11/13/2015
The Future of Manufacturing in a Connected World
Rockwell Automation
Joe Whyte
Global Serialization Lead
Ph: 973-768-3617
jwhyte@ra.rockwell.com
PUBLIC
PUBLIC - 5058-CO900H
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Manufacturing Control Disciplines
Command and
Control
Data / Information
Energy Management
Visualization
Condition
Monitoring
Drive
Systems
Batch
Systems
Process
Control
PUBLIC
Discrete
Control
Safety
Systems
Servo
Systems
Robot
Systems
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Multiple Control Disciplines
Condition
Monitoring
PUBLIC
Drive
System
Servo
Systems
Safety
Systems
Discrete
Control
Robot
System
Process
Control
Energy
Management
Batch
Systems
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Control System Evolution
Safety System
Controller / I/O
HMI
Switch
ENET
SERCOS / IRT
Freq
Drive
DNET / RT
Motion Control
Distributed I/O
Power
Monitoring
Integrated Condition
Monitoring
Distributed I/O
Safety Relay
Safety Relay
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Control System Evolution – ENET IP
Safety System
Controller / I/O
HMI
Switch
ENET
Freq
Drive
Motion Control
Distributed I/O
Power
Monitoring
Integrated Condition
Monitoring
Distributed I/O
Safety Relay
Safety Relay
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Control System Evolution – Ring
Integrated Safety
Safety System
Controller / I/O
HMI
ENET
Freq
Drivs
Motion Control
Distributed I/O
Power
Monitoring
Integrated Condition
Monitoring
Distributed I/O
Safety Relay
Safety Relay
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Control System Evolution –
Embedded Historian
Historian / Trending
Controller / I/O
Secure
Access
HMI
ENET
Freq
Drive
Motion Control
Distributed I/O
Power
Monitoring
PUBLIC
Integrated Condition
Monitoring
Distributed I/O
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Purdue Reference Model
Level 4 - ERP
Business Planning & Logistics
Executive
Finance
Production Scheduling, Operational Management,
Resource Planning, etc.
Level 3 - MES
WAN
Manufacturing
Operation & Control
Operations
Quality
IT
Dispatch Production, Detail Production,
Scheduling, Asset Management, etc.
Level 2,1,0 –
Control, I/O, Batch
Devices
Control
LAN
Continuous
Control
Discrete
Control
Engineering
Maintenance
Purchasing
Control Networks
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
8
11/13/2015
IIoT for Manufacturing Systems
Level 5 - Cloud
Cloud
Level 4 - ERP
Consumer, Social, Serialization,
Mobility, Analytics,……..
Business Planning & Logistics
Production Scheduling, Operational Management,
Resource Planning, etc.
Level 3 - MES
Manufacturing
Operation & Control
Level 2 - Control
Dispatch Production, Detail Production,
Scheduling, Asset Management, etc.
Manufacturing
Control Systems
Level 1 – Smart Devices
Batch, Continuous, Discrete
HMI, Alarming, Trending, Asset Mgmt
I/O & Devices
Sensors, Power, Instrumentation, Controls
Level 0 – Physical
Physical Plant
Equipment
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
9
11/13/2015
<14%
21%
2 Exabytes
75%
$20B
$65B
Machines tied to
Enterprise Networks
Manufacturers who
have suffered IP
loss in past year
Big data generated
by manufacturing
More than any other
sector
US Plants more than
20 years old
Risk in the cost of
unplanned
downtime
Global installed
base if legacy
automation systems
nearing end of life
SOURCE: Industry Week
SOURCE: Kapersky (2014)
SOURCE: McKinsey
SOURCE: ARC
SOURCE: Industry Week
SOURCE: ARC
IoT - $19T Value at Stake in the Private sector over next 10 years
IIoT - $3.9T in Manufacturing
7
Copyright © 2014 Rockwell Automation, Inc. All Rights Reserved.
10
11/13/2015
v
Data
Materials
Time
People Resources
MANUFACTURING
PROCESS
Product
Energy
Waste
PUBLIC
Copyright © 2015 Rockwell Automation, Inc.11
All Rights Reserved.
11
11/13/2015
THE GOAL:
Optimizing Manufacturing Performance
43%
of industrial companies make
management decisions without
the support of relevant data
and information
Source: ARC Insights Report, Global survey of CIOs, Gartner, Inc.’s Executive Programs
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
1212
11/13/2015
What’s stopping you?
PUBLIC
Standards - Everyone should have them
Security - Interconnectivity and access vs IP and Risk
Data Privacy and IP - Internal Silos and transparency
Legacy Systems - If it isn’t broken don’t fix it
Role Models - Who can I copy? Who will let me copy
C-Suite Champions - What get’s you up in the morning?
Silo vs. Matrix - One or the other?
