Are Your Inspection Systems Talking to You?

They should be. Connectivity is the ability of your inspection systems and other production line equipment to communicate with your line’s operating system and with data collection systems that store production and inspection data. That capability not only speeds production by reducing changeover times, but also keeps data immediately available for your production line quality improvement reviews and to produce when the FDA conducts an inspection – something, by the way, that they have recently announced will be increasing in number in 2015.

When you evaluate new inspection equipment today, you should ensure that it supports connectivity, and that it can connect with a data collection system such as METTLER TOLEDO’s ProdX system, which can store data collected from multiple lines, and even multiple facilities, and make it immediately available when needed. Standardized reporting such as ProdX provides also meets the due diligence requirements required by your HACCP-based food safety plan, required by FSMA.

These systems allow multiple product inspection devices to be integrated into a central system that can be monitored from multiple locations. The user interface provides at-a-glance device status and health. As a result, operations managers can plan maintenance and/or repair interventions for times of lowest production activity, such as on weekends or during shift changes, to maintain maximum productivity, rather than responding to crises as they occur.

The ProdX dashboard, for example, enables management to receive in one central location critical early warning alerts about key situations affecting product quality, such as receipt of non-conforming raw materials from suppliers, serial automatic product rejections and machinery maintenance requests – all of which can have a significant impact on overall product quality standards.

These systems can carry out changes to product set-ups on multiple product inspection devices at one or more plant sites simultaneously, reducing reliance on multiple line operators. This both reduces the likelihood of unforeseen human error and lets management keep product data secure.

All levels of data and performance information are designed to be as transparent as possible. If any issues arise the ProdX program will immediately issue an alert.

Rejects and event monitoring screens and their associated reports further enhance production uptime. By receiving detailed information in real time, users can avert potential downtime events and product waste, manage production processes proactively and better utilize valuable maintenance and production personnel.

Such a sophisticated data collection and management system literally tells you what is going on in production on a regular basis, alerts when it foresees a problem, and keeps accurate and complete records to produce on demand when required by an FDA visit and to provide insight for your quality management team. Being automated, it never takes a break or vacation, and being an electronic system, it is reliable both for speed and accuracy, and relieves your human staff of the drudgery of collecting and storing data, letting them concentrate instead on analyzing the data and using it to improve the quality of your operation.

Written by: Robert Rogers
Senior Advisor for Food Safety and Regulations
METTLER TOLEDO Product Inspection

If Product Testing Revisions to FSMA Preventive Controls Rules Will Affect You, Speak Up

On September 19, in response to comments on its earlier proposed rules, the FDA updated the revised FSMA Preventive Controls rules and opened up another 75-day round of public comment. The deadlines for when the final rules will be published remain the same: Aug. 30, 2015, for preventive controls for human food and for animal food.

Will these revisions affect your operation? The revisions in general are generally what was expected and are consistent with what the FDA said it would change. But there are some exceptions. One of the most notable is the proposed revision to the preventive controls rule that would incorporate product testing, environmental monitoring and domestic supplier verification requirements in that final rule.

While this potential rule was mentioned in the preamble of the proposed rule, it was not included in the rules text. Even so, it provoked controversy. Now the FDA is providing an opportunity for input on specific language and seeking comment on whether to include it in the final rule.

The comments would address whether the preventive controls for human food should require a facility, where appropriate, to conduct product testing to verify implementation and effectiveness of preventive controls; to conduct environmental monitoring to verify implementation and effectiveness of preventive controls if an environmental pathogen is a significant hazard; and supplier verification when analysis identifies a significant hazard for a raw material or ingredient and that hazard is controlled before the facility receives the raw material from a supplier.

Significance
While these revisions are generally less burdensome, the product testing and supplier verification rules are likely to provoke negative comments. Each would involve additional cost in the form of new equipment, labor and potentially visits to each supplier to conduct verification.

If you will be one of the companies affected by the changes, now is your chance to comment and express your opinion about the burden versus the efficacy of product testing as a means to ensure food safety.

The FDA pointed out that previous comments had varied on the value of product testing, with some commenters denying its effectiveness as a preventive control, others accepting it and still others accepting product testing but not finished product testing. These varying opinions are why the FDA is opening a new period for further comment with respect to when and how product testing is an appropriate means of implementing FSMA, and whether it should be required by the final rule.

