Safeguarding Chemical Regulations Compliance throughout the Supply Chain

Safeguarding Supply Chain Chemical Compliance with

Robust Management System Processes

Malcolm Pollard – CEO, Baytouch Ltd

©Baytouch Ltd 2014

2 ©Baytouch Ltd 2014

“Why do people hate the word 'chemicals'?”

With acknowledgement to Dr Mark Lorch and his Four

Thought piece on BBC Radio 4 on Wednesday 27 November

http://www.bbc.co.uk/news/magazine-25103941

Or download the Four Thought podcast

http://downloads.bbc.co.uk/podcasts/radio4/fourthought/f

ourthought_20131127-2100a.mp3 (UK only)





http://downloads.bbc.co.uk/podcasts/radio4/fourthought/fourthought_20131127-2100a.mp3





Agenda


Baytouch

The regulatory affairs climate

Managing Supply Chain Chemical Compliance

Solutions

About Baytouch


Based in East Lancashire with clients in the UK, EU and N America

Cloud-based IT provider of regulatory management and compliance solutions:

ReachSuite: For company Lead Registrants and REACH Consortia with SIEF Management / Communications, SIEF cost allocation and sharing with online Letters of Access Contracts

PSMmonitor: Workplace Safety - EHS and PSM in high hazard chemical handling sites

ProductTraq: Product regulatory data storage and management solution

Common thread is “robust”, information-rich change management solutions

Clients and Partners


Large, influential trade associations leading REACH registrations

Lower Olefins, Higher Olefins, CONCAWE, European Aluminium, Polyester Monomers, Petrol Additives, Grease Thickeners, etc.

Lead registrant and chemical-using corporate clients

Kemira, IFF, Kimberly Clark, Shell, Eastman, Arkema

Consultancy Services and Expertise Partners

Caleb Management Services, Ernst & Young (Netherlands), Jongerius Consult, Penman Managed Services, WSP Environmental

Cloud-based solutions with tens of thousands of users and <2 hours unplanned downtime in the last 365 days

Chemical Industry Trends


1970s

Bulk chemical manufacture predominates

Small number of large companies making everything

― Centralised regulatory affairs resource

1980s

Speciality chemicals

Post-Bopal, Responsible Care and Process Safety Management start to take hold

1990s

Downsizing/rightsizing to adjust to the rise of the east

Quality Management / Assurance, Responsible Care et al become entrenched

2000s

MBOs/MBIs, divestments and the emergence of VC power

Industry fragmentation to VCs resulting in lots of small companies making “a few things”

― Loss of technical resource

2010 onwards

Advent of REACH and global regulatory uptake – the decade of the Regulatory Affairs consultant..?

Chemophobia!


Orange Juice E300 – vitamin C by

any other name

• There is no such thing as “chemical-free”

• SO DEAL WITH IT!

10

“… beginning in January 2015, it would require

suppliers to disclose ingredients online for items

sold at its stores,, and In January 2016, it would

begin to report publicly on what progress is being

made.”

©Baytouch Ltd 2014

REACH Article 33 and Procurement

Standards as Drivers


“..Knowledge is in the hands of the supplier,

- power is in the hands of the customer.”

Customer drivers -

Reduce business risk

Minimise environmental impacts

Improve corporate image as a global citizen

Regulatory Needs & Challenges


Objectives:

Speed to market

Compliance assurance

Risk management

Dependencies:

Management of all compliance declarations from suppliers

Supplier qualification: e.g. questionnaires

Coordination of all information to produce a declaration of compliance for the finished product

Challenges:

Complexity of global requirements

Change management of requirements

Change management of declarations

Supply Chain Compliance Transparency

What Information required to validate product compliance

How does THIS translate to product compliance

How is it updated / maintained

Benchmarks, supplier trust rankings, KPIs, etc.

Processes to ensure all compliance information is

collected, validated, stored and current

Management of Change

Processes are key!


Collect Supplier

Documents

Review Certs /

Declarations

Produce

Compliance

Documents

Manage Change

Process status


Processes are frequently manual

Often within a small regulatory team

Supplier information formats inconsistent – manual

and/or electronic

Periodic updates are often required, which may not be

automatic!

“We bother them until we get what we want…”

Consolidated overview of compliance status sometimes

hard to discern – and metrics not easily acquired

Process aspirations


Collect, store and update supplier information as well as testing results would be a start

And flexible enough to collect supplier data in all sorts of formats

Management of Change would keep the business in step with requirements

Information shareable internally and with trusted service providers

Compatibility with enterprise systems is desirable

De-skill as many processes as possible to free up high value regulatory expertise

Dedicated to the Regulatory Team


– or the hard-pressed individual!

As the list of chemicals of concern grows,

How will you check that your business is on track?

What will your REACH compliance statement actually mean?

Will you have sufficient information to support your Article

33 declarations?

How will you deal with the changes to the Candidate List?

What will you do if something goes wrong?

SVT – how will you efficiently and accurately capture

substance import volumes

ReachSuite evolved into ProductTraq


ReachSuite ProductTraq

Large scale Substance

Management across in-house

teams and Service Providers

Product Management portfolio –

substances, mixtures, polymers,

articles (in-house teams and

Service Providers)

Document store and Proprietary

Information for dossier compilation

Store and manage declarations,

SDS, supplier/SC communications

SIEF Portal - large scale

communications, surveys and

information exchanges to/from

SIEF members

Suppliers Portal - large scale

product formulation and

declaration requests to/from

suppliers

Action tracking, change

management and version control

Action tracking, change

management and version control

ProductTraq sector functionality


Bill of Substances


Chemicals by CAS, EC or EC name

Total substance volumes across all Products

Also accommodate articles, packaging and other

unclassified product volumes

Exclusions for OR-managed substances

Automated comparison against SVHC Candidate List,

SIN List or any other defined list and become proactive

Formulations - supplier data entry


IT Integration Options

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“Open” interfaces for integration

Excel/CSV file import and export at a simplistic level

Web Services Description Language (WSDL) for more comprehensive integration with ERP

Secure IT Platform

Secure Virtualised servers, SSL connections

Hashed and salted password encryption

Backups at ISP, at Baytouch

Cloud solutions since 2008

<2hrs unplanned downtime in last 365 days

100,000+ registered users supported

©Baytouch Ltd 2014

Conclusions

22

Systematic approaches to request and receive supplier

information:

Increase response levels to information changes

Improve change management

Support best practices and demonstrate leadership in

chemical handling management

Institute Compliance dashboard leading to supplier

benchmarking

Lower risk which promotes corporate sustainability and a

positive image

©Baytouch Ltd 2014

Safeguarding Chemical Regulations Compliance throughout the Supply Chain

Business

Transcript of Safeguarding Chemical Regulations Compliance throughout the Supply Chain