Tag Archives: FSQA

The Validation Conversation

By Joy Dell’Aringa
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Our industry is in a perpetual food safety discussion. We are constantly mulling over the finer points of hazards, risk, preventive controls, training, sanitation, and regulations. Validation is also a key component of the food safety dialog. Here we will explore common themes industry professionals discuss in regard to validation in this era of food safety.


In any good conversation, terms must be set and semantics agreed upon. It is helpful to start off with a simplistic definition of validation and verification that can be applied across industries and applications. We often return to these reductive definitions throughout conversations to recalibrate and ensure that all parties are on the same page.

  • Validation:  Are we using the correct system / method?
  • Verification: Are we using the system / method correctly?

From there, we narrow our focus. Using the FSMA backdrop, from the FDA’s “Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods” we find the following definitions:

Validation: Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

Validation and Verification: Semantics Matter.

Definitions for validation and verification are available from various standards organizations and regulatory bodies. What is most important, however, is that in this conversation there is a clear distinction between validation and verification—both in activities and objectives. These are not interchangeable terms. Further, validation and verification can be discussed from two general perspectives in the food safety landscape. Process validation addresses manufacturing activities and controls to prevent product hazard and contamination. Method validation addresses the analytical methods used to verify the physical, chemical or microbiological properties of a product.

Process Validation

Our industry is comprised of a variety of categorical segments. Each segment faces unique processing challenges, risks and requirements that must be addressed in the validation and verification conversation.

Some segments, such as the dairy industry, have long standing processes in place that have a robust scientific backbone and leave little room for guesswork, experimentation or modification. “Milk  processes were validated years ago and are part of the Pasteurized Milk Ordinance (PMO). The science is there,” states Janet Raddatz, vice president of quality & food safety systems at Sargento Foods, Inc. ” It is well established that when you pasteurize the product for the time and temperature that has been validated, then you simply verify the pasteurizer is working to the validated specifications.”

However, process validation challenges arise when novel applications, ingredients and processes are employed. Even in an established industry, reformulations of products such as sauces and dressings require fresh validation perspective and risk assessment. “You must assess the risk anytime there is a change. Properties such as pH, salt and water are critical variables to the safety and microbial stability of a product. Novel processing techniques aimed at ‘all natural’ or ‘minimal processing’ consumer demands should also be challenged.” Raddatz suggests conducting a full assessment to identify potential areas of risk. A challenge study may also be a critical piece to validate that a certain process or formulation is appropriate.

To help the food industry understand, design and apply good validation and verification practices, the Institute for Food Safety and Health (IFSH) published “Validation and Verification: A Practical, Industry-driven Framework Developed to Support the Requirement of the Food Safety Modernization Act (FSMA) of 2011.” This insightful document provides various definitions, guidance, practical advice, and offers several Dos and Don’ts on validation and verification activities.


  • Divide validation and verification into separate tasks
  • Think of validation as your scientific evidence and proof the system controls the hazards
  • Use science-based information to support the initial validation
  • Use management to participate in validation development and operations of verification
  • Use lessons from “near-misses” and corrections to adjust and improve the food safety system


  • Confuse the activities of verification with those of routine monitoring
  • Rely on literature or studies that are unlike your process/ product to prove controls are valid
  • Conduct audit processes and then not review the results
  • Perform corrective actions without determining if a system change may be needed to fix the problem
  • Forget, reanalysis is done every three years or sooner if new information or problems suggest

Method Validation

Analytical methods used to verify a validated food process must also be validated for the specific product and conditions under which they will be conducted. For example, a manufacturer that has their laboratory test a product for Salmonella to verify that a kill step in the manufacturing process worked, must ensure that the method the laboratory uses is both validated for that product and has been verified as appropriate for use in that laboratory. Three general considerations should be discussed with the laboratory:

  • Is the method validated for the product (matrix)?
    • Often, the method will carry several matrix validations that were previously conducted by the diagnostic provider, an industry organization or as a reference method.
    • If the matrix to be tested is not validated the laboratory should conduct a validation study before proceeding.
  • Has the laboratory verified this method on the product (matrix)?
    • The laboratory should demonstrate that they can indeed perform the validated method appropriately.
    • Verification activities typically involve a matrix specific spiked recovery.
  • Are there any modifications made to the validated method?
    • All method modifications should be validated and verified. Additionally, modification should be noted on the laboratory report or Certificate of Analysis issued.
    • Method modifications may include time and temperature alterations, media changes and sample preparation factors.

AOAC International is an organization that certifies the validation of methods to a specific prescribed standard. “Diagnostic companies seek AOAC approval, which entails rigorous validation protocol with the selected matrices,” says Ronald Johnson Ph.D., president of AOAC International and associate director of validation for bioMérieux, describes the importance of commercial standardization.  “The AOAC validation scheme ensures that the method is robust, rugged, inclusive and exclusive, stable and meets the sensitivity presented.” Standards such as these provide confidence to the user that the method is fit-for-purpose, a critical first step in method selection.

While many diagnostic companies will perform standardized validation as described above, how a laboratory validates and verifies a method is incredibly nuanced in the food industry. Currently, there is no standardized approach to study design and execution. Even ISO 17025 accredited laboratories are only required to have a validation and verification protocol—there is no dictation about what that protocol should look like.

