Tag Archives: documentation

Melanie Neumann, Neumann Risk Services

Today’s Inspection and Audit Reality: The New Normal

By Melanie Neumann, JD, MS
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.

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Phil Moyer, Unyson
FST Soapbox

Six Considerations When Choosing Your 3PL Provider

By Phil Moyer
2 Comments
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
1 Comment
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.

Alert

Five Errors That Impact GFSI Compliance

By Jason Dea
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Alert

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.

John Sammon, ParTech
Retail Food Safety Forum

Break the Pencil: Goodbye Paper, Hello Technology

By John Sammon III
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John Sammon, ParTech

With the passage of FSMA, any location that handles food for public consumption must implement Hazard Analysis and Critical Control Points (HACCP) plans to reduce food safety risks across the food chain. Many businesses with multiple locations in the restaurant and retail industries are finding that traditional paper-based methods of record keeping are no longer adequate to comply with the FSMA. By abandoning paper-based systems and adopting cloud-based technology, restaurant and retail locations can embrace and enforce stronger food safety cultures and help eliminate human error.

According to the CDC, each year an estimated 48 million Americans get sick, 128,000 are hospitalized and 3,000 die from foodborne disease.

Why? The process of purchasing, transporting, preparing and serving food heavily revolves around individual human behaviors related to cooking, cleaning, handling and refrigerating food. When employees do not follow the correct processes and procedures, it can lead to accidental food safety issues.

FSMA & HACCP Plans

In an effort to shift from responding to food contamination incidents after the fact to proactively preventing them, the FDA introduced FSMA in 2011. To allow businesses time to adjust to new rules and regulations, the FSMA requirements are implemented in phases, which began in September 2015 and will continue through May 2016.

As part of a larger food safety initiative, FSMA requires any business that handles food for public consumption to implement a HACCP plan. The purpose of the plan and its procedures is to identify potential hazards in any food-related processes where a lapse in attention or failure to complete a task could turn a potential hazard into an actual one.

The three main components of an HACCP plan that are required to be documented are:

  • Hazards: Evaluate potential hazards that exist in the enterprise. For example, how, when and why Salmonella or Listeria could migrate into a finished product
  • Critical Control Points: Identify critical control points where failures could occur, such as when products are moved from preparation to the sales floor
  • Preventative Steps: Establish the preventative steps that must be followed at each critical control point to reduce hazards, for example, interval checks to make sure correct temperatures, whether hot or cold, are consistently maintained

FSMA also mandates a record of food safety compliance to ensure a company follows its HACCP plan. Every location must document all actions, including ongoing monitoring of when a problem was spotted and corrective actions taken. These records, which have traditionally been created and maintained with pen or pencil and paper logs, must be kept for a minimum of two years.

Deli worker checks cold food temperatures using a handheld probe and wireless device. Maintaining proper food temperatures and recording checks for consistency is an important part of HACCP guidelines.
Deli worker checks cold food temperatures using a handheld probe and wireless device. Maintaining proper food temperatures and recording checks for consistency is an important part of HACCP guidelines.

Compliance Challenges

With multiple locations and an ever-changing labor force, it is difficult for companies to be confident that the food they sell is safe and that every employee is acting diligently when it comes to food safety across the entire enterprise.

In a busy restaurant or retail environment with ever-changing customer demands for a variety of different products and services, a food safety culture and plan can unintentionally become compromised.

With local farmers to international food manufacturers supplying fresh, frozen and prepared foods and a variety of workers in contact with each for different reasons, it can be difficult to track food safety procedures.

Add an inefficient, manual, paper-based food safety record-keeping system that does not proactively remind employees to complete tasks or prompt corrective actions when needed, and you are opening the door to potential problems.

It’s Time to Break the Pencil

Companies must implement the highest standards of food safety processes at all levels and locations. Once a food safety culture is defined, it needs to be enforced every day. Employees should be well trained on policies, feel empowered and mandated to behave consistently.

A major part of the solution is abandoning traditional pen or pencil and paper-based record-keeping systems. By adopting technology, restaurants and retail locations can embrace and enforce stronger a food safety culture and help eliminate human error.

Electronic and intelligent checklists and digital record keeping on mobile, handheld solutions that are integrated into the Internet of Things (IoT) represent a major technological advancement over what was previously possible, and can manage and dynamically influence food safety processes. Through connectivity to the cloud, mobile, digital solutions can be deployed anywhere throughout a business, from warehouses to sales floors, to prompt the desired behaviors and provide a detailed, accurate audit trail of completion. Devices can also keep track of relevant safety alerts and recalls to improve efficiencies and initiate steps that may not be part of a typical routine.

Daily employee work schedules can be preloaded and custom electronic-based checklists and templates can be built specifically around potential hazards to manage employee tasks and processes. Any missed steps or violations are flagged for easy correction.

As tasks are completed, data is electronically gathered and transmitted directly to the cloud where it can be stored, analyzed and reported for compliance.

In addition, through the cloud and IoT, employees at various levels of an organization, from corporate headquarters to store managers, can view and access real-time data from each location. New information can be uploaded from any location and automatically distributed to a particular store, region or all locations across an enterprise. Enterprise-wide access helps ensure all locations are practicing the most up-to-date HACCP plan and procedures.

