Tag Archives: documentation

Dana Johnson Downing, TraceGains
FST Soapbox

Six Signs Your Quality Department Is Still in the Dark Ages

By Dana Johnson Downing
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Dana Johnson Downing, TraceGains

Increasingly, we turn to technology to simplify tasks in our personal and business lives. Platforms like Facebook and Twitter allow us to connect, shop, advertise and publish with just a few clicks. LinkedIn is where people turn to prospect for new business, publish articles, discuss issues within industry groups, and look for a job. Need a ride? Apps like Uber and Lyft can usually get you where you’re going cheaper and more easily than a taxi. Devices like Google Home and Amazon Echo can listen to your voice commands to play music, manage your shopping list, adjust your lights, or tell a joke. And experiments are underway for driverless cars, which could make us the last car-owning generation.

Food safety documentation

With technology automating and solving so many tasks, how is it possible that food production is still dependent on paper-driven and manual processes?

The current way of doing things in the food and beverage industry is outdated, labor intensive, and—most importantly—error-prone. Under FSMA, companies need to be able to justify their decisions and processes, and of course, document them. It’s not only critical for brand protection—it’s a regulatory requirement. Ignorance is not bliss. Now, senior management is obligated to demonstrate their commitment to food safety and they risk criminal prosecution if their operations don’t measure up. There’s too much at risk to keep doing things the same old way. The following are some signs that your quality department is still in the Dark Ages.

1. You’re using clipboards.

In defense of clipboards, they were a wonderful invention. They are quite well suited for gathering signatures on petitions to save the whales or signing up for a PTA bake sale. But if you’re still using clipboards to log temperatures or document sanitation procedures, then your food safety records are not as current and organized as they could be. Inputting data later is not an effective use of time. Processes like these not only take away from the core competencies of your quality team, but they also make staff spend more time analyzing everything manually, which could lead to costly mistakes or inaccuracies. Tablets and PCs have replaced paper-based logs and other quality recordkeeping. Why make your staff do a task twice? By digitizing these records, you can ensure that your records are up-to-date in real time and reduce the likelihood of errors made during transcription. Trust me, your staff will thank you for rescuing them from extra data entry. Plus, the modern workforce expects digital solutions.

Filing cabinet, food safety documentation
Still using a filing cabinet to store documentation? All images courtesy of TraceGains

2. You’re still using a physical filing cabinet to store food safety documentation.

If you’re putting your food safety plan, supplier documents and certificates of authenticity (COAs) in a filing cabinet, you have a transparency problem. Your department isn’t the only one that needs access to those critical documents. And if everyone has their own paper copy, then you are going to have problems with version control. Solve your transparency and version control problems by keeping critical documents in the cloud where the data can be extracted, analyzed and shared internally and externally across your supply chain.

Food safety documentation
Three-ring binders are no longer an appropriate place to store important information.

3. Three-ring binders are for middle school, not food safety.

If your idea of ensuring compliance involves keeping COAs in a three-ring binder, you probably still have a flip phone, too. Seriously, 1980 called and they want their Trapper Keeper back. Whether your documents are in filing cabinets or binders, you still don’t have the transparency you need to efficiently share that information with your peers and other departments. Plus, your audits are sure to drag on longer than necessary if you are doing audits with stacks of three-ring binder instead of using an online platform where you can show the auditor any documentation they need with just a few clicks of a mouse.

4. Your suppliers send critical food safety documents to you via e-mail.

Email is a great way to communicate. It’s just not the best way to gather and manage supplier documents. Admit it; we all get behind on email, and sometimes things slip through the cracks. What happens if an out-of-spec allergen declaration gets buried under the 586 emails you receive each day? I can tell you, it’s certainly not good. The alternative is allowing your suppliers to upload those documents into a platform, so they are immediately available to you and anyone else in the company that you’ve given access to the system. Leveraging a platform, you also have access to a dashboard that can quickly show you which suppliers are in compliance and which ones have issues that need to be addressed. And if you have incoming certificates of authenticity (COAs), you can sit back and rely on software to read those documents for you and spot anything that doesn’t match your specifications or purchase order details. Isn’t it time that you not only collected supplier documents, but really use that data within the documents to better manage your incoming material to ensure food safety and quality?

