Leveraging PLM to achieve

REACH Compliance
Rajat Kaushal, Pranab K Ghosh

Abstract REACH is a new European community regulation on chemicals and their safe use. It deals with the Registration, Evaluation, Authorization and Restriction of chemical substances. Achieving REACH compliance is a challenge to businesses as well as to IT organizations relating to the chemical industry. A holistic view of REACH requirements shows that an integrated PLM backbone enables REACH compliance through various functionalities of PLM. This viewpoint shows how Infosys PLM based solution helps achieve REACH compliance in addition to faster time to market through process improvements during product creation, thus making REACH compliance not just a point reporting solution but "A step in the road to excellence". It gives an overview of the proposed solution framework and its implementation roadmap using Infosys proprietary PLM Maturity Model.

For more information, contact askus@infosys.com Jun 2009

Introduction
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) has been introduced in the European Union region (EU Region) by ECHA (European Chemical Agency) for chemicals used in industrial processes as well as in daily life. The primary objective of REACH is improving and protecting human health and environment from the risks posed by hazardous chemicals. Establishing a successful REACH compliance framework within an organization requires well-managed information, effective collaboration, traceability, robust processes for approvals and consistency across the organization. These are also the fundamental issues addressed by a PLM backbone. Hence this gives an opportunity for the Chemical Manufacturers or Importers to assess their Product Lifecycle Management (PLM) capabilities around product development and to redefine or restructure their processes, wherever needed, while becoming REACH compliant. Such process assessments and refinements also impact the overall Research and Development (R&D) costs and time to market new products. The restructured, refined and optimized processes subsequently help in producing green products that are not only more profitable, but also help address regulatory requirements upfront as responsible corporate citizens.
Figure 1: Areas of consideration for REACH and outcomes

Approvals

Consistency

Traceability

Product Time to Market

Collaboration

REACH CHEMICAL REGISTRATION

R&D Cost

ROBUST PRODUCT MANAGEMENT FRAMEWORK

Green Product

Cost Reduction Alternatives

Socially Faster Innovation Conscious Company Image

Infosys with its rich experience in the process industry and Product Lifecycle Management (PLM) processes and technologies has developed a unique solution framework for REACH compliance using the PLM backbone. As the factors influencing success of new initiatives vary between organizations, Infosys suggests a staged approach towards compliance rather than an out-of-the-box solution.

Business challenges posed by REACH

REACH regulation poses fresh challenges to various organizational entities:

Regulatory managers must establish REACH compliance processes, control mechanisms and organizational roles.

Supply chain managers have to manage their operations at the substance and entity level to prevent entry of noncompliant substances into the product through the supply chain.

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Procurement managers must establish new supplier relationships to ensure substance supply and compliance with increased levels of transparency and tracking. HR organizations are challenged in hiring and training personnel skilled in REACH along with capabilities for faster response in critical situations. R&D departments must revamp product lifecycle processes and reprioritize product portfolios based on the new competitive and customer service realities. Sales and marketing executives must respond to escalating customer demands and the opportunities that REACH compliance provides. Product managers have to manage pricing and market focus keeping in mind a cascading increase in the product costs and development lead times due to additional cost and process steps Need for enhanced IT systems for managing REACH business processes across stakeholders and support consortia of joint submission for dossiers.

Infosys PLM based solution for REACH compliance

Infosys REACH compliance solution framework is developed based on Integrated Product Lifecycle & Engineering Solution. This solution is designed considering the following:

Treating REACH as an opportunity for improvements in process compliance, product innovation and time to market Achieving REACH compliance as an objective during PLM implementation journey Process based integration to provide REACH compliance requirements involving reports and data Leveraging existing IT/ PDM/ PLM infrastructure Leveraging REACH compliance to achieve business excellence by facilitating collaboration with suppliers & customers

