Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs ©baytouch ltd2014
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Presented by Baytouch CEO, Malcolm Pollard, at Chemspec Europe 2014 in Budapest. In this presentation Malcolm examines the challenges facing chemical handling companies in keeping regulatory data up-to-date, accessible and accurate in an era where failing to do so can considerably impact their licence to operate.
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Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs ©baytouch ltd2014
- 1. Responsibly Managing Supply Chain Chemical Compliance Malcolm Pollard – CEO, Baytouch Ltd © Baytouch Ltd 2014
- 2. Agenda Baytouch Supply Chain challenges Solutions 2© Baytouch Ltd 2014
- 3. About Baytouch Based in Manchester, England with UK, EU and USA clients 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 to what Baytouch does is “robust”, information-rich change management regulatory affairs solutions 3© Baytouch Ltd 2014
- 4. 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 4© Baytouch Ltd 2014
- 5. Chemical IndustryTrends 1970s 1980s 1990s 2000s 2010 onwards Bulk chemical manufacture predominates Small number of large companies making everything Centralised regulatory affairs resource Speciality chemicals Post-Bhopal, Responsible Care and Process Safety Management evolve Downsizing/rightsizing to adjust to the rise of the east Quality Management / Assurance, Responsible Care et al become entrenched 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 The rise of REACH and global regulatory uptake – the decade of Regulatory Affairs..? 5© Baytouch Ltd 2014
- 6. Statement of the obvious… REACH is burdensome! And so are the many other emerging and evolving formal and “informal” regulatory drivers: • e.g. China, Korea, etc. and NGO black lists such as the ChemSec SIN List, California DTSC and others REACH is here to stay and needs to be in the core of your business processes Size is irrelevant 6© Baytouch Ltd 2014
- 7. But I’m a (small?)Downstream User (DU), what has REACH got to do with me? No duty to register products - not classed as a manufacturer BUT not removed from duties under REACH Participation in supplying information up and down the supply chain Only use substances registered with your intended uses Provide Safety Datasheets (SDS) with your products Ensure supplier SDS are made available to all who need them Implement the necessary Risk Management Measures (RMM) 7© Baytouch Ltd 2014
- 8. Compliance Challenges Multiple SDS from different suppliers of the same product • Review and re-edit before making available to customers Managing multiple conformity declarations • By supplier; product; batch; etc. • Could include SVHC presence (Article 33), Intermediates status (REACH Article 17/18), Conflict Mineral, Halal and Kosher, ROHS, WEEE, etc. Cyclic activity examples • SVHC Candidate list updated 6-monthly • Halal, Kosher only valid for 12 months 8© Baytouch Ltd 2014
- 9. Spreadsheets & filing cabinets… 9© Baytouch Ltd 2014 Hardly translates into “Best Available Technology” Fast forward 5 years…..a Competent Authority Inspection
- 10. Robust 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 ensuring all compliance information is collected, validated, stored and current, and communicated effectively Structured data storage and management with robust Management of Change processes 10© Baytouch Ltd 2014
- 11. Typical Current Processes Small regulatory team Frequently manual processing Supplier information formats inconsistent – manual and/or electronic Periodic updates often required, probably not automated! • “We bother them until we get what we want, if we can remember…” Consolidated overview of compliance status hard to discern, metrics not easily acquired 11© Baytouch Ltd 2014
- 12. 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 or 17/18 declarations? (SVHC, Intermediates) • How will you deal with the changes to the Candidate and other Lists? • What will you do if something goes wrong? SVT – how will you efficiently and accurately capture substance import volumes 12© Baytouch Ltd 2014
- 13. Efficient processes to focus on Collect, store and update supplier information as well as product specs and testing results would be a start • Flexibility to collect supplier data in multiple formats • “Management of Change” to keep the business aligned with its compliance requirements Information securely shareable internally and with trusted service providers, stakeholders and supply chain Compatibility with enterprise systems is desirable De-skill as many processes as possible to free up high value regulatory expertise 13© Baytouch Ltd 2014
- 14. 14© Baytouch Ltd 2014
- 15. Short term pain versus long term gain Regulatory Affairs are rapidly becoming key to business’ licence to operate (both to manufacture and to sell) Businesses that excel at managing regulatory affairs will grow at the expense of others that don’t Business systems and document management must accommodate and integrate Regulatory Affairs to survive and prosper: Procurement - Manufacturing - Sales and Marketing - R&D - Strategic Planning 15© Baytouch Ltd 2014
- 16. Conclusions Structured document handling and systematic approaches are necessary for requesting, receiving and forwarding supply chain information: • Ensures timely response levels to information changes • Improves change management • Supports best practice and demonstrates leadership in chemical handling management • Contributes to a Compliance dashboard leading to supplier benchmarking • Lowers risk which promotes corporate sustainability and a positive image 16© Baytouch Ltd 2014
- 17. To coin the words of the great Leonardo Da Vinci: "Simplicity is the ultimate sophistication". This is precisely what we at Baytouch have strived for in bringing ProductTraq to the market, all your compliance data 2-clicks away…. 17
- 18. All your compliance data just two clicks away! Manufacturers & Importers Formulators Distributors Retailers A comprehensive supply chain record management system for: www.ProductTraq.com © Baytouch Ltd 2014
- 19. 19 Questions Find this presentation at : www.slideshare.net/Baytouch © Baytouch Ltd 2014
Notas del editor
- Research carried out by Baytouch over the last 2 years has shown that many SMEs - especially those with lean sourcing and supply operations such as distributors and importers of low volume specialty chemicals, flavours, fragrances and food ingredients - are finding themselves particularly vulnerable. The low tech solutions used to address ever-increasing paperwork flows are typically PC-based office tools and filing cabinets in conjunction with their accounts software. These are fast approaching breaking point and pose a long term threat to business viability because they are neither robust nor transparent enough to meet regulatory requirements.
- REACH has been with us for over five years and in that time suppliers of articles have been working through the complex and often confusing requirements for finished goods, sub-assemblies and components with the responsibility for compliance delegated to Regulatory Team and/or the hard pressed individual
- By adopting a structured approach to the long term storage and accessibility of this information, business risk will be reduced and environmental impacts minimised. The resulting supply chain transparency and corporate image improvement will in turn create enhanced business opportunities through elevated status in the supply chain by having all the information at your fingertips to be able to satisfy customer requirements.