challenging task to complete manually but a routine task for software.

Using Software for Environmental Tracking and Data Visibility
Using software enables environmental tracking and provides and data visibility. Image courtesy of Dietz & Watson

In addition, ensuring test-point coverage is a key component to sampling plans. An interval for test-point coverage is typically included in environmental sampling plans. It is up to quality teams to ensure that their sampling programs are consistent with these business rules. When this is tracked in an Excel spreadsheet, randomization is typically sacrificed to ensure test-point coverage. This is tracked in a large table with dates on one axis and test points on the other. The challenges to this approach include randomization, analysis and management of more than one test-point coverage interval. Business rules of this nature can be easily managed through software algorithms. In fact, the task of creating a schedule according to a series of business rules is not unlike a macro.

Lastly, robust sampling programs include detailed remediation and response plans in the event of a positive or presumed positive test result. The details on these plans are reviewed internally to ensure that the issues have been adequately addressed. Documentation that each step has been completed in a timely manner is absolutely essential in today’s regulated food production environment. Remediation records may be requested in a government or supplier food safety audit. Emails, meeting notes, pictures and cleaning records can certainly be kept in file drawers, but the more accessible this information is, the more likely it will be used. Approval processes and business workflows have been automated in a variety of software tools. Everything from sales to expense reports has sought support from software to ensure that their workflows are executed consistently and with traceability. Software can support food safety efforts in this way as well.

Dos and Don’ts of Data Analysis

The next challenge in environmental monitoring is the volume of data generated and the tools required for effective analysis. A robust environmental sampling program for Listeria can range from 10 to 15 samples per week per line—often much more. Each test result includes metadata such as sample location, day and time, sample collector and result. In a plant with 10 lines, there are 150 test results per week, or 7,800 test results per year. When compiling results for the past three years, the numbers reach nearly a quarter of million just for pathogen testing. Routine testing such as yeast, mold and Enterobacteriaceae should also be considered in the analysis. The sheer volume of the data can be challenging in a spreadsheet but routine in a database.

Don’t rely on unmanageable spreadsheets. Analysis should look for trends in the data as well as compliance to the program. Completing this task in spreadsheets requires that the data be properly formatted. Further, the database-like structure that would enable analysis is often inconsistent with the table format used for sample schedule generation. In addition, this task is time consuming, manual and error prone; therefore, the frequency of analysis may be reduced.

Don’t take an analog approach to floor plans and risk it being outdated. Particularly for environmental data, it is important to understand the proximity of test points and their results. This allows managers to look for patterns or workflow trends that may be impacting results. This task typically requires mapping the test points and their results to a floor plan. Many plants keep a copy of the floor plan and recent findings posted on the wall.

Do use the tools available. In today’s data-rich food production environment, successful data analysis must be automated.

Answering the Call for Communication

Lastly, for an environmental monitoring program to be effective, communication is critical. The members of the quality team need to know what specific tasks are expected of each of them and when. Sanitation workers need to know what areas require their timely response. Executives need visibility into the results and actions underway so that they can support their teams and make critical food safety decisions. While these tasks can be completed manually, it is ripe for automation and new tools are streamlining the communication process.

Food safety managers and quality teams are working diligently with their sanitation teams to keep their plants and product safe.  However, they need to leverage the available tools needed to do their jobs efficiently and effectively. New software tools designed for the food safety industry are changing the way the industry handles safety initiatives. In particular, sampling program, data analysis and communication tools are ripe for automation. Take advantage of technologies and tools already in use in business today so you are prepared to manage the food safety challenges of tomorrow.

Robin Stombler, Auburn Health Strategies
In the Food Lab

Five Questions Food Facilities Should Ask About Testing

By Robin Stombler
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Robin Stombler, Auburn Health Strategies

The FDA issued the first of several final regulations aimed at modernizing the food safety system through the use of hazard analysis and risk-based preventive controls. Inherent in this system are a number of requirements that eligible food facilities must follow, such as developing a written food safety plan, monitoring, corrective actions and verification. Laboratory testing is an essential component as well.

Robin Stombler presented “Laboratory Oversight and FSMA: Why and When” at the Food Labs Conference in Atlanta, GA | March 7–8, 2016So, what should food facilities know about laboratory testing within the context of the preventive controls for human food final rule?  First and foremost, the final rule states, “facilities have a responsibility to choose testing laboratories that will produce reliable and accurate test results.”  While a future regulation is expected to address the need for accredited laboratories and model laboratory standards, the preventive controls rule adopts other requirements pertaining to testing. Here are five questions that food facilities should ask about testing and the preventive controls rule.

