Tag Archives: Preventive Controls

Omar A. Oyarzabal, Ph.D.

Unraveling the Impact of FSMA On Acidified Food Regulations

By Omar A. Oyarzabal, Ph.D.
2 Comments
Omar A. Oyarzabal, Ph.D.

The world of acidified foods is complicated—the question of how an acidified food is distinguished from an acid food, how to measure pH of acidified foods that are not homogeneous, what kinds and how records should be maintained and finally, how FDA enforces requirements? As consultants to FDA regulated industries, we receive numerous questions, as does FDA directly, on acid and acidified foods. This Q&A, answered by EAS Independent Consultant, Omar Oyarzabal offers insight into commonly received questions and their answers.

Q: How you distinguish an acid food from an acidified food?

Omar Oyarzabal: Acid ingredients have a natural pH of 4.6 or below, while low acid ingredients have a natural pH above 4.6. Acidified foods are comprised of low acid ingredients mixed with acid ingredient or acid to bring the finished product equilibrium pH to less than 4.6. Remember, all pH meters have a normal variation in the measurements, and therefore that variation must be understood and accounted for when measuring the equilibrium pH. For instance, if you measure a pH of 4.3, and may have a ± 0.02, the actual pH is between 4.28 and 4.32. If the variation is ± 0.05, the actual pH may be between 4.35 and 4.25. We would like to see some room for safety and therefore the highest target equilibrium pH is, in many cases, 4.4. The finished equilibrium pH is the pH of all components of the product. It can happen quickly after mixing and final preparation, or it may take hours or days.

Note: pH meters perform potentiometric measurements, meaning that the electrode measures a potential of [H+] or [OH-] in the test solution by comparison against known [H+] or [OH-] standard buffers. The numerical numbers produced by a pH meter are calculated following a scale. Therefore, we need to verify that the calculated pH scale is reliable by proper and regular calibrations.

Total Cases Reported for Previous Years
Botulism Cum 2017 Five-year weekly average  2016  2015  2014  2013  2012
Total 79  4  201 195 161 152 168
Foodborne 5  0  31 37 15 4 27
Infant 71  3  144 138 127 136 123
Other (wound and unspecified) 3  0  26 20 19 12 18
Table I. The main biological hazard of concern in acidified foods continues to be Clostridium botulinum. The latest Notifiable Diseases and Mortality Table was released by the CDC on January 5, 2018. Cases of botulism reported in the United States (Week ending December 23, 2017).

Q: Is there a formal procedure for assessing initial/raw pH? Specifically, should pH be immediately measured or should the system be given time to come to equilibrium?

Oyarzabal: There are two important pH measurements, the raw pH and the equilibrium pH. The raw pH is the pH of all the low acid food ingredients without the addition of the acid ingredients or acid to bring the finished product equilibrium pH to below 4.6. The equilibrium pH is tested in finished product after the pH has “equilibrated” and all particles and components of the finished product have the same pH. It is customary to measure the equilibrium pH after 24 hours of manufacturing, but the actual time depends on the products. If the product has particles with high buffer capacity, the product may take more than 24 hours to achieve an equilibrium pH. The shift from raw pH to equilibrium pH is called the “pH shift”.

Q: What is the basis for the 10% rule for non-acid ingredients, and is it acceptable to have more than 10% but still have acceptable shift in pH?

Oyarzabal: There is no regulation requiring less than 10%. It is a rule of thumb based on experience that has been used for some acidified products over the years. It is not part of any regulation per-se. The actual amount of acidification in a formulation is something for a process authority to evaluate and make a final recommendation.

Q: A challenge study is generally requested for an acidified food filing, however, the detail for the challenge study is not specified. Previously the three main pathogens were suggested for evaluation (pathogenic E. coli O157:H7, Salmonella and Listeria monocytogenes) and a 5-log reduction as criteria. What are current requirements?

Oyarzabal: A challenge study may be needed when developing a new product. But the microorganism of public health concern and/or spoilage concern will depend on the type of product (ingredient formulation) and process. New product should be treated on a cases-by-case basis and a processing authority should make recommendations.

Q: What is the focus of the FDA inspections of acidified foods? What are the agency recommendations for processors?

