Gary Smith, Eurofins’ Food Safety Systems

Why Food Safety Training Fails, and What Can be Done?

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

The food industry has multiple levels of people involved, ranging from leadership and supervisors, all the way to line and front-end workers. Training, thus, has to not just give directions, but also provide better understanding of why we do what we are supposed to, says Gary Smith at Eurofins.

Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, says that “training for supervisors and leadership usually works well. But training workers is fraught with challenges. General training is focused more on giving directions, but not so much on providing understanding. People often skirt this rationale with the line workers, or it’s lost in translation, or missed out due to time constraints, turnover, vacation days etc. That’s where training fails.”

What would happen if we don’t spend this time address the ‘why’ behind training? People then get busy, and then miss out on steps and processes, and that causes problems, Smith replies. “It’s also critical to aim to strike a balance, for instance with line workers training – you have to ensure they understand the importance of what you are training them on, but at the same time, you cannot go too deep into the training, that would be either unnecessary or redundant.”

So what kind of training will continue to be the focus for the industry? The usual ones will continue to be important, according to Smith: Regulatory requirements for seafood, specific HACCP requirements for meat, HACCP training for employees directly responsible for food safety and quality, standards training; training for audits… For line workers, training also needs to cover specifics of their jobs, employee hygiene practices (for instance, why it’s important to wear gloves, hairnets etc.), and how to handle customer complaints.

Proposed rules under the Food Safety Modernization Act are having a positive impact on training needs, says Smith. “Everyone is now waiting for the final set of rules to be announced and implemented. A lot of good things are coming out of it, such focus on risk management and process control, understanding which products are high risk and low risk. FSMA has brought back HACCP for those industries that haven’t really had strict regulatory requirements for food safety – such as seafood, fresh produce, juice etc., or ready-to-eat products that may have escaped regulatory scrutiny in the past, such as fresh produce, and bakery products. Now the industry as a whole needs to focus on FSMA implementation, by companies helping its employees understand where the food safety risks are, how to manage them, document them, and mitigate them.

How can training help companies towards certification? When training leaders that are going to be implementing the food safety standards within their facility, it’s important to be comprehensive about understanding the specific standard. There is also the opportunity to focus on common non-conformances and say ‘this is where others have struggled and this is what you can do to avoid those non-conformances.’ Training can provide lessons, solutions and ideas to address common problems to addresses non-conformances before an audit. It can help drive continuous improvement, and help secure management commitment.

What are some of the common training themes that have resonated with Smith? He says that mostly employees bring up the issue of getting management to understand the need to focus on food safety training and procedures. “People who have attended my classes are usually struggling with getting management commitment. They are often told they need to be certified to a particular standard by end of the year, and so figure it out, but there’s no skin in the game from management. I help these trainees walk through the various steps that they can take to secure that commitment, how to talking their language in terms of more efficient production, and higher dollar savings etc.,” Smith describes.

Some challenges that he has observed in his years of training? Smith says that often times the trainers are great auditors, but poor trainers. “They will quote standards, and regulations. They are too black and white, and objective. However, training can have successful outcomes only when it’s practical and linked to real situations and ideas.”

Holly Mockus, Product Manager, Alchemy Systems

Real Training Needs – Time and Resources

By Holly Mockus
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Holly Mockus, Product Manager, Alchemy Systems

With the announcement on September 19, 2014 of the released re-proposals to the main FSMA-related rules – Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program – it is time to take another look at the real need within the food industry related to training and education.

The word ‘train’ in some form or format appears over 100 times in the Produce Safety rule and the Preventive Controls for Human Food documents. One Hundred Times! This is clear indication that it’s time to take another look at the training programs in place today.

When asked, managers and supervisors responsible for training today typically respond that their biggest challenges or needs are having the time and resources available to conduct meaningful training for the workforce. Gone are the days where a ‘good’ training program consisted of shoehorning a training session into a segment of line downtime and hoping for enough time to cover all the learning objectives. As regulatory and customer emphasis on employee empowerment and engagement continues to escalate – food industry training programs must grow and evolve.

