QA Manual

Report
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

similar documents