Oyarzabal: FDA has stated in the Preamble to the final Preventive Controls for Human Foods (PCHF) regulation that acidified foods would not be exempt from 21 CFR 117, Subparts C (specific preventive control requirements) and G (supplier management). Essentially, an acidified food manufacturer, during an FDA inspection, will be have to demonstrate compliance with both 21 CFR 114 (acified foods) and 21 CFR 117 (all foods). During any given FDA inspection, the FDA investigator may focus their attention on just part of the acidified food operation and the applicable regulations or on the entire acidified food operations and all applicable regulations. It is dependent upon the individual FDA investigator, the circumstances triggering the investigation, any recent illness outbreaks or deaths associated with a similar acidified foods, written FDA headquarters programs on acidified foods, etc.

Q: Is a continuous recording method required to prove compliance in meeting Critical Control Points at all times or is periodic manual check acceptable?

Oyarzabal: From a preventive controls perspective, there is no requirement for continuous monitoring. Monitoring has to be performed frequently enough to make sure there is “demonstrated” control of the hazard(s) addressed at that process or step. It may come down to what equipment is in place. But at the end of the day, the preventive control regulation provides flexibility for frequency, so long as it is appropriate to control the identified hazard. If a firm has justification that monitoring at a certain frequency is sufficient to control a hazard, it would be helpful to provide that justification if the issue came up during an inspection. Justification should be emphasized for the frequency of monitoring and verification, and must be robust enough to guarantee safety.

Q: Are salad dressings exempt from the acidified food regulations? What about cold brew coffee?

Oyarzabal: Most salad dressings may be exempt, but it would be wise for any salad dressing manufacturer to ensure that they are using a processing authority with expertise in the type of product to conduct a food safety evaluation and put their recommendations in writing, just in case there is a challenge by FDA, a customer or competitor.

All the cold brew coffees we are aware of are sold under refrigeration and therefore are exempt from low acid or acidified food product regulations.

Note: Most states have individuals that will help the industry identify the laws covering their products. The FDA also has a portal for submission of industry request related to food safety regulations that may apply to specific products.

Q: I want to produce a cold-fill beverage that will have preservatives in the recipe, do I still require a process authority to create a process schedule?

Oyarzabal: You need to have someone to review the product formulation and the process to see if it is a low-acid or acidified food, and determine the food safety regulation under which the product falls. It may be exempt from some regulations, but someone with the appropriate knowledge, such as an FDA recognized “Process Authority”, needs to make that determination. The FDA also has a portal for submission of industry questions related to food safety regulations that may provide a more direct answer to this question.

Q: What are FDA’s expectations on cold-filled acidified foods? Do we need to hold the products till the product formulation ensures 5-log reduction of relevant pathogens?

Oyarzabal: This is a product-related question and without the full understanding of the formulation and process, it is hard to provide any recommendation. The cold-filled process can be managed for acidified foods in a manner that would maintain the safety of the food and not impact the pH requirements or result in recontamination.

Q: Does FDA consider “water” ingredient as a “low-acid” ingredient? What about under the FSMA Rule?

Oyarzabal: Yes, traditionally water has been considered a low acid ingredient as it has the ability to modify the pH of the food. In some recipes water is added in such a low amount that it doesn’t change the rest of the formulation. The addition of water in those cases doesn’t change the rest.

Q: Are inspectors using the Acidified Guidance Document that was pulled a couple of years ago for inspections?

Oyarzabal: The 2010 draft received lots of comments, and ultimately was never finalized from draft form. Investigators inspecting acidified foods are aware of the 2010 guidance, but they should not be enforcing the provisions in this draft guidance. A guidance document is not binding on FDA or industry, but provides recommendations to consider as it contains the agency’s thinking at a given time in relation to a given piece of regulation. That being said, based on observations and comments from the acidified food manufacturing industry, FDA investigators are using the draft guidance as a reference source.

Q: Are electronic records permitted for process controls (e.g., electronic record of temperature instead of chart recorders)?

Oyarzabal: Yes. The Preventive Controls rule speaks to the acceptability, in theory, of electronic records, though, as stated in 117.305(g) they are not required comply with 21 CFR 11 (Electronic Records; Electronic Signatures). These along with any other records should be accessible and retrievable as appropriate in a reasonable time frame for review by an FDA investigatory.

Lance Roberie, D.L. Newslow
FST Soapbox

Can You Defend Your Food Safety Plan?

By Lance Roberie
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Lance Roberie, D.L. Newslow

As a food safety plan manager, do you ever get asked these questions regarding your food safety plan: What was your thought process for making this decision? Why do you do it this way? How do you answer this?

