Weitere ähnliche Inhalte Ähnlich wie Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs ©baytouch ltd2014 (20) Kürzlich hochgeladen (20) Responsibly Managing Supply Chain Chemical Compliance in the Decade of Regulatory Affairs ©baytouch ltd20143. 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
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
Hinweis der Redaktion 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.