Holistic Serialization Solution - Rockwell Automation · Title: Click to Add Title, Arial 30pts Author: Shannen Oesterreich Subject: Rockwell Automation Keywords: Rockwell Automation

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PUBLIC - 5058-CO900H Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.

Holistic Serialization Solution

Rockwell Automation

Joe Whyte

Global Serialization Lead

1

Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.PUBLIC

Agenda

Serialization Implementation Challenges & Solutions

Why Serialize

What is Serialization

The Future of Serialization – Connected Enterprise

Why Rockwell Automation

2


Serialization Requirements

3

Blister Pack (Unit) Bundle Case Pallet

8305254961 4693602591

8305254961

1112131415

4693602591

8305254961

1452267440

1112131415

4693602591

8305254961

Human readable unique serial number

On each package (USA)

On primary package (EU)

Aggregation of all primary package serial

numbers to their lower level sub-package

serial numbers in parent/child relationships

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=j4NlrNlMZcZXpM&tbnid=Oi2K3cHvJEhUVM:&ved=0CAUQjRw&url=http://www.rockwellautomation.at/applications/gs/emea/GSEMEA.nsf/pages/ls_symposium_09_serialization_workshop&ei=8uNTUuf4MYLC4AO7woDABw&bvm=bv.53537100,d.dmg&psig=AFQjCNHOR5k38NoH7QX9JHKwhgUOP1iaPQ&ust=1381315946017278



Serialization Requirements

SupplierWarehouse

Manufacturer

Distribution CenterPharmacy

Raw Materials

Finished Goods

Central Database(What? When? Where? Why?)

Real world goods EPC / Barcode data

GenerateAcquire, Manage UID for

each saleable item

AggregatePackage level serial

numbers in Parent/Child

Data relationships

StoreCode information in a

secure database

Track & TraceTrack & trace raw

materials

AssociateCode information when

dispatching products

ScanCodes to verify

authenticity of product

ValidateSerialization data matches

the physical product received

TrackStatus of dispensed

items to prevent re-use of

serial numbers

ConfirmThat products have

complete and accurate

documentation



Agenda


Why Serialize




6


Market Trends:Global Medicinal & Food Product Safety

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

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.

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=ub_zjilegJbi-M&tbnid=4BoA-qNb3-OdWM:&ved=0CAUQjRw&url=http://spotlightenglish.com/listen/counterfeit-drugs-dangerous-medicine&ei=GbRTUsr8DJe14APVj4CQDw&psig=AFQjCNGumDcCEL6zxdl9cYW7tqkHyKKY0A&ust=1381303280325687

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=ub_zjilegJbi-M&tbnid=4BoA-qNb3-OdWM:&ved=0CAUQjRw&url=http://spotlightenglish.com/listen/counterfeit-drugs-dangerous-medicine&ei=GbRTUsr8DJe14APVj4CQDw&psig=AFQjCNGumDcCEL6zxdl9cYW7tqkHyKKY0A&ust=1381303280325687

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=VlWAy1MLKEOs1M&tbnid=hockJjIbZKH1GM:&ved=0CAUQjRw&url=http://money.cnn.com/2012/09/27/news/economy/counterfeit-goods/index.html&ei=KbNTUsC_DvLB4AO8tIGgBA&bvm=bv.53537100,d.dmg&psig=AFQjCNF5fBClu5qz7SpI1jQB3F--I4ax9w&ust=1381303430978635

http://www.google.ie/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=VlWAy1MLKEOs1M&tbnid=hockJjIbZKH1GM:&ved=0CAUQjRw&url=http://money.cnn.com/2012/09/27/news/economy/counterfeit-goods/index.html&ei=KbNTUsC_DvLB4AO8tIGgBA&bvm=bv.53537100,d.dmg&psig=AFQjCNF5fBClu5qz7SpI1jQB3F--I4ax9w&ust=1381303430978635


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

AdministrationBrazilian 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.