And, do you ever answer with one of the following statements:

  • I’m not sure? What do you mean?
  • That’s the way it has always been.
  • Our customer asked us to do it that way.
  • That’s what our last auditor recommended.
  • We make a low-risk product.

If this is one of your answers, defending your food safety plan may be a challenge. There is a major shift taking place in the world of food safety. With the implementation of FSMA Preventive Controls, the widespread adoption of GFSI audits, along with advanced technologies such as rapid pathogen and allergen detection, whole genome sequencing, and transparency efforts such as Blockchain, as well as with the increasing use of social media and access of information via the internet, food industry professionals are more educated and informed than ever before and ready to challenge your every move. As a food safety plan manager, you and your team must be ready! Being prepared to defend your food safety plan can be the difference between a recall and a routine audit. If you cannot fully explain the reasoning behind your decision-making, then how will you be able to prove that you are in complete control and are being proactive against food safety hazards? It will not be easy.

You must be ready to defend each and every part of your food safety plan. You must be able to defend questions and challenges with certainty and facts. Every decision made in your hazard analysis should be written down and backed with factual evidence whenever possible. Even the “none identified” areas should be backed by strong reasoning if no other factual evidence is available. You can use the data that you collect daily to help justify your decisions. Data collected from your prerequisite programs (ATP swab results, allergen cleaning validations, GMP audit findings, pest control trends, etc.) and food safety plan (CCP’s, validations, verifications) is all support for your decisions. Have this on file and ready to review when necessary.

If something looks out of the ordinary in your plan, make sure you can fully explain it and can back it with solid justification. If not, auditors, regulators, customers, etc. may start to become suspicious, which can lead to unwanted questions. You will then oftentimes start to get suggestions for change based on others’ individual expertise. Regulators may make “strong suggestions” for changes, for instance, and some people will just go along with it to avoid the pushback or because they simply don’t have a better solution. If this happens, soon your plan is no longer yours—it’s everyone’s. Some of these suggestions may be good, but is it really the right change for your plan? If not, it will often make the plan less rational and often difficult to defend.

The following are tips to help you avoid this situation.

  1. Meet with your food safety team regularly. Go through each part of your food safety plan and figure out how to answer the “why’s”. Why are things done this way? Why did we decide if this hazard was significant or not? Have annual reviews to make sure your plan is still functioning as originally intended and review new industry trends to be proactive regarding new potential hazards.
  2. Write a process narrative. Writing a process narrative documenting what happens at each step of your process and explaining your “thought process” for making decisions is a great support tool. It gives your team a chance to elaborate on the “justification” column in the hazard analysis, providing more decision-making details without crowding the hazard analysis form.
  3. Gather supporting documents. Scientific studies, guidance documents, expert opinions, etc. are vital pieces to have in your supporting documents library. Make sure it is appropriate for your individual products and the documents are from reputable sources, such as FDA, USDA, universities, process authorities, etc. Oh, and don’t forget about history! A reputable supplier with a long track record of safe product, a low history of recalls for the products you produce, etc. can help justify your decision-making.
  4. Conduct Internal Audits. Having an internal audit schedule and well-trained internal auditors help with finding inconsistencies within your program and allow you to make corrections before outside parties find these issues.
  5. Prepare. Have a “mock audit” and prepare for questions that are commonly asked during audits. Practice your answers and make sure you have supporting evidence when needed. Stay up-to-date with industry trends, especially common audit non-conformances.
  6. Be organized. It’s great to have all the supporting documents that you need, but if you cannot find them, then you just as well have nothing.
  7. Be confident. People, especially experienced auditors and inspectors, can quickly sense fear and lack of confidence. This often prompts more questions. Knowledge is power, and knowledge also builds confidence. Simply put, the more knowledgeable you are about your food safety plan, the more confident you will be when someone is trying to test you.
  8. Continuously Improve. It’s understandable that mistakes will be made. However, the next logical question you will be asked is: What did you do about it? Remember, for every nonconformance you find in your system, there should be a correction or corrective and preventive action to address it. It must not simply restate the problem, but legitimately correct the issue. This will give regulators, auditors, customers and anyone else looking at your system confidence that you are in control and can provide a consistently safe product.
Question mark

FSMA: What Does ‘Qualified’ Mean?

By Maria Fontanazza
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Question mark

The term “qualified” appears a few different ways in the FSMA rules. In a Q&A with Food Safety Tech, Cathy Crawford, president of HACCP Consulting Group, was invited by DNV-GL to clear up some of the ways the term is used in the FSMA rules.

