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Practical Solutions toTraceability and Uncertainty inAccreditationPresented to CITAC NCSLI Joint Workshop Traceability and Uncertainty .
Key Technical Issues and LaboratoryAccreditation PITTCON 2002 New OrleansSunday 17 March 2002Warren Merkel A2LA Technical Manager.
American Association for Laboratory Accreditation Presentation Overview Relevant ISO IEC 17025 Requirements Accreditation Body Policies Practical Approaches for Laboratories.
Future Developments QuestionsAmerican Association for Laboratory Accreditation Measurement Traceability 17025 Requirements.
Calibrations reference materials traceable toSI where possible Where not possible traceable to certifiedreference materials agreed methods and orconsensus standards.
Unless it has been established that theassociated contribution from the calibrationcontributes little to the total uncertainty of thetest resultAmerican Association for Laboratory Accreditation.
Traceability Definition Relation to stated references through anunbroken chain of comparisons Traceability to some stated reference availablewith most RMs.
Normally not SI unit for amount of substance butoften other SI units All having stated uncertainties Little evidence of verification of uncertainty claimsAmerican Association for Laboratory Accreditation.
Traceability in Practice In many cases traceability to the test method isall that is required by clients Uncertainty statements on RMs are important but usually not a significant contributor to.
uncertainty of test Performance in proficiency tests can serve asan indicator of traceability problemsAmerican Association for Laboratory Accreditation Measurement Uncertainty .
17025 Requirements 5 4 6 2 Testing laboratories shall have and applyprocedures for estimating uncertainty of measurement Nature of the test method may preclude rigorous metrologically and statistically valid calculation of.
uncertainty of measurement Laboratory shall at least attempt to identify alluncertainty components make a reasonable estimation and ensure that the form of reporting of result doesnot give a wrong impression of uncertainty.
American Association for Laboratory Accreditation Measurement Uncertainty 17025 Loopholes Note 1 Degree of rigor depends on Requirements of the method.
Requirements of the client Existence of narrow limits on specification conformance Note 2 In cases where a well recognized test methodspecifies limits to the values of the major sources ofuncertainty and specifies the form of presentation of.
calculated results the laboratory is considered to havesatisfied this clause by following the test method andreporting instructionsAmerican Association for Laboratory Accreditation Measurement Uncertainty .
17025 Reporting Requirements 5 10 3 1 c Information on uncertainty is neededin test reports when it is relevant to the validity orapplication of the test results when a client sinstruction so requires or when the uncertainty.
affects compliance to a specification limit 5 10 1 In the case of a written agreement with theclient results may be reported in a simplified wayAmerican Association for Laboratory Accreditation A2LA Interim Policy on Measurement.
Uncertainty for Testing Laboratories Five categories of test methods Intended to facilitate transition pragmaticapproach not ideal in all cases Results from review at annual meeting .
Some modification of language Publish list of example methods for each categoryby field of testing Publish guidance on determining uncertainty intesting based on ISO 5725.
American Association for Laboratory Accreditation A2LA Interim Policy on MeasurementUncertainty for Testing Laboratories Five categories of test methods I Qualitative.
No uncertainty calculations requiredExamples Ignitability Microbiological screeningII Well recognized methods that specify limits touncertainty contributions Note 2 No further uncertainty calculations required.
Examples Flash point HardnessProblems Modification of methodWhat if a client wants uncertainty American Association for Laboratory Accreditation A2LA Interim Policy on Measurement.
Uncertainty for Testing Laboratories Five categories of test methods continued III Published methods that do not specify limits touncertainty sources and or reporting formatUncertainty estimated using standard deviation of.
laboratory control samplesExamples Alloy analysis by OES VOAProblems Normal process for analyzing controlsamples may lead to an underestimate ofuncertainty.
Quality of control sampleAmerican Association for Laboratory Accreditation A2LA Interim Policy on MeasurementUncertainty for Testing Laboratories Five categories of test methods continued .
IV Methods requiring identification of majoruncertainty components and reasonable estimateof uncertaintyExamples PBMS One off testsV Methods requiring full uncertainty analysis.
consistent with ISO Guide to the Expression ofUncertainty in MeasurementExample Reference material value assignmentAmerican Association for Laboratory Accreditation A2LA Interim Policy .
Chemical Laboratories Majority of methods classified asCategory II III IV Classification can vary by laboratory and Use of RMs critical to demonstrating.
process control and evaluating bias More practical guidance requiredAmerican Association for Laboratory Accreditation 17025 Requirements Quality Controland Proficiency Testing.
Laboratory shall have procedures for monitoringvalidity of tests including regular use of CRMs or internal QC using secondaryreference materials participation in interlaboratory comparison or proficiency.
testing programs Record data so trends are detectable Laboratories in most cases already have sufficientdata for estimating uncertaintyAmerican Association for Laboratory Accreditation.
Practical Approach Category II Laboratories performing tests in Category II canutilize precision data published with method asuncertainty estimate if Laboratory has data demonstrating that its.
repeatability is comparable to the method data Material used for precision estimate is similar tomaterials tested by lab Method not modified Basis for estimate clearly stated.
American Association for Laboratory Accreditation Practical Approach Category III Intermediate measures of precision provideadequate estimate of uncertainty if Measurement method standardized.
Measurement process is in control Control sample well characterized preferably CRM Process for collecting data designed to vary allsignificant uncertainty componentsAmerican Association for Laboratory Accreditation.
Steps Laboratories Can Take Identify major uncertainty components App D of EURACHEM CITAC Guide Establish control charts ISO 8258 Attempt to design QC process to ensure representative.
variation of inputs Fewer points more emphasis on design May need to record additional data related to precisionas objective evidenceAmerican Association for Laboratory Accreditation.
Steps Laboratories Can Take When required to report uncertainty clearlydefine the basis for the estimate Clarify during contract review process If possible determine with client end use of data.
Make use of PT study data Compare internal precision data to spread of results ofparticipants If study based on reference value compare lab result uncertainty with reference.
American Association for Laboratory Accreditation Future Developments Consensus method development More rigor in precision data Additional detail regarding uncertainty sources.
Accreditation of RM producers Increased focus on PT based on referencevalues vs consensus values Increased awareness of traceability uncertaintyissues in user community.
American Association for Laboratory Accreditation Conclusions Accreditation bodies and laboratoriesreconciling 17025 requirements that areahead of the state of development in many.
industries Pragmatic approach to requirements is Goal provide data that is fit for purposeAmerican Association for Laboratory Accreditation Contact Information.
Warren Merkel5301 Buckeystown Pike Suite 350Frederick MD USA 21704Direct line 301 644 3204Main 301 644 3248.
Fax 301 662 2974wmerkel a2la orgwww a2la orgAmerican Association for Laboratory Accreditation.
Methods requiring identification of major uncertainty components and reasonable estimate of uncertainty Examples: PBMS; One-off tests V. Methods requiring full uncertainty analysis consistent with ISO Guide to the Expression of Uncertainty in Measurement Example: Reference material value assignment A2LA Interim Policy - Chemical Laboratories ...

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