Tag Archives: audits

Manik Suri, CEO and co-founder, CoInspect
Retail Food Safety Forum

Rodent Poop, the Olympics and Food Safety Inspections that Work

By Manik Suri
Manik Suri, CEO and co-founder, CoInspect

Another day, another potentially brand damaging story—just ask Little Caesars. On February 7, the health department closed down an Indianapolis-based location because customers found some rodent feces on their pizza—it was clearly a food safety violation, and pretty disgusting. Meanwhile on the other side of the planet, athletes prepared their entire lives to compete in the Olympics. More than 100 people contracted Norovirus around the Olympic sites in Pyeongchang, where the athletes were in danger of getting a violent, contagious stomach illness that would derail their dreams and prohibit them from competing.

We live in a world that eats out, and if we don’t develop new techniques to protect customers in restaurants and food service settings, more people are going to get sick (or worse) from foodborne illnesses. The current food safety process is broken, and needs to be fixed in restaurants nationwide and globally.

At Google, Larry Page has spent two decades managing the speed of a search result for the company’s core service. From 1997 forward, Page has obsessed about the right results as fast as possible. When has Google ever been slow? People use the search engine daily because it always works.

For restaurants to grow and thrive, they need habit formation from fickle consumers. Habits are formed when restaurants deliver on their value proposition slice after slice, burger after burger, and salad after salad. So what is your organization doing to make sure that every meal is extraordinary— not only delicious, but also safe? What are you doing to prevent Norovirus and other foodborne illnesses?

Well, you’re probably not studying the data to create better processes. A 2017 survey of the top 500 restaurant chains found that 85% use paper logs or spreadsheets as their core technology for safety, quality and standards management. Paper logs, line check clipboards or homemade Excel sheets on a laptop are inefficient and ineffective systems to manage something as critical as food safety.

Many restaurants have upgraded their mobile ordering software and relaunched their menus on LED screens, but still make employees use clipboards to conduct food safety line checks and QA audits. This devalues the importance of their food safety operating protocols. Restaurant teams are comprised mostly of millennials and Generation Z— the mobile generations. They expect to be trained, do work and solve problems with their phones. But when their employers train with paper manuals and complete work with paper forms, it’s a huge disconnect for them.

Moreover, how did people at Little Caesars HQ in Detroit have insight into that recent incident in their Indianapolis store? What operating data do they have to examine? What line checks happened in store on the day in question? When was their last third-party food safety audit? What corrective actions were taken? That information would be hard for them to know, if, like the vast majority of restaurant chains, they were not collecting and analyzing data with modern tools.

Upgrading your operating technology so that your people have digital tools is not expensive. Software is much more affordable today because of the software-as-a-service revolution and the extraordinary computing power and proliferation of mobile devices. An emerging ecosystem of safety and software companies is ready to take your facilities into the 21st century. But the C-Suite has to decide it wants to empower its employees to do their best work and commit to having real-time data that is actionable and accurate.

Having mobile ordering software and LED screens for menus is helpful and valuable. But food safety is the most important component of every restaurant (and other food service companies). It is imperative that the food service industry embraces digital solutions to elevate their food safety standards. Without proper food safety standards, any organization could face a crisis like Little Caesars and the Olympics recently experienced. All it takes is one tainted meal to harm your guests—and your brand.

Eurofins and Orion Assessment Partner to Expand Auditing and Certification Services

Eurofins Food Safety Systems and Orion Assessment Services have announced a partnership that will expand their auditing and certification services on a global scale.

“The partnership will allow Eurofins to broaden their BRC Global Standards and GFSI scheme auditing resource base and provide them additional expertise in BRC to utilize. It will also allow Orion Assessment Services to operate under the Eurofins accreditation for BRC, SQF and FSSC 22000 schemes,” according to a Eurofins news release. “As a certification body, this collaboration will enhance the standards currently offered through Orion Assessment Services’ accreditation for ISO 17065 and ISO 17021, as well as offering brand new opportunities in the various GFSI schemes, for both existing and new clients internationally.”

