Tag Archives: inspection

Chris Keith, FlexXray
FST Soapbox

What Should I Do if I Have a Foreign Material Problem?

By Chris Keith
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Chris Keith, FlexXray

Imagine this: While cleaning a slicing machine during a sanitation break, one of your employees discovered a piece of harp wire was missing from the machine. The meat that had been sliced since the cutting machine’s last inspection had already been added to your product, and the product had been packaged. It had already passed through your company’s inline inspection machines without any foreign contaminants being detected.

You enjoy a spotless reputation in the food industry and know that if consumers lose faith in the product, it will suffer significant damage to both its reputation and its bottom line. So what do you do now?

Here’s a look at four different scenarios and how each one can affect a respected food manufacturer.

Option 1: Dispose of the Full Production Run

Disposing of a full production run will give your company complete confidence that the contaminant issue is resolved and will never reach the public. However, you have to take into consideration the full cost and implications of such a move, such as:

Where to dispose of the contaminated product. The FDA has specific rules about disposing of contaminated food products, but those guidelines can be affected by local, state and even federal regulations. Among the disposal options are landfills, rendering or incineration. You must find the proper facility, arrange the safe transportation of the product and procure all the required permits for the disposal.

Food waste. With 40% of the food produced in the United States going to waste, and 50 million Americans not knowing where their next meal will come from, you don’t want to add to the problem.

Product out of stock. Having your product out of stock will be costly. In addition to the lost sales, there’s a chance that consumers will turn to another brand—and not return to buying your product.

Cost of reproduction. To re-run the entire product line, you will essentially double your costs. You will have to pay for the cost of the products used, as well as pay for new packaging and all labor costs.

Option 2: Rework the Product In-House

You can use your own resources and inline equipment to try and troubleshoot the problem. Running the product through the metal detector to look for the harp wire could salvage most of the product, and would give your company the ability to supervise the entire process. That way, if you find the metal, you’d know firsthand that the contaminated product is out of production and won’t reach consumers.

But there are some expensive downsides to this approach. Among the factors that your company must consider are:

Loss of productivity. Both from the standpoint of equipment utilization and the productivity of employees, reworking the product would be costly to the company. You would have to have to slow the production line and manually re-run all the product through the metal detector to look for the missing wire.

Increased labor costs. You would have to pay overtime to your employees and keep your standard production line running while it re-runs the product and looks for the suspected contamination.

Limitations of their inspection equipment. Your results are only as good as the equipment you are using, and there’s always a risk that the metal detector that missed it the first time won’t find it the second time, either.

It seems like a bit of a gamble; if the metal detector catches it the second time around, then it could be worth it. If the product is re-run and no contaminants are found, however, your company is back where it started and must decide how to move forward.

Option 3: Risk It and Ship the Product to Retailers

Since the metal wasn’t detected by the company’s inline inspection system, you cannot be absolutely sure the metal is in the product. You only know that a broken piece of harp wire is missing; it’s unclear whether that wire made it into the food.

The least expensive option—but also the riskiest—is to go ahead and ship the product, hoping that the missing wire didn’t make it into the food and, therefore, never gets discovered by consumers.

There’s a chance that the metal detector was right, the wire isn’t in the food, and things will be fine. However, if the risky gamble doesn’t go in your favor, the consequences could be severe and this becomes the most expensive option of all. Among the risks the company faces are the following.

Costly recall. Food recalls are always expensive. According to a study from the Food Marketing Institute and the Grocery Manufacturers Association, the average recall runs up a $10 million tab in direct costs alone.

This includes the cost of notifying the supply chain and consumers, retrieving the product, storage, disposal and additional labor costs associated with having to perform all of these actions.

Possible litigation. Food recalls often are accompanied by lawsuits, and if the metal wire is eaten by a customer and causes injury, you could be held liable for everything from medical bills to time lost from work due to pain and suffering.

Bad publicity and lost sales. In today’s 24/7 news world and with the power of social networking, news of a food recall can reach consumers at lightning speed. This equates directly to lost sales and can have a negative impact on your brand reputation and market value.

A recent Harris Interactive Poll found that 55% of consumers would switch brands temporarily after a recall, and 15% would never buy the product again. What’s more, 21% said they would avoid buying any other products made by that manufacturer.

Option 4: Use an X-ray Inspection Service

A fourth option can help avoid lawsuits, recalls and bad publicity, while at the same time sidestepping unnecessary waste and the costs associated with disposing of an entire production run or reworking it internally.

You can have your product shipped to an X-ray inspection facility, or use an X-ray inspection rental service.

