The Chemical and Technical Documentation …€¦ · Agenda Introduction ... 2002/95/EC 27 January 2003 2005/84/EC 14 December 2005 EC/1907/2006 18 December 2006 2009/48/EC ... 2012

The Chemical and

Technical Documentation

Challenges of the Toy Industry

Dr. Vincent Tam

The Hong Kong Toys Council

Jetta Company Ltd.

October 22, 2012

For the Hong Kong Council for Testing & Certification

2 Dr. Vincent Tam October 22, 2012

Agenda

Introduction

Chemical challenges

Documentation challenges

HKTC – Chemical management database

(CMD)

Conclusions


Introduction


Introduction

Toys are vital tools that help foster

the mental, physical, emotional and

social development of boys and girls.

Toys are basic instruments for

the development of children’s

fantasy, thoughts and creativity.


Introduction

In late 1969, President Nixon signed

into law the Toy Safety Act.

Formal efforts to assure toy safety

by TIA began in early 1930s…


Introduction


Introduction

Chemical, chemical, chemical:

2002/95/EC

27 January 2003

2005/84/EC

14 December 2005

EC/1907/2006

18 December 2006

2009/48/EC

18 June 2009


Introduction

http://www.google.com.hk/imgres?q=health+effect+%2B+child&um=1&hl=zh-TW&rlz=1T4GGLG_zh-TWHK309&biw=1260&bih=475&tbs=isch:1&tbnid=QZ1Kopjznh4M0M:&imgrefurl=http://children.foreignpolicyblogs.com/2009/12/29/how-will-health-care-reform-affect-children/&imgurl=http://www.freedomhealthnet.com/blog/uploaded_images/childhealth-794095.JPG&zoom=1&w=1600&h=1600&iact=rc&dur=454&ei=L-P9TNTXMJGmugPo5ai-Bw&oei=J-P9TPHPF4eCvgPdqbCBCA&esq=2&page=2&tbnh=148&tbnw=146&start=11&ndsp=12&ved=1t:429,r:4,s:11&tx=51&ty=74


Chemical Challenges

The revised Directive brings in more

references on chemicals by limiting

the amounts of certain chemicals.

19 heavy metals are regulated with

tight migration limit.

TSD 2009/48/EC


Chemical Challenges

CMR substances are no longer allowed

in accessible parts of toys.

Allergenic fragrances are not allowed.

Strong allergenic potential fragrances

have to be labeled.

TSD 2009/48/EC


Chemical Challenges

Require comprehensive chemical data:

Bill of substance (BOS)

Safety data sheet (SDS)

Conduct chemical safety assessment.

TSD 2009/48/EC


Chemical Challenges

Provide chemical and safe use

information.

Conduct chemical risk management.

SVHC : Currently 84 substances.

REACH EC1907/2006


Chemical Challenges

Washington’s Children’s Safe Products Act;

Maine’s Kid-Safe Products Act Amendment;

California’s Green Chemistry Initiative –

Safer Consumer Products Regulations (draft).


Chemical Challenges

Very low limit on many chemicals.

Many more chemicals are being regulated:

Number of CMR 1/2 : 300+ substances.

New chemicals are being added everyday:

SVHC : 1,000+ potential candidates.

California : Initial list ~ 1,200 chemicals.


Chemical Challenge


Chemical Challenges

How to combat the chemical challenge ?

Acquire chemical expertise.

Optimize your supplier base.

Consider in-house chemical laboratory.

Find a right partner for your chemical

safety assessment (CSA).


Chemical Challenges

How to combat the Chemical Challenge ?

Utilize an IT tool to help you to:

Track compliance;

Manage chemical data / information;

Identify chemicals of concern;

Provide alert;

Evaluate supplier performance.


Documentation Challenges

Manufacturer’s responsibilities:

Keep the technical documentation and

the EC declaration of conformity for

a period of 10 years after the toy has

been placed on the market.

TSD 2009/48/EC




Keep the technical documentation and

the EU declaration of conformity for

10 years after the EEE has been placed

on the market.

2011/65/EU - RoHS 2.0




To maintain records (including test

records) for 5 years.

16 CFR Part 1107


Documentation (EU TSD)

1. Description of the design and manufacture

2. List of components and materials (BOM & BOS)

3. Safety data sheets (SDS)

4. Safety assessments

5. Conformity assessment procedure

6. EC declaration of conformity

7. Address of manufacturer and storage

8. Copies of document submitted to notified body, if any

9. Conformity record, description and reports


Documentation (EU TSD)

1. A color photo (high resolution)

2. Conceptual design, drawings, etc.

3. Necessary description and explanations

4. The print of the packaging

5. Instructions or accompanying documents

6. Intended and foreseeable use

7. The age suitability

8. Manufacturing process and procedure De

scri

ptio

n o

f th

e d

esig

n a

nd

ma

nu

factu

re



~ Several dozens ~ Several hundreds



For each Sku:

Several dozens to several hundreds documents.

Coming from different sources (brand, factory,

supply chain, test laboratory, etc.).

Coming in at different time throughout toy life.

Require active management (renewal / update).

Many documents are not specific to one Sku.

Keep expired & update documents for 10 / 5 years.



How to combat the Documentation Challenges ?