Food Safety Supply Chain panel 2017

Registration Open for 4th Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Supply Chain panel 2017

Do you trust your suppliers? What about your supplier’s suppliers? Strengthening the links within your supply chain can be a challenging task, but it is necessary with FDA, and FSMA, recognizing the risk that exists.

Key topics, including vulnerabilities, inspections & audits, traceability, supplier verification, transportation, and recalls will be addressed at the 4th Food Safety Supply Chain conference from June 12–13 in Rockville, MD. The event will be held at the U.S. Pharmacopeial Convention.

This year’s agenda will be posted by March 1. In the meantime, the following are some topics covered at last year’s event:

Industry Experts Weigh in on Supply Chain Issues

Import Safe Food, Stay Out of Trouble with FDA


Lance Roberie, D.L. Newslow
FST Soapbox

Can You Defend Your Food Safety Plan?

By Lance Roberie
1 Comment
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.
3M Food Safety

From Culture To Compliance: The Link Between Food Safety Culture & Audit Preparedness

3M Food Safety

On Tuesday, December 5th, 3M Food Safety and Neumann Risk Services will host the final part of a 4-part webinar series on the Food Safety Modernization Act (FSMA). A special panel discussion of food safety experts will provide insight into how a robust food safety culture can positively impact audit preparedness and signal a culture of compliance.

Attendees will learn what a strong food safety culture looks like and how it can help comply with FSMA and the Safe Quality Food (SQF) Code. The free webinar will be recorded at the 2017 SQF International Conference in Dallas on November 9. It will conclude with a live Q&A for attendees and be offered on-demand to webinar registrants.

The first three webinars are currently available for on-demand listening at the 3M Health Care Academy, and each presents the opportunity to learn about the challenges companies are facing in operationalizing FSMA rules. The webinars offer real-world insight into how companies streamline implementation and execution of food safety plans, supply chain programs and other FSMA-driven programs.

Melanie Neumann, Neumann Risk Services
Melanie Neumann Neumann Risk Services, LLC

Melanie Neumann, president, Neumann Risk Services, a Matrix Sciences Company, will be moderating the panel discussion. Panelists will include:

  • Bill McBride, principal and managing director of Foodlink Management Services and SQFI Asia Pacific representative
  • Dr. Lone Jespersen, principal and founder, Cultivate
  • Dr. Martin Wiedmann, Gellert Family professor in food safety, Cornell University
  • Dr. Jay Ellingson, corporate director of food safety and quality assurance, Kwik Trip, Inc.

The webinar will take place on Tuesday, December 5 at 1:00 p.m. Central Standard Time. To sign up for the webinar, click here.

Patricia Wester, PA Wester Consulting

Q&A On FSMA Audits: A Conversation With AFSAP CEO Patricia Wester

By Food Safety Tech Staff
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Patricia Wester, PA Wester Consulting

As a trade association for auditors and the auditing industry, AFSAP has researched the various references to audits found in all of the FSMA rules, and monitored the steps taken across the auditing community to meet these requirements. In this Q&A, we sit down with Patricia Wester, chief executive officer of AFSAP, to talk FSMA audits, criteria for supplier audits, preventive controls and FDA guidance. She will be running the Pre-Conference AFSAP Food Safety Auditing Fundamentals Course at this year’s Food Safety Consortium.

Background on the AFSAP and FSC Alliance

In July 2016, GFSI announced they would re-open the Guidance document revision process so that FSMA’s requirements could be considered for inclusion. When the final GFSI Guidance document was released, it included most of FSMA’s requirements. At this point, the Schemes still had to accommodate these changes, which were then provided to the CB’s. Depending on the Scheme, a CB also had to consider including content to address any FSMA related gaps. In the end, these audits could take more than a year to reach the market, and depending on the individual site’s renewal period, it could be many more months before a supplier was actually audited.

Patricia Wester moderated the Plenary Panel “What’s Next for Audits”
and running the
Pre-Conference AFSAP Food Safety Auditing Fundamentals Course at the
2017 Food Safety Consortium November 29 – December 1, 2017 in Schaumburg, IL.

