Underhålletsprocesser ochledarskap

Jerry Johansson

4th of October 2019

Agenda:

AstraZeneca

OrganisationQuality systemProcess ManagementLean/TPMQ&A

30 September 2019Speaker Kit

AstraZeneca: global dimensionsFor year ending 31 December 2018

$22.1bn $5.9bn 64.6k

$21.1bn 149 45%

$1bn 23 30

Total Revenue(down 2% over 2017)

invested in R&D with research across five countries

Product Sales(up 4% over 2017)

projects in clinical development and eight NMEs in late-stage development

of our senior roles are filled by women

Externalisation Revenue

NME approvals in 2018 (and 71 since 2014)

operations sites in 17 countries

employees

3

01

0304

05

06

07

08

09

10

1112

13

14

15

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17

18

19

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1. Lomas Verdes (Mexico)

2. Boulder (Colorado, USA)

3. Mt Vernon (Indiana, USA)

4. West Chester (Ohio, USA)

5. Newark, Frederick, Maryland,

Philadelphia, Westborough (USA)

6. Canovanas (Puerto Rico)

7. Buenos Aires (Argentina)

8. Cotia (Brazil)

9. Avlon, Macclesfield, Speke (UK)

10. Reims, Dunkerque (France)

11. Nijmegen (Netherlands)

12. Wedel (Germany)

13. Södertälje: Snäckviken & Gärtuna

(Sweden) + Biologics

14. Cairo (Eqypt)

15. Vorsino (Russia)

16. Bangalore (India)

17. Jakarta (Indonesia)

18. Taizhou, Wuxi (China)

19. Maihara (Japan)

20. North Ryde (Australia)

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Gothenburg

AstraZeneca in Gothenburg

30 September 2019Speaker Kit5

Supporting our three main therapy areasand the full R&D value chain

Södertälje

AstraZeneca in Södertälje

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AstraZeneca’s largest high-tech manufacturing and supply site include manufacturing of active pharmaceutical

ingredients, formulation, tableting, filling and packing of finished products

AstraZeneca Sweden Operations

Sweden Operations products

• Turbuhaler

Symbicort, Pulmicort, Oxis

• Tablets

• Capsules

Nexium, Losec, Seloken och Atacand.

• Pumpspray

• Solutions for injektion

Rhinocort Aqua och Nexium i.v.

• API

Our vision

There are no break downs at AstraZeneca, caused by lack of maintenance.

A break down due to lack of maintenance or competence is a failure for the

maintenance organization.

We are the best within AstraZeneca in delivering capital projects .

In time

To the right cost

With the right function

authority requirements

Code of conduct

Policies

Standards

Standards

Regulations

Guidelines

Regional demand for

Sweden Operations

AstraZeneca demand

All pharma companiesMaintenance has

+300 written standards SOPs

Yearly training must be done

Updates are controlled by Q

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Kvalitet är ett holistiskt begrepp

Product & Process Design

✓ Components, Unit Operations

Control Strategy for Critical Quality

Attributes

✓ Process Parameter set points and

ranges, In-process testing, Finished

Product testing

Quality is everything

QMS

Say what you do

Do what you say

Prove it

Improve it

Regulatory Compliance

✓ Specifications, Product Design,

Manufacturing Process

Legislation

✓ GMP

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How du we control/develop our maintenance system?

Our main processes

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Early

Equipment

Management

Perform

Maintenance

Face out and

reinvestment

Early Equipment Management

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Plan Do Check

Analyze

The Lean Journey Sweden Operations

TPM Strategy

Basic (future) requirements for an operator in EMEA( agreed with representatives from all sites Europe )

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An operator must/should be able to:

- Run, adjust, set up and improve the line/machine/equipment

- Solve problems by using Problem Solving

- Develop, follow and improve standards by using Standard Work and CI

- Clean, lubricate and inspect - the base of Autonomous Maintenance(AM)

With increased operating competence we will develop engagement and ownership

and can also introduce formal Equipment Ownership for our operators.

All linked together!

.

Key initiatives

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• Competence development

• Maintenance development

• Investment plans

• Smart Maintenance/digitalization

AI can that help us understand things we

normaly cant understand?

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Upplägg på projektet

3 utrustningar

2 år historisk data

3 IT-system

PIS• Processdata:

• Temperatur

• Luftflöde

• Tryck

• Produktionsdata:• Batchstorlek

• Receptfas

WO from

Maintenace

system

Production

Parameters

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Deep dive: Hur gjorde vi?

Anomaly

detection

Failure detection

Our industry is changing

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Contract manufacturer

No blockbuster?

Personalized medicine, smaller series

Our efficiency must up!

No “Losec” can save us in the future…..

Fokus areas for maintenance

• Right Maintenance Strategy

• Competence development

• Planning and execution of maintenance

Shorter and more efficient stop

Higher flexibility

&

KPIs and structure for follow up.

Clear ownership of the availability

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Questions?

Successful management

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• Organization form is not important

Clear objectives and the management defines the result.

• Work together with production!

• We have all the tools we need!

It's all about usage.

so if you would like to have

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• Highly motivated teams

• Collaboration between groups

• Groups with a desire to achieve the best in class (WCM).

I am really glad if I inspired you and can help you in the

future.

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Jerry Johansson HEAD OF EMA Engineering Maintenance and Asset Management _____________________________________________________________ AstraZeneca Sweden Operations | E.M.A | Maintenance Strategy and Governance SE-151 85 Södertälje, Sweden Telephone: +46 8 553 21389 Mobile: +46 70 5289177 Jerry.johansson@astrazeneca.com

Confidentiality Notice

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