New Requirements for the Food & Beverage Industry
The Food Safety and Modernization Act (FSMA), which was signed into law in January 2011, dramatically strengthened the FDA's authority and enforcement capabilities within the food and beverage industries. The law imposes new requirements, such as:
- Development of a food safety plan that includes establishing corrective procedures (also known as CAPA)
- Additional recordkeeping
- Increased inspections
- Development of a product tracking system
- Biennial registration of all food facilities
Economic Impact to the Food & Beverage Industry
Complying with the FSMA’s requirements will undoubtedly cost money. But noncompliance that could lead to food recalls could be even more costly. Food growers, processors, and retailers saw a $201.9 million decline in spinach sales following the outbreak of E. coli disease in 2006. The peanut recall in 2009 was estimated to have cost the food industry more than $1 billion. In addition to reduced sales, any food or beverage recall also entails hundreds of millions of dollars in product-recall insurance costs, not to mention fines and litigation costs.
The food and beverage industry face the twin demands of complying with new FSMA requirements and at the same time controlling business costs. Is your company equipped to do both?
MasterControl quality and compliance software is designed for companies in regulated environments — companies that comply with FDA regulations or EC directives and regulations and those that adhere to ISO standards or European Union GMP or other standards.
To comply with the FSMA, MasterControl can help you:
- Automate document control processes to ensure efficiency and compliance
- Establish automated corrective action procedures (CAPA) to mitigate risks
- Connect all document control and quality processes to increase inspection readiness
Food & Beverage Industry - What Can MasterControl Do for You?
MasterControl document control and process management systems are designed to automate and streamline the quality management systems of regulated companies, including food and beverage companies. MasterControl's quality management system was also recently selected by the FDA for internal use in the Office of Regulatory Affairs.
If you are not ready for a software solution yet, MasterControl has both in-house expertise as well as a network of partners that can assist you with your regulatory or quality needs.
How Can MasterControl Make The Food & Beverage Industries More Efficient?
Compliance is very important, but compliance for compliance’ sake doesn’t always make business sense. A compliance software solution should also make your processes and your company more efficient. Here are a few ways in which MasterControl can help increase food and beverage companies efficiency:
- Search and Retrieval: Documentation is the lifeblood of any QMS but can be extremely difficult to search and retrieve when it is managed manually or with an ad-hoc system. MasterControl provides automated search and retrieval of any document (of any file type) from a secure, centralized and web-based system. Add up the time each employee spends looking for information using ad-hoc systems and the potential time savings of implementing MasterControl as a food safety software solution becomes very apparent.
- Process Efficiency: Quality-related processes are cumbersome without automation. Processes such as training, internal audits, deviations, CAPA, or other quality processes require iterative tasks, meetings, documentation, tracking and reporting. These tasks, when "controlled" without automated solutions take literally ten or twenty times longer than their automated counterparts (if not more). Surely the initial investment is worth the amount of revenue that would be used for administrative personnel, paper and ad-hoc applications.
- Process Speed: Every glitch in a quality process causes more deviations, more nonconformance events and longer product manufacturing cycles. Slow processes cost more money. Fast, automated processes save money every minute of the working day.
- Improved Turnaround: In quality processes if a change needs to occur but the process for approving that change takes weeks instead of minutes, how much money is a food and beverage company losing every day during those weeks when a change is being discovered, manually routed, approved and "implemented?" Real-time turnaround and response will help food and beverage companies cut the cost of implementing change.
Food & Beverage Industries Common Objections for not Purchasing a Food Safety Software Solution
Many food and beverage companies would like to implement an efficient and automated food safety quality management system. However, they often find it difficult to justify the initial expense and will often encounter objections from various stakeholders, like the ones outlined below.
- We Don't Need Software, We Can Manage With Paper: The new FSMA legislation changes the way records need to be kept as well as the amount of documentation required. Additionally, with paper-based or ad-hoc quality management systems (i.e, a system made up of various applications and manual processes) companies — in the long run (or even in the short run) - will spend far more on quality mishaps, Band-Aid fixes, lost information, and communication gaps than it will pay for the initial expense of consultation (if necessary) and the automation of the food safety QMS.
- Inspections are Few and Far Between: The new FSMA legislation changes the inspection frequency and increases the FDA’s enforcement capabilities. There are also new requirements for documentation when inspectors do show up. You can continue to roll the dice or look into a less risky way to maintain compliance.
- We Have Never Had a Recall: Damage to a brand can happen quickly and painfully. Ensuring systems are in place before a problem emerges is the best way to protect a brand. MasterControl can help reduce the possibility of recalls by ensuring preventive processes are followed. In the event of a recall, the system can also be used to help ensure all the steps of a recall are properly executed.
- We Trust Our Suppliers: Most companies today rely on high quality suppliers to help them deliver their products. The new legislation also includes additional requirements for documenting and verifying supplier safety – the FDA is now requiring you to document the basis behind your trust.
- A Software Solution Will Cost Too Much: MasterControl offers variety of configurations and deployment options for our food safety software systems, including on-premise and cloud-based offerings that can be matched to your unique situation. Additionally, the system uses a generous concurrent licensing model where licenses are not assigned to a specific user, but instead are only consumed during the time when someone is logged in using the application.
Learn More About Our Food & Beverage Industry Software Solutions
To learn more about MasterControl's food safety software solutions for the food and beverage industry, please feel free to contact a MasterControl representative.