A contaminant removal service and professional catalog reporting with full traceability could also ensure that the specific contaminant was located and removed, and you would have the confidence that the problem had been resolved as the product reached consumers. There are several other advantages to using a company that offers this type of solution as well, including:

Reduced waste. Because the only product being thrown away would be the product that was contaminated, there would be minimal waste. This is the only option that allows you to recover the rest of the product, with the certainty that it has been inspected and is safe for its customers.

Advanced detection capabilities. You can be confident in inspection process using custom technology that enables the detection of foreign particles down to 0.8 mm or smaller. In addition to metal, such systems can also detect product clumps, glass particles, stones, bone, rubber, plastic, wood, gasket materials, container defects and missing components.

This type of solution far exceeds the capabilities of inline inspection machines, and, because it can run a single pallet an hour, instead of the average 10,000 pounds an hour, and thus it spends more time focusing on what is passing through the machine to ensure no contaminants pass through.

Final Thoughts

When it comes to the quality of your product, it’s better not to take any chances. When you put your product line in the hands of a third-party X-ray food inspection company, you know you will get results since food safety is our specialty — and it’s what they do, all day, every day.

X-ray systems

Production and Inspection: What to Do When Contamination Occurs

By Chris Keith
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X-ray systems

As much as food manufacturers take precautions to avoid all types of contaminants, there can still come a moment when you realize that your best efforts have failed. Maybe you find a broken blade or a missing wire during a sanitation break, but the product has already gone through your inline inspection machines—and nothing was detected.

This is the freak-out moment that no plant manager or quality assurance manager wants to have. Knowing that there’s possible contamination of your food product (and not knowing where that contaminant might be) creates a hailstorm of possibilities that your plant works hard to avoid. And you’re probably wondering how this could have happened in the first place.

X-ray systems
In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.

Understanding How Contaminants Get Past Detection

To prevent physical contamination from occurring, it’s important to understand the reasons why it happens. In-house inspection systems often fail to detect contaminants for the following reasons:

  • The equipment isn’t calibrated to detect contaminants to a small enough degree, or the contaminants are materials that aren’t easily detected by the in-house machinery (glass, rubber, plastic, etc.)
  • The machines aren’t constantly monitored
  • The speed of the production line doesn’t allow for detecting small particles

Metal detectors are the most commonly used inline inspection devices in food manufacturing, and they depend on an interference in the signal to indicate there is metal contamination in the product.
Despite the fact that technology has progressed to deliver fewer false positives, the machines can still be deceived by moisture, high salt contents and dense products that could provide interference in the signal. When that continues to occur, it’s common for manufacturers to recalibrate the machine to get fewer false positives—but that also decreases its effectiveness.

Another limitation of the metal detector is that, as the name indicates, it can only find metal. That means contaminants like plastic, glass, rubber and bone won’t be found through a metal detector, but will hopefully be discovered through some other means before the product is shipped out.

Oftentimes, contamination or suspected physical contamination is discovered when a product, such as cheese or yogurt, goes through a filtration system, or when a piece of machinery is inspected during a sanitation break.
If the machinery is found to be missing a part, such as a bolt or a rubber gasket, the manufacturer then has to backtrack to the machinery’s last inspection and determine how much, if any, of the product manufactured during that time has been contaminated.

X-ray inspection
X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. In this image, you can see foreign material detected in canned goods.

What To Do When Contamination Occurs

Once a food manufacturer discovers that it may have a physical contamination problem, it must make a decision on how to handle the situation. Options come down to four basic choices, each of which comes with its own risks and benefits.

Option 1: Dispose of the full production run

The one advantage of disposing of a full production run is that it entirely eliminates the possibility of the contaminated product reaching consumers.

However, this is an expensive solution, as the manufacturer has to pay for the cost of disposal in a certified landfill and absorbs the cost of packaging, labor and ingredients. It also presents the risk of lost revenue by having a product temporarily out of stock.

Option 2: Shut down your production lines for re-inspection/re-work

Running the product through inline inspections a second time may result in finding the physical contaminant, but there’s also a risk that the contaminant won’t be found—and now the company has lost money through overtime pay and lost productivity.

If the inspection equipment was not sensitive enough to find the contaminant the first time around, it may not find it the second time, which puts the manufacturer back at square one. The advantage to this method is that the manufacturer maintains complete accountability and control over the process, although it may not yield the desired results.

Option 3: Risk it and ship the product to retailers

There’s always a chance that a missing bolt didn’t make its way into the product. Sometimes, if a metal detector goes off and the manufacturer can’t find any contaminants upon closer examination, they will choose to ship the product and take their chances.

The advantage for them is that, on the front end, this is the least expensive option—or it could be the costliest choice of all if a consumer finds a physical contaminant in their food. In fact, the average cost of a food recall is estimated at $10 million; lawsuits may push that cost even higher and result in a business being closed for good.