Food Safety Tech: Can you break down the difference what “qualified” means as it relates to a qualified individual, qualified auditor and qualified facility?

Cathy Crawford, HACCP Consulting Group
Cathy Crawford, president of HACCP Consulting Group

Cathy Crawford: Explaining the term happens all at once. I think it’s not clear in the preventive controls or sanitary transportation [FSMA] rules; they use the word in two different ways. “Qualified” sometimes means that you’re officially recognized as trained or suitable for something, but “qualified” can also mean modifications or limitations or exceptions. That’s why it is confusing, because it can seem like it has opposite meanings.

“Qualified” [means] trained or ready to do a certain job—that’s the most common meaning. The preventive controls rule talks about a qualified individual, as a person who has the training, education or combination of those needed to manufacture, process or hold food. That’s appropriate to their duties—meaning not everyone has to be qualified to do everything, but individuals have to be qualified when it comes to doing their job when it pertains to food safety.

The regulation goes on to say that it might be education and experience, but there is also some mandatory training. I think a lot of companies aren’t paying attention to this—that all qualified individuals have to be trained in food safety, hygiene and the specific duties of their job, and because that’s a regulatory requirement, they have to have documentation to support that they did this. The regulation also says that supervisors should have the education or experience necessary to supervise, so their training should demonstrate that it’s a little more in depth than what other qualified individuals would get.

Then there’s the PCQI, the preventive controls qualified individual. That’s someone with the education, experience or training to be able to perform specific functions that are called out in the preventive controls rule—meaning they can create a food safety plan, they can conduct or oversee verification, validation and corrective action, or they can reanalyze the food safety plan. The regulation specifically says the PCQI has to do those things. So that’s a different sort of qualified individual; it’s another step basically.

The other term is the qualified auditor. That definition starts with a qualified individual (QI) and elevates from QI to supervisor to PCQI and then to a qualified auditor. A qualified auditor is a QI who has the technical experience needed to conduct audits. That’s about as far as it goes in the regulation, except that they give examples such as that it could be a government employee or an agent of a certification body, but you have to take it in context. The regulation doesn’t say those are the only examples, so I think there’s some flexibility in those examples, and we have yet to see how FDA is going to implement the rule going forward.

When we talk about these qualified individuals, we mostly think about the preventive controls rule, but it also pops up in the sanitary transportation rule. In that rule, the term isn’t defined at all, so I suspect they would share the definition that’s in the preventive controls rule for a qualified individual. But under the sanitary transportation [rule], only the qualified individual can make decisions about what to do when there is an unusual circumstance in transportation such as an accident or a refrigeration unit that breaks down.

FST: Can a “qualified” person be company staff or is there an inclusion that someone can be brought in to take care of these duties, for example, on an outsourcing basis?

Crawford: That’s certainly an option. I haven’t experienced any companies that have chosen that option. I suspect maybe smaller companies or those that are members of a strong affiliation like a coop or trade association might reach out to get someone to play the role of PCQI. But it’s a very significant role, and there’s a certain level of responsibility and therefore liability associated with it, so I think it’s best that the person is a company employee.

I also highly recommend training. Although the two-and-a-half-day class on the preventive controls rule isn’t technically mandatory, it’s extraordinarily helpful.

At first when our company (as a consulting group) was teaching this course, many of the classes contained 50% or more of participants from FDA. It was interesting because industry and FDA were learning together. I think most companies are sending one or two people so they can get the information and share it when they come home.

FST: Discuss some of the confusion surrounding the term “qualified facilities”.

Crawford: This is where “qualified” has almost the opposite meaning. Here’s an analogy: There’s the concept of a lifeguard—you can be qualified to be a lifeguard like a person can be a qualified individual in a food facility, but you could also have a qualified lifeguard certificate, which means you’re limited and can only do lifeguarding when there’s no more than 25 people in the pool; versus someone who has more training and can do it anytime. It’s a limitation.

In the regulation, a facility is the qualified facility when it meets certain characteristics that don’t have to follow the entire rule, but can follow a smaller piece of it.

“Qualified” is based on size. If a facility is very small, with inventory less than $1 million in food assets and sales annually, then they are a qualified facility, so they don’t have to follow the entire preventive controls. They follow a modified version, which is primarily around having the GMPs in place but not necessarily having a food safety plan like the larger facilities must have.

