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Presented by:Bruce CalderVP Consulting Services
Webinar - Building an RoHS Technical FilePractical approaches to EN 50581:2012
![Page 2: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/2.jpg)
Overview - Agenda• Introduction
• RoHS Recast
• CE marking and conformity assessment
• Swedish enforcement results
• EN 50581
• Supporting documents
• Example RoHS technical file
• Sections
• Elements in each sections
• Practical approaches
• Risk management
• Risk management and enforcement
• Q&A
Webinar is 50 minutes with 10 minutes of Q&A
(hopefully)
![Page 3: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/3.jpg)
Claigan - Technical Files• Claigan standard RoHS technical file services
• Preparation of technical files for products
• Process development / review
• Risk mitigation testing
• Claigan has supported hundreds of RoHS technical files
• Let us help you.
![Page 4: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/4.jpg)
Next Webinar - REACH 2018• Chemical Registration in 2018
• Practical approaches for importers of mixtures
• Mother registrations
• Implementation of LOA
• Becoming a downstream user
• Downstream user responsibilities
• Alternatives, options, and managing cost
• Tentatively March 22, 2017
![Page 5: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/5.jpg)
Claigan Environmental - Difference• Claigan’s focus
- Compliance
- End Deliverables
• If a step or process does not contribute to compliance or end deliverables, then it needs to be justified
• End deliverables for RoHS Recast1. Product compliant with the materials restrictions
2. CE marking
3. DoC
4. Technical file
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RoHS Recast• RoHS Recast
- EU Directive 2011/65/EU
• RoHS compliance applies to - Finished electrical and electronic products
- Maximum in homogenous materials
- 1,000 ppm Pb, Hg, Cr6+, PBB, PBDE
- 100 ppm Cd
• RoHS Commission Delegated Directive (2015/863)- Starting in 2019 (2021 for medical / monitoring + control)
- 1,000 ppm DEHP, BBP, DBP, DIBP (specific phthalates)
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EU RoHS - Deliverables (Finished Products)
• RoHS compliant product • Meets Article 4 restrictions in homogenous materials
• CE Marking• CE Mark
• CE mark to exact specifications of the EU Commission
• Name and postal address of manufacturer
• Serial or model number
• Declaration of Conformity • For all applicable CE marking directives
• To Decision 768/2008
• Technical File • Technical documentation according to EN 50581:2012 and
Decision 768/2008
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Swedish RoHS and POP Enforcement
• In December 2016, Kemi (Swedish enforcement agency) released their report on RoHS and POP enforcement
- https://www.kemi.se/global/tillsyns-pm/2016/tillsyn-11-16-tillsyn-av-elektriska-lagprisprodukter.pdf
- pg 6 is a summary in English
• Summary- 58 of 154 products tested had RoHS or POP substances above
the threshold (38% failure rate)
- POP substance - SCCP
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Example of Results
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Sweden - Product Documentation Enforcement
• CE marking- 64 out of the 129 products (50 %) were non-compliant.
- Many companies are reporting EU enforcement for poor CE marking
• DoC and Technical File- 15 out of the 35 products (43 %) for which documentation (DoC
and technical file) were non-compliant.
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Technical File - Format• Claigan format
- Master spreadsheet /w folders for each item
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EN 50581:2012• EU RoHS Recast Technical File Standard
• The standard EN 50581:2012 does not provide a specific format for the technical documentation but does provide guidance on acceptable supporting documentation for a conformity assessment for RoHS Recast.
• Key elements of EN 50581:2012
- Tasks to be undertaken by the manufacturer:
• 4.3.2 - Determination of the information needed;
• 4.3.3 - Collection of the needed information;
• 4.3.4 - Evaluation of the information;
• 4.3.5 - Updating and ensuring validity of the documentation.
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Technical File - Sections• Sections
• Article 7 -
• Obligations of the manufacturer
• Article 4 -
• Conformity shown by voluntary harmonized standard EN 50581:2012
Article 7
Article 4
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Technical File - Process• Process
• Process and criteria for supporting documentation
• referencing EN 50581
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Supporting Documentation• Allowed documentation - EN 50581:2012
- Supplier Declarations • Declaration of compliance by the
• Manufacturer or supplier
- Material Declarations • Sufficient materials information infer RoHS compliance
- Analytical test results • Analytical testing according to EN 62321
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Supporting DocumentationKey Criteria
• Process• 4.3.2 - Determination of the information needed and
• 4.3.4 - Evaluation of the information are normally handled by
• Process document with
• Documents accepted
• Criteria for the documents
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Technical File - Summary of Supporting Documents
• Summary of supporting documents• Not a dump of all of your supporting documents
• A summary of the products supporting documents showing that all of the parts are compliant
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Summary of Supporting Documents• Summary of supporting documents
• Showing 100% of parts are either compliant or out of scope
• Reference repository of specific data
• Referencing document standards of EN 50581
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Technical File - Final Integrator Statement
• The most commonly missed (and critical) document
• Final integrator statement• Statement of compliance by final integrator
• Often not included in the BOM documentation
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Final Integrator Statement• Compliance statement
• By final integrator
• That processes used and parts chosen by final integrator are compliant
• Final integrator
• Could be a contract manufacturer, or
• Could be your own manufacturing floor
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Technical File - Summary of Exemptions
• Summary of exemptions used• Each exemption used
• (but not how many times each exemption is used)
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Summary of Exemptions• Summary of exemptions used
• List of exemptions used
• According to EN 50581, exemptions are supposed to be collected
• But there is no requirement to itemize each instance in the technical file
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Technical File - Maintenance of Compliance
• 4.3.5 - Updating and ensuring validity of the documentation.