5. You rely on file sharing to store your food safety and quality documentation.

SharePoint and other file sharing systems may look more modern than the paper alternative, but they weren’t designed specifically for vendor management or supply chain transparency. They can file and retrieve, but it’s not automated document management. Ask yourself how long do you or fellow employees spend searching for requested documents? Perhaps you need certain documentation for your GFSI/FDA audit, but different pieces of information are stored in various locations, either in a shared drive like SharePoint or a custom vendor portal. Every minute counts when it comes to document retrieval. These systems are often a little more than an electronic filing cabinet. They can store the information electronically, but unless it’s gathering, analyzing, validating and sharing that data across all departments, you still don’t have an automated system.

Spreadsheets, food safety documentation
If you’re still using spreadsheets, consider moving data to the cloud.

6. Spreadsheets are the main source of tracking your data.

While quality managers at competing companies are investing in the latest technology, other food companies are still inputting supplier lists and data in spreadsheets. Often, managers are reluctant to move their data to the cloud, opting instead to stick with what they know by using a spreadsheet that lacks a comprehensive system to track supplier performance in real time. This is a major disadvantage when different departments need one source of the truth about supplier performance and trend data about incoming material. Not only are spreadsheets hard to share and keep up-to-date, but the majority of them also contain errors.

  • A report by Ray Panko, a professor of IT management at the University of Hawaii, found that 88% of spreadsheets contained errors.
  • Coopers & Lybrand found that 91% of spreadsheets with 150 rows or more produced results that were off by more than 5%.
  • In a sample of 22 spreadsheets, KPMG found that 91% contained serious errors.

If your executives think automated supplier, compliance and quality systems are a “nice-to-have,” chances are you are still operating in the Dark Ages. This final advice is true no matter what software your business is thinking of implementing. Whatever the aims of the system, you must choose a long-term partner. Make sure your vendor can solve these six problems and meet the needs of your business now and in the future.

magnifying glass

Sanitation and FSMA: Is Your Program Deficient?

By Maria Fontanazza
1 Comment
magnifying glass

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.

Melanie Neumann, Neumann Risk Services

Today’s Inspection and Audit Reality: The New Normal

By Melanie J. Neumann
2 Comments
Melanie Neumann, Neumann Risk Services

Food industry inspection and audit protocols are evolving at a rapid pace, and rightly so. This is not surprising given today’s regulatory, audit and ever-changing risk landscapes, which are driving further complexity and expansion of requirements to ensure the industry is, “audit ready, all the time.”

This evolution of inspections and audits has been primarily triggered by newer regulations such as FSMA and private standards, such as GFSI and its certification programme owners (CPO’s, fka Scheme Owners) like SQF, BRC, FSSC 22000, IFS, etc. Heightened customer demand and consumer visibility into food safety incidents –many thanks to mainstream and social media– and the resulting increased demand for information has also fueled this evolution, compelling industry to focus on higher levels of transparency, both internally and throughout the supply chain.

The changes above are driving the food industry to face a new reality. One where the following questions continue to rise to the surface:

  • How have “yesterday’s” inspection and audit expectations changed from what companies are experiencing today?
  • Based on this evolution, how will “tomorrow’s” inspection and audit expectations change?
  • In short, what does the new reality or the “new normal” look like now for inspection and audit readiness?

We will take a look at what some of the first inspections are shaping up to look like under the Preventive Controls for Human Food (PCHF) Rule and the Foreign Supplier Verification Program (FSVP) Rule. Some common themes and some tips to successfully manage regulatory inspections as well as audit readiness tips are set forth below.

More Inspectors

Roll out the welcome mat because more inspectors are coming to the party. We are seeing an average of three to upwards of six regulatory inspectors performing the inspections under the PCHF rule. This may cause an initial shock wave but when you stop to consider the rationale it has a certain level of reasonableness to it. Industry has invested in its personnel for nearly two years in updated training to meet new FSMA regulations such as preventive controls qualified individual (PCQI) training, updated current GMP training and perhaps qualified auditor training, if applicable. It makes sense that FDA needs to make a similar investment in its people to ensure its inspectors are prepared to knowledgeably perform FSMA-related inspections.

FDA has implemented a robust training program for its inspectors. Regarding PCHF inspections for example, only inspectors who have successfully completed the PCQI training plus FDA’s internal training will lead other inspectors through the facility inspections as an in-field training exercise. So, the good news is at least one inspector is fully trained under FDA’s training program standards. This said, with more inspectors, there are more eyes, and with more eyes, more opportunities to see risk through different perspectives. It’s best to be on your game, with a tested playbook so you have confidence you are prepared when the team of inspectors arrive at your facility. Conduct a mock inspection against your policies, procedures and food safety plan that have been updated for the new PCHF and other applicable FSMA requirements. You will be thankful you did.

