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Operational Excellence: Building Compliance and Traceability into the Process

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Operational Excellence: Building Compliance and Traceability into the Process

Continuing on with GE's series, see how getting ahead of compliance issues, after you've automated your data collection, is better in the long run.

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We are up to step two in the seven step journey for operational excellence. The last installment of this OpEx series focused on manufacturing data and the importance of automatic collection of this information. This week, we will dive deeper into the second step — building compliance and traceability into your processes.

It doesn’t take an expert to realize that one of the largest shifts in recent years is the increasing focus on regulation and compliance — especially among F&B manufacturers. The introduction of the Food Safety Modernization Act (FSMA) caused major changes in how food and beverage manufacturers manage the safety and quality of their products, as well as how organizations will have to handle any issues that arise. Tighter control, documentation, and tracking of every ingredient and process used throughout the enterprise is now required. Even though FSMA was signed into law back in 2011, companies today are still scrambling and focused on complying with this mandate that continually evolved (up until November 2015) and others like it (GMP, GFSI, FSIS, etc.). The main goal of these regulations can be summed up quite simply — keep your products safe by preventing non-conformances before they occur.

The FDA defines HACCP as a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

A widely adopted approach to preventative food safety has been the adoption of a system like Hazard Analysis and Critical Control Points (HACCP). Companies in the meat, seafood, or juice segments are very familiar with this system, as the FDA or USDA require mandatory HACCP programs as an effective approach to food safety and protecting public health. Companies outside of those segments and outside of the US may be more familiar with a Hazard Analysis and Risk-based Preventive Controls (HARPC) plan. Also, while programs like HACCP have historically been focused in the F&B industry, CPG companies such as those cosmetics and pharmaceuticals sectors are adopting this approach to improve their quality performance.

Building compliance and traceability into a manufacturing processes is actually a twofold strategy itself:

  1. Identify those in-process critical control points that can be measured and are predictive in regards to final product quality. Then metrics should be established and threshold levels determined for these critical control points. Finally, you must measure these critical control points in real or near real-time. This allows for in-process adjustments and ultimately the assurance of finished product quality and compliance.
  2. Having the ability to recreate what happened to a product through the manufacturing process, from the initial raw material to distribution of the final product. This is essential for root cause analysis and helps to create a closed-loop process that allows for continuous improvements to be made.

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The only way to assure compliance and traceability is through the continual monitoring of production processes. There is significant value to this approach, primarily the regulatory environment in these industries requires this step to stay compliant. However, this approach also reduces the dependence of testing to ensure final product quality, which ultimately lowers costs and saves time.

This is the third blog in a series around OpEx. The next blog will dive into step three – utilizing historical and real-time data to minimize asset downtime.

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