Here are some basic areas that need the proper time and resource dedication for maximum impact:

  • An analysis to determine gaps in the current training program should be very robust. Don’t skimp on the resources needed to do an effective job here. The use of this data is the first steps on the training journey and becomes the cornerstone as you build employee expertise.
  • The development of content should not be under resourced at any step in the process. Content is critical in providing the ‘How’ and the ‘Why’ (Who, Where, and When too). Worry less about fitting the material into a specific time slot and more about the quality and applicability for the specific workforce audience.
  • Partnering with a Subject Matter Expert or a content provider is an investment that will pay dividends as employees soak in the knowledge and ask for more.
  • Delivering the content in an environment that is conducive to group training where there are now distractions, all questions and answers can be heard by the participants in another resource that is critical to the success of a robust and effective program. Learning labs for more one-on-one self-directed learners are another means of providing knowledge to the workforce without having to incur line downtime. An investment that will pay for itself in a relatively short period of time.
  • Coaching employees for success in one of the best gifts that a supervisor or manager can provide. Constructively correcting incorrect behaviors and positively reinforcing good behaviors may take good people skills and a little extra time. Making it a habit costs very little and will provide a clear concise roadmap throughout the training process.

Training is a journey, not a destination. Teaching ‘how’ starts the journey – ‘why’ builds the culture. Spending time and resources for training should be a no-brainer for the food industry today. Stop looking at training as time spent losing operational effectiveness and start looking at training as the best investment you can make in your people, products and brands!

Hear the author speak more on Food Safety training at the Food Safety Consortium, November 17-18, 2014, Schaumburg, IL. Click here for more details and to register.

 

John Kukoly of BRC Global Standards

Where BRC is Going, and How Can You Get There?

By Sangita Viswanathan
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John Kukoly of BRC Global Standards

Food Safety Tech (FST): We’re very excited to have you participate in the SafetyChain/ FoodSafetyTech’s GFSI Leadership Webcast Series with the October 24 BRC – The Road Ahead webcast. We know that you’ll first be addressing what is new with BRC today. What are some of the things you’ll be talking about in terms of current changes?

Kukoly: We are just on the cusp of releasing Issue 7 for BRC. This is scheduled to be released in January 2015. With this, there will be some changes made to how food companies and facilities can obtain the BRC standard. We have a really unique system, termed BRC Participate, that we propose to unveil during this time, which I will talk about more during the webinar.

FST: We know that audits will be a topic of many questions. Is BRC planning changes to the way it does audits? What are some of audit-related topics you’ll be addressing in the webinar?

Kukoly: One of the changes I will be talking about is the auditor-competency program. Other topics will include expansion of our unannounced audit program. BRC is currently the leader in this area, and Wal-Mart has specifically asked us about this. We have done such audits in over 600 sites already, and are currently the go-to people for unannounced audits now. We are also forming BRC Global Markets, which will help small and less developed companies to get ready for certification.

FST: You will also be talking about the direction of BRC in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to BRC?

Kukoly: In my opinion, the two most critical areas of focus for the food industry right now are risk management and supplier management. These are the two main key elements being covered in all new regulations under development, and if a food facility has these covered, then they are in a good place. These are the two specific drivers that are shaping future changes to the BRC standard.

FST: While we all know that while change is important, it’s not always easy to get already-burdened food safety organizations to embrace change. What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of BRC certification?

Kukoly: I don’t think ‘why’ should be the right question. We should focus on ‘HOW’ to go about this. And I think we need to talk about food safety culture and change management. These are the areas that are key to success and embracing change.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s BRC. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Kukoly: One of the topics I will be addressing is training, not necessarily for BRC, but for obtaining the right skill sets such as risk assessment or HACCP. These are necessary for any food manufacturing organization to prepare for tomorrow’s BRC, and to have robust systems and processes in place.

FST: It has been said that GFSI certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance and alignment with BRC?

Kukoly: If you look at FSMA expectations, they are very well aligned with requirements of BRC standards, whether it be supplier management and verification requirements, or risk assessment etc. Beyond that, it is about strength of traceability procedures, knowledge of FSMA within the facility and its qualified individual. The focus is primarily on robust supplier management programs and implementation. If all these are in place, then you are in a very good starting place for FSMA compliance.

Listen to John Kukoly talk more on these topics and take your questions live in the BRC – The Road Ahead webinar on Friday, October 24, 2014 at 10:00 PT/ 1:00 ET. Click here to register

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.

Microbiological Method Validation: The Elephant in the Lab

By Evan Henke, PhD, MPH
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Although commonly overlooked, microbiological method validation studies are the linchpins of entire quality programs, and method validations done without rigor are crippling our industry’s ability to truly ensure the quality and safety of foods on a daily basis.

