Food industry quality manufacturing requirements are stringent, and the FDA’s Food Safety Modernization Act (FSMA) is aimed at preventing purposeful adulteration from acts intended to cause wide-scale harm to public health. The preventive controls rules require facilities to develop and implement written food safety plans as they will be held accountable for monitoring their facilities and identifying any potential hazards in their products as well as preventing those hazards.
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In a recent feature on the FDA website Joann Givens, co-chair of the FSMA Operations Team Steering Committee, addressed the question, “What is the best thing covered food facilities can be doing now?” She writes, “They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.” She also suggests that facilities should set up a thorough system for documenting what they do. “The better the records, the more a company can demonstrate that it is meeting the legal standard…and consider having some redundancy in the system so that if one measure fails, another can take its place,” she writes.
FSMA requires that companies implement safety plans that detail points in the manufacturing process that could be risky, but the question remains whether technology automation and information systems could play a role in helping manufacturers comply with the new regulations.
All About Data
Most food manufacturers have automation and information hardware and software systems, including PLCs, DCS, HMI SCADA, Batch, Data Historians, OEE, MES, WMS, and ERP. While these systems are necessary, some are legacy systems (meaning they are not supported anymore), most systems are from multiple vendors, and many are not connected. So, how can your company meet the intent of the FSMA and extract the required information that lies within these multiple, disparate systems? Extraction is not always easy, as some information is paper-based or tied up in ERP, WMS, Data Historian, or MES systems. Getting data out of disparate automation and information systems is time consuming, inefficient, and even inaccurate.
Then what’s the better solution? Data, data, and more data! Many food companies collect data in multiple ways—automatically, via operator entries, on chart recorders, etc.—and lots of it. Whether your company is automated or not, your laboratory information management systems (LIMS) may be the most important system providing data on food quality as they collect quality data from raw materials to final product. Once your company has this data, what do you do with it? Can it be retrieved in a timely manner, and can you make use of it during and/or after the product is manufactured? If your LIMS aren’t integrated in the automation and information layer of the company, they should be! LIMS data, combined with automation and information data, enables true manufacturing and process knowledge.
Quality by Design
In the life science industry, the Quality by Design (QbD) initiative from the FDA provides guidance on pharmaceutical development to facilitate design of products and processes that will maximize the product’s efficacy and safety profile while enhancing product manufacturability and control. QbD is defined by the European Medicines Agency as “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management.” The FDA has proposed in its guidelines for industry a definition for process validation that is “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”