FST: When a company is uncertain about their status, where can they go to get help?

Crawford: Many companies ask their own attorneys and FDA. The FDA has a website called the TAN (Technical Advisory Network) where companies or citizens can submit questions. It takes a bit of time but you will get an answer, and that’s a good way to go.

FST: With all the differences and nuances in these terms, what can companies do to better familiarize themselves with what these terms mean as they relate to FSMA so they can effectively execute required tasks?

Crawford: Number one: Either read the regulation on your own or attend the class that goes over the regulation like the two-and-a-half-day preventive controls course.
Second, companies need to document their training activities, because it’s required to demonstrate that someone is qualified. FDA has said they don’t intend to visit a facility and then document a 483 due to lack of a PCQI or a QI. That’s not the focus of their inspection—it’s an important part of the regulation, but they wouldn’t write a 483 just for missing training records. What they’re looking for is an effective system. If they visit and the system isn’t in place or it’s not documented, then they might back up and realize the reason it wasn’t done right is because they don’t have a QI or PCQI.

Finally, understand the terms, and make sure you have qualified people in place and that you can prove with records that they really are qualified.

Randy Fields, Repositrak
FST Soapbox

How Your Approved Supplier Program Can Reduce Your Risk

By Randy Fields
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Randy Fields, Repositrak

Editor’s note:
Randy Fields, Chairman & CEO of Park City Group and CEO of ReposiTrak, will be featured in the keynote panel on the past, present and future of food safety journey at the upcoming Food Safety Consortium November 29, 2017 in Schaumburg, Il. He will discuss how to leverage technology and an approved supplier program to reduce a company’s risk. Here’s a preview of some of that content.


Everyone in the extended food supply chain, from ingredient and packaging suppliers through manufacturers and ultimately to the retailers or foodservice operators work hard to ensure the safety of the consumer. It’s why they’re in business. These companies also work to understand the various risks inherent in the supply chain and deploy comprehensive and repeatable processes designed to reduce the potential impact of those issues.

Selecting suppliers has inherent risks, so a comprehensive process is needed to mitigate any threats. Without properly vetting potential suppliers, companies may encounter existential challenges without the right tools needed to survive.

One of the most important areas for this risk mitigation is the approved supplier program which helps to ensure product quality standards are met. These programs are also required under the Preventive Controls portion of the Food Safety Modernization Act.

A best-in-class supplier approval process includes certifying suppliers, monitoring external and internal risk levers, continual and repetitive analysis to determine how programs are affecting the business and mitigating risk by planning for potential disruptions. It needs to be proactive and predictive to address the ever-changing consumer and business environments.

A successful supplier approval program attempts to address every foreseeable risk concern, from product recalls to supply chain disruptions. It is typically based on a standardized checklist that includes a comprehensive list of questions to assess a supplier’s food safety and quality systems. Sample questions focus on items like food safety certificates, compliance documentation, quality assurance programs, HACCP plans and third-party audits.

Supplier and product risk assessment is a critical element of the supplier approval program. Companies need to examine hazards that could contaminate products or create issues related to allergies. The risk assessment is usually a scorecard that establishes a series of levels and a baseline under which a supplier is not acceptable.

To ensure accuracy and consistency throughout the onboarding and subsequent procurement processes, companies should have a single repository of supplier information. Having a centrally located database of supplier information and required documentation will not only increase efficiency, it can help maintain compliance and give your organization the visibility it needs to take action. This database should include details on the approved primary suppliers and any potential risks associated with the supplier or its products. The system should have a process to conduct ongoing monitoring of suppliers to ensure that agreed upon standards are maintained.

Once the supplier approval program is up and running, it needs to be monitored constantly or the risks companies are trying to mitigate will return. Managing risk is not a one-time event., nor is managing supplier information. Implementing a process where established suppliers will update their information annually will help ensure companies are working with the most current information.

The bottom line is that a company’s reputation may be tarnished if there is a product recall or worse. Ensuring approved procedures and processes are followed every time a new supplier or product is considered will greatly help to mitigate the risks involved.