Food quality managers, it is time we discussed the critical importance of validation studies in the quality lab. Although commonly overlooked, microbiological method validation studies are the linchpins of entire quality programs, and method validations done without rigor are crippling our industry’s ability to truly ensure the quality and safety of foods on a daily basis. This article discusses the purpose and importance of microbiological method validation studies and why the food industry should insist on validation study designs of maximum rigor and validity.

What is a microbiological method, and what exactly is a validation study?

A microbiological method, for the purposes of this discussion, is any microbiology test or assay used in the food industry. It may be a test for indicator organisms such as Coliforms or yeast and mold, pathogens such as Salmonella or E. coli O157, or toxins secreted by microorganisms such as Staphylococcal enterotoxin.

A validation study is a one-time study that food safety risk managers complete in order to assure themselves that a new microbiological method produces accurate results that will enable them to effectively measure and manage food safety risk. A validation study is conducted in the actual lab where testing will be performed, with current laboratory analysts, with the specific formulations of foods that are tested regularly.

Food industry regulators and certifying bodies such as SQF expect food producers to use microbiological test methods that are proven fit for use on specific foods. If we are to draw inferences about the fitness of a new test method on specific foods, then we must study how that new test method compares to an accepted reference method, or “gold standard” method. Reference methods are those written in the Food and Drug Administration’s Bacteriological Analytical Manual, the United States Department of Agriculture’s Microbiological Laboratory Guidebook, or ISO methods. Regulators and experts agree that these methods represent the standard to which all other tests should measure up. Methods certified by the Association of Analytical Communities (AOAC) are not considered reference methods and must be validated as fit for use on foods that are appreciably different from the matrices studied. Likewise, AOAC Performance Tested Method (PTM) and Official Methods of Analysis (OMA) certificates are not substitutes for internal validation studies in any given food plant.

In my experience working with quality labs across the United States, I have seen several different validation study designs used to evaluate alternative, more rapid and cost-effective microbiological methods. Some common validation study designs are shown in Table 1. Multiple alternative tests are available, however an internal validation study is needed regardless of the test kit manufacturer. Rarely does a validation study include a comparison to agar plates, which are required for almost every microbiological reference method. Material costs, labor costs, and emergency situations typically prohibit food labs from conducting a rigorous validation study that can speak to the performance of a new method in relation to the current gold standard.

Table 1: Scientific Questions Inherent in Food Microbiology Method Validation Study Designs 

 Validation Study Design  Inherent Scientific Question  Does Study Explain Performance
of New Test?
 
Test positive or spiked samples side by side on reference method and the new test  Does the test perform comparably to the reference method on my food? Yes 
Test positive or spiked samples on the new test  Regardless of accuracy, can the test detect certain or specific bacteria in my food?   No, but may be useful to understand workflow
Test any samples side by side on current AOAC certified method and new test  How do the new test’s results compare to my current AOAC certified method on my food?  No, but may be useful to understand workflow 
Test any positive or negative samples on the new test  Will the new test’s workflow improve my lab’s efficiency?  No, but may be useful to understand workflow 
This table presents several validation study designs common in the food industry and the scientific questions that are addressed by each design.

It is in the best interests of food producers and the public’s health to conduct rigorous validation studies that give food safety risk managers good information to make correct risk management decisions. In theory, some percentage of unsolved epidemiological foodborne illness clusters must be due to incorrect risk management decisions that allowed contaminated products to reach the market. At the same time, some percentage of all food lot rejections and recalls must be made incorrectly. A portion of these events must be related to food matrix interference that yielded incorrect microbiological results and caused the wrong risk management decision. As they say, “Garbage in, garbage out.”

In addition, including a comparison to agar reference methods in your microbiological method validation study is critical, as it reduces your chances of making an incorrect risk management decision.

Look at things this way: Plants certified with a GFSI accredited quality scheme have already put in effort to ensure analytical equipment such as thermometers and scales are calibrated. Similarly, validating microbiological methods against a reference method is equally if not more important. Finished product microbiology results inform decisions made every day that affect your profits and losses, and those results are likely a primary metric you use to study the effectiveness of your prerequisite programs and preventative controls.