Digging Deeper

Into Records: FSMA and the seven rules that comprise it requires more controls, monitoring and verification activities by the food industry, thus naturally giving inspectors more records to access and review. Further, FDA received expanded records access authority upon the signing of FSMA. FSMA allows FDA to access records relating to articles of food for which there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death to humans or animals. Before FSMA the standard FDA had to meet to access records was “credible evidence”; now its “reasonable probability”—a standard that is far lower and subjective—allowing access to more types of records than before. Another new addition is FDA now may access records beyond those relating to the specific suspect food if the agency reasonably believes that other food articles are likely to be affected in a similar manner.

Example: If you have a potential problem on production line 1, and you firmly believe the issue is contained to line 1, but that line is in even arguably close physical proximity to line 2, depending on the issue an inspector may invoke this new authority and ask for all records associated with line 2 in addition to line 1 for the same time period to be sure that the situation indeed did not spread or otherwise impact line 2. (e.g. confirm no risk for cross contamination or allergen cross-contact).

This should not mean it’s open season on all your records, but it certainly means more records are open to review and scrutiny, so having a robust record retention and management system becomes mission-critical. How sound is yours? Record-keeping and document management have long been important to GFSI / CPO’s. However, many food companies do not have a certification from one of these entities, which begs the question whether the scope of your third-party audit, or that of a supplier you are currently evaluating for approval, adequately evaluates this important area.

Into your Hazard Analysis: Inspectors are spending significant time reviewing the adequacy of the hazard analysis performed as part of the requirement of the food safety plan under the PCHF Rule and as part of the foreign supplier verification plan requirement under the FSVP rule. If facilities do not identify all the hazards of concern that require a preventive control associated with their facility and foods they produce, then the rest of the food safety plan falls apart. If you work with peanuts to produce peanut butter and identify Salmonella as a hazard requiring a preventive control but not aflatoxin or peanut allergen you have likely missed the mark.You may not have the appropriate preventive controls, monitoring, verification activities, validations and corrective actions identified in your hazard analysis and food safety plan to control for the most significant hazards your facility / the finished food is facing from a food safety risk perspective. (note the identification of hazards requiring preventive controls is highly dependent on the food, facility, processing methods of the manufacturer, upstream supplier and will vary if products are RTE or nRTE)

How are auditors tackling this issue? Many third-party audit firms have invested in providing PCQI training for its auditors so they are better prepared to evaluate the sufficiency or gaps in the hazard analysis. It is a good idea to ask your audit firm what updated skills and training have been given to its auditors to ensure you are getting the assistance you need.

Continue to page 2 below.

Phil Moyer, Unyson
FST Soapbox

Six Considerations When Choosing Your 3PL Provider

By Phil Moyer
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Phil Moyer, Unyson

The third-party logistics provider  (3PL) market is expected grow at a compound annual growth rate of more than 5% through at least 2024, according to Hexa Research. In addition, Aberdeen Research reports that industry leaders have increased the number of 3PLs they work with by more than 20% since 2013. Clearly, companies are outsourcing more of their logistics activities, and there are many factors to consider when choosing a 3PL, especially in the food industry. This article discusses a few essentials to take into account before betting your company reputation on a new 3PL relationship.

1. Experience

Transporting food is a serious and complex business, and it’s one place you don’t want to be a trailblazer. If the 3PL you’re considering doesn’t have extensive experience with products similar to yours, you are better off looking elsewhere. After all, it’s your reputation that will take the hit if things go wrong. This is one area where it pays to check references.

A company’s supply chain can be the weakest link in its food safety program. Learn how to mitigate these risks at the Food Safety Supply Chain conference | June 5-6, 20172. Familiarity With Food Safety

First and foremost, ensure your 3PL understands the ramifications of the latest legislation regarding food handling — including FSMA and HACCP. It should be able to point to material handling data sheets for every item of food it handles. Give the 3PL bonus points if it can personalize the handling instructions to each shipper.

Make sure the 3PL understands the rules in all the geographic areas where you ship, since local regulations can vary.

3. Certified Processes

FSMA requires specific documentation. The 3PL you choose should already be aware of the rules and have processes in place for compliance. It should have taken the initiative to have its processes audited for compliance. After all, compliance with regulations is part of the service it provides for you.

Ask the provider to show you its method for conveying handling instructions to carriers, and how it ensures that carriers follow the instructions. The burden of proof for cold-chain integrity or HACCP compliance falls to you, so don’t entrust your business to a 3PL that doesn’t understand it.