Recognizing the need to inform the market, the inaugural Plenary Panel on Auditing, moderated by AFSAP’s Patricia Wester was presented at the 2016 Food Safety Consortium meeting. Dr. Ostroff opened the discussion to share FDA’s perspective on the use of audits for FSMA. His remarks were followed by representatives from GFSI, Schemes and CB’s as each described their role and recent activities to meet the new regulatory requirements, and provide insight into the timelines involved.

Dr. Ostroff has agreed to join us again for the 2017 meeting, and will participate in the Plenary Panel “What’s Next for Audits” as Industry, Retailers and the auditing community prepares for the accredited certification audits necessary for VQIP.

FoodSafetyTech: How are audits used in FSMA?

Patricia Wester: In the Third Party Audit rule, FDA outlines an accredited certification program for imported food that applies in 2 specific situations. The first applies to any imports FDA designates as “a high risk food” and the second is the use of certification audits for importers in The Voluntary Qualified Importer Program, (VQIP). Under VQIP, participating importers are required to source their products from suppliers that are certified under the FDA program.

In addition to the certification audits for VQIP and high-risk foods, audits are one of the options for supplier verification activities under the human and animal food preventive controls rules. When the hazard analysis identifies a raw material has a serious hazard, (SAHCODHA hazard), that ONLY the supplier controls, a supply chain preventive control is required, and the supplier verification activity must be an onsite audit. FDA allows some flexibility here, the audit can be a second or third party audit as long as it meets the requirements listed in 117.435, and is performed by a qualified auditor as defined in 117.3. These requirements are applicable to audits used to verify foreign suppliers (FSVP) as well as domestic suppliers.

FST: Don’t GFSI Scheme audits meet the criteria for Supplier Audits?

Wester: FDA allows the use of any audit that meets FDA’s criteria for audit content. This includes second party audits executed by employees of the receiving facility and third party audits, including GFSI audits, as long as they meet the requirements for audit criteria and are performed by a qualified auditor.

FDA acknowledges that the GFSI Auditor Competence provisions are consistent with the Agency’s findings, but that recognition does not extend to the audit criteria/content of GFSI audits.

In fact, any audit program in use prior to the publication of FSMA’s rules would probably need to be updated for these new requirements. GFSI, the Schemes, the CB’s, and others involved in the delivery of audits have likely all updated their audits to eliminate the major gaps, however, there are still some key FDA requirements that remain unmet.

FST: So, even though audit programs have been updated for FSMA’s new requirements, they are still missing some of FDA’s requirements? Why didn’t they just add everything?

Wester: In most cases, it appears to be due to a misinterpretation of the audit criteria that underpins all FDA’s audits. FDA’s audits focus on assessing a suppliers compliance with “applicable food safety regulations, the HACCP and/or Food Safety Plan and the plan’s implementation”. The Preventive Controls for Human Food Rule states the audit requirements in Subpart G:

§117.435 states:

If the raw material or other ingredient at the supplier is subject to one or more FDA food safety regulations, an onsite audit must consider such regulations and include a review of the supplier’s written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled.

We (FDA) have revised phrasing to state “and its implementation” to emphasize that implementation of the plan is distinct from the plan itself (e.g., § 117.126(c). (The PCHF Final rule preamble)

Similar phrasing such as “any applicable FDA regulations” is used elsewhere when FDA discusses audit criteria, such as FSVP and VQIP and the Third Party Certification Audit rules. Further, the PCHF rule, §117.190 provides a comprehensive list of “Implementation Records” that can be used as a guide to understanding what meets this element of the FDA’s requirement.

The auditing community and Industry have assumed the regulatory reference was limited to the FSMA regulations, such as Preventive Controls for Human or Animal Food or the Produce Safety final rules), and has focused on those regulations to update their audit programs. Other FSMA regulations, such as Intentional Adulteration and Sanitary Transport, could easily be considered part of the requirement, so there are a few audit options that include those rules.

FST: What about products that are exempt from the Preventive Controls Rules?

Wester: Audits for products that are exempt from the PCHF (human Food) rule, such as Juice and Seafood HACCP, are probably available under a general HACCP format, but they may not include the level of detail required under FSMA, and would have to specifically requested when arranging a supplier audit.

