OPTIMISING CHEMICAL ANALYSIS FOR THE WFD BY QUALITY ASSURANCE PROCEDURES & ACCREDITATION

An Overview

Michael Jackman, Chemical Expert

Module 2: Water Budget, Pressures and Impacts, Significant Water Management Issues,

Monitoring, Characterization Report

Objectives

To ensure the National Information is optimised for the WFD the data must be correct.

To achieve this there must be satisfactory laboratory quality assurance procedures in place

Laboratory Accreditation

To ensure the laboratories results are credible, ideally the laboratory should be optimum quality assurance which are outlined in accreditation procedures.Accreditation can be: National, International EN ISO/IEC 17025:2005, Good Laboratory Practice GLP Organization for Economic Cooperation and Development (OECD)  This consists of many components and are formally defined in the Quality Manual.

QA Manual

The QA Manual defines the quality assurance management procedures for:

 StaffEquipment, reagents & standards.SamplingAnalysisQuality ControlData managementDocumentation & Reporting

Laboratory Staff Mission Statement of the Laboratory’s standard.Diagram of Staff Reporting StructureStaff Organisational Plan with their roles and responsibilities.Terms of reference for each staff member. Ensure confidentiality of results Analysts’ Training record and requirements.Independent Quality Control Manager Adequate Supervision of Staff Ensuring staff are competent in undertaking the analysis (Training Certificates)

Analytical Equipment Equipment maintenance plans,Calibration procedures Logs of performance and maintenance.Operational Manuals.

Standards & ReagentsStock standards should be certified.Quality Control Standards should be from a different source than the Calibration StandardsAll standards and reagents should have shelf life date – (Date Received & serial number)Stock Control system

Laboratory AnalysisRecord of Method Validation Methods’ specifications.Standard operating procedures (SOP) for each method.Use 3 working standardsRecord of:Date of analysis, Analyst ResultAQC resultsCalculationAny relevant environmental conditions temperature, biological sterility

Sampling SOP for sampling procedure, transport & preservation of sample.Sampling ScheduleRegistration of the samples, submitted to the Laboratory- Chain of Custody.Record Condition of Sample

Analytical Quality ControlSOP for Quality ControlInternal & External AQCMethod Validation Procedures Corrective and Protective Actions Audit Trails predetermined scheduleAll Administered by QC Manager

Document Control  All management documents approved and signed by senior staff before issuing(Document changes must undergo the same procedure) (Laboratory Information Management Systems (LIMS))

Data Management Analysis of Data Procedures (LIMS) TraceableWhen mistakes should be crossed out and the correct value entered.Alterations should be signed Equivalent controls on the computer (LIMS)

Results Reports  Clear & unambiguous Predefined certificate format including signature of manager.Specifying :Method Condition of and identification of the sample.Statement of compliance with appropriate National, EU standardsQuality Control Results

Management should be regularly try to improve the quality of the results and systems by reviewing the : Quality of Analytical & AQC ResultsAudit Trail ResultsCustomer feedbackStaff feedbackAssessments by external bodies

Thank you and good luck with establishing optimum quality assurance procedures