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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
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0304
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1112
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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
30 September 2019Speaker Kit6
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 [email protected]
Confidentiality Notice
This file is private and may contain confidential and proprietary information. If you have received this file in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the contents of this file is not permitted and may be unlawful. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, UK, T: +44(0)203 749 5000, www.astrazeneca.com
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