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  1. Quality Management -Standards Joan Kelley 28th Nov 2002

  2. Background • Employed UK MoD Assessor in QC system • Transferred to UKAS (then NATLAS) on inception • Testing lab UKAS (now ISO 17025) Accredited since 1984

  3. Accreditation Bodies • UKAS-UK Accreditation Service • NAB-National Accreditation Board,Ireland • BELCERT and BELTEST, Belgium • Comite Francais d’Accreditation • Deutscher Akkreditierungsrat • Raad voor Accreditatie

  4. Cooperative Bodies • European co-operation for Accreditation (EA) • EA 4/10 Accreditation for Microbiological Laboratories, July 2002 www.european- accreditation.org • International Laboratory Accreditation Cooperation (ILAC) www.ilac.org

  5. Context • Regulations = EN45001, European Standard (others GLP, ISO 9000 etc) • But since early 2000…………. • ISO/IEC 17025 came into force • General Requirements for the Competence of Testing and Calibration Laboratories

  6. Current Standards • ISO 17025- Testing and ‘methods’ • ISO 9000 series-production and management systems • National and international GLP standards-Medical research

  7. Change in Philosophy • Process driven approach • -does the system work, rather than -does it contain specific features • More flexibility for the lab.

  8. Format • Most technical standards have two main sections ……………... • Management requirements • Technical requirements

  9. Management • If part of larger company, key personnel for lab must be defined • Lab must have tech management but can be a team-individual not necessary

  10. Documents • Quality Manual • Methods (Technical Operating Procedures) • Standard Operating Procedures

  11. Quality System • Management review • Audit programme • Document control • Control of complaints and anomolies • Clear job descriptions • Training records • etc etc etc

  12. Contract Review • Lab must have procedures which ensure that…… • methods to be used are defined,documented and understood • lab assured it has capability and resources to carry out work • appropriate methods are used to meet clients needs

  13. Preventive Actions • Pro-active look for opportunities to improve not just corrective actions • Can come from…….. • Internal audits,review of AQC data,staff suggestions,management review

  14. Technical requirements ISO 17025 • Increased emphasis on uncertainty of measurement, always a minefield for microbiol. • In house calibrations given emphasis • Future training to be addressed • Opinions and interpretations can be accredited

  15. Application of Standards to Microbiology labs Some Guidelines

  16. Quality Control • Internal AQC to monitor individual performances,cross checks between microbiologists,duplicate preps. of single samples by different people. • QC of batches of media and diluents ( more later)

  17. Inter-laboratory comparisons • Lab should participate in external AQC schemes when available and appropriate-Collections to establish system?? • eg PHLS Water and Food QC, FAPAS,NEQAS, SMART etc etc • Must be seen to act on results-don’t just file and forget

  18. Staff • Senior member of staff must have appropriate qualifications • Alternatives may be acceptable with extensive experience

  19. Equipment • Records for all essential equipment • Cleaning programmes for appropriate equipment together with documented records • eg water baths, incubators, fridges, freezers

  20. Reagents • Generally ANALAR • Water -deionised or distilled • Regents labelled, identity, opening and expiry dates,conc, storage requirements • Includes all media and diluents

  21. Calibration • Must have a co-ordinated, recorded programme encompassing all lab activities • Measurements of significance to methods must be traceable to national/international standards

  22. Temperature Measuring Devices • Fridges, incubators,water baths,drying ovens, autoclaves • Where temp needs to be better than +/- 1C calibrated thermometer in appropriate range essential • Otherwise BS 593 may be adequate or calibrated ref used to check working thermometers

  23. Cont……. • Ref thermometers, calibrated every 5 years • Annual ice point check • Thermocouples-traceable to national standards • Working thermocouples can be calibrated in house against ref standards

  24. Weights and Balances • Must be calibrated at least annually depending on use and environment • In house or by Accredited service • Daily drift checks

  25. Volume • Pipettes etc must be calibrated and traceable to national standards • Variable volume automatic pipettes discouraged • Disposable pipettes should be batch checked even if supplied from ISO manufacturer

  26. pH • Checked daily or before use • Buffers from quality supplier • Buffers prepared to standard and stored appropriately with an expiry date

  27. Humidity • Must be calibrated and traceable • Easiest to send to experts!

  28. Autoclaves • On purchase-multi point validation for all typical loads and put results to use! • Traceable to national standards • Thereafter calibration of timer and temperature measuring equipment annually • Again act on the results

  29. Cont • Records of all loads and runs must be taken and kept • In addition load monitors must be used with each load

  30. Air velocity • If used in eg safety cabinets (ie not done under contract) must be checked for accuracy at regular intervals.

