The seven HACCP principles are achieved by analyzing food hazards in your manufacturing process and addressing them accordingly.
FSMA compliance checklist
The FSMA requires businesses registered under to FDA to comply with the set rules and regulations. An established food ...
- The FSMA requires businesses registered under to FDA to comply with the set rules and regulations.
- An established food safety plan contains elements consisting of identified food safety hazards, activities that ensure food safety, corrective actions, and recall plans.
- A solid food safety plan should have the same proactive nature.
In this article you'll learn about FSMA compliance checklist and what are the 7 rules of FSMA. The Food Safety Modernization Act (FSMA) is a complex yet helpful law that aims to direct the focus of food processors and health auditors towards the prevention of foodborne illnesses from responding to them.
FSMA is a comprehensive law consisting of 7 major rules with a few other, equally important food safety regulations. The words comprehensive and complex may throw some business owners in the food industry off, but the FSMA is mandatory for select businesses.
Under this law, local and international businesses registered under the FDA are required to comply. This means that you need to familiarize yourself and your whole team with all the rules and regulations set by the law. The key to making this easier is to start with the major rules.
There is absolutely no reason to worry. FoodDocs was created to help you get through your food safety journey without sweat and to have more time for other matters. If you want to know what is FSMA and get an overall understanding of the topic then read our guide article to FSMA.
FSMA 7 Rules
In the pursuit of minimizing the number of foodborne illnesses from manufactured products, the FDA, together with the government of the United States, has devised seven major rules under the FSMA to emphasize the role of all participating businesses in the food supply chain.
- Produce Safety - this FSMA rule imposes a science-based approach in the food safety analysis of potential hazards during the processes of growing, harvesting, packing, and storage of fresh produce intended as human foods. Included in the rule is the establishment of minimum food quality standards for fresh produce.
- Foreign Supplier Verification Program - FSMA compliance is also mandatory for importers. This rule aims to maintain an equally high standard of food safety from importers.
- Sanitary Transport Rule - food businesses are also required to maintain high safety standards on sanitary transportation practices. Under the FSMA law, the transportation equipment conditions must also be maintained to keep transported foods wholesome. This FSMA rule does not apply to products shipped through the air.
- Protection Against Intentional Adulteration - your FSMA compliance would also require your business to submit a Food Defense Plan which aims to control vulnerable points in your operation line and propose preventive controls against intentional contamination or adulteration of food.
- Accredited Third-Party Certification - this FSMA rule was established to maintain quality standards of accredited third-party certification bodies that will conduct food safety audits.
- Preventive Control Rule for Human and Animal Food - the FSMA compliance applies both to human and animal foods under this rule.
- Voluntary Qualified Imported Program - as a part of FSMA compliance, importers have the option to increase the speed of the analysis and acceptance of their imported products.
FSMA Related Programs
The FSMA has also established a few other food safety programs and rules that contribute to the fulfillment of the law's goals. Some of these programs are improvements on preexisting rules, whereas some are proposed rules and await approval.
FSMA Food Traceability (Proposed rule)
Under this proposed rule, FSMA compliance would also require food businesses to follow the amendments to the preexisting food traceability rules. This rule aims to make tracking of contaminated products to prevent foodborne illness outbreaks and other serious health hazards. A Food Traceability List was established to identify which products are considered as high-risk of contamination. The FDA focused on listing biological hazards and acute chemical toxins in creating this rule. Food products under the traceability list are determined based on a risk-ranking model that identifies which foods are potential sources of contamination. The traceability list is continuously improved and updated.
FSMA Laboratory Accreditation (Proposed rule)
Among the pending proposed rules to be added in the FSMA compliance for food businesses seeks to standardize the quality and process of laboratory testing centers. If approved, this rule will require testing centers to submit to accreditation by the FDA. This food safety program aims to ensure food safety and the integrity of food testing procedures under the watchful guidance of the FDA. Model standards are established for the laboratories to follow.
FSMA Amendments to Registration of Food facilities
(Effectivity date: July 14, 2016)
This food safety program lays out additional requirements for the registration of local and foreign facilities to protect public health from food safety issues. Under the approved rule, on-site activities for the validation of the food facility are required. The amendments under this rule also expand the definition of retail food establishments and clarify if your business is required to comply.
FSMA Amendment to Record Availability Requirements
(Effectivity date: April 04, 2014)
The powers of the FDA have been strengthened under this rule by expanding their authority to access records related to food products with questionable integrity that may cause serious public health hazards. FSMA compliance would also mean allowing the FDA to access records to products that they believe are related to suspected contaminated products.
FSMA Information Required in Prior Notice of Imported Foods
The FDA has finalized the interim rule issued on the onset of FSMA compliance in 2011. This rule requires importers of food to submit a prior notice of their importation and to report countries where the product has been refused entry. This rule helps the FDA prevent foodborne illness from any contaminated products from entering the country through advanced planned inspections.
FSMA Criteria Used to Order Administrative Detention of Human and Animal Foods
Amendments to the previous rules of the FDA on the detention of questionable foods aim to expand the agency's oversight of such concerns. Under this new ruling, the FDA is given the authority to detain potentially contaminated products with just a reasonable probability. This rule increases the stringency of inspection and reduces the probability of contaminated products from being released to the public.
FSMA compliance checklist
Inspection by the FDA can come at any time. This fact means that your business must have a solid and working food safety system at all times. Your food safety plan must have a proactive approach to tackle potential food hazards.