Audits for other PCHF exempt products, such as bottled water or low acid canned foods, would be audited using a general food safety audit, with the specific product treated as a product category under that audit. Once again, these audits lack the product specific regulatory content and implementation details required by FSMA.

The question becomes, which FDA regulations (beyond FSMA) apply to an audit used for regulatory compliance and how much detail in the audit is necessary?

In other words, what is the full scope of regulations needed for the audit, and what are the audit criteria? Is it just FSMA or does it go further?

FST: Where does one look for this information? Does FDA offer any guidance about the scope of the audit?

Wester: The CFR, or Code of Federal Regulations is the starting place for regulations. Finding the regulatory information would not be difficult, Title 21, CH 1 Parts 1-1499 include FDA’s food regulations. In addition each part can have multiple subparts etc.

Given the sheer quantity of regulations, and that some are product specific while some are not, developing different audits for all of the possible regulatory combinations would be a daunting task and enormously costly. Remember, every auditing company will have to go through this process.

There are FDA references to scope and criteria in several responses to comments:

Audit Criteria means the set of policies, procedures or requirements used as a reference against which audit evidence is compared. During regulatory and consultative audits, accredited third-party certification bodies will examine compliance with applicable food safety requirements of the FD&C Act and FDA regulations within the scope of the audit. In consultative audits, the third-party certification bodies also may be conducting an examination to determine conformance with applicable industry standards and practices.

The applicable requirements that accredited third-party certification bodies and their audit agents will use relate to the food safety standards under the FD&C Act, such as the adulterated food provisions in section 402 of the FD&C Act and the provisions on the misbranding of food allergens in section 403(w) of the FD&C Act. The applicable requirements of the FD&C Act and FDA regulations would depend on the type of eligible entity being audited. Other examples include labeling requirements and the CFR citations listed under scopes.

Certainly, more detail than this is needed, and AFSAP is working to engage all parties, including FDA, in collaborative discussions to resolve these questions and concerns. The auditing community will need to address these issues in the near future, and industry should be vigilant to understand the requirements and make sure any audits used for FSMA are compliant.

Chelle Hartzer, Orkin
Bug Bytes

How to Prepare for an Audit at Any Time

By Chelle Hartzer
1 Comment
Chelle Hartzer, Orkin

Everybody knows to prepare for the worst while hoping for the best. But being prepared for an unannounced audit isn’t something that can be done overnight, especially when it comes to pest management.

That’s why it’s important to carefully review your food safety plan and the specific pest management measures contained within it. Pest management can account for up to 20% of an audit, so it can make or break a facility’s score. There’s no room to gamble—between federal regulations, audit regulations, internal standards and customer expectations, you need to stay in compliance.

With FSMA in full effect, it’s important to become familiar with the regulations found on the FDA’s website if you haven’t yet. Reacting to problems isn’t good enough anymore, as many of these regulations emphasize a preventive strategy. The FDA has the authority to mandate recalls, shut down facilities and more. If you need help determining the rest of your facility’s food safety program, the FDA has a helpful downloadable food safety plan builder.

To make sure pest issues don’t spoil your score during an unannounced audit, remember that pest management is an ongoing partnership that requires your entire staff’s participation. It’s something you should plan for as part of regular maintenance and sanitation schedules.

The first step is to establish an integrated pest management (IPM) program. This plan should be developed with your pest management provider and should be a comprehensive look at all factors that may contribute to pest issues. It should be designed to reduce pest pressure around a facility, address all sanitation and exclusion issues, actively monitor for pests and set action levels.

The goal is to proactively deal with pests and prevent as many issues as possible. An IPM program is tailored to meet a facility’s specific needs based on a wide range of different factors. An IPM program uses pesticide treatments as a final step once all conducive conditions have been identified and addressed. The program should adapt as both the facility and the pest pressures change over time.