4. Track and Trace, Lot and Expiration Controls

Recalls happen. Your 3PL should have technology in place to provide visibility throughout the supply chain, including the ability to track and trace from end to end. Ask to see its picking process, and how it ensures first-in-first-out (FIFO) lot picking so you minimize spoilage. How does it handle expired or soon-to-expire lots? Can it segregate the goods so it doesn’t actually ship them? How does it notify you of upcoming expirations? Proactive alerting is the ideal mechanism.

5. Size and Locations

Once the 3PL you are considering has proven it understands how to handle food products safely and legally, the next step is to ensure it can provide the coverage you require. It should have offices in or near your distribution points. Ask to see the 3PL’s customer list. You don’t want to be much larger than its current largest customer because it may not be equipped to deal with your volumes. You also don’t want to be among its smallest shippers, because you may not get the attention you deserve.

Make sure the provider is fiscally sound, especially if you are entering this relationship for the long term.

6. Technology

Technology is fast becoming the biggest differentiator for a 3PL. Ask about the systems it uses for collaboration and visibility. Does it have automated picking capabilities? Are your business systems easily compatible if you want to integrate, or does it provide a shipper portal for 24/7 access? What are its future technology plans? A good 3PL should be excited to talk about its technology because it would know it’s a key differentiator. If the provider is reluctant to talk about it or lagging in the technology arena, it will not be a good long-term partner.

Your business depends on a great 3PL, and your customer’s health and safety may rely on it as well. Take the time to thoroughly vet any 3PL you are considering before signing on the dotted line.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Are You Ready for an FDA Inspection?

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Don’t miss the Plenary Mock Food Safety Trial: Sam I Am who made Green Eggs and Ham is represented by Shawn Stevens vs. Food Safety victims represented by Bill Marler. Judged by Steve Sklare | November 30 at the 2017 Food Safety Consortium | Learn moreWith FSMA regulations coming into effect, food companies must prepare for the arrival of FDA investigators, as the agency has made it a priority to inspect U.S. food facilities, and they won’t always show up announced. Prior to an investigator’s arrival, it’s important to iron out several details in order to be adequately prepared. The following are 10 questions that every company should add to its pre-inspection checklist and make sure they are addressed before the inspection.

  1. Where will you meet? Pinpoint a place where you will host the FDA investigators. It should be a space that has enough room for them to review records, but it should not provide access to records (paper or digital) that could be viewed unsupervised.
  2. Who are the Designated Individuals? Assign a primary and secondary Designated Individual (DI) for each facility. This person serves as the liaison with the FDA investigators and should coordinate vacation time to ensure that one DI will always be available if FDA arrives. Although not required, the DI should also complete Preventive Control Qualified Individual Training.
  3. Has the written food safety plan been finalized? And, do the primary and secondary DIs know its components (i.e., GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food DefensePlan, and Produce Safety Plan)?
  4. Are records readily accessible? The DI should be able to immediately access any supporting records from the past three months for FDA review (FDA requires that most records are maintained for at least two years, but investigators usually ask to review the preceding three months).
  5. Have corrective actions been documented? When a deviation occurs, you must document all corrective actions. These actions should identify the deviation’s root cause and actions to prevent recurrence. If product safety is not affected, this should include a written conclusion that the deviation “does not create an immediate or direct food safety issue.”
  6. Have you conducted environmental monitoring and environmental sampling? If your company processes ready- to-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. In addition, the agency will collect 100–200 microbiological samples from your facility, so you need to know exactly what FDA will find before it arrives. By conducting your own FDA-style facility swabbing, you’ll be able to identify and immediately correct any hidden problems. It’s also important to develop your swabbing and testing plan with the help of legal counsel so that  the final testing results are confidential.
  7. Do you have a “No Photographs” policy? If not, you should. FDA Investigators will often insist on taking photographs while inspecting the processing environment. If your corporate policy prohibits visitors from taking photographs, you may in some cases be able to prevent FDA from taking pictures as well.
  8. Do you have a “Do Not Sign” policy? Sometimes, FDA Investigators will insist that a company representative sign a statement or affidavit during an inspection. You’re not legally obligated to do sign such a document. You should develop a policy stating you will neither sign nor acknowledge any written statements presented by FDA Investigators.
  9. Have you identified a suitable “on call” food industry lawyer? Add a food industry lawyer familiar with the inspection process to the company’s emergency contact list. This lawyer should be notified and remain “on call” during the inspection and serve as a resource to help answer any regulatory or investigator-related questions that arise during the process.
  10. Did you conduct a mock FDA inspection? One of the most effective ways to prepare for an FDA visit is to conduct a mock inspection. Food industry consultants and/or lawyers can visit your facility and play the role of the Investigator. Ask them to review your programs to identify possible regulatory shortfalls, and work with you to implement strategies that will strengthen your programs and reduce your regulatory exposure.