Similarly, in regard to environmental monitoring for potential pathogens, some commented earlier that the rule was too broad and included facilities were occurrence was unlikely, but there was general agreement that such monitoring was a valuable control where appropriate. Now the FDA is asking for comments on potential new requirements under which facilities could tailor their environmental monitoring programs based on risk.

New regulations now proposed affecting supplier verification reply to comments resisting broad application of such regulations to all facilities regardless of potential risk, while recognizing a general agreement that supplier verification is needed.



Written by: Robert Rogers
Senior Advisor for Food Safety and Regulations
METTLER TOLEDO Product Inspection

It Seems So Simple...

Every food product that is packaged––whether in glass, rigid plastic, paperboard carton or flexible pouch––is labeled, and that label lists––or should list––every ingredient in the product. The product manufacturer is aware of what goes into each product and is aware of the regulatory requirement to list every one of those ingredients.

It seems so simple: You know your ingredients; you list your ingredients. How likely is it for an error to occur? Yet the FDA reports that the most common cause of a food safety product recall is mislabeling: incomplete, incorrect or damaged labels––and the most frequent error is an unlisted allergen.

A large, well-respected food company with a global operation recently had to recall 41 tons of sausage because a commonly recognized allergen was not disclosed on the product’s label. That not only constitutes a large non-recoverable expense; it will also very likely deal a considerable blow to the company’s brand image. When consumers discover that a company has not been careful enough to disclose all of its ingredients, they begin to wonder if they can trust the quality of that company’s products.

How do errors happen?
As simple as labeling a package seems, the process involves several steps that offer opportunities for error. The list of ingredients that begins with a knowledgeable food chemist or technician may go through the hands of 3 or 4 people to be typed, typeset, proofread, etc. before it becomes a printed label. Each handoff offers the opportunity for a miscommunication.

Then at the last stage, on your packaging line, the product, package, closure and label all come together for the first time. Now there are opportunities for new errors. The label may go onto an unrelated package, or the front label and the back label may be separated and applied to different packages. The simple act of selecting and mounting the correct roll of labels onto the labeler is an opportunity for a mistake.

A reliable solution
Machine-based vision inspection systems inspect labels using cameras, comparing the ingredient list on the label with input entered directly into the inspection system software by your production department, eliminating the data passing through a number of hands. In addition, using codes assigned to each product and related label, the system confirms that label and product match. Using a Label Control Number (LCN) that is assigned to each label, it also confirms that the label being used is the most current version of that label, including up-to-date revisions.

While confirming that the label is being applied to the right product, the system also ensures that it is applied perfectly, with no wrinkles or flags hiding ingredients, and that it is positioned correctly. This protects not only against recalls but simultaneously ensures that the package projects a strong brand image.
With such a system in place, confirming that your labels are correct once again becomes simple.



Written by: Robert Rogers
Senior Advisor for Food Safety and Regulations
METTLER TOLEDO Product Inspection

Dietary Supplements Makers Should Prepare Now for Full FSMA

The Food Safety Modernization Act (FSMA), signed into law in January of 2011, places the responsibility for food safety squarely on food producers, with requirements that will come into force as all portions of the Act are finalized and implemented. From the beginning, dietary supplements were considered to be foods, and supplement makers were required to register with the U.S. Food and Drug Administration (FDA). However, Supplement makers were not then required to create and implement specific food safety control plans, as were general food manufacturing and processing companies.

Nevertheless, many supplement manufacturers have since been “waiting for the other shoe to drop” and for FSMA’s full regulations to apply to them. Few doubted that, inevitably, that day would come. 

FSMA will have enormous impact on the dietary supplement industry. The law gives FDA additional authority on recalls, which it has already used to recall some pre-workout supplements that were associated with cases of liver damage. FSMA also gives FDA enforcement tools to regulate the import of ingredients. 

The law will revolutionize how the supplements industry operates, as it has revolutionized the food industry, and each company should be educating itself now and preparing to meet those requirements, rather than waiting for them to come into full force.  

What is involved?

That preparation is not as awful as companies may imagine; In fact, it includes planning and preparations that most prudent managers are already considering. 

