Set Sail for Efficiency: How LIMS Addresses the Challenges of IS0 17025

Related Vendors

4.4 Review of Request, Tender or Contract: An oil and gas laboratory must demonstrate that it has the requisite experience, capabilities and resources to meet the requirements of the client (whether internal or external). This ensures that the laboratory is actually capable of meeting its promise to provide quality results. Because the LIMS offers a system-wide view of resources, methods, instrument calibration, etc., it plays an important role in the contract review process. Sample Manager LIMS for example, pulls in data from operator loading reports to provide real-time insight into operator workload and possible resource conflicts. This avoids post-contract surprises that could trigger a compliance audit or, much worse, jeopardize a customer relationship.

Once work is complete, the LIMS also plays an important role in matching final delivery and pricing to scope of work. The LIMS tracks the handling of surface and subsurface oil and gas samples at all stages of the extraction and refining process from their delivery into the lab to the return of results to the customer. Everything is documented, ensuring full compliance and providing a record trail useful in ongoing quality control and efficiency analysis.

4.5 Subcontracting of Tests and Calibrations: Testing overflow is common, but cannot be handled haphazardly. ISO17025 requires that laboratories are able to “demonstrate” that any subcontractor is “competent to perform the activities in question,” and that it is also in compliance with the standards. A lab must therefore maintain an up-to-date register of all subcontractors, including its precise area of expertise and an assessment of past performance and testing results. When using a LIMS, all this information, including current certification statuses, is stored within comprehensive “supplier tables” for fast, universal access.

4.6 Purchasing Services and Supplies: Laboratories are responsible for the quality of all services and supplies that affect the quality of tests or calibrations. Specific procedures must be in place for the purchase, receiving and storage of all supplies and consumables, and failure to verify and document compliance with a stored consumable constitutes non-compliance. Using a paper-based process, compliance is nearly impossible. With a LIMS, however, all supplier statuses, including reagents and other consumables, are easily managed using “supplier management” entry screens that feed into real-time reports and dashboards.

4.8 Complaints: ISO 17025 requires that laboratories have policies and procedures in place to resolve complaints. This includes a full record of investigations and corrective actions taken, if necessary. With a LIMS, all this information is easily captured and stored within an incident summary, ensuring compliance and providing an historical record for avoiding such issues in the future. In SampleManager LIMS, this incident management capability can also be using to assign and track actions due to “non-conforming work,” which is addressed in section 4.9 of ISO 17025.

4.11 Preventative Action: ISO 17025 includes provisions for prevention as well complaint resolution. This is one of places where the regulations align with the LIMS “best practices” capabilities. Several tools within SampleManager, for example, help proactively identify issues before they become serious or systemic. In addition, Analytical Quality Control functionality can detect problems with running analyses, and the data feeds into a built-in statistical quality control (SQC) package to proactively monitor analyses, identify trends and highlight potential issues.

(ID:42278760)

LIMS/Standards