Category Archives: Blog

How is HARPC Different From HACCP?

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and the similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

HACCP HARPC
(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

HARPC covers food safety concerns beyond Critical Control Points and is mandated by the FDA for most facilities, with some exemptions. Instead of only looking at process steps where controls can be applied (as in HACCP plans), HARPC relies on the applicable FDA regulations, standards, and guidance documents to develop a Preventive Controls Plan.

How HACCP Works

HACCP is a globally recognized risk-based preventative approach recommended by the Codex Alimentarius Commission (or the ‘Food Code’) and the National Advisory Committee on Microbiological Criteria for Foods. It commonly focuses on controlling the three main food safety hazards: biological, chemical, and physical. The primary goals (in order of priority) are to prevent occurrences of the hazard, or eliminate, or reduce the food safety hazard to acceptable or safe levels.

 The HACCP plans are developed, implemented, and maintained by a multi-disciplinary team and the entire process is facilitated by a HACCP Coordinator, a person who is sufficiently knowledgeable and skilled in food safety concepts and principles and has undertaken a training program that has preferably been accredited by the International HACCP Alliance. The responsible person must review the HACCP plan at least annually, or whenever there are significant changes in food safety design layout, processes, product composition, or technology.

 The HACCP program is legally mandated for meat and poultry establishments (under USDA jurisdiction) and juice and seafood processing establishments (under FDA’s jurisdiction). Even though the HACCP program for several food establishments may be voluntary (unless specified by regulations, industrial standards, or by customers), it does not absolve a facility from implementing Current Good Manufacturing Practices (as provided in the 21 CFR 110 legal document) and other relevant pre-requisite program requirements necessary to maintain the safety and legality of the food products. In the Food Code, prior to HACCP recommendation, there are General Principles of Food Hygiene (provided in 10 sections) that have to be followed. Auditors, inspectors, customers, and other stakeholders may inspect the HACCP or food safety plan.

12 Steps of HACCP:

  • Assemble the multidisciplinary HACCP team
  • Describe the product
  • Identify its intended use
  • Construct a flow diagram
  • Conduct on-site confirmation of the flow diagram, and draw up the plant schematic
  • List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (Principle 1)
  • Determine Critical Control Limits (Principle 2)
  • Establish Critical Limits for each CCP (Principle 3)
  • Establish a monitoring system for each CCP (Principle 4)
  • Establish corrective actions (Principle 5)
  • Establish verification procedures (Principle 6)
  • Establish documentation and record-keeping (Principle 7)

How HARPC Works

In brief, this preventive control system mandated by FDA’s FSMA Act is to be implemented by all food establishments unless specifically exempted. Thus, it applies to food facilities in the U.S. that manufacture, process, pack, distribute, receive, hold, or import food, and for those firms exporting foodstuff to the US. The FDA has issued implementation deadlines for each of the different facility types (kindly refer to updated guidelines on the FDA site, www.fda.gov). Within a HARPC plan, the food safety hazards assessment is broader; generally, the following risks are considered:

  • Biological, physical, chemical, and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposed material, parasites, allergens, and unapproved food and color additives
  • Naturally occurring hazards
  • Unintentionally introduced hazards
  • Intentionally introduced hazards, including acts of terrorism

Preventive controls are science-based and shall be adequate to significantly minimize or prevent identified hazards “known or reasonably foreseeable” for each type of food subject to the relevant FDA regulation. The HARPC plan is developed, implemented, and maintained by a team of “preventive controls qualified individuals” as defined in the FSMA act, who have been trained or are sufficiently conversant with the FDA FSMA Final Rule for Preventive Controls for Human Food, and any other relevant rulemakings, such as the Final Rules on Animal Food, Produce Safety or Foreign Supplier Verification Program etc. (for more information, refer to the FDA site, www.fda.gov).  The responsible person must review the HARPC plan at least one every 3 years (if no significant changes occur in the plan) or whenever there is a significant change at the facility that might increase a known hazard or introduce a new one.

7 Steps of HARPC

  1. Assess the hazards—This includes the normal product-specific hazards, along with a broad range of other hazards (listed above) and facility-specific concerns such as food defense and emergency management issues.
  2. Institute Preventive Controls—These include sanitation procedures for food contact points, staff hygiene training, environment monitoring, supplier verification, and more.
  3. Monitor effectiveness of the controls—Not all controls are measurable by critical limit numbers, but these Preventive Controls can be evaluated on a routine basis.
  4. Establish corrective action measures—Recall plans may not seem preventive, but the critical steps between knowing something is wrong with a product and keeping it away from consumers’ hands should involve identifying and correcting the weak spots within the controls. The objective is to prevent occurrences of unsafe and non-conforming food product.
  5. Establish verification measures—The process of verification ensures that the facility is effectively meeting its food safety standards on a consistent basis.
  6. Follow proper and required recordkeeping—As with any FDA ruling, nothing is properly done until it’s recorded.
  7. Reanalyze the plan once every 3 years, or when needed—When changes in process or product happen, HARPC plans should be reevaluated.

Recap of Some Key Differences:

Hazard Analysis Method

The three conventional types of hazards that are addressed in the HACCP plans—physical, chemical, and biological—are accompanied by many more concerns in HARPC plans.

Radiation, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, unapproved food or color additives, naturally occurring hazards, and intentionally and unintentionally introduced hazards round out the list of HARPC-related hazards.

