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From Good Laboratory Practice to Total Quality Management in Medical Laboratories : The Perspective. October, 2002 S Cheng. What is Quality. Quality is the entity of a product ( service ) which fulfils the defined and expected requirement

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from good laboratory practice to total quality management in medical laboratories the perspective

From Good Laboratory Practice to Total Quality Management in Medical Laboratories : The Perspective

October, 2002 S Cheng

what is quality
What is Quality
  • Quality is the entity of a product ( service ) which fulfils the defined and expected requirement
  • The customer checks if the product meet the requirements
quality in medical laboratory testing
Quality in Medical Laboratory Testing
  • The right test result, at the
  • Right time, on the
  • Right specimen, from the right patient, with result interpretation based on
  • Correct reference data, and at the
  • Right price
evolution of quality management philosophy
Evolution of Quality Management Philosophy

1930 – 60, Q.C. ( Cure )

1970 – 80, Q.A. ( Preventive )

To-day, TQM ( Holistic involvement )

quality management system
Quality Management System
  • Achieving customer satisfaction by meeting customer’s expectation and preventing non-conformity at all stage of process from design to service.
  • Enhance the performance of the organization through internal and external audit
why quality management is everybody s darling
Why Quality Management is everybody’s darling
  • Quality costs, but poor Quality costs more
  • Regulator : reduces workload, ( manpower )
  • Blood Industry Officials: makes the environment transparent
  • Hospitals : reduces responsibility to patients
slide12

Demings chain

Improvement of quality

Improvement of productivity

Market-share

Price-reduction

Cost-reduction

Secure position

Secure jobs

slide13

Demings chain in Laboratory Service

Improvement of quality

Improvement of productivity

Market-share

Price-reduction

Cost-reduction

Secure position

Secure jobs

my problems with the definitions of quality
My problems with the definitions of quality
  • Does the customer have all the information he needs to qualify the products? Service?
  • Is it his responsibility to check the quality or standards?
  • Is’nt there a discrepancy between customer’s expectations and requirements ?
it is our ethical responsibility to define the level of quality
It is our ethical responsibility to define the level of quality
  • A patient is not able to figure all transfusion risks. He might be unconscious on intensive care.
  • We know all about transfusion risk and must be responsible for the safety.
  • A perfect balance is the major support for a good quality management.
flawless quality management error management
Flawless quality management:( Error Management )
  • Quality management has to be flawless. Discovery of errors in documents, or problems must lead to the consideration to end, or change the process.
quality layers
Quality Layers
  • Minimal requirements “ Bad Quality”
  • Functional Requirement “Quality”
  • Non-functional requirements “Good Quality”
  • Far ahead of customer expectations “Excellence”
should nt we achieve excellence
Should’nt we achieve excellence ?

Quality = Excellence

Excellence begins in your mind

quality planning
Quality Planning
  • Part of Quality management focused on setting quality objectives and specifying necessary processes and related resources to fulfil the quality objective
3 e in quality
3 E in quality
  • Effectiveness ( doing the right things)

- extent to which planed activities are realized and planed results achieved

  • Efficiency ( doing things right )

- relationship between the result achieved and the resources used

  • Excellence

- Doing the right things right !!

the 8 columns of excellence
The 8 columns of excellence

Orientation on results

Responsibility for

the community

Orientation of customers

Building partnerships

Continuous learning

Leadership &

consequences of goals

Involvement of

employees

Management of

processes & facts

achieved by good practices
Achieved By Good Practices
  • GLP – Good Laboratory Practice
  • GCL – Good Clinical Practice
  • GMP – Good Manufacturing Practice
  • GTP – Good Transportation Practice
  • GDP – Good Distribution Practice
  • GAMP – Good Automated Manufacturing Practice
  • GRP- Good Regulatory Practice
medical laboratory quality system
Medical laboratory quality system
  • A quality system is essential in the laboratory to ensure the correct results for the correct patient / donor
  • By Good Laboratory Practice

( GLP )

good laboratory practice glp
Good Laboratory Practice( GLP )
  • Main areas of GLP

- Organization and personnel

  • Facilities
  • Equipment
  • Reagent / test kits
  • Documentation
  • Inter-laboratory comparison
organization and personnel
Organization and Personnel
  • Quality management system

On Accountability

-Responsibilities

-Authorities

  • Training

- Competency based

facilities
Facilities
  • Appropriate infrastructure
  • Safety measures
  • Hygiene measures
equipment
Equipment
  • Validated

- Does it do what you want it to do ?