Consider a quality lab that is using an alternative microbiological method that has not been rigorously validated with the plant’s specific foods. Unknown to the lab, the test results every day are twice as variable as the reference agar method and are frequently inaccurate relative to the plant’s product specifications. A rigorous method validation would demonstrate that results on the current method vary widely, while the same samples are consistent with a reference method. This well-intentioned plant is unknowingly making incorrect risk management decisions not just multiple times per year, but multiple times per week, either accidentally releasing contaminated product, reworking product that is acceptable, or disposing of perfectly good product. For the millions of dollars the food producer invests in prerequisite programs, preventative controls, quality personnel, and testing, the plant is unable to optimize their food safety risk management simply due to an unknown and overlooked incompatibility of the microbiological method with the plant’s product.

In my estimation, the costs of rigorously validating a microbiological method on all of your food products outweigh the potential hidden costs that could result from method incompatibility. The business case justifying the costs of a validation study are strong and compelling. And learning how to apply current microbiological methods specific to your foods is not as hard as you might think, considering the large host of test manufacturers, third-party labs, consultants, food safety extensions, and industry groups available to regularly provide study design education and services.

Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

High False Positive Rates for Pathogen Food Safety Testing

By Thomas R. Weschler
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Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

This article looks at proficiency testing (PT) for pathogen analysis, and the recent finding by the the American Proficiency Institute (API) of a 6.6 percent false-negative rate on food safety PT samples (14-year average for the 1999-2012 period).

While at IAFP this year, I met with Heather Jordan, who directs food PT programs at API. The proficiency testing programs are used at many food labs in conjunction with lab accreditation programs. Proficiency testing is done at food plant labs (FPLs) and corporate labs, as well as at food contract testing labs (FCLs) as a way to demonstrate quality results in their food micro and chemistry testing.

More proficiency testing but less proficiency?

In fact, the use of PTs is increasing in food labs, which is probably tied in part to the push for lab accreditation by FSMA and non-government groups like GFSI. Yet it seems to me that the current use of PTs doesn’t go far enough to enable an FPL or FCL to demonstrate overall laboratory competency, and gain or maintain accreditation (ISO 17025).

In most labs, PTs are done just a few times a year. And really, they test the competency of the lab technician and protocols used in analyzing the PT samples. They are not a holistic measure of the lab and its ability to consistently generate quality results on every test run by every operator in the lab.

In a previous life I ran a group of environmental testing labs, which also are required to run PT samples during the year. From this experience, I know that lab personnel are aware that PTs are in-house: The sample-receiving group logs them in, and then alerts management. As a result, the best operators usually are assigned to run the PTs. This kid-glove treatment is not representative of day-to-day practices and processes. If we really want to validate and accredit the proficiency of an entire lab, shouldn’t every operator be tested on all protocols in use?

Plus, if labs know when they are running PT samples, and likely have their best operators running them, shouldn’t there be few, if any, false-negative or false-positive results? Surprisingly, that’s not what the API research found…

API study: Performance accuracy for food pathogens remains problematic

In a retrospective study, “Pathogen Detection in Food Microbiology Laboratories: An Analysis of Proficiency Test Performance,” API analyzed the results from 39,500 food proficiency tests conducted between 1999 and 2012 to see how U.S. labs are doing in detecting or ruling out contamination of four common food pathogens.

Over the 14-year period, “False negative results ranged from 3.3 percent to 14.0 percent for E. coli O157:H7; 1.9 percent to 10.6 percent for Salmonella spp; 3.4 percent to 11.0 percent for L. monocytogenes; and 0 percent to 19.8 percent for Campylobacter spp.” Most concerning is that while both false positive and false negative rates were down in the last year of the study, the cumulative false negative rate for the 14-year period was 6.6 percent.

As we know, false positive results (in which a sample that does not contain pathogens is incorrectly shown as positive) are a nuisance. But false negative test results—which fail to detect true pathogenic organisms in the sample—are not unacceptable.

Tom-Weschler-False-Negatives-Sep-2014

The cumulative average false positive rate was 3.1 percent, less than half of the false negative rate for the same period.

The objective of the study—and, I would think, of proficiency testing in general—is to demonstrate improvement in lab performance year over year. The results of the API report concluded to the contrary, however: “Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.”

