1. (c) Alan Rowley Associates 20092 Laboratory Accreditation Dr Alan G Rowley Quality Policy based on Quality Objectives Quality Management System Communicate.

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(c) Alan Rowley Associates 2009 2

Laboratory Accreditation Dr Alan G Rowley

Quality Policy based on Quality Objectives

Quality Management System

Communicate and Implement

Document system, defined responsibilities and procedures

Monitor to ensure system is implemented and being

followed by all.

Audit

Monitor to ensure system is delivering required

objectives

Review

Based on recognisedquality management

system standard

CONTINUAL SCRUTINY AND RESPONSE TO ANY

INFORMATION ABOUT PROBLEMS

IMPROVEMENT TO SYSTEM !



QUALITY MANUAL-Key Document

DOCUMENTATION

States quality policy

Describes quality management arrangementsAssigns responsibilities and authority

Often describes quality procedures

The QUALITY MANUAL

should be a first point of reference.

It either tells you what to do or tells you where to find the

relevant information.



MUST BE IDENTIFIED IN DOCUMENTATIONQUALITY MANAGER

Can be called by any title which suits organisation.

Typically a part time function except in large organisations.

Responsible for overall management and monitoring quality system.Main point of contact for accreditation body.



QUALITY MANAGER

Main advisor to management on quality issues. Organises audit plan and audits.

Reviews all corrective actions and follows up to confirm effectiveness.

Ensures non-conformances are all properly investigated.

Reports to management when quality is being compromised.



TECHNICAL MANAGEMENT

Structure must be clearly defined.

Responsible for ensuring all technical activities are carried out in conformance with quality system.

Approves methods as technically sound and valid.

Ensures appropriately trained staff are assigned to technical activities.



TECHNICAL MANAGEMENT

Responsible for ensuring quality controls are operated and evaluated; approves data as technically sound.

Management of laboratory throughput, sample reception, technical client liaison.

Ensures equipment is maintained and calibrated.

Preparation and authorisation of reports at technical level.



MUST BE ‘CONTROLLED’.DOCUMENTATION

Properly authorised; identify responsibility for authorising each type of document and authorising amendments.Check for technical accuracy and compliance with quality system.

Ensure copies carry version number, date, authorisation.



MUST BE ‘CONTROLLED’.DOCUMENTATION

Record issue.

Numbered copies issued and holders identified.Allows all copies to be located for withdrawal or amendment. No unofficial copies.Record dates of each version and when withdrawn.Retain superseded documents for reference.



QUALITY PROCEDURES

DOCUMENTATION

May be included in Quality Manual

Describe how various requirements of standard are implemented and operated in laboratory.

Describe records to be kept and format



TECHNICAL PROCEDURES

DOCUMENTATION

Describe all technical activities

In-House calibrations

Operation of equipment

Test methods

May be prepared by laboratory or can be by providing

published documentation.e.g. Equipment manuals,

published methods.

ESSENTIAL POINT IS THAT INFORMATION SHOULD ENABLE PROCEDURE TO

BE PERFORMED PROPERLY AND CONSISTENTLY



OTHER DOCUMMENTS

DOCUMENTATION

Forms and worksheets.

Notices posted in laboratory conveying information on technical activities or quality system.

Any other documents referred to in procedures or Quality Manual.



Whenever documentation says we will do something then we must create a record which shows it was done

RECORDS

Who did it and when !

Wherever possible the outcome, e.g. measurement, calibration details.



Staff must be authorised for each activity whether technical or administrative.

PERSONNEL

Authorisations must be justified by training records and objective test of competence.

Competence must be reviewed, typically annually, but ongoing.



To speak of an ‘accredited laboratory’ is not strictly correct.

METHODS and SCOPE OF ACCREDITATION

It would be more accurate to speak of a laboratory accredited for a specific scope of methods.

Rarely is a laboratory accredited for every method it performs. It selects which methods to accredit.



Methods which require accreditation for credibility or for regulatory purposes.

METHODS and SCOPE OF ACCREDITATION

Commercial considerations; do customers demand accreditation ?

Method must be performed reasonably regularly to make inclusion in scope worthwhile/possible.



Can be in-house or published standard methods or in-house based on………….

METHODS

Must carry out validation/verification to show any claims made for method are objectively verified; performance characteristics.

Accuracy, precision and limit of detection at least.

Show ‘traceability’, certified

reference materials,

interlaboratory comparison, proficiency

testing.



Must apply quality control to ensure methods continue to perform to required standard.

METHODS

Routine quality control samples to show consistent performance.

Trend analysis with statistics if possible, control charts.

Routine participation in proficiency testing and running of CRMs.



Commission and calibrate before using routinely.EQUIPMENT

Establish maintenance and calibration plan.

Calibrate traceably to SI units.

Carry out verifications between formal calibrations.

Label to show calibration status and expiry date.

Ensure defective or out of calibration equipment is removed or clearly marked as such.



MONITORING AND IMPROVEMENT OF QUALITY SYSTEM

Audit entire system on annual cycle according to prepared plan.

Identify instances of non-conforming work.

Customer feedback; complaints & surveys.

Review quality regularly; preventive action.

Ensure auditors are trained in audit and in reporting system.



MONITORING AND IMPROVEMENT OF QUALITY SYSTEM

Carry out corrective action.

Preventive action is pro-active IMPROVEMENT.Look at quality issues regularly, trends and respond before serious issues arise.

Required to address ‘ROOT CAUSE’, i.e. IMPROVE quality system.

Corrective action to be followed-up to confirm effectiveness.



THE END

THANK YOU

1. (c) Alan Rowley Associates 20092 Laboratory Accreditation Dr Alan G Rowley Quality Policy based on Quality Objectives Quality Management System Communicate.

Documents

c alan rowley associates

accredited laboratory

quality controls

quality issues

documentation quality

monitoring quality system

scope of accreditation

accreditation body