“Currently, there is a lot of variation in the industry around [method] validation,” says Patrick Bird, microbiology R&D laboratory supervisor at Q Laboratories. Bird is a method validation expert who is on the U.S. ISO TAG TC34/SC9 working group 3 for the new ISO validation and verification standards, including ISO/DIS 16140-4 guidelines, “Microbiology of the food chain – Method Validation – Part 4: Protocol for single-laboratory (in-house) method validation.”

“Variables such as number of replicates, spike levels, and even acceptance criteria vary widely from lab to lab—both in manufacturing laboratories and contract testing laboratories. We hope the ISO guidelines will standardize that, ” says Bird. He goes on to discuss the importance of good laboratory stewardship in the industry. “While some look at validations as a proprietary or competitive advantage, the testing industry must realize that without standardization, poor validation and verification practices by a few can tarnish the great science done by the many, and ultimately jeopardize the safety of our food supply.” He stresses the importance of quality operations and open communications with laboratories, whether in house or third party. “Now that validation is highlighted as a required area in FSMA Preventive Controls, more and more companies are paying attention to the methods and associated validation/verification data their labs can provide.”

Continue to page 2 below.

Mobile FSQA apps

Are Mobile Apps a Game Changer for Food Safety Professionals?

By Maria Fontanazza
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Mobile FSQA apps

Many food safety and quality assurance (FSQA) professionals are constantly on the go in the workplace. They can be found on the floor of a manufacturing facility, off-site conducting supplier audits, or out in the field performing pre-harvest inspections, just to name a few locations during their busy day. “To benefit from food safety automation, these folks need more than the capability of logging into a system through a desktop,” says Levin. “They need a true mobile app that provides automation support out in the field,” says Barbara Levin, senior vice president of marketing and customer community at SafetyChain.

While other industries have been quick to adopt mobile platforms, the food safety industry has been much slower. Adoption is, however, gaining traction. In a recent conversation with Food Safety Tech, Levin talks about the value of FSQA mobile apps in today’s environment, where access to real-time, actionable data is crucial for the food industry.

Food Safety Tech: What common challenges faced by FSQA teams do mobile apps specifically address?

Barbara Levin: Mobile apps allow collection of FSQA at the point of origin, along with immediate access to the information for analysis, CAPA and reporting:

  1. Getting timely feedback on non-compliances for CAPA. When FSQA data is inspected at the end of the shift on paper, finding non-conformances often means rework. The instances in which this happens are too numerous to count. With mobile apps, you receive timely feedback. Information in the system is immediately analyzed to specs, so you’re catching non-compliances at the earliest point possible.
  2. Consistency in following your FSQA programs. This could be your USDA HACCP plan, FSMA HARPC plan, GFSI program, customer quality attributes and other components of your FSQA programs. Program components change all the time (i.e., Specifications, processes, rules in HACCP, GFSI code, forms, workflow, etc). Are FSQA managers confident that everyone is following the most up-to-date program? Is everyone following the workflow and doing everything in the right order? Are they completing tasks accurately? Using the right forms? Unfortunately companies find out that steps are missed or outdated forms were used during an audit; or when missed steps result in expensive rework or in the worst case, a customer rejection, withdrawal or a recall.

    Mobile apps will always have the most up-to-date forms, processes, specs and more. They act as a coach, leading the FSQA team member through the proper steps. When you enter incorrect or incomplete information on paper, it may not be detected until the end of the day or shift. A mobile app will issue an alert if incorrect information is entered; and it won’t let you submit a form if all fields aren’t complete. Because all of the updates are made in the system and pushed out to the app, if the specification changes while an FSQA team member is on the plant floor, when he or she logs in, the latest spec will always be there. You’re ensured that only the up-to-date program is being followed and that only the most up-to-date forms are being used.

  3. A lack of information for continuous improvement trending. If you have multiple facilities and products (resulting in mountains of FSQA paper), it’s a huge, manual task to make all of the data useful and relevant. With mobile apps, all FSQA data is entered “once and done,” making it accessible and actionable for immediate FSQA result tracking, daily KPI reporting and continuous improvement.
  4. Audit readiness. Mobile apps take audit readiness to a different level. With FSMA and GFSI, the saying is, if it’s not documented, you didn’t do it. By collecting FSQA data at the point of origin, all data is time and data stamped and uploaded to your permanent FSQA record. There’s no redundant data entry, mistakes are avoided, and there’s greater record efficacy that helps companies be audit ready, on demand.
Mobile FSQA apps
Mobile forms capture safety and quality data at the point of origin; data is actionable and then uploaded into a central repository for reporting and audit readiness. Image courtesy of SafetyChain Software. (Click to enlarge)

FST: What is the biggest benefit that FSQA mobile apps offer? 

Levin: The first benefit is real-time feedback. If you think about how things were done in the past, using an example of a pre-harvest inspection, you’re out there with a clipboard, making observations and recording non-compliances. Then you have to go back and enter the information into a spreadsheet, or turn it into a PDF, and send it to the food safety manager, who may or may not be sitting at his or her desk. Waiting to get a response equals time lost. And in the food industry, time equals money.

When you’re entering information into a mobile app, it analyzes that information in real-time and according to specifications. When there are non-compliances, alerts are pushed to the FSQA manager – wherever [he or she is located]. The manager can then generate a CAPA, which can then be completed, documented on the mobile device and electronically signed off by the manager. The process is expedited, and expensive rework is avoided.  

