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From-Good-Laboratory-Practice-to-Total-Quality-Management-in-Vet-Medical-Laboratories

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

Dr.Kedar Karki

1

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

2

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
3

Evolution of Quality Management Philosophy
1930 – 60, Q.C. ( Cure ) ⇓ 1970 – 80, Q.A. ( Preventive ) ⇓ To-day, TQM ( Holistic involvement )
4

Evolution of Quality Systems
>2000 1975-90 West 1962-75 Japan 1950-62 TQC Deming, Juran, Ishikawa 1942-45 TPC 1930 SPC Shewart 1920-1945 QC Depts 1915 Gilbreth 1890's Taylor
Beyond TQM Total Quality Managment Quality Management System Quality Assurance Good Manufacturing Practice Quality Control

ISO9001:2000 ISO9004:1994 ISO9001:1994

1980's ISO9000 1988 EEC 1972 EPIC 1969 WHO 1968 UK 1962 USA
5

Overview on the Functions of The Medical Laboratory
Reference Standards and/or Statutory Requirements

Subcontracting Laboratories
(Tests & Calibration)

Hospital, Clinicians & Clients

Medical Laboratory

GLP/ISO/TQM

6

Clinical Specimen Adulteration
Result:  Accuracy  Precision  Reliability  Efficiency  Confidentiality Microbial Contamination Physical Damage or Contamination Environment Personnel Information Patient or Client (sample sources)
7

Material Suppliers

rX M

sY M

Equipment Tissue Process or Techniques

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
8

QM, QA and QC interrelationships
Quality Management
Policy, Objective, Committent & Direction Organization Structure, Responsibility, Accoutability Internal QA Operational & Technical Activities on Fulfilling Quality Requirements

Quality System
External QA

Quality Assurance

Quality Control

9

• Quality costs, but poor Quality costs more

Why Quality Management is everybody’s darling

• Regulator : reduces workload, ( manpower ) • Blood Industry Officials: makes the environment transparent • Hospitals : reduces responsibility to patients

10

Cost of Quality
Appraisal

gain

Appraisal

Failure

Failure

Prevention

Prevention

Before

After

11

Demings chain
Improvement of quality Improvement of productivity

Market-share

Price-reduction

Cost-reduction

Secure position

Secure jobs

12

Demings chain in Laboratory Service
Improvement of quality Improvement of productivity

Market-share

Price-reduction

Cost-reduction

Secure position

Secure jobs

13

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 ?
14

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.

15

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.

16

Quality Layers
1. Minimal requirements “ Bad Quality” 2. Functional Requirement “Quality” 3. Non-functional requirements “Good Quality” 4. Far ahead of customer expectations “Excellence”
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Should’nt we achieve excellence ?
Quality = Excellence Excellence begins in your mind

18

Quality Planning
• Part of Quality management focused on setting quality objectives and specifying necessary processes and related resources to fulfil the quality objective

19

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 !!
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The 8 columns of excellence
Responsibility for the community Building partnerships Continuous learning Involvement of employees Orientation on results

Orientation of customers Leadership & consequences of goals Management of processes & facts
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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
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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 )
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Good Laboratory Practice( GLP )
• Main areas of GLP - Organization and personnel - Facilities - Equipment - Reagent / test kits - Documentation - Inter-laboratory comparison
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Organization and Personnel
• Quality management system On Accountability -Responsibilities -Authorities • Training - Competency based
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Facilities
• Appropriate infrastructure • Safety measures • Hygiene measures

26

Equipment
• Validated - Does it do what you want it to do ? • Maintained • Calibrated
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Reagents / Test Kits
• Evaluated • Methodology validated • Test run validated - Kit / reagent controls - Internal control

28

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

29

Documentation (2)
• Records - Test results - Equipment maintenance - Equipment calibration - Control charts - Validation - Training
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Inter-laboratory comparison
• External Quality Assurance Scheme ( Proficiency Test , P.T. )

31

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 )

