Introduction to Requirements of ISO/IEC 17025:2005

Transcription

1 Introduction to Requirements of ISO/IEC 17025:2005 Christina Oscroft Campden Laboratory Accreditation Scheme Manager Tel:

2 International Laboratory Quality Standard ISO/IEC Standard : 2005 General Requirements for the Competence of Testing and Calibration Laboratories Outlines standards for management of laboratory operations and control of technical activities Used by Accreditation Bodies to Assess Laboratories

3 Control of Laboratory Operations Service to client Management control Staff Samples Equipment Calibration Proficiency data Bench Practice ANALYSIS Methods Validation Document Control Facility Results Media Quality Control NCW Corrective Actions Records Audits/Reviews Improvement

4 Quality System Top Level Quality Policy (Mission) Statement Management objectives in relation to quality of work, standard of service etc etc. Formalised documentation of quality system All aspects of laboratory operations to be documented Describe how lab works, what is to be done, how, when, parameters for activities to be within and actions to taken if not met Document Control (identification, approval for issue, amendment procedure,+ records, archive superseded documents, policies to prevent unauthorised changes

5 TYPICAL QUALITY SYSTEM Quality Manual Policy The intent Procedures Instructions and/or Training What will be done How it will be done Operations Manual Records/Completed forms Evidence that it has been done Ensures standardisation/consistency Provides point of reference + assists training

6 Organisation/Management Management Lab a clearly identifiable legal entity Provision of adequate resource Effective in maintaining operations + quality of work. Organisation Defined and clear line management structure (within lab and to production/factory/clients) Individuals assigned responsibility for: i. Overall responsibility for lab ii. Day to day management/supervision of laboratory iii. Quality of work + quality system maintained

7 Organisation/Management Laboratory Administration Ensure timely analysis of samples Effective in progressing work Identifying and timely resolution of problems Timely issue of results Release of Results Individuals authorised to report/release results (internal/external in spec/out of spec). Competence / Ability to interpret results

8 Management of Personnel Qualifications/Experience Appropriate for job/responsibilities Training Approaches (Internal/external) Supervision Appraisal of competence + technical data to show competence Records Assessment of Ongoing Competence In methods Following updates/amendments to procedures Records

9 Control of Facility Location (separate to production/chemistry; type of organisms handled, customer requirements ) Containment (suitable for organisms handled/screened/bio-security Act) Access control (restricted/controlled) Layout (separation of activities - time/space, cross contamination risks) Furnishing/fabrics (suitable, condition) Housekeeping (facility/equipment, cleaning schedule/records) Environmental Monitoring (swabs, air plates, frequency, criteria, records)

10 Control of Hygiene Hygiene Rules (eating, drinking, smoking, personal effects, sensory appraisals). Clothing (suitable, distinct from production/other lab coats, correctly worn, frequency of changing, provision for visitors/engineers). Hand-wash facilities (dedicated, bactericidal soap, non hand operated taps; correct handwash/coat change on entry/exit). Protective Equipment (gloves, masks, aprons, fume hoods, safety cabinets etc)

11 Confirmation of Work and Client Requirements Ensure resource available to perform work. Tests required clearly defined/established. If not take action to ensure requirements understood Show required tests were done on samples Provide reasonable co-operation with clients

12 Handling Test Items/Samples Protect from contamination, maintain traceability, preserve condition to ensure reliable results Lifting at source (trained staff, aseptic technique, sterile implements/containers, labelling) Transport /Delivery (time, conditions, protection, identification, interim storage) Receipt (registration; condition/suitability, rejection procedure, tests required established, temperature checks, storage) Traceability (unique code, labelling, traceability of bulked or sub samples, transfer between labs)

13 Handling Test Items/Samples Storage Pre/Post Analysis (appropriate, controlled, contamination risks, shelf life requirements) Handling (aseptic, glp). Retention ( time, conditions, packaging, traceability) Disposal (safe, suitable, legal requirements)

14 Methods of Analysis Method Selection Essential to use correct method Fit for required purpose Customer requirements/legislation Source/origin must be known Demonstrating Suitability for Use Validation data and in house performance data Data to show ability to get good results and method fit for purpose Documentation Fully documented Accessible to staff for reference

15 Methods of Analysis Reviewed for continued suitability Update to source method Developments in methodology Managing unauthorised deviations from methods Appraise impact on method performance + results, Corrective actions, records. Management of authorised deviations Justification to show no impact on method performance, Records, client informed

16 Technical Records All data necessary to calculate, verify and defend final results to be held Examples: Dilution Colony count Number selected for confirmation Individual confirmation results Biochemical reactions MPN values Traceable to samples and people

17 Reporting of Test Results Content Clear/unambiguous Traceable to individual samples Correct reporting of results (e.g. presumptive/confirmed; units of measurement; detection limits) Regular cross checks Authorised for release Out of specification reporting procedures (if role of lab) Correct use of Accreditation Logo and relevant disclaimers

