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OilfieldTechnology
February
2014
that is part technology, part discipline and all encompassing.
Inotherwords, when somebody thinks of ISO 17025, insteadof
thinking ‘compliance’, they shouldbe thinking ‘higher‑quality
product.’
But certainly conforming to ISO 17025 standards is
time‑consuming, costly and technologically complex. It covers
everything from contract review tomethod validation and
quality assurance. Onedoes not simply check a fewboxes to stay
in compliance; if itwere that easy itwouldnot be sobeneficial
in the long run. But getting into compliance – and realising
thebenefits of doing so – does not need tobe overly costly or
time‑consuming. The rest of this articlewill explainhow this is
possible today.
Howapurpose‑builtLIMSsupportsISO17025
compliance
Sections 4 and 5 of ISO 17025 are theprimary areas of alignment
between regulatory compliance and LIMS functionality. In fact,
ThermoScientific SampleManager LIMS is preconfigured for
compliance; no additional programming or bolt‑onmodules
are required. For anonsite or thirdparty laboratory in the oil
and gas industry, built‑in functionality saves time,money and
months of aggravation that canbe associatedwith custom
softwaredevelopment.
At a glance, sections 4 and 5 of ISO 17025 resemble a list
of ‘best practices’ for any lab. Butwhat is spelledout in each
section ismore complex thatmany realise. With somany
interdependencies and somuch relational data, it is nearly
impossible tomanagewithout assistance from software.
Certainly, some havedevelopedhome‑grownpaper systems that
seem intuitive, but ultimately they cannot scale, often contain
troublesome, burdensomeprocesses and canbe slow to track
downdata, especially during an audit.
An integrateddatamanagement system, such as
SampleManager LIMS, is designed tomitigate complexity, easing
compliancewithinoil and gas laboratories and,most important,
exposingpreviously unrecognisedopportunities for performance
improvement.
Managementrequirements
4.1Organisationandmanagement
Labsmust not onlymeet standardswithin their own facilities;
they are responsible for compliance at thirdparty facilities and
temporary facilities, such as field‑based labs, aswell. This not
only strengthens compliance, but also it establishes aquality
benchmark towhich all laboratory practices anddatamust
conform. Tomanage this level of complexitywithout disrupting
daily activity, a LIMSmust use aweb services architecture that is
both secure and extensible.
Proper security controls are especially important for external
laboratories – and thosedoingbusinesswith them, because
proprietary, confidential data is continuously stored and
accessible. Aproven LIMSwill address this by providing ‘group
security,’ which limits access to specific projects or clients, and
by providingnativebrowser encryption (SSL) forweb access.
4.2Qualitysystem
Quality and consistency aremerely concepts unless policies,
systems andprogrammes aredocumented and reinforced.
ISO 17025 not only calls for documentationof quality systems
andprocedures, it requires that it “be communicated to,
understoodby, available to and implementedby” appropriate
personnel. The LIMS system canbe the conduit for quality
systemdocumentation and reinforcement. Not only can
relevant quality informationbe storedwithin the LIMS – or
easily accessible through the LIMS via an intranet, but labs can
also insert hyperlinks on landingpages anddashboardswithin
the LIMS as just‑in‑time reminders to staff of quality system
requirements.
4.3Documentcontrol
Document control is an important component of aquality
system. All documents generated internally or externallymust be
indexed and available on‑demand. This includes any document
type, includingdrawings,manuals andmethods. The LIMS can
store relevant documents innearly any standard format as
an attachment,making compliancewithdocument control a
natural extensionof routine laboratorywork.
4.4Reviewofrequest,tenderorcontract
Anoil and gas laboratorymust demonstrate that it has the
requisite experience, capabilities and resources tomeet the
requirements of the client (whether internal or external).
This ensures that the laboratory is actually capable of
meeting its promise toprovide quality results. Because the
LIMSoffers a system‑wide viewof resources,methods,
instrument calibration etc., it plays an important role in the
contract reviewprocess. SampleManager LIMS, for example,
pulls indata fromoperator loading reports toprovide real time
insight intooperatorworkload andpossible resource conflicts.
This avoids post‑contract surprises that could trigger a
compliance audit or,muchworse, jeopardise a customer
relationship.
Oncework is complete, the LIMS alsoplays an important
role inmatching final delivery andpricing to scope of work.
The LIMS tracks the handling of surface and subsurface oil and
gas samples at all stages of the extraction and refiningprocess
from their delivery into the lab to the returnof results to the
customer. Everything is documented, ensuring full compliance
andproviding a record trail useful inongoingquality control and
efficiency analysis.
4.5Subcontractingoftestsandcalibrations
Testing overflow is common, but cannot be handled
haphazardly. ISO17025 requires that laboratories are able to
“demonstrate” that any subcontractor is “competent toperform
the activities inquestion,” and that it is also in compliancewith
the standards. A labmust thereforemaintain anup‑to‑date
register of all subcontractors, including its precise areaof
expertise and an assessment of past performance and testing
results. Whenusing a LIMS, all this information, including
current certification statuses, is storedwithin comprehensive
‘supplier tables’ for fast, universal access.
4.6Purchasingservicesandsupplies
Laboratories are responsible for the quality of all services and
supplies that affect the quality of tests or calibrations. Specific
proceduresmust be inplace for thepurchase, receiving and
storage of all supplies and consumables, and failure to verify
anddocument compliancewith a stored consumable constitutes
non‑compliance. Using apaper‑basedprocess, compliance is
nearly impossible. With a LIMS, however, all supplier statuses,
including reagents andother consumables, are easilymanaged