  • Maintained
  • Calibrated
reagents test kits
Reagents / Test Kits
  • Evaluated
  • Methodology validated
  • Test run validated

- Kit / reagent controls

- Internal control

documentation 1
Documentation (1)
  • Testing strategies / protocols

- Specimen identification

- Confidentiality

  • SOPs

- Sample processing

- Test performance and result interpretation

- Inspection of incoming goods

- Validation

- Equipment maintenance and calibration

- Safety

documentation 2
Documentation (2)
  • Records

- Test results

- Equipment maintenance

- Equipment calibration

- Control charts

- Validation

- Training

inter laboratory comparison
Inter-laboratory comparison
  • External Quality Assurance Scheme

( Proficiency Test , P.T. )

by other quality management system
By Other Quality Management System

International Standards

e.g. ISO 9000 series,

ISO/IEC 17025:1999

( General Requirements for the Competence of Testing and Calibration Laboratories )

slide34
In 1985 JCAHO published its 10-step QA monitoring process.
  • Assign responsibility for QA plan.
  • Define scope of patient care.
  • Identify important aspects of care.
  • Construct indicators.
  • Define thresholds for evaluation.
  • Collect and organize data.
  • Evaluate data.
  • Develop corrective action plan.
  • Assess action; document improvement.
  • Communicate relevant information.
slide35
JCAHO has also established nine dimensions of performance that must be included and measured in the design of the organization’s quality assessment and performance improvement plan:
slide36
Nine Dimension
  • Efficacy
  • Appropriateness
  • Availability
  • Timeliness
  • Effectiveness
  • Continuity
  • Safety
  • Efficiency
  • Care and Respect
national accreditation scheme
National Accreditation Scheme
  • CAP Laboratory Accreditation Programm ( LAP ), USA
  • CPA , Clinical Pathology Accreditation

( UK) Ltd., Standards for the Medical Laboratory

slide38
ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration Laboratories ( Based on ISO9001:1994 )
  • An international standard for recognising competence in testing & calibration laboratories
slide39
ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration Laboratories con’t
  • Sets out basic quality system requirements in accordance with ISO9001 or 9002
  • Laboratories carrying out calibration and testing activities and meeting the requirements will therefore also operate accordance with the ISO 9000 series quality system
management and technical criteria for accreditation
Management and Technical criteria for Accreditation
  • Compliance with criteria in Section 4, Management Requirements;
  • Compliance with the criteria in Section 5, Technical Requirements of Technical Criteria for Laboratory Accreditation HKLAS 003
  • Compliance with HKLAS 002 – regulations governing the administration of HOKLAS and the obligations of accredited laboratories.
uncertainty of measurement
UNCERTAINTY OF MEASUREMENT

Calibration Laboratories

  • Accredited for calibrations under the “Calibration Service” Test category
  • Refer to ISO “Guide to Expression of Uncertainty in Measurement” (GUM)
  • Refer to EA-4/02, for application of GUM

website:www.european-accreditation.org

testing laboratories
Testing Laboratories
  • Required to estimate the uncertainty of measurement in accordance with 5.4.6.2 of the HKLAS 003
asia pacific laboratory accreditation cooperation aplac
Asia Pacific Laboratory Accreditation Cooperation (APLAC)
  • Established in 1992, Secretary Office in Australia
  • MRA, Mutual Recognition Agreement
  • Members consisted of 7 countries, 13 Laboratory accredition bodies (December, 1999 figure)
  • China, China Taipei, China Hong Kong
  • Australia
  • New Zealand
  • Korea
  • Singapore
  • United State
  • Japan
the hong kong laboratory accreditation scheme hoklas
The Hong Kong Laboratory Accreditation Scheme (HOKLAS)
  • Found in 1985
  • Function : identifying and recognising competent testing & calibration laboratories in Hong Kong
  • Expanded in 1998, forming Hong Kong Accreditation Service (HKAS)
hklas scope of accreditation
HKLAS – Scope of Accreditation
  • Electrical and Electronic Products
  • Textiles and Garments
  • Toys and children product
  • Food
  • Calibration service
  • Construction materials
  • Environmental testing
  • Chemical testing
  • Miscellaneous

Other Test Categories may be added when significant needs are identified.

pathology laboratory accreditation in hong kong
Pathology Laboratory Accreditation in Hong Kong
  • In year 2003
  • Mandatory or

Voluntary ??