Implement regular training for all employees and encourage participation. Something as simple as a poster featuring the “most wanted pests” in break rooms or locker rooms can help train personnel to recognize the signs of potential pests around the facility. Make it clear that each employee is a key player in your program and empower them to speak up should they see something. Ensure you have a pest-sighting log and all personnel are aware of where it is and how to report issues. Their help will be vital to point out issues, ensure sanitation is adequate and identify problem areas on a daily basis. Your pest control professional can host a training meeting for you and your staff if needed.

When implementing an IPM program at your facility, there are numerous preventive tactics you can implement and perform on a regular basis.

  • Monitoring devices: Using devices like fly lights, rodent traps and bait stations can help reduce pest populations and keep them away from food products. These monitoring devices also offer insight as to how many and what kinds of pests are plaguing the facility, which is valuable information when determining a strategy to resolve existing pest problems and minimize pest pressure.
  • Sanitation: Any food source, including the foods you are producing and storing, can draw pests. Clean up product spills quickly. Don’t forget about food in employee areas such as break rooms and locker rooms. While it is impossible to clean up every food particle (you are producing food at your site!), you can work to limit the access pests have to food sources.
  • Take out the trash: Emptying trash daily and cleaning out the trash bins helps prevent the buildup of organic material, which can attract many different pests. Make sure dumpsters are placed away from the building if possible and always keep them closed. Don’t a smelly garbage or a full bin—when in doubt, take it out!
  • Seal cracks and crevices: Keep a constant watch around the facility for any openings big enough for a pest to fit through. Remind employees that rats only need a quarter-size hole to squeeze into a facility, while mice only need an opening the size of a dime. And that’s not the worst of it; cockroaches only need one sixteenth of an inch, making it vital to seal off any openings found. Don’t forget to look at your facility from the outside as well!
  • Install automatic doors: Often, open doorways are prime locations for pests to enter. All doors should remain closed when not in use. Especially in docking areas when loading/unloading, try to open dock doors only when needed and keep the gap from the truck to doorway sealed off if possible. Installing automatic doors can reduce the likelihood flying pests inside the facility by ensuring doors stay closed when not in use.
  • Inspect shipments: Anytime a new shipment arrives, it should be inspected closely for pests. Stored product pests could be in products and spread to others in close proximity quickly, so catching them early is key. Don’t forget to inspect shipping containers for outgoing product too, because if your product goes in an infested truck, your product will be considered infested!
  • Remove clutter: Many pests love to hide under clutter. Remove unused equipment, product and packaging—especially cardboard boxes—to avoid giving pests a convenient hiding place. Don’t forget about clutter outdoors, too.
  • Outdoor concerns: Sanitation is important outside the facility as well. Make sure to remove clutter and garbage on the ground and near the facility to help reduce pest pressure. Many pest issues start outside, so removing clutter outdoors means fewer pests to potentially get into your site. In addition, installing sodium vapor lights instead of mercury vapor lights near the building will attract fewer insects.
  • Install air curtains: The perfect complement to automatic doors, air curtains create positive airflow—or air flowing outwards from building entrances—to push pests away from the building.

Auditors are looking for a number of things when it comes to pest management. One important item they want to see is the record of past pest issues and the steps taken to resolve them. You and your pest management provider should ensure all records are up to date and accurate with pest trends that can be explained.

Documentation is perhaps the most critical part of a strong IPM program. It ensures your efforts are captured, organized and available should an unexpected auditor arrive on site.

The following are six main documents to have ready at all times.

