The represents the most significant expansion of animal and human food safety requirements since the original enactment of the Food, Drug and Cosmetic Act (FDCA) of 1938. It grants the FDA a number of new powers, including mandatory recallauthority. Specifically, it covers the following areas (this is a non-exhaustive list): traceability, recordkeeping and expanded records access; certification/accreditation of third party auditors; laboratory accreditation; whistle blower protection; sanitary transportation of food; improving the Reportable Food Registry; and fees, increased inspection of facilities, administrative detention, food defense, preventive controls, produce safety standards, food safety plans and many other requirements.
An illustration of where the FDA may believe that food or feed will cause serious adverse health effects might be horse feed contaminated with elevated levels of antibiotics. Under the Expanded Records Access, the firm must provide access to records for the product in question as well as access to records for any other article of food or feed that may also have been affected. This access pertains to processing, packing, distribution, receipt, holding or importation records.
Preventive standards and food safety plans
Animal food facilities will be required to analyze food or feed hazards in their manufacturing systems, identify and implement preventive controls to these hazards, monitor the controls and maintain monitoring records, and conduct verification activities. The FDA will be using a Hazard Analysis Critical Control Points (HACCP) approach in developing this new regulation, and firms must document their controls through a “Food Safety Plan.” This might include labeling of pet and animal feed, control of feed nutrient content or control of salmonella in pet food which could cause illness in humans by cross-contact during pet feeding.
How should you prepare?
Any process which has as a goal to prevent problems and improve your is probably worth taking a look at and figuring out how to implement in your feed manufacturing business.
Gap Assessment
The first order of business is to become familiar with the requirements of the law and perform an initial gap assessment of compliance — i.e. where are the areas you meet the regulations and where are the areas you don’t. Secondly, you should develop and implement a system to actively manage feed safety to include the following items:
1) Find the balance between your available resources and your business objectives;
2) Make a commitment to feed safety and communicate this to all parties involved (put this commitment in your strategic plan, and communicate this to all stakeholders: employees and customers alike);
3) Establish a budget line item for feed safety and regulatory compliance.
Develop Emergency Response Plan
Consider establishing a regulatory compliance team. This team is charged with implementing compliance to , developing an emergency response plan to deal with potential feed safety/contamination issues; developing a recall program to inform customers of problems if uncovered and bring back/dispose of product; putting together an internal audit program to track the effectiveness of your feed safety program; and finally tracking and managing whistle blower issues.
Continuous Monitoring
After the regulatory team has been established, you need to make sure that your feed safety programs are in place and are continuously monitored. These key areas of best practice will be spelled out in the soon to be released preventive standards mandates by . The controls will need to be documented in a feed safety plan.
Corrective Action Plan
The final stage of managing compliance with FSMA involves working with in-house or external counsel to bring them up to speed on compliance issues and associated liability concerns. Another strongly suggested management strategy is to develop a set of written FDA compliance policies and guidelines. The audit program should be built upon a corrective action system. Emphasis should be put on education and training, with a focus on awareness of the regulations and working with your staff so that they understand proper compliance methods.
Invest in Warehouse Management System (WMS)
If you are managing any portion of your manufacturing, warehouse or supply chain manually, this is the time to make the shift. Automation is not as intimidating or costly as it may seem. Finding the right can be easy and its use and make noticeable improvements in productivity, profitsm and your ability to swiftly report and recall. Your warehouse management system is essential to conduct the necessary tracking of your inventory for proper traceability and compliance.
At Appolis, our WithoutWire™ is being used in many feed, seed, food and beverage facilities. The robust tracking capabilities allow visibility and reporting to meet your needs. Visit our website .
Thanks for sharing this information. I fully agree with you. Having a good tracking not only ensures safety, but it ensures people complete details about the products or services they avail. Especially in case of food products people must know what all they are going to eat as eating wrong can leads to serious health consequences. So a traceability system is very much required for both producer and consumer.
I agree on the part about using warehouse management system. Nowadays everything is more convenient even if there are additional costs it is still worth every penny. I also suggest using inventory management like Cyberstockroom (www.cyberstockroom.com) a too to keep track of the inventories.
Dynamics is a great platform to use to manage all of FSMA data that drive efficiencies and enable accountability in the food chain. ISV add-ons greatly enhance the functionality available out-of-the-box.
Then there’s the challenge that exists with all of the paper associated with FSMA compliance.
A comprehensive food safety plan must document how an organization is able to store and manage all of the paper generated throughout the food supply chain—from procedure documents, to quality documents, to material safety data sheets (MSDS), to certificates of analysis, etc.
Powerful extensions of the basic need to store and manage this paper are the ability to maintain all of the inherent data relationships among batches, formulas, items, vendors, etc. in Dynamics and to enable people to review and process documents based on their role in the organization. might include when
a quality manager needs to review production quality results to determine whether there is a possible issue with a formula, review documents related to finished batches as well as those still in process, etc.
an R&D specialist needs to process a new formula request from a customer and review documents related to previous batch results for that formula, including product specifications, nutritional analysis, and the MSDS related to specific raw materials used in the batch, etc.
a cost accountant needs to review batch cost overruns by identifying specific formulas for additional review by looking over physical batch tickets from the shop floor that reflect unusual circumstances that were recorded during production run, and even drilling down to review raw material lots, price fluctuations, and vendor COAs, etc.
a purchasing manager could review vendor performance by comparing COAs to item specifications, see all vendors that supply a specific item and their related documents, review batch yields by going to batches that contain these items, etc.