Digital food safety solutions have many benefits for a business:

  • Overall Food Safety: Ensures critical control points are monitored and proper corrective actions are taken when necessary
  • Higher Performance: Employees are reminded to complete assigned tasks, so more tasks are completed on time with fewer misses
  • Audit Trail: Detailed, automated audit trail of who completed the action, what time it was completed and the data retrieved from the action
  • Process Improvement: A single database of comprehensive information detailing timing, missed checklists, commonly missed items and top violations to help improve overall processes
  • Cost Savings: Fewer resources are needed to complete food safety inspections, a 60% reduction in time compared to pen or pencil and paper-based systems1
  • Quality Improvement: In addition to HACCP compliance, the information gathered can be used for quality control. For example identifying where there has been over- or under-cooking in the food preparation process

Handheld, wireless and cloud-based technologies can serve as more accurate, reliable and efficient systems. Electronic systems are part of the solution for businesses to comply with new FSMA regulations and improve food safety procedures. When implemented properly, these technologies can help turn food safety in a positive direction and potentially avoid the next foodborne illness outbreak.

Reference

  1. National Grocers Innovation Center, Center for Advancing Retail Technology. Intelligent Checklist for Quality and Safety in the Supermarket. Retrieved from http://info.partech.com/whitepaper-intelligent-checklist-for-food-safety

GFSI and the Road to FSMA

By Maria Fontanazza
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Many companies certified to a GFSI scheme appear to have a leg up on preparing for FSMA, especially in the area of documentation and record keeping. During a quick chat with Food Safety Tech, Bob Butcher, group operations manager at Ipswich Shellfish Company, explained how GFSI has helped the seafood processor get ready for FSMA. Do you agree? Sound off in the comments section.

Food Safety Tech: What common challenges do companies experience when managing compliance with a GFSI scheme?

Bob Butcher: Every time there’s a new regulation it’s a matter of understanding how that regulation applies to us. The seafood industry has been regulated by FDA mandatory HACCP requirements for years now. Some of the items that are covered under FSMA have already been covered by the seafood regulations. Our facilities have also undergone third-party audits for a number of years and three are already SQF certified—so in order to meet those certifications, we comply with all the FSMA requirements at this point. That being said, there’s always a challenge or opportunity to make sure we comply with all the regulations and above that, make sure that the quality [of the product] we send to our customers meets both their standards and our standards.

FST: Has being certified to a GFSI scheme helped your company better prepare for FSMA compliance?

Butcher: Because we’re SQF certified and are meeting most of the requirements of the seafood industry, we’re well ahead of meeting FSMA requirements. Maintaining the GFSI requirements put us in great shape for FSMA.

GFSI covers so many areas. [Regarding] vendor compliance, we critically examine the seafood that comes in every day and it’s a very perishable commodity, but every plant is a little different in the talent they have and the number of people. We’ve been able to focus on making sure that the product meets the same criteria at each of the facilities no matter who is receiving it and documenting it accordingly. And whether [complying with] GFSI or FSMA, documentation is important.

We’ve gone the extra step in automating so we can better track how each of the plants and suppliers are performing. We started rolling it out at one plant two years ago and then extended it to all plants. All of our facilities have been under it for a year.  

I think more and more companies are acknowledging the need to automate. With paper forms it’s difficult to make sure the employee has the correct and latest version, and the filing and recovery of that document [is difficult]. If it’s digital, you can get your hands on the latest version any time you want. Plus, you can analyze digital information and easily look for trends.

However, the seafood industry isn’t like a number of other industries—the margins are low, and so cost is absolutely a factor. If it’s a single facility, having paper forms, depending on the extent of the operation, may be acceptable. But if you get into multiple locations, it’s a whole different challenge all together.

FST: What are the broader issues that the seafood industry is currently facing?

Butcher: Supply and sustainability—making sure that you have a handle on the sustainability of the species and are able to explain that to your customers. That ties into record keeping—getting the right product, when it’s an MSC [Marine Stewardship Council] or ASC [Aquaculture Stewardship Council] chain of custody, or whether it’s having the right relationship with the vendors so you know your source. Cost is a concern, along with quality and inventory levels.

There are a lot of very small companies and a lot of them aren’t GFSI certified. A lot of them don’t even have any type of third-party audits, so I’m not sure how ready they are. It’s always a challenge for a small company to get up to speed.

FST: Does compliance with a GFSI scheme help address these issues to some extent?

Butcher: As we started working on GFSI or FSMA, and even HACCP many years ago, we started looking at products differently. You’re documenting more and gaining information—and once you have that information, you can focus on cost factors and inventory. So from that standpoint, it has been very helpful.  At this point, we’re SQF Level, and we plan to go Level 3, which involves more quality parameters and certification. That will greatly impact the product and the profitability as well.

FST: What are your tips for companies in terms of being audit ready?

Butcher: The software program we use helps us maintain our facilities to be as audit ready as we can from a documentation standpoint. With SQF there will be unannounced audits, and it’s always been FDA’s practice or the state inspector’s practice to pop in anyway, so you have to be ready for that inspection at any time. The whole principle of HACCP is to make sure you’re documenting what you’re doing. And whether it’s an auditor or an inspector, they’re coming in at any time and can look at records for the past two years, so you should be in compliance and be able to prove that.