Clearly if false negatives happen in proficiency programs, they happen in the course of regular testing at food labs. I’m told that many FCLs and FPLs rely on other parts of their QA systems to make sure testing is being conducted properly. Even so, the documentation of ongoing and unacceptably high false negative rates in PT testing is a big concern for everyone. It also points to a number of follow-on questions:

  • Would the false negative and false positive results be even higher if every technician, rather than the best operator, performed the analysis?
  • PT samples are created in only a couple of sample matrices. Would results be even worse if performed on the myriad of sample matrices present in the food industry?
  • What are the performance results among all of the pathogen methods available? Are some methods better than others when measured in real world conditions? Do the more complex protocols of some pathogen diagnostic systems result in poorer PT performance results?
  • Would PT results and, even more important, lab proficiency improve if the frequency of PTs increased, and were required of every technician involved with real food samples?
  • How can proficiency testing be used to isolate problem areas, whether in the pathogen diagnostic method or the competency of lab operators and processes?
  • And finally, is the performance data different between food contract labs and food plant labs? And are all FCLs are equal, or are some more able to deliver quality results?
Holly Mockus, Product Manager, Alchemy Systems

10 Training Concepts for an Effective, Engaged Workforce

By Holly Mockus
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Holly Mockus, Product Manager, Alchemy Systems

Effective training programs are the cornerstone of a high performing workplace. Providing the basic knowledge to workers and reinforcing the need to apply that learning in their daily activities are just two critically important facets of a well thought out training system.

Here are 10 concepts that need to be implemented to bring training and education full circle and to provide forward momentum in the process of developing a fully engaged highly productive workforce.

  1. Set learning objectives – determine first what the key points or factors are that will be influenced by this knowledge exchange and how will the outcomes be measured.
  2. Create the content – tailor the message or training information to the specific audience for maximum absorption and comprehension.
  3. Deliver the content – ensure the set-up is conducive to learning. Keeping the message relevant to the workers level of comprehension and using real life examples that they can relate to is a best practice.
  4. Keep training top of mind – use awareness programs as visual and audio prompts that keep the topic out in front of the organization. When everyone walks the walk and talks the talk it makes it harder for the individual leaner to forget what needs to be done and how to do it.
  5. Verify comprehension – use testing, observation and constructive feedback to help employees apply what they have been taught. Be sure that feedback is constructive not punitive and is delivered in real time for maximum effectiveness and greater adoption by the worker.
  6. Track and trend using metrics – Measurement of desired outcomes should be used as a yardstick to help determine if the content, delivery and application of the training is on track or needs course correction.
  7. Never pass up an opportunity to train – refresher training on a regular basis is needed for any program to be effective. Retraining is also very impactful when used as a corrective action or as part of an investigative process.
  8. Keep it fun – capture the learner’s attention by using bright colorful presentations, games or game show formats, and some light humor. A little friendly competition between departments is a great way to engage the workforce while promoting the learning process.
  9. Use positive reinforcement – those that absorb and apply need to be recognized and reinforced. Don’t just say thank you. Recognize the positive impact of their good work habits and how their application of those work habits has resulted in good outcomes.
  10. Hold people accountable – employees that are unwilling to follow training principles need to be held accountable with appropriate consequences. Deciding in advance what the consequences are and hold all employees to the same level of accountability will drive continuous improvement and strengthen the overall training program.

These 10 basic training concepts will provide an excellent cornerstone to support programs across an organization and drive consistency, accountability and employee engagement.

Hear the author speak more on food safety training at the Food Safety Consortium, November 17-18, 2014, Schaumburg, IL. Click here for more details and to register


 

Tim Lozier, EtQ, Inc.

What are the 4 Key Elements in Compliance Management Software?

By Timothy Lozier
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Tim Lozier, EtQ, Inc.

Compliance is a broad term in business today. It’s a term that gets thrown around in meetings, operations, regulations, and covers so many definitions. It almost borders on cliche – compliance is broad. But what does it mean?

In simplest terms, “Compliance” means that you are able to do business with confidence. You can operate your business in a manner that means less risk, better quality, safety and governance. It means that you are doing business as you should – as people will expect you to. Compliance management software is designed to help foster this concept, but again, it becomes broad in definition on what can be offered.