Robert Rogers
FST Soapbox

Validating Your Foreign Material Inspection System

By Robert Rogers
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Robert Rogers

The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing companies identify potential hazards within their production systems and then:

  • Put in place preventive controls to address those hazards,
  • Monitor those preventive controls to ensure their effectiveness &
  • Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying potential food safety hazards and preventive controls to counter them, and to establish the monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe food enters the market enables food manufacturers and processors to meet the specific regulatory standards mandated by the countries where they operate and sell. This enables them to avoid product recalls that are costly and that severely damage brand identity. But these processes, in addition to satisfying regulators, also play a valuable part in protecting the companies from potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are inspection systems (checkweighers and metal detection, X-ray and machine vision inspection systems) that quickly and efficiently detect non-standard and contaminated products and defective packaging and reject them from production lines before they can enter the marketplace. The performance of these systems must be validated, verified and monitored on an ongoing basis to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating confusion within organizations and across industries because people interpret and use these terms in different ways. In fact, each term identifies a distinct process that has a clear purpose and role to play at different points throughout the equipment lifecycle. It is important to understand the purpose of each process to make sure that validation, verification and routine performance monitoring tests are performed to comply with regulatory requirements, particularly where the equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food manufacturing or processing production line, is conducting an objective, data-based confirmation that the system does what it was designed, manufactured and installed to do. The International Featured Standards (IFS) organization defines validation as “confirmation through the provision of objective evidences, that the requirements for the specific intended use or application have been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.” An important part of the validation procedure is the production of detailed data that demonstrates to line managers and to regulators that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing it with generic products and packaging similar to what the customer will be producing. But that is only the beginning of the validation process. Onsite, that same system needs to be validated when inspecting the specific products that the production line where it will operate will be processing and/or packaging. This is ideally done at the time the system is originally installed in a production line, and then becomes one element of a complete program of validation, periodic verification and ongoing monitoring that will keep the system operating as intended and ensure that products are adequately and accurately inspected, and that accurate records of those inspections are kept.

It is critical for producers to remember, however, that the original onsite validation relates only to the specific products tested at the time. As new or additional sizes of products are developed and run on the production line, or packaging (including labeling) changes, the system will need to be re-validated for each change.

Verification

Verification is the process of periodically confirming that the inspection equipment continues to be as effective as when it was first validated. The verification process uses standard, established tests to determine whether the inspection system is still under control and continuing to operate as originally demonstrated. This verification process is conducted periodically at regular intervals to provide evidence-based confirmation that the system continues to be effective as specified. Formal performance verification is typically an annual process, to support audit requirements. It should continue throughout the productive life of the system.

Both validation of an installed system and periodic verification of operating systems can be conducted either internally by the end-user, or by the supplier of the equipment. Validation and verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as distinct from periodic verification, consists of a series of frequent, regular performance checks, during production, completed to determine whether processes are under control and to confirm that there has not been a significant change in the system’s performance level since the last successful test. The monitoring frequency may be as often as every two hours, depending on company standards, industry standards and/or retailer codes of practice.

If the monitoring process finds that a particular device is out of specification, all product that has passed through the production line since the last successful routine performance-monitoring event must be considered suspect and re-inspected.

In many cases, it is line operators that conduct online performance monitoring. However, many of today’s more sophisticated product inspection systems incorporate built-in performance monitoring software that automates this process and alerts operators when deviations occur. This valuable software feature removes any human error factor from the monitoring activity to help ensure that inspection processes are still being performed properly. It also provides documentation that will guide the end-user company’s QA groups in their continuous improvement efforts, and that will also be a valuable asset in the event of an inspection visit from regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE. Installing a system with built-in condition monitoring capability that automatically detects when the system may need correction and communicates that information directly to line operators reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable experts regarding their products, it is their equipment suppliers that are the experts on the capabilities and qualification procedures of their equipment. That expertise makes them the best source of reliable recommendations on questions from the most effective inspection equipment type for specific product needs, where to place that equipment on the production line for optimum results and how to validate, verify and monitor its performance.

Relying on these experts to conduct onsite validation and to advise on conducting periodic verification and ongoing performance monitoring can reduce both the time needed for the original onsite validation time and that needed for verification and ongoing monitoring procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on the most current food safety regulations and the technology that affect equipment validation. It is critical for their success that they stay current on those topics, and sharing that knowledge is a valuable part of their service.

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Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
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Proper sanitation plays a crucial role in the FSMA Preventive Controls rule, and FDA is paying more attention during facility inspections. However, many companies currently have deficient sanitation programs, according to Bill Bremer, principal at Kestrel Management, LLC. “It’s a key aspect of FSMA and requires that you have key personnel or a qualified sanitation manager either at each site or over each site (if it’s not local). That’s in FSMA,” he says. “In most cases, and for high-risk companies, sanitation must be supported by validated environmental testing programs (i.e., the typical swab-a-thons that FDA has done under FSMA). Sanitation chemicals that are used must be diligently approved for use and validated. In addition, chemicals must be appropriately applied, which is a big issue. These areas are key inspection points for FDA under FSMA, as well as for customer requirements. Sanitation has been elevated with FSMA and Preventive Controls, and it has to be addressed at a higher level—and for the most part, it isn’t.”

