Prevention is the best medicine.
According to the FDA, "The Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus to preventing contamination of the food supply, rather than responding to it. The law applies to human food as well as to food for animals, including pets."
Initially signed in 2011, the FSMA has seven main areas of focus:
- Preventative control for human foods
- Produce safety
- Sanitary transport of food and feed
- Foreign supplier verification
- Third-party verification
- Intentional adulteration
- Preventative control for animal food
All of which must be addressed in a facility's Food Safety Plan. The Food Safety Plan is outlined by the FDA as follows:
"In general, you are a covered facility if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Covered facilities are required to have and implement a written food safety plan that includes:
- Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).If the hazard analysis reveals one or more hazards that require a preventive control, the facility must have and implement written preventive controls for the identified hazards.
- Preventive controls: Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls:
- Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.
- Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products.
- Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards.
- Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.
- Oversight and management of preventive controls: Once a facility has identified a preventive control for a hazard, the facility must make sure that the controls are being met.
- Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented.
- Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.
- Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records.
- Verification: These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented.Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.
- Supply chain program: Manufacturers must have and implement a risk-based supply chain program if the hazard analysis identifies a hazard that (1) requires a preventive control and (2) the control will be applied in the facility’s supply chain.
- Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements.
- Manufacturers are responsible for ensuring that raw materials and other ingredients requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. (Suppliers are approved by the facility after the facility considers several factors, such as a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)
- Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.
- Recall plan: If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product. The recall plan must include procedures to notify consignees, to notify the public when necessary, to conduct effectiveness checks and to appropriately dispose of recalled product."
How Does Metal Control Fit into FSMA Requirements?
Effective metal control falls into the Food Safety Plan as a Preventative Control for Other Hazards, that requires a plan, monitoring, corrective action, and verification with appropriate documentation. It also requires that operators who are responsible for metal control are trained on the risks, mitigation practices, and equipment needed to effectively manage the threat of metal contamination.
Elements of a FSMA Appropriate Metal Control Plan
At a basic level, the following elements should be part of your metal control plan:
End-To-End Strategy – Metal control is a strategy, not a piece of equipment. Some facilities will make the mistake of believing a metal detector at the end of their product line is sufficient to protect their product - this is inaccurate, can result in product recalls, and increases the amount of finished product that is wasted when metal that could have been removed earlier in the process is detected only at the end of processing.
An end-to-end metal control strategy beginning with operator training and including prevention, elimination, and verification is necessary for product protection.
Prevention, Elimination and Verification – A complete metal control strategy includes equipment and processes designed to prevent metal from entering the product stream, eliminate any metal that does enter the product stream, and then verify the final product is free of metal contamination at the point of finishing. This system should include a combination of receiving, primary, and finishing magnets, along with supplier management, and product inspection with x-ray or metal detection.
Certified Equipment - Every new piece of magnetic equipment should be shipped with a certificate which states the performance from the factory of your magnetic separator. This may include pull values on contact with a ¼”, ½” and/or 1” ball and/or gauss values. The magnet should also be serialized to match the certificate or get a replacement certificate from the manufacturer if needed.
Product Manuals and Drawings - All product manuals and/or drawings should have the following sections documenting:
- Cleaning instructions
- Proper testing methods
- Preventative maintenance
- Spare parts
- Exploded parts view
Weld Specifications - Ensure magnets are constructed to the proper sanitary standards for your industry. The weld and finish specifications should be documented.
Cleaning Schedules - Maintain a regular cleaning schedule and document each time it is completed. Don’t forget to make adjustments. if a magnet is becoming saturated with metal between cleanings, increase frequency of cleanings.
Metal Control Systems Audit - In addition to regular in-house strength testing and verification of magnetic and metal control equipment, annual third-party verification of the entire metal control system with appropriate documentation and recommendations should be included in the Food Safety Plan.
Vendor Selection - Choosing a Metal Control Partner
It is important that your vendor explain not only what their equipment can do, but what it cannot do.
Magnetic Separators - When sized correctly and installed properly are very effective in capturing ferrous and weakly magnetic non-ferrous metals. In many cases, magnets can go beyond the capabilities of most metal detection and X-ray systems. Nonferrous or nonmagnetic metals, such as aluminum, will not be eliminated by a magnetic system. To control and capture these types of metals, metal detectors or X-ray systems should be considered.
Metal Detectors – Metal detector technology is based on a product’s “conductivity”. Highly conductive products like meats and baby food will be more challenging to sense smaller sized, specific types of metals. This typically results in a more generalized “metals sensing spectrum” to ensure quality standards are being achieved, while avoiding costly “false” positive rejects.
X-ray – X-ray technology is based on a product’s “density”. Some products are easier to inspect than others and some are not able to be screened by X-ray technology at all. If the targeted materials have a similar density of the products being inspected, such as non-calcified bones in chicken, the X-ray will be ineffective.
Take the time to talk to more than one vendor. It is necessary that the vendor you choose not only understand, but is able to explain the technological limitations of the equipment. He or she should be able to present the physics-based principals for particulate detection in layman’s terms. You should come away from the assessment knowing at least one thing you didn’t know before and feeling confident in your new-found knowledge and the decision to be made.
It’s important to select a vendor who will partner with your company in offering service packages that provide education, training, and periodic retraining for your employees. Technologies in this industry are constantly evolving, the goal being to make the detection of foreign material contamination in food ever better. On average, between 20 and 25 percent of recalls are due to detectable foreign matter such as bone, plastic, glass, or metal making its way to the consumer’s table. It is vitally important that the people responsible for monitoring and maintaining the detection equipment are knowledgeable on its operation and maintenance. Even without a high turnover rate, simple changes in mixtures or recipes can require a system calibration and reprogramming. In regards to electronic inspection equipment, one size does not fit all.
Ensure Technical Support is Readily Available
Technical support means providing an understanding of the system that goes well beyond its installation. This may include system validation, programming requirements, preventative maintenance, or reports required to fulfill a regulatory requirement. This support also needs to be easily accessible.
You may find that a U.S.-based company will be more willing and able to provide the technical support that goes with its products. The ideal situation is to purchase from a vendor that services what they sell, even if that may mean paying a premium price.
Opt for Sanitary Design
With all equipment - even that meant for product safety - there is a risk of the equipment itself creating a food safety concern. Metal control equipment is no different and a sanitary design should be considered.
A sanitary design is one that eliminates the need for disassembly in order to be cleaned. If it must be disassembled, it should be quickly accomplished and preferably require no tools. Food processing is a dirty business. Be it wet or dry, food matter can find the smallest nook and cranny in which to collect and grow colonies of potentially deadly germs. Nuts, bolts, and screws are all capable of harboring pathogens, as are the tools used to remove them. Routine cleaning is a fact of life, one that will be included in any comprehensive hazard analysis and critical control points (HACCP) plan. It is a chore that is time-consuming and messy, which is why it is often not completed properly and/or on schedule, if at all. Investing in a built-in, well-thought-out sanitary design will more than pay for itself over time.
When in Doubt - Ask the Experts
Metal control seems straightforward, but it is a complicated process requiring precision equipment specific to each application that can be maintained and verified throughout its lifetime by individuals with the training necessary to ensure proper functioning. More likely than not, on-site staff are not experts in metal control, which is why partnering with a company that focuses on the end-to-end strategy and is passionate about customer education is essential. Contact our experts today to learn more.