New Working Cultures - Dichotomies of epic proportion
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Today’s Food Safety Programs
This isn’t new HASIP invented 30 years ago
Paper based / spreadsheet
Snap-shots in time
Difficult to track or trace products – can you link process parameters to
track product track & traceability
Not responsive to the demands that will come in the future
REFERENCE: Food Engineering Study statistics
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
LIKE
AUTHENTIC
POST
SHARE
Amplified by
social media.
Rockwell Automation TechED 2015
@ROKTechED
#ROKTechED
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
15
11/13/2015
Tomorrow’s Food Safety Programs
Increase consumer confidence / meet regulatory demands / improve
operational efficiency
Move from reactive to proactive approach
Ease record keep and traceability – improve product tracking
Labelling issues – especially for allergens
Avoid costly product recalls
Maintain brand loyalty.
ACCESS TO REAL TIME INFORMATION
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
IMPROVE YOUR FOOD SAFETY PROGRAM
1
Get
connected
PUBLIC
2
3
Secure your
Employ a riskbased preventative
networks
program
4
Implement
product
traceability
5
Improve
operational
efficiency
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
The Connected Enterprise
EXECUTION MODEL
Assessment
Secure, Upgrade
Working Data Capital
Analytics
Collaboration
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Serialization & Product Traceability
Rockwell Automation
Joe Whyte
Global Serialization Lead
jwhyte@ra.rockwell.com
PUBLIC
PUBLIC - 5058-CO900H
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Agenda
What is Serialization
Why Serialize
Serialization Implementation Challenges & Solutions
The Future of Serialization – Connected Enterprise
Why Rockwell Automation
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
20
11/13/2015
Serialization Requirements
Blister Pack (Unit)
Bundle
8305254961
4693602591
8305254961
Human readable unique serial number
On each package (USA)
On primary package (EU)
PUBLIC
Case
1112131415
4693602591
8305254961
Pallet
1452267440
1112131415
4693602591
8305254961
Aggregation of all primary package serial
numbers to their lower level sub-package
serial numbers in parent/child relationships
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
21
11/13/2015
Serialization Requirements
Track & Trace
Track & trace raw
materials
Generate
Acquire, Manage UID for
each saleable item
Aggregate
Package level serial
numbers in Parent/Child
Data relationships
Store
Code information in a
secure database
Associate
Code information when
dispatching products
PUBLIC
Scan
Codes to verify
authenticity of product
Validate
Serialization data matches
the physical product received
Raw Materials
Track
Status of dispensed
items to prevent re-use of
serial numbers
Confirm
That products have
complete and accurate
documentation
Warehouse
Supplier
Central Database
(What? When? Where? Why?)
Manufacturer
Finished Goods
Pharmacy
Distribution Center
Real world goods
EPC / Barcode data
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Agenda
What is Serialization
Why Serialize
Serialization Implementation Challenges & Solutions
The Future of Serialization – Connected Enterprise
Why Rockwell Automation
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
24
11/13/2015
Market Trends:
Global Medicinal & Food Product Safety
The World Health Organization estimates counterfeit drug sales to range between $35 and 40 billion per year.
Between 8 and 10% of the worldwide drug supply is estimated to be counterfeit.
Growing health and safety risk with counterfeited drugs
Growing involvement in the drug supply chain of under-regulated
wholesalers and re-packagers
Proliferation of Internet pharmacies, advancements in technology that
make it easier to produce counterfeit drugs
Increased importation of gray market medicines
Ex: the 2008 contamination of Chinese infant formula
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Regulations & Requirements
Regulations and industry standards specify what but not how to
implement Serialization.
EU Falsified
Medicines Directive
Drug Supply Chain
Security Act (U.S.)
China Food & Drug
Administration
Brazilian Health Surveillance Agency
Directive 2001/83/EC- prevention of
the entry of falsified medicinal
products
Identification of suspect product
and notification
Electronic Drug Supervision Code
(EDSC)
Resolution RDC 54
Published Dec 10th, 2013
Other countries have begun instituting increased government regulations.
