What Lean means for Quality
Geraldine Murphy Site Quality Head – AstraZeneca, North Ryde July 2017
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
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
3
44
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
Visual Management
5
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
• 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
8
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
Standardised Ways of Working
10
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?
11
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
Mapping & Transforming
13
Plan
Do Check
Act
✓ Clarify audience, scope and purpose
✓ Flowchart
✓ Rules
✓ Style guide – template
✓ Write from scratch
✓ Coaching by structure writing expert
✓ 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 ……..
14
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
Innovation
15
• Use of QR codes linked to documentation system
• Video-based procedure system
• Use of voice recognition software
16
Innovation in Quality
171
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
Questions?
18