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Think GLOBAL. Think STANDARD.

Multiple MES deployments

Buy-in, Timeline, Management and Execution

Rey Ramos

Multiple MES DeploymentsBuy-in, Timeline, Management and Execution

Rey Ramos

Develop a URS for a Core MES application based on Standard Business Process that can be used at multiple sites using OOB features and no customization…

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01

02

Core and extended teams

constantly traveling to multiple locations.

Define commonalities and

differences among

manufacturing & business process and technologies

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03

04

Evaluate multiple

manufacturing and business

process to develop future

common business process

flows and requirements

definition within only six months period.

Define requirements for design

and build a reusable core

based on common business

and manufacturing requirements.

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05

06

Define and agree on over 27

business process flows with its respective requirements

Perform a fit gap analysis on

the MES technology to avoid system customization

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Last but not least, The Team…

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Team alignment – The most important task

I have special

requirements for my

automated warehouse and

material management system

Site 2 – I am special..

My system has

been customized to do…

Site 4 – Don’t let

it go…

I want the system to cold

chain…Specific vs generic.

Site 1 Specific

requirements

Our solid manufacturing

process includes both

electronic and paper process.

Site 3 Actual vs

future state

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Creating a team…

A team with clear and

common objectives sharing

accountability is crucial to

accomplish the goal.

Leader must develop trust

and credibility among

members by being impartial

and challenge site’s specific

requirements to avoid

customization. Focus on:

“WHY”. Why do we do what

we do?.

Understand users’ request

and facilitate discussion to

achieve common solutions.

Is all about trust:

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Team Structure

Extended Team

Sponsor:

Core Team Members

BPS / Operations:

Steering Group

Sr. Director Project Leader:

MES COE manager

Quality Lead

Global Director

IT Lead

IT Global Director

Site 1 Rep.Site 2 RepSite 3 RepSite 4 Rep

Site 1 RepSite 2 RepSite 3 RepSite 4 Rep

Extended Team

Standards:

Standards

Site 1 LeadSite 2 LeadSite 3 LeadSite 4 LeadConsultant

Extended Team

MES Supplier Rep.

Business Case

MES ConsultMES ConsultTech LeadOthers

Extended Team

Site leads- MES supplier- IT / AS / Others

Extended Team

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Our commonalities are more than our differences…

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based on the manufacturing and business process analysis its standardization, creating an URS for a core MES-System, with clear and precise distinguishing between common requirements and site specific requirements.

The task is to,

FPO

-1

Detailed Business Process Flows and manufacturing flows are identified, updated, standardized before fit gap analysis, and approved after the fit gap for all four sites.

FPO

-2

Complete cross alignment fit gap analysis of Standard (out of the box) MES solution (assessment report) for all 4 Sites.

FPO

-3

Approved User RequirementsSpecifications for core and site requirements for all four sites based on standardized business and manufacturing process

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Identifying standardized processes, and gap re. processes

Internal prep.& alignment

Knowledge sharing meeting

Preparation per site:- Identify, update and create process flows to one aligned and agreed level

(Documenting process flows)

Knowledge sharing MES provider

training

Site 1(Fit/gap focus on processes,

assisted by MES supplier)

Site 2 (Fit/gap focus on processes,

assisted by MES supplier)

Site 3(Fit/gap focus on processes,

assisted by MES supplier)

Site 4(Fit/gap focus on processes,

assisted by MES supplier)

Summarizing anticipated future stateCreating the

URS

Gap

-1

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Decision making point

Fit/gap analysis focus on MES system

Gap

-2

Decision making point

Agr

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Operations Team leader

All extended team

Individual ETM

output

Decisionmakingpoint

Gap

-1

FPO#1FPO#2

FPO#3

The Plan…

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The complexity…

Manufacturing processes

Site

s

Site 1Site 2Site 3Site 4

e.g. formulation, filling, weighing & disp., Tablet press

etc.Material master management,

production schedule, execution management,

production tracking, training verification, cleaning

management, etc.