There are several more points to add to your pre-inspection checklist. To get the rest, attend the webinar, FDA Inspection Readiness Checklists, on March 28.

Randy Fields, Repositrak
FST Soapbox

Sanitary Transportation Rule: Ignore at Your Own Peril

By Randy Fields
1 Comment
Randy Fields, Repositrak

FDA posted the FSMA rule on the Sanitary Transportation of Human and Animal Food in April. The majority of retailers, wholesalers, suppliers and carriers will have one year to comply with this new rule. The sanitary transportation rule sets out to prevent practices that would introduce contamination risk during the transportation of food through the supply chain.

For retailers, wholesalers, suppliers and carriers, the final rule is really the sleeper regulation among the new FSMA laws. You probably have your HAACP plans and preventative control procedures in place, but do you have the necessary documents in place with your carriers to meet the FDA’s requirements?  And, are those documents easily accessible?

Under FSMA, you must address all FDA record inquiries within 24 hours, and these inquiries can go back two years, plus 12 months beyond the expiration of related service agreements. Failure to respond to an FDA records inquiry is considered a “prohibited act” and can land you in hot water with both the FDA and Department of Justice, which acknowledged they will enforce FSMA through civil and criminal penalties. That’s a game changer.

You are now required to ensure that transportation equipment does not cause the food it is carrying to become unsafe. You must also maintain adequate temperatures throughout your portion of the supply chain and prevent cross contamination. And, you must train your personnel in sanitary practices. All of these factors—processes and procedures, agreements and formal training of personnel—must be documented and made available to the FDA. Put simply, compliance with FSMA is proven through documentation because according to the FDA, if it is not documented, it did not happen!

So what’s the best way to comply with the new rules? Having the information on paper in filing cabinets simply won’t do. Can you imagine searching for specific confirmation that an employee received the proper training in a bank of file cabinets? Even with an efficient system, that could be like looking for a needle in a haystack. Collecting the information in spreadsheets is only slightly better, as it simply digitizes the disorganization.

Retailers, wholesalers, suppliers and carriers need to start their compliance process by reviewing and understanding all of the FSMA rules, guidance procedures and responsibilities. You ignore them at your own peril.

Then, consider automating your recording keeping system.  It is really the only way to efficiently collect and manage the documentation needed to comply with the new law.  When reviewing technology options, make sure you choose a system that is not only easy to use by frontline workers, but also provides sophisticated reporting and alerts to point out potential problems in real time. And, if possible, the solution should do more than just report on food safety activities. As long as you’re investing in a technology to meet FSMA requirements, you might as well implement a system that can potentially save money in other areas such as managing business or training documentation, new vendor approvals, or carrier optimization.

The bottom line is that the sanitary transportation rule will require that you devote additional resources to make the entire extended grocery channel more risk free for consumers and companies alike. And the best way to do that is to implement new technology that gives visibility to product transfers from point of production or processing to the point of purchase, and documents each step along the way.

Five Errors That Impact GFSI Compliance

By Jason Dea
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The Global Food Safety Initiative (GFSI) is a global initiative for the continuous improvement of food safety management systems. From a functional standpoint, you might be surprised to learn that one of the most challenging elements of keeping up with GFSI compliance for many food producers is sufficient document control. In fact, data compiled by SQF shows that document control-related issues are one of the most common sources of a non-conformance during GFSI-benchmarked audits. Examples of these non-conformances are associated with documentation of training requirements, business continuity planning, and corrective and preventative actions.

The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain. This work is accomplished through collaboration between the world’s leading food safety experts from retail, manufacturing and food service companies, as well as international organizations, governments, academia and service providers to the global food industry. They meet together at technical working group and stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry. GFSI is facilitated by The Consumer Goods Forum (CGF), a global, parity-based industry network, driven by its members.

So what exactly are some of the most common causes for document control issues as it relates to non-conformances? Keep an eye out for the following five errors that can affect compliance.

1. Lack of document control altogether

Lack of correct usage of document control in the context of GFSI compliance is a common error. This is an issue that often occurs as a result of document sprawl—specifically as it pertains to duplicate documents and supporting documents. For example, an organization might create internal reference material designed to be cheat sheets or summaries of larger policies. These could include simple charts that list key equipment set-up parameters or charts summarizing abbreviated information from product specification sheets. Many organizations fail to realize that because of the nature of the information in these files, these reference documents must also be included in their document control program to ensure that the information in them is current and universally applied.