1. What is the difference between pathogens and microorganisms?

The final rule defines “pathogen” to mean a microorganism that is of public health significance. A microorganism is defined as “yeasts, molds, bacteria, viruses, protozoa and microscopic parasites, and includes species that are pathogens.” Microorganisms that are of public health significance and subject food to decomposition or indicate that the food is adulterated or is contaminated with filth are considered “undesirable.”

2. How must food facilities account for pathogens?

Food facilities must prepare and implement a written food safety plan. One component of the food safety plan must include a written hazard analysis. This analysis must identify known or reasonably foreseeable hazards. These hazards may be biological, which includes parasites, environmental pathogens and other pathogens.

In another example, the food safety plan must include written verification procedures. This is to demonstrate that the facility is verifying that its preventive controls are implemented consistently and are significantly minimizing or preventing the hazards. These verification procedures are intended to be appropriate to the particular food facility, the food in question, and the nature of the preventive control and its role within the facility’s food safety system. With this in mind, facilities must conduct activities such as product testing for a pathogen or an appropriate indicator organism or other hazard, and environmental monitoring.

3. Are there written procedures specific to product testing?

Yes. Procedures for product testing must be scientifically valid and must identify the test microorganisms or other analytes. The procedures for identifying samples, including their relationship to specific lots of products, must be written and implemented. The procedures for sampling, including the number of samples and the sampling frequency, must be outlined. The facility must recognize the laboratory conducting the testing as well as describe the tests that are performed and the analytical methods used. Corrective action steps must also be included.

4. What are the procedures for environmental monitoring?

Similar to product testing, these procedures must be scientifically valid, identify the test microorganisms, and be put in writing. For routine environmental monitoring, the location from which the samples are collected and the number of sites that are tested must be stated. The final rule indicates that the “number and location of sampling sites must be adequate to determine whether preventive controls are effective.”  Written procedures must also identify the timing and frequency for collecting and testing samples. Again, similar to product testing, the laboratory conducting the testing and the tests and analytical methods used must be divulged. Corrective action procedures must also be included.

5. How does the supply-chain program incorporate testing?

A receiving facility is required to document a written supply chain program in its records. A component of that program includes documentation of sampling and testing performed as a supplier verification activity. The documentation must include identification of the raw material or other ingredient (including, if appropriate, lot number) and the number of samples tested. It also means that the tests conducted and the analytical methods used must be identified. The date the test is conducted as well as the date of the test report must be provided, and the identity of the laboratory performing the testing must be revealed. Any corrective actions that were taken in response to a hazard detection must also be reported.

This Q&A provides a glimpse into how the preventive controls final rule for human food incorporates laboratory testing. For more details, access the final rule.

FST Soapbox

Risk in Our Supply Chain: Where Do We Start?

By Traci Slowinski
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FSMA has arrived with the launch of the first two preventive control rules – Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food (or cGMP and HARPC, for short). With these new FSMA rules, the food and beverage industry will now be held accountable for being more proactive versus reactive, and will be responsible for identifying and managing risk throughout their supply chain. Of course, this emphasis on risk can also be seen in other sectors of the industry (i.e., GFSI and ISO), and risk has become the focal point for a number of compliance initiatives.

Supply chain challenges in food safety
Supply chain challenges in food safety (Click to enlarge)

These days a number of supply chain challenges are driving risk. Continued global expansion of the industry is resulting in more import and export activities. We are seeing consumer food trends shift toward riskier food/preparation options. Regulatory agencies continue to work on improving their food safety requirements. And the growing population is putting more demands on our current resources. All of these factors equates to great risk within all stages of the supply chain.

Therefore, it will be important that you understand what risk management entails and have the right tools to identify, assess and control the risks that you find throughout your supply chain.

So where do we start looking for risk? Here are a few examples of where your risk assessments should be performed:

External Partners. You need to build strategic relationships with your external partners (suppliers, contract manufacturers/co-packers, service providers, carriers, etc.) across the supply chain. Building trust through good communication and collaboration is essential to ensure that you can rely on your partners to do the right thing for both parties.

RiskAssessmentSupplyChainRaw Materials. Many hazards can be introduced into a facility through raw materials—whether we are talking about raw ingredients, packaging materials, chemicals, or other components used to produce your product. Some hazards to assess include pathogens, allergens, chemical residues, pests and foreign material.

Storage and Handling. When looking at risk during storage and handling, it is important to address several hazards including allergen control, temperature control, foreign material control, proper segregation and product flow.