Critical Control Points Versus Preventive Controls

Critical Control Points during process steps are central to HACCP. Each control point must include measurable critical limits—the temperature and length of time a sauce must be held at, for example, as a kill step. The objective of each control step is either to prevent, eliminate, or reduce food safety hazards to a safe and acceptable level. Food safety measures that aren’t specific to the process, such as personnel hygiene, are covered under Standard Operating Procedures (SOPs).

HARPC focuses on Preventive Controls that are science- or risk-based, and should be adequate to “significantly minimize or prevent” known or foreseeable hazards for each type of food subject to the federal regulations.

 

To learn more about HACCP, download our whitepaper, “HACCP Planning for Food Safety,” or contact our knowledgeable customer service representatives at cs@remcoproducts.com or at 317.876.9856. Contact us today to schedule a complementary on-site consultation regarding HACCP and HARPC plans.

To view more information about this and other sanitation topics, visit http://www.remcoproducts.com/knowledge-center.

 

SELECTED REFERENCES:

Food and Drug Administration. (2015). FSMA final rule for preventive controls for human food.

Joint FAO/WHO Codex Alimentarius Commission, Joint FAO/WHO Food Standards Programme, & World Health Organization. (2003). Codex Alimentarius: Food hygiene, basic texts. Food & Agriculture Org.

US Food and Drug Administration. (2011). Food safety modernization act (FSMA). Public Law, 2011, 111-353.

Website: www.fda.gov

 

Common Food Industry Cleaning Problems Solved

The goal of any good sanitation plan is to minimize cross-contamination and cross-contact through better hygiene and cleaning practices. But—what happens when workers can’t feasibly reach that tall ceiling fixture or get a brush to follow the curves of a spiraling pipe? If employees don’t have the right tools for the job, they’ll end up improvising sub-par solutions, or—even worse—they just won’t clean that area.

Here are some examples of specialty tools solving common cleaning problems in food processing plants:

High walls

Standard handles just aren’t going to reach all the way up a factory’s walls. Use a telescopic handle to clean walls top-to-bottom. Because they’ll need to be adjusted many times, handles should be easy to extend and shorten. Ideally, they should also be hollow to minimize weight for worker comfort and to make the handles easier to control at longer lengths.

Ceiling and pipe condensation

Sometimes handled by makeshift tools like a sock on a telescopic pole, cleaning condensation is vital to food safety and deserves its own tool. Condensation dripping into food or processing equipment can lead to microbial cross-contamination and a costly recall. Use a condensation squeegee to prevent drops from forming and falling into products. A condensation squeegee catches and drains water from overhead into either tubing or bottles to keep products safe.

Large tanks

Specially designed tank brushes have curved heads to reach every angle. When combined with an easy-to-use telescopic handle, workers can reach to clean the tops, sides, and bottoms of tanks, all without having to pull out a cumbersome ladder.

Long pipes

Pipe brushes need to be the right diameter to reach the interior walls, but they also have to be the right length to reach through the pipe, or debris will build up just out of reach. Remco offers pipe brushes on stainless steel handles that can be lengthened again and again with 30-inch extenders to reach through the longest pipes.

Curved or helical pipes

Stainless steel handles are flexible, but only to a degree. For truly helical pipes, a nylon handle will follow all of its curves while being strong enough to get the pipe walls clean. Nylon is FDA-approved for food contact and can follow through even the most spiraling pipes.

Overhead pipes

Condensation isn’t the only worry when it comes to overhead pipes. These surfaces are often repositories for dirt and contaminants since workers have a hard time reaching around and over them to clean. Use an overhead adjustable-neck brush to get them clean. The brush should have a flexible head to reach over and on the side of pipes. An adjustable neck will allow workers to reach pipes at any angle. Combined with a telescopic handle, an overhead brush is especially useful for reaching high pipes.

Machinery with blades

Though ideally most bladed machinery like bowl cutters are disassembled for cleaning, often this isn’t the case. A brush with a hand guard to help protect workers allows dangerous machinery to be cleaned in place more frequently.

Cross-contamination and allergen cross-contact can both be prevented by better hygiene practices. When you’re able to fully clean your facility, you’re able to control the spread of contaminants. These tools can help solve your common cleaning problems.

 

5S in the Food Industry

Sort, straighten, shine, standardize, and sustain. These five principles comprise the 5S lean manufacturing method that originated in Japan. While 5S can help any organization, the principles contained in the alliterative method should especially appeal to those in food processing for its ability to promote food safety through a clean, safe, and organized workplace.

5S principles are based on the idea that a well organized and clean workplace increases employee satisfaction, promotes worker safety, and decreases product waste. 5S relies on everything having its own place that’s easily identifiable. Like color-coding, 5S uses the idea of a “visual factory” that lets workers know at a glance where tools are and where they should be put back after they’re cleaning.

Sort

For the sort step, work areas should be cleared of things that aren’t needed daily. Discard junk that’s broken or simply not needed, along with broken tools. Items that are needed, but only on an infrequent basis, should be moved to storage. If an item is misplaced or stored illogically, it should be moved to a more convenient location.

Sorting can help minimize chances of cross-contamination and cross-contact by sorting food-contact and non-food-contact items apart from each other.

Set in Order

To set a processing plant in order, it’s important to remember the goal is to increase efficiency in the work environment. This makes it easy for the employee to find the right tool at the right time, thus minimizing chances cross-contamination between raw and finished product. Items should be organized logically, with like items together. Color-coding can be introduced to keep food-contact and non-food-contact items in separate zones and to keep allergens apart where needed. Shadow boards can be used to give every tool a place.

