driving sustainable cultural transformation · driving sustainable cultural transformation gerald...
TRANSCRIPT
Driving Sustainable Cultural Transformation
Gerald Heddell Director Inspection Enforcement and Standards
IPA Annual Conference, Mumbai 23rd February 2018
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Quality
Culture
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Agenda
• What is quality culture?• What is cultural excellence?• Why is it important?
• Can culture be measured?• How can we transform?• How do we sustain the
change?
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Be Transformed!!
Sign Up Now at pda.org/transform
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Define
Measure
AnalyseImprove
Sustain
DEVELOPMENT CYCLE
The Quality Culture Journey
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Define
Measure
AnalyseImprove
Sustain
DEVELOPMENT CYCLE
The Quality Culture Journey
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Follow quality guidelines
See others taking quality focused actions
Hear others talking about quality
Feel quality all around them
THE FUTURE
What is quality culture?
Adapted from: “Creating a Culture of Quality” by Ashwin Srinivasan & Bryan Kurey.
- April 2014 Harvard Business review
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Quality Culture: what MHRA looks for
• Confidence that the company is (and will remain) in control• Understanding of how quality attributes impact the patient• Confidence in quality-related decision making• Maturity of organisational mind set:
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What Do We Mean by Cultural Excellence?
Culture determines quality outcomes, because it affects the organization's ability to identify and act upon near-miss shortages, assure transparent problem escalation, and strive for operational excellence.
ISPE Cultural Excellence Report, April 2017https://www.ispe.org/products/cultural-excellence-report-six-key-dimensions
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Define
Measure
AnalyseImprove
Sustain
DEVELOPMENT CYCLE
The Quality Culture Journey
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Can Quality Culture be measured?
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There are several existing quality maturity models
Measurement Categories Stage 1:
Uncertainty
Stage 2:
Awakening
Stage 3:
Enlightenment
Stage 4: Wisdom Stage 5: Certainty
Management Understanding
and Attitude
No
comprehension
of quality as a
management
tool. Tend to
blame quality
department for
"quality
problems"
Recognizing that
quality
management may
be of value but not
willing to provide
money or time to
make it happen
While going
through quality
improvement
program learn
more about quality
management;
becoming
supportive and
helpful
Participating,
understand
absolutes of quality
management.
Recognize their
role in continuing
emphasis
Consider quality
management as an
essential part of company
system
Quality Organization Status Quality is hidden
in manufacturing
or engineering
departments.
Inspection
probably not part
of organization.
Emphasis on
appraisal and
sorting
A stronger quality
leader is appointed
but main emphasis
is still on appraisal
and moving
product. Still part
of manufacturing or
other
Quality department
reports to top
management, all
appraisal is
incorporated and
manager has role in
management of
company
Quality manager is
an officer of
company; effective
status reporting
and preventive
action. Involved
with customer
affairs and special
assignments
Quality manager on board
of directors. Prevention
is main concern. Quality
is a thought leader.
Problem Handling Problems are
fought as they
occur, no
resolution,
inadequate
definition; yelling
and accusations
Teams are set up to
attack major
problems. Long
range solutions are
not solicited
Corrective action
communication
established.
Problems are faced
openly and
resolved in an
orderly way
Problems are
identified early in
their development.
All functions are
open to suggestion
and improvement
Except in the most
unusual cases, problems
are prevented
Quality Improvement
Actions
No organized
activities. No
understanding of
such activities
Trying obvious
"motivational"
short-range efforts
Implementation of
multi-step
program. With a
thorough
understanding and
establishment of
each step
Continuing the
multi-step program
and starting other
pro-
active/preventative
product quality
initiatives
Quality improvement is a
normal and continued
activity
Company Quality Posture "We don't know
why we have
quality problems"
"Is it absolutely
necessary to always
have problems
with quality"
"Through
management
commitment and
quality
improvement we
are identifying and
resolving our
problems"
"Defect prevention
is a routine part of
our operation"
"We know why we do not
have problems with
quality"
Crosby Maturity Grid
ISONACCHO
CEB
Crosby
DuPont
ISPE
PwC
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Define
Measure
AnalyseImprove
Sustain
DEVELOPMENT CYCLE
The Quality Culture Journey
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Knowledge & priorities
Management commitment
Diligence
Transparency
Vigilance
Visibility to patient
THE OPTIONSAnalysis outcomes – what is required?
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Define
Measure
AnalyseImprove
Sustain
DEVELOPMENT CYCLE
The Quality Culture Journey
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Quick wins Long term goals
MetricsTraining
Transformation requirements
Vision
Transformation
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Define
Measure
AnalyseImprove
Sustain
DEVELOPMENT CYCLE
The Quality Culture Journey
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LINES OF BUSINESS
Develop a road map/ deployment plan
Develop a learning organisation
Clear Leadership
Set goals – KPIs and KBIs
Encourage accountability
Sustainability
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and when it goes wrong….
seventh largest corporation in the US ( year 2000)
revenues close to
$101 billion in (year 2000)
“America’s Most Innovative Company” for six successive years (by Fortune magazine)
In December 21, 2001…
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Knowledge & priorities
Management commitment
Diligence & accountability
Transparency
Vigilance
THE OPTIONS
Quality Culture
requirements x Top executives at Enron used
corruption, greed and deception
Toxic culture
Failed to sustain an open relationship and
trust with its employeesx
Employees who questioned practices or
decisions of leaders were either ignored or fired
Leaders cared more about enriching
themselves than the demands of its
followers – structured finance techniques
No shared vision with its employees that go
beyond making profitsx
x
x
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Engage employees
Sustainable growth
Strong processes
Continuous improvement & reflection
OUR PROCESSSummary
Clear vision and priorities
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