18 Assuring Quality of Test Results Generates Data to Demonstrate Ongoing Lab Competence, Method Control and Staff Proficiency Carry out to defined plans + frequencies Design approaches suitable for each test Review results/performances Poor performances investigated, corrected +data generated to show resolved Keep good records Look for trends/bias

19 Assuring Quality of Results EXAMPLES External Proficiency Schemes Internal Ongoing Method Verification/Lab Competence Duplicate analyses (repeatability/reproducibility data) Spiked Samples/Reference Materials (recovery data, detection limits, ability to recover target organism from sample types)

20 Assuring Quality of Results Media QC: Sterility, ph, growth, volume Confirmation tests: Positive/negative controls Commercial Kits: Positive controls, kit controls Daily Controls: Sterility and positive controls

21 Control of Equipment Suitability (accuracy, resolution, stability, capacity etc) Commissioning (before enter use) Service/maintenance (scheduled and/or as required) Calibration (NPL traceable, certified reference materials/standards, technically valid approaches, criteria to appraise results). Calibration Procedures (equipment; parameter to calibrate/check; frequency; acceptable tolerances/limits for deviation; procedure). Calibration Results (appraise impact on use, conduct of tests and reliability of results, policies on applying offsets/adjustments/ correction factors).

22 Control of Records All data/information relevant to tests and supporting activities to be held Traceability (throughout system; work can be repeated under conditions close to original; sources of error/corrective actions taken to be identified) Maintenance (legible, in indelible ink; Mistakes neatly cross out + correct entry made along side + initialled). Storage/Retention (protect from damage, loss, misuse; Maintain confidentiality; retention times) Electronic Data (access control; loss of data minimised; amendments verified/traced; protect from unauthorised changes)

23 Non Conforming Work Definition Any aspect of laboratory operations or testing activities that do not conform to defined/prescribed parameters Examples Out of spec equipment Poor EQA performance Failure to follow methods Poor GLP/bench practice Media QC failures Failure to maintain operations

24 Managing Non Conforming Work PRESENT problem has been identified Investigation to establish cause FUTURE: Corrective action Verification of effectiveness PAST: Impact on work, results

25 Managing Non-Conforming Work Responsibility Investigation (prompt) Corrective Action (timely, appropriate, address cause not symptom) Appraise significance/impact (on tests, client requirements, reliability of results -must include halting work if necessary until problem fixed and informing clients). Records

26 Corrective Action Loop (Continuous Improvement) Solution?? Effective YES NO NCN Check effect Implement solution Quick Fix Analyse Evidence Corrective Action Should: Address cause, not symptom (often only quick fix taken) Strengthen/improve systems Identify Solution/ preventive action Establish Cause Prevent re-occurrence Be timely

27 Monitoring for Improvement Proactively examine systems for potential weaknesses, drifts or trends in stability and make improvements to strengthen operations. Common Approaches management reviews internal audits trends in proficiency performances risk analysis complaints analysis

28 Internal Audits Planning (responsibility, schedule, all areas once per year, including witness of tests). Auditors (trained/qualified in principles of audits; independent). Conduct (depth to give confidence in effectiveness/maintenance of systems; examine on going activities + historical records). Identification of NCW/Improvements Corrective actions (Actions, Responsibility, Time-scales) Appraisal of Findings (impact on testing activities, previously issued results) Verification (completion of corrective actions/audit sign off) Records

29 How to Make Audits Effective? Provide adequate resource Understand principles of, and reason + benefits for audits Understand your quality system! Operate a defined procedure for managing + conducting audits Schedule audits according to risk/stability of operations Train auditors + ensure audits thorough Keep audits independent, objective + challenge system

30 How to Make Audits Effective? Identify true NC s + proactively look for beneficial improvement Draw clear conclusion on status of area Take timely corrective/improvement action Verify actions are taken + are effective Maintain good records Ensure findings are formerly reviewed/appraised

31 Management Review Frequency (at least annually). Attendees (Senior Company Management and appropriate lab personnel) Agenda (DEFINED) Records (minutes, action points, responsibilities, timescales) Ensure Appropriate data/information is extracted from quality system and presented to give management full and accurate picture of the true status of operations including any weaknesses

32 Complaints Responsibility Investigations (prompt, thorough, impartial) Outcome (inform complainant and management) Corrective Action (if complaint justified; if casts doubt on results clients affected must be informed). Feedback (complaint, any clients whose work affected) Records.

33 Sub-Contracting Selection (accredited subcontract lab; or if not possible appraise suitability of lab) Verification (evidence of accreditation status or result of assessment/appraisal; approve methods) Notify Clients Reporting Results (subcontract work to be identified and reported as such).

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