The document discusses key aspects of manufacturing operations management (MOM), manufacturing execution systems (MES), lean manufacturing, paperless manufacturing, automated supply chains, traceability, business intelligence (BI), and electronic batch records (EBR). It explains that MOM, MES, lean manufacturing, and other approaches aim to provide the right information to the right people, eliminate waste, improve efficiency, quality and compliance, and deliver a single version of operational truth across manufacturing organizations. EBR is said to eliminate costly paperwork errors and speed information distribution, collaboration, and time-to-market while ensuring data integrity and regulatory compliance.

1. CRITICAL
THINGSTOLEARN
FOR
DISCRETE MANUFACTURING
&
CONTINIOUS IMPROVEMENT
GAFFAR RIAYAZ

2. WHY
“MOM”
MANUFACTURING OPERATIONS MANAGEMENT

3. ManufacturingOperations
Management(MOM)waslaidoutand
detailedactivitiesandbusiness
processesweredefinedwithin
theMOM,includingtheareasof:
Production,Quality,Maintenance,and
Inventory.
 Providing the right information to the right people at the right
time to make better decisions about every aspect of
manufacturing, including advanced planning, production capacity
analysis, Work-in-Process (WIP), inventory turns and standard
lead times
 Managing all of the various interdependencies of production to
simplify processes and enable greater collaboration by providing a
single, enterprise-wide system of record
 Delivering a "single version of the truth" that eliminates "silos" of
operations and departments, thereby enabling a synchronized and
coordinated flow of information for tighter control over disparate
manufacturing processes
 Empowering manufacturers to meet their goals for reducing
waste, inventory and cycle times to improve efficiency, quality and
customer satisfaction
 Providing a true foundation for enterprise quality, continuous
improvement and regulatory compliance for the lowest total cost

4. WHY
“MES”
MANUFACTURING EXECUTION SYSTEM

5. Amanufacturingexecutionsystem(MES)isa
controlsystemformanagingandmonitoring
work-in-processonafactoryfloor.
AnMESkeepstrackof
allmanufacturinginformationinrealtime,
receivingup-to-the-minutedatafromrobots,
machinemonitorsandemployees
 Manage all of the various interdependencies and establish a
collaborative production management ecosystem while providing an
enterprise-wide system of record
 Provide a "single version of the truth" that enables a synchronized and
highly coordinated flow of information - eliminating traditional "silos"
of data and processes - for tighter visibility and control over disparate
manufacturing processes
 Enable paperless manufacturing that delivers paperless work
instructions throughout the extended production process for rapid
responsiveness and consistent deployment of processes
 Empower manufacturers to meet their goals for reducing waste,
inventory, and cycle times while improving efficiency, quality and
customer satisfaction
 Deliver the right information to the right people at the right time to
make better decisions about every aspect of manufacturing, including
advanced planning, production capacity analysis, Work-In-Process
(WIP), inventory turns and standard lead times
 Offer a true foundation for an enterprise approach to quality,
continuous improvement initiatives and compliance, helping you to
achieve manufacturing excellence that is consistently executed and
delivered

6. WHY
“LEAN”
MANUFACTURING EXECUTION SYSTEM

7. Leanmanufacturingisasystematic
methodforwasteminimizationwithin
amanufacturingsystemwithout
sacrificingproductivity.Leanalsotakes
intoaccountwastecreatedthrough
overburdenandwastecreated
throughunevennessinworkloads
 Eliminating waste, cutting process complexity and reducing
business process cycle-times as new processes are embraced
 Modeling business processes through an easy to use interface to
visualize updates for operations execution at the level of detail
required to eliminate potential waste
 Providing deep and broad histories of process data, allowing Lean
"Kaizen" teams to quickly locate waste for continuous
improvement of your processes
 Identifying the best-practice processes, which can then be
deployed consistently to any plant with lean practice
 Managing Just-In-Time (JIT) and Just-In-Sequence (JIS) to
support advanced Pull-based production models
 Extending the power of Kanban concepts "beyond the plant's four
walls" by providing data collection, automation, strict
identification of parts and goods, rigorous automated production
reporting to third-party enterprise applications, such as ERP, and
the necessary traceability to comply with industry and
government regulations

8. WHY
“PAPERLESS”
MANUFACTURING EXECUTION SYSTEM

9. Paperlessmanufacturingisone,
perhapstheonly,waytocontroland
optimizeyourquality,efficiencyand
profitabilityovertime
 Accelerate Global Innovation – Electronically synchronize new
product introduction workflows on a global scale to ensure every
site has up-to-date, accurate information. What results is
improved market responsiveness that supports design, build and
sell anywhere operations strategies.
 Expand Material Synchronization Across all Operations –
Integrate manufacturing with planning and design applications
(ex: ERP, PLM, etc.) to synchronize Work in Process (WIP), raw
materials, finished goods and other inventory on an enterprise-
wide scale to better support Pull, Lean, Quality, NPI, Six Sigma,
Just-in-Time / Just-in-Sequence and other manufacturing
initiatives.
 Improve Quality & Compliance on a Global Scale – A solution to
transform “As built” genealogy and process history into
intelligence that enables proactive compliance monitoring, rapid
response to adverse quality events, reduce warranty costs,
improve on-time shipments and respond with greater agility to
ever changing market conditions.