  31. Method Validation • Methods developed in house, modifications and applications of standard methods must be validated • But also need to prove you can get the correct results even in standard tests

  32. Essential Features • Limits of detection • Selectivity • Precision • Reproducibility • Procedures depend on requirements/qualitative or quantitative/new or existing method? • Reference materials

  33. Qualitative Results (Presence or Absence) • Limit of detection • Selectivity determined to ensure interference not occurring-use a range of micro-organisms

  34. Quantitative methods • Sensitivity • Selectivity • Precision • Expression of uncertainty

  35. Environment • Restricted access • Lab coats • ‘Potential for contamination minimised’ ie non-absorbent surfaces,easy clean, blinds,no plants,no personal possessions,minimal paperwork • Documented cleaning programme

  36. Cont • Microbiological monitoring • Records kept • Action and alert limits • Documented procedures

  37. Sample/Deposit Handling and Identification • System can be simple as notebook or complex LIMS system • Adequate facilities for storage and segregation essential (fridges,freezers) • Samples must be stored and examined under conditions which minimise changes in the numbers or viability of micro-organisms

  38. Disposal of Contaminated Waste • All waste should be autoclaved before leaving the laboratory • If disposal of waste is subcontracted control measures must be in place • However if pathogens involved also follow ACDP guidelines and WHO Manuals

  39. Organisms in Quality Systems Use, preservation and traceability

  40. Organisms in Quality Systems • Challenge testing • Method validation • Media QC • Analytical Quality Control (AQC) • Proficiency Testing

  41. Guidance for ISO 17025 • States two fundamental requirements:- ‘…shall maintain records of checks on batch to batch variation of media and other reagents by using working standards of known micro-organisms’ ‘...shall hold reference cultures obtained from a recognised national collection in order to demonstrate traceability’

  42. Common Confusions • Definitions of reference/stock/working cultures • Can you subculture and if so how many times • Are the newer delivery systems acceptable

  43. Reference Organisms-1 • Reference cultures (i.e. from a collection) may be subcultured once to provide reference stocks • Reference stocks shall be maintained ‘...by techniques which maintain the desired characteristics of the strains’ • Examples-freeze drying, LN,deep freeze methods

  44. Reference Organisms-2 • Reference stocks are used to prepare working stocks for routine use • Working stocks can be subcultured if:- • required by a standard method • documentary evidence exists to show changes do not occur over a defined number of subcultures, and this has been validated

  45. Reference Organisms-3 • Once thawed or otherwise reconstituted reference stocks must not be refrozen or re-used • Working stocks must not be sub-cultured to replace reference stocks

  46. Things often forgotten • Document traceability of strains including date purchased,dates sub-cultured dates beads removed etc.. • Continuous monitoring of freezer temp. or at least max/min. • Place shelf life on all stocks, reference and working

  47. ‘New’ Delivery Systems • E.g Culti loops, Quanticult etc • All previous requirements still apply • Proof of quality, traceability etc falls to the laboratory • Treat like any other goods and service supply but with extra ‘calibration’ requirements

  48. Questions to Ask • ISO 9000.. Company? • But what for -manufacture,supply? Who actually makes the products? • Traceability to national collection? • How many passages? • What preservation techniques are used?

  49. Documents Required • Validated methods and QC data • Certificate of traceability to National Collection number • Statement of uncertainty i.e. if quantitative, number of cfu +/- but also details of how this is calculated, cumulative errors etc.

  50. Finally • Whatever route chosen, the onus falls on the laboratory to demonstrate quality is being maintained.