1
Process
Improvement
Process Improvement-Module 14
Process Improvement-Module 14 2
Learning Objectives
At the end of this module, participants
should be able to:
Appreciate the importance of process improvement
Describe the historical perspective of process improvement;
Describe the importance of process improvement in maintaining quality
Explain the need for tools to monitor laboratory processes so that
problems can be identified and improved
Define process improvement
Develop the quality indicators for the QMS
Monitor the performance of QMS
Carry out remedial actions
Develop and implement the preventive action Plan
Quality Gurus
•Walter Shewart
–In 1920s, developed control charts
–Introduced the term “quality assurance”
•W. Edwards Deming
–Developed courses during World War II to teach
statistical quality-control techniques to engineers and
executives of companies that were military suppliers
–After the war, began teaching statistical quality control
to Japanese companies
•Joseph M. Juran
–Followed Deming to Japan in 1954
–Focused on strategic quality planning
Process Improvement Module 14
Armand V. Feigenbaum
In 1951, introduced concepts of total quality control
and continuous quality improvement
Philip Crosby
In 1979, emphasized that costs of poor quality far
outweigh the cost of preventing poor quality
In 1984, defined absolutes of quality management—
conformance to requirements, prevention, and “zero
defects”
Kaoru Ishikawa
Promoted use of quality circles
Developed “fishbone” diagram
Emphasized importance of internal customer
Quality Gurus (cont.)
Process improvement Module 14
Process Improvement-Module 14 5
W. Edwards Deming
14 Points for Quality
•create constancy of purpose for
improvement
•improve constantly and forever
Two points address continual
improvement:
Deming’s Principles
1.C reate Consistency for
Improvement
2.Preventive Approach (#
inspection-rejection-
rework)
3.Mass inspection => quality
4.Select suppliers on quality
& loyalty (# price alone)
5.Constantly & permanently
improve
6.Institute training
7.Institute leadership ( #
authority)
8.Make people feeling secure
(# fear)
9.No conflicting goals
between departments
10.Eliminate slogans
etc..(only telling to
improveis not working…
people must ACT)
11.Eliminate numerical
quotas (degrade often
other indicators
somewhere else)
12.Increase workers pride &
self esteem(better
supervision, design,
maintenance, tools &
materials)
13.Promote education & self
improvement (+modern
statistical control)
14.Take action (+ adapted
environment +
involvement of Top
Management)
Process Improvement-Module 14 7
The Deming Cycle
Act
Institutionalize
improvement.
Continue the cycle
Plan
Identify the problem
Make plan to solve
Do
Implement the plan
on a test basis
Check
Assess the plan
Is it working?
Quality for Services
•Time & Timelines (How long to wait? Delivered on
time?)
•Completeness(everything asked provided?)
•Courtesy(how are customers treated by
employees?)
•Consistency(each time same standards?)
•Accessibility & Convenience?
•Accuracy(rightly performed each time?)
•Responsiveness(how suited are the reactions to
unusual situations)
Process Improvement-Module 14 9
Continual Improvement
(ISO 15189:2007)
develop plan
for
improvement
identify
potential
sources
of error
implement
review the
effectiveness
of action
adjust the
action plan
and
modify the
system
Process Improvement-Module 14 10
Conventional Improvement Tools
•internal audits
•external quality assessment
•external audit and accreditation
•management review
•opportunities for improvement
•quality indicators
Monitoring Quality
Process Improvement-Module 14 11
Quality Plan
Internal
Audit
External
Audit
Quality
Control
Quality Goal
Opportunities for
improvement
Quality
Assessment
Monitoring Monitoring Monitoring
Process Improvement-Module 14 12
Optimizing
space,
time, and
activityto
improve the
physical paths of
workflow.
Lean
New Trends-Improvement Tools
Process Improvement-Module 14 13
Path of workflow and maintenance by
blood culture technologist
Pre Lean Post Lean
New Trends-Improvement Tools
Six Sigma
A formal structure of project
planning to implement change
and improvement.
