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Quality Management -Standards. Joan Kelley 28th Nov 2002. Background . Employed UK MoD Assessor in QC system Transferred to UKAS (then NATLAS) on inception Testing lab UKAS (now ISO 17025) Accredited since 1984. Accreditation Bodies. UKAS-UK Accreditation Service

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Quality management standards l.jpg

Quality Management -Standards

Joan Kelley

28th Nov 2002

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  • Employed UK MoD Assessor in QC system

  • Transferred to UKAS (then NATLAS) on inception

  • Testing lab UKAS (now ISO 17025) Accredited since 1984

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Accreditation Bodies

  • UKAS-UK Accreditation Service

  • NAB-National Accreditation Board,Ireland

  • BELCERT and BELTEST, Belgium

  • Comite Francais d’Accreditation

  • Deutscher Akkreditierungsrat

  • Raad voor Accreditatie

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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)


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  • 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

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Current Standards

  • ISO 17025- Testing and ‘methods’

  • ISO 9000 series-production and management systems

  • National and international GLP standards-Medical research

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Change in Philosophy

  • Process driven approach

  • -does the system work, rather than -does it contain specific features

  • More flexibility for the lab.

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  • Most technical standards have two main sections ……………...

  • Management requirements

  • Technical requirements

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  • 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

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  • Quality Manual

  • Methods (Technical Operating Procedures)

  • Standard Operating Procedures

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Quality System

  • Management review

  • Audit programme

  • Document control

  • Control of complaints and anomolies

  • Clear job descriptions

  • Training records

  • etc etc etc

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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

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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

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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

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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)

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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

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  • Senior member of staff must have appropriate qualifications

  • Alternatives may be acceptable with extensive experience

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  • Records for all essential equipment

  • Cleaning programmes for appropriate equipment together with documented records

  • eg water baths, incubators, fridges, freezers

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  • Generally ANALAR

  • Water -deionised or distilled

  • Regents labelled, identity, opening and expiry dates,conc, storage requirements

  • Includes all media and diluents

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  • Must have a co-ordinated, recorded programme encompassing all lab activities

  • Measurements of significance to methods must be traceable to national/international standards

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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

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  • 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

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Weights and Balances

  • Must be calibrated at least annually depending on use and environment

  • In house or by Accredited service

  • Daily drift checks

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  • 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

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  • Checked daily or before use

  • Buffers from quality supplier

  • Buffers prepared to standard and stored appropriately with an expiry date

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  • Must be calibrated and traceable

  • Easiest to send to experts!

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  • 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

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  • Records of all loads and runs must be taken and kept

  • In addition load monitors must be used with each load

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Air velocity

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

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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

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Essential Features

  • Limits of detection

  • Selectivity

  • Precision

  • Reproducibility

  • Procedures depend on requirements/qualitative or quantitative/new or existing method?

  • Reference materials

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Qualitative Results (Presence or Absence)

  • Limit of detection

  • Selectivity determined to ensure interference not occurring-use a range of micro-organisms

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Quantitative methods

  • Sensitivity

  • Selectivity

  • Precision

  • Expression of uncertainty

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  • 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

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  • Microbiological monitoring

  • Records kept

  • Action and alert limits

  • Documented procedures

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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

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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

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Organisms in Quality Systems

Use, preservation and traceability

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Organisms in Quality Systems

  • Challenge testing

  • Method validation

  • Media QC

  • Analytical Quality Control (AQC)

  • Proficiency Testing

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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’

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Common Confusions

  • Definitions of reference/stock/working cultures

  • Can you subculture and if so how many times

  • Are the newer delivery systems acceptable

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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

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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

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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

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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

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‘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

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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?

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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.

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

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Media QC

  • Checked to ensure support growth of appropriate organisms (this includes negative control)

  • Must be quantitative if counts involved

  • Sterility must be confirmed

  • pH,and other parameters set by manufacturer must be checked post sterilisation

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Diluent QC

  • As media where appropriate

  • Volume of batches dispensed prior to autoclave must be established post sterilisation and monitored at intervals if stored

  • Select percentage, assess gravimetrically

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Batch number



Date (of set up and read)



Test strains (+ve,-ve)

Test conditions (temp,atmosphere)

Results (expected and actual)

Signature of staff

Cross ref to autoclave batch and strain records

Media QC Records-

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QC Methods

  • Simple streak/assess growth and morphology

  • Quantitative/known count

  • Spiked simulated samples-available for purchase or prepare in-house

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  • Brown,MRW;Gilbert P. Microbiological Quality Assurance: a guide towards relevance and reproducibility. Boca Raton,FL:CRC Press, 1994

  • National Committee for Clinical Laboratory Standard M22-A2. Quality Assurance for Commercially prepared microbiological culture media. Wayne PA NCCLS, 1996