2. Document version control

From using outdated forms to referencing outdated employee procedures, lack of proper document version control and enforcement is the most common GFSI compliance-related non-conformance. These issues can arise from operational errors (employees don’t know where to find up-to-date documentation or how to ensure that it is being used) to technical errors (the document control system is unable to properly manage document versioning, or in the case of home-grown document control software systems, they may be unable to do so altogether). To avoid these errors, it’s necessary to establish where controlled versions of documents are located and ensure that they are kept up to date. It’s also important remove obsolete versions of these documents—this is a basic principle of document control, but it’s often an area where errors compound over time. Reinforcing training so employees are made aware of document control best practices and policies is critical to keeping your compliance activities current.

3. Document revision errors

One of the most common activities and most common sources of error within any document control program involves publishing revisions to documents. These errors include:

  • Updating the contents of a document but forgetting to update information such as the version number
  • Improper tracking of revision history
  • Adding new documents to the database rather than revising or updating existing documents

4.  Inclusion of documents from external sources

If your food safety management system includes or makes use of external documents, these must be controlled in the same manner in which you control internal documents.

Some examples of external documents that may need to be included in your document control program include:

  • Sample labels provided by your chemical and pest management suppliers
  • Raw material specifications provided by your suppliers
  • Customer expectations manuals provided by your customers

5.     Improper identification of approval personnel

A best practice of document control is for the person knowledgeable about the content of a document to be assigned the responsibility of approving updates to it. In many organizations, this is interpreted to mean that all approval responsibilities are assigned to a single person across the organization. This could be the food safety coordinator or the document control administrator, despite the fact that it is not reasonable for a single person to be knowledgeable about all the procedures across the organization.

A better approach to approval responsibilities is to identify individuals who can be responsible for authorizing changes based on function or discipline. By spreading the responsibilities across more people, your document control program is more likely to be current and accurate.

When it comes to food safety compliance and best practices, particularly as they relate to GFSI, it’s often the basic principles that get overlooked once your organizations processes and systems are up and running. Setting up a process for document control and maintaining this process over time is a key to achieving and maintaining compliance. As such, it’s important to revisit your controlled document process and library regularly to ensure things are operating as designed and avoid costly compliance surprises at the same time.

Zia Siddiqi, Orkin
Bug Bytes

Get Your Food Manufacturing Facility Audit-Ready

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

Being audit-ready at any moment can be a daunting task, but pest management is one aspect of your audit that you can ace if you’re doing the right things. Pest control can account for up to 20% of your score, so taking it seriously can give you a huge boost the next time an auditor comes to your facility.

There are two components needed to help ease the stress of a third-party audit: An Integrated Pest Management (IPM) program and proper documentation.

IPM programs focus on incorporating green prevention and exclusion tactics into your facility’s ongoing sanitation and facility maintenance strategies, only using chemical solutions as a last resort. FSMA established that these tactics should be used when dealing with food safety issues and that thorough records should be kept to document the risk-based prevention efforts. This gives food manufacturing facilities even more of a reason to employ an IPM program.

A strong IPM program already has documentation built into it, as tracking pest activity and monitoring results over time are crucial steps to implementing the most effective pest prevention techniques for your business. Every IPM plan is tailored to your facility’s needs, so it needs to be dynamic and adaptable over time as new technologies emerge and your business needs change. Having the ability to show documentation of these changes and their positive effects will get you off to a great start on your next audit in showing your risk-based prevention food safety plan. If you do not already have an IPM program in place, speak with your pest management provider about establishing one.

Auditors like to see IPM programs in place because it means your business is taking a proactive approach and keeping detailed records.

Think about it like this: If the auditor is the judge and there’s no jury, would you ever walk into a court case without any evidence to prove your innocence? Of course not! So you wouldn’t want to walk into an audit without any documentation either.

In other words, document everything. Facilities must prepare and implement written food safety plans that identify potential risks to food safety, enumerate the steps and processes that will be executed to minimize or prevent those dangers, identify and implement monitoring procedures, keep detailed records of the food safety program, and list actions that will be taken to correct problems that do arise. If you’re doing all of this, you’ll make an auditor’s life that much simpler and improve the chances of receiving a high score.