Shine

Tools, machinery and the work area itself should be cleaned as a part of the shine step, which should be repeated as frequently as necessary. Regular cleaning prevents biofilm build-up and increases the facility’s overall hygiene. Factories that deal with particularly sensitive material such as meat or ready-to-eat foods should consider using hygienically designed tools, which are easier to thoroughly clean and sanitize, than standard tools.

Standardize

To standardize, you must first observe the natural flow of workers’ movements. Before writing procedures, watch employees to see where they have consistent methods that work. Take notes on what works, and problem-solve with workers to find solutions to inconsistent and inefficient steps in the process. When you write Standard Operating Procedures or SOPs, consult with employees again on how the entire process should work. The process should feel natural to workers and not be forced. Come up with a training program for new employees, and refresh current employees on the procedures at least yearly, or when there are changes.

Sustain

There are generally three different methods to sustain 5s improvements:

  1. Daily checks

Supervisors should be on the floor and check to make sure procedures are followed daily and to help employees with any process problems.

  1. Periodic checks

Using a 5S checklist, supervisors can perform quarterly or monthly checks to make sure 5S is being followed. They can find and address any problems in these checks.

  1. Change-only checks

Supervisors can check to make sure 5S is being followed only when a process change is being implemented. They can revisit SOPs to integrate the change and to make sure it’s working well for employees.

 

Implementing 5S can help food processing facilities increase hygiene in their organization, as well as increasing their efficiency.

FDA Inspection Checklist

Remco Products presents Food Industry Counsel’s FDA Inspection Checklist as a part of our commitment to bringing our audience the best information in the food industry. We don’t endorse any legal services or provide legal advice. For legal services or advice, please consult your attorney.  You can also contact Shawn Stevens, the author of this post, at stevens@foodindustrycounsel.com.

What to do Before, During and After Your Next FDA Inspection

Food Industry Counsel, LLC is pleased to provide you with the most comprehensive and useful FDA Inspection Checklist available. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) was given the mission of overhauling the safety of the nation’s food supply. The new FSMA regulations written by FDA are now coming into effect, and the agency is now aggressively enforcing its new rules during routine inspections. Within the coming years, FDA Investigators will conduct an onsite inspection of every food facility in the U.S.

Here are FDA’s new enforcement priorities during routine unannounced inspections:

(1) To carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements;

(2) To conduct extensive Zone 1, Zone 2, Zone 3 and Zone 4 microbiological sampling inside all food facilities to find evidence of pathogenic contamination;

(3) To require recalls if the percentage of FDA samples testing positive for Listeria Monocytogenes, Salmonella or other pathogens exceeds FDA thresholds;

(4) To compare the DNA fingerprints of any pathogens found in the facility against the >1,000,000 human isolates stored in the CDC’s PulseNet database to identify any matches, and then require food product recalls if any matches are found; and

(5) To initiate broader investigations, including criminal investigations, against food companies whose products are found to have caused human illness. Against this backdrop, all companies should begin taking steps to prepare for their next FDA inspection.

Companies can use the following checklists to ensure that they have completed the needed preparations before the FDA Investigators arrive, to help effectively navigate the inspection process once the inspection is underway, and to appropriately respond to any FDA criticisms once the FDA inspection concludes.

PREPARING IN ADVANCE FOR YOUR NEXT FDA INSPECTION

PRE-INSPECTION CHECKLIST

Much of the work needed to ensure that the FDA inspection ends successfully should be completed long before the FDA Investigators arrive. All companies should begin work immediately to ensure that they have accomplished the following critical tasks:

□ Identify a Meeting Space: Identify a space within the facility to host the FDA investigators when they arrive. This might be a conference room or a vacant office with sufficient desk space to review large amounts of records. The space selected, however, should be free of any records (in binders, boxes or on computers) which FDA Investigators could access, unsupervised, while they occupy the space.

□ Assign Designated Individuals: Assign a primary and secondary Designated Individual (DI) for each facility to serve as the liaison with the FDA Investigators once they arrive. DIs should coordinate vacation time (and time off) to ensure that one DI will always be available in the event FDA arrives.

□ Complete PCQI Training: Ensure that the primary DI has received FDA’s Preventive Control Qualified Individual (PCQI) Training. Although the training is not required under FDA regulations to become a Qualified Individual, FDA Investigators will typically expect the training to be completed by at least one facility employee.

□ Finalize Written Food Safety Systems: Ensure that the company’s written food safety systems are finalized, and the primary and secondary DIs are familiar with each of the elements of the plans. Depending upon the size of the business and the nature of the products, this could include GMPs, Sanitation Programs, Preventive Control Plan, Recall Plan, Environmental Monitoring Program, Foreign Supplier Verification Plan, Sanitary Transportation Plan, Food Defense Plan, and Produce Safety Plan.

□ Ensure Ease of Records Access: Ensure that the supporting records for each of the programs are organized and maintained in such a way that the DI can immediately retrieve the past three months of records for FDA review. Although FDA requires the majority of these records to be maintained for at least two years, the FDA investigators will typically ask only to review records for the preceding three months.

□ Document Corrective Actions Properly: Ensure that, in the event there is a deviation, you are documenting all corrective actions correctly. 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.”

□ Upgrade Sanitation Flashlights: This may seem obvious, but many facilities are still using flashlights are severely underpowered or outdated. Be sure to equip your sanitation employees with the same high-power flashlights that the FDA Investigators will use so that your employees will be able to see (and then clean) what the FDA would observe with its own flashlights when it arrives.

□ Review Allergen Controls: FDA is requiring companies to recall vast amounts of products if the FDA Investigators find, during their visual inspection, that the companies’ allergen controls are not adequate. Make sure that your ingredient labels are accurate, and that opportunities for cross-contact are being guarded against and avoided.

