quality managment is used for the upgrading of quality. in lab quality is improve by means of management system

1. MUHAMMAD ASIF ZEB
LECTURER MLT (KMU)
MHPE (MPIL)
M.SC. HEMATOLOGY
B.SC MLT
CHPE
CHR
Introduction- Laboratory Quality
Management System
Introduction Laboratory Quality Management System-Module 1 1

2. Introduction Laboratory Quality Management System-Module 1 2
At the end of this activity, participants will be able to:
 Explain the importance of a quality management system
 List the quality system essential elements
 Describe the history of development of quality principles
 Discuss relationship of this quality model to ISO and CLSI
standards
Learning Objectives

3. Introduction Laboratory Quality Management System-Module 1 3
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
The Quality Management System

4. Introduction Laboratory Quality Management System-Module 1 4
What is Quality?

5. Introduction Laboratory Quality Management System-Module 1 5
5
Achieving a 99% level of quality
means
accepting a 1% error rate1%

6. Introduction Laboratory Quality Management System-Module 1 6
In France a 1% error rate
would mean everyday
 14 minutes without water or electricity
 50,000 parcels lost by postal services
 22 newborns falling from
midwives’ hands
 600,000 lunches contaminated
by bacteria
 3 bad landings at Orly Paris airport

7. Introduction Laboratory Quality Management System-Module 1 7
7
Result: 1% failure

8. Introduction Laboratory Quality Management System-Module 1 8
Essential to all aspects of
health care are laboratory
results that are
 accurate,
 reliable, and
 timely

9. Introduction Laboratory Quality Management System-Module 1 9
How do we
achieve
excellent
performance
in the
laboratory?
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety

10. Introduction Laboratory Quality Management System-Module 1 10
Quality Management System Definition
Coordinated activities to direct and
control an organization with regard
to quality (ISO,CLSI).
All aspects of the laboratory operation
need to be addressed to assure
quality; this constitutes
a quality management system.

11. Introduction Laboratory Quality Management System-Module 1 11
Complexity of a Laboratory System
•Data & Laboratory
Management
•Safety
•Customer Service
Patient/Client Prep
Sample Collection
Sample Receipt and
Accessioning
Sample Transport
Quality Control
Testing
Record Keeping
Reporting
Personnel Competency
Test Evaluations

12. Introduction Laboratory Quality Management System-Module 1 12
Path of Workflow
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis
Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase

13. Introduction Laboratory Quality Management System-Module 1 13
WHY is the Path of Workflow essential to consider in
health laboratories?
The entire process of managing a sample must be
considered:
 the beginning: sample collection
 the end: reporting and saving of results
 all processes in between.

14. Introduction Laboratory Quality Management System-Module 1 14
Laboratory tests are influenced by
 laboratory environment
 knowledgeable staff
 competent staff
 reagents and equipment
 quality control
 communications
 process management
 occurrence management
 record keeping

15. Introduction Laboratory Quality Management System-Module 1 15
Twelve Quality System Essentials
set of
coordinated
activities that
function as
building blocks
for
quality
management
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety

16. Introduction Laboratory Quality Management System-Module 1 16
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
Path of Workflow

17. Introduction Laboratory Quality Management System-Module 1 17
Organization
Responsibilities, Authorities
CommunicationProvision
of
resources
Quality
Policy

18. Introduction Laboratory Quality Management System-Module 1 18
Personnel
 human resources
 job qualifications
 job descriptions
 orientation
 training
 competency assessment
 professional development
 continuing education

19. Introduction Laboratory Quality Management System-Module 1 19
Equipment
 acquisition
 installation
 validation
 maintenance
 calibration
 troubleshooting
 service and repair
 records

20. Introduction Laboratory Quality Management System-Module 1 20
Purchasing and Inventory
 vendor qualifications
 supplies and reagents
 critical services
 contract review
 inventory management

21. Introduction Laboratory Quality Management System-Module 1 21
Process Control
 quality control
 sample management
 method validation
 method verification

22. Introduction Laboratory Quality Management System-Module 1 22
Information Management
confidentiality
equisitions
ogs and records
eports
computerized laboratory
nformation systems (LIS)

23. Introduction Laboratory Quality Management System-Module 1 23
Documents Records
creation collection
revisions and review review
control and distribution storage
retention

24. Introduction Laboratory Quality Management System-Module 1 24
Occurrence Management
 complaints
 mistakes and problems
 documentation
 root cause analysis
 immediate actions
 corrective actions
 preventive actions

25. Introduction Laboratory Quality Management System-Module 1 25
Laboratory Assessment
External
Proficiency
testing (EQA)
Inspections
Accreditations
InternalInternal

26. Introduction Laboratory Quality Management System-Module 1 26
Process Improvement
 opportunities for improvement (OFIs)
 stakeholder feedback
 problem resolution
 risk assessment
 preventive actions
 corrective actions

27. Introduction Laboratory Quality Management System-Module 1 27
Customer Service
customer group identification
customer needs
customer feedback

28. Introduction Laboratory Quality Management System-Module 1 28
Facilities and Safety
 safe working environment
 transport management
 security
 containment
 waste management
 laboratory safety
 ergonomics

29. Introduction Laboratory Quality Management System-Module 1 29
In summary
 Quality management is not new.
 Quality management grew from the good works of
innovators who defined quality over a span of 80
years.
 Quality management is as applicable for the
medical laboratory as it is for manufacturing and
industry.