8


Sta

tus

Country Co

dif

icat

ion

Ser

ializ

atio

n

Ag

gre

gat

ion

Tam

per

Evi

den

t

Oth

er

Reg

ula

tio

ns

Deadline Scope

China December 2015 2012/13 EDL list*

India July 2014 All Rx drugs - Exports

Nigeria October 2014 Anti-Infective drugs

Denmark January 2014 All Pharmaceutical Products

Algeria January 2015 All Pharmaceutical Products

Korea January 2015 All Rx drugs

U.S. (Phase 1) January 2015 All Rx drugs

Slovenia January 2015 All Rx drugs

Saudi Arabia (Phase 1) May 2015 All Rx drugs

Japan July 2015 All Rx drugs

Brazil (Phase 1) December 2015 All Pharmaceutical Drugs

- Final Regulation - Pending final approval *EDL: Essential Drug List

Regulatory Timelines

9


LEVEL 1

LEVEL 5

MOBILE APP EPCIS

MES ERP

EIG

EIG

EIG

SITE SERVER

LINE CONTROLLER

CONSUMER

AUTHENTICATION

(BRAND LOYALTY)

EPCIS CERTIFIED

CLOUD BASED

EVENT REPOSITORY

CONSUMER

AUTHENTICATION

(BRAND LOYALTY)

BACKEND PMC

MOBILE CLIENT PEC

PLC

LEVEL 4

LEVEL 3

LEVEL 2

Holis

tic S

erializ

ation S

olu

tion

LEVEL 0

OE

MS

12

PRIMARY PACKAGING AGGREGATION WORKSTATION

CASE PACKAGING AGGREGATION WORKSTATION

PALLETIZER PACKAGING AGGREGATION WORKSTATION

Brazil – 3 batches from plant to consumer by Dec 2015

– Full traceability of all products by Dec 2016

Manually packed

L0 – L2 modular solution

Deploy & Run in 2-3 Days

Temporary Azure Cloud

database to track 3

batches from plant to retail

Cloud Serial number

generation management &

provisioning to packaging

Central communication hub

for Web portal data entry by

supply chain partners

Rockwell Automation’s Proof of Principal Model for Brazil Dec 2015 Deadline


Why Serialize?

Business Category Business Benefit

CONSUMER SAFETY/BRAND PROTECTION

• Regulatory compliance

• Product adulteration control

• Diversion source & location control

CUSTOMER SERVICE & RETURNS PROCESSING

• Authenticate transactions

• Improve chargeback payment accuracy

SUPPLY CHAIN INTEGRITY

• Complete Supply Chain Traceability

• Increase recall accuracy & efficiency

• Direct to customer notifications

SUPPLY CHAIN OPTIMIZATION

• Improve forecasting

• Optimize inventory

• Improve supply chain planning

MARKETING & BRAND LOYALTY PROGRAMS

• Real time consumer & product market data

• Customer specific target marketing programs

• Consumer authentication via mobile device

BUSINESS OPTIMIZATION –CONNECTED ENTERPRISE

• Share data across departments: Sales, Marketing, Finance, Operations, Supply Chain, etc.

13


Agenda


Why Serialize




14


LEVEL 1

LEVEL 5

LEVEL 4

LEVEL 3

LEVEL 2

LEVEL 0

OE

M

IMP

LE

ME

NT

AT

ION

CH

AL

LE

NG

ES

Operational Challenges for Data Generation & Acquisition• Uniqueness of applied numbers (preferred randomized)• Physical product limitations (limited space, different pack. materials)• Wide range of products, formats, country requirements, packaging line

types

Data Integration & Data Management• High amount of data• Printing and verification in a high speed environment

Data Accessibility & Management (Level 3)• Data security• Data exchange with external partners and interfaces between systems• Data consistency, Data redundancy, Data Ownership, Master data

Scalability in Supply Chain• Scalable serialization solution to support distributed operations:

manufacturing, distribution, warehouse, pharmacy• How to manage additional lines? Countries? Formats? Regulations?

