iso lab introduction slides
TRANSCRIPT
-
8/18/2019 ISO Lab Introduction Slides
1/41
Introduction-
Laboratory Quality
Management System
-
8/18/2019 ISO Lab Introduction Slides
2/41
Introduction Laboratory Quality Management System-Module 1 2
At the end of this activity, participants will beable 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
I! and "LI standards
Learning !b#ectives
-
8/18/2019 ISO Lab Introduction Slides
3/41
Introduction Laboratory Quality Management System-Module 1 3
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management ssessment
Process
Improvement
Customer
!ervice
"acilities
&
!afety
$he %uality &anagement ystem
-
8/18/2019 ISO Lab Introduction Slides
4/41
Introduction Laboratory Quality Management System-Module 1 4
'hat is %uality(
-
8/18/2019 ISO Lab Introduction Slides
5/41
Introduction Laboratory Quality Management System-Module 1 55
Achieving a 99% level of quality
means
accepting a 1% error rate
1%
-
8/18/2019 ISO Lab Introduction Slides
6/41
Introduction Laboratory Quality Management System-Module 1 6
In )rance a 1% error rate would mean everyday
*+ minutes without water or electricity
-,--- parcels lost by postal services
.. newborns falling from
midwives/ hands
0--,--- lunches contaminated
by bacteria
1 bad landings at !rly 2aris airport
-
8/18/2019 ISO Lab Introduction Slides
7/41
Introduction Laboratory Quality Management System-Module 1 77
3esult: 1% failure
-
8/18/2019 ISO Lab Introduction Slides
8/41
Introduction Laboratory Quality Management System-Module 1 8
Essential to all aspects of
health care are laboratoryresults that are
accurate,
reliable, and
timely
-
8/18/2019 ISO Lab Introduction Slides
9/41
Introduction Laboratory Quality Management System-Module 1 9
Laboratory errors cost in
time
personnel effort
patientoutcomes
-
8/18/2019 ISO Lab Introduction Slides
10/41
Introduction Laboratory Quality Management System-Module 1 10
How do weachieveexcellenter!ormancein thelaboratory"
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Managementssessment
Process
Improvement
Customer
!ervice
"acilities
&
!afety
-
8/18/2019 ISO Lab Introduction Slides
11/41
Introduction Laboratory Quality Management System-Module 1 11
%uality &anagement ystem Definition
"oordinated activities to direct andcontrol an organi4ation with regardto quality 5I!,"LI67
#ll asects o! the laboratory oeration
need to be addressed to assure$uality this constitutes
a $uality management system&
-
8/18/2019 ISO Lab Introduction Slides
12/41
-
8/18/2019 ISO Lab Introduction Slides
13/41
Introduction Laboratory Quality Management System-Module 1 13
'ath o! (or)!low
)E PIE* est selection !ample Collection
!ample ransport
#a$oratory nalysis
E+amination Phase
Report CreationReport ransport
Pree+amination Phase
Result Interpretation Poste+amination Phase
-
8/18/2019 ISO Lab Introduction Slides
14/41
Introduction Laboratory Quality Management System-Module 1 14
(H* is the 2ath of 'or8flow essential
to consider in health laboratories(
$he entire rocess of managing asample must be considered:
the beginning: sample collection
the end: reporting and saving of results
all processes in between7
-
8/18/2019 ISO Lab Introduction Slides
15/41
Introduction Laboratory Quality Management System-Module 1 15
Laboratory tests are influenced by
laboratory environment
8nowledgeable staff
competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record 8eeping
-
8/18/2019 ISO Lab Introduction Slides
16/41
Introduction Laboratory Quality Management System-Module 1 16
+welve Quality System ,ssentials
set ofcoordinated
activities thatfunction as
building bloc8sfor
quality
management
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Managementssessment
Process
Improvement
Customer
!ervice
"acilities
&
!afety
-
8/18/2019 ISO Lab Introduction Slides
17/41
Introduction Laboratory Quality Management System-Module 1 17
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Managementssessment
Process
Improvement
Customer
!ervice
"acilities
&
!afety
Path of Worflo!
-
8/18/2019 ISO Lab Introduction Slides
18/41
Introduction Laboratory Quality Management System-Module 1 18
!rgani4ationesonsibilities. #uthorities
/ommunication'rovisiono!