□ Conduct Environmental Monitoring: If your company processes readyto-eat food products that are exposed to the environment prior to packaging, FDA will require you to have an environmental monitoring program. Ensure that an appropriate program is developed and implemented before FDA arrives.

□ Conduct More Environmental Sampling: Because FDA will collect between 100 and 200 microbiological samples from your facility, it is critical to know exactly what FDA will find before it arrives. Thus, you should “Play FDA for a Day,” and conduct your own FDA-style facility swabbing, to identify and immediately correct any hidden problems. If done correctly, and if your swabbing and testing plan is developed with the assistance of legal counsel, the final testing results can be kept confidential.

□ Develop a Microbiological Sample Retain Policy: If, after reporting your testing results, your lab retains your isolates or testing materials indefinitely, create a policy requiring the lab to discard all testing material within 24 hours after testing. This is appropriate as long as the records of the final results are maintained.

□ Develop a Companion Sample Policy: When FDA collects food product or environmental samples, some companies elect to collect companion samples at the same time. Although we typically counsel against this practice, if you choose to collect companion samples, make sure to have a policy in place governing exactly how those samples will be handled, tested and/or discarded following collection.

□ Develop a “No Photographs” Policy: In many cases, FDA Investigators will insist on taking photographs while inspecting the processing environment. If you have a corporate policy which prevents visitors from taking photographs, you may be able to use the policy to prevent FDA from taking pictures.

□ Develop a “Do Not Sign” Policy: Sometimes, during an FDA inspection, the FDA Investigators will insist that a company representative sign a statement or affidavit. You have no legal obligation to do so. Develop a policy that states you will neither sign nor acknowledge any written statements presented by FDA Investigators.

□ Identify an Appropriate “On Call” FDA Lawyer: Long before your next FDA inspection, you should add an FDA lawyer familiar with the Inspection process to the company’s emergency contact list who can be notified and remain “on call” once the inspection begins. This person can serve as a useful resource to help quickly answer any difficult regulatory or investigator-related questions that arise during the inspection.

□ Conduct a Mock FDA Inspection: One of the best ways to prepare for a visit from FDA is to conduct a mock inspection. FDA consultants and/or lawyers can visit your facility and play the role of the FDA 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.

MANAGING THE ACTUAL FDA INSPECTION

INSPECTION CHECKLIST

When the day comes, the FDA Investigators will arrive unannounced. The FDA Investigators will present their credentials and ask to conduct an entrance meeting. During this meeting, the FDA Investigators will detail how they plan to conduct the inspection, how long the anticipate the inspection will last, and the specific tasks they intend to accomplish. These tasks will typically include the following:

(1) a facility inspection, during which the FDA Investigators will tour and carefully inspect the processing and other areas of the facility;

(2) a records review, during which the FDA Investigators will carefully scrutinize the company’s written food safety programs, and at least three months of monitoring and verification records; and

(3) a swab-a-thon, during which the FDA investigators will collect approximately 100 to 200 microbiological samples from: (a) incoming ingredients; (b) outgoing finished products, and (c) Zone 1, Zone 2, Zone 3 and Zone 4 environments.

The entire inspection process will usually take a few days and, in some cases, can last weeks. Once the inspection begins, use the following checklist to help appropriately navigate the inspection process.

□ Attempt to Negotiate the Areas Being Sampled: During the entrance meeting, the FDA Investigators will typically disclose the types of ingredients, products and/or environmental areas they intend to sample. Attempt to negotiate with the agency to limit the amounts, types or overall focus of the sampling in such a way that, if any results are positive, you can limit to the greatest extent possible the scope of any recall.

□ Carefully Document the Areas Being Sampled by FDA: While the FDA Investigators are conducting their sampling, be sure to carefully document the exact areas from which the FDA Investigators are collecting their samples. In addition, be sure to appropriately characterize the areas being sampled by the agency as Zone 1, Zone 2, Zone 3, or Zone 4. This information will be critical in the event that any samples are positive to determine the most appropriate response.

□ Carefully Consider Whether to Collect “Companion Samples”: In some instances when a company collects companion samples, the samples that the FDA collects test negative while the companion samples test positive. Because taking companion samples doubles the chances that a positive will be found (whether because of the presence of actual contamination or lab error) we generally do not recommend taking companion samples. With that said, be sure to consult with legal counsel because there may be some limited circumstances where companion sampling would be advisable.

□ Hold any Product that FDA Samples: In the event FDA collects finished product samples to test for the presence of Listeria Monocytogenes, Salmonella or any other pathogens, be sure to hold any products produced from the same lot or batch, or any products produced using the same ingredients, until the FDA results come back. If any results are positive, and the product has been held, a recall will not be necessary.

□ Hold any Product from any Lines that FDA Samples: In the event FDA collects any Zone 1 samples from any processing lines, be sure to hold the products that were produced during the periods that FDA was sampling until the FDA results come back. Here too, if any results are positive, and the product has been held, a recall will not be necessary. To provide additional protection, the company may also consider holding any product processed on equipment where Zone 2 samples were collected as well.

□ Aggressively Clean and Sanitize all Areas Sampled by FDA: As soon as possible after FDA has completed its sampling, be sure to aggressively clean and sanitize each of the areas that the agency sampled. This is because, in the event any sample is positive, you will be able to argue that whatever contamination existed at the time of sampling was eliminated and thus could not have affected any additional production.

