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Delivering value from MES: Optimizing Manufacturing Efficiency. Paul Murray MES Manager Cordis . The following Strategic Initiatives of MESA International are associated with this presentation : Lean Manufacturing Quality & Regulatory Compliance Real-Time Enterprise. Agenda. Introduction

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delivering value from mes optimizing manufacturing efficiency

Delivering value from MES: Optimizing Manufacturing Efficiency

Paul MurrayMES ManagerCordis

slide2
The following Strategic Initiatives of MESA International are associated with this presentation:

Lean Manufacturing

Quality & Regulatory Compliance

Real-Time Enterprise

agenda
Agenda
  • Introduction
  • Manufacturing IS Strategy
  • Business Drivers
  • Business Process Mapping
  • Interfaces & Information exchange
  • Issues
introduction
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
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
    • API
    • Secondary batch based manufacturing
    • Biotech
    • Medical Device 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
Business Drivers
  • Operational business drivers
    • 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
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
  • There are many business processes required to allow a business to function
gaps and overlaps
Gaps and Overlaps
  • 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
  • When we understand the this we can develop an application and integration roadmap.
  • We can also have an opportunity to lean out existing processes.
  • Based on the this we can make decisions on application implementation

Manugistics

ERP

MES

LIMS

clearly define the technology and interfaces
Clearly define the technology and interfaces

Reports

ERP

Enterprise Resource Planning

EDM

Enterprise Document

Management

LMS

Learning Management System

CAPA

Deviation Management

CMMS

Computerized Maintenance Management

LIMS

Laboratory Information Management

Level 3 & 4

Global Application Instances

MES

Weigh & Dispense

Finite Capacity Scheduling

Electronic Instructions/EBR

Resource Tracking

PIM

Process Monitoring

Process Modeling & Optimization

Level 3

Plant Information Systems

Data Historian

Continuous and event data

CDS

Chromatographic

Data Systems

Level 2

Realtime Monitoring & Control Systems

DCS & PCS

Process Control Systems

EMS & BMS

Environment & Building Monitoring

Lab Equipment

Analysis systems

interface information exchange
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
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
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
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