Based on which standard (S ) ??

technical criteria iso iec17025 1999 4 management requirements
4.1 Organizaton

4.2 Quality system

4.3 Document control

4.4 Review of request, tenders or contract

4.5 Subcontracting of tests and calibrations

4.6 Purchasing services and supplies

4.7 Service to the client

4.8 Complaints

4.9 Control of NC Testing and/or calibration work

4.10 Corrective action

4.11 Preventive action

4.12 Control of records

4.13 Internal audits

4.14 Management Reviews

Technical Criteria – ISO/IEC17025:1999 4. Management Requirements
5 technical requiremnts
5.1 General

5.2 Personnel

5.3 Accommodation & environment conditions

5.4 Tests & calibration methods and methods validation

5.5 Equipment

5.6 Measurement traceability

5.7 Sampling

5.8 Handling of test and calibration items

5.9 Assuring the quality of test

5.10 Reporting the results

5. Technical Requiremnts
benefits of quality systems
Benefits of Quality Systems
  • Consistently achieve ‘customers’ requirements
  • Minimize errors, “waste” and complaints
  • Improve efficiency
  • Reduces

- negative impact on customers

- likelihood of litigation

- communication breakdown

con t
Con’t
  • Improve safety and morale
  • Standardization
  • Ensure adequacy of resources
  • Build-in improvement tools
  • Facilitates changes & easier problem solving
slide56
ISO 15189 Medical Laboratories – Particular requirements for quality and competence ( Based on ISO9001:2000)

4 Management requirement

4.1 Organisation and management

4.2 Quality management system

4.3 Document control

4.4 Review of requests and contracts

4.5 Examination by referral laboratories

4.6 External services and supplies

4.7 Advisory services

medical laboratories particular requirements for quality and competence con t
Medical Laboratories – Particular requirements for quality and competence (con’t)

4.8 Resolution of complaints

4.9 Identification and control of nonconformities

4.10 Continual improvement

4.11 Corrective action

4.12 Preventive action

4.13 Quality and technical records

4.14 Internal audits

4.15 Management review

medical laboratories particular requirements for quality and competence con t58
Medical Laboratories – Particular requirements for quality and competence (con’t)

5 Technical requirements

5.1 Personnel

5.2 Accommodation and environmental conditions

5.3 Laboratory equipment

5.4 Pre-examination procedures

5.5 Examination procedures

5.6 Assuring the quality of examination procedures

5.7 Post-examination process

5.8 Reporting of results

5.9 Alterations and amendments of reports

new rules of the game
New Rules of the Game…..
  • Diminishing Resources
  • Lowering of staff level
  • Increasing Accountability
  • Increasing Regulation
  • Complex Relationships
  • Rate of changes
  • New value Systems

The Age of Innocence is over

the drive for public sector efficiencies
The Drive for Public Sector Efficiencies
  • The quest for balanced Budgets
  • Monopolies and monopsonies
  • Privatisation
  • Regionlization
  • Price signals
some common goals
Some Common Goals
  • Standardize Business System
  • Standardize System Performance
  • Strengthen the Skills of our People
overview of iso 9001 2000
Overview of ISO 9001:2000

Model of process-based quality management system

Continual Improvement of

the Quality Management System

Customers

(and other

interested

parties)

Customers

(and other

interested

parties)

Management

responsibility

Resource

management

Measurement,

analysis & improvement

Satisfaction

Product

Realization

Product

Requirements

Input

Output

the system approach begins when first you see the world through the eyes of another

“The system approach begins when first you see the world through the eyes of another”

C.W. Churchman

1968