□ Correct all FDA Observations Immediately: During the course of the inspection, the FDA Investigators will likely share their findings and observations with the DI. Wherever possible, make sure to immediately correct to the satisfaction of the FDA Investigators any observations that are critical of the company. Doing so will demonstrate that the company is committed to quickly resolving any concerns, and the FDA Investigators may choose not to record those observations in the final FDA Form 483.

□ Know What Records FDA is Permitted to Review: FDA has very broad powers to access records. Generally speaking, FDA will be able to review a company’s written food safety programs and related records. The agency is not entitled, however, to review or copy any recipes, financial data, pricing data, personal data (other than to ensure that the company’s employees have received training appropriate to their position and responsibilities), research data, and sales data (other than shipment information).

□ Protect the Confidentiality of any Records FDA Copies: If FDA requests copies of any records the company deems confidential, be sure to mark those records with the following statement: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN CONSTITUTES TRADE SECRET, CONFIDENTIAL AND PROPRIETARY COMMERCIAL INFORMATION PURSUANT TO 5 U.S.C. 552(b)(4), AND SHALL BE STRICTLY PROTECTED AS SUCH FROM ANY DISSEMINATION AND/OR DISCLOSURE. This will put the agency on notice that the information must be protected and may not be disseminated publicly.

□ Do Not Leave the FDA Investigators Unaccompanied: Make sure that while the FDA Investigators are in your facility they remain accompanied. This way, the DI can observe and document the actions of the FDA Inspectors, and respond immediately to any concerns. Additionally, if a company employee remains present at all times, the FDA Investigators will be less inclined to develop or discuss additional “unplanned” inspection “strategies” or “goals” with each other during the course of the inspection.

□ Do Not Sign Any Statements of Affidavits: At the conclusion of the inspection, the FDA investigators may ask you or your employees to author or sign a statement or affidavit describing the inspection, the observations and/or the conclusions. Do not sign, correct or acknowledge any documents, as you have no legal obligation to do so. If such a request is made, consult with your FDA lawyer immediately.

MANAGING THE AFTERMATH OF AN FDA INSPECTION

POST-INSPECTION CHECKLIST

Once the FDA Investigators have finished with their assigned tasks, they will conduct an exit interview and share their findings, observations and conclusions. In most cases, where violations have been identified, the FDA Investigators will issue a FORM 483, which details the specific violations observed by the FDA Investigators. In some cases, depending upon the nature of the observations and conclusions, the FDA Investigators may also ask the company to consider a recall of certain products. The following checklist can be used to help navigate the aftermath of the FDA inspection and bring all issues to closure.

□ If FDA Issues a FORM 483, Prepare a Written Response: During the exit interview, the FDA Investigators will likely present their observations, findings and conclusions. In most cases, any regulatory or food safety violations will be documented in an FDA FORM 483. Although a response is not required by law, a company is generally expected to provide a written response within 15 business days. If the written response adequately addresses FDA’s concerns, FDA will not pursue further regulatory action. If the response is inadequate, however, the agency may issue a “Warning Letter” threatening to withdraw the company’s registration and prevent it from producing product.

□ Support Your Written Response with Documentation: When FDA issues a FORM 483 or “Warning Letter,” make sure your response is appropriately supported with adequate documentation. For instance, FDA will not be satisfied if you simply state in your response that you corrected a problem that the FDA Investigators observed by “conducting additional employee training.” Rather, in addition to stating that you completed the training, FDA will expect you to attach a training log or other document to your response which provides evidencing that the training was, in fact, completed.

□ If FDA Suggests a Recall, Consult Your FDA Counsel: Sometimes the FDA Investigators will observe conditions they believe warrant a recall. The decision whether to announce a recall in the first instance, and any determinations regarding the scope of any such recall, can vary greatly depending upon the facts and data. Any recall decisions should thus be made very carefully, and only after consultation with an experienced FDA compliance attorney. Many companies have successfully convinced FDA, based upon the availability of supporting facts, forensic analysis and scientific data, that the agency is incorrect and a recall is not needed, or the scope can be significantly limited.

Although there are countless variables which will ultimately affect the way in which your next FDA inspection unfolds, the information provided within this FDA Inspection Checklist is designed to provide some of the tools you will need to deal with the most common scenarios. We truly hope that you will find these checklists useful as you prepare for and manage your next FDA Inspection.

About the Author: Shawn Stevens is a food safety consultant and lawyer, and the founding member of Food Industry Counsel LLC, the only law firm in the world that represents the food industry exclusively. Mr. Stevens works throughout the country and abroad with food industry clients (including the world’s largest growers, food processors, national restaurant chains, and food distributors and grocery chains) helping them protect their brand by complying with FDA and USDA food safety regulations, managing recalls, and defending high-profile foodborne illness claims. Additional information about Mr. Stevens’ legal and consulting practice can be found at: www.foodindustrycounsel.com.

 

What are Documents of Compliance in Food Processing?

Food contact surfaces like cleaning and material handling tools must comply with the FDA’s rules about what they can contain and how they must be designed. FDA CFR21 110 Subpart C, states that “Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents.”

There currently isn’t an obligation to test finished products to comply with FDA regulations, however, it is a generally accepted practice to provide documents that show the base materials of food contact tools are FDA compliant.

But, companies that trade with Europe must follow a much stricter set of documentation laws. According to Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011, each food contact material (FCM) needs to undergo migration testing and be declared safe for food use.