The second benefit involves data efficiencies. When data is collected on a mobile device, it’s entered only once and is then immediately available for multiple uses, such as a customer’s certificate of analysis, attachment to GFSI code for audit, or to be produced upon demand for a regulatory inspector. With a manual system, there’s a tremendous amount of redundant data entry. We hear this all the time from food safety folks— that they feel like they’re managing paper instead of food safety programs. When data is entered into a mobile app, it’s accessible immediately to FSQA, operations, vendor purchasing, management – any stakeholder who has a need.

“The Power of FSQA Automation Via Mobile Applications” Download the whitepaperFST: What approach should be taken to encourage the investment in and implementation of an on-the-go FSQA mobile platform?

Levin: I would love to think that in an ideal world, the creation of operational efficiencies that enable a higher level of confidence that you are sending out safer food is enough. Food companies are businesses, and they have obligations to consumers, which they take very seriously. But they also have obligations to their shareholders. When we talk to folks who really want this, it’s very easy to create a business case to senior management based on ROI. When you can close the gap by hours and days in the food industry, that time equals money. Avoiding rework also saves money.  And there’s ROI in faster sales throughput and increased shelf life by reducing hold and release times. We’ve heard from our customers that the solutions have paid for themselves and started to create ROI within three to six months.

HACCP and HARPC Plan Management Demands Automation

By Food Safety Tech Staff
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Manual management of HACCP and HARPC plans is often a resource-intensive and inefficient process that can create a data rich vs. information poor sentiment. Next week Dan Bernkopf, vice president of food safety applications at SafetyChain, will share insights on how companies can use automation to help assess risks to effectively create critical control points and preventive controls, during a webinar, “Conquering HACCP/HARPC Plan Management: The Power of Automation”. He will also share insights to help companies learn how automation can ensure that HACCP and HARPC plan components are scheduled, monitored and documented.

How else can automation help companies with their HACCP and HARPC plans?

  • Provide real-time non-conformance reports for CAPAs, minimizing waste and rework
  • Leverage mobile technology to collect food safety data at the source
  • Conduct meaningful trend analysis for continuous improvement with accessible, actionable data
  • Be audit ready for USDA, FDA and customer inquiries

Register for “Conquering HACCP/HARPC Plan Management: The Power of Automation
Thursday, August 6
1 pm ET / 10 am PDT
The webinar is part of SafetyChain’s FSQA Tech Talk series

Unleashing the power of the cloud on Food Safety and Food Quality

By Food Safety Tech Staff
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SafetyChain’s FSQA Tech Talk conversation continues next week with a discussion on why cloud and mobile technologies are becoming a game changer for food safety and quality assurance (FSQA).

As part of an ongoing series that focuses on how technology is being leveraged to solve FSQA execution challenges, the next FSQA Tech Talk session’s special guest speaker will be Michele Eddy, Corporate QA Manager with UniSea.  Eddy will be sharing her experience and insight as to how realtime FSQA data, which is  available, anywhere, and at anytime, is helping to provide sales with immediate quality gradings, better manage HACCP, CAPA, and direct observations for UniSea’s pillars of sanitation,  and how the cloud is making it easier for participants in their supply chain to work together.  Eddy will also discuss use and employee adoption of mobile devices.

The session will start with SafetyChain’s Director of Technical Solutions who will discuss key benefits of the cloud on FSQA, including the ability to have realtime data proactively pushed out and acted upon,  as well as how cloud and mobile devices support FSQA transparency and visibility across the value chain. Also discussed will be common cloud misperceptions including security and employee adoption.

The speakers will be taking questions live from the audience, and FSQA attendees are encouraged to bring their IT folks to participate. Attendees who would like to see what the cloud and mobile FSQA apps look like in action, are invited to stay online after the Tech Talk for a 15 minute demo of SafetyChain’s cloud and mobile solutions. The session is being held on Tuesday, May 19 at 10:00 am PDT, and those interested in attending can visit here for more information and to register.

The FSQA Tech Talks are a part of SafetyChain’s 2015 FSQA Technology Series: “Enabling Technologies – The Food Safety & Quality Assurance Game Changer” – which includes Leadership Forums, FSQA Tech Talks and Executive Briefs. Jill Bender, SafetyChain Vice President of Marketing Communications, said, “SafetyChain has been very proactive these past several years in educating industry on key FSQA challenges such as FSMA, GFSI, cost of quality and more. Input from the thousands of people who have attended our webinar forums was that they’d also like to learn more about how their peer companies are leveraging technology to execute on these challenges – and so the 2015 FSQA Technology Series was born!” “So far more than 1,500 hundred FSQA and food company IT folks have participated in the series, and we’re very excited to continue with fabulous speakers such as Michele Eddy,” Bender continued.

To learn more about SafetyChain’s FSQA Technology series visit www.safetychain.com/2015techseries.

Upcoming FSQA Tech Talks Include:
June 23: Harnessing Cost of Quality
July 21: Conquering HACCP, HARPC and Food Safety Plan Management
Participants of this series need only sign-up once and will automatically receive notice of the next topic and login/call information.  Register here for this complimentary series.

