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.
The LIMS Approach to Data Management
The use of a LIMS (laboratory information management system) is commonplace in QA labs to record and monitor laboratory samples, tests, and results in order to simplify and automate processes and procedures. LIMS can maintain a clear, audit-trailed, searchable record of all samples and test results, and reports issued. It can demonstrate the date/time of sampling, of results, and details regarding how/when they were reported, by whom, and to whom. In the event of a recall, it is possible to quickly retrieve test results for every lot analyzed. This makes it possible to query/analyze historical data to drive process improvement since all results can be documented and any trends identified. In this way, LIMS makes it possible to:
- Implement data management strategies that increase security and availability of data;
- Eliminate manual assembly of data for analysis and audit; and
- Make data more useful with easy retrieval/visibility.
Perhaps most importantly, a LIMS configured to automatically link test results to specific sampling points in the facility can provide a suitable framework for setup and adjustment by the environmental monitoring expert while reducing the expertise required to operate it on a daily basis. A standard operating procedure that can be developed, which will increase testing and start “out-of-specification” actions if abnormal microbial contamination is detected. All actions must be clearly documented, which can be done by adding appropriate records directly into the LIMS. In the event of failures, investigators will want to focus on the particular sample points and the “out-of-specification” actions that were initiated to investigate and resolve these failures. Typically, three months of data are requested around these sample points, though up to two years’ worth of data could be requested.
Getting the Most From LIMS
LIMS, in principle, provides the capability to handle the requirements of environmental monitoring. However, the system will need to be configured to do so and this may not be a trivial exercise. The software will need to be configured to represent user requirements in terms of workflows, screen designs, menu designs, terminology, numbering schemes, report designs, and much more. Full configuration for specific applications requires custom coding, which will require re-validation. However, LIMS that provides configuration tools using an interactive user interface where the core code remains unchanged remove the need for re-validation. This latter approach allows the implementation of an environmental monitoring program by non-specialist personnel and the configuration tools allow customization for any facility and monitoring program. Sampling point locations, test results, and corrective action plans can be linked in a single graphical environment. Trend analysis of the results can be made without needing to transfer the information to a separate, non-validated spreadsheet. This approach offers a way for food and drink companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions.
Using External Laboratory Resources
Not all food companies choose to have their own internal QA labs. This may be either because they are too small or because they choose to outsource this function. Such companies will use an external contract laboratory to ensure their environmental monitoring program is fit for purpose. In any inspection, the FDA (or equivalent authority) will want to see proof that preventive regimes are in place and corrective actions are proactively taken to ensure food safety.