Processing. A number of areas in processing can introduce hazards and therefore should be included in your risk assessment. These include improper sanitation, cross contamination/contact potential, foreign material contamination, critical control point deviations, pre-requisite program failures and mislabeling.

Shipping and Transport. Lastly, you must safeguard your shipping and transportation procedures in order to account for any potential risk once the product has left your facility. Areas to consider during your risk assessment include temperature control, condition and sanitation of truck and storage units, loading/unloading practices, security/tampering potential, accident/emergency recovery, and traceability.

For more information on risk management within the food and beverage supply chain, register to attend the free webinar “Supply Chain Management: Does What I Eat Put Me at Risk” on October 28, 2015. Speakers will discuss risk throughout the supply chain, focusing on supplier management and some of the new FSMA requirements. They will provide an overview of risk management and some of the tools that can be used to identify and assess risk. In addition, they will discuss how technology can help companies meet FSMA requirements.
AJ McCardell, Food safety technology
In the Food Lab

New Food Safety Technology Addresses FSMA Rules

By AJ McCardell
1 Comment
AJ McCardell, Food safety technology

In ongoing efforts to eliminate foodborne illness, the FDA recently issued the next step in rules designed for the enforcement of FSMA. The rules are aimed at modernizing food manufacturing processes after a wave of deadly outbreaks in the past decade stemming from contaminated cantaloupes, apples, spinach, lettuce, peanut butter, ice cream, cucumbers and other products. The rules require companies to draw up and implement written plans for keeping food safe. An important part of any food safety plan is the implementation of methods to verify that the controls put in place are working.

The food industry faces many challenges in meeting these new regulations. Two significant technical challenges for control verification are that the testing process takes too long and the sampling plans are often inadequate.

The pathogen testing process for all commercially available diagnostic tests requires an upfront culture or growth step to allow any pathogens present to multiply to a level that they can be detected by the test in use. This growth step, referred to by microbiologists as enrichment, is especially challenging in heavily processed foods and environmental samples, because the bacteria present in the sample have been stressed and are not in a rapid growth phase at the time of sampling. Advances in diagnostic sensitivity and robustness have reduced the amount of time required for enrichment from three or more days with traditional methods to about 24 hours on average with rapid methods. Even with rapidly growing and low-stress organisms such as E. coli O157:H7, enrichments take more than eight hours before implementing the diagnostic. The time required for this growth step creates a bottleneck in the production and distribution process. Although diagnostic companies are continuously improving the sensitivity of their methods and new methods are constantly being developed, there are practical limitations that have thus far prevented the elimination of the upfront culture step prior to testing. Historically, improvements in the sensitivity of rapid food pathogen diagnostics have been traded for time. In other words, having a more sensitive test means that fewer bacteria are needed for detection and therefore, less time is needed for bacteria to divide during the enrichment step.  Some commercially available assays require as few as 1,000 to 10,000 target cells in the sample for detection. Since the purpose of the enrichment step is to increase the number of target pathogens in the sample to a detectable limit and bacteria reproduce by cell division, further diagnostic sensitivity improvements would need to be greater than ten-fold to have a significant impact on further reducing enrichment times.

Unreliable sampling methods are an even bigger issue for industry. An example demonstrating current practice is a field of 40,000 heads of lettuce with four (.01% of the total) heads of lettuce contaminated by a pathogen. The current best practice is to go into the field and collect 60 (.15% of the total) leaves from the heads of lettuce, mash them together and test them for contamination. The probability of this sampling method finding the four contaminated heads of lettuce in the sample is much less than 1%. When the undiscovered four heads of lettuce are washed with the other 39,996 heads of lettuce, cross contamination occurs and people get sick.

Technology advances that reduce or eliminate the requirement for enrichment and make the sampling process more reliable could have a big impact on improving control verification testing. But, those advances need to be delivered in a practical and affordable manner. I recently learned about a technology that has great potential to make improvements on both of these fronts, especially for the produce industry and any process that is able to use a wash step as a control point. The recently patented OmniFresh sampling system (developed by OmniFresh, LLC) concentrates a sample from the food processing wash water, allowing immediate testing representative of the food being processed. The concentration process is performed during the entire washing cycle for a lot and is consequently representative of the entire lot.

Concentration technology has been used for many years by academic researchers and scientists to collect samples for biological testing.  Ultrafiltration methods for concentrating samples have typically used smaller sample sizes in the 1-10 liter range.  The OmniFresh system allows for very large samples to be concentrated, typical volumes of 400 liters are concentrated to 50 ml.