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
26
11/13/2015
Aggregation
India
Country
Nigeria
Tamper
Evident
Other
Regulations
Serialization
China
Status
Codification
Regulatory Timelines
Denmark
Scope
December 2015
2012/13 EDL list*
July 2014
All Rx drugs - Exports
October 2014
Anti-Infective drugs
January 2014
All Pharmaceutical Products
Algeria
January 2015
All Pharmaceutical Products
Korea
January 2015
All Rx drugs
January 2015
All Rx drugs
U.S. (Phase 1)
Slovenia
January 2015
All Rx drugs
Saudi Arabia (Phase 1)
May 2015
All Rx drugs
July 2015
All Rx drugs
December 2015
All Pharmaceutical Drugs
Japan
Brazil (Phase 1)
- Final Regulation
PUBLIC
Deadline
- Pending final approval
*EDL: Essential Drug List
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
27
11/13/2015
Serialization
Brazil (Phase 2)
Canada
Jordan
January 2017
All Rx Drugs
Ukraine
January 2017
All Rx Drugs
Saudi Arabia (Phase 2)
March 2017
All Rx Drugs
U.S. (Phase 2)
November 2017
All Rx Drugs
UK
Q4 2017
All Rx Drugs
EU
Q4 2018
All Pharmaceutical Products
Taiwan
January 2018
All Rx Drugs
U.S. (Phase 3)
November 2023
All Rx Drugs
Tamper
Evident
Other
Regulations
Codification
Status
Mexico
Country
- Final Regulation
PUBLIC
Aggregation
Regulatory Timelines
Deadline
Scope
January 2016
All Rx Drugs
December 2016
All Rx Drugs
January 2017
All Rx Drugs
- Pending final approval
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
28
11/13/2015
Albania
Cameroon
Chile
Columbia
Libya
Singapore
Tamper
Evident
Other
Regulations
Aggregation
Serialization
Country
Codification
Status
Regulatory Timelines
TBD
All Pharmaceutical Products
TBD
All Pharmaceutical Products
TBD
All Pharmaceutical Products
TBD
All Pharmaceutical Products
TBD
All Rx Drugs
TBD
All Rx Drugs
TBD
All Pharmaceutical Products
- Pending final approval
Country
PUBLIC
Scope
Malaysia
- Final Regulation
Deadline
Regulation
Deadline
Scope
U.S.
UDI
Varies
All Med Devices
UK
UDI
TBD
All Med Devices
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
29
11/13/2015
Why Serialize? - Business ROI Reasons
Business Category
Business Benefit
•
CONSUMER SAFETY/
BRAND PROTECTION
•
•
CUSTOMER SERVICE &
RETURNS PROCESSING
SUPPLY CHAIN
INTEGRITY
•
•
•
•
•
SUPPLY CHAIN
OPTIMIZATION
•
•
•
MARKETING &
BRAND LOYALTY PROGRAMS
•
•
•
BUSINESS OPTIMIZATION –
CONNECTED ENTERPRISE
PUBLIC
•
Regulatory compliance
Product adulteration control
Diversion source & location control
Authenticate transactions
Improve chargeback payment accuracy
Complete Supply Chain Traceability
Increase recall accuracy & efficiency
Direct to customer notifications
Improve forecasting
Optimize inventory
Improve supply chain planning
Real time consumer & product market data
Customer specific target marketing programs
Consumer authentication via mobile device
Share data across departments: Sales, Marketing, Finance, Operations, Supply Chain, etc.
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
30
11/13/2015
Agenda
What is Serialization
Why Serialize
Serialization Implementation Challenges & Solutions
The Future of Serialization – Connected Enterprise
Why Rockwell Automation
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
31
PUBLIC
LEVEL 5
Scalability in Supply Chain
• Scalable serialization solution to support distributed operations:
manufacturing, distribution, warehouse, pharmacy
• EPCIS - How to manage additional lines? Countries? Formats? Regulations?
LEVEL 4
Data Integration & Data Management
• High amount of data
• Printing and verification in a high speed environment
LEVEL 3
Data Accessibility & Management (Level 3)
LEVEL 2
• Data security
• Data exchange with external partners and interfaces between systems
• Data consistency, Data redundancy, Data Ownership, Master data
LEVEL 1
OEM
IMPLEMENTATION CHALLENGES
11/13/2015
LEVEL 0
Operational Challenges for Data Generation & Acquisition
•
•
•
•
•
•
Uniqueness of applied numbers (preferred randomized)
Product handling, product rejection, product rework, line modifications
Physical product package limitations (space, materials, environment, etc.)