32

ISO1/IEC 17025, ISO15189 Development History
>2000 ISO9000-2000 ISO9000-1994
Beyond TQM ISO/DIS 15189 (2002) Medical Laboratories Particular Requirements for Quality & Competance ISO/IEC 17025:1999 (Standard) ISO/IEC Guide 25 2nd Ed. 1990 ISO/IEC Guide 25 1st Ed. 1982 ISO Guide 25 1978
Standards Requirements for Competence of Testing & Calibration Requirement (Testing/Calibration) Requirement (Testing) Guideline (Testing)

ISO9000-1987

NATA ILAC (1947) (1945)

33

In 1985 JCAHO published its 10step QA monitoring process.
2. Assign responsibility for QA plan. 3. Define scope of patient care. 4. Identify important aspects of care. 5. Construct indicators. 6. Define thresholds for evaluation. 7. Collect and organize data. 8. Evaluate data. 9. Develop corrective action plan. 10.Assess action; document improvement. 11.Communicate relevant information.

34

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

35

Nine Dimension
• Efficacy • Appropriateness • Availability • Timeliness • Effectiveness • Continuity • Safety • Efficiency • Care and Respect

36

National Accreditation Scheme
• CAP Laboratory Accreditation Programm ( LAP ), USA • CPA , Clinical Pathology Accreditation ( UK) Ltd., Standards for the Medical Laboratory

37

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

38

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
39

ISO9001:1994 – The Role and Function of 20 Elements
4.1 4.2 Policy & Organisation Structure Control Management & Training

4.5 4.16 4.18 4.14 4.17

4.8

4.13

4.20 Measuring, Identification & Traceability

4.12

4.10

4.11 Essential Processes

4.3

4.4

4.6/7

4.9

4.15

4.19

Q
40

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.
41

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.europeanaccreditation.org 42

Testing Laboratories
• Required to estimate the uncertainty of measurement in accordance with 5.4.6.2 of the HKLAS 003

43

Established in 1992, Secretary Office in Australia • MRA, Mutual Recognition Agreement • Members consisted of 7 countries, 13 Laboratory accredition bodies (December, 1999 figure) 4. China, China Taipei, China Hong Kong 5. Australia 6. New Zealand 7. Korea 8. Singapore 9. United State 44 10. Japan

•

Asia Pacific Laboratory Accreditation Cooperation (APLAC)

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)

45

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. 46

Pathology Laboratory Accreditation in Hong Kong
• In year 2003 • Mandatory or Voluntary ?? Based on which standard (S ) ??

47

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
48

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

49

Quality Policy – determined and issued by the Top Management
Policy Statement, Vision, Mission & Quality Planning: Commitment to  Quality of Professional Standards  Quality Standard Requirements e.g. ISO9000; ISO/IEC17025 etc

Objectives

Service Standards and / or Statutory Requirements

Communication

Understanding, Implementation & Review 50

Documentation Structure : hierarchy

QM QP WI

Quality Manual (Policy, Vision, Mission, Objectives and Commitment to Quality) Structure, Responsibility & Authority

SOP

Quality Procedure (Guidelines to perform quality related activities)

Records

Forms, Results, Reference Standards & Equipment Manuals 51

Documentation System
Quality Policy
Service Standards OS&H Ordinance International Standards (ISO 9000) (ISO 17025)

Codes of Profession Quality Policy Manual Quality Records
Materials Computer Maintenance Calibration Distribution Training Production Patient / Client QC/QA Testing Registers / Log Other Records Management QPs
Collection Processing Testing/ Workplace WIs Exam Storage Labelling Personal Data and Testing Audit Incident and Complaint Surveillance QA Disposal System Reviews

Organization Background, Vision, Mission, Objectives, Plans Organization Reviews Responsibilty, Authority

Specifications
Chemicals (MSDS) Reagents / Kits Critical Materials Labels Process Quality Control Equipment Calibration Device

