Kein Folientitel

Kein Folientitel

Fit for Purpose A Customers View Bernd Wenclawiak Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Analytical measurements should be made to satisfy an agreed requirement Wenclawiak, B.: Fit for Purpose A Customers View

In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Analytical measurements should be made using methods and equipment which have been tested to ensure they are fit for purpose Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Staff making analytical measurements should be both:

qualified and competent to undertake the task and demonstrate that they can perform the analysis properly Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching There should be a regular independent assessment of the technical performance of a laboratory Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003

Quality Assurance in Analytical Chemistry Training and Teaching Analytical measurements made in one location should be consistent with those made elsewhere Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Organizations making analytical measurements should have well defined quality control and quality assurance procedures Wenclawiak, B.: Fit for Purpose A Customers View

In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Method validation is an important requirement in the practice of chemical analysis Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching What is Validation? Confirmation by examination and provision of objective evidence that the particular requirements for a

specified intended use are fulfilled ISO 8402 (1994) Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching What is Method Validation? - 1 The process of establishing the performance characteristics and limitations of a method and the identification of the influences which may change these characteristics and to what extent. Which analytes can it determine in which matrices in the presence of which interferences? Within these conditions what levels of

precision and accuracy can be achieved? Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching What is Method Validation? - 2 The process of verifying that a method is fit for purpose, i.e. for use for solving a particular analytical problem This means the method must be suitable Method validation is not solely the process of evaluating the performance parameters Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.)

Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching The Method Validation Process Implies: the use of equipment within its specifications that the operator is fit for purpose Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Why is Method Validation Necessary? Importance of analytical measurement

The professional duty of the analytical chemist Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching When should Methods be Validated ? Comparing methods Replacement of instruments Change of operator Other significant changes Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.)

Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching How should Methods be Validated? Who carries out method validation? Deciding what degree of validation is required The analytical requirement Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Choosing, Developing and Evaluating Methods Problem requiring chemical analysis:

Set analytical requirement Develop method Yes Identify existing method or develop new method Method validation consists of this evaluation stage, together with any performance parameters that may be evaluated under method development Fit for purpose... . Regardless of what existing performance data may be available for the method,

fitness for purpose will be Evaluate method fit for purpose as used in the laboratory Yes No Further development feasible? Yes No Relax

analytical requiremen t ? No Analytical work proceeds Unable to do work subcontract? Analytical requirement re-stated in terms of what has been accomplished En d

Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching How should Methods be Validated? Who carries out method validation? Deciding what degree of validation is required The analytical requirement Method Development The different performance parameters of a method and what they show Wenclawiak, B.: Fit for Purpose A Customers View

In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching How should Methods be Validated? The different performance parameters of a method and what they show Confirmation of identity and selectivity/specificity Limit of detection Limit of quantitation Working and linear ranges

Accuracy Trueness Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching How should Methods be Validated? Interpreting bias measurements Measured value (laboratory mean) True value Total bias Interlaboratory mean

Laboratory bias Method bias Note: Laboratory and method biases are shown here acting in the same direction. In reality this is not always the case Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching How should Methods be Validated? The different performance parameters of a method and what they show

Confirmation of identity and selectivity Limit of detection Limit of quantitation Working and linear ranges Accuracy Trueness Interpreting bias measurements

precision repeatability reproducibility sensitivity ruggedness or robustness recovery Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching How should Methods be Validated? The different performance parameters of a method and what they show

Confirmation of identity and selectivity Limit of detection Limit of quantitation Working and linear ranges Accuracy Trueness Interpreting bias measurements

precision repeatability reproducibility sensitivity ruggedness-robustness recovery Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching The Tools of Validation

Blanks reagent blanks sample blanks Samples/test materials fortified materials/solutions spiked materials incurred materials independently characterised materials (Measurement) Standards Reference Materials

Certified reference materials Statistics Replication Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Using Validated Methods Two issues to consider: are existing validation data adequate is the analyst sufficiently competent can he achieve the performance level claimed in the method? Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.)

Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Rules Recommended to Ensure Acceptable Performance Analyst should be familiar with method before using it for the first time Work firstly under supervision get training think ahead of process, solutions etc required Make an assessment how many samples can be handled at a time Make sure everything needed is available before work starts Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.)

Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Using Validation Data to Design QC Internal QC External QC Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Using Validation Data to Design QC Internal QC includes:

blanks chemical calibrants spiked samples blind samples replicate analysis QC samples control charts (recommended) Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003

Quality Assurance in Analytical Chemistry Training and Teaching Using Validation Data to Design QC External QC e.g. proficiency testing (external quality assessment) participation in proficiency testing schemes Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Documentation of Validated Methods 1 When the validation process is complete document the procedures of the method (also important for auditing and evaluation purposes)

With appropriate documentation reuse of method is more consistent uncertainty contribution is decreased Test quality of documentation with a competent colleague Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Documentation of Validated Methods 2 Standard guidance for documentation is found in ISO 78 series house style is also adequate Documented methods form an important part of a labs quality system

document control is documentation complete authorized for use which version which date author copyrights when last updated Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.)

Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Method Documentation Protocol Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Implications of Validation Data for Calculating Results and Reporting Translate data in results to solve customers problem Consider: are observed differences significant? precision data for repeatability and reproducibility

Quality controls confirm method is in control based on validation data producing meaningful results Estimation of measurement uncertainty enables expression for level of confidence Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching Implications of Validation Data for Calculating Results and Reporting The analyst needs access to validation data to support validity of results The customer may not need or understand it

Information about uncertainties might not be understood by everybody (lawyers) When required: uncertainty should be reported (confidence limits e.g. 95 %) Wenclawiak, B.: Fit for Purpose A Customers View In: Wenclawiak, Koch, Hadjicostas (eds.) Springer-Verlag Berlin Heidelberg 2003 Quality Assurance in Analytical Chemistry Training and Teaching

Recently Viewed Presentations

  • Sequences and Series 1.7 & 1.8 - Math Exams

    Sequences and Series 1.7 & 1.8 - Math Exams

    In maths, we call a list of numbers in order a sequence. ... These ideas can be discussed in more detail during the plenary session at the end of the lesson. A sequence can be infinite. That means it continues...
  • LESSON 5: LQ: Can I analyse the presentation of courtly love ...

    LESSON 5: LQ: Can I analyse the presentation of courtly love ...

    Love: platonic, courtly, unrequited, godly, familial, illicit, adulterous, lustful. ... Some readers see the poem as Keats' personal rebellion against the pains of love. In his letters and in some of his poems, he reveals that he did experience the...
  • Geometry Presentation - Kentucky Transportation Cabinet

    Geometry Presentation - Kentucky Transportation Cabinet

    * * * * * * * * You don't have to be a genius to be an engineer, but people who become engineers like math, science, and problem solving. * In general this is a flow chart of the...
  • SSIP Review Process - NYSED

    SSIP Review Process - NYSED

    Smart Schools Bond Act Update. 52 districts have approved Smart Schools Investment Plans ($4 million in High-Tech Security planned) ~140 districts have submitted and are in various stages of review
  • ADL CODING IMPACTS THE MDS FOCUSED SURVEY TERRY

    ADL CODING IMPACTS THE MDS FOCUSED SURVEY TERRY

    I wanted to talk a little about the financial importance of ADL coding. Both Medicare and Medicaid have RUG classification systems in Pennsylvania. The Medicare is a 66 RUG system and Medicaid is a 44 RUG system. They both have...
  • 7.3 Volumes - Oxford School District

    7.3 Volumes - Oxford School District

    Volumes with Known Cross Sections. A solid has as its base the circle x2 + y2 = 9, and all cross sections parallel to the y-axis are squares. Find the volume of the solid. Solids with Known Cross Sections. If...
  • Voetbalquiz 2018 - VV SJS

    Voetbalquiz 2018 - VV SJS

    Ron Jans heeft de meeste wedstrijden op zijn naam staan als hoofdtrainer van FC Groningen; ruim 300. Welke hoofdtrainer volgt met 270 wedstrijden? Hans Westerhof. Ronde 2: Vraag 5. Foppe de Haan was hoofdtrainer van Heerenveen van 1992-2004. Hij keerde...
  • Fluid Dynamics with Erosion Brandon Lloyd COMP 259

    Fluid Dynamics with Erosion Brandon Lloyd COMP 259

    Fluid Dynamics with Erosion Brandon Lloyd COMP 259 May 2003 Overview Sediment transport in open channels Bed-load transport Suspensed transport Sediment transport models Model used for this project Implementation issues Future work Sediment Transport Bed-load transport: sliding, rolling, saltating Suspended...