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Safeguarding Supply Chain Chemical Compliance with
Robust Management System Processes

Malcolm Pollard – CEO, Baytouch Ltd

©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)

2

©Baytouch Ltd 2014
Agenda


Baytouch



The regulatory affairs climate



Managing Supply Chain Chemical Compliance



Solutions

3

©Baytouch Ltd 2014
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:




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





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

ProductTraq: Product regulatory data storage and management
solution

Common thread is “robust”, information-rich change
management solutions
4

©Baytouch Ltd 2014
Clients and Partners


Large, influential trade associations leading REACH
registrations




Lead registrant and chemical-using corporate clients




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

Consultancy Services and Expertise Partners




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

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
5

©Baytouch Ltd 2014
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..?

6

©Baytouch Ltd 2014
Chemophobia!

Orange Juice

E300 – vitamin C by
any other name

• There is no such thing as “chemical-free”
• SO DEAL WITH IT!
7

©Baytouch Ltd 2014
8

©Baytouch Ltd 2014
9

©Baytouch Ltd 2014
“… 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.”

10

©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

11

©Baytouch Ltd 2014
Regulatory Needs & Challenges


Objectives:



Compliance assurance





Speed to market
Risk management

Dependencies:



Supplier qualification: e.g. questionnaires





Management of all compliance declarations from suppliers
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
12

©Baytouch Ltd 2014
Processes are key!


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
Collect Supplier
Documents

Produce
Compliance
Documents

Review Certs /
Declarations
13

Manage Change

©Baytouch Ltd 2014
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

14

©Baytouch Ltd 2014
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
15

©Baytouch Ltd 2014
Dedicated to the Regulatory Team
– or the hard-pressed individual!


As the list of chemicals of concern grows,



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?





How will you check that your business is on track?

What will you do if something goes wrong?

SVT – how will you efficiently and accurately capture
substance import volumes
16

©Baytouch Ltd 2014
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
17

©Baytouch Ltd 2014
ProductTraq sector functionality

18
©Baytouch Ltd 2014
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

19

©Baytouch Ltd 2014
Formulations - supplier data entry

20

©Baytouch Ltd 2014
IT Integration Options


“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
21

©Baytouch Ltd 2014
Conclusions


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

22

©Baytouch Ltd 2014
Questions

23

©Baytouch Ltd 2014

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Safeguarding Chemical Regulations Compliance throughout the Supply Chain

  • 1. Safeguarding Supply Chain Chemical Compliance with Robust Management System Processes Malcolm Pollard – CEO, Baytouch Ltd ©Baytouch Ltd 2014
  • 2. “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) 2 ©Baytouch Ltd 2014
  • 3. Agenda  Baytouch  The regulatory affairs climate  Managing Supply Chain Chemical Compliance  Solutions 3 ©Baytouch Ltd 2014
  • 4. 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:   PSMmonitor: Workplace Safety - EHS and PSM in high hazard chemical handling sites   ReachSuite: For company Lead Registrants and REACH Consortia with SIEF Management / Communications, SIEF cost allocation and sharing with online Letters of Access Contracts ProductTraq: Product regulatory data storage and management solution Common thread is “robust”, information-rich change management solutions 4 ©Baytouch Ltd 2014
  • 5. Clients and Partners  Large, influential trade associations leading REACH registrations   Lead registrant and chemical-using corporate clients   Kemira, IFF, Kimberly Clark, Shell, Eastman, Arkema Consultancy Services and Expertise Partners   Lower Olefins, Higher Olefins, CONCAWE, European Aluminium, Polyester Monomers, Petrol Additives, Grease Thickeners, etc. 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 5 ©Baytouch Ltd 2014
  • 6. 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..? 6 ©Baytouch Ltd 2014
  • 7. Chemophobia! Orange Juice E300 – vitamin C by any other name • There is no such thing as “chemical-free” • SO DEAL WITH IT! 7 ©Baytouch Ltd 2014
  • 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.” 10 ©Baytouch Ltd 2014
  • 11. 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 11 ©Baytouch Ltd 2014
  • 12. Regulatory Needs & Challenges  Objectives:   Compliance assurance   Speed to market Risk management Dependencies:   Supplier qualification: e.g. questionnaires   Management of all compliance declarations from suppliers 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 12 ©Baytouch Ltd 2014
  • 13. Processes are key!  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 Collect Supplier Documents Produce Compliance Documents Review Certs / Declarations 13 Manage Change ©Baytouch Ltd 2014
  • 14. 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 14 ©Baytouch Ltd 2014
  • 15. 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 15 ©Baytouch Ltd 2014
  • 16. Dedicated to the Regulatory Team – or the hard-pressed individual!  As the list of chemicals of concern grows,   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?   How will you check that your business is on track? What will you do if something goes wrong? SVT – how will you efficiently and accurately capture substance import volumes 16 ©Baytouch Ltd 2014
  • 17. 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 17 ©Baytouch Ltd 2014
  • 19. 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 19 ©Baytouch Ltd 2014
  • 20. Formulations - supplier data entry 20 ©Baytouch Ltd 2014
  • 21. IT Integration Options  “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 21 ©Baytouch Ltd 2014
  • 22. Conclusions  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 22 ©Baytouch Ltd 2014