Utilize an IT tool to help you to:

Track completeness / expiry situation;

Auto filing;

Provide alert;

Keep documentations for 10 / 5 years;

Evaluate supplier performance.


Dealing with the Challenges

To deal with the chemical & documentation

challenges, brands & factories, irrespective

of their size, will require:

A good chemical / document

management tool


Dealing with the Challenges

Solutions :

Brands and factories design and develop

their own IT system.

There is an “industry” IT system that

brands and factories can choose to use.

CMD Chemical Management Database

A Chemical & Technical

Document Management Tool


CMD - Goals

C

A

S

E

One Industry One System

Cost minimization;

Alignment in early stage;

EDI exchange.

Standardization;


CMD – Functionalities

Chemical management

(except chemical safety assessment)

A Chemical & Technical

Document Management Tool

Document management


CMD – Features / Benefits

Chemical management:

Compliance validation.

Chemicals on watch.

Data mining.

What if analysis.

Supplier performance, KPI measurement.


CMD – Chemical Management

Compliance validation:

Test data check against compliance rules.

International compliance rule is maintained

by BV, update via auto update function.

Retailer / brand / factory rule is inputted & maintained by brand / factory itself.



Chemicals on watch:

Provide immediate alert.

Provide data to aid reporting.

Current list include chemicals

from TSD; EC1272/2008; REACH

California Prop 65; Washington

Children’s Safe Product Act;

Maine Safer Chemicals in

Children’s Products.



Data mining:

A useful quality / safety assurance tool.

Allow trend analysis.



What if analysis:

Evaluate impact of future legislation.

Assure systemic transition to new rule.



Supplier performance, KPI



Chemical management:

Compliance validation.

Chemicals on watch.

Data mining.

What if analysis.

Supplier performance, KPI measurement.



Documentation management:

Document / data transfer.

Email alert engine.

Automatic filing capability.

Documentation package.

Supplier assessment, KPI.

Document storage / security.


CMD – Doc Management

Document / data transfer:

Can transfer data from MRP / ERP.

Can upload data from Excel.

Accept upload of all types of document:

pdf, word, excel, JPEG, etc.



Email alert engine:

Missing document /document expiry &

update – email automatic reminder.

New requirement broadcast.



Automatic filing capability:

File a component test report to multiple

sku – e.g. paint incoming test, an update

resistor RoHS report.

File a document to multiple sku – e.g.

update BOS, SDS, DOC from supplier.



Documentation package:

Package required documents

to retailer, government, etc.

Supplier assessment, KPI



Document storage / security:

‘Real time’ exchange - brand and factory.

Documents reside within own firewall.

Supplier goes out of business ?

Store old + new documents for 10+ years.



Documentation management:

Document / data transfer.

Email alert engine.

Automatic filing capability.

Documentation package.

Supplier assessment, KPI.

Document storage / security.


ERP data download

- Material

- BOM

- Supplier

- Shipment

SDS, DOC, Test

Report

RoHS, CPSIA, REACH ...

& Customer specification

E-alert

Supplier

assessment

Auto-email

Web folder

CAS library 資料庫

SVHC / CMR list Image and

values

download

CMD Operations


CMD Operations

Brand

BOM Excel & Doc upload

Brand’s own spec & Rules

Factory with Excel only

Vendor upload Portal

Factory with CMD – Web based

CMD lite Web based

Upload

Factory

Factory

Factory C

Factory with CMD - Server based


Factory

CMD Exchange One Industry One System

Brands Brands

Supplier

10 years e-filing BOM, BOS of customer format Data for transfer (via web folder)

Outside Lab

Web Exchange platform

Safety

assessment co. +


CMD – Current Status

72 factories + 4 brands have signed up.

Brands: Hasbro, Tomy (RC2), Spin Master,

and Brio.

CMD implementation – Brand + Factories.

CMD Technical Board – monthly meeting.

CMD Advisory Board.


CMD – Current Status

CMD enhancement.

Working with other brands (Top Toys, LEGO,

Hallmark, Mattel, etc).

BOS generation for direct integration

to SciVera Lens (a chemical safety assessor).

Partnering with BTHA to run a CMD pilot

of ‘small brand + small factory’.


CMD - Future Development

Pdf + Excel test result file from 3rd Party

Lab to ease CMD data input.

Data transfer from ICP and GC/MS machine

to CMD.

BOM warehouse (multi-versions BOM - with

change in component, packaging, etc.).

Cloud enablement.


CMD - Future Development

BOS module for standard paint & auto BOS

generation for mixed paint.

Develop standard data mining analytics.

Set up training course to improve knowledge

of MSDS, new EU requirement, etc.


Conclusions

Brands and factories will require a software

tool for meeting the technical documentation

requirement and managing the ever changing

chemical requirements.

Using CMD instead of self-developing

a software tool for this usage provides

benefits to brands & factories.


Conclusions

Benefits of using CMD:

1. Cost minimization.

2. Assurance of a robust software tool.

3. Enhance communication – eliminate

duplicate entry, reduce error, real time.

4. Assurance of meeting future

legislations’ needs.


Conclusions

Benefits of using CMD:

One Industry

One System

[email protected]

“One's first step in wisdom is to question everything - and one's

last is to come to terms with everything.”

- Georg C. Lichtenberg