Food Safety Culture: Measure What You Treasure

By Lone Jespersen, Brian Bedard
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A culture of food safety is built on a set of shared assumptions, behaviors and values that organizations and their employees embrace to produce and provide safe food. Employees must know the risks and hazards associated with their specific products, and know why managing these hazards and risks in a proactive and effective manner is important. In an organization with a strong food safety culture, individuals and peers behave in a way that represents these shared assumptions and value systems, and point out where leaders, peers, inspectors, visitors and others may fail to protect the safety of both the consumers and their organizations.

A number of factors influence these organizations, such as changing consumer demographics, emerging manufacturing hazards, and the regulatory environment. The United Nations predicts that the number of people over 60 years will double by 2035, the number of diabetes patients will increase by 35% (International Diabetes Federation), and the number of individuals living with dementia will increase by 69% (Alzheimer’s Disease International). This poses an increased urgency for food manufacturers, as these population cohorts are more susceptible to foodborne infections or may have challenges with food preparation instructions.

Much has been published on food safety culture, and we owe it to the front-runners to use their work to go deep into practical, everyday challenges and to continuously strengthen organizational and food safety culture.1 An element common to most of these publications is a reference to the importance of behaviors.2-8

There is a renewed recognition of the importance of individual behaviors specific to food safety and personal self-discipline in food processing and manufacturing organizations. Employees throughout the organization must be aware of their role and the expected food safety behaviors, and held accountable for practicing these behaviors. Embedding food safety culture in an organization can be very challenging given the need to carefully define appropriate behaviors, the difficulty in changing learned behaviors, and the complexity of objectively evaluating the level of food safety culture in a company. This article is an attempt to define useful food safety behaviors and to describe a behavior-based method that you can use to measure the maturity of your organization’s food safety culture.

Defining measurable behaviors

Behaviors is the element that, when combined with results, creates performance.9 Behaviors, if used to measure and strengthen food safety culture, must be defined carefully in a consistent, specific, and observable manner. Martin Fishbein and Icek Ajzen, authors of multiple publications on the Reasoned Action Approach, teach us how these three factors can be used to predict and explain human behavior, attitude, perceived norms and perceived control.10 They also teach us that behaviors can be defined consistently by including four elements (Figure 1).

Figure 1: Four components to a consistently defined behavior
Figure 1: Four components to a consistently defined behavior

Case: CCP operator on a baked chicken line. I work in a chicken processing company and am responsible for monitoring the internal cook temperature of chicken breasts after the product has gone through the oven. One of the important behaviors for my role could be defined as “Measure temperature of chicken after oven at predetermined time intervals”. This behavior is consistent, as it includes all four elements of the behavior definition (Table 1). The content of the behavior is defined in a way that makes it relevant for me, the CCP operator, and I am clear on the assumptions made by others on the processing line about my behavior. The behavior is observable and most people would be able to enter the processing area, observe the behavior and assess if it is performed as needed, YES or NO.

Leaving out any of the four elements of a behavior definition or becoming too general in your statements leads to poorly defined behaviors that are difficult to use as an assessment of behaviors, and ultimately as a measure of the sites for food safety culture (Table 1).

 Scenario  Behavior  Action Context Target Timing
Consistent, relevant, and observable  Measure and record temperature of three chicken pieces every hour at end of oven  Measure and record temperature  End of oven  Three chicken pieces  Every hour
Missing definition elements  Measure temperature at pre-determined intervals  Measure temperature  Not defined  Not defined  Pre-determined time intervals
Not specific  The product is cooked and checked every hour  Not defined  Not defined  The product  Every hour
Not observable  The product is cooked and check to see if it meets standard  Checked  Not defined  The product  Not defined
Table 1: Scenarios of defining behaviors

Behaviors are observable events and for this to be true, a behavior must be defined objectively in a language clear to everyone involved. It can be helpful to target a grade-six readability level, as it forces everybody writing the behavior to avoid words that are not understood in plain language.

Using behaviors to measure food safety culture

Assuming that behaviors are defined in a consistent, specific, and observable format, how do we decide the critical few behaviors that get measured? A suggested method is the use of the food safety maturity model (Table 2). The model outlines five capability areas that a processor or manufacturing company can use to measure its current state and to set priorities and direction. One capability area is Perceived Value that describes how an organization might see the value of food safety. The maturity level ranges from a low level of maturity of “Checking the box because regulators make us” to a high level of maturity for “food safety is an enabler for ongoing business growth and improvement”. Consistent, specific, and observable behaviors can be defined for each of these stages of maturity. By assessing the performance of these behaviors we can aggregate these assessment scores into a site or organization measure of the maturity of the site or organizational food safety culture. It is important to note that the maturity score does not measure “good or bad” culture. The measure is one of progression along the food safety maturity model scale, and can therefore be used to highlight areas of strength and help prioritize areas of improvement for the individual organization.


Table 2: Food Safety Maturity Model. The Food Safety Maturity Model was developed by Lone Jespersen in collaboration with Dr. John Butts, Raul Fajardo, Martha Gonzalez, Holly Mockus, Sara Mortimore, Dr. Payton Pruett, John Weisgerber, Dr. Mansel Griffiths, Dr. Tanya Maclaurin, Dr. Ben Chapman, Dr. Carol Wallace, and Deirdre Conway.

For more details on the food safety maturity model, visit www.cultivatefoodsafety.com.