Following the storage model and batch model – S95

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Fit gap analysis – Business process• First fit gap assessment among sites – Areas for standardization: (Example)

– Solutions holding time application

– Review by exception strategy

– Batch record content

– Batch release cockpit

– Data integrity strategy

– CMMS and Training interface usage

– Master Data definition and management

– Pre-weighing process

– Management cleaning activities within MES

– Tooling management

– Manage solutions as a batch by itself or part of a product batch

– Training verification schema, and interface

– Cleaning as a batch process, definition and usage

– How to manage revision changes

– IPC management

– Define equipment classes and behaviors ahead

• Site specific process or performed different: (Example)– Cold chain process

– Pre-blends and combined weights

– Batch number and batch names

– Roller compactor

– Be able to define rules to change the product number once is dispensed. (Intermediates)

– Interface with Warehouse Management system

– MES controlling laminar flow hoods

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The attendance and invites at Site 1

Site 1 LeadProcess representatives/SME’sSite leadETM’s

Site 3 Lead

Site 2 Lead

Site 4 Lead

Legacy/ERP

MES supplier

QACore team

Operations Lead

Core Team Lead, Standards (URS)

lead

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Ohh…This is quite smart, we could actually do it the same way in Schaffhausen, and

benefit from a standard process. I’ll take a note and ask about details during coffee

break!

Ohh…This is quite smart, we could actually do it the same way in Paris, and benefit from a standard process. I’ll take a note and ask

about details during coffee break!

The process is like this…, and these are our requirements… and then we do this…and this…, therefore we have a need to do this and this…

Any questions?

I am here to evaluate how and if the described processes and related

requirements will be handled by MES. It is great that I have a list with many

requirements stated already… In this list I’ll note everything that fits and everything

where there is a potential gap.

I am here to evaluate how the described processes and the site’s

expectations related to the standard ERP interfaces that has

been outlined by new ERP project. I remember to note everything that

is a potential misalignment.

To the process rep.: Please explain the process step by step. Let me ask, how do you

perform….?To the group: Is this process relevant for all 4

sites? Are all details covered? Potential for standardization, if we consider this and this?

Interesting…London operates this process exactly the same way as we do in Madrid,

apart from the handling of sample points…I make sure to take a note of this equality

and this difference on my PFD/WFD

I know the current content of the core, and I am here to assure that all relevant requirements becomes

part of the core, so that only configuration is left for the sites.

It is good that this team has already encountered the requirements from the golden package, that gives an overview, and easy for me to add

notes into this list.

I am in full control of the tool to capture all sorts of information e.g. requirements,

applicability for sites, fit/gaps between sites regarding potential for standardized processes, and fit/gaps towards Syncade. The list I work in

has full traceability and applies the S95-structure for continuous overview…

Storage- & batch model

Workshop roles & responsibilitiesRey Ramos

3D matrix (1:3)Applicable to sites:

ProcessSite 1 Site 2 Site 3 Site 4 Process flow currently

available in draft?

Material Master, Creating new material & approval x x x x YMBR management x x x x YEquipment management x x x x YResource management (people) x x x x NTraining management x x x x NOrder flow/order life cycle x x x x YMaterial inventory management x x x x YWeighing & Dispense x x x x YCampaign weighing x X NPre-weighing X NSolution suspension prep. x x X x YContinuous processes X NRey Ramos

The process across sites:

Site 1 Site 2 Site 3 Site 4

Deltas

Agenda:Day 1: All invites welcome, setting the sceneTour around facilityDay 2:Tour continued/prepare to start workshopsDay 3:Platform: Solids:

Production order dispatchProduction order StartMaterial requestW&DSolution/susp. PrepGranulationBlendingCompressionCoatingPackaging (blister + bottle)Production order closureProduction order verification

Day 4: Parenterals:CompoundingComponent prepFormulationfillingFreeze drying and cappingPackaging (vials & syringes)

Day 5: Continous productionxxxxClosing

Agenda:Day 1: All invites welcome, setting the sceneTour around facilityDay 2:Tour continued/prepare to start workshopsDay 3:Platform: Solids:

W&D DELTA’sSolution/susp. Prep – DELTA’sOptical inspectionPackaging (BFS)

Day 4: Parenterals:Pre-weighingFormulation – DELTA’Sfilling – DELTA’SDry granulation production

Day 5: xxxxxxxClosing

Agenda:Day 1: All invites welcome, setting the sceneTour around facilityDay 2:Tour continued/prepare to start workshopsDay 3:

DELTA’s from last timenew process 1etc.