Process Improvement-Module 14 14
Process Improvement-Module 14 15
Structure in Six Sigma
•A process for developing and delivering near perfect
products and services
•Measure of how much a process deviates from perfection
•3.4 defects per million
opportunities
Organized processes
to assist in decision
making for continual
improvement:
DMAIC
Process Improvement-Module 14 16
What is Quality?
“Quality is defined as
conformance to requirements ,
not as 'goodness' or 'elegance'.”
Philip Crosby
Four Absolutes of Quality Management
1979
Process Improvement-Module 14 17
Quality Indicators Definition
Established measures used to
determine how well an
organization meets needs and
operational and performance
expectations.
ISO 9001:2000 (5.4.1; 8.4)
ISO 15189:2007 (4.12.4)
Process Improvement-Module 14 18
So…
Quality Indicators
•indicate performance
•determine quality
•highlight concerns
•identify areas needing further study
•track changes over time
Process Improvement-Module 14 19
Measuring Performance
•fewer quality indicators are better
•link to factors needed for success
•based on customer and stakeholder
needs
•start at the top flow down
•change with changing environment
and strategy
•have targets or goals based on
research rather than arbitrary values
Mark Graham Brown
Process Improvement-Module 14 20
Eight Steps to Developing
Successful Indicators
1.objective
2.methodology
3.limits
4.interpretation
5.limitations
6.presentation
7.action plan
8.exit plan
Instructions for quality indicators
•Introduction
•The identification of quality indicators (QIs) is
a crucial step in enabling users to establish the
extent to which the quality objectives have
been/are being achieved.
•Scope/abbreviations/initials
Tasks, responsibilities and
accountabilities
Task ResponsibleAccountable
Establishment of objectives QO Lab Manager
Ensure Quality indicators are
established
QO Lab Manager
Monitoring quality indicators All staff Lab Manager
Establishment of policy
•Intention of the organisation with regard to
quality with reference to the standard ISO
15189:2012.
•From policy, SMART objectives are set with
traceability to the policy
•Each objective traceable to an element of the
policy
Types of quality indicators
Outcome
Structure
Process
=select outcome, while noting the limits of each
type.
Monitoring of quality indicators
•Frequency of monitoring-Monthly
•Indicator matrix -Quarterly
a.Indicator
b.Target
c.Performance per quarter
•Analysis against targets in objectives
a-charts, graphs,
Review
•Evaluate Relevance of an indicator in
monitoring an objective
•Modify the indicator to monitor the same
objective
e.gminor/major NC closure %
SECTION B
•QI-In relation to the policy, objectives
Matrix, MR, Actions
Evidence
•Matrix on controlled documents
•Management review report
•Management review action plan
•ppt/attendance
matrix
Quality
indicators
from
objectives
2017
Management
reviewdecision
Actions
Targ
et
Qtr
1
Qtr
2
Qtr
3
Qrt
4
%Sample
rejected
2%4%3.2
%
2.4
%
2.2
%
Maintain the
targetat2%
StartQIprojecton
samplerejection
Trainnursesinwards
%
Verificatio
ns
100
%
70
%
80%95%100
%
Drop this
indicatorbut
ensure
verificationis
doneattheset
interval.
Trainsectionheadson
statisticalprocess
control
Contingencyplanfor
availabilityofcontrols
%ofNCs
closedon
time
85%80
%
90%95%93%Setnewtargetat
95%formajor
nonconformities,
90%forminor
nonconformities
Addressthisinthe
revisionofdocs
Review of policy
•Quality policy is still relevant, and objectives
should just be revised based on the decisions
from the MR.
Process Improvement-Module 14 33
The BIG SECRET for
Quality Indicator Team
Engage the folks
who do the work,
because they
know what
they do!
