QC Change management

SAP EHS & 3E online
at GSK Vaccines :
A success story
Elisabeth Magnette/Yves De Maesschalck
March 2015
GSK vaccines:
The world’s leading vaccine company
GSK Vaccines processes
and systems
March 2015
2
GSK is a world’s leading vaccine company
Paediatric
AMBIRIX
HIBERIX
PRIORIX - TETRA
BOOSTRIX
INFANRIX
POLIO SABIN
BOOSTRIX POLIO INFANRIX HEXA
POLIORIX
CERVARIX
INFANRIX PENTA
ROTARIX
DITANRIX
KINRIX
SYNFLORIX
ENGERIX-B
MENHIBRIX
TYPHERIX
FLUARIX
MENITORIX
TRITANRIX
FLUARIX TETRA
NIMENRIX
TRITANRIX HEP B
FLULAVAL
PEDIARIX
TWINRIX (HAB)
HAVRIX
PRIORIX
Adolescent
Adult
& Travel
AMBIRIX
FLUARIX TETRA
BOOSTRIX
FENDRIX
BOOSTRIX POLIO
HAVRIX
CERVARIX
MENCEVAX
DITANRIX
HEPATYRIX
ENGERIX B
NIMENRIX
FLULAVAL
PREPANDRIX
FLULAVAL TETRA
PANDEMRIX
FLUARIX
POLIO SABIN
Elderly
PRIORIX
TWINRIX
TYPHERIX
VARLIRIX
ENGERIX B
FLUARIX
FLULAVAL
HAVRIX
MENCEVAX
PANDEMRIX
TWINRIX
GSK Vaccines Today - 2014
Over
12,000
employees
worldwide
Over
30
marketed
vaccines
Available
worldwide
900 million
vaccine doses to
170 countries
Over
15
vaccines
in
clinical
£3.3
billion sales
development
More than 2,600 people working on the research and the development of our vaccines
4
IT strategy : International Deployment supported by SAP
SAP deployed in all major Vaccines Manufacturing sites
One Single SAP instance located in Belgium to support the sites
Standardized processes from SAP template are deployed
Global Support provided by GSK Vaccines IT SAP Competence Center
5
Integrated Chemicals Management System (MSDS)
SAP EH&S and 3E Online integrated solution
GSK Vaccines processes
and systems
March 2015
6
Health, Safety, Environnment in the industry
Product regulatory compliance
•Product characteristics
•Classification
•Transport
•Safety sheets
•Storage
•Product labels
•Certificates registration
•Regulatory
•Regulatory
•Volumes
control
compliance
People exposure
•Profiles & exposure levels
evaluation
•Means to implement to reduce the
risk (EPI, EPC,…)
•Medical monitoring
Risk management
Performance & environmental
compliance
•Environmental permits
•Green certificates
•Emissions (Air/ Water / Grounds) &
levels
•Natural resources & energy
consumption
•Allocations des coûts énergétiques
•Production de déchets
t
Incident management
Integrated Chemicals Management System Project
Live since September 2014
• Context:
– SAP EH&S was introduced in 2008 to comply with the EHS regulations
– But Regulations have changed over time
– GSK vaccines is only a downstream user and is not producing dangerous
goods
• Project objectives:
– Validation by EHS of the procurement of IP chemicals in SAP
– Improve process to link materials and substances
– Ensure that chemical products are linked to original supplier (e)MSDS
– Ensure that all EHS information of dangerous chemicals products are
available in SAP required to prove compliance with the regulations :
SEVESO, REACH (SVHC, exposure scenario, …), Permit, …
– Report of stock records of EHS-relevant materials and comparison to legal
limits
– Provide One single entry point to retrieve NIP and IP linked MSDS
GSK Vaccines processes
and systems
March 2015
8
Substance management process (1)
MSDS and data Management
Before
the
project
MSDS
Generated
at GSK
Third party
IT
intervention
Required
reports
(inventory,
SEVESO,…)
Supplier
MSDS
After
the
project
GSK Vaccines processes
and systems
March 2015
3E
VMSDS
Portal
Required
reports
(inventory,
SEVESO,…)
9
Substance management process (2)
Material creation workflow – VMSDS portal
Material creation
workflow : first
approval
• Flag if EHS relevant
• Assess the substance to be linked to the material, reference it
in the request and assess the need for a new substance
• Launch the automatic link of substance and material:
Material creation
workflow : second
approval
VMSDS portal
GSK Vaccines processes
and systems
• If a new substance is required, it is automatically created and the material is linked to it and a
request is sent to 3E to ask for data and MSDS PDF
• If there is no need for new substance, the existing substance referenced at step 1 and the material
are linked
• Download PDFs and data from the portal
• Assess which data and documents are relevant
March 2015
10
Substance management process (3)
VMSDS Portal - Integration with SAP
Original
PDF
Meta Data
Will be printed to end users
through SAP portal
Both PDF of original supplier MSDS and
selected meta data get saved into SAP EHSM
GSK Vaccines processes
and systems
March 2015
Enables to build inventory
and legal reports
13
Substance management process
Master data structure
SAP EHS Master data
Link Substances
and materials
SUBSTANCE XXXXXX
Supplier 1
Supplier 2
MSDS PDF
SAP Logistic master data
MSDS PDF
Material A – Supplier 1
Material B – Supplier 1
Material C – Supplier 1
Material D – Supplier 2
MSDS REQUEST
Structured property
Data set 1
----------------
VMSDS portal
Data set 2
--------
Supplier 1
MSDS PDF
SEVESO CLASSIFICATION
GSK Vaccines processes
and systems
March 2015
Structured property
-----------
3E Regulation database
Supplier 2
MSDS PDF
Structured property
-----------
Substance management process (4)
Compliance with regulation : SEVESO report
Stock amounts classified based on SEVESO regulation and compared to legaly
authorised amounts
GSK Vaccines processes
and systems
March 2015
15
Substance management process (5)
Chemical inventory report
GSK Vaccines processes
and systems
March 2015
16
Substance management process (6)
Single SAP portal Search for users at GSK
Before
the
project
After
the
project
GSK Vaccines processes
and systems
March 2015
GSK MSDS for IP
linked
substances
SAP portal
search for IP
linked
substances
Supplier MSDS
from EHS
department for
NIP linked
substances
Intranet
search for
NIP linked
substances
Supplier MSDS
from 3E for IP
linked
substances
Supplier MSDS
from EHS
department for
NIP linked
substances
SAP portal
search for all
substances
17
SAP Portal search
GSK Vaccines processes
and systems
March 2015
18
Portal search
GSK Vaccines processes
and systems
March 2015
19
Now some figures
– Specifications linked to IP materials 550
– IP materials 1200
– MSDS from 3E for IP materials 1350
– About 90 vendors for IP materials
– Specifications for NIP materials 250
– MSDS for NIP materials 280
GSK Vaccines processes
and systems
March 2015
20
Questions ?
GSK Vaccines processes
and systems
March 2015
21
Thank you !