Day 4:Multi batch processQC samplingBatch status updateNon-comformity management

Day 5: xxxxxxxClosing

Agenda:Day 1: All invites welcome, setting the sceneTour around facilityDay 2:Tour continued/prepare to start workshopsDay 3:

DELTA’s from last timenew process 1etc.

Day 4:Kitting processKanban processWhat ever remaining processes

Day 5: xxxxxxxClosing

Deltas Deltas

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Workshop outcome - Assessment report

• Standard process identified - Confirmed common process across sites

• Gap assessment - Identified Deltas with other sites to be reviewed during next site assessment.

• Potential unique requirement or customization

• Potential changes to existing interfaces or to any other system. (ERP interface, CMMS, Training, Serialization, Lab system, Master Data, PLM, DMS, etc.)

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Standard Process flow diagram example

Interface with other systems

Process flow

Generic requirements based on business process

Create building blocks or repeatable flows that can be referenced to. Example:Resource readiness verification, material verification, etc.

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Site leads participation

1. Site leads review proposed future standard process flows – Can the site operate with the proposed business process? Why not?

2. Standardization workshop with site leads to review gaps and deltas.

3. Standardize deltas or agree on site specific requirement based on: Compliance, Market specific, efficiency, unique process.

4. URS review and approval.

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Core concept

Ver. 1.0

Local configuration validated and

supported by site.

Site configuration

Configuration and common

definitions based on common site’s

technology and recipes.

Core configuration

Set up based on Std. Business

Process.

Core set up

Add on features, reports,

interfaces, core customization.

Supported by vendor and COE.

Core customization

OOB Features. Mus.

Product Version

Master dataAIL

Recipes

Enterprise systems

ERP

Serialization

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Lessons Learned

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Before starts standardization process…

• Provide MES , Std 95 and Std 88 overview before start standardization process workshops.

• Provide requirements definition methodology to create generic, system’s agnostic requirements.

• Define system architecture and interfaces

• AIL strategy with clear data and information flow defined

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Lessons learned, continued…

• Some process flows need QA, Training Rep, etc. from the beginning.

• Work load to be split among site’s leads.

• Some potential business process flows and URS can be started early and update as new sites are visited.

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Quality (NCR, Events)

Training Learning Management

Plant Maintenance (CMMS, Maintenance, calibration,

tools)

Mfg. Process control (SCADA, Data acquisition, Supervisory & control)

Process instruments, CMM, gauges, scales, cameras, 2D Barcode

Laboratory and testing (eLIMS)

Automation/Integration Layer (OPC, OSI-PAI)

L4

L3

L2

SOP, Drawings, Work Instructions

Product Recipes

Historian

Analytics & Visualization

Automated lines

Product Lifecycle Management PLM Planning & Manufacturing (ERP)

Enterprise Recipe Management system

OEE, Dashboards, Labor tracking

Samples Test resultsProcess Recipes

MES Process Architecture (example)

Sampling plan -Attribute, variable

data

2D BarcodeSPC

Manufacturing Execution

Productdefinition

Productionresource Mgt

Detailed production scheduling

Productdispatching

Productionexecution

Production data collection, AQL

Producttracking

Production analysis

Detailed Production scheduling

Work orders, BOMs, Routes, Products

Material status, NC, consumption

W.O. status, Lot status, Order confirm

Test Data

Training status

Resource status

Events, NC #

Release 1

Release 2

Materials Master Data

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Questions

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