Under FSMA, registered companies will have to develop and maintain a written food safety plan. The FDA’s Rule for Preventive Controls for Human Food requires risk-based preventive controls based on hazard analysis described as being “similar” to the HACCP system, and including controls that may be required at points other than traditional Critical Control Points.

This broader approach means that, while the preventive controls are science- and risk-based, and required to prevent hazards to public health, they are also flexible enough so that firms can develop preventive controls that fit their specific operations––as long as they can significantly minimize or prevent all food safety hazards. 

Next, each company must maintain records of how these controls have worked in its operations, and produce those records on request from the FDA.

Fortunately for supplements makers, they are following in the steps of food companies that have spent three years meeting FSMA requirements. Metal detection inspection of products and vision inspection of labels that form an essential part of every Food Safety program will work as well for supplement makers as for meat packagers, and electronic data collection systems like the Mettler Toledo ProdX System that store and retrieve data instantly will keep that essential data ready for any inspection.

The proven tools for meeting FSMA’s requirements are already in place, but the time to implement them is now, not when the FDA is knocking on your door.

Written by: Robert Rogers

Senior Advisor for Food Safety and Regulations

METTLER TOLEDO Product Inspection

FSMA Extensions do not Reflect a Weakening Commitment

Since the Food Safety Modernization Act (FSMA) was signed into law in 2011, deadlines for publication of the rules governing food safety have been extended several times. Recently, in response to a suit by several consumer advocacy groups, the FDA has finalized those dates as follows:

• August 30, 2015 – Preventive control rules for human food and preventive

     control rules for animal feed

• October 31, 2015 – Produce safety standards, foreign supplier verification

     program, and accreditation of third party auditors

• March 31, 2016 – Sanitary transport of food and feed

• May 31, 2016 – Intentional adulteration of food

However, the FDA emphasizes that manufacturers, processors and packagers of foods, including pet foods and dietary supplements should not interpret these extensions as signaling a weakening of its commitment to the primary purpose of the FSMA law: to focus on the prevention of foodborne illnesses, rather than reacting to them after the fact. Some people within the industry have suggested that, with Washington focused on reducing expenditures, the FDA would not have the resources to adequately enforce FSMA. This can lead some food companies to believe they can risk continuing to operate as usual without risk of penalty.

That would be unwise. In addition to continuing to be committed to implementing FSMA, the FDA has also extended the reach of its oversight by encouraging food industry employees to report unsafe practices by their employers directly to the FDA, and by protecting those that do.

FSMA, in addition to giving the FDA the authority to detain a food or dietary supplement product if the agency has reason to believe it is adulterated or misbranded, also supports employees who blow the whistle on their employers’ unsafe food practices. FSMA provides protection for those whistleblowers, and on February 13, 2014, the Occupational Safety and Health Administration (OSHA) announced further support for those protections by publishing interim regulations entitled “Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act” that establish systems and time frames for filing, handling, investigating and ruling on FSMA-related retaliation complaints.

Under these Procedures, a company may not retaliate against, discipline or otherwise take an adverse action against an employee on the basis that the employee has provided information to the federal or state government about violations of FSMA, testified about those violations or refused to follow instructions that the employee believed would violate FSMA regulations.

Encouraging and protecting whistleblowers enables the FDA to extend its food safety oversight capability further, even in the face of threatened budget reductions. And, enlisting the help of personnel already on site within companies to report unsafe practices is much more efficient than using its own limited staff to keep tabs on the large number of companies registered under FSMA.

FSMA will be fully implemented and enforced. Those companies that gamble against that outcome are putting their brand image and even the future of their company at risk.

Written by: Robert Rogers Senior Advisor for Food Safety and Regulations METTLER TOLEDO Product Inspection

Keeping an (Electronic) Eye on Labels

According to research done by groups as diverse as the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) and the baking industry’s information center AIB International, the number one reason for food product recalls is mislabeling, and especially mislabeling that omits allergens. According to the FDA, in 2008-2009 mislabeling that failed to identify major food allergens accounted for 43% of recalls.

In other words, attention to detail in preparing label information, and thorough inspection to ensure that labels are accurate, complete and are placed on the correct package would enable food manufacturers to avoid almost half of all recalls.

Consumers today read labels more often and with more attention to detail as concern about allergens has increased, and they rely on the label’s accuracy in making their purchase decisions. For the manufacturer who omits an allergen from a label, the recall he faces may be the least of his worries. A lawsuit as the result of anaphylaxis caused by an undisclosed allergen and the resulting publicity can cause much more severe damage to a company and to its brand image. And restoring a tarnished brand image is a very long and difficult process.