The concentration process takes about one hour to complete after the first wash cycle.  During processing, a side stream of water from the first wash tank is diverted to the concentrator unit. Tens to hundreds of gallons of wash water, depending on the size of the wash tank and the type and amount of produce being washed, flows into the concentrator. Throughout the sample collection period, large particulates are removed through a course filtration. Using ultra-filtration, bacteria and other small particles are isolated from the large volume of wash water into a much smaller, concentrated final sample. This concentrated sample can then be tested directly by a diagnostic test, eliminating the need for enrichment.1

OmniFresh System with diagnostic platform
The OmniFresh System with diagnostic platform installed at a processing facility. (Click to enlarge)

The wash water in the tank comes into contact with all of the produce being washed, the majority of bacteria is removed from the produce, and it then enters the wash water.2-4 This process, combined with the continuous sampling of wash water, means that low levels of intermittent contamination can be detected without testing high numbers of samples. Field testing of the OmniFresh System has returned promising results. The ability to rapidly screen produce for contamination could also provide a practical lot definition instead of cumbersome field-based definitions that can impact multiple processors.

Improvements in sample preparation and sampling technologies have much to offer the industry. Improved sampling methods which are representative of entire lots identify contaminated food earlier and with high confidence.  Additionally, the negative test result is of much higher quality and will result in an increase in the overall confidence of the food supply.

The OmniFresh technology is one example of the type of improvements that are needed. More research that focuses on these most challenging aspects of control verification testing is needed.

References

  1. Dyer, M.A. (2009). “New biosensors for food safety screening solutions.”  SPIE.
  2. Beuchat, L. R., and Ryu, J.-H. (1997). “Produce Processing Practices,” Emerg. Infect. Dis 3 (4), 459-465.
  3. Sapers, G. M, (2001). “Efficacy of washing and sanitizing methods for disinfection of fresh fruit and vegetable products,” Food Technol. Biotechnol. 39 (4), 305-311.
  4. U.S. Food and Drug Administration. (1998). “Water: Control of Potential Hazards: Wash Water.” Chap. II.B.2.3 in Guide to minimize microbial food safety hazards for fresh fruits and vegetables, by US FDA.
Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

2015 Food Safety Heroes Announced

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

Many of you are committed to doing everything possible to prevent people from becoming ill or dying from foodborne illness, and you whole-heartedly embrace a strong food safety culture. On November 17, 2015, STOP Foodborne Illness is pleased to be hosting Food Safety Heroes, an interactive fundraising event sponsored by Chemstar Corp. and Food Safety Tech.

We are excited that Food Safety Heroes will take place during, and in conjunction with, the Food Safety Consortium Conference, which is a summit meeting for Food Safety and Quality Assurance (FSQA) industry experts and government officials. In our eyes, every guest coming to this event is a food safety hero! Each day these people contribute to the overall health of our nation, and we couldn’t be more proud to be working alongside such outstanding men and women. To be a part of efforts to increase public awareness and collaboratively seek solutions is a great honor for us.

In addition to raising much-needed funds for the important, life-saving work of STOP Foodborne Illness, we also have the great pleasure of honoring two individuals who have seen the national conversation about safe food grow from its infancy, born from tragedy, to an increasingly aware industry of food safety professionals and consumers. Their efforts have been instrumental in cultivating the food safety culture that we see today.

The 2015 Food Safety Heroes award will honor:

former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness
Nancy Donley

Nancy Donley, former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness. Donley will be presented with the 2015 Legacy Tribute in recognition of her four-year-old son Alex, who died from an E. coli infection in 1993. From the time of her son’s death until her recent retirement from STOP, Donley has worked tirelessly to raise public awareness of foodborne illnesses by providing information and support for the millions of people who get sick from eating each year.

Frank Yiannas, vice president of food safety at Walmart Corp. A pioneering force in advancing the concept of a strong food safety culture, Yiannas is being celebrated as our 2015 Industry Advocate Hero. Going far beyond his role in overseeing the safety of the world’s largest food retailer, Yiannas is recognized for his commitment and dedication to building unique partnerships and participating in innovative approaches to food safety.

Please join us on November 17!
Food Safety Heroes
Time: 7–9 pm
Where: Renaissance Convention Center in Schaumburg, IL
Guests will enjoy cocktails and hors d’oeuvres, lively entertainment, a silent auction and more
(Follow the Food Safety Consortium link to the STOP Foodborne Illness Fundraiser)
Timothy Ahn, LRQA
FST Soapbox

Tackling the “Why” of Food Safety

By Timothy Ahn
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Timothy Ahn, LRQA

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

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

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

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

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