In today’s risk-based world, companies can’t just trust a third-party auditor based on a handshake, according to Melanie Neumann of Neumann Legal Services and Matrix Sciences. It is also a manufacturer’s responsibility to verify the auditor. Watch the following video, shot at this year’s Food Safety Consortium, to hear Neumann’s take on “trust but verify” and the importance of inspection and audit readiness both today and in the future.
Today FDA released a draft guidance to provide information about what actions by a foreign food establishment or government are considered a refusal of inspection. “FSMA gives the U.S. Food and Drug Administration the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment that produced the food,” FDA stated in a release.
The 12-page draft guidance, Refusal of Inspection by a Foreign Food Establishment or Foreign Government, outlines how the agency goes about scheduling inspections of foreign establishments (despite the fact that FDA is not required to pre-announce inspections), the inspection activities themselves, and very detailed examples of what it considers an inspection refusal from a facility (from a lack of communication with FDA that delays the agency’s request to schedule an inspection, to preventing an FDA investigator from entering a facility, when a facility sends staff home and tells FDA that it is not producing product).
The draft also details what it considers to be refusal of inspection by a foreign government. Some of the actions include preventing FDA investigators from entering the country or asks them to leave the country before an inspection is scheduled; and limiting access to areas of the facility that manufacturing, processing and packaging occurs; and limiting investigators from collecting samples for analysis.
If either a foreign food establishment or a foreign government refuses an inspection, they will stay on the agency’s Red List of Import Alert 99-32 until FDA is able to schedule and conduct an inspection.
Here’s a typical scenario.
You are the QA Manager for a dairy manufacturing facility in the Midwest. It’s been a long week and you decide to come in a little earlier than normal to catch up on paperwork. You find out when you arrive that product is on hold because the filling line is down. Maintenance is all over the machines, and orders are piling up; the paperwork will have to wait. You head out to the line to see what you can do to help.
This only happens when the plant manager is on vacation, you think to yourself.
As you walk out to the floor, your ears perk up as you hear your name paged over the intercom. The receptionist needs you in the front office—immediately.
What now?
You can’t think of anyone who is scheduled to visit today. You heart sinks a little. You don’t like surprises and this could be a bad one.
You come around the corner to the lobby to see exactly who you were hoping you wouldn’t see: An FDA investigator.
“My name is Investigator Brown,” he says as he flashes a badge. “We’ve had an allegation of an illness from your product. I am here to look into it.”
You smile politely and nod. He does not smile. You motion for him to follow you to a conference room.
Your day just got a whole lot longer.
How will this go?
The answer to that question is, in many ways, up to you.
FDA investigators are people and they take their job as seriously as you do. They are there because they need answers. Their boss expects answers. If people are getting sick, they need to find out quickly and take action. If this is truly the case, you need to know as well. So does your boss. No one wants people to get sick.
The absolute wrong thing to do in this situation is to not have a plan. You need to know how to handle a regulatory inspection. You need a plan to prevent a misunderstanding or create a situation where something minor gets blown out of proportion.
This is not the time to play it by ear. You need training and you need a plan.
An important point to remember is that your product may not have caused the illness. People often assume the last food they ate is the one that made them sick. In reality, incubation times may take significantly longer for symptoms to manifest. Samples of the product in question are rarely available to test. Dosage, health of the person, and other factors also come into play. You need to work with facts and not supposition—as does the FDA.
In general, you can assume that FDA thinks you are at fault; that is why they are there. You will have a hole to dig yourself out of before you can convince them otherwise. Don’t let that rattle you, they are only doing their job, and your job is to show them all the great food safety programs you have in place to prevent what they are concerned about. Keep this in mind as you go through the visit. If you are doing a good job, you should see their demeanor soften as they gain confidence in what you do.
Don’t be a hero, you need a team to help you in this situation. You need the people in the plant and you need people at corporate ready to back you up. You most likely also need access to outside counsel that specializes in food regulations. Your role in the room is to facilitate and work with FDA to get them what they need. You and FDA are on the same side of the table in this respect. Both of you are working to find out if the illness is real.
If you are not sure of an answer, say so! Call corporate QA and your legal counsel and discuss it. Find out what the answer is from someone who does know. If you still don’t have an answer, it’s better to admit it than to make something up. Tell them when they can expect an answer, even if it may be after the audit concludes. Never make stuff up.
The company should have only one voice (most likely, you) responding during the inspection. This avoids confusion and keeps you in control over the message being delivered. Other agencies, such as OSHA, have the right under the law to interview employees during an investigation. It is not that clear cut with FDA. Make sure you explain to FDA that you are the designated spokesperson for this inspection and that all questions need to be routed through you. The personnel in the facility need to understand this as well and defer to you if FDA questions them. If the question is out of the ordinary, it may need to be in writing. When on the floor, never leave the investigator alone, accompany them at all times (don’t go crazy, they can use the bathroom by themselves).
