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Quality Management -Standards

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QC of batches of media and diluents ( more later) Inter-laboratory comparisons ... media and diluents. Calibration ... Diluent QC. As media where appropriate ... – PowerPoint PPT presentation

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Title: Quality Management -Standards


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 dAccreditation
  • 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-dont 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.

51
Media Quality Control
  • Why and How

52
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

53
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

54
Media QC Records-
  • Type
  • Batch number
  • Container
  • pH
  • Date (of set up and read)
  • Sterility
  • Volume
  • Test strains (ve,-ve)
  • Test conditions (temp,atmosphere)
  • Results (expected and actual)
  • Signature of staff
  • Cross ref to autoclave batch and strain records

55
QC Methods
  • Simple streak/assess growth and morphology
  • Quantitative/known count
  • Spiked simulated samples-available for purchase
    or prepare in-house

56
References
  • Brown,MRWGilbert P. Microbiological Quality
    Assurance a guide towards relevance and
    reproducibility. Boca Raton,FLCRC Press, 1994
  • National Committee for Clinical Laboratory
    Standard M22-A2. Quality Assurance for
    Commercially prepared microbiological culture
    media. Wayne PA NCCLS, 1996
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