Infosys PLM based REACH Solution Framework focuses on collaboration among various functional entities such as Registration & Notification Management, Consortia Management, Interfaces with ECHA Tools (REACH-IT, IUCLID), Document management, Portfolio Management, Substance data management, Supply chain collaboration - as depicted in figure 2 below.
Figure 2: Functional Entities of REACH Compliance Solution

Registration
Workbench Team and consortia collaboration Project Management and monitoring

Supplier collaboration Customer Collaboration

Registration & Notification Mgmt Supply chain Collaboration collaboration monitoring

Questionnaire MSDS Shipment Substance Volume Substance Property

tracking tree

Research studies,
Test Results, Test Reports CSA/ CSR (Chem. Safety Assessment/ Report) Safety Data sheets GLP Reports Document Management

Registration tracking, Portfolio Mgmt, RMM

Data Maintenance & Mgmt

Usage and exposure Substance Inventory IUCLID Interface GLP Data RMM (Risk
Management Management Measures Management

Substance Portfolio
Management Cost revenue analysis Substance landscape monitoring Business Prioritization

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Infosys PLM based REACH solution framework proposes a PLM backbone (various integrated applications like LIMS, ELN, PDM etc.), integrated with supply chain functions and point integrations with REACH IT/ IUCLID applications. This framework can be governed by a dashboard with added functionality for risk monitoring. Figure 3 below gives a high-level conceptual view of Infosys integrated REACH compliance solution.
Figure 3: Conceptual View of Infosys Integrated REACH Compliance Solution

ERP Landscape

Supplier Legacy

PLM
Customer

SIEF

EH&S

Compliance System

Dossier Creation

Pre-Registration

Dashboard and Risk monitoring

Monitoring

IUCLID 5 Registration & Approval

ECHA (REACH-IT)

Holistic SOA based PLM approach integrating various tools (LIMS,

ELN, PDM etc.), creating a PLM backbone, supporting Supply Chain functions and enabling REACH solution

Infosys PLM based solution for REACH compliance

Process based integration to provide REACH compliance

requirements (reports/ data) without base technology change minimal process disruption

Rapid, future proof and reusable building block based architectural

solution

Package & Product agnostic solution framework Leverage existing PLM/IT infrastructure to provide cost-effective and
scalable solution

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Implementing Infosys PLM based REACH solution

Infosys suggests a phased approach to implement the REACH compliance solution.
Figure 4: Phased Implementation Approach

PLM Diagnostic

PLM Strategy, Planning and Initiation

PLM Execution and Ownership

PLM CoOwnership & Continuous Improvement

Customer As-Is
Scenario Alignment

Detailed
Implementation Plan

Process
Implementation

Continuous
Improvement

High Level
REACH Implementation Plan

Key entities like

SMEs, scope, timeline etc. identification

IT System
enablement

System
Maintenance

REACH Solution has to align to your Business, Process and Existing Landscape There is no Standard Solution that works for all - Hence the need for a diagnostic phase

PLM diagnostic phase (typically with a duration of few weeks) focuses on analyzing the organization's robustness for setting up REACH compliance framework. Some key aspects that will be looked into during this phase are as-is regulatory framework, stakeholders, supporting systems & infrastructure, organizational future goals, PLM Maturity level and key business processes. The diagnostic phase will be followed by PLM Strategy planning and Initiation stage, wherein detailed implementation plan is developed. The gating criteria, various phases, scope, stakeholders, subject matter experts (SMEs), risks and timelines for the entire implementation are some key entities that are looked into during this stage. The solution is implemented as per the roadmap and plan developed in the PLM execution and ownership phase. The organizational role in this stage is to provide the experts with detailed requirements and access to process repository and infrastructure. The final stage is aimed at bringing the organizational stakeholders and Infosys in a co-ownership model where continuous improvement of the organizational processes is the focus.