Have someone who can tag along with you to take written notes of the visit. Train them on what you expect. Time stamp the notes and use a stream of consciousness approach. Write down everything, more notes are preferred. You may need them in the future. Never take the notes yourself, you are going to be too busy to do that. Mark the notes confidential and do not give a copy to FDA. Also, make sure that you have a clear and explicit ‘no photography’ policy in place. Train your people and enforce it. FDA may want to take pictures and they will tell you that they have the right to do so. That is open to debate and the issue has yet to be resolved in court. In the meantime, your policy is clear, so insist that they do not take pictures. This is your plant and your proprietary process; even with the best care, your competitors might find out more than they should about what you do.
This rule applies everywhere in life, and especially during an FDA inspection. Gather all the information you can. Are they going to take samples? If so, you need to prepare for that. Ask for the purpose of the visit and any supporting information you can get. Seek to first meet the needs to the investigator and to understand the exact context of the inquiry. The better you understand the purpose, the easier the day will be. Just like the investigator, you have a boss. You have limits to what you can and cannot do. Make sure the FDA understands that you are the representative, but the answer may need to come from other sources. Company policies are not written by you and cannot be altered. You are both on the same side of the table and rules need to be followed. They will understand and respect that.
FSMA is a major reform of the U.S. food safety laws. It shifts the emphasis for food safety to preventing contamination during manufacture instead of just responding to it. As part of the implementation process, the FDA will enforce these new rules during routine random inspections at food manufacturing sites. With such a significant change in emphasis, Shawn K. Stevens of Food Industry Counsel LLC, released an FDA Inspection Checklist. The checklist is designed to help food and beverage manufacturers to prepare for an agency inspection and to ensure they have the required controls and checks in place. Before we look in more detail at the checklist, it is worth reviewing some of the underlying requirements.
One of the fundamental requirements of FSMA is the establishment of an environmental monitoring program at each facility. It defines the testing protocols for appropriate microorganisms and verifies that the preventative measures undertaken are effective. Clear procedures and systems are required to identify the test microorganisms most suited to the risks in their systems. They need procedures to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventative controls are effective. They also need to identify the timing and frequency for collecting and testing samples. The tests to be conducted must be specified, including the analytical methods used and the corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Just as importantly, all of the data associated with this testing program needs to both be recorded and accessible for audit purposes.
Any environmental monitoring program will come at a cost to the food manufacturer. While the program itself will need to be set up by experts in the field, much of the implementation can be carried out by lesser-qualified technicians. So a key aspect is having the tools to implement a program where the most effective use is made of each resource available, as this keeps costs down. In principle, one such tool is a Laboratory Information Management System (LIMS). The use of a LIMS is commonplace in QA Labs to record and monitor laboratory samples, tests and results in order to simplify and automate processes and procedures. There is a variety of ways in which a LIMS could facilitate the environmental monitoring process to enable best practice even by non-specialist staff. For example, analysis can be simplified if each set of test results can be automatically linked to respective sampling points in the facility. Out-of-specification test results could be linked to corrective and preventive actions (CAPA). Test failures at a particular sampling point could be used to trigger more frequent testing at that point according to pre-set criteria.
Perhaps most importantly, a properly configured LIMS can provide a suitable framework for set-up and adjustment by the environmental monitoring expert, while reducing the expertise required to operate it on a daily basis.
This comprehensive document highlights the steps that companies need to take to prepare for the inspection process, navigate the inspection itself and respond to any criticisms arising from the inspection.
There are three main areas in the checklist where a LIMS could help satisfy FSMA requirements:
FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an out-of-specification result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. This captures the actions that each quality improvement cycle needs in order to discover the likely root cause of any problems and how they may be avoided in the future.
All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”
The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.
While most LIMS in principle provide the capability to handle the requirements of environmental monitoring, the system will need to be configured to do so, and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs and much more. For many LIMS, full configuration for specific applications requires custom coding, which will require re-validation.
Once configured, LIMS can offer a practical way for food and beverage companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.
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.
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.
Every year, FDA conducts thousands of food safety inspections and issues approximately 2,500 Form 483s to food companies. When the FDA investigators complete their inspection, they use the Form 483 to list the violations about which they are most concerned. Sometimes, if the violations are serious enough, and the company does not provide an adequate written response, FDA will send a follow-up warning letter threatening to shut the company down. The information contained in the 483s and warning letters issued to companies can be a useful tool to predict what FDA investigators will be looking for when they visit your own facility.
