Everything we do as manufacturers, and food processors, can be described as a process. FMEAs help identify what can go wrong within a process as you create, make or assemble your product. Although this is often associated with a manufacturing process, it can be applied to any process (which involves inputs being turned into outputs). FMEAs are used to analyze possible failures or risks, along with the potential severity, chance of occurrence and detection rate of each risk.
FSMA ≠ FMEA
However, food processors already follow food safety laws under the Food Safety Modernization Act (FSMA). Wouldn’t an FMEA cover what’s already mandated through these regulations, making it redundant and unnecessary? Not really. While the FSMA functions to prevent hazards with serious health consequences associated with them, an FMEA works to prevent potential failures or defects that don’t just involve health hazards, but failures in quality as well. This means it is beneficial to use both the FSMA and an FMEA together to prevent the most risks possible and produce quality products.
Quality is much more than producing safe food. There are many instances where this is evident in the food industry, including:
- a salad served with too much dressing
- pizza prepared with too little sauce or toppings
- a muffin that’s slightly overcooked or dry
- potato chips that aren’t evenly seasoned
- a resealable bag that doesn’t seem to reseal
Where does an FMEA fit into all this? The focus of an FMEA is to consider, identify and prevent any potential defects or failures. Scrap, rework and dissatisfied customers all come with a cost. Having to discard inferior goods, remake products or make employees work overtime to redo orders only amplifies the impact. Identifying defects or risks in the planning process – before they become an issue – could yield enormous benefits down the line.
To get the most out of performing an FMEA, follow these three steps:
- Do the FMEA.
- Identify each step in your process and for each ask the question, "What can go wrong?" This would be your Failure Mode.
- For each identified Failure Mode, determine the type and severity of potential consequences. This would be the Effects. Be sure to look at the potential cause of the Failure Mode to determine how to prevent it from occurring.
- Look at how the Failure Mode could be detected so it won't reach the consumer, or even the next step in the process. Although you may not be able to control how bad the effect would be, you will likely be able to lessen the likelihood of it happening or make it easier to detect.
Recently, contaminated romaine lettuce left experts baffled and hundreds sick around the United States. In June 2018, officials reported the outbreak strain of E. coli bacteria had been found in an irrigation canal in the Yuma, Ariz., area, where it was originally grown, recalling all affected lettuce. While preventive controls measures (those outlined in the FSMA) should involve water testing measures or finished product cleaning measures, an FMEA would have identified the irrigation canal as an ‘area of concern’ when looking at the process of growing romaine lettuce. Performing this FMEA could have prevented this health and safety catastrophe from ever occurring, proving just how beneficial an FMEA can be.
MEET OUR EXPERT
Food Business Development Manager
John works to develop and expand the food program at The Center. His experience operating his own business has given him knowledge in production, sales, food safety, marketing, warehousing and logistics. John comes from a long line of entrepreneurs, following both parents and grandparents in operating their own family food businesses. Prior to joining The Center, John owned and operated his own food processing company for more than 20 years.
Since 1991, the Michigan Manufacturing Technology Center has assisted Michigan’s small and medium-sized businesses to successfully compete and grow. Through personalized services designed to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.the-center.org.