For your food business to ensure FSMA compliance, a set of documented processes are needed to be prepared. An established food safety plan contains elements consisting of identified food safety hazards, activities that ensure food safety, corrective and recall plans, and others.
Below, we give you a checklist of what you need:
1. Food safety plan - FSMA compliance requires your business to create a product and facility plan which includes hazard identification, established critical control points, and specifications. This plan includes information about your product such as its intended use and ingredients. Hazards are properly identified as a result of raw materials, manufacturing practices, sanitation controls, and equipment maintenance procedures. Your food safety plan must also include a proper risk assessment to determine the severity of the identified hazards.
2. Preventive and corrective controls - identified and analyzed hazards must also be accompanied by a set of preventive controls to control them. The FSMA compliance requires more than the usual preventive controls for critical control points. Under the FSMA ruling, preventive controls for processes, supply chain, allergens, sanitation procedures, and recall procedures are also required.
3. Supply chain program - under the FSMA, your company is also required to ensure that the suppliers you are dealing with apply equally stringent food safety plans. Your suppliers are required to submit proof that they conduct a proper hazard analysis and apply adequate preventive controls.
4. Recall plan - to maintain the high integrity of your food safety plan, a well-structured recall strategy is required. This plan will contribute to FSMA compliance by presenting steps on how to address and perform recalls. Steps may include notification of consignees of the article of food in question, potential directives on how to dispose or return contaminated food, notifying the public about the potential leak of contaminated products, and verifying the effectiveness of the plan. The plan must be set to immediately control the further release of the food products in question and quickly retrieve batches that are already circulating the market.
5. Monitoring and verification procedures - to provide proof that the current FSMA food safety plan implemented on your business is effective, records of monitoring and verification are needed. Reports, records, and forms on tracking the progress and application of the food safety plan must always be ready in case of an audit of company practices.
This checklist only proves that FSMA compliance requires your business and all personnel to have all of their hands on deck and participate in making a well-rounded food safety plan. This also tells you that a ton of paperwork needs to be compiled and filed, let alone all the information on the FSMA compliance you have to familiarize yourself with.
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We will help you get ready for an audit any time by tracking all of your progress on food safety activities. It even helps you monitor your business activities in just one place.
FSMA compliance statement
Once your food business has ticked most of the boxes in your FSMA compliance checklist, your business is required to create an FSMA compliance statement. This document states which conditions and rules of the FSMA have your company already complied with.
The FSMA compliance statement is used to list which of the seven major rules and related programs is your business compliant with. Along with the rules are the compliance dates when your food business has fully complied. It must also contain which among the food safety plan checklist have you fulfilled (e.g. hazard analysis, preventive controls, recall plan, etc.).
This in-house document does not have to be too technical but it must be forwarded if asked as proof of your FSMA compliance. Your FSMA compliance statement is somehow similar to what the Preparedness and Response Act of 2002 (Bioterrorism Law) requires for you to provide your customers. Upon request or delivery of some products, this document must be provided.
Preparing for FSMA compliance
Complying with the FSMA requirements requires very detailed tasks. The process can be overwhelming especially for food business startups. Without proper training on how to make a comprehensive food safety plan, your FSMA compliance may become at risk.
The key characteristic of a solid food safety plan is that it should have the same nature as the FSMA law - proactive. The whole plan must be able to address potential food safety hazards and minimize any health hazard risks. FSMA compliance would mean that your business is prepared should these hazards be detected and apply corrective actions with proper monitoring procedures.
Extensive and proper training of all the team members in your business is required to orient them and help them understand what is the importance of FSMA compliance. Skilled members in the field of food safety can significantly contribute to building a wholesome and complete food safety plan. In addition to this, everyone must be committed to maintain FSMA compliance and perform regular evaluations.
But can this really be done on top of the daily activities that you need to do to keep the business running and successful? The good thing is you do not need to do it all the traditional way.
Going digital with planning food safety for FSMA compliance
With the increasing complexity of creating a solid food safety management system, keeping it work, and running a food business, it all just seems impossible to do. Luckily, our innovation has enabled almost 10,000 food business owners to handle all the work with just a single food safety management software.
FoodDocs was made to help you create a food safety plan fit for your business with super-simple steps. It also allows you to monitor the application of your plan and get your FSMA compliance without spending all the time with meetings and paperwork. Monitoring programs, critical control components, an overview of your whole manufacturing status, and storing all your food safety data are made easy and possible by our built-in food safety software.
Get expert advice from our team on how to make your food safety plan FSMA compliant. You do not need any prior knowledge of food safety management to make your food safety plan work with us. The food safety software we developed lets you finish all your food safety tasks 100 times faster than hiring a food safety consultant.
Going digital for your food safety plan lets you improve on the following points of your business:
- Real-time overview of your food hygiene
- Monitoring manufacturing practice
- Secured food safety data compilation
- Ease of access to records
- Cost and time management
- Food safety compliance updates
- Facilitated traceability
- Communication with your team
- Organization of tasks
- Expert advice on food safety
If you are worried if our technology is not fit for your business, you would be happy to know that our food safety software can be tailored to your business's nature. By answering a few questions related to your food company the software puts up a comprehensive plan that is compliant with the food safety laws and regulations of your country. This feature ensures an easy journey towards your FSMA compliance.
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