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