One of the fundamental requirements of the Food Safety Modernization Act (FSMA) is the establishment of an environmental monitoring program at each facility. This must define the tests, including the analytical methods, to be carried out for appropriate microorganisms that could be present in their facilities. Procedures are required to identify the locations from which samples will be collected and the number of sites to be sampled, since the number and location must be adequate to determine whether the preventive controls are effective. The timing and frequency for collecting and testing samples must be specified. There is a need to include corrective action procedures in the event that testing detects an environmental pathogen or an indicating organism. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff, and so forth. Just as importantly, all of the data associated with this testing program, including the results and corrective actions taken when microorganisms exceed safe levels, need to be recorded and accessible for audit purposes. All corrective actions should identify the root cause of the deviation, actions taken to prevent recurrence, and, if product safety is not affected, a written conclusion (supported by factual and scientific data) issued to say that the deviation “does not create an immediate food safety issue.” The emphasis should always be on pre-emptive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.
Challenges for Manufacturers and Processors
To help meet these challenges, specialist expertise is needed, which comes at a cost to the organization. Yet this should be seen as money well spent. A general guideline is that if the preventive controls are effective, every dollar spent in preventive measures is likely to save the company $10 in corrective controls where something needs to be fixed. Also, every dollar spent in prevention is likely to save over $100 if there was a failure of control such as a recall or an FDA-mandated closure or the requirement to re-design their plant. Since the FSMA requirements are new and are not necessarily well understood by many companies, there are a lot of programs and consultants offering services to help companies set up their environmental monitoring programs. Clearly, specialist expertise is needed, but when building a program from scratch it can be extremely costly, mostly due to the fact that companies continue to rely on these experts when technicians don’t know for sure what they are supposed to do. So they end up bringing in the expert person for more of the time. A lot of work or time is lost in uncertainty because they have to look at the guidelines, look up the requirements, and ask for help. The most cost-effective way of utilizing resources is to get the program itself set up by experts with clear instructions and processes so that much of the implementation can be carried out by lesser-qualified technicians.
In addition to the challenges associated with designing and staffing a program, many organizations struggle with unwieldy information management. Important data can be scattered across the organization in spreadsheets and forms, etc. Any time the bigger picture needs to be examined, and while senior managers are trying to ascertain the status, there can be a lot of time spent in compiling and analyzing that data. If an auditor or inspector is expecting that information quickly, it does not reflect well if it takes a long time to pull that information together. This is especially true if, for greater scrutiny of those details, it is necessary to sift through a patchwork of records and documentation. Of course, all the time spent on retrieving and analyzing data also takes away from productive management of the operations. This approach also keeps the awareness of the actual status of the facility to a very small group of people instead of enabling more people to devote their attention to making sure that quality processes are being followed. The use of an appropriate information management system can provide structure to ensure that technicians follow the program guidelines and make it much easier to keep track of and analyze all the data more effectively.