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Sakhalin Energy: Automating laboratory best practices with LIMS

27th August 2013

This article explores how an integrated data management solution, such as Thermo Fisher’s LIMS can help oil and gas companies adhere to ISO 17025 standards and how that can be a catalyst for better overall performance

Sakhalin Energy: Automating laboratory bast practices with LIMS
Sakhalin Energy standardized on SampleManager LIMS for its main lab located at the LNG plant/oil export terminal, as well as upstream satellite labs

What if ISO 17025 wasn’t a standard, but instead a technology that automated laboratory best practices? What if following the regulations to the letter – often without even thinking about it – actually led to better overall business performance? In that case, it’s likely every business would aggressively deploy that technology.

 

“That technology” does indeed exist, and it’s commonly known as LIMS, short for a laboratory information management system, an essential data management and enterprise integration tool for managing laboratory workflow, samples, reporting and compliance requirements. And while many in the oil and gas industry think of LIMS as a way to manage important data, it is, in fact, much more than that. Paula Hollywood of ARC Advisory recently wrote that “hydrocarbon processing laboratories are becoming almost like third-party service laboratories… this means that accreditation with standards such as ISO 17025 is no longer just nice to have, but a necessity to ensure conformance and customer satisfaction”. 

 

A “necessity for customer satisfaction” doesn’t sound anything like onerous regulation. Instead it sounds like a catalyst that is part technology, part discipline and all-encompassing. In other words, when you think of ISO 17025, don’t think compliance, think higher-quality product.

 

But certainly conforming to ISO 17025 standards is time-consuming, costly and technologically complex.  It covers everything from contract review to method validation and quality assurance. One does not simply check a few boxes to stay in compliance; if it were that easy it wouldn’t be so beneficial in the long run. But getting into compliance – and realising the benefits of doing so – doesn’t need to be overly costly or time-consuming. This article will explain how this is possible today.

 

How a Designed-for-Purpose LIMS Supports ISO 17025 Compliance

 

Sections 4 and 5 of ISO 17025 are the primary areas of alignment between regulatory compliance and LIMS functionality. In fact, Thermo Scientific SampleManager is preconfigured for compliance; no additional programming or bolt-on modules are required. For an onsite or third-party laboratory in the oil and gas industry, built in functionality saves time, money and months of aggravation that can be associated with custom software development.

 

At a glance, sections 4 and 5 of ISO 17025 resemble a list of best practices for any lab.  But what’s spelled out in each section is more complex than many realise. With so many interdependencies and so much relational data, it’s nearly impossible to manage without assistance from software. Certainly, some have developed home-grown paper systems that seem intuitive, but ultimately they can’t scale, often contain troublesome, burdensome processes, and can be slow to track down data, especially during an audit.

 

An integrated data management system, such as Thermo Scientific SampleManager LIMS, is designed to mitigate complexity, easing compliance within oil and gas laboratories and, more importantly, exposing previously unrecognised opportunities for performance improvement. Next, we’ll look at several key ISO 17025 sections, specifically “Management Requirements” and “Technical Requirements”, and discuss how LIMS is purpose-built to align with each section.

 

MANAGEMENT REQUIREMENTS

 

4.1 Organization and Management

 

Labs must not only meet standards within their own facilities, they are responsible for compliance at third-party facilities and temporary facilities as well – such as field-based labs. This not only strengthens compliance, but also establishes a quality benchmark to which all laboratory practices and data must conform. To manage this level of complexity without disrupting daily activity, a LIMS must use a web services architecture that is both secure and extensible.

 

Proper security controls are especially important for external laboratories – and those doing business with them – because proprietary, confidential data is continuously stored and accessible. A proven LIMS will address this by providing “group security”, which limits access to specific projects or clients, and by providing native browser encryption (SSL) for web access.

 

4.2 Quality System

 

Quality and consistency are merely concepts unless policies, systems and programmes are documented and reinforced. ISO 17025 not only calls for documentation of quality systems and procedures, it requires that it “be communicated to, understood by, available to and implemented by” appropriate personnel. The LIMS system can be the conduit for quality system documentation and reinforcement. Not only can relevant quality information be stored within the LIMS – or easily accessible through the LIMS via an intranet, but labs can also insert hyperlinks on landing pages and dashboards within the LIMS as just-in-time reminders to staff of quality system requirements.

 

4.3 Document Control

 

Document control is an important component of a quality system. All documents generated internally or externally must be indexed and available on-demand. This includes any document type, including drawings, manuals and methods. The LIMS can store relevant documents in nearly any standard format as an attachment, making compliance with document control a natural extension of routine laboratory work.

 

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 delivering on its promise of providing 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. SampleManager 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, jeopardise a customer relationship.

 

Once work is complete, the LIMS also plays a significant 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. ISO 17025 requires that laboratories be 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 used 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 the places where the regulations align with 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 (AQC) 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.

 

TECHNICAL REQUIREMENTS

 

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 with staff turnover and 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 authorised 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 AQC 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 customised as needed, are designed with oil and gas laboratories in mind.  The system is preconfigured for rapid, cost-effective implementation.

 

Conclusion

 

ISO 17025 compliance in the oil and gas industry isn’t easy, especially in labs still using paper-based processes, but for those labs that take a comprehensive approach the benefits are significant. Compliance processes can be part of an integrated program that improves overall multi-facility performance and profitability. ARC Advisory is more direct, stating that: “Compliance with ISO 17025 demonstrates a commitment to quality and provides customers the assurance that the laboratory’s management and technical requirements adhere to globally accepted best practices.”

 

So whether an oil and gas laboratory starts with regulation as its impetus or simply wants to improve quality, the end result with LIMS is the same: an integrated system that can deliver the best of both worlds. And, with systems such as SampleManager LIMS pre-configured for the industry, getting up-and-running on the road to compliance and higher performance is only a log-in screen away.

 

 

This was article was written By Colin Thurston, director of product strategy, Process Industries, Thermo Fisher Scientific.