Never Finished: Continuous Improvement and the FSMA
By: Bill Bremer
Principal, Food Safety Compliance, Kestrel Management
If you aren’t moving ahead, you’re falling behind. Under the Food Safety Modernization Act (FSMA), continuous improvement will become a vital element of food safety plans. The new law mandates strict penalties for contamination, with the potential for criminal charges and fines of up to $250,000 for companies, plants and employees who fail to prevent a foodborne outbreak. This makes it imperative for production facilities to move ahead and address potential problems. The Qualified Individual (QI) responsible for implementing your food safety plan must continuously improve Foods Safety Plans, preventive controls and proactively contain risks before they turn into problems.
The Plan is Always in Progress
Complacency is the enemy. Your food safety plan should always be a work in progress, and problems are opportunities for improvement. The FSMA requires addressing problems promptly: when contamination risks appear, the QI must take corrective action within one week, and the food safety plan must be amended within a month. The underlying reasons for the lapse in safety need to be investigated and solutions analyzed--and like the rest of the food safety plan, these steps need to be thoroughly documented and validated by a qualified auditor.
The food safety plan should include the proactive search for problems. Preemptively culturing samples from the plant environment and production line can reveal contamination before an outbreak occurs. For example, a swab from a floor drain may reveal a listeria contamination in the environment of the production area long before the bacterium makes its way into a product. Once you have found a problem, eliminating these risks will require conducting thorough environmental testing to determine the necessary changes to your sanitation regimen, and your response to the threat must be recorded. This process will be the key to ensuring compliance and correcting lapses in implementation prior to resuming operations.
Root Cause Analysis
Continuous improvement means investigating the underlying causes of every contamination risk. If a floor drain is found to be harboring listeria, it would not be enough to simply mop the production area with bleach and consider the problem fixed. The listeria came from somewhere, and if your testing, response and record keeping is thorough, you should be able to identify which preventive controls for the facility’s unsanitized areas need to be addressed to safeguard the production areas and prevent cross-contamination.
The root cause of contamination is often a combination of factors. Listeria may have been able to colonize the drain because the surrounding floor tiles were cracked, creating impossible to clean crevices. If so, the cause of the cracked floor tiles must be investigated--perhaps the floor is old and needs to be resurfaced, or maybe a heavy piece of equipment was dragged across the floor when it should have been loaded onto a cart.
Continuous Improvement as Culture
The QI can only do so much. Workers on the production line need to be empowered to stop their work and fix problems when they emerge. If the food safety plan is seen as “someone else’s problem,” lapses are bound to occur. This will require building a culture of safety, with every worker aware of their individual responsibility to food safety.
If a worker sees a lapse in safety--if they observe a technician stepping onto the production floor without proper PPE, or notice that a cracked a floor tile--they should have the awareness to immediately call for corrective action. Ultimately, your workforce should strive to become a learning organization, with each lapse spurring all employees to increase their food safety awareness.
Decide carefully, implement rapidly
When making improvements to the food safety plan, the QI should seek advice from all involved, and weigh the efficacy of potential solutions. Perhaps the staff needs additional sanitation training, or increased oversight of PPE compliance. Maybe maintenance should be required to make periodic surveys of the floor’s condition; maybe the entire floor should be replaced with a more durable surface. Or the solution may be a revision to the daily pre-operational routine to ensure sanitation and address the condition of the production area.
Once the QI decides upon a solution, implementation should be swift. A safety training infrastructure should be in place to help the staff quickly adopt new procedures, and a true learning organization will embrace the opportunity for improvement. Finally, the QI should follow up with an audit of the changes made to the food safety plan.
On to the Next One
The search for contamination risks is never finished, and no set of preventive controls can ever fully guarantee safety. The job of the QI team goes far beyond the implementation and verification of the food safety plan--they must lead the effort to instill a culture of safety that values continuous improvement, food safety, and food safety awareness.
Bill Bremer is a Principal with Kestrel Management’s Chicago area practice and heads Kestrel’s food safety consulting group. In his food compliance roles, he has led compliance and assurance activities to help many food industry companies meet FDA/FSMA, GFSI (i.e., BRC, IFS, FSSC22000, SQF), HACCP, EHS, and overall operations management requirements.
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