Application & Inspection of printed codes
Wide range of products, data formats, packaging line types
Data Sequencing & Coordination of Material Handling, Printing & Inspection
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
32
11/13/2015
Operational Challenges
IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1)
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Printing Expertise Required
IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1)
Selecting the right technology for the
application is critical to success
• Thermal Ink Jet HP
• Laser
• Preprinted Label
• Drop on Demand
• Thermal Transfer
• Continuous Ink Jet
• Hybrid – Flexo / Digital
• Inks – Solvent, UV, Waterbased, Security
• Substrates – Paper, Foil, PVC, Tyvek Metal,
Direct part marking
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Vision Expertise Required
IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1)
Tablet
Inspection
Selecting the right technology for the
application is critical to success
• Gray Scale & Color
• 3D Imaging, Line Scanners
• OCR / OCV
Laser
Engraved
Metal
• Part Features
• Barcode Grading (ANSI Standards)
• Integration into HMI Packages
• High Speed Applications
TIJ Printed Carton
w/ Serialized Data
PUBLIC
• High Speed Web Inspection
• 2D Matrix Code Grading @ 400 PPM
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
35
11/13/2015
Commercial Off-The Shelf Technology
IMPLEMENTATION SOLUTION (LEVEL 0 – LEVEL 1)
• Open Serialization platform to
interface with existing packaging
equipment
• PLC/PAC controllers for data
management at Level 0 & Level 1
• Open Network & Communication
Standards (Ethernet-IP)
• PLC/PAC Software in standard IEC
61131-3 programming languages
• Modular, Reusable & Scalable
Solution
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
36
11/13/2015
Data Management Challenges
Serial range
SITE
SHOP FLOOR
GTIN
Order(ENTERPRISE)
number
Order
INTERNAL
CHAIN
SSCC
Order
end status
Order
start
Batch
number SUPPLY
Expiry
Prod.date
date
Produced quantity
LEVEL 4
LEVEL 3
Alarms
Plant AOEE data
Serialization-relevant data isPlant
widely
distributed over
different
B
Contractor
Automation and Information Systems at different ISA-95 levels!
SHOP FLOOR A1
A2
B2
B1
C1
SSCC
OrderOrder
statusstart Produced quantity
number
Line A1-1GTIN
Order end
SSCC
BatchOrder
number
Alarms
Serial number
Expiry date
Prod. date
Print data
CARTONER
PUBLIC
Serial number
EPCIS EVENT REPOSITORY
EPC data EPC event
PHARMACIST
EXTERNAL SUPPLY CHAIN
WHOLESALER
ERP
EPCIS
IMPLEMENTATION CHALLENGES (LEVEL 2 – LEVEL 4)
OEE data
DM data
Verification data
BUNDLER
Line configuration
Label Layout
EPC data EPC event
Unit configuration
Packaging size
CASE PACKER
LEVEL 2
LEVEL 0,1
PALLETIZER
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
37
11/13/2015
Data Accessibility & Data Management
IMPLEMENTATION CHALLENGES (LEVEL 2 – LEVEL 4)
How to integrate different external level 3/4 MES/ERP/EPCIS systems?
Do you have to customize for every external system?
Are you able to extend and adapt quickly?
How to seamlessly integrate with Level 0/1/2 systems and equipment?
Can you cope with high-speed, real-time Serialization systems?
Can your site server cope with the diversity of products, formats, country requirement,
packaging line types?
Is your site server CFR 21 Part 11-compliant?
Code of Federal Regulations Part 11 of Title 21: electronic records, electronic signatures
Is your site server pre-validated according to GAMP 5?
A risk-based approach to compliant good automated manufacturing practice computerized
systems
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
38
11/13/2015
Data Convergence
(ISA-88 aligned data model)
EPCIS EVENT REPOSITORY
WHOLESALER
PHARMACIST
EXTERNAL SUPPLY CHAIN
LEVEL 4
ERP
EPCIS
IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4)
INTERNAL SUPPLY (ENTERPRISE) CHAIN
SHOP FLOOR
SITE
ERP INTEGRATION GATEWAY
Delivering the right data to the right place at the right time!
GTINSSCC
Batch number
Unit configuration
Packaging
size
EPC event
EPC
SerialSerial
rangeExpiry
Label Layout
Verification
Line
data
configuration
Order
start
number
DM data
OEEOrder
data
EPC data
Order
status
OrderProduced
end
number
quantity
Prod.
datePrint
datedata
Alarms
SHOP FLOOR A1
A2
B1
B2
C1
Line A1-1
LEVEL 2
LEVEL 0,1
CARTONER
PUBLIC
LEVEL 3
SITE SERVER
BUNDLER
CASE PACKER
PALLETIZER
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
39
11/13/2015
ISA-88 aligned data model
IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4)
Serialization Master Data
Master Recipe
SSCC
Serial
range level
Randomizer
→GTIN
Per
packaging
Site Model
Line
configuration
Unit
configuration
→ Per
packaging
line
Print and Camera Format
→
Per
packaging
level
Print
DM
data
Verification
data
data
→ Per product
Label Layout
Packaging size
Graphical
workbench
ISA-88
Approval
recipe
workflow
structure
Version
control
User
Management
Re-usable
Real-time
Mass
Import/Export
change
building
blocks
verification
Packaging Order
Batch number
Serial number
→Expiry
Per order
date /
Prod.
