Alarm Management’s Role in the Food Safety Modernization Act

There are many aspects to the recent FDA Food Safety Modernization Act and I do not claim to be an expert in many of the details which can be found on the FDA website.  What I do recognize in reviewing the requirements at a high level is that the manufacturing quality and product traceability requirements have many similar components to other regulated industries such as pharmaceuticals.

When a food manufacturer releases a product for public consumption you should be confident that the product was produced in accordance with applicable quality standards and documented operating procedures.  Manufacturers should also be able to trace the supply chain and product transport from the raw material stage through to consumer purchase.  In addition, companies should be able to quickly identify differences between production lots.

So how does alarm management fit into this picture? There are several areas where alarm management in the food and beverage industry will help support manufacturer’s compliance efforts with the Food Safety Modernization Act:

    • Adherence to quality standards requires fundamental good manufacturing practices.  When you have “bad actor” alarms, whether they are the result of nuisance alarms, chattering alarms, stale alarms or other alarm issues; they negatively impact operational performance.  Rather than having operators focused on optimizing manufacturing performance they spend their time responding to these “bad actor” alarms which also tend to reduce an operator’s ability to recognize and manage real abnormal situations. Alarm management software is targeted at the identification and elimination of these alarms.
    • Alarms, particularly on critical process parameters (CPPs) affecting quality, should be captured and stored as part of the historical production record for a given lot.  The alarm information helps establish operating conditions at the time of production.  This information should be reviewed prior to release of a production lot and is also a vital component of historical production records should issues be found with the lot after release.
    • How does a food manufacturer prove that alarms, particularly for quality CPPs as related to the Food Safety Modernization Act, are the right alarms, with the right priorities, and appropriate limits?  Performing an alarm rationalization, then subsequently establishing and maintaining an evergreen alarm knowledge base is essential to documenting that you have gone through a logical decision process for creating alarms and their associated attributes.
    • Alarms limits can be changed including quality related CPP alarms.  How do you manage changes to alarms and update your knowledge base with these changes?  Who reviews, and approves or rejects alarm changes?  Alarm management software can help facilitate this change management which is now more visible than ever as part of ensuring quality manufacturing.

 

While the Food Safety Modernization Act is very comprehensive in nature, I hope that the food and beverage industry recognizes alarm management as a vital part of successfully managing quality manufacturing to support compliance efforts.

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