Chapter 1 -Background And Principles

Chapter 1 - Backgroundand PrinciplesBy J.E.J. (Ned) GravelCourse Outline Introduction – Welcome and objectives Chapter 1 – Background and principles Chapter 2 – Basic technical requirements Chapter 3 – Technical measurement requirements------------------------- Chapter 4 – Basic management system requirements Chapter 5 – Active management system requirements Chapter 6 – Monitoring and measuring the quality systemWhy laboratories need or want aquality system? Improve the consistencyquality) of lab results.(and/or Demonstrate competence to a client ora regulatory agency. Meet a market specification fromlaboratory clients (market) or aregulatory agency to stay in business.1

Consistency is the Aim“We can produce consistentresults, day after day, withintheninety-fivepercentconfidence region. Day afterday.”Drawing by Iutta Waloschek.From the website of the University of St. Andrews,Scotland. www-gap.dcs.stand.ac.uk/ history/PictDisplay/Einstein.htmlDescription of the Perfect Lab“An organisation that produces consistentresults, day after day after day after day . atspecifieduncertaintieswithinthe95%confidence region.” Sounds boring to the marketing types butnot to lab people. It is about the science It is about consistency It is about technical competenceRationale for ISO/IEC 170251.2.3.4.There is only one question.What does the standard require?Participants select their own answers.The whole group is balloted for the most appropriateresponse.5. Clapping indicates a correctly answered question.Buzzer indicates an incorrectly answered question.6. The citation from the standard is displayed next to themost correct answer.7. The quiz then advances to the next question.Press2

Rationale for ISO/IEC 17025Rationale for ISO/IEC 17025Introduction:ISO/IEC 17025 is primarily to allow laboratoriesto satisfy customer requirements.A. TRUEB. FALSEC. NOT APPLICABLE17025 Labs produce Consistent Results.Proof is in PT Scores.Accredited laboratories achieved higher scores, a greater number of perfectscores, and fewer unsatisfactory scores in each of the five parameters. Seewww.cala.ca/perfacred-2001.pdf.3

Quality SurveyWhich has more quality? The1999 Rolls Royce SilverCloud? The 1956 Massey-Ferguson?Competence ComponentsThe laboratory with: The People with the Skills and Knowledge The Environment with the Facilities andEquipment The Quality Control, and The ProceduresAll aimed at producing valid results.CompetenceAsk your clients and regulators which is mostimportant:A. Labs conform to an international standardB. Labs are competentC. Labs produce valid (correct) resultsThey will respond in this priority:1. Correct results2. Competence3. Conformance to a standard4

Competence Laboratory clients and regulators want labs to be correctand that it is telling them the truth. They want to trustthat both of these conditions exist whenever a labproduces a result. Instead of facing all of the labs andasking them if (and how) they would do this, many havecome to trust an organisation whose recognition of thelaboratory indicates that both conditions are being met. That type of organisation is a recognised accreditationbody.Standards vs RegulationsApproachDocument/Specification(W hat is it?)(1)RegulatorySpecifier(W ho wants it?)RegulationProcess(How do they get dardisationApproachVoluntary StandardMarketConformity Assessment(Voluntary) Red Govt Regulation, ENFORCED by Inspectors through INSPECTION- FDA Lab Licensing Fail to comply? Jail or fines Black Govt Regulation, MONITORED through Audits for CONFORMANCE- Most Lab Accreditation Fail to conform? Lose registration Blue Market Demand, MONITORED through Assessments for COMPETENCE- ISO 9000. Fail to demonstrate competence? Lose accreditationThe Scope of Lab OperationsContactSamplingReportingFeedbackPROCESS CONTROLQuality Control (QC)SalesPreparation of ProcessTesting/Calibration/Inspection Data ValidationPost SalesCONTROL OF DATAQuality Assurance (QA)QUALITY MANAGEMENT SYSTEMS (QMS)Includes all functions that influence the validity of technical results All All All All All All Allbusiness operations functionsmanagement and administrative functionsfinance functionsHR functionspurchasing and contract review functionsmarketing and communications functionsmaintenance functions5

Quality Control and Quality Assurance Quality control activities are aimed atensuring the processes continue to be fitfor purpose. Quality assurance activities are aimed atensuring the results of the processescontinue to be fit for purpose. A quality management system covers bothof these disciplines and the othersupporting procedures used to ensure thata laboratory produces technically validresults.The Documents that Govern ISO/IEC 17025 and accreditation body Interpretationsof the Requirements in 17025 Accreditation body criteria documents will normallyinclude:– Traceability– Uncertainty– Method Validation– Detection Limits– Acceptable range of measurement– Internal Audit / Management Review– Use of ITWhere to Start? ISO/IEC 17025 - General Requirementsfor the Competence of Testing andCalibration Laboratories. Sometimes called “Quality Systems forDummies.”6

Principles behind ISO/IEC 17025 These principles are about the standard - they are notthe standard. They are a guide to understanding“WHY” a particular requirement exists within thestandard. These principles do not replace any requirement orgroups of requirements in the standard. These principles are just one more way of looking atthe basis of the requirements.Principles behind ISO/IEC 17025 CapacityExercise of ResponsibilityScientific MethodObjectivity of ResultsImpartiality of ConductTraceability of MeasurementRepeatability of TestTransparency of ProcessCapacityConcept that a laboratory has the resources(PEOPLE with the required skills andknowledge, the ENVIRONMENT with therequired facilities and equipment, the QUALITYCONTROL, and the PROCEDURES) in order toundertake the work and produce competentresults.7

Exercise of ResponsibilityConcept that persons in the organisationhave the authority to execute specificfunctions within the overall scope of work –and that the organisation can demonstrateaccountability for the results of the work.Scientific MethodConcept that the work carried out by the organisationis based on accepted scientific approaches,preferably consensus-based, and that any deviationsfrom accepted scientific approaches can besubstantiated in a manner considered generallyacceptable by experts in that field.Objectivity of Results Concept that the results produced within the scopeof work of the organisation, are mainly based onmeasurable or derived quantities. Concept that subjective test results are producedonly by persons deemed qualified to do so and thatsuch results are noted as being subjective or areknown by experts in the field of testing to be mainlysubjective.8

Impartiality of ConductConcept that the pursuit of competentresults through the use of generallyaccepted scientific approaches is theprimary and overriding influence on thework of persons executing tests - allother influences being consideredsecondary and not permitted to takeprecedence.Traceability of Measurement Concept that the results produced, within the scope ofwork of the laboratory, are based on a recognisedsystem of measurement that derives from accepted,known quantities (SI system) or other intrinsic or wellcharacterised devices or quantities. Concept that the chain of comparison of measurementbetween these accepted, known quantities or intrinsicdevices or quantities, and the device providing theobjective result, is unbroken for the transfer ofmeasurement characteristics, including uncertainty, forthe whole of the measurement chain.Repeatability of TestConcept that the test which producedthe objective results, will produce thesame results, within accepted deviationsduring subsequent testing, and withinthe constraints of using the sameprocedures, equipment and personsused during a previous execution of thetest.9

Transparency of ProcessConcept that the processes existentwithin the laboratory producing theobjective results, are open to internaland external scrutiny, so that factorswhich may adversely affect thelaboratory's pursuit of objective resultsbased on scientific method, can bereadily identified and mitigated.10

1 Chapter 1 -Background and Principles By J.E.J. (Ned) Gravel Course Outline Introduction –Welcome and objectives Chapter 1 –Background and principles Chapter 2 –Basic technical requirements Chapter 3 –Technical measurement requirements----- Chapter 4 –Basic management system requirements