• Process to maintain compliance (EN 50581 4.3.5)
• Preferably the exact same process as was used for initial compliance
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Maintenance of Compliance• Process to maintain compliance
• Preferably the same process (and document) as was used to initially make the product compliant
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Technical File - Declaration of Conformity
• Declaration of Conformity to Decision 768/2008
• Newer CE marking format
• Different than previously used by LVD, EMC, and MDD Directives
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Declaration of Conformity• Single Declaration of Conformity
• to all applicable CE marking directives
• in format of Decision 768/2008
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Technical File - Design and Function
• Description of design and function of the product
• Normally one of
• manual,
• data sheet, or
• quick start guide
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Technical File - CE Mark
• CE mark• Exactly to EU specifications
• As art work or photograph
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CE Mark• CE marking
• Five requirements• CE
• Exactly to proportions and shape
• Name of the manufacturer
• Model or serial number
• Postal address of the manufacturer
• Notified body number (if applicable)
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Technical File - Risk Management
• Risk Management• Risk management process
• Risk management results
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Risk Management• Risk management
• Managing the risk is a mandatory part of Decision 768/2008 and RoHS Recast
• Many options of risk management• High / low risk of suppliers
• Supplier auditing
• Product testing
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Testing of Sample Product• Most effective method of risk management
• In terms of• time
• cost, and
• effectiveness
• Testing a sample product that used the compliance process
• Output• If the product passes,
• the compliance process works
• due diligence is served
• If the product fails,
• identify the cause of the failure and show solution
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Test Report• Test report
• of example product using the compliance process
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Non-Compliance Metrics - CE Marking
Error Lack of Effort
Large Penalty
Small Penalty
Example - Lead solder on all PCB boards
Example -Pb in PVC in one hook up wire
Example - Gathering no data from suppliers
Example -Gathered data and Performed Risk Mitigation Testing
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CE Marking - Penalties - Scale
Large Penalty
Small Penalty
Public Recall from Customers
Public Withdrawal from Market
No Import of New Units into EU until Corrected.
But No Public Recall or Withdrawal from Market
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Note on RoHS Compliance• Everyone fails
• Virtually every manufacturer will unintentionally produce a non-compliant product this year.
• Breath in. Breath out.
• Reduce the risk of non-compliance• In both risk of identification by authorities, and
• Magnitude of penalty
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Technical File - Registrar of Non-Compliance
• Catch-all document• To record any non-compliance and how they were addressed
• Hopefully not needed
• But needed far more often than companies would like
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Technical File - Format• Claigan format
- Master spreadsheet w/ folders for each item
![Page 39: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/39.jpg)
Claigan Environmental - Difference• Claigan’s focus
- Compliance
- End Deliverables
• If a step or process does not contribute to compliance or end deliverables, then it needs to be justified
• End deliverables for RoHS Recast1. Product compliant with the materials restrictions
2. CE marking
3. DoC
4. Technical file
![Page 40: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/40.jpg)
Next Webinar - REACH 2018• Chemical Registration in 2018
• Practical approaches for importers of mixtures
• Mother registrations
• Implementation of LOA
• Becoming a downstream user
• Downstream user responsibilities
• Alternatives, options, and managing cost
• Tentatively March 22, 2017
![Page 41: Webinar - RoHS Technical File - Feb 22 2017 v3 · 2017-02-28 · VP Consulting Services Webinar - Building an RoHS Technical File Practical approaches to EN 50581:2012. Overview](https://reader033.vdocuments.mx/reader033/viewer/2022060215/5f05ebe97e708231d41563ba/html5/thumbnails/41.jpg)
Claigan - Technical Files• Claigan standard RoHS technical file services
• Preparation of technical files for products
• Process development / review
• Risk mitigation testing
• Claigan has supported hundreds of RoHS technical files
• Let us help you.
Q&A