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.
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.”
A food manufacturer requires a complete understanding of their manufacturing process as well as its management’s responsibility to drive a culture, which ensures that the facility, its production processes, and its employees understand expectations throughout the production chain. The company should analyze and document what automation and information systems exist (if they do not already know), generate a risk-assessment plan, and prioritize next steps. Cost of implementation is always a part of the equation, so the fact that increased knowledge can also increase product quality and improve the production methodology— hence reducing the production costs—is an important argument to get buy-in from management.
Integrated modular automation and information systems, when designed and configured properly, address product quality, compliance, productivity, information accuracy, process repeatability, human error, human safety, product traceability, downtime, operational efficiency, and more.
So how do you collect process, batch, and quality data today? Kjell Francois, industry software delivery manager, Siemens, comments, “It is not just a matter of combining your process and batch data, it’s also the move from sample-driven lab data to process-driven online measurements, which will increase the product quality monitoring abilities and process knowledge. The idea is to move QA from the lab to the line. This is an approach that is now already applied, for example, in some dairy companies.”
Within your manufacturing process, do you know your key production critical-to-process and critical-to-quality data points that, when out of spec, can adversely affect final product quality? Do you collect all data or just key data, and what are you doing with it? Are you just storing it? A high rate of quality data has been collected in food companies in LIMS environments over the years. Typically, trend charts are made and key performance indicators (KPIs) are followed over time, often based on sample data from samples collected in the production lines. Integrated data—process, batch, and quality—would enrich the (near-) real-time dashboard information displayed. Is this a practice you are following today?
How do you retrieve this data if it is requested? Are you recording data automatically, and/or on paper? Are you still using chart recorders in certain areas? Are you doing any statistical analysis? If yes, is it off-line and after-the-fact, or is it on-line, at-line, in-line, and proactively making real-time corrections to your manufacturing process? Can you predict final product quality by proactively controlling around these key data points? Technology exists today that enables you to meet these on-line/at-line/in-line sampling goals, allowing you to more accurately predict your final product quality.
Finally, how do you handle an investigation? When it comes to your final batch report, is it a hodgepodge of paper and electronic data that requires too much time to assemble, then analyze? Is your batch report retrievable in a timely manner? In today’s investigations, it might take a significant amount of time to find and extract the necessary data, but it doesn’t have to. FSMA makes it clear that the FDA would ideally like the information in under 24 hours, and emerging technology will allow you to meet this goal.
Putting It Into Practice
Today’s modular automation and information systems, including LIMS, collect a lot of raw data. Are you simply collecting this data (rendering it basically useless), or are you merging collected data to allow full contextualization? Once combined or merged, this information can be made available to the employees in real time, enabling them to make timely decisions. KPIs can be generated and utilized by all process food manufacturers, and these metrics can be managed and measured. These KPIs are then able to address many common challenges that companies face, as well as uncover points in the manufacturing process that could be risky. In addition, this information can be made available to the entire business for deeper analysis, and the results are then used to help your company make better decisions when addressing potential risk.
Dave Sharpe, global industry director, CPG for Rockwell Automation, notes, “An enterprise-wide approach that embraces information-enabled technologies and automation can help address food safety across operations while increasing productivity. The right technology can help apply a more proactive approach to your food safety program. Beyond compliance, a food safety program can be used to improve product quality, asset utilization, yield, and energy usage. By taking advantage of technologies that improve asset utilization, you can meet demanding production goals and support fast changeovers while also maintaining high product quality.”
Tracking and tracing your supply chain—mandatory in Europe for 10-plus years in all food and feed production—from raw ingredients to finished goods also addresses potential risks that can adversely affect a company’s brands’ final product quality. Having the ability to document, track, and retrieve all informational ingredients that make up the batch aligns with FSMA and is becoming more important to customers and consumers. Quickly accessing the information that was used to make a specific product will save time, effort, and potentially a customer. For most food manufacturers, it is not a question of if they will need to provide this information, but when. Having a solution that provides the least disruption to production and shipping can often provide enough of an ROI to offset the cost incurred by the adaption of this type of solution. It also ensures brand protection and loyalty when consumers in today’s markets are quite fickle.
Ultimately, increasing the use of modular automation and information systems and fully integrating your LIMS and quality data directly address the increasing need for traceability, food safety, and competition. If you fully and proactively integrate data from disparate automation and information systems, it will allow your company to meet the intent of FSMA, which in turn will fuel growth, protect brand integrity, and meet current and new national and international regulations.
What’s the bottom line? Automation and information systems not only help your company meet the regulations of FSMA, but they also enable consumers to feel confident in their purchase of your product. In an age where up-to-the-minute information is at the consumer’s fingertips, your company can proactively market that it has taken the steps necessary to meet the latest food safety government regulations.