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(c) Alan Rowley Associates 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 recognised quality management system standard CONTINUAL SCRUTINY AND RESPONSE TO ANY INFORMATION ABOUT PROBLEMS IMPROVEMENT TO SYSTEM !

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley QUALITY MANUAL-Key Document DOCUMENTATION States quality policy Describes quality management arrangements Assigns 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.

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

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

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

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

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley 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

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley 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

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

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

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley  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.

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley  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.

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley  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.

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley  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.

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley  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.

(c) Alan Rowley Associates Laboratory Accreditation Dr Alan G Rowley  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.

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

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

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