Call to Action

The organization’s culture will influence how individuals throughout the group think about safety, their attitudes towards safety, their willingness to openly discuss safety concerns and share differing opinions with peers and supervisors, and, in general, the emphasis that they place on safety. However, to successfully create, strengthen, or sustain a food safety culture within an organization, the leaders must truly own it and promote it throughout the organization.8

The call-to-action for food industry leaders and regulators is to embrace a standardized measure of food safety culture to allow for comparison and sharing within an organization and between companies. “Food safety is everybody’s responsibility” was the theme of the recent GFSI Global Food Safety Conference in Kuala Lumpur, but to act on this with food safety culture as the ultimate outcome, we must adopt standardized measure. The GFSI benchmarking technical working group is an ideal forum to continue this dialogue.

During the upcoming GMA Science Forum April 12-15, 2015 join the conversation at a practical and detailed level. The preconference Food Safety Culture workshop takes place April 12, with facilitators from leading organizations;  the Food Safety Culture Signature Session on April 13 will discuss what our industry requires to enable this level of standardization and collaboration. For more information and to sign-up, visit http://www.gmaonline.org/forms/meeting/Microsite/scienceforum15.


  1. Schein, E. H. (2010). Organizational culture and leadership. San Francisco: Jossey-Bass.
  2. Ball, B., Wilcock, A., & Aung, M. (2009). Factors influencing workers to follow food safety management systems in meat plants in Ontario, Canada. International Journal of Environmental Health Research, 19(3), 201-218. doi:10.1080/09603120802527646.
  3. Hanacek, A. (2010). SCIENCE + CULTURE = SAFETY. National Provisioner, 224(4), 20-22,24,26,28-31.
  4. Hinsz, V. B., Nickell, G. S., & Park, E. S. (2007). The role of work habits in the motivation of food safety behaviors. Journal of Experimental Psychology: Applied, 13(2), 105-114. doi:10.1037/1076-898X.13.2.105.
  5. Nickell, G. S., & Hinsz, V. B. (2011). Having a conscientious personality helps an organizational climate of food safety predict food safety behavior. Food Supplies and Food Safety,189-198.
  6. Jespersen, L., & Huffman, R. (2014). Building food safety into the company culture: A look at maple leaf foods. Perspectives in Public Health, (May 8, 2014) doi:DOI: 10.1177/1757913914532620.
  7. Seward, S. (2012). Assessing the food safety culture of a manufacturing facility. Food Technology, 66(1), 44.
  8. Yiannas, F. (2009). In Frank Yiannas. (Ed.), Food safety culture creating a behavior-based food safety management system. New York: Springer, c2009.
  9. Braksick, L. W. (2007). Unlock behavior, unleash profits (Second ed.) McGraw-Hill.
  10. Fishbein, M., & Ajzen, I. (2009). Predicting and changing behavior: The reasoned action approach. London, GBR: Psychology Press.

CAPA and Root Cause Analysis for the Food Industry

By Dr. Bob Strong
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A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.

Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.

Who should perform the RCA?

Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan

CAPA: The process unpacked

A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:

  1. Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
  2. Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
  3. Investigate: Make a plan to research the problem.
  4. Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
  5. The Action Plan: Narrow the list of possible causes.
  6. Implement: Execute the action plan
  7. Review: Verify and assess effectiveness

CAPA benefits

A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.

This article is an excerpt from a white paper prepared by SAI Global Assurance Services, and has been published in Food Safety Tech with permission. Click here to download the white paper in its entirety.

Thermometer, Thermostat, or Smart Thermostat? Supply Chain Quality Approaches

By John McGlinn
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What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?

The seasons bring with them our sensitivity to weather conditions, and especially to how hot or cold it is, inside or out. We measure those conditions, and we try to regulate them so that we can stay within a safe and comfortable range. In many ways, the processes we use to do these things have analogies in the world of Quality Assurance. What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?


The definition of a thermometer is “a device that measures temperature or a temperature gradient, using a variety of different principles.” Two components are required: it must be able to sense the temperature and any change in it, but then it must also convert that information into some kind of scale using numbers. A key property is standardization, especially when regulating production processes. There should be nothing subjective about a temperature reading. Without standardization and agreement on the scale to be used, the readings are meaningless.

While a thermometer is critical to many production processes (not to mention in medicine, weather and scientific research) it has, by design, some limitations. 1. A thermometer does not initiate a reading. Someone decides to use a thermometer at a certain time to get a reading. In this way, a thermometer is a highly effective, yet passive instrument. 2. It shows a snapshot of what is happening at the moment of the reading. 3. It does not show any comparisons to what happened before, or what comes after, unless it is integrated into a system that goes beyond being the technology of the thermometer, i.e., beyond the” bulb” and the “mercury” it contains.

Supply chain quality tools: Audits and self audits

The analogue to the thermometer in the world of Quality Assurance is an audit. An audit is initiated by some agent (management, legislative enforcement, voluntary compliance with industry standards). Someone or something then takes the “temperature” of a process at some moment in time. It shows just that – what is happening at the moment. It makes the assumption that the next moments in time, until the next audit, will be just as “healthy.”


Rather than a self-contained tool (like a thermometer), a thermostat is a part of a control system. The system has the capacity to sense the temperature of a system, and respond in such a way that the system returns to a certain level, a “set point.” When it senses an anomaly, it responds by switching on either the heating or cooling components, or by regulating the flow of heat transfer materials.

