February
2014
OilfieldTechnology
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using ‘suppliermanagement’ entry screens that feed into
real time reports anddashboards.
4.8Complaints
ISO17025 requires that laboratories havepolicies andprocedures
inplace to resolve complaints. This includes a full recordof
investigations and correctiveactions taken, if necessary.With
aLIMS, all this information is easily capturedand storedwithin
an incident summary, ensuring complianceandproviding
anhistorical record for avoiding such issues in the future. In
SampleManager LIMS, this incidentmanagement capability can
alsobeused toassignand trackactionsdue to “non‑conforming
work,”which is addressed in section4.9of ISO17025.
4.11Preventativeaction
ISO 17025 includes provisions for prevention aswell complaint
resolution. This is one of theplaceswhere the regulations align
with the LIMS ‘best practices’ capabilities. Several toolswithin
SampleManager, for example, helpproactively identify issues
before they become serious or systemic. In addition, analytical
quality control functionality candetect problemswith running
analyses, and thedata feeds into abuilt‑in statistical quality
control (SQC) package toproactivelymonitor analyses, identify
trends andhighlight potential issues.
Technicalrequirements
The technical requirements section addresses themyriad factors
that influence the correctness and reliability of laboratory
tests and calibrations. These factors range frompersonnel to
equipment andhandling.
5.2Personnel
ISO17025 requires that laboratorymanagement take full
responsibility for theongoing competencyof all staff at all
stages of testingandanalysis. For this, aLIMS isparticularly
useful; not only for compliance, but also for ensuring that staff
remainproperly trainedand certified. SomeLIMS systemswith
an ‘Operator Training’ functionality can set specificuser input
restrictions so that onlypersonnelwhoare certifiedonparticular
instruments, analyses or preparations canenter ormodifydata
associatedwith these items. These rules and requirements can
changewith staff turnover, or as requirements or training results
change.
5.4Testandcalibrationmethodsincludingsampling
Using appropriatemethods andprocedures for tests and
calibration is asmuch about best practices as it is compliance.
ISO 17025 requires that labs have easily accessible instructions
for operation andhandling of instruments and test samples,
that allmethods are appropriate and compliant/current and
that personnel have the requisite experience touse themethod.
Calibration standards need tobe fully tracked throughout their
lifetime, so the LIMS stores up‑to‑date inventory andpreparation
records, usage and expiry data. The system also stores a full
audit trail of anymodifications, and labs can implement
electronic signature controls for added securitywhen standards
are authorised for use.
SampleManager LIMS also supports validationofmethods,
requiredunder section 5.4.5. This critical function for any oil and
gas laboratory is addressed throughAQCWorksheets that enable
analytical QA/QC support. This is done through abatch system
that augmentsQAoperations by including spiked samples,
recoveries and surrogate support in the analytical sequence.
Once the labdetermines analysis parameters, the results for
both analytical and standard samples are stored in the LIMS for
future compliance reporting.
5.5Equipment
ISO 17025makes it clear that all equipmentmustmeet the
requiredperformanceparameters for its stateduse. The
requirements relate to samplepreparation, testing, processing
and analysis, and this also extends to equipment that is outside
the lab’s permanent control. To accomplish this, the LIMS
maintains comprehensive records for each instrument aswell
as eachof its components and complete calibrationhistory and
status. Having this information tohandmeans that it is possible
to identify the exact instrument configurationdeployed at any
point in time to test aparticular sample.
5.7–5.9Samplingplan,handlingandtransport,assuringthequality
oftestandcalibrationresults
ISO17025 requires that labs havedefinedprocedures for sampling
plans, handlingand transportationof samples, as
well as themanagement of calibration items and for ensuring
thequalityof results. Although theseprocedures canbe
complex and time‑consumingwithout a systemof record, with
LIMS it ispossible to createa samplingplan froma template
that automatesmanyof thenecessary steps. Toaddress handling
requirements, for example, each laboratory samplehas aunique
identifier, which is combinedwitha full lifecycle (from receipt
todisposal) that canbe tracked through theLIMS. Hierarchical
definitions allow real lifephysical locations tobemapped, and the
assignment ofmaterials, samples andequipment tobe tracked
andaudited. Formonitoring thequalityof results for tests and/or
calibrations, theLIMSautomates established statistical analytical
quality control techniques toensure the reliabilityof theprocess
andequipment beingdeployed.
5.10Reportingtheresults
No laboratorywoulddispute the ISO17025 requirement that each
test or calibration carriedout shouldbe reported “accurately,
clearly, unambiguouslyandobjectively.” Thatwouldbeabest
practice. But this is easier said thandone, andnearly impossible
without software. ALIMSprovides apowerful and flexible
reporting tool that generatesmultiple reports fromdata stored
within the system. The reports, which canbe customisedas
needed, aredesignedwithoil andgas laboratories inmind. The
system ispreconfigured for rapid, cost‑effective implementation.
Conclusion
ISO 17025 compliance in the oil and gas industry is not easy,
especially in labs still usingpaper‑basedprocesses, but for
those labs that take a comprehensive approach thebenefits are
significant. Complianceprocesses canbepart of an integrated
programme that improves overallmulti‑facility performance
andprofitability. ARCAdvisoryGroup ismoredirect, stating
that: “Compliancewith ISO 17025demonstrates a commitment
toquality andprovides customers the assurance that the
laboratory’smanagement and technical requirements adhere to
globally acceptedbest practices.”
Sowhether anoil and gas laboratory startswith regulation
as its impetus or simplywants to improve quality, the end result
withSampleManager LIMS is the same: an integrated system that
candeliver thebest of bothworlds.
