Management System
Learning Objectives
At the end of this activity, participants will be
able to:
Personnel
Purchasing
&
Inventory
Process
Control
Documents
&
Records
Occurrence
Management
Process
Improvement
Customer
Service
Equipment
Information
Management
Assessment
Facilities
&
Safety
What is Quality?
Result:
1% failure
accurate,
reliable, and
timely
Introduction Laboratory Quality Management System-Mo
personnel
effort
patient
outcomes
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
11
Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
Data & Laboratory
Management
Safety
Customer Service
Record Keeping
Quality Control
Testing
Sample Transport
12
Path of Workflow
THE PATIENT
Test selection
Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport
Result Interpretation
Report Creation
Postexamination Phase
13
14
laboratory environment
knowledgeable staff
competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record keeping
Introduction Laboratory Quality Management System-Mo
15
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
Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Path of Workflow
Documents
&
Records
Occurrence
Management
Process
Improvement
Customer
Service
Assessment
Facilities
&
Safety
17
Organization
Responsibilities, Authorities
Quality
Policy
Provision
of
resources
Communication
18
Personnel
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education
Introduction Laboratory Quality Management System-Mo
19
Equipment
acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records
Introduction Laboratory Quality Management System-Mo
20
vendor qualifications
supplies and reagents
critical services
contract review
inventory management
Introduction Laboratory Quality Management System-Mo
21
Process Control
quality control
sample management
method validation
method verification
22
Information Management
confidentiality
requisitions
logs and records
reports
computerized laboratory
23
Documents
creation
revisions and review
control and distribution
Records
collection
review
storage
retention
24
Occurrence Management
complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
preventive actions
Introduction Laboratory Quality Management System-Mo
25
Laboratory Assessment
External
Internal
Internal
Proficiency
testing (EQA)
Inspections
Accreditations
Introduction Laboratory Quality Management System-Mo
26
Process Improvement
opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions
Introduction Laboratory Quality Management System-Mo
27
Customer Service
customer group identification
customer needs
customer feedback
28
29
Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
But it detects
errors that may
occur and
prevents them
from recurring
30
Organizatio
n
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
Assessmen
t
Process
Improvement
Customer
Service
Facilities
&
Safety
Laboratories not
implementing a
quality management
system guarantees
UNDETECTED
ERRORS
31
Laboratory
Quality Management System
Coordinated activities to direct and
control an organization with regard to
quality.
ISO 9000:2000
32
Innovators of Quality
Walter
Shewhart
1891-1967
Joseph Juran
1904-2008 (103 years)
Philip Crosby
1926-2001
W. Edwards
Deming
1900-1993
Robert Galvin
b. 1922
33
Innovator
Date
Cycle
Walter A.Shewhart
1920s
W. Edwards Deming
1940s
Joseph M. Juran
Philip B. Crosby
1950s
1970s
Statistical Process
Control
Continual
Improvement
Quality Toolbox
Robert W. Galvin
1980s
Quality by
Requirement
Micro Scale Error
Reduction
34
Standards Organizations
ISO
International Organization
for Standardization
Guidance for quality in
manufacturing and service
industries
Broad applicability; used
by many kinds of
organizations
Uses consensus process in
developing standards
CLSI
35
36
ISO 15189:2007
The
foundation of international
medical laboratory quality
management
Medical laboratoriesParticular
requirements for quality
and competence
Introduction Laboratory Quality Management System-Mo
37
38
In summary
39
Key Messages
40
Organization
Personnel
Equipment
Questions?
Purchasing
&
Inventory
Process
Control
Documents
&
Records
Occurrence
Management
Process
Improvement
Customer
Service
Information
Management
Comments?
Assessment
Facilities
&
Safety
41