What do people need in compliance management software solutions? Here are 4 basics:

A flexible platform

You cannot necessarily place compliance into one operational area. Quality Management Systems, EHS Management Systems, Governance and Risk Systems, and others all fall under the umbrella of compliance. But the core common theme is that you want a solution that will track all your processes, manage them and put controls in place to fix any adverse events quickly and effectively. Trouble is, that you will change processes, you will need to adapt to market changes, business changes and beyond. Having a flexible platform that enables you to periodically make changes easily is a key to compliance management software. You want to make sure the platform you select has this flexible for rapid business process change. Look for a solution that has this flexibility; it enables you to change workflows, and forms as you need to – without any signifcant effort.

Risk management

More and more, compliance is centered around Risk. This is because in the rapdi pace of business today, you cannot easily keep up with compliance without having some level of objective and systematic means to measure events and make decision on those events. Risk tools, and quantitative risk methods are paving the way to enable businesses to quantify their events that are out of compliance, and make decisions on how to mitigate the risk of those events. You want to ensure that your compliance management platform incorporates some level of risk management solution, or builds in a risk assessment to ensure that not only are you addressing the most critical events, but you are also building our a risk based strategy on how to ensure they are mitigated.

Integration and Scalability

Compliance, as stated above is broad. It does not live in a silo; many compliance processes span multiple facilities, departments and operational areas. It also spans multiple business systems. You want a solution that provides a macro-view on the data, and pulls in from other systems, as well as pushes compliance information to other business systems. This way you are creating a “Hub” for compliance that touches all other areas of the business. Similarly, you want to be able to harmonize and standardize your processes related to compliance throughout the enterprise. This requires a system that can span multiple facilities, and create a single source for compliance data. Having a solution that can operate across several business units and locations, while remaining centralized the the core enterprise location is important to maintain control over compliance processes.

Visibility into compliance data

Having a system that can automate the processes related to compliance is immensely valuable, but it is only half the battle. Without visibility into the data, it becomes difficult to get an accurate picture on top-down compliance. You want to make sure that you are building in enterprise reporting and analytics tools to the compliance information. This way, you can see any trends, make decisions on continuous improvement, identify areas for preventive action, and generate compelling and accurate reports on the overall “health” of your compliance management system.

These 4 elements are just basics on compliance management software. Again, there are broad categories to which compliance falls under, and each category will have its own specifics. The key is that with a robust, yet simplistic framework, built upon a enterprise-level platform, you can achieve the goal of doing business with confidence.

Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Environmental Monitoring – Another Leg on the Food Safety Management Stool

By Sangita Viswanathan
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Dr. Douglass Marshall, Chief Scientific Officer – Eurofins Microbiology Laboratories

Eurofins laboratories routinely test for the presence of the infectious bacterial generaSalmonella and Listeria monocytogenes in the food processing environment. While L. monocytogenes long has been known as an environmental contaminant, only recently Salmonella has been considered a persistent environmental contaminant.

At this year’s Food Safety Consortium (November 17-18, 2014, Schaumburg, IL), Dr. Douglas L. Marshall, Chief Scientific Officer – Microbiology, for Eurofins Scientific Inc. will present a workshop on Environmental Monitoring. This workshop will provide an overview of analytical methods used, a discussion of the zone approach to environmental monitoring, and a practical example of the use of microbial genetics in Eurofins’ Source Tracking Program to identify and eliminate a pathogen harborage.

In this Q&A with Dr. Marshall, we present a sneak-peek into what to expect in this workshop. Register today to learn more.

Food Safety Tech (FST): How are environmental monitoring requirements changing under FSMA?

Dr. Marshall: The Food Safety Modernization Act passed by Congress contains language in SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS stating: ‘‘(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means” and ‘‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.”

The Preventive Controls for Human Food Proposed Rule has moved environmental testing to the appendix. It is clearly FDA’s intention that firms use environmental monitoring but how this will ultimately play out in the final rule is unknown. The companies we work with are finding a substantial non-regulatory push for environmental monitoring from their customers. As a result, firms without environmental monitoring programs will find it challenging to escape criticism from inspectors, auditors, and customers.

FST: What are some broad topics you are going to be covering in your FSC presentation?

Dr. Marshall: This EMP workshop will deliver tips for an effective pathogen monitoring program. Highlights include information relevant to answering many EMP questions such as what to test for, what is the value of indicators; where to test, what methods to use, what test volumes are appropriate, how to use trending, and how to remediate an environmental problem.

FST: What are some key challenges when companies do environmental monitoring? For Salmonella, and for Listeria?

