Quality Management System for Laboratory Accreditation

1. B E S T B E S T B E S T

2. Quality Policy based on Quality Objectives Review Quality Management System Document system, defined responsibilities and procedures Audit Based on recognised quality management system standard Laboratory Accreditation Dr Alan G Rowley CONTINUAL SCRUTINY AND RESPONSE TO ANY INFORMATION ABOUT PROBLEMS IMPROVEMENT TO SYSTEM ! Communicate and Implement Monitor to ensure system is implemented and being followed by all. Monitor to ensure system is delivering required objectives (c) Alan Rowley Associates 2009

3. 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. Laboratory Accreditation Dr Alan G Rowley DOCUMENTATION • QUALITY MANUAL-Key Document • States quality policy • Describes quality management arrangements • Assigns responsibilities and authority • Often describes quality procedures (c) Alan Rowley Associates 2009

4. Laboratory Accreditation Dr Alan G Rowley QUALITY MANAGER • MUST BE IDENTIFIED IN DOCUMENTATION • 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. (c) Alan Rowley Associates 2009

5. Laboratory Accreditation Dr Alan G Rowley 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. (c) Alan Rowley Associates 2009

6. Laboratory Accreditation Dr Alan G Rowley 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. (c) Alan Rowley Associates 2009

7. Laboratory Accreditation Dr Alan G Rowley TECHNICAL MANAGEMENT • Management of laboratory throughput, sample reception, technical client liaison. • Responsible for ensuring quality controls are operated and evaluated; approves data as technically sound. • Preparation and authorisation of reports at technical level. • Ensures equipment is maintained and calibrated. (c) Alan Rowley Associates 2009

8. Laboratory Accreditation Dr Alan G Rowley DOCUMENTATION • MUST BE ‘CONTROLLED’. • 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. (c) Alan Rowley Associates 2009

9. Laboratory Accreditation Dr Alan G Rowley DOCUMENTATION • MUST BE ‘CONTROLLED’. • 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. (c) Alan Rowley Associates 2009

10. Laboratory Accreditation Dr Alan G Rowley DOCUMENTATION • QUALITY PROCEDURES • 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 (c) Alan Rowley Associates 2009

11. Laboratory Accreditation Dr Alan G Rowley May be prepared by laboratory or can be by providing published documentation. e.g. Equipment manuals, published methods. DOCUMENTATION ESSENTIAL POINT IS THAT INFORMATION SHOULD ENABLE PROCEDURE TO BE PERFORMED PROPERLY AND CONSISTENTLY • TECHNICAL PROCEDURES • Describe all technical activities • In-House calibrations • Operation of equipment • Test methods (c) Alan Rowley Associates 2009

12. Laboratory Accreditation Dr Alan G Rowley DOCUMENTATION • OTHER DOCUMMENTS • 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. (c) Alan Rowley Associates 2009

13. Laboratory Accreditation Dr Alan G Rowley RECORDS • Whenever documentation says we will do something then we must create a record which shows it was done • Who did it and when ! • Wherever possible the outcome, e.g. measurement, calibration details. (c) Alan Rowley Associates 2009

14. Laboratory Accreditation Dr Alan G Rowley PERSONNEL • Staff must be authorised for each activity whether technical or administrative. • Authorisations must be justified by training records and objective test of competence. • Competence must be reviewed, typically annually, but ongoing. (c) Alan Rowley Associates 2009

15. Laboratory Accreditation Dr Alan G Rowley METHODS and SCOPE OF ACCREDITATION • To speak of an ‘accredited laboratory’ is not strictly correct. • 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. (c) Alan Rowley Associates 2009

16. Laboratory Accreditation Dr Alan G Rowley METHODS and SCOPE OF ACCREDITATION • Methods which require accreditation for credibility or for regulatory purposes. • Commercial considerations; do customers demand accreditation ? • Method must be performed reasonably regularly to make inclusion in scope worthwhile/possible. (c) Alan Rowley Associates 2009

17. Laboratory Accreditation Dr Alan G Rowley METHODS Show ‘traceability’, certified reference materials, interlaboratory comparison, proficiency testing. • Can be in-house or published standard methods or in-house based on…………. • 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. (c) Alan Rowley Associates 2009

18. Laboratory Accreditation Dr Alan G Rowley METHODS • Must apply quality control to ensure methods continue to perform to required standard. • 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. (c) Alan Rowley Associates 2009

19. Laboratory Accreditation Dr Alan G Rowley EQUIPMENT • Commission and calibrate before using routinely. • 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. (c) Alan Rowley Associates 2009

20. Laboratory Accreditation Dr Alan G Rowley MONITORING AND IMPROVEMENT OF QUALITY SYSTEM • Audit entire system on annual cycle according to prepared plan. • Ensure auditors are trained in audit and in reporting system. • Identify instances of non-conforming work. • Customer feedback; complaints & surveys. • Review quality regularly; preventive action. (c) Alan Rowley Associates 2009

21. Laboratory Accreditation Dr Alan G Rowley MONITORING AND IMPROVEMENT OF QUALITY SYSTEM • Carry out corrective action. • Required to address ‘ROOT CAUSE’, i.e. IMPROVE quality system. • Corrective action to be followed-up to confirm effectiveness. • Preventive action is pro-active IMPROVEMENT. • Look at quality issues regularly, trends and respond before serious issues arise. (c) Alan Rowley Associates 2009

22. Laboratory Accreditation Dr Alan G Rowley THE END THANK YOU (c) Alan Rowley Associates 2009