Migration tests

Each base material—whether it’s the blue plastic used in a brush or the green bristles used on a broom—is put through migration testing. Migration testing reveals how much of any or a particular substance (such as harmful chemicals/compounds from the base materials) can be transmitted from the tool’s material to the food products. The maximum permitted quantity (QM) left behind in the food product is most often 10 mg/dm2 for overall migration limits (the total amount of migrated material left behind), but that figure changes when infant food or volatile substances are in play.

Specific migration limits, which consider the total amount of one specific substance that’s left behind, must be checked against Annex I for the maximum limit of each substance’s limit. The maximum amount allowed depends on the substance.

Documentation

According to Regulation (EU) No 10/2011 – Annex IV, each declaration of compliance must contain the following:

  • Identifying information for the business issuing the declaration, and the business that manufactures the product
  • The materials used in the product, and confirmation they all conform to EU’s regulations
  • Migration test results, and that they conformed to the standard
  • Product information about what type of food the tool is meant to be used with, and the time/temperature it can safely be used at

For more specific information, read Regulation (EU) No 10/2011 – Annex IV here.

Use of documents of compliance

There must be one document of compliance for each product, excepting those made out of the same exact composition, which can share documentation. For example, one document for a blue push broom and a blue scrubber, as long as the plastic and bristles were made out of the same materials, is acceptable. However, one document for a blue and a red scrubber is insufficient to meet the requirements, since the color dye changes the product’s material composition.

This documentation is designed to give food processors the information they need to safely use tools in their production facilities. Though the FDA doesn’t require this type of documentation, it can greatly enhance your food safety plan. To obtain these documents, request them from your equipment manufacturer. Make sure that each document is unique to the material it’s made of. One generic document of compliance isn’t enough to comply with European regulations. For Remco Product customers, email our customer service department at cs@remcoproducts.com, and our representatives will get you copies of the documents you need.

 

Sources

Smith, Debra. “Are your cleaning tools food safe?” Vikan, 2015. http://ust.vikan.com/media/1288/food_hygiene_int_article_en_0615.pdf.

“Union Guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain.” European Commission Health and Consumers Directorate-General, 2013. https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_en.pdf.

Grosmans, Sonja; Thomis, Nadine. “Food Contact Materials EU No. 10/2011 lesgislation.” Intertek, 2012. http://www.intertek.com/events/2012/hes/eu-no-10-2011-for-plastic-food-contact-materials-webinar/slides/.

e-CFR. “Title 21: Food and Drugs, Part 110, Subsection C.” U.S. Government Publishing Office, 2016. http://www.ecfr.gov/cgi-bin/text-idx?SID=114e23c93d8ac137c1f2103395d974c8&mc=true&node=pt21.2.110&rgn=div5#sp21.2.110.c.

New-Employee-Proof Your Safety Plan with Color Coding

In the food processing industry, like many factory-based jobs, employee turnover is high. When you’re seeing a turnover rate of about 35% yearly, how do you train your staff to follow important safety plans? When you’re in an industry where a simple mistake by a single employee could result in thousands of people getting sick, how do you ensure HACCP compliance?

For many, color coding has become the easiest answer. Color coding offers a simple solution to an otherwise complex problem. Even the newest employee can quickly learn that red products belong with the raw product, and white goes with the finished.

Here are our top 5 tips to using color coding to ensure all of your employees follow CGMPs.

  1. Set up cleaning stations

Cleaning stations serve as a visual reminder that everything has its place. Put a sign over a station filled with blue tools to remind everyone that those tools are used to clean floors in the packing area, and another sign over a pink wall bracket to tell employees that those tools are used in receiving. Cleaning stations also remind employees to hang tools back up once they’ve been cleaned.

  1. Separate allergen control zones

Training new employees on how and why to respect allergen control zones is difficult. Popular culture has made everyone aware of the danger of peanuts, but many people don’t respect the potential harm trace residues of milk ending up in the wrong product can do. Even if your individual employee doesn’t understand why blue tools are only to be used in a certain area, they can at least quickly understand that it’s the way the factory operates. If the new employee still doesn’t respect the separation, they can be quickly corrected, since it will be immediately obvious they’re using a tool outside its zone.

  1. Back up your plan with pictures

It’s riskily idealistic to think every employee who walks through your door will know how to read in English, or know how to read at all. Photos of what to use each tool with will back up your written signs and make them easy to understand for all of your employees, no matter what their background or education level is. Use easy photos like a picture of peanuts with a big red X over them for your peanut-free tools, or a photo of a purple scoop next to wheat grains so employees know what those tools should (and shouldn’t) touch.

  1. Don’t use commonly color-blind colors

When you choose colors, be aware that some are more easily confused than others. Of people with color-blindness, about 99% have trouble distinguishing between red and green. Try not to use these colors in the same color coding plan. Also, be aware of the fact that about one in 12 men are colorblind, and one in 200 women. Choose shades that are contrasting, like white and red, and avoid putting similar shades near each other, like brown and orange or blue and purple.

  1. Use color-coding to spot training issues

Is someone using the brush meant for a different shift or a different area of the facility? It’s time for a small, informal retraining conversation with a floor manager. These easy discussions can essentially boil down to telling the employee the color they should be using for their purpose. Quick one-on-one sessions with a manager will reinforce these guidelines, and with very little time or effort wasted. Floor managers should have color-coded zones memorized so they can make the most of their time on the floor and correct problems where they see them.

 

Food safety is everyone’s job in the plant, but training comes down to managers and owners. Creating an environment where safety comes first starts with using the right tools for the job, and color coding can help with that.