10. WHY
“AUTOMATED
SUPPLY CHAIN ”
MANUFACTURING EXECUTION SYSTEM

11. Collaborative,Planning,Forecasting
andReplenishmentisaconcept
popularizedandinstitutionalizedbythe
organizationtoenablemanufacturers
andretailerstobettercollaborateon
forecastingandpromotionalplanning
toachievesupplychainefficiencies
 Providing real-time visibility into plant, supply chain and
other operations activities, throughout your enterprise
 Enabling immediate action to resolve issues within
business operations and plant activities
 Delivering critical information to whoever needs it, from
executives and plant managers, to quality technicians and
shop floor workers
 Covering all areas of manufacturing operations, including
warehouse, receiving, production, logistics, quality, and
equipment
 Offering a vendor-agnostic user interface and application
integration capability to seamlessly integrate each of your
supply chain vendor operations into a single system for
simplified, more effective process and material flow
management across your product supply network

12. WHY “TRACEABILITY”
MANUFACTURING EXECUTION SYSTEM

13. Inmanufacturingthatrequiresquality
andriskprevention,traceabilityisused
inordertoprovewhereitcamefrom,
thatthere'snocounterfeitproduct,and
theproductiswhatitshouldbe.
 Improve collaboration – between corporate quality, manufacturing sites
and trade partners to better coordinate corrective actions, reducing
manual and time-consuming tasks prone to error
 Centralize track and trace analysis – without requiring replacement of
existing manufacturing systems to provide better insight into product
genealogy and packaging hierarchy at any time
 Handle Big Data of end-to-end traceability – without impacting
operational performance, as data is received from plants, suppliers and
logistics providers
 Capture detailed global traceability and genealogy data automatically
–from multiple sources, to help reduce risk, protect brand equity and
help reduce the threat of counterfeiting
 Address changing and emerging compliance requirements – by
providing readily available, detailed product pedigrees to demonstrate
auditable compliance and product authenticity
 Accelerate process innovation – by leveraging manufacturing big data
and intelligence gained from expanded visibility, process improvement
across key operational areas is now possible, including beyond the four
walls

14. WHY
“BUSINESS INTELLIGENCE”
MANUFACTURING EXECUTION SYSTEM

15. Oneofthemostimportantreasons
whyyouneedtoinvestinaneffective
BIsystemisbecausesuchasystemcan
improveefficiencywithinyour
organisationand,asaresult,increase
productivity.
 BI can help to improve efficiency at manufacturing organizations.
Globalization and new competition, in addition to weak economies, are
forcing manufacturers to run leaner and meaner. At the same time, they
must produce a greater number of types of products, if not custom products,
as well as maintain increasingly difficult standards.
 Business intelligence: Business intelligence (BI) is a broad category of
applications and technologies for gathering, storing, analyzing, and
providing access to data to help enterprise users make better business
decisions. BI applications include the activities of decision support systems,
query and reporting, online analytical processing (OLAP), statistical
analysis, forecasting, and data mining.
 Corporate performance management: Corporate performance management
(CPM) is the area of BI involved with monitoring and managing an
organization's performance, according to key performance indicators (KPIs)
such as revenue, return on investment (ROI), overhead, and operational
costs. For online businesses, CPM includes additional factors such as page
views, server load, network traffic, and transactions per second.
 Key performance indicator: A key performance indicator (KPI) is a business
metric used to evaluate factors that are crucial to the success of an
organization. KPIs differ by organization: Business KPIs may be net
revenue or a customer loyalty metric, while government might consider
unemployment rates. KPIs are applied in BI to gauge business trends and
suggest tactical courses of action.

16. WHY
“EBR”
ELECTRONIC BATCH RECORDS

17. Eliminatescostlypaperworkerrors,
speedsupinformationdistributionand
collaboration,andenablesstrategies
forimprovingqualityand
efficiency.MostImportantly tracks
batchrecords,modelandchange
complexprocesses,andspeedtime-
to-market.
 Complete Data Capture: All user entries are captured, electronically stored, and available for
reporting. This includes loading of external files, making them part of the batch record.
 Data Integrity Checks: Each field can run automatic checks to ensure that the data entered is in
the correct format. Missing data, incorrect date formats or incorrect units of measure will never be
a problem.
 Automated Calculations: Calculation logic ensures that each data item only has to be entered once
and can feed into calculations such as yield calculations or recipe amount calculations. Never worry
about accuracy of calculations again.
 Performer/Witness Signoff: Each signature point can be configured for a single signature or
Performer/Witness signatures within an electronic batch record systems. Performer/Witness
signature points allow two users to submit their signatures from a single signoff window.
 Parallel and Sequential Processing: Processing steps can be set up in a combination of sequential
and parallel units.
 Integrates with Deviations: Every manufacturing process needs a mechanism to deviate from the
prescribed procedure, but controls must be in place to ensure that a deviation is acceptable.
Electronic batch records software seamlessly integrates the recording, assessment, and approval of
a planned or unplanned deviation into the overall manufacturing process. Deviations solutions also
link to other quality management modules such as Nonconformance and Controlled CAPA.
 Analytics Reporting Tool: This built-in tool of an electronic batch records system comes with a
standard set of pre-configured reports that can be customized by the user. Production records can
be trended and analyzed by product, recipe, process stage, etc. These data-mining capabilities
provide important insights into overall production activities such as turnaround, quality issue
rates, etc.
 Compliant System: EBR integration with regulations, providing time-stamped audit trails,
reporting, and electronic signature capabilities. Security features include dual passwords for
document approval as well as password expiration, encryption, and certification.
 Unparalleled Validation: EBR validation an integral part of solutions for FDA-regulated
customers. EBR is revolutionary approach to validation dramatically cuts the time, effort, and cost
of validation, making it easier to validate future upgrades.