When working to get audit-ready, you’ll want to have the following forms of documentation ready to go:

Proof of Training and Certification

Even though you know that your pest management professional is properly trained and certified, your auditor does not. Keep documentation on hand at your facility, as auditors may want to see one or more of the following documents:

  • A copy of the valid registration or certification document
  • hysical, written evidence that your pest management provider has been properly trained to use the materials necessary for your IPM program
  • Evidence of training on IPM and Good Manufacturing Practices (GMPs)

Proof of Service and Material Changes

A strong IPM program changes as new technologies emerge and your business’s needs shift over time, so be sure to have detailed documentation of these changes as they occur. It’s also important to note the reasons for making changes. Auditors will be looking for written documentation for even the smallest of changes to your IPM program, so take careful notes as your program adapts along with your business.

It can also help to assign specific roles to your employees. This not only will give employees clear direction on how they can contribute to your IPM program, but it can also help your case with an auditor by showing that your facility is maintained by an entire team rather than just a few people. Teamwork is a key part of any IPM program, so be prepared to show how your team runs effectively.

Pest Sighting Reports That Correspond with Corrective and Preventive Actions

When there is a pest sighting in your facility, record it immediately. Keeping records of sightings will help ensure that steps are taken to improve and show accountability to an auditor. Once action is taken, record exactly what was done and the results of the counteractive efforts. That way, you’ll have a paper trail that shows an auditor that for every pest problem, your pest management provider came up with a proactive pest solution that resolved—or is working to resolve—the issue.

After taking corrective action, continue monitoring the issue over time and note any developments in order to help prevent the issue from reoccurring. Creating a trend report that keeps track of which pests your facility is dealing with over time can help, too, as it will help you determine which pests are the most problematic. Your provider can help build such a report.

Records of Pest Monitoring Devices and Traps with Corrective Actions

Pest monitoring devices and traps are great for giving insight into areas around your facilities that are most susceptible to pests. Along with these devices, however, you’ll need to show the following information to an auditor:

  • When and how often the monitoring devices and traps were checked
  • The type and quantity of each pest found
  • Corrective actions taken to reduce pest activity and prevent further issues

Work with your pest management provider to gather all of this information, as it is usually the technician who works on these devices regularly. Being able to give an auditor the full picture can certainly help you on your inspection as it demonstrates attention to detail throughout your entire facility.

Annual Pest Management Assessments and Resulting Actions Taken

With most IPM programs, your pest management provider will thoroughly inspect your facility annually to identify areas that can be improved. Many auditors require these annual check-ups, and they will be looking for proof that these facility assessments occurred and that action was taken as a result that led to positive changes. Year-over-year improvement is important, so measure your success against the areas of improvement specified in these annual inspection reports. That way, you can meet the objectives prior to an audit.

These annual inspections give you a chance to look back and see the progression over the years. If there are any pest issues that pop up year after year, make them a priority in order to show that your program is trending in the right direction.

This proactive approach to pest management will help protect your business from pests and the inherent risks, as well as help give you a better chance of receiving an excellent score on your next audit.

So don’t be afraid of an audit the next time one comes around. With a strong IPM program in place and detailed documentation over the course of the year, there won’t be an exorbitant amount of preparation needed. Stay organized and keep all of the above-mentioned documents together and on-site to keep things simple for both you and your auditor. All of these elements will help your facility receive a strong score and be audit-ready at a moment’s notice.

Survey: Not All Food Companies Sure if FSMA Applies, More Help Needed

By Maria Fontanazza
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How ready is your company for FSMA compliance?
How ready is your company for FSMA compliance? 69% are somewhat ready, 25% are ready, and 6% are not ready at all, according to a recent survey. (Click to enlarge)

Many companies need to prepare for FSMA compliance by September, yet three out of four only consider themselves “somewhat ready”, according to a recent survey of about 400 food companies. However, the findings generally indicate that companies are taking action now to be FSMA ready—they just might need some help along the way.

Sponsored by SafetyChain Software and The Acheson Group, “2016 FSMA Readiness & Compliance Strategy” surveyed mainly U.S. companies (88% with more than $1 million in revenue) that produce and manufacture food for human consumption.

An effective food safety plan is a fundamental part of FSMA compliance. The majority of participants (80%) are either currently updating their food safety plans or plan on doing so this year. Conducting a gap analysis is a common way to assess the effectiveness of a food safety plan: 84% of respondents plan to conduct a gap analysis, have one in progress, or have already completed the exercise. More than half of these companies are tackling it using internal resources, and 29% are seeking expertise outside their organization.