Bremer was invited by DNV-GL to discuss the importance of sanitation as a goal of FSMA in a Q&A with Food Safety Tech.

Food Safety Tech: Let’s first talk about the importance of a proper sanitation program. What are the factors at play here and what are the deficiencies with current sanitation programs?

Bill Bremer: We’re starting to conduct major sanitation program process improvements or process assessments for companies big and small. What we’re seeing in some of the key areas is that chemicals are not validated with the chemical provider. That includes the fit for use for them as well as the training of the people using them (i.e., if it’s liquid, it has to be diluted at right level and confirmed at right parts per billion).

Before you sanitize, you’re supposed to clean (in some cases it’s called debris removal). You can’t sanitize unless surfaces that are being sanitized are clean. We’re finding that cleaning isn’t done appropriately and thus companies are sanitizing over dirt, and you can’t sanitize over dirt or debris.

We’re also running into cases where the cleaning is done, and because it looks clean, a company is not sanitizing, so you run into another issue with those missed steps. And, this entire process needs to be validated and you must have records on it. You also have to support it with environmental programs, especially for high risk. So that means swabbing to make sure that once you clean and sanitize, you prove that the activities have ultimately removed any bacteria, germs or allergens from the process.

This is a high-profile area for FDA to inspect.

Some of the common deficiencies are with the program itself and the documented procedures to follow. It’s a weak area. Sometimes, a company will have different cleaning and sanitation programs documented (e.g., shift-by-shift or site-by-site), which leads to people who do the cleaning not following a standard set of instructions. It really gets down to both the programs and lack of qualified supervision and management of the cleaning and sanitation process.

Food Safety Tech: What methods should companies employ to meet FSMA requirements?

Bremer: This is an area where a diligent documentation program review is not always conducted. It’s assumed that we see the cleaning process—you see the foaming up of the cleaner, the sanitizer is all good—and we may see the cleaning record, but it’s not an SSOP, or standardized sanitation operating procedure.

However, when you look deeper and look at the documented programs, there very weak and unclear, and they need to be updated. That is one of the first things that we would investigate for a company. It’s also the qualification and training of the people—whether at the lower level or the management level, you have to be trained appropriately and the training has to be current.

Then we look at the physical process: Are they really doing debris removal in the cleaning process prior to sanitizing to make sure there’s no residue left for sanitation to be effective?

We also look at the environmental programs: Do they have a well-developed environmental program swab test? Are they using a third-party lab to validate their results? Today there are automatic test readers [that enable in-house] results. If you perform this in house, you need to have qualified people do it—and you should be checking those results with a third-party laboratory or service.

A proper sanitation program is an imperative. It’s an area where FDA is going to be investigating companies, even if they don’t have any record of products being recalled. If you look at the Blue Bell case, the big issue was that they didn’t do a good job of sanitizing their drains for Listeria, which got out of control and then it spread through the air system and to their suppliers, as well.

FSMA

FDA Releases Chapter 6 of Draft Guidance for PC Rule

By Food Safety Tech Staff
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FSMA

Last week FDA released the sixth chapter of the draft guidance, “Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food”. The document aims to assist food facilities in establishing and implementing a heat treatment (i.e., baking or cooking) to prevent bacterial contamination.

Learn more about FSMA compliance at the 2017 Food Safety Consortium | November 28– December 1 | The 60-page draft guidance addresses the use of heat treatments as a process control, providing information on understanding potential hazards, design and validation of the heat treatment, establishing and implementing monitoring procedures (and how often), verification, and record keeping.

FDA states that it intends to publish at least 14 chapters of the guidance. In just two weeks, the compliance date for the preventive controls for human food rule falls for small businesses (fewer than 500 full-time employees).

USP Food Fraud Database

Why Include Food Fraud Records in Your Hazard Analysis?

By Karen Everstine
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USP Food Fraud Database

Food fraud is a recognized threat to the quality of food ingredients and finished food products. There are also instances where food fraud presents a safety risk to consumers, such as when perpetrators add hazardous substances to foods (e.g., melamine in milk, industrial dyes in spices, known allergens, etc.).

