QA Manual

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Module 2: Water Budget, Pressures and Impacts,

Significant Water Management Issues,

Monitoring, Characterization Report

OPTIMISING CHEMICAL ANALYSIS FOR THE WFD BY

QUALITY ASSURANCE PROCEDURES & ACCREDITATION

An Overview

Michael Jackman, Chemical Expert

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:

Staff

Equipment, reagents & standards.

Sampling

Analysis

Quality Control

Data management

Documentation & Reporting

Laboratory Staff

Mission Statement of the Laboratory’s standard.

Diagram of Staff Reporting Structure

Staff 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 & Reagents

Stock standards should be certified.

Quality Control Standards should be from a different source than the Calibration Standards

All standards and reagents should have shelf life date – (Date

Received & serial number)

Stock Control system

Laboratory Analysis

Record of Method Validation

Methods’ specifications.

Standard operating procedures (SOP) for each method.

Use 3 working standards

Record of:

Date of analysis,

Analyst

Result

AQC results

Calculation

Any relevant environmental conditions temperature, biological sterility

Sampling

SOP for sampling procedure, transport & preservation of sample.

Sampling Schedule

Registration of the samples, submitted to the Laboratory- Chain of

Custody.

Record Condition of Sample

Analytical Quality Control

SOP for Quality Control

Internal & External AQC

Method Validation Procedures

Corrective and Protective Actions

Audit Trails predetermined schedule

All 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)

Traceable

When 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 standards

Quality Control Results

Management should be regularly try to improve the quality of the results and systems by reviewing the :

Quality of Analytical & AQC Results

Audit Trail Results

Customer feedback

Staff feedback

Assessments by external bodies

Thank you and good luck with establishing optimum quality assurance procedures

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