Supply chain quality tools: Reports

The analogue to a simple thermostat in the supply chain quality world is an assortment of reports. They include information that is collected, such as:

  • Certificates of Analysis (COA)
  • Certificates of Compliance (COC)
  • Dynamic questionnaires
  • PDF Forms
  • Certifications

When the reports show that, at that moment, things are “too hot” or “too cold” (in other words, out of specification), then the system responds to what is collected with:

  • Corrective action plan
  • Material specifications, whether new or adjusted
  • Purchase order information
  • Supplier nonconformances
  • Supplier scorecards
  • Supplier rankings
  • Supplier processes (to be used)
  • Supplier procedures (to be used or changed.)

It’s clear that the system is set up to respond. However, it also means that the system may swing between various points of being outside the range of necessary specifications, just as a simple home thermostat may be constantly adjusting to return to a desired temperature, although much of the time it is in a condition of “returning to” rather than “at” a specified temperature. Once it reaches that temperature, it immediately begins to destabilize. Once it reaches a certain boundary, the thermostat kicks in to move back toward the “ideal.”

In the supply chain quality management context, this may allow for material variability that is constantly trying to return to a condition of compliance with specifications.

Smart Thermostat

No modern building is without a “smart” thermostat. What makes smart thermostats truly smart is that they reduce the amount of variability. They are so sensitive to changes that the response is quick and decisive. The variability is broken up into very small stages, and even a small increment triggers a quick correction, making the system much more consistent and stable.

Supply chain quality tools: Material variability management and Statistical process control

Just as a thermostat is really a component of a system, Material Variability Management (MVM) is a “smart thermostat” in the domain of supply chain quality management. Electronic documents flowing at a constant rate through a system, powered by Statistical Process Control (SPC), can spot trends and anomalies much more quickly than the large increments that cause a system to constantly react, getting too hot and too cold, while assuming that averaging the two makes the environment pleasantly warm.

Material Variability Management is based on the physical inspection and/or testing of all critical inputs and sub-assemblies in real time, along with specification verification, as well as approval to ship so that no material that doesn’t meet specifications moves through the supply chain. It is a system that integrates an array of tools such as:

  • Specification collaboration/distribution/sign-off
  • Supplier COA test data capture (manual and computer-to-computer)
  • Production batch tests data capture
  • Outbound COA generation from batch test data capture
  • SPC Analyses including individual test trending of out-of-spec conditions and into problem zone (beyond 3 sigma and approaching spec limits)
  • Ship-to-Control visualizations and range setting
  • Alerts for material problem performance
  • ANSI Z1.4 Sampling data capture and analysis
  • Lab test analysis data capture and comparisons
  • Advanced-BI for user-definable reports and dashboards
  • Material and location QA audits

MVM powered by SPC turns a supply chain quality management system into a truly SMART thermostat. Instead of taking a snapshot of reality and reacting to it, it can sense trends and send early warning signals that prevent the entire system from becoming unstable. Your enterprise deserves state-of-the-art support, especially when the technology is affordable, reliable, will save you money, and will secure your reputation for high quality.

USDA Approves Browning-Resistant GM Apples

The agency has described that the GE apples are “unlikely to pose a plant pest risk to agriculture and other plants in the United States and that “deregulation is not likely to have a significant impact on the human environment.”

The U.S. Department of Agriculture has decided to approve new types of apples that have been genetically modified to not brown soon after after being cut. The company that has developed the Arctic Granny and Arctic Golden varieties – Okanagan Specialty Fruits Inc. – is currently engaging in a voluntary food safety assessment consultation with the Food and Drug Administration regarding the varieties.

According to USDA, the decision to deregulate the apples and allow them to be commercially planted after assessments showed that “the GE apples are unlikely to pose a plant pest risk to agriculture and other plants in the United States” and that “deregulation is not likely to have a significant impact on the human environment.”

According to the company, Arctic apples will age, turn brown and rot like any other fruit, but produce less of the substance that causes browning. So when the apples are sliced or bruised, the fruit’s flesh retains its original color longer instead of turning brown.

Consumer groups opposed to genetically modified foods have indicated their disapproval of USDA’s decision. “Pre-sliced apples are a frequently recalled food product,” noted the Center for Food Safety. “Once the whole fruit is sliced, it has an increased risk of exposure to pathogens. Since browning is a sign that apples are no longer fresh, ‘masking’ this natural signal could lead people to consume contaminated apples.”

These groups are also concerned about the lack of standardized labeling for genetically modified crops and their processed forms. The Environmental Working Groups said that the approval of Arctic apples “underscores the need for a transparent and consistent national labeling standard.”

USDA’s announcement came the day after Sens. Barbara Boxer (D-CA) and Richard Blumenthal (D-CT) and Rep. Peter DeFazio (D-OR) reintroduced legislation to label genetically engineered food.

Interview: FSQA Enabling Technologies as a Food Safety and Quality Assurance Game Changer

By Barbara Levin
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In an interview withFood Safety Tech, Barbara Levin, Senior Vice President and Co-Founder of SafetyChain Software, talks about FSQA Enabling Technologies – the Food Safety and Quality Assurance (FSQA) Game Changer, a series of leadership forums, tech talks and executive briefs that SafetyChain has launched this month.