FSMA’s Preventive Controls Rules require food manufacturers to identify and evaluate all “known or reasonably foreseeable hazards” related to foods produced at their facilities to determine if any hazards require a preventive control. The rules apply both to adulterants that are unintentionally occurring and those that may be intentionally added for economically motivated or fraudulent purposes. The FDA HARPC Draft Guidance for Industry includes, in Appendix 1, tables of “Potential Hazards for Foods and Processes.” As noted during the recent GMA Science Forum, FDA investigators conducting Preventive Controls inspections are using Appendix 1 “extensively.”

The tables in Appendix 1 include 17 food categories and are presented in three series:

  • Information that you should consider for potential food-related biological hazards
  • Information that you should consider for potential food-related chemical hazards
  • Information that you should consider for potential process-related hazards

According to the FDA draft guidance, chemical hazards can include undeclared allergens, drug residues, heavy metals, industrial chemicals, mycotoxins/natural toxins, pesticides, unapproved colors and additives, and radiological hazards.

USP develops tools and resources that help ensure the quality and authenticity of food ingredients and, by extension, manufactured food products. More importantly, however, these same resources can help ensure the safety of food products by reducing the risk of fraudulent adulteration with hazardous substances.

Incidents for dairy ingredients, food fraud
Geographic Distribution of Incidents for Dairy Ingredients. Graphic courtesy of USP.

Data from food fraud records from sources such as USP’s Food Fraud Database (USP FFD) contain important information related to potential chemical hazards and should be incorporated into manufacturers’ hazard analyses. USP FFD currently has data directly related to the identification of six of the chemical hazards identified by FDA: Undeclared allergens, drug residues, heavy metals, industrial chemicals, pesticides, and unapproved colors and additives. The following are some examples of information found in food fraud records for these chemical hazards.

Undeclared allergens: In addition to the widely publicized incident of peanuts in cumin, peanut products can be fraudulently added to a variety of food ingredients, including ground hazelnuts, olive oils, ground almonds, and milk powder. There have also been reports of the presence of cow’s milk protein in coconut-based beverages.

Drug residues: Seafood and honey have repeatedly been fraudulently adulterated with antibiotics that are not permitted for use in foods. Recently, beef pet food adulterated with pentobarbital was recalled in the United States.

Heavy metals: Lead, often in the form of lead chromate or lead oxide which add color to spices, is a persistent problem in the industry, particularly with turmeric.

Industrial Chemicals: Industrial dyes have been associated with a variety of food products, including palm oil, chili powder, curry sauce, and soft drinks. Melamine was added to both milk and wheat gluten to fraudulently increase the apparent protein content and industrial grade soybean oil sold as food-grade oil caused the deaths of thousands of turkeys.

Pesticides: Fraud in organic labeling has been in the news recently. Also concerning is the detection of illegal pesticides in foods such as oregano due to fraudulent substitution with myrtle or olive leaves.

Unapproved colors/additives: Examples include undeclared sulfites in unrefined cane sugar and ginger, food dyes in wine, and tartrazine (Yellow No. 5) in tea powder.

Adulteration, chili powder, skim milk powder, olive oil
Time Series Plot of Records for Chili Powder (blue), Skim Milk Powder (green), and Olive Oil (orange)

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Food fraud

Mitigating Food Fraud: Top Tips

By Food Safety Tech Staff
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Food fraud

The complimentary webinar, Top Tips to Mitigate Food Fraud, takes place on June 22 at 1 pm ET. Register now.Recently, the topic of food fraud has been discussed with increasing urgency. From understanding the basics of what is food fraud to navigating the regulatory requirements, quality assurance, compliance and procurement professionals must have a general understanding of the components.

An upcoming free webinar will review the hazard analysis requirements surrounding the FSMA Preventive Control for Human Food, GFSI requirements for raw materials and risk assessments and food fraud mitigation plans. Attendees will also learn about food fraud mitigation implementation strategies. The speakers participating in this webinar are Jeff Chilton, vice president of professional services at Alchemy Systems and Peter Claise, marketing director for foods programs at USP.

PCQI Risk-Based Preventive Controls

Recorded: June 13, 2017 – Do you know everything that is required of a Preventive Controls Qualified Individual (PCQI)? Are you prepared for your FSMA compliance date? Attend this webinar to ensure you understand the PCQI basics.