  1. Food Safety Plan
    Perhaps the most important piece of documentation, the overarching food safety plan is absolutely necessary to have on hand. The plan should be a comprehensive document describing all activities to ensure the safety of food during manufacturing, processing, packing and holding. It should include a list of potential hazards, preventive controls and corrective actions to mitigate those risks, along with monitoring and verification procedures.
  2. List of Service Changes
    An IPM program needs to be dynamic. But when modifications are made to meet the ever-changing needs of a facility, make sure to keep careful records of how and why the plans have changed.
  3. List of Monitoring Devices/Traps
    Your plan must include a map documenting all monitoring equipment, traps and any other devices used around the facility to reduce pest pressure. Note the locations and activity levels of each. The trend report from the collected data can show important information and help make management decisions. Your pest management professionals can help with this, as they should be noting activity each time they inspect your property. Auditors will want to see the historical data of pest monitoring devices and the corrective actions associated with any issues. Monitoring devices work as a great early warning system for developing pest issues and are a great proactive approach.
  4. Annual Assessments
    Each year, you should review your food safety plan and current IPM program. These annual assessments will note problem areas and set goals for the coming year. Auditors will be looking for these yearly assessments, and if you’re able to demonstrate year-over-year improvement then you’ll give your facility a better chance at a great audit score.
  5. Sighting Reports
    If a pest is spotted within the facility, employees should document it on the pest-sighting log. The report should include information about the location of the pest within the facility, who found it and the number of pests spotted. Capturing the pest is ideal, but it’s not always feasible to do so. In that case, photo evidence helps with identification, so obtain a close-up picture of the pest(s) if possible. Ensure the pest is identified and any corrective actions documented.
  6. Proof of Training/Certification
    You know that your pest management professional is trained and certified, but an auditor doesn’t. To demonstrate your provider’s expertise, keep a valid license or certification document, written evidence of the pest management professional’s training, and documentation of internal training on IPM and Good Manufacturing Practices (GMPs).

According to FSMA guidelines, a strong food safety plan identifies potential hazards to food products, and focuses on a preventive, risk-based strategy instead of a reactionary one. With an IPM program in place and detailed documentation of actions taken, you’ll be prepared anytime an auditor decides to “pop in” for a “quick chat.”

SGS, food safety

SGS First Certification Body Approved to Audit Against Gluten-Free Standard

SGS, food safety

Earlier this week SGS became the first certification body approved to audit against the Gluten-Free Certification Organization (GFCO) standards worldwide. GFCO, a program of the Gluten Intolerance Group, is globally recognized, providing independent certification services to gluten-free product producers. The program, which has certified more than 40,000 products from more than 900 companies in 29 countries, requires product reviews, on-site inspections, testing and ongoing compliance activities. The third-party certification verifies that a product meets strict gluten-free standards, ensuring valid gluten-free processes were followed during manufacturing.

SGS will be conducting the GFCO audits as a stand-alone service or in combination with its Food Safety certification audits.

Best Practices for ISO 17025 Accreditation: Preparing for Your Food Laboratory Audit (Part II)

By Joy Dell’Aringa

In Part I of this article, we explored the considerations a laboratory should initially evaluate when pursuing accreditation, as well as guidance from leading industry experts on how to prepare for an ISO 17025 audit. Here we will review what comes after the on-site assessment and provide practical user-based advice for preparing a response, common areas of non-conformance, and future changes to the ISO 17025 Standard.

The Response

Once the assessor has completed the audit, they will typically hold a closing meeting on-site where they present their findings, also referred to as deficiencies or non-conformances. For each finding they will document a specific reference to the standard as evidence and provide opportunity for questions and discussion. Most assessors will be open and conversational during this final portion of the assessment; laboratories are well suited to take advantage of this time. Some assessors will even brainstorm possible responses and corrective actions while onsite; this is valuable insight for the laboratories quality team and can help them get a jump on the response.

Depending on the accrediting body, the laboratory will have a certain amount of time to respond to the findings, usually 30–60 days. The anatomy of a well-assembled response will include a full corrective action report, complete with root cause analysis. Often, the assessor will also request supporting documents and records to show the effectiveness of a corrective action. Most laboratories will have forms to help guide users through the corrective action and root cause process. It is important to have a systematic approach to ensure your corrective action is thorough and balanced.

Determining root cause is a critical part of this exercise. Erin Crowley, CSO of Q Laboratories shares their approach. “We use a variety of root cause analysis techniques, but have found for our operation the principle of the ‘5 Why’s’ is very effective,” she says. “Don’t simply answer the singular deficiency. Accrediting bodies will want to know that you have addressed all variables that might be associated with a finding. For example, if a specific incubator was out of range on a specific date, don’t just indicate that someone fixed it and move on. Assess how they addressed the issue, any impact on data, what they did to react to it, and how they are putting systems in place to prevent it from happening in the future on any other incubator. You have to show the full process.”