Barbara-Levin2The focus of the series is how technology can help FSQA teams execute to meet today’s biggest food safety and quality challenges in program management, compliance, continuous improvement, risk mitigation and much more.

Food Safety Tech (FST): SafetyChain is launching a new series, called FSQA Enabling Technologies – the Food Safety and Quality Assurance Game Changer. What is the series about and what will it include?

Barbara Levin: For the past three years, working with thought leaders throughout the food and beverage industry, SafetyChain has helped educate and share insights on critical topics – such as FSMA and GFSI. In 2015, we’re excited to bring the conversation to the next level – to discuss the tools that are available to execute on challenges such as FSMA compliance, managing GFSI programs, risk management/brand protection, audit readiness, cost of quality, supplier compliance, operational KPI performance and much more.

FST: Why is technology an important topic in food safety today as we enter 2015?

Levin: I strongly believe that adoption of FSQA enabling technologies is vital, necessary and inevitable – and the only way food companies are going to be able to scale to meet all of the challenges ahead of them. And industry is realizing this and wants to learn more as technology adoption is becoming more mainstream. Think about the technologies we all use at work and home today – things like employee portals to view our paychecks, email, online banking, all of the apps on our computer tablets – none of us can imagine doing without them now. Well think about suppliers entering Certificate of Analysis info on portals. FSQA folks doing pre-harvest inspections on mobile app forms, getting safety and quality information in realtime to determine if there are non-conformances and CAPAs required. And there are hundreds of other examples. We think these will become a way of life too in food safety and quality. So we’re really excited to provide a forum for this FSQA technology conversation.

FST: What changes have we seen in Food Safety and Quality Assurance enabling technologies that are allowing them to achieve more widespread, mainstream adoption?

Levin: There’s a wrong perception that the food industry lags behind some other industries when it comes to technology adoption. In reality, food companies have automated a lot of their functions – look at finance, human resources, payroll systems, supply chain, purchasing, inventory and such. These functions were automated because it saved time, saved money and created operational efficiencies.

Where there was a lag was in adoption of FSQA technologies. I think that this was because first generation safety and quality technologies were behind the firewall – and as we know food safety and quality folks are not sitting at their desks looking at a computer all day. Instead, they are out in the field doing a pre-harvest inspections, or on the plant floor, or at the supplier site doing an audit, or with the customer… basically they are everywhere except at a desk. But today, there are many cloud-based, mobile food safety and quality technologies that can be accessed anywhere, at anytime – and this has really been a game changer when it comes to adoption. Now, food companies are deploying technologies and gaining the same advantages – saving time, saving money and creating efficiencies that improve FSQA.

FST: What are some of the triggers leading teams to explore technology for the first time?

Levin: The word “more” is key to this answer. FSQA is seeing more regulation (think FSMA), more third party schemes like GFSI to manage, more audits, more pressure to improve operational KPIs and reduce the cost of quality. The only thing there’s not more of usually is people – and so technology is the most efficient way to scale to do “more with less.” Additionally technology is the key to getting FSQA information in the fastest manner possible – for timely CAPAs – and be preventive vs. reactive in ensuring that non-compliant products do not go into commerce.

FST: Where do you see FSQA enabling technologies as having the biggest impact on safety and quality operations?

Levin: For me, FSQA enabling technology can have great impact in these areas:

  • Reducing risk for withdrawals, rejections and recalls;
  • Having real time and continuous information to generate CAPAs and ensure safe, quality food;
  • Managing supplier risk and supply chain controls;
  • Scalability to do more without having to add more people;
  • Being audit ready – for regulatory, GFSI, customer and internal audits all the time – even for unannounced audits;
  • Reducing the cost of quality; and
  • Having actionable data for meaningful continuous improvement.

All of these really come under one umbrella, which is protecting the brand and financial value of your company.

FST: What’s coming up in terms of topics and speakers during the series kickoff?

Levin: The series has three components – Leadership Forums on “big picture” topics, Tech Talks on specific FSQA issues and how technology helps resolve challenges associated with those issues, and executive brief whitepapers on the business side of technology benefits.

The first leadership forum, scheduled for March 13, will feature Bob Butcher, Ipswich Shellfish Company’s FSQA Group Operations Manager, and Jeff Chilton, President of Chilton Consulting Group, and will focus on The Business Case for Food Safety and Quality Technology. Future topics include the Role of Technology in Risk Mitigation and Brand Protection, and Technology as an Enabler to Reduce the Cost of Quality.

The FSQA Tech Talks kick off at the end of March with the following topics:

  • March 31 – Tackling FSMA Compliance: How Automation Enables HACCP-to-HARPC migration, FSMA Reporting, Supply Chain Controls and More
  • April 21 – Harmonizing FSQA – It’s All About the Cloud: How the Cloud and Mobile Technologies Enable Anywhere, Anytime FSQA Data Capture and CAPA Generation
  • May 19 – Facilitating Continuous Improvement: Enabling Actionable Data for Trending, Benchmarking and Reporting Across Your Entire Operation

The first executive brief is available now and is titled, “The Critical Role of FSQA Enabling Technologies for Today’s Food Safety and Quality Operations: Technology as an Enabler to Fundamentally Change How Food Safety & Quality Operations Manage Risk and Meet Key Performance Indicators.”