Process Improvement-Module 14 34
Characteristics
Timed
short and long term
Engaging
all levels
Balanced
full cycle Actionable
action oriented
Interpretable
specific
Achievable
contained
Measurable
objective
Good
Quality
Indicators
Process Improvement-Module 14 35
Keeping Score
“Many organizations spend thousands of hours
collecting and interpreting data. However many of
these hours are nothing more than wasted time
because they analyze the wrong measurements,
leading to inaccurate decision making.”
Mark Graham Brown
Using the Right Metrics to Drive World Class Performance
1996
Computer Non sense Indicators
Process Improvement-Module 14 36
[urine culture] * [glucose] * [INR]
[NUPA hr] * [Telephone minutes]
X100
Just because a
computer can
calculate a value,
doesn’t mean that it
should.
Quality Indicators Examples
SystemPre exam-Examination-Post exam
test order
accuracy and
appropriateness
patient
identification
adequacy
accuracy of
point-of-care testing
critical values
reporting
turnaround
time
clinician
satisfaction
accuracy of
sample
information
cervical
cytology/biopsy
correlation
clinician
satisfaction
clinician
follow-up
clinician
follow-up
diabetes
monitoring
hyperlipidemia
screening
blood culture contamination
Process Improvement-Module 14 37
40 60 80 100
Proficiency
testing
Quality
control
Competency
personnel
Result turn
around time
Patient ID Process Improvement-Module 14 38
Most common indicators tracked (%) 2005
Reference: Hilborne L. Developing a core set of laboratory based quality
indicators. IQLM Conference; 2005 Apr 29.
Process Improvement-Module 14 39
Caution
Theoretically,patient outcome indicators
best assess quality, but are the
most difficult to measure.
too many variables
requirelarge amounts of data
need extended collection periods
David Hsia
Medicare Quality Improvement Bad Apples
or Bad Systems?
JAMA.2003;289:354-356.
Process Improvement-Module 14 40
Essentials for Implementation
Continual
Improvement
Commitment
Planning
Structure
Leadership
Participation
and
Engagement
Planning
Process Improvement-Module 14 41
Consider:
root causes of error
risk management
failures and potential
failures and near-misses
costs, benefits, and
priorities
costs of inaction
Errors?
Failures?
Benefits?
Priorities?
Process Improvement-Module 14 42
Leadership
Fosters the culture for
improvement:
opennessthat others
have good ideas
commitment that
improvement will occur
opportunitythat staff
can participate
Process Improvement-Module 14 43
Participation
•management does
not always know
what workers know
and do
•continual
improvement
requires leadership
and
team participation
Process Improvement-Module 14 44
Quality Improvement Activities
One project every 6 months.
Set a timeline.
Quality Improvement Activities
Process Improvement-Module 14 45
Use a team approach.
Involve bench-level staff.
Quality Improvement Activities
Process Improvement-Module 14 46
Use Quality Tools
audits
reviews
EQA
OFI
indicators
Six Sigma
lean
Quality Improvement Activities
Process Improvement-Module 14 47
Correct or prevent poor practices
Report progress to
management and
laboratory staff
Quality Improvement Activities
Use available information to study:
•customer’s suggestions or complaints
•identified errors from occurrence
management program
•problems identified
in internal audits
Process Improvement-Module 14 48
Quality Improvement Activities
If possible, design a study so that results
can be statistically measured.
Process Improvement-Module 14 49
Pre lean state for final
positive blood culture reports
Post lean state for final
positive blood culture reports
Process Improvement-Module 14 50
Quality Indicators and Timing
Use an indicator only as
long as it provides
useful
information.
Don’t get tied to
your indicators.
Process Improvement-Module 14 51
Summary
Plan
DoAct
CHECK
Each step is
essential to keep
the quality cycle
cycling.
Process Improvement-Module 14 52
Key Messages
•quality counts
•continual improvement is the core of
quality management
Questions?
Comments?
Process Improvement-Module 14 53