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Back to Basics
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
eed
&
alig
ned
co
re
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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