date
batch
Alarms
OEE data
Order number
Order status
Order start
Order end
Produced quantity
Well structured data, ISA-88 and -95 aligned:
PUBLIC
Consistent
Reusable
Scalable
No redundancies
EPC data
EPC data
EPC event
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
40
11/13/2015
Open Architecture
IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4)
J2EE – proven technology for missioncritical enterprise applications
High data volumes, high throughput
Many users accessing data concurrently
Security and stability
Complex business logic
Scalability without limits
Scalability
Service Oriented Architecture (SOA)
Feature rich business layer
Supports rich and thin (HTML) clients
Variety of supported software
Operating Systems
Databases
Multi-tier data model
Application development framework
J2EE Strengths
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
41
11/13/2015
Integration with ERP Business Systems
IMPLMENTATION SOLUTION
IMPLEMENTATION
SOLUTION
(LEVEL
(LEVEL
3– 2Level
– LEVEL
4) 4)
Serialization Module
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
42
11/13/2015
Supply Chain Challenges
IMPLEMENTATION CHALLENGES (LEVEL 5)
EPCIS Certified
Event Repository on
Microsoft Azure
Brazil - Dec 2015
Manufacturing
Consumers
Consumers
Brasilia RDC
Product Flow
Data Flow
CDC – Central Distribution Center
RDC – Regional Distribution Center
PUBLIC
Sao Paulo CDC
RDC’s
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
43
11/13/2015
Forward/Reverse Logistics
IMPLEMENTATION CHALLENGE (LEVEL 5)
EPCIS Event
Repository
Checking Service
Checking Service
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
44
11/13/2015
GS1, EPCIS & Global Interoperability
ALL COUNTRIES WITH THE EXCEPTION OF CHINA ARE FOLLOWING THE GS1 STANDARDS
GSI - An International not-for-profit
association with over 100 country
organizations
• Design and implement global
standards and solutions that
improve efficiency and visibility of
supply and demand chains globally
across sectors.
• Most widely used supply chain
standards system in the world.
GS1 Standards
•
•
•
•
•
•
•
•
Barcode Standards
Data Accuracy Standards
eCom Standards
Electronic Product Code
(EPC) Standards
Global Data Synchronization
Network (GDSN) Standards
Global Data Dictionary
Global Product Classification
(GPC) Standards
Extensible Markup Language
(XML) Standards
EPCIS: Electronic Product Code
Information Services
• Enables disparate applications to
leverage EPC data via EPCrelated data sharing, both within
and across enterprises.
© RC Partners 2015
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
45
11/13/2015
IDENTIFY: GS1 identification numbers
GS1 Standards begin with GS1 Identification Numbers
used to uniquely distinguish all products (trade items), logistic units, locations,
assets, and relationships across the supply chain from manufacturer to consumer.
© RC Partners 2015
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
46
11/13/2015
Capture: GS1 Data carriers
GS1 Data Carriers
are capable of
holding varying
amounts of data to
accommodate
different needs for
different products.
The appearance of the EPCglobal Seal is to inform
that an EPC-Enabled RFID tag is present on or
within the packaging of the product(s).
47
© RC Partners 2015
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
SHARE: GS1 Data EXCHANGE
Interoperability, made possible by identification standards, data
capture standards, and data exchange standards, allows product
information to flow through the supply chain.
48
© RC Partners 2015
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
FDA Draft Guidance on data exchange
Transaction Statement, Transaction Information, Transaction History
2015:
1.
2.
3.
Transaction Statement
Transaction Information
Transaction History
2023:
1.
2.
3.
Transaction Statement
Transaction Information
“facilitate gathering the information
necessary to produce the transaction
information for each transaction going back to
the manufacturer” …
(TIn)
© RC Partners 2015
PUBLIC
49
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
FDA Draft Guidance on data exchange
Transaction Statement, Transaction Information, Transaction History
© RC Partners 2015
PUBLIC
50
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
FDA Draft Guidance on data exchange
EPCIS Basics
+
1.
2.
3.
4.
PUBLIC
Purpose Built for T&T
Extensible
Includes Query Capability
Global
+
1.
2.
Application Identifiers (things we want
to track)
Global (National Health
Reimbursement Numbers)
51
1.
2.
3.
4.
5.
Business Steps
Product Dispositions
Standard Vocabularies
Extensible
Global
© RC Partners 2015
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
What is EPCIS?
Purpose built for T&T – Flexible – Extensible - Global
Manufacturer
Distributor(s)
Dispenser
Dispense
1
Commission
<
Pack
<
Ship
<
Rcv
<
Unpack
<
Pack
<
Ship
<
Rcv
<
Unpack
Destroy
<
Decommission
2
DSCSA Data
DSCSA Data
EPCIS was purpose built for Track & Trace
3
EPCIS includes the
ability to query or
ask for information:
All events for Item
“00312345325671”?
•
•
•
PUBLIC
Commissioning Event
Packing Event
Shipping Event
52
1.
Extensible “events” and “Dispositions”
2.