The Differences Between Non-Sparking and Anti-Static Tools

Non-sparking and anti-static tools both have a common purpose—preventing fires or explosions in production facilities where flammable materials present a concern. However, they each are designed to prevent specific dangers, and shouldn’t be confused. Non-sparking tools are characterized by their lack of ferrous metals (steel and iron), which means they don’t cause sparks that could ignite under the right conditions.

Anti-static tools are carefully designed to work within a system of grounding equipment to prevent static electricity from building to the point it could damage electronics or provide enough of a charge to start a fire or explosion.

However, being non-sparking doesn’t mean a tool can’t also be anti-static. When properly grounded, a non-sparking tool can also prevent electrostatic discharge.

When are non-sparking tools needed?

Non-sparking tools are important for use in a facility that may have an explosive atmosphere or any reason to be especially concerned about the possibility of sparks causing a fire or an explosion. This typically concerns production facilities that contain flammable gas, mists, dusts, or liquids. Non-flammable tools are often used in oil refineries, paper companies, and ammunitions plants. Food processing facilities that use powdered milk, egg whites, cornstarch, grain, flour, or cornstarch may also use non-sparking tools since these can all create combustible dust hazards.

What are non-sparking tools?

Non-sparking tools are, essentially, those that don’t contain ferrous metals. Ferrous metals include steel and iron, in all of their different iterations. Items that are made from carbon steel, stainless steel, cast iron or wrought iron all have the possibility of producing a spark.

Non-ferrous metals include aluminum, copper, brass, silver and lead. They’re not the only materials that non-sparking tools are made out of, though.

Common non-sparking tools are made of:

  • Plastic
  • Brass
  • Bronze
  • Copper-nickel alloys
  • Copper-aluminum alloys
  • Copper-beryllium alloys
  • Wood
  • Leather

Plastic is a common non-sparking material for items like shovels, scrapers, paddles, and scoops.  Tools that need a higher tensile strength, like hammers or screws, are often made out of copper alloys, though beryllium tends to be avoided because of its possible toxicity.

There is a possibility that even non-sparking tools could cause a reaction called a “cold spark”, which doesn’t contain enough heat to ignite even the most flammable of substances, carbon disulfide. Cold sparks can still give the appearance that sparks are happening, but are safe around even the most flammable of substances.

When are anti-static tools needed?

Electronics components—especially motherboards—are extremely electrostatic discharge (ESD) sensitive. A simple static charge created by a worker walking across a floor to a workstation could destroy a motherboard, rendering the entire component useless. Most industries don’t need to worry about static discharge, but when flammable gas is in the air, such as acetone or methane, even a small discharge can create a fire or explosion.

What are anti-static tools?

Anti-static tools are more complex than not containing a specific type of metal. They must be a part of a complete program to safely discharge static.

Static electricity naturally builds up through three different processes:

  1. Tribocharging: Two materials (like socks and carpet) are brought into contact and then separated.
  2. Electrostatic induction: An electrically charged object is placed near a conductive object that isn’t grounded.
  3. Energetically charged particles impinge on an object: This is mostly a problem for spacecraft.

The most effective prevention for static electricity isn’t so much a single tool, as it is a system of precautions, grounding mechanisms and a lack of highly charged materials. Together, this creates an Electrostatic Discharge Protection Area (EPA) that works to keep electrostatic discharge (ESD) sensitive materials safe.

The principles of a successful EPA include:

  1. No highly charged materials
  2. All conductive materials are grounded
  3. Workers are grounded
  4. Electrostatic charge builds up on ESD-sensitive electronics is prevented

The hand tools you use in this environment are often made from plastics that are specifically created to work within this delicately balanced system. These electrostatic dissipative (ESD) tools have a balanced charge and low surface resistivity, which means they don’t gain or lose charge to the objects and surfaces that surround them. These tools have precise temperature and humidity ranges that they work in. If they’re used outside those ranges, they may still create a static charge.

 

If your facility needs non-sparking tools, all of our lines except our metal detectables will fit your needs. With the exception of some of our handles, they’re made of plastic, which makes our tools durable and safe to use in many different environments.

If you have a static sensitive environment, you may require anti-static tools, which we currently do not offer.

Some of our products, such as our green shovels, are made of plastic mixed with a static resistant compound. The compound is designed to reduce static and keep products from clinging to the tool. This doesn’t make them anti-static, and they shouldn’t be used in areas that have anti-static requirements.

 

3 Surprises from the 2016 Food Manufacturer Survey

Food Engineering Magazine’s annual State of Manufacturing Survey is here, and it shows the industry has a lot of room for growth, despite taking some extremely positive steps last year. In this year’s survey, 72% of respondents reported that they have a food safety management system in place, and 69% report having a recall plan.

2016 Food Safety Methods
Chart courtesy of Food Engineering Magazine

Though having a food safety management system in place isn’t the same as being FSMA-ready, in 2014, only 38% of those surveyed said they followed FSMA recommendations, and in 2015, manufacturers reported 41% compliance.

GFSI Adoption and Food Safety Management Systems Grow

As FSMA has begun to take effect this year, more plants are adopting Global Food Safety Initiative programs like BRC, SQF 2000 and FSSC 2200. Plants are following these schemes, which all include an audit protocol, to ensure they’re ready for the possibility of an audit by the FDA, as well as to ensure they’re following current best practices. These programs often include measures like color coding facilities to minimize cross-contamination and using durable tools that are less likely to contribute to foreign body contamination.