Additional details on the entire series – along with registration and download information – is available at www.safetychain.com/2015TechSeries.

FST: Who should attend this series, and how can they get more information?

Levin: Folks from Food Safety, Food Quality, Operations, Legal, Financial, Executive and Information Technology Management from all sectors of the food and beverage industry are encouraged to register and participate in the series. Everything is complimentary and new topics and dates will be announced frequently. We also invite FoodSafetyTech readers to let us know what topics they’d like to see – they can email us at info@safetychain.com.

John Kukoly of BRC Global Standards

BRC in 2015: What’s Changing, and How to Get There?

By Sangita Viswanathan
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John Kukoly of BRC Global Standards

What’s new for BRC this year?

2014 has been an extremely busy year for BRC. We wanted to think of BRC standard as not just an audit or a standard for certification. We want to strengthen food safety and help grow respect for food safety around the world. So in that spirit, we have strengthened our program.

One of the new changes is auditor competency programs. Under this, auditors need to understand the standard, know the audit technique, have a strong grasp of the industry they are in, whether it be dairy or thermal processing etc. They need to truly understand the processes involved, and where the risks are. While there have been some challenges with the auditor competency program, we have identified some auditors that are clearly strong. We are also addressing the gaps.

With the horse meat scandal, we realized that there are some times gaps and barriers with distributors and agents. So we have developed a standard for brokers and distributors to strengthen the supplier approval program. This year, we have also worked on BRC Issue 6, and developed best practices from our experiences. The standard has been growing in the U.S., Canada, Mexico, and Italy, and we are also expanding into new areas both geographically and industry sectors such as packaging, storage and distribution etc.

One major development in 2014 was growth in unannounced audit, in response to customer requests. Customers came to us and asked us for that option that if they really feel ready for unannounced audits, they should do it. BRC currently has over a 1000 sites that are getting audited unannounced. And while it hasn’t been simple or straightforward, this is great progress.

Where’s BRC going in 2015 and beyond?

2015 is going to be a big game changer for us. In January, BRC Issue 7 will be launched, and for the first time, you can download the entire standard from the BRC website free of charge. Audits using the new Issue 7 will begin July 1. It’s a nice clean standard with a handful of changes, and cleaned up from Issue 6. Things we have added are food fraud, based on industry demand, given what happened with horse meat, olive oil, rice etc. BRC auditors are not forensic auditors or food fraud investigators. They will, however, focus on food defense programs, to confirm that you have control mechanisms in place to prevent fraud.

The revised standard will also included Expanded High Care, in which we have identified certain products with certain characteristics for greater scrutiny, for instance RTE products susceptible to pathogen growth. You need to make sure there’s no process to reintroduce the pathogens in the final product. This change has been a huge shift for some industries. While all standards cover the basic GFSI requirements, we have noticed that when it comes to RTE products, BRC is much more rigorous.

Another focus area will be prevent labeling errors to avoid recall. Often, the number one or two cause for recall is mislabeling, where the product inside the packaging is not accurately specified on the label. Often this is around allergen control, but if it’s in the package, it has to be on the label, and this is a big focus for the new version.

We are also expanding our BRC Global markets program to align better with the GFSI global markets program. In this we have roughly split the standard into three schemes – beginning, intermediate and full certification. If companies don’t have the ability, knowledge, or processes in place to get fully certified, it’s a systemic approach to work themselves forward. It’s one thing to get the standard and set the bar, but another process to prepare these companies for certification. So it’s very exciting program to work with real small sites, in developing areas of the world, where the food industry is still growing.

How will companies be affected by these changes? And why is embracing these changes important?

Management commitment is always important. We have done a lot of audits: Over the world, we have over 17,000 sites that are BRC certified on the food side alone. Ones that have done best are those that have embraced food safety culture as an organization. It’s really about how as an organization, you take something on. The companies that have always struggled are those that say, ‘it’s the QA manager’s job, and let them take care of it.’ BRC is trying to see how to improve, engage and then measure the culture of an organization especially when it comes to food safety. And this starts with training and the commitment to training. Sites should increase and improve their training, and focus on continually evolving and getting better with their food safety, food quality and regulatory compliance programs.

It’s important to embrace these changes, because we need to move forward to continue to reduce risks. Knowing our suppliers is a big part of that, and the new standards enable enhanced supplier approval, and controls, and transfer of information. In BRC Issue 7, supplier controls will be a critical focus area.

We also do have to get the internal house in order, so we need to have strong internal controls in place, and quality internal audits. Companies need to understand how to do these internal audits very well, and have process controls and, verification and validation programs in place. People understand the importance of food safety. But they don’t often use all the tools they have in their tool box as well as they can. We can use internal audits, root cause analysis, risk assessment, etc. more effectively to get more insights in our internal FSQA progams.

Overall, we should enhance food safety. The bar should be constantly raise. We can never be in a position where we say it’s safe and good enough, and we don’t have to do any more. We constantly have to move forward to meet expectations of consumers and customers. We need to follow continuous improvement, and get our partners involved, whether they are raw material suppliers, packaging providers, or distributors. What do they need to do, and how do we expect them to be our partners? We are certified, that’s great, but how can we transfer that along the supply chain? All these questions need to be continually addressed.

Listen to John Kukoly address more questions on how BRC can help you better prepare for FSMA and take on questions for the participants. Click here to access the webinar.