15


Operational Challenges

Line Integration Challenges

1. Different Controllers

2. Proprietary Platforms

3. Different Protocols

4. Proprietary Networks

5. Proprietary Communications

6. Custom Drivers Maintained by Users

PalletizingCase PackingBundlingCartoningPRINT & VERIFY INSPECT, CONFIRM,

PRINT & VERIFY

INSPECT, CONFIRM,

PRINT & VERIFY

INSPECT, CONFIRM,

PRINT & VERIFY

IMPLEMENTATION CHALLENGES (LEVEL 0 – LEVEL 1)

LEVEL 1

PRIMARY PACKAGING AGGREGATION WORKSTATION

CASE PACKAGING AGGREGATION WORKSTATION

PALLETIZER PACKAGING AGGREGATION WORKSTATION

Serialization Unit Controllers

Serialization Level 0 - OEM Machines, Printers & Vision Systems

LEVEL 0

OE

M




• 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

Commercial Off-The Shelf Technology

19

IMPLEMENTATION SOLUTION (LEVEL 0 – LEVEL 1)



ER

P LEVEL 4INTERNAL SUPPLY (ENTERPRISE) CHAIN

SHOP FLOOR A1

PALLETIZERCASE PACKERBUNDLERCARTONER

Line A1-1

LEVEL 2

LEVEL 0,1

B2 C1B1A2

SH

OP

FL

OO

RE

PC

IS

EXTERNAL SUPPLY CHAINWHOLESALER PHARMACIST

EPCIS EVENT REPOSITORY

20

Data Integration & Data Management

ContractorPlant BPlant A

LEVEL 3

SIT

E

GTINSSCCBatch number

Line configuration Unit configuration

Serial range

Label LayoutPrint data

Verification data

DM data

Order number

EPC data

Packaging size

Alarms

Order status

OEE dataEPC event

Produced quantityOrder startOrder end

GTIN SSCCSSCC

Batch number

Serial number

Serial number

Expiry date

Expiry date

Prod. date

Prod. date

EPC data EPC event

AlarmsOEE data

Order number Order status Produced quantityOrder startOrder end

Serialization-relevant data is widely distributed over differentAutomation and Information Systems at different ISA-95 levels!


ER

PE

PC

IS

LEVEL 4

INTERNAL SUPPLY (ENTERPRISE) CHAIN

EXTERNAL SUPPLY CHAINWHOLESALER PHARMACIST

EPCIS EVENT REPOSITORY

PALLETIZERCASE PACKERBUNDLERCARTONER

Line A1-1

LEVEL 2

LEVEL 0,1

B2 C1SHOP FLOOR A1 B1A2

SH

OP

FL

OO

R

21

Data Convergence (ISA-88 aligned data model)

ERP INTEGRATION GATEWAY

LEVEL 3SITE SERVER

SIT

E

GTINSSCCBatch numberSerial rangeSerial numberExpiry dateProd. datePrint dataDM dataLabel LayoutVerification dataLine configurationUnit configurationPackaging sizeEPC dataEPC eventAlarmsOEE dataOrder numberOrder statusOrder startOrder endProduced quantityDelivering the right data to the right place at the right time!


Copyright © 2015 Rockwell Automation, Inc. All Rights Reserved.PUBLIC 22

Data Accessibility and Management

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



Open Architecture

J2EE – proven technology for mission-

critical enterprise applications

Security and stability

Scalability without limits

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

High data volumes, high throughput

Many users accessing data concurrently

Complex business logic

Scalability



Integration with ERP Business Systems

Serialization Module

IMPLMENTATION SOLUTION (LEVEL 3– Level 4)IMPLEMENTATION SOLUTION (LEVEL 2 – LEVEL 4)


Supply ChainIMPLEMENTATION CHALLENGES (LEVEL 5)

26

Sao Paulo CDC

Brasilia RDC

EPCIS Certified Event Repository on

Microsoft Azure

RDC’s

ManufacturingConsumers

Product FlowData FlowCDC – Central Distribution Center

RDC – Regional Distribution Center

Consumers

Brazil - Dec 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 EPC-related data sharing, both within and across enterprises.


