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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

Quality Management -Standards

Joan Kelley

28th Nov 2002

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

context
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
current standards
Current Standards
  • ISO 17025- Testing and ‘methods’
  • ISO 9000 series-production and management systems
  • National and international GLP standards-Medical research
change in philosophy
Change in Philosophy
  • Process driven approach
  • -does the system work, rather than -does it contain specific features
  • More flexibility for the lab.
format
Format
  • Most technical standards have two main sections ……………...
  • Management requirements
  • Technical requirements
management
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
documents
Documents
  • Quality Manual
  • Methods (Technical Operating Procedures)
  • Standard Operating Procedures
quality system
Quality System
  • Management review
  • Audit programme
  • Document control
  • Control of complaints and anomolies
  • Clear job descriptions
  • Training records
  • etc etc etc
contract review
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
preventive actions
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
technical requirements iso 17025
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
quality control
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)
inter laboratory comparisons
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
staff
Staff
  • Senior member of staff must have appropriate qualifications
  • Alternatives may be acceptable with extensive experience
equipment
Equipment
  • Records for all essential equipment
  • Cleaning programmes for appropriate equipment together with documented records
  • eg water baths, incubators, fridges, freezers
reagents
Reagents
  • Generally ANALAR
  • Water -deionised or distilled
  • Regents labelled, identity, opening and expiry dates,conc, storage requirements
  • Includes all media and diluents
calibration
Calibration
  • Must have a co-ordinated, recorded programme encompassing all lab activities
  • Measurements of significance to methods must be traceable to national/international standards
temperature measuring devices
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
slide23
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
weights and balances
Weights and Balances
  • Must be calibrated at least annually depending on use and environment
  • In house or by Accredited service
  • Daily drift checks
volume
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
slide26
pH
  • Checked daily or before use
  • Buffers from quality supplier
  • Buffers prepared to standard and stored appropriately with an expiry date
humidity
Humidity
  • Must be calibrated and traceable
  • Easiest to send to experts!
autoclaves
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
slide29
Cont
  • Records of all loads and runs must be taken and kept
  • In addition load monitors must be used with each load
air velocity
Air velocity
  • If used in eg safety cabinets (ie not done under contract) must be checked for accuracy at regular intervals.
method validation
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
essential features
Essential Features
  • Limits of detection
  • Selectivity
  • Precision
  • Reproducibility
  • Procedures depend on requirements/qualitative or quantitative/new or existing method?
  • Reference materials
qualitative results presence or absence
Qualitative Results (Presence or Absence)
  • Limit of detection
  • Selectivity determined to ensure interference not occurring-use a range of micro-organisms
quantitative methods
Quantitative methods
  • Sensitivity
  • Selectivity
  • Precision
  • Expression of uncertainty
environment
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
slide36
Cont
  • Microbiological monitoring
  • Records kept
  • Action and alert limits
  • Documented procedures
sample deposit handling and identification
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
disposal of contaminated waste
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
organisms in quality systems

Organisms in Quality Systems

Use, preservation and traceability

organisms in quality systems40
Organisms in Quality Systems
  • Challenge testing
  • Method validation
  • Media QC
  • Analytical Quality Control (AQC)
  • Proficiency Testing
guidance for iso 17025
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’

common confusions
Common Confusions
  • Definitions of reference/stock/working cultures
  • Can you subculture and if so how many times
  • Are the newer delivery systems acceptable
reference organisms 1
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
reference organisms 2
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
reference organisms 3
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
things often forgotten
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
new delivery systems
‘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
questions to ask
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?
documents required
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.
finally
Finally
  • Whatever route chosen, the onus falls on the laboratory to demonstrate quality is being maintained.
media qc
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
diluent qc
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
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

Media QC Records-
qc methods
QC Methods
  • Simple streak/assess growth and morphology
  • Quantitative/known count
  • Spiked simulated samples-available for purchase or prepare in-house
references
References
  • 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
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