To see what FDA has been up to, we took a close look at some higher-profile 483s and warning letters recently issued by the agency.
Shawn Stevens will lead the webinar, “Who’s Getting FDA Form 483s? Recent Issues You Can Learn From” on February 23, 2017 at 1 pm ET Just recently, FDA issued a warning letter to a raw cookie dough manufacturer, threatening to shutter the company. The inspection was extremely extensive and lasted a total of eight business days. During the inspection, FDA investigators collected more than 100 environmental samples and tested them for the presence of Listeria monocytogenes (Lm). Four of the samples, collected from a ladder, pallet jack and other non-food contact surfaces, were positive. The company also had a handful of recent positive Lm samples from its own in-house testing program. FDA insisted on access to the company’s own isolates and conducted whole genome sequencing on all the positive samples. The strains of the environmental samples matched, and FDA urged the company to recall all products produced over a four-month period. In the warning letter that followed, FDA warned the company that “it is essential to identify harborage sites in the food processing plant and equipment where [Lm] is able to grow and survive and take such corrective action as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.”
This pattern is reflective of FDA’s new investigational approach during routine inspections. During a similar inspection of SM Fish Corp. last summer, FDA collected and tested 105 environmental samples (many of them taken from Zone 3 and Zone 4 areas, which were far-removed from the production of food) for the presence of Lm. When 29 of the 105 environmental samples collected tested positive for Lm, the agency withdrew the company’s registration and urged a massive recall. FDA adopted this aggressive stance even though no food contact surfaces or finished products tested positive for Lm during the routine inspection.
More recently, while FDA was performing a routine inspection of the Sabra Dipping Company, LLC’s manufacturing facility in Colonial Heights, Virginia, the agency adopted a nearly identical approach. After performing extensive microbiological sampling within the facility, the agency confirmed that 27 samples of more than 100 collected tested positive for Lm. Although none of the samples were collected from food contact surfaces or finished products, the agency nevertheless urged the company to announce a recall of hummus products that it had shipped.
These are just a few examples highlighting the significant consequences that can result from any routine FDA inspection. FDA is moving increasingly closer toward a zero-tolerance attitude toward Lm in the processing environment, and companies should heed the message contained in these most recent 483s and warning letters. With some careful preparation, you can avoid the mistakes of others and increase the likelihood that your own FDA inspection will end with much better results.
FlexXray will be exhibiting at the 2016 Food Safety Consortium in Schaumburg, IL. At the booth representing FlexXray will be CEO Kevin Fritzmeyer and Project Manager John Hower. They will be discussing their food inspection process and capabilities of foreign material detection.
FlexXray is the leader in Inspection & Recovery Services dedicated to serving food companies. The company X-rays food products for various types of foreign material and contaminants, which it can see down to 0.8 mm or even smaller. Metal, plastic, gasket material, glass, stones and bone are a few of the items our customers ask us to inspect for.
FlexXray provides quick turn IN/OUT service, your truckload of product is inspected, contaminants removed and returned in only 8-12 hours. The company has introduced a new audit program for our customers to conform to the new HACCP and FSMA regulations. It is meant to help catch and prevent problems before recalls occur.
Our goal is to work with food companies to inspect their finished product for foreign material versus their other option, throwing it away. We strive to provide your company a cost-effective option in the event that you have an incident.
For more information, visit the FlexXray website.
Note: FSMA will include the scheduled compliance inspection as part of the implementation of rules. This will occur in the next several years for many food companies.
With FSMA rules moving to the compliance stage, food companies must prepare appropriately to best respond to the requirements and, correspondingly, to additional inspections. These inspections are in addition to others, including GFSI with its emphasis on unannounced level audits for some schemes. For example, these audits may be required by the code (as with SQF) or as part of customer arrangements per certification contracts.
Learn more about FSMA Inspection Readiness at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERWith the growing potential for inspections and audits, a well-planned program and response must be developed, implemented and tested to achieve a most successful outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources.
For companies experienced with past FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals (QI). The inspectors will look to focus heavily on new requirements and the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Food Safety Plan QIs, qualified audit resources and competent sanitation management, along with competent plant operators. It is critical to have established roles, planning and testing as part of any inspection readiness program.
The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to developing inspection readiness. To complete your own planning assessment, review your progress compared to the questions in Table I.
Companies must have the appropriate plans and resources to comply with FSMA and certifications or face possible violations that can include fines and penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider for Inspection readiness. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.
Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.
First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International. Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.
At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.
High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.
Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?
FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.
Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:
I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.
Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.
Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.
Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.
Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.
Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.
The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.
Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.