resources
Quality'olicy
-
8/18/2019 ISO Lab Introduction Slides
19/41
Introduction Laboratory Quality Management System-Module 1 19
2ersonnel
human resources #ob qualifications
#ob descriptions
orientationtraining
competency assessment
professional developmentcontinuing education
-
8/18/2019 ISO Lab Introduction Slides
20/41
Introduction Laboratory Quality Management System-Module 1 20
Equipmentacquisition
installation
validation
maintenance calibration
troubleshooting
service and repair
records
-
8/18/2019 ISO Lab Introduction Slides
21/41
Introduction Laboratory Quality Management System-Module 1 21
2urchasing and Inventory
vendor qualifications
supplies and reagents
critical services
contract review
inventory management
-
8/18/2019 ISO Lab Introduction Slides
22/41
Introduction Laboratory Quality Management System-Module 1 22
2rocess "ontrol
quality control
sample management
method validation
method verification
-
8/18/2019 ISO Lab Introduction Slides
23/41
Introduction Laboratory Quality Management System-Module 1 23
Information &anagement
confidentiality
requisitions
logs and records
reports
computeri4ed laboratoryinformation systems 5LI6
-
8/18/2019 ISO Lab Introduction Slides
24/41
-
8/18/2019 ISO Lab Introduction Slides
25/41
Introduction Laboratory Quality Management System-Module 1 25
!ccurrence &anagement
complaints
mista8es and problems
documentationroot cause analysis
immediate actions
corrective actionspreventive actions
-
8/18/2019 ISO Lab Introduction Slides
26/41
Introduction Laboratory Quality Management System-Module 1 26
Laboratory Assessment ,xternal
'ro!iciencytesting ,Q#2
Insections
#ccreditations
InternalInternal
-
8/18/2019 ISO Lab Introduction Slides
27/41
Introduction Laboratory Quality Management System-Module 1 27
2rocess Improvement
opportunities for improvement 5!)Is6sta8eholder feedbac8
problem resolution
ris8 assessment
preventive actions
corrective actions
-
8/18/2019 ISO Lab Introduction Slides
28/41
Introduction Laboratory Quality Management System-Module 1 28
"ustomer ervice
customer group identificationcustomer needs
customer feedbac8
-
8/18/2019 ISO Lab Introduction Slides
29/41
Introduction Laboratory Quality Management System-Module 1 29
)acilities and afety
safe wor8ing environmenttransport management
security
containment
waste management
laboratory safetyergonomics
-
8/18/2019 ISO Lab Introduction Slides
30/41
-
8/18/2019 ISO Lab Introduction Slides
31/41
Introduction Laboratory Quality Management System-Module 1 31
Organization
Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
ssessmen
t
Process
Improvement
Customer
!ervice
"acilities
&
!afety
Laboratories not
implementing a
quality management
system guarantees
9DE$E"$ED
E33!3
-
8/18/2019 ISO Lab Introduction Slides
32/41
Introduction Laboratory Quality Management System-Module 1 32
Laboratory
%uality &anagement ystem"oordinated activities to direct and
control an organi4ation with regard to
quality7
IS4 955567555
-
8/18/2019 ISO Lab Introduction Slides
33/41
Introduction Laboratory Quality Management System-Module 1 33
Innovators of %uality
(alterShewhart*;
-
8/18/2019 ISO Lab Introduction Slides
34/41
Introduction Laboratory Quality Management System-Module 1 34
A ?rief @istory of %uality &anagement
Innovator 0ate /ycle'alter A7hewhart 1975s tatistical 2rocess
"ontrol
'7 Edwards Deming
19:5s"ontinual
Improvement
oseph &7 uran 19;5s %uality $oolbox
2hilip ?7 "rosby 19
-
8/18/2019 ISO Lab Introduction Slides
35/41
Introduction Laboratory Quality Management System-Module 1 35
tandards !rgani4ations
IS4 International !rgani4ationfor tandardi4ation
/LSI "linical and Laboratorytandards Institute
5formerly 8nown as ""L6
Buidance for quality inmanufacturing and serviceindustries
tandards, guidelines, andbest practices for quality inmedical laboratory testing
?road applicabilityC used
by many 8inds oforgani4ations
DetailedC applies
specifically to medicallaboratories
9ses consensus process in
developing standards
9ses consensus process in
developing standards
-
8/18/2019 ISO Lab Introduction Slides
36/41
Introduction Laboratory Quality Management System-Module 1 36
I! Documents = LaboratoryIS4 955167555 Quality Management
System e$uirements &odel for %A in design, developmentproduction, installation, and servicing
IS4>I,/ 1
-
8/18/2019 ISO Lab Introduction Slides
37/41
Introduction Laboratory Quality Management System-Module 1 37
I! **;
$he foundation of internationalmedical laboratory quality
management&edical laboratories2articular
requirements for quality
and competence
-
8/18/2019 ISO Lab Introduction Slides
38/41
Introduction Laboratory Quality Management System-Module 1 38
"LI %uality Documents
HS1-#7 # Quality Management System Model!or Health /are
describes quality system model, *. essentials
aligns to I! **;< and parallels I!
-
8/18/2019 ISO Lab Introduction Slides
39/41
Introduction Laboratory Quality Management System-Module 1 39
In summary %uality management is not new7
%uality management grew from the good wor8s ofinnovators who defined quality over a span of ;-years7
%uality management is as applicable for the medicallaboratory as it is for manufacturing and industry7
-
8/18/2019 ISO Lab Introduction Slides
40/41
Introduction Laboratory Quality Management System-Module 1 40
A laboratory is a complex system and allaspects must function properly to achievequality7
Approaches to implementation will vary withlocal situation7
tart with the easiest, implement instepwise process7
9ltimately, all quality management system
elements must be addressed7
ey &essages
-
8/18/2019 ISO Lab Introduction Slides
41/41
I t d ti L b t Q lit M t S t M d l 1 41
%uestions(
"omments(
Organization Personnel Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Managementssessment
Process
Improvement
Customer
!ervice
"acilities
&
!afety