Presented by:Bruce CalderVP Consulting Services

Webinar - Building an RoHS Technical FilePractical approaches to EN 50581:2012

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)

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.

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

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

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)

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

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

Example of Results

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.

Technical File - Format• Claigan format

- Master spreadsheet /w folders for each item

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.

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

Technical File - Process• Process

• Process and criteria for supporting documentation

• referencing EN 50581

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

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

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

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

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

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

Technical File - Summary of Exemptions

• Summary of exemptions used• Each exemption used

• (but not how many times each exemption is used)

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

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

Maintenance of Compliance• Process to maintain compliance

• Preferably the same process (and document) as was used to initially make the product compliant

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

Declaration of Conformity• Single Declaration of Conformity

• to all applicable CE marking directives

• in format of Decision 768/2008

Technical File - Design and Function

• Description of design and function of the product

• Normally one of

• manual,

• data sheet, or

• quick start guide

Technical File - CE Mark

• CE mark• Exactly to EU specifications

• As art work or photograph

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)

Technical File - Risk Management

• Risk Management• Risk management process

• Risk management results

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

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

Test Report• Test report

• of example product using the compliance process

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

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

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

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

Technical File - Format• Claigan format

- Master spreadsheet w/ folders for each item

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

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

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