Option 4: Use third-party X-ray inspection

X-ray inspection is the most effective way to find physical contaminants. In addition to metal, X-ray systems can find glass, plastic, stone, bone, rubber/gasket material, product clumps, container defects, wood and missing components at 0.8 mm or smaller.

When a food manufacturer has a contamination issue, it can have the bracketed product inspected by a third-party X-ray inspection company and only dispose the affected food, allowing the rest of the product to be distributed. This option allows the manufacturer to maintain inventory and keep food deliveries on schedule while still eliminating the problem of contamination.

X-ray inspection can find what other forms of inspection cannot, because it’s based on the density of the product, as well as the density of the physical contaminant. When X-ray beams are directed through a food product, the rays lose some of their energy, but will lose even more energy in areas that have a physical contaminant. So when those images are interpreted on a monitor, the areas that have a physical contaminant in them will show up as a darker shade of gray.
This allows the workers monitoring machines to immediately identify any foreign particles that are in the food, regardless of the type of material.

Detection is Key to Avoiding Contamination Issues

Handling contamination properly is vital to every food manufacturing company. It affects the bottom line and the future of the company, and just one case of a physical contaminant reaching the consumer is enough to sideline food companies of any size. As X-ray technology continues to evolve, it remains an effective and efficient form of food inspection.

Educating plant managers and quality managers on what to do if inline inspection machines fail to detect contaminants should include information on how X-ray technology can be a food company’s first line of defense. While physical contaminants can’t always be avoided, they can be detected—and the future of your company may depend on it.

Aaron Biros, Melanie Neumann, Food Safety Consortium

In Today’s Risky World, Verifying Suppliers a Must

By Food Safety Tech Staff
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Aaron Biros, Melanie Neumann, Food Safety Consortium

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 Risk 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.

FDA

FDA Issues Draft Guidance on Inspection Refusal for Foreign Food Facilities

By Food Safety Tech Staff
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FDA

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.

Bryan Armentrout, Food Leadership Group
FST Soapbox

Tips on Handling an FDA Audit

By Bryan Armentrout
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Bryan Armentrout, Food Leadership Group

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.

Tips for an FDA Inspection

  1. You are guilty until proven innocent
  2. You are not alone
  3. You are the company spokesperson
  4. Take lots of notes
  5. Seek first to understand, then to be understood
  6. Answer the question being asked
  7. Know what is in scope and what is out of scope
  8. Don’t sign or initial anything

1. You are guilty until proven innocent

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.

2. You are not alone

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.

3. You are the company spokesperson

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).

4. Take lots of notes

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.

5. Seek First to Understand, then to be Understood

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.

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Tim Daniels, Autoscribe Informatics
In the Food Lab

Using LIMS to Get In Shape for FDA’s Visit

By Tim Daniels
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Tim Daniels, Autoscribe Informatics

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.

Some Basic 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.

Acquiring and Managing Environmental Monitoring Data

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.

  • The data management capabilities within a LIMS make it possible to:
  • Implement data management strategies that increase security and availability of data
  • Eliminate manual assembly of data for analysis and audit
  • Make data more useful with easy retrieval/visibility

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.

Laboratory Information Management Systems
The Matrix Gemini Environmental monitoring solution is an example of an information management system that uses the capabilities of a LIMS to record and monitor laboratory samples, tests and results to simplify and automate environmental monitoring in QA Labs. Image courtesy of Autoscribe Informatics

FDA Inspection Checklist

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:

  1. Finalizing written food safety systems and making sure certain employees know the plans. LIMS provides the framework to set up documented food safety sampling requirements and track microbial test results over time. This facilitates recall and more detailed investigation should a sample fail.
  2. Well organized and maintained data, and ease of records access. LIMS should be capable of date and time stamping every entry and since it will contain all the test data over time, this can be easily recalled should the need arise. Typically a standard operating procedure would be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. LIMS can provide a full audit trail for all test data and produce reports showing result trends over time, highlighting variance and peaks in data.
  3. Proper documentation of corrective actions. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, although up to two years’ worth of data could be requested. LIMS should allow data to be instantly pulled from the database as a report for further investigation.

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.

Configuring a LIMS for Environmental Monitoring

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.

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.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Learning from Recent FDA 483s and Warning Letters

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

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.

Inspection and Recovery Services

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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.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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Post-FSMA Food Safety Inspection: Are You Ready?

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

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.

Self-Diagnostic Assessment Tool

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.

FSMA Inspection checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of inspection readiness and preparedness for FSMA compliance.

Get Compliance-Ready

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.