Directions
Management QMs

52

Document Control
Easy Accessible to All
Distribution Retrieval

Prepare Documents as Authority Required in Standard Format

Use Only Valid & Controlled Documents

Authority

Regular Review, Revise

Return & Destroy

Obsolete Document
53

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

54

Con’t
• Improve safety and morale • Standardization • Ensure adequacy of resources • Build-in improvement tools • Facilitates changes & easier problem solving

55

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
56

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
57

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

58

Continual Improvement
Improvement
nfo I
Act Check Do Plan

n tio ma r

Benchmarking or Beyond TQM

Objective of Changes Quality Management System Time
59

Deming Cycle
(Plan, Do, Check & Act)
Act (Head & Manager)

Check (Monitor & Auditor)

P-D-C-A

Plan (Manager & Supervisor)

Do (Operator)

60

Seven Determinants in TQM
Machine Materials

Information

Man
÷ ¾

Monitoring & Measuring

5M 1E 1I

Methods

Environment
61

ISO17025 (ISO15189) GENERAL LAYOUT
Clinical Diagnosis Patient/Client Seeking Health Service Medical Questioning Medical History Laboratory File

Accommodation & Environmental Conditions
Laboratory-clinic Interface Feedback

Quality Planning
Requirements & Specifications

Appropriate Choice of Tests Collection Logistics Testing Sample Transport

ISO15189 (Based on ISO9001:2000) ISO17025 (Based on ISO9001:1994)

DOCUMENTATION, RECORD, DATA CONTROL

Policies Objective Structure Responsibilities Complaint Audit Resources Personnel

Purchasing & Supplies
Logistics

Corrective Preventive Action
Request, Tenders & Contract Review

Management Review

QUALITY SYSTEM
Contracted Laboratories for tests and calibrations STAFF TRAINING & COMPETENCE Material Control Acceptance, Quarantine & Storage Inventory Management

NON-COMFORMITY CONTROLS
Feedback

Registration (Reconciliation) EQUIPMENT MAINTENANCE & CALIBRATION

Communication

Testing

Monitoring, Measuring & Testing
Test/Calibration Results Assurance Q.C., Q.A. EQAS Proficiency Test (ISO/IEC Guide 43) Measurement Traceability

Dispensing / Archive Analysis & Testing Analytical Test Result Confirmatory Test Result Verification Re-test INFORMATION SYSTEM
Security Control Patient & Laboratory Data Up-Date, & Storage

SYSTEM VALIDATION

Hygiene Sterility Control OS&H

Handling of Test and Calibration Items Storage Security Disposal Management

Result Distribution Logistics

ISO15189 (Continual Improvement)
Laboratory-clinic Interface Patient during at after Health Service ISO15189 Ethics in Laboratory Medicine

Authorization To Release

Reporting
Use of Laboratory Data

62

Laboratories with Patient / Client as “Customer”
FUNDING AGENCY SUPPLIERS Medical Laboratory PERSONNEL

hardware software consumables

Education and Competency

Patient/ Client
Seeking Clinical Pathology Service

sampling testing

MANAGE SUPPORT

END-USERS reporting
result analysis

PATIENT
during &after Health Service

SUBCONTRACTORS
(tests & calibration)

LEGISLATURE

REGULATORY AGENCY
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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
64

The Drive for Public Sector Efficiencies
• The quest for balanced Budgets • Monopolies and monopsonies • Privatisation • Regionlization • Price signals

65

Some Common Goals
• Standardize Business System • Standardize System Performance • Strengthen the Skills of our People

66

Customers Focus and Expectation continue for Good Price for Best Quality

67

Overview of ISO 9001:2000
Model of process-based quality management system
Continual Improvement of the Quality Management System

Customers (and other interested parties)

Management responsibility

Customers (and other interested parties)
Satisfaction

Resource management

Measurement, analysis & improvement

Requirements

Input

Product Realization

Product

Output

Quality Standard Compliance Triangle & Quality System Accreditation/Certification

Documentation

QMS Certification Accreditation

Training

Audit

69

“The system approach begins when first you see the world through the eyes of another”
C.W. Churchman 1968
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