Transcript Delivering value from MES - MESA

Delivering value from MES:
Optimizing Manufacturing Efficiency
Paul Murray
MES Manager
Cordis
www.mesa.org
2009 ISPE/MESA Seminar Merck Sharp & Dohme Biologics Ireland
The following Strategic Initiatives of
MESA International are associated with
this presentation:
Lean Manufacturing
Quality & Regulatory Compliance
Real-Time Enterprise
Agenda
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Introduction
Manufacturing IS Strategy
Business Drivers
Business Process Mapping
Interfaces & Information exchange
Issues
Introduction
• Cordis (part of Johnson & Johnson)
• Medical Device - Cardiovascular
• Cashel Manufacturing facility (In start up)
– Manufacture next generation of Drug Filled Stents
– Full eBR in place at start up
Manufacturing IS Strategy
• No one size fits all strategy to define what level of automation or
what level of information acquisition is appropriate.
• Highly diverse business processes with this industry
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API
Secondary
Biotech
Medical Device
batch based manufacturing
discrete manufacturing
But Convergence is happening!
• Technology and business drivers are not the same. Technically
driven strategies tend to run into problems that do not always
maximise the value of the technology.
• A strategy that takes a balanced view of all business drivers and is
well aligned will generally be more successful and deliver greater
value.
Business Drivers
• Operational business drivers
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One, few or many products?
Fastest throughput, or maximised capacity?
Headcount – as driven by rest of design and philosophy?
Quality – by exception or checked/tested
Shop floor visibility, access to real time information
Lower Inventory
• Regulatory business drivers
– Enforce greater compliance
• Project Business Drivers
– Project execution intent – fast track, minimum cost, balanced?
What is a business
process?
• A business process is the
sequence of steps
followed by various users
in order to complete an
end to end business
operation
Start
Identify demand
Order Raw
Materials
Manufacture
Product
• There are many business
processes required to
allow a business to
function
Test Product
Ship Product
End
Gaps and Overlaps
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Start
BPM will identify data collections
inputs/outputs, decision points
within the process
By mapping our applications to the
BPM we can identify integration
points, gaps and overlaps
Identify demand
Order Raw
Materials
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When we understand the this we
can develop an application and
integration roadmap.
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We can also have an opportunity to
lean out existing processes.
Test Product
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Based on the this we can make
decisions on application
implementation
Ship Product
Manugistics
Manufacture
Product
End
ERP
MES
LIMS
Level 2
Realtime Monitoring
& Control Systems
Level 3
Plant Information
Systems
Level 3 & 4
Global Application
Instances
Clearly define the
technology and interfaces
ERP
EDM
LMS
Enterprise
Resource
Planning
Enterprise
Document
Management
Learning
Management
System
CAPA
Deviation
Management
MES
Weigh & Dispense
Finite Capacity Scheduling
Electronic Instructions/EBR
Resource Tracking
CMMS
LIMS
Computerized
Maintenance
Management
Laboratory
Information
Management
PIM
Process Monitoring
Process Modeling &
Optimization
Data Historian
CDS
Continuous and event
data
Chromatographic
Data Systems
DCS & PCS
EMS & BMS
Lab Equipment
Process Control
Systems
Environment &
Building Monitoring
Analysis systems
Interface/Information
exchange
• Clearly define data dependencies/what needs to
be exchanged between systems.
• Keep it simple – complicated interfaces will be
require more effort to support/maintain.
• Use permissive type data exchange. i.e. status
flag good/not good to go.
• Only interface where it makes sense – where
there is ROI
Focus on reuse and little
customization
• Can core systems be used
• Common platform, interfaces to global systems (ERP)
• Standard business practices, minimize local
customization
• Minimize local validation
• Can standard configuration objects be reused
• Same process, different products (e.g. tablet
compression), different parameters.
• Minimize configuration and validation effort.
Issues/Risks
• Having an agreed Strategy is crucial
• Buy-in / commitment of all stakeholders essential –
Systems have cross functional impact
• Invest thoroughly in the design to GET IT RIGHT FIRST
TIME!…. SAVES MONEY!!
• Prototype to get stakeholder buy in and set expectations
• Risk-Based Approach to Validation
• Supply Vendors with standards / detailed information
(e.g. specifics on data structuring, interfaces OPC, XML,
etc)
People challenges vs
technology challenges
• The way we have always done it is fine.
• ERP/MES enforces business process. Different
departments/sites may/will have different views
• Traditional ‘business’ IT vs. ‘Manufacturing’ IT
• Fear of e – systems