Instrument maintenance and calibration. Routine maintenance and workflow-related calibration play an important role in defensibility. And keeping track of what was done, when, and by who is time-consuming and error-prone. But not with a LIMS. Lab managers can organize and retrieve maintenance and calibration records by instrument, time period, and even staff member, and they can proactively set alerts to ensure maintenance occurs on a pre-defined schedule.
You Might Also Like
Explore This IssueAugust/September 2015
Also By This Author
For calibrations, the LIMS can easily track reference materials as it tracks the data from the calibrations. If there is an issue with a reference material or an out-of-specification instrument, this will be quickly revealed during the gathering of defensibility data.
2. Staff performance. Human error is just as troublesome in the lab as instrument error. Fortunately, the LIMS is designed to help here as well, addressing issues that arise in each of three broad categories: training, process, and data management. Labs should be able to document adherence to policies and procedures across each of these categories.
Staff training. Training is an important function in any food lab. New staff may be unfamiliar with new instruments or workflows and existing staff are confronted with constant change. Training is dynamic enough to warrant greater discipline and rigorous documentation. And whenever discipline and rigor are required, a LIMS is a wise choice. And this is especially true in a laboratory environment where training and certifications can be different instrument to instrument and process to process. Something as simple as a lapsed certification on a GC- MS/MS instrument can be all it takes to negate a test result and cause a costly production slowdown.
Process quality assurance. Workflows are fundamental to laboratory productivity and quality. There are no shortcuts and variation is unacceptable. So what takes place, by whom, and in what order is critical and must be tracked. A LIMS
can help in two ways: it stores the SOPs, automating as much as possible, and it stores the adherence to these SOPs. There is no room for error-causing interpretation. And if a step is missed, the LIMS records that misstep in real-time, perhaps preventing a future indefensible result before it its memorialized as a record of failure.
For labs looking to engineer defensibility into the process, it’s almost possible to monitor process quality in real time—the LIMS is constantly looking for exceptions that violate the rule. And it doesn’t matter how many different processes and rules are in place, the LIMS is adaptable and can store as many SOPs as a food lab has tests and results to defend.
Data entry and transcription. Manual data entry errors are a well-documented cause for data indefensibility. Even when processes are entirely automated, just a single—even minor—error can cause a bad result downstream. With a LIMS, however, nearly every step can be automated and the resulting data integrated, even from instruments from different vendors. For labs that aspire to engineer defensibility into their processes, there’s no question that a LIMS can be the system of record for “designing out” manual entry errors and using automation to close the loop on unintended transcription or other errors.
Visibility Leads to Defensibility
Whether a food safety lab is analyzing complex matrices with GC-MS/MS or using high-performance liquid chromatography to analyze carbohydrates in foods and beverages, there are many fail points. And without a way to ascertain where a result went wrong, it’s nearly impossible to defend it.
By engineering defensibility into the process, a lab can take a proactive stance. Upfront work may be required, but the long-term savings in time, aggravation, and cost are immeasurable. And with increasing oversight necessary, thanks to the Food Safety Modernization Act and even stricter European Union regulations, manufacturers will require even more visibility into production processes and related quality assurance and control procedures.