May Extend Information for:
3.
Geographies
Industries
Trading Partners
Includes Query functionality
© RC Partners 2015
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
EPCIS Vs. EDI for DSCSA
EDI … ASNs:
EPCIS:
• For 2015 requirements:
• For 2015 requirements:
•
Extended version is working.
•
• For 2023 requirements:
•
•
•
•
•
•
•
•
We’re asking a lot from a message format that wasn’t
created for this purpose.
It’s not global (Format: ANSII in US, GS1 elsewhere)
It’s not extensible without Standards action (multi-year
process)
Carries more data than needed
No Exception Processes
No query mechanism
Needs Checking/Discovery process
Needs Certification process
Extended version is working.
• For 2023 requirements:
•
•
•
•
•
•
•
•
Purpose built for T&T
It’s global
It’s extensible without Standards action
(multi-year process)
Carries minimum data
Exception Processes
Query mechanism
Needs Checking/Discovery process
Needs Certification Process
© RC Partners 2015
PUBLIC
53
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
11/13/2015
Serialization Event Repository Database
IMPLEMENTATION SOLUTION (LEVEL 5)
Database is EPCIS certified by GS1 to support global exchange of data with supply
chain partners
Generation of random or sequential serial numbers in GS1 format - prevents
duplication across enterprise (multiple sites)
Hosted in Microsoft Azure Cloud
Data centers located in 89 countries
Compliance with SOC2 / SOC3 and ISO/IEC27001:2005 for security, routine backup, and disaster recovery
Includes event repository, which captures every event (e.g. commissioning,
decommissioning, rework, authentication) of each package barcode. Event file is
maintained for the life of the product.
Provisions serial numbers and downloads to the Level 3 site server at client’s facility.
Receives serial numbers after completion of batch.
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
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11/13/2015
Supply Chain Applications
IMPLEMENTATION SOLUTION (LEVEL 5)
Configuration of supply chain partners to enable rework of pallets and
cases while maintaining aggregation integrity
Authentication by supply chain partners using smart scanners
Track & Trace through downstream supply chain
Detection of gray market diversion
More efficient recall management
More accurate returns management, including returns price verification
Consumer authentication, communications and loyalty programs using
mobile devices
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
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11/13/2015
Multi-function Dashboards
IMPLEMENTATION SOLUTION (LEVEL 5)
PUBLIC
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11/13/2015
© Microsoft 2015
11/13/2015
Huge infrastructure scale is the enabler
19 Regions ONLINE…huge datacenter capacity around the world…and we’re growing
North Europe
Central US
North Central US
Iowa
Illinois
Ireland
West Europe
Netherlands
China North *
US Gov
Beijing
East US
Iowa
West US
Virginia
South Central US
Texas
India West
US Gov
India East
Japan
West
TBD
Osaka
TBD
Virginia
Saitama
Shanghai
East US 2
California
Japan East
China South *
Virginia
East Asia
Hong Kong
SE Asia
Singapore
Australia East
Sydney
Brazil South
Sao Paulo
100+ datacenters
One of the top 3 networks in the world (coverage, speed, connections)
2 x AWS and 6x Google number of offered regions
G Series – Largest VM available in the market – 32 cores, 448GB Ram, SSD…
Australia West
Melbourne
Announced
Operational
* Operated by 21Vianet © Microsoft 2015
11/13/2015
Virtual Machines
Cloud Services
App Services
Windows Store
iOS
Android
HTML5/JS
Windows Phone
iOS
Android
Nokia X
GALLERY
DEPLOY
YOUR
CODE
Load Balancer
Gallery
Load Balancer
Windows
VIRTUAL MACHINES
WEB ROLE
INSTANCES
Load Balancer
APP
INSTANCES
Linux
QUEUE
VIRTUAL
NETWORK
SQL
CACHE
TYPE X
TYPE Y
APP
TYPES
…
API APP
Blobs/Files
Database
STORAGE BLOBS / FILES (Virtual Disks)
Get full control over a server in the
cloud and maintain it as your
business requires.
Managed Virtual Machines with
specific web and worker roles that
are stateless
Batch
For running large scale parallel and
high performance computing
(HPC) applications
Scheduler
Create jobs that run reliably on
simple or complex schedules to
invoke any type of service.
Access Windows apps that run
within the Service on VM’s from
any device and any location.
Express
Route
Provision and manage VPNs in
Azure and securely link to your onpremises IT infrastructure.
Connect on-premises and cloud
data centers directly through
dedicated, non-internet lines.
Store binary application data and
web content – store for dedicated
and shared virtual disks for VM’s
Add backend capabilities to mobile
apps, with native client support on
most device platforms.
API
Apps
Create and surface your app logic
as APIs for other services and apps
to consume.
