Set Sail for Efficiency: How LIMS Addresses the Challenges of IS0 17025
The technical requirements section addresses the myriad factors that influence the correctness and reliability of laboratory tests and calibrations. These factors range from personnel to equipment and handling.
- 5.2 Personnel: ISO 17025 requires that laboratory management take full responsibility for the ongoing competency of all staff at all stages of testing and analysis. For this, a LIMS is particularly useful, not only for compliance, but also for ensuring that staff remain properly trained and certified. In SampleManager LIMS, for example, the system’s “Operator Training” functionality sets specific user input restrictions so that only personnel who are certified on particular instruments, analyses or preparations can enter or modify data associated with these items. These rules and requirements can change as staff turnover, as requirements change or based on updated training results.
- 5.4 Test and Calibration Methods Including Sampling: Using appropriate methods and procedures for tests and calibration is as much about best practices as it is compliance. ISO 17025 requires that labs have easily accessible instructions for operation and handling of instruments and test samples, that all methods are appropriate and compliant/current and that personnel have the requisite experience to use the method. Calibration standards need to be fully tracked throughout their lifetime, so the LIMS stores up-to-date inventory and preparation records, usage and expiry data. The system also stores a full audit trail of any modifications, and labs can implement electronic signature controls for added security when standards are authorized for use. SampleManager LIMS also supports validation of methods, required under section 5.4.5. This critical function for any oil and gas laboratory is addressed through AQC Worksheets that enable analytical QA/QC support. This is done through a batch system that augments QA operations by including spiked samples, recoveries and surrogate support in the analytical sequence. Once the lab determines analysis parameters, the results for both analytical and standard samples are stored in the LIMS for future compliance reporting.
- 5.5 Equipment: ISO 17025 makes it clear that all equipment must meet the required performance parameters for its stated use. The requirements relate to sample preparation, testing, processing and analysis, and this also extends to equipment that is outside the labs permanent control. To accomplish this, the LIMS maintains comprehensive records for each instrument as well as each of its components and complete calibration history and status. Having this information to hand means that it is possible to identify the exact instrument configuration deployed at any point in time to test a particular sample.
- 5.7 – 5.9 Sampling Plan, Handling and Transport, Assuring the Quality of Test and Calibration Results ISO 17025 requires that labs have defined procedures for sampling plans, handling and transportation of samples, as well as the management of calibration items and for ensuring the quality of results. Although these procedures can be complex and time-consuming without a system of record, with LIMS it’s possible to create a sampling plan from a template that automates many of the necessary steps. To address handling requirements, for example, each laboratory sample has a unique identifier, which is combined with a full lifecycle – from receipt to disposal – that can be tracked through the LIMS. Hierarchical definitions allow real-life physical locations to be mapped, and the assignment of materials, samples and equipment to be tracked and audited. For monitoring the quality of results for tests and/or calibrations, the LIMS automates established statistical Analytical Quality Control techniques to ensure the reliability of the process and equipment being deployed.
- 5.10 Reporting the Results No laboratory would dispute the ISO 17025 requirement that each test or calibration it carries out should be reported “accurately, clearly, unambiguously and objectively.” That would be a best practice. But this is easier said than done, and nearly impossible without software. A LIMS provides a powerful and flexible reporting tool that generates multiple reports from data stored within the system (in the case of SampleManager LIMS, data stored in external databases is accessible too). The reports, which can be customized as needed, are designed with oil and gas laboratories in mind. The system is preconfigured for rapid, cost-effective implementation.
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