Even when the “undisclosed” allergen is not the result of omitting it from the ingredient list, but is caused by a wrinkle in a label that obscures the ingredient, the result is equally damaging and still puts the manufacturer at risk.

Yet, when research shows that 43% of recalls are due to mislabeling, many manufacturers are obviously not taking full advantage of the existing systems that can help eliminate the problem.

           

The sharpest eye

The days of the human package inspector are long gone. The speed of production and the complexity of packages and especially of labels today has made them ineffective. Today’s defects, from low fill levels and cocked caps to missing codes, are detected by machine vision systems that inspect with 100% reliability in the blink of an eye, then contact downstream rejecters to remove the faulty package.

This same technology can identify mislabeled packaging with equal accuracy and speed. By comparing a camera-viewed label with a stored file, the system can easily catch a missing, skewed or wrinkled label and can ensure that all labels on a package match. When fully integrated into a facility’s management system and properly operated, a vision system can go even further toward ensuring proper labeling. When the line manager enters a product code into the line control system, the vision system accesses the stored parameters for that product, confirms that the listed ingredients are on the label and rejects those packages that do not conform.

Vision systems are cost-effective to operate and can usually be installed within or over a line without line reconfiguration. Given the impact of the risks associated with not thoroughly inspecting labels, the investment in this company  “life insurance” is well worth it.


Written by: Robert Rogers Senior Advisor for Food Safety and Regulations METTLER TOLEDO Product Inspection

Detection: Preventive Control of the “Other” Food Safety Challenge

The most publicized recalls of unsafe foods involve food-borne illnesses: salmonella, listeria, E. coli, C. perfringens, etc. caused by unsafe processing, storage or handling of foods. These are dangerous and frightening events–both for the public and the responsible companies that face damaging consequences–which is what leads to their being widely publicized.

Events that don’t make the evening television news but that can be equally damaging are the “other” food safety challenges: contamination by material inclusions such as metal, glass, plastic and bone that can cause serious injury if ingested, and labeling errors where the wrong label is applied to a package or labels carry incomplete or incorrect content listings.

While less dramatic and newsworthy, these events are also regulated by FSMA, and can cause equally serious injury, damage to the brand image of the responsible producer and can lead to costly personal injury lawsuits in addition to any penalties imposed by regulators.

The majority of contaminations take place during the processing of a food product. High-speed deboning of chicken, for example, can leave small bone fragments in the meat, small metal pieces can be separated from blades, screens and other metal processing equipment components and plastic bits can become detached from product handling equipment. Unless detected, these contaminants, often smaller than the human eye can easily see, will pass through processing and enter the marketplace.

Labeling errors, on the other hand, are primarily due to human error. The wrong incorrect label can be loaded onto a labeler on the packaging line, and occasionally a skewed label will wrinkle during application, causing an important ingredient to be obscured and unreadable.

According to the FDA, such labeling errors are the source of about 43% of product recalls.

Failing to disclose an allergen or other potentially harmful ingredient can lead to dire consequences both for the consumer who suffers from the result and the food processor who is responsible.

Detection as a preventive control

FSMA stresses prevention as the key to food safety assurance and requires written prevention plans and preventive controls that assure that foreseeable hazards are minimized or prevented. These rules apply to preventing contamination and label errors as well as to potential sources of foodborne illness. It is essential that you include controls that can detect and prevent these defects from entering the marketplace in your preventive plan.

Preventing in-process contamination events from happening is virtually impossible. High-speed operations by their very nature sacrifice precision for productivity; bone fragments will inevitably be left in boned meats and high speeds will inevitably cause equipment to wear and experience damage. Regular and thorough maintenance of equipment may reduce instances of metal and plastic contamination, but never eliminate them.

The best preventive controls that can adequately address these potential contamination and labeling challenges are X-ray and metal detection systems that detect physical contaminants––even minute fragments of bone, metal and plastic––and machine vision systems that detect skewed and wrinkled labels and compare labels with product codes to ensure proper labeling.

Written by: Robert Rogers Senior Advisor for Food Safety and Regulations METTLER TOLEDO Product Inspection