Logic
Apps
Build/execute business processes
by linking your own custom API’s
with an API Gallery/Marketplace
Simple message queue for
application de-coupling
architecture for scale out.
Load-balance incoming global
traffic across multiple services
running in multiple data centers.
Active
Directory
Identity and access management
for cloud applications and ability to
link to on-premises Server AD.
Multi-Factor
Authentication
Safeguard access to data and apps
with additional physical layer of
security control.
API
Management
Publish and Manage APIs to
developers, partners and
employees securely and at scale.
Notification
Hubs
Deliver millions of cross platform
push notifications from any
application backend, anywhere.
HDInsight
Big Data (based on Apache
Hadoop) analytics that integrate
easily with Microsoft Office.
Machine
Learning
Stream
Analytics
Data
Factory
Mine historical data with compute
power to predict future trends or
behavior.
Process data streams in real-time
to discover and react to trends.
Ingest data from multiple sources
to combine into a cloud based
Data Warehouse.
Media
Services
Range of services that support
video on-demand and live
streaming workflows.
Content Delivery
Network (CDN)
Cache content for your apps at
100’s of edge locations to improve
user experiences.
Managed service that handles
backup/restore of Windows Server
machines/backup agent.
Import/Export
For massive data transfer – ship
encrypted disks to move data
in/out of blob storage.
Site
Recovery
Coordinate replication and
recovery of System Center private
clouds
StorSimple
Automated, policy driven solution
to extend on-premises primary
storage for backup / DR.
SQL
Database
DocumentDB
Managed relational database
service with high availability and
selectable performance levels.
Store/retrieve millions of JSON
objects from a highly scalable
NoSQL document database.
Portal
Key
Vault
Redis
Cache
Make applications scale and be
more responsive under load by
keeping data closer to app logic.
MANAGEMENT
Biztalk
Services
Build EDI and Enterprise App
Integration (EAI) solutions in the
cloud.
Hybrid
Connections
Connect apps in Azure with onpremises resources without a VPN
or dedicated line.
Service
Bus
Messaging capabilities (pub/sub,
queues) and on-premises to cloud
connectivity solution.
Automation
Run durable PowerShell scripts to
automate frequent, long running,
complex Azure tasks.
Event
Hubs
Ingest, persist, process millions of
events per second from millions of
devices.
Mobile
Engagement
Ingest, persist, process millions of
events per second from millions of
devices.
DEVELOPER SERVICES
DATA
Backup
HYBRID INTEGRATION
Storage
Queues
Traffic
Manager
ANALYTICS
Mobile
Apps
STORAGE & BACKUP
Storage Blobs
& Files
MEDIA & CDN
IDENTITY & ACCESS
Virtual
Network
Remote App
WEB & MOBILE
Managed web platform, get
started for free and scale as you
go using many tools/ languages.
API MARKETPLACE…
NETWORKING
Cloud
Services
Web Apps
Tables/NoSQL
MOBILE APP
WEB APP
STORAGE SOLUTIONS
COMPUTE
Virtual
Machines
LOGIC APP
Search
Managed, scalable search service
for your apps, create tunable
search results and ranking models.
Tables
Massive scale for semi-structured
key/value type data in this
schema-less NoSQL store.
Visual Studio
Online
Store code, plan and track
projects, build, deploy and test
apps in the cloud collaboratively.
Application
Insights
Analyze app usage, availability and
performance to detect issues and
solve problems proactively.
COMMERCE
Web based experience to
provision, control and monitor all
Azure services.
Safeguard and control keys and
secrets in cloud scale hardware
security modules.
Operational
Insights
Analyze and troubleshoot onpremises IT infrastructure without
using instrumented code.
Store /
Marketplace
Find and manage other services
provided by third parties.
VM Depot
Find free open source VM images
that you can download and run in
Azure Virtual Machines.
© Microsoft 2015
11/13/2015
Support & Maintainability Challenges
When serializing for regulatory compliance reasons Serialization system failures in production sites = No Production
Network infrastructure
Site Server
Unit & line controllers
Equipment data interfaces
Operator interfaces
Printers & Vision systems
PUBLIC
Mission critical production assets require immediate attention
Single point of contact for the entire Level 0 – Level 3 system
Real-time Serialization Application-level support
Periodic performance analysis and reviews
Remote monitoring & diagnostics
Emergency dispatch
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
60
11/13/2015
Remote Serialization Application
& Monitoring Support
Internet
Process
Firewall
Industrial
Security
Zone
VSE- Remote
Access
Cell/Area
Zone
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
61
11/13/2015
Scalable Supply Chain Connectivity Model
IMPLEMENTATION SOLUTION (LEVEL 5)
Scalable Distribution Center Site Server Solution
–
Servers, Switches, Storage, Memory & Software
Standard Solution for Long Term Support
Tested, validated reference design
Inclusive of all hardware, software and services
Best choice of server, network & storage
Lower total lifecycle cost
–
Reduced IT administration and support
–
Reduced server footprint
–
Enhanced security
–
Simplified backup
–
Simplified restore
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
62
11/13/2015
Agenda
What is Serialization
Why Serialize
Serialization Implementation Challenges & Solutions
The Future of Serialization – Connected Enterprise
Why Rockwell Automation
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
63
11/13/2015
The Connected Enterprise
Prediction All manufacturers will serialize
their products within 10 years
BUSINESS BENEFITS
•
•
•
PUBLIC
Real time product
consumption &
demographic data
Customer buying behavior
information
Brand protection, brand
loyalty, compliance….