Allergen Controls Reportedly Used Less

It’s tempting, as an industry, to be satisfied with this growth. However, as plant managers put some measures and checks into place, they’re leaving others by the wayside. Food safety management systems and recall plans have gone up in use, but allergen controls, which could prevent recalls like the 2016 Oreo undeclared allergen recall, have declined in use.
Food Safety Magazine reports that 34% of all recalls between 2009-2012 occurred because of undeclared allergens. In 2015, that number was 33%. The lesson? We aren’t getting any better at controlling allergens and allergen cross-contamination. Now isn’t the time to step back on things like allergen control, especially when the FDA reports more consumers have food allergies than ever.

Lot-Level Traceability Experiences Sharp Decline

Traceability, a process done using adhesive labeling that tracks products from the farm to consumer’s hands, experienced a sharp decrease in use this year. It’s entirely possible the track-and-trace feature has been incorporated into ERPs or other inventory systems, but the survey doesn’t have a way of reflecting that possibility. Either way, the 15% decline in its use is unexpected in a year that’s been dotted with around 450 food recalls, according to the FDA’s website.

Looking Forward

It could be, as Food Engineering Magazine proposes, that other safety plans have made some measures redundant, but it’s worth examining whether stricter FDA regulations have made plants fall back onto the bare minimum, or whether safety and efficiency really are walking side-by-side now.

What you need to know about FSMA: Part 1

If you are in the food industry and have had your eyes and ears open, then most likely you have heard the word FSMA being thrown around… a lot. However, some people might find themselves unfamiliar with the term or have limited knowledge of it, so in this entry we are going to cover some general information regarding FSMA and in upcoming blogs we will go into further detail about each proposed rule issued by the FDA that supports this legislation.

image00

The people, pathogens and food of today are not those of the past. Our population is living longer and with problems that make them more susceptible to foodborne illness complications. Pathogens are evolving and becoming more adaptable and harder to kill. Our food is traveling more than it ever has. For example, the FDA states that 15% of food we eat is imported. A total 75% of our seafood, 20% of our vegetables, and 50% of our fruit is imported. However, one thing has not changed and that is the threat that foodborne illness presents to the food industry and its consumers. Continue reading What you need to know about FSMA: Part 1

Hosting My First Thanksgiving

Hosting a Thanksgiving dinner is already stressful to begin with, especially if you have a large family like myself, but being a food safety enthusiast added a whole new level of importance to the holiday because I wanted to take this opportunity to teach my family more about food safety.

Thanksgiving Turkey

In my family we rotate who hosts Thanksgiving so it doesn’t fall on the same person every year to do all the work…and this year was my year.  I was so excited because my husband and I just recently got a house and I was anxious to show off my hosting, cooking, and most importantly, my food safety skills.

The whole process started about two weeks before the event when I went to the grocery store to get the turkey. I worried that if I procrastinated buying the turkey then the store would run out. (Side note…I went to the store the day before Thanksgiving to grab last minute items and there were TONS of turkeys left). I put the turkey in the freezer when I got home.

As the host, we were responsible for the turkey, stuffing, mashed potatoes and a sweet potato and carrot sauté, while the rest of the family was responsible for other various traditional Thanksgiving dishes.  About five days before Thanksgiving I went and bought the rest of the ingredients and promptly put them in the refrigerator or pantry when I got home.  A few days before Thanksgiving, I moved the turkey from the freezer to the refrigerator to safely start thawing and I also cubed loaves of bread to lay out to dry out for the stuffing (my family does not actually stuff the turkey, so some may call this dressing).

Food Thermometer

The day before Thanksgiving was prep time, so I washed and cut celery, diced onion, peeled and cut carrots and cleaned the turkey.  I stored the prepped ingredients in proper containers and put them in the refrigerator until the big day.  While doing so, I made sure to wash my hands, utensils, and countertops thoroughly between handling the raw turkey and my produce. No cross-contamination at this house!  I also calibrated my meat thermometer in case I had to get a new one. (You can do this by boiling a pot of water, sticking your thermometer in the water, not touching the pot, for 1 minute and you should read a temperature between 210-214°F).

The day of Thanksgiving, after the oven was preheated, I got Fred out of the refrigerator (yes, I named the turkey) and put him into the roaster, smothered him with butter, surrounded him with stuffing, and put him in the oven covered.

Meanwhile, my sister-in-law brought appetizers that we snacked on before the big dinner, such as cheese and crackers, deviled eggs, and chex mix. I made sure to refrigerate the perishable items as soon as she arrived, and only put out a portion of each appetizer at a time and refilled the snacks only when needed, leaving nothing out that should be refrigerated for more than 2 hours.

I checked the turkey about every hour to baste and stir the stuffing, meanwhile getting the rest of the food prepared and cooked. Finally, after 4.5 hours the thermometer read 165°F when I checked the turkey. I did this by inserting the thermometer in to the meatiest portion of the turkey and made sure to not get too close to the bone because that will give an inaccurate reading. The rest of the food was ready, so we feasted!

After Thanksgiving dinner, my husband and I cleaned the dishes and stored the leftovers in the refrigerator right away. I did not sit until all the leftovers were put in shallow containers (to allow for quicker cooling than deep containers). I divided the leftovers into individual containers for my family members to take home. I made sure to make it a point to tell them as a general rule to freeze or eat the leftovers within 3-4 days and to put the containers in the refrigerator as soon as they get home.

All in all, I was in the kitchen for about 8 hours that day. It was stressful, exhausting, and completely wonderful. I practice food safety in my everyday life, but this time I wanted to set an example for my family to observe and practice when it is their turn to host.

For more information on Thanksgiving and Holiday food safety please visit:  
http://www.cdc.gov/features/turkeytime/ 
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm328131.htm