Implementing procedures as an outcome of a corrective action can also bring challenges to an operation. As a national multi-site reference lab, Eurofins Quality Manager Peter Dragasakis must work with other departments and locations to deploy new or changed systems for compliance. “Sometimes the most challenging part of the entire audit process is coordinating internal stakeholders across other departments such as IT or complimentary analytical departments,” he says. “Coordinating a response in a timely manner takes full organizational cooperation and support.” Communication throughout the quality and operational arms of an organization is critical to a successful response. Often, accrediting bodies and laboratories may shuttle a response back and forth a few times before everyone is satisfied with the outcome.

Common Areas of Non-Conformance: Pro-Tips

While all areas of the standard are important to a conformant operation, there are a few key areas that are frequently the focus of assessments and often bare the most findings.

Measurement Uncertainty. Depending on the laboratories Field of Testing (FOT), Measurement Uncertainty (MU) can be captured in a multitude of ways. The process aims to systematically and quantifiably capture variability in a process. For chemical analysis this is typically well defined and straightforward. For microbiological analysis the approach is more challenging. A2LA’s General Manager, Accreditation Services, Adam Gouker says the reason many labs find themselves deficient in this area is “they don’t consider all of the contributors that impact the measurement, or they don’t know where to begin or what they need to do.” Fortunately, A2LA offers categorical guidance in documents P103a and P103b (for the life sciences laboratories, two of the of many guidance documents aimed at helping laboratories devise systems and protocols for conformance.

Traceability. There are several requirements in the ISO 17025 standard around traceability. In terms of calibration conformance, which accrediting bodies seem to have emphasized in the last few years, Dragasakis offers this tip: “When requesting [calibration] services from a vendor, make sure you’re requesting 17025 accredited service. You must specify this, as several levels of service may be available, and “NIST Traceable” certificates are usually no longer sufficient.” He also advises that calibration certificates be scrutinized for all elements of compliance closely. “Some companies will simply state that it is ‘ISO 17025 compliant’, [and] this does not mean it is necessarily certified. Look for a specific reference to the accrediting body and the accreditation certificate number. Buyer beware, there is often a price difference between the different levels of calibration. Always practice due diligence when evaluating your calibration vendor and their services, and contact the calibration service if you have any questions.”

Validation vs. Verification. One of the more nuanced areas of the standard lies in determining when a test requires validation, verification, or an extension, specifically when there is a modification to a method or a sample type not previously validated by an internationally recognized organization (AOAC, AFNOR, etc.). Certified Laboratories Director Benjamin Howard reminds us, “think of validation and verification as existing on a spectrum. The more you stray away from an existing validation, the more validation work is required by the analyzing laboratory.” For example, analyzing Swiss cheese for Salmonella by a method that has already been validated for soft queso cheese may require only minimal verification or matrix extension. However, a laboratory that is altering a validated incubation time or temperature would require a much more robust and rigid validation process. Howard cautions, “Accredited laboratories must be transparent about modifications, not only on their scope of accreditation but on their reports [or CofA’s] as well. Under FSMA, companies are now accountable to the data that their laboratories generate. If you see a “modification” note on your report, perform due diligence and discuss this with your laboratory. Ensure a proper validation of the modification was performed. “Additionally, the ISO 17025 standard and accrediting bodies do not mandate how a validation or verification should be done. Laboratories should have a standalone SOP that outlines these procedures using scientifically supported justification for their approach.

CAPA / Root Cause. A good corrective action / preventive action (CAPA) and root cause (RC) analysis program is at the heart of every sound quality system. “Corrective and preventive action (CAPA) processes can either add value or steal time away from the organization according the quality of the root cause analysis,” says Vanessa Cook, quality systems manager at Tyson Foods Safety & Laboratory Services. “CAPA might be the single greatest influence on an organization’s ability to continuously improve and adapt to change if diligence is given to this activity.” Investing in resources such as ongoing training in CAPA/RC programs and techniques are key components to ensuring a robust and effective CAPA / RC program.

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