what lean means for quality - pharmout...what lean means for quality 1. lean house and its links to...
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What Lean means for Quality
Geraldine Murphy Site Quality Head – AstraZeneca, North Ryde July 2017
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AstraZeneca at a glance
Key
exporter to
15global
markets*
60 years of rich
history
88Different
manufactured
product lines
A$1075 million
In total sales
in 2016***
A$230million
of site
Investment from
2011-2019
Approximately
460 Employees
onsite
30Years
Of technical
leadership in
BFS
435million
respules**
*2016 Sales **2017 Budget Data ***Export+Domestic
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What Lean means for Quality
1. Lean House and its links to Quality
2. Case Studies
• Daily Control Meetings & Visual Management
• SOP simplification
3. Innovation in Quality
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We play to win
We are entrepreneurial
We put patients firstWe follow the science
We do the right thing
Our Vision
Priorities: SHE, Quality, Supply, Costs
Standardised Ways of Working
Process Centric Leadership and Teamwork
Rig
ht fr
om
Me
Ju
st In
Tim
e
We push the
Boundaries of science
to deliver life-changing medicines
Elimination of waste
Continuous
Improvement
Customer Focus
AZ Values
Lean principles
AZ common purpose
The AZ lean house lean house
4
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Visual Management
5
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Before
• Individual meetings – discussing same thing
• Decisions being changed
• More meetings
• Lack of uniformity
After
• Cross functional – support for issue resolution
• Standard Approach to Metrics – SQSP
• Uniform, repeatable approach for communication
• Clear escalation process
• Less meetings
Daily Control Meetings using VM
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• S
• Q
• S
• P
Agreed
Month Plan
S Q
S P
Incident
Forms
Priority Line Day ____ Day ____ Week __ Week __
T= Target
A= ActualT
A
T
A
T
A
T
A
4010-0
4010-1
4010-2
4010-3
4010-4
4010-5
4010-6
Agenda
Upcoming
Weeks
Daily Control
Escalation
Matrix
Inbox
Action
Tracker
(Short
Term)
Stop
CalendarMaintenance
Issues/ Plan
Weekly Control
AgendaAction
Tracker
LongTerm
Gemba
Walk
Schedule
GO Cards
STOP
Cards
DCM Board
Deviation
Log
Stop Calendar
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Quality mgt
Site Leadership
Site Leadership
Monthly Strategy
Line Board
meetings
Cross
Functional
PET
Lab
T. Services
P. Quality
Engineering
Shift 9am 10am Tuesday Wednesday
Change
Daily Weekly Monthly
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Standardised Ways of Working
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Case Study : The WAR on Complexity
- Complexity : Easy solution, no thinking required
- Simplification : Difficult, takes energy
SOP Simplification
What are you trying to solve ?
What process are you going to use?
Where will you start?
How will this be resourced?
What’s your measure of success?
How will this be sustained?
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A
P
D
C
Step 4
BENEFITS AND
LESSONS
LEARNED
Step 3
RECONCILIATION
Step 2
TRANSFORMING
Step 1
MAPPING
SOP Simplification using lean methodology : PDCA cycle Plan
Do Check
Act
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Mapping & Transforming
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Plan
Do Check
Act
✓ Clarify audience, scope and purpose
✓ Flowchart
✓ Rules
✓ Style guide – template
✓ Write from scratch
✓ Coaching by structure writing expert
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✓ Verify that crucial information has not been lost
✓ Independent review of document(s) to be withdrawn compared to
document created
✓ Record the benefit
✓ PROTECT AND SUSTAIN
BENEFITS to date ……..
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Reconciliation & benefits Plan
Do Check
Act
• ~48 % reduction in SOPs
• ~60 % reduction in page numbers
• read and sign man hours decreased by ~70%
• Less deviations
• Audit friendly
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Innovation
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• Use of QR codes linked to documentation system
• Video-based procedure system
• Use of voice recognition software
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Innovation in Quality
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7
We play to win
We are entrepreneurial
We put patients firstWe follow the science
We do the right thing
Our Vision
Priorities: SHE, Quality, Supply, Costs
Standardised Ways of Working
Process Centric Leadership and Teamwork
Rig
ht fr
om
Me
Ju
st In
Tim
e
We push the
Boundaries of science
to deliver life-changing medicines
Elimination of waste
Continuous
Improvement
Customer Focus
AZ Values
Lean principles
AZ common purpose
The AZ lean house lean house
17
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Questions?
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