85% of companies surveyed know which rules apply to their company. Survey sponsored by Safety Chain and The Acheson Group
85% of companies surveyed know which rules apply to their company. Survey sponsored by SafetyChain and The Acheson Group

Documentation plays a large role in meeting FSMA requirements, and in the event of an audit, companies must be able to produce records within 24 hours. The good news is that 76% of companies say they can retrieve records required by FDA within this time span, but 22% are still unsure. Half of the organizations anticipate being audit ready on day one of FSMA enactment. And despite a push to migrate to electronic documentation, most of the companies surveyed (84%) still keep both paper and electronic records; only 3% keep strictly electronic documents.

FSMA compliance, technology
Companies indicate that they’re using technology to aid in FSMA compliance.

The survey authors concluded that companies still need more information on how they can meet FSMA requirements, what resources are available, and how certain systems can help. In addition, they indicated that corporate executives must play a larger role in implementing compliance.

FST Soapbox

Inquiries, Responses and Audits: The Chipotle Effect

By Dan Bernkopf
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In an age where news is reported instantly, those outside the food industry have a heightened awareness and concern over their favorite brands’ commitment to food safety. Conversely, every food industry’s safety and quality operations teams are more than likely putting measures in place to tighten up their supply chain controls and re-evaluate their own food safety programs to ensure that their companies don’t become the next headline.

You better believe suppliers and their customers alike are also re-evaluating their ability to quickly, and effectively, respond to such an incident with the data and records needed to determine root causes—and with good merit, especially if you take a step back and really think about what is needed when a response or inquiry comes in surrounding a Chipotle-type food safety incident. Responses to such incidents typically fall along the lines of: 

  • Evidence of current food safety plan, including comprehensive risk analysis, HACCP/HARPC plan, validation studies or documents
  • Inspection data and documents on your suppliers, including onsite inspection, transportation and product receiving inspections, complete with non-compliance reports and CAPAs for the last six months
  • All data records relative to your internal processing CCP(s) or equivalent, including monitoring frequencies and all non-compliance reports, complete with their CAPAs for the last six months
  • All regulatory and non-regulatory audit reports or actions, including non-compliance reports and their CAPAs
  • Additional available internal or external laboratory evidence that demonstrates environmental monitoring of your facilities and resulting continuous improvement and sanitation validation for the last two years
  • Additional internal or external laboratory pathogen monitoring programs for field, transportation, raw material supply and finished products, etc. as evidence to support your food safety program

The sheer volume of records, data and information needed in such an on-demand short timeframe can be extremely overwhelming. Without quick access to the critical records needed to determine root cause or, more importantly, thwart an incident from expanding, food safety and quality operations should be taking a close look at how they are managing their food safety data records and reports.

Are binders full of documents, or a combination of paper/silo data records going to suffice when it comes to inquiries, responses (and audits)? Or, is there a better way to manage food safety and quality data to ensure not only data is accessible, but also that food safety programs are working?

One sure bet is that there will be a higher number of audits and inquiries. Is your team and/or supplier prepared for the increase of these types of activities?

  • Inquiry: A request for a single or series of data and or documents usually related to a specific FSQA event or question
  • Response: The collected data, data reports, document or document reports related to a specific audit or inquiry
  • Audit: An activity that reviews one or many elements of a food safety plan to assure that the plan is complete, performed as described and meets the food safety design as intended. Audits are known and expected activities to review such safety plan elements even though the actual audit date and time may be known or unknown

We all know that audits are often lengthy exercises, yet they are still predictable. On the other hand, inquiries can be more difficult in that information requests may involve a very deep dive into a very specific area of inquiry.

In all honesty, if inquiries or responses or audits have to be planned for in advance, then you are not prepared. In order to always be prepared, it’s imperative to have better systems in place to manage any type of internal or external examination of your food safety and quality information. Regardless of whether it is an audit, response or inquiry, it is important to have easy access to records, verify that your programs are working, have corrective actions in place, and show visibility (and transparency) in your operation.

Thus it all comes back to how you or your suppliers are managing food safety records day in, day out. If FSQA operations are still relying on manual-based food safety and quality management processes versus food safety and quality management technologies, then chances are that you’re reacting to latent results, and you’re not able to identify trends and opportunities for improvement. The burden to manage inquires, responses or audits—as they continue to grow in cadence—will become overwhelming.

Without a doubt, the Chipotle effect is being felt throughout the industry. There will be increased accountability to ensure an adequate food safety program is in place and verification that the program is working. It will become even more imperative—and expected—that data and records are readily available to efficiently respond to inquiries, responses and audits.