EDI or EPCIS for DSCSA

© RC Partners 2015 28

EDI … ASNs:

• 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

EPCIS:

• For 2015 requirements: • 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


What is EPCIS?Purpose built – Flexible - Extensible

© RC Partners 2015 29

Com-

mission Pack Ship Rcv Unpack Pack

Dispense

Destroy

Decommission

Rcv Unpack <<Ship <<<<<<<

Manufacturer Distributor(s) Dispenser

DSCSA Data DSCSA Data

EPCIS includes the

ability to query or

ask for information:

1

2

3

All events for Item

“00312345325671”?

• Commissioning Event

• Packing Event

• Shipping Event

EPCIS was purpose built for Track & Trace

1. Extensible “events” and “Dispositions”

2. May Extend Information for:

Geographies

Industries

Trading Partners

3. Includes Query functionality


Forward/Reverse Logistics

30

Checking Service

Checking Service

Refund

Awarded

Manufacturing Distribution Center Retail

EPCIS

Event Repository

A

Event Event Event

Event

Flow of Goods Flow of Goods

Product(s)

Forward Logistics:1. Distribution Center

2. Retailer

3. Customer

Reverse Logistics:1. Customer Not Satisfied

2. Faulty Order

3. Overstock

4. End of Life

5. Recalls

Reverse Logistic Partner Retail

IMPLEMENTATION CHALLENGES (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

Supply Chain ApplicationsIMPLEMENTATION SOLUTION (LEVEL 5)


Serialization Event Repository Database

33

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.

IMPLEMENTATION SOLUTION (LEVEL 5)


Scalable Supply Chain Connectivity Model

34

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

IMPLEMENTATION SOLUTION (LEVEL 5)


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

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

Support & Maintainability Challenges


Internet Process

Firewall

IndustrialSecurity Zone

Cell/Area Zone

VSE- Remote Access

Remote Serialization Application & Monitoring Support

http://images.google.com/imgres?imgurl=http://upload.wikimedia.org/wikipedia/commons/thumb/4/4c/US_Department_of_Homeland_Security_Seal.svg/360px-US_Department_of_Homeland_Security_Seal.svg.png&imgrefurl=http://commons.wikimedia.org/wiki/Image:US_Department_of_Homeland_Security_Seal.svg&h=359&w=360&sz=82&hl=en&start=1&usg=__g68ZxZ1Czwnbm-C8k0D2deynJXk=&tbnid=fqr03iu-bFLMmM:&tbnh=121&tbnw=121&prev=/images?q=department+of+homeland+security&gbv=2&hl=en

http://images.google.com/imgres?imgurl=http://upload.wikimedia.org/wikipedia/commons/thumb/4/4c/US_Department_of_Homeland_Security_Seal.svg/360px-US_Department_of_Homeland_Security_Seal.svg.png&imgrefurl=http://commons.wikimedia.org/wiki/Image:US_Department_of_Homeland_Security_Seal.svg&h=359&w=360&sz=82&hl=en&start=1&usg=__g68ZxZ1Czwnbm-C8k0D2deynJXk=&tbnid=fqr03iu-bFLMmM:&tbnh=121&tbnw=121&prev=/images?q=department+of+homeland+security&gbv=2&hl=en


Agenda


Why Serialize




37


The Connected Enterprise

38

• Real time product

consumption &

demographic data

• Customer buying behavior

information

• Brand protection, brand

loyalty, compliance….

Prediction All manufacturers will serialize

their products within 10 years

BUSINESS BENEFITS

• 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

BIG DATA

• A company’s serialization

data, when used to optimize

the way a business

operates, will become one

of its most valuable assets

“INTERNET OF EVERYTHING”


Agenda


Why Serialize




39


Why Rockwell AutomationTurnkey 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

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Holistic Serialization Solution - Rockwell Automation · Title: Click to Add Title, Arial 30pts Author: Shannen Oesterreich Subject: Rockwell Automation Keywords: Rockwell Automation