BIG DATA
•
•
Serialized products will
optimize businesses by
serving as a common
thread across the
connected enterprise
Various departments will
use the common data for
their specific needs
“INTERNET OF EVERYTHING”
•
A company’s serialization
data, when used to optimize
the way a business
operates, will become one
of its most valuable assets
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
64
11/13/2015
Agenda
What is Serialization
Why Serialize
Serialization Implementation Challenges & Solutions
The Future of Serialization – Connected Enterprise
Why Rockwell Automation
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
65
LEVEL 5
CONSUMER
AUTHENTICATION
(BRAND LOYALTY)
EPCIS CERTIFIED
CLOUD BASED
EVENT REPOSITORY
CONSUMER
AUTHENTICATION
(BRAND LOYALTY)
EPCIS
MES
ERP
Turnkey,
holistic solution
providing complete serialization
LEVEL 4
EIG
EIG
BACKEND
LEVEL 3
SITE SERVER
LEVEL 2
LINE CONTROLLER Mobile applications
MOBILE CLIENT
From controllers to
MES to ERP
PUBLIC
MOBILE APP
EIG
Holistic Serialization Solution
11/13/2015
Secure Cloud-based
central data storage for
serialized date
connectivity to support
consumer product
authentication
PMC
PEC
Serial number
generation management
PLC
Central communication
hub for supply
chain partners
OEMS
LEVEL 1
PRIMARY PACKAGING
CASE PACKAGING
PALLETIZER PACKAGING
AGGREGATION WORKSTATION
AGGREGATION WORKSTATION
AGGREGATION WORKSTATION
LEVEL 0
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
66
11/13/2015
Why Rockwell Automation
Turnkey Serialization Solution
•
Unique ability to provide all the key components
of a complete serialization solution
•
EPCIS certified Cloud-based serial number generation, management & event repository
•
Expertize in Level 3 – 4 integration (serialization site server to MES & ERP systems)
•
Packaging line serialization solution for all package types using open architecture
•
Supply chain applications to provide business benefits and a potential Return on Investment
•
Modular, reusable and scalable solutions
•
Solution built with Commercial-off-the Shelf (COTS) products and software
•
Proven technology & integration expertize with ERP & MES applications
•
Capability to provide internal and external supply chain tracking
•
Stable, global partner with global delivery and global support capabilities
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
67
11/13/2015
Why Rockwell Automation:
Global Support Centers
Global technical telephone support centers
Trained resources for deployment in 80 countries
Real-time response 24 / 7 /365
Cleveland / United States
Vancouver / Canada
Backup / Disaster Recovery
PUBLIC
Sao Paolo / Brazil
Milton Keynes / UK
Haan-Gruiten / Germany
Shanghai / China
Singapore
Melbourne / Australia
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
68
11/13/2015
Why Rockwell Automation:
Remote Serialization Application & Monitoring Support
Administration
Configuration & Change
Management
Knowledge
Management
Portal for all
reference information
Network
Design
Services
Surveillance
and Alarming
Infrastructure standards
and governance
Remote Asset &
Process Health
Monitoring
Serialization
Application
Support
TechConnect
PUBLIC
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
69
11/13/2015
Why Rockwell Automation:
Remote Serialization Application & Monitoring Support
Serialization
Application
Support
PUBLIC
Site Visit
Gather documentation, code
familiarization
Designated support team becomes
intimately familiar with your system
Real-time Serialization application-level support
Dedicated telephone and e-mail
Periodic performance reviews
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
70
11/13/2015
Why Rockwell Automation:
Remote Serialization Application & Monitoring Support
Surveillance
and Alarming
PUBLIC
Remote Asset and Process Health
Monitoring
Network and virtual infrastructure
Control process and infrastructure
Drive systems
Alarm acknowledgement in agreed
upon SLA’s
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
71
11/13/2015
Upcoming Events
Serialization in Action
Join us at this upcoming event to learn
more about Serialization
November 18-19, 2015
Automation Fair
PUBLIC
Chicago, IL
Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.
72