Dr. Marshall: Many companies find it difficult to start an EMP program and fail to use the program in a proactive manner as an assessment tool. Environmental monitoring is an essential tool for microbial control, but it is not a control program. Robust programs target areas in a processing plant where environmental pathogen control is critical to product safety. The pathogen of concern may differ depending on food product type and processing conditions.

FST: Why is it important for food companies to pay attention to this critical area of testing?

Dr. Marshall: Numerous recent high-profile foodborne disease outbreaks and large recalls have been traced to poor environmental controls. Lack of effective environmental monitoring by producing firms contributed to these events. As a result, inspectors, auditors, and customers are demanding the placement of environmental monitoring programs as an additional leg on the food safety control stool, adding to GMPs, SSOPs, and HACCP.

FST: What kind of technologies will you be talking about in your presentation?

Dr. Marshall: The talk will present an overview of analytical tools required for routine monitoring and give an example of the use of genetic strain typing as a source-tracking tool for remediation.

Learn more, and register today for the Food Safety Consortium – Multiple Conferences, One Event, featuring 30 plus expert industry speakers, and speakers from FDA, CDC and USDA. 

Dr. Bob Strong

How to Perform Root Cause Analysis?

By Sangita Viswanathan
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Dr. Bob Strong

SAI Global logoDr. Strong was speaking in a recent webinar onThe Importance of CAPA and Root Cause Analysis for the Food Industry, in which he discussed CAPA, Root Cause Analysis and the benefits of these quality systems. We present below the comprehensive list of questions as presented by Dr. Strong.

Questions to ask: People

  1. Does the person know what he’s expected to do in this job?
  2. Is he well trained?
  3. How much experience does the person have?
  4. Does the person have the right tools/ equipment needed to do the job?
  5. Is the workload reasonable?
  6. Does the person have adequate supervision and support?
  7. Do physical conditions such as light or temperature affect their work?
  8. Who does the person contact when problems arise?

Questions to ask: Method

  1. How is the process used defined?
  2. Is the process regular reviewed for adequacy?
  3. Is the process used affected by external factors?
  4. Have any changes been made recently in the process?
  5. What adjustments must the operator make during the process?
  6. How does the operator know if the process is operating effectively?
  7. Have other methods or processes been considered?

‘What would you do if things go wrong,’ this could be the most revealing question you can ask your employees that it may identify a real issue, added Dr. Strong.

Questions to ask: Equipment

  1. How old is the equipment or machinery?
  2. Is preventive maintenance performed regularly on it?
  3. Is the machine affected by heat, vibration, or other physical factors?
  4. How does the operator know if the machine is operating correctly?
  5. What adjustments must the operator make during the process?
  6. Have any changes been made recently in the equipment?
  7. How is the equipment cleaned?
  8. What tools are used to clean the equipment?

Questions to ask: Raw materials

  1. What is the source of the raw material?
  2. Has there been a change in suppliers recently?
  3. How is the raw material produced?
  4. How is the safety of the raw material verified?
  5. How old is the raw material?
  6. How is safety assessed prior to your operation?
  7. What is the level of safety and quality?
  8. How is the raw material packaged?
  9. Can temperature, light or humidity affect the material quality?

Questions to ask: Environment

  1. How are environmental conditions monitored?
  2. How are environmental conditions controlled?
  3. How is environmental control measuring equipment calibrated?
  4. Are there changes in conditions at different times of the day?
  5. Does environmental change affect the processes being used?
  6. Does environmental change affect the materials being used?

Questions to ask: Inspection System

  1. How frequently are products inspected?
  2. How is the measuring equipment calibrated?
  3. Are all products measured using the same tools or equipment?
  4. How are inspection results recorded?
  5. Is there a set of procedures and do inspectors follow the same procedures?
  6. Do inspectors know how to use the test equipment? 

Ask your team ‘what would happen if the systems weren’t calibrated? Are they giving you valid results?’ Probably that’s why you are not in compliance, explains Dr. Strong. 

All this take takes time and effort, and Dr. Strong urges management to devote the resources to go around ask these questions and get the answers.

What is your experience with Root Cause Analysis? Have your used such questions? Do you have more to add? Join the discussion by commenting below.

For more information, visit SAI Global’s Food Safety Resource Center, to access this complimentary, ON-Demand webinar.