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Infosys PLM maturity model- REACH Compliance, a step to Excellence

Infosys emphasizes that REACH compliance can be effectively achieved with a comprehensive approach to PLM. The effectiveness and the ROI of the solution depend on the PLM maturity level of the organization. The Infosys PLM maturity model (IPMM) with respect to REACH is depicted in the figure 5 below.
Figure 5: Infosys PLM Maturity Model

Value

Characteristics
Intelligent response and decision execution Inter and intra enterprise event and business process management Supply chain decision support and workflow automation Dynamic intra-enterprise information exchange for efficient decision based activity Flexible loose coupled just in time process based integration between entities Extended enterprise process re-alignment and data
exchange Event based process management External Data sharing and visibility

REACH Global Data repository for tests Process improvement for faster time to market
Excellence
reduction and quality improvement

Comply & Excel

Dossier Preparation/
Optimize/ Comply

Tracking, test requests

response, test proposals

Submission

Extended enterprise collaboration (Supplier,

Information\Process Management

Integration based on Processes Data exchange for higher process productivity Efficient process tracking and management Intra enterprise data exchange automation PLM (PDM, LIMS, ELN) integrated to ERP functions Rudimentary level Collaboration Process uniformity Usage of PDM, ELN, Standardize
LIMS tools Established Protocols

customer)

Collaborate

Supplier/ Customer Collaboration Prod./ Proj./ Portfolio mgmt SDS and Specification exchange and
optimization

Recipe Mgmt tightly integrated with ELN, LIMS and

Automate

REACH substance identification IUCLID Integration, Substance Volume Tracking

ERP functions

EH&S for specification mgmt ELN, LIMS for experiments/ lab-trials

management

Manual Local network,

scattered teams

Manual/ Ad hoc

Compositions, specifications managed in office Lab experiments', analytical tests' results

recording paper/ office tools based tools

Time

Conclusion
The Infosys Integrated PLM solution for REACH compliance, enabled through its proprietary methodology of PLM maturity model, provides a holistic approach using the PLM backbone. It gives an opportunity for organizations to enable more transparency, traceability, effectiveness and efficiency in their product development processes, and to remove hidden cost components by restructuring and optimizing their PLM processes. The framework can help systematically prepare the organization towards REACH compliance and process improvement initiatives in a staged approach, thus avoiding the resistance to changes that could arise from people, process, and systems perspective. The benefit of the solution can be realized better if it is viewed as an enabler for driving innovation, collaboration in upstream/downstream processes and transformation of the organization towards achieving "green" objectives, rather than just a tool for meeting REACH reporting requirements.

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Abbreviations
REACH Registration, Evaluation, Authorization and Restriction of Chemicals ECHA PLM SIEF OEM RM M GLP MSDS EHS SVHC ERP SOA Enterprise Resource Planning Service Oriented Architecture REACH-IT is the central online workflow-system of the European Chemicals Agency European Chemical Agency Product Lifecycle Management Substance Information Exchange Forum Original Equipment Manufacturer Risk Management Measures Good Laboratory Practice Material Safety Data Sheet Environmental Health and Safety Substance of Very High Concern SVT EAI TCO IPMM SME IUCLID PDM ELN LIMS Product Data Management Electronic Lab Notebook Laboratory Information Management System Substance Volume Tracking Enterprise Application Integration Total Cost of Ownership Infosys PLM Maturity Model Subject Matter Experts International Uniform ChemicaL Information Database

Further Reading

http://en.wikipedia.org/wiki/Registration,_Evaluation,_Authorisation_and_Restriction_of_Chemicals http://ec.europa.eu/enterprise/reach/ http://echa.europa.eu/reach_en.asp http://iuclid.eu/ http://www.unece.org/trans/danger/publi/ghs/implementation_e.html https://webinsight.arielresearch.com/

About the Authors

Rajat Kaushal is a Business Manager in Product Lifecycle and Engineering Services at Infosys. He can be reached at rajat_kaushal@infosys.com Pranab K Ghosh is a Senior Consultant in Product Lifecycle and Engineering Services at Infosys. He can be reached at pranab_ghosh@ .com

To know more about Infosys' PLM service offerings, please visit: http://www.infosys.com/engineering-services/lifecycle-management/serviceofferings/default.asp

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