2009 International Cooperation on Product Safety SymposiumToronto, Canada

The role of standards in product safetyNew perspectives and ideas – a modular approach to standardization

Presented by Mark Bezzina – On behalf of Standards AustraliaManaging Director, StanCert27 October 2009 (1:30 pm to 3.00pm and 3:30 to 5:00pm)

Overview

• Focus - product vs systems

• The Product Compliance and Safety Management System (PCSMS)

• The Modular Standards Building Methodology (MSBM – aka PSF)

Focus

Supplier/supply chain assessment & control

Ongoing product compliance and risk assessment

Product risk assessment and standards testing i.e. Modular Standards Building Methodology

Product Compliance and Safety Management System (PCSMS)

To ensure safe products there is a need to do at least two things.......

• Management commitment

• Identify and understand regulatory requirements

• Responsibility & authority

• Adequate PC&S resources

• Risk assessment of products

• Research and development

• Safety in design

• Information to customers

• Supplier assessment

• Outsourced and off shore products

• Pre-purchase assessment of product

• Proactive issues management system

• Effective management of non-conforming product

• Ongoing assessment of product conformance

• Product identification, traceability, recall and emergency management

• Training and experience

• Continuous improvement

Prod

uct C

ompl

ianc

e an

d Sa

fety

M

anag

emen

t Sys

tem

Product standards (the good)

Standards have many benefits. They:– reduce risk to consumers and organisations

– offer a benchmark of what constitutes reasonable (or best?) practice

– create a common language that enables communication of compliance and conformity

– enable validation infrastructure to be developed which leads to confidence and efficiency in testing

– enhance trade when harmonised

Product standards (the bad)Voluntary and mandated standards are excellent tools although they do not offer a total solution to product safety because they:

Stan

dard

s

• are often politically motivated and ad hoc

• only cover a small proportion of products

• struggle to keep pace with product innovation

• cannot possibly anticipate or encompass all users and their uses

Product standards (the ugly)

Standards can introduce red tape or be used by unscrupulous suppliers to:

– exclude competition

– favour their products (become involved in the standardisation process)

– purposely supply risky products not covered by standards

Standards bodies

• Need to be diligent in maximising the good, minimising the bad and eliminating the ugly from standards development.

• This can mean that standards development processes are challenging, complex and at times slow

MSBM – the need

• Calls from industry participants to improve product safety standards because:

– Existing standards only cover a small proportion of products (approximately 30 out of 2000)

– It takes an extraordinarily long time to produce a product standard

– New products are coming on to the market at an increasingly rapid rate and through multiple channels

– There was a recommendation from the 2006 Productivity Commission Research Report on the Australian Consumer Product Safety System to make all standards hazard focused

Modular Standards Building Methodology

Industry engagement

Partners– Standards Australia– INPAA– ACCC– CHOICE (ACA)– Kidsafe– Victorian State Coroner– Monash University Accident

Research Centre– StanCert– NATA

Communicated to:– MCCA/SCOCA– CPAC – State regulators

Industry – BABYCO– Bubzilla – C Stuart– Coles Myer – Funtastic – IGC Dorel Pty Ltd– Mali Furniture– Nice Pak– Sunbury Nursery Furniture– Target– TGA Baby– Vision Australia

What is the MSBM

• The MSBM is used when there is no suitable Australian or International Standard available for the product or area being standardised

• The MSBM modularises existing standards by extracting identified components such as hazards and re-packaging test methodologies and then re-assembling these modules into a new standard in a fraction of the time it would take to develop a traditional standard

Why use the MSBM and what are the benefits?• Offers an alternative content development pathway

for new projects• Speeds up development of standards• Drives and practically enables harmonisation of

standards• Ensures efficiency in the development of standards• Creates a standards based product safety assessment

and test methodology where no other relevant standards exist to provide guidance

MSBM - Document Development

Limited time and resources

Limited time and resources

NoNo

YesYes

Traditional standard

Traditional standard

MSBM (Handbook)

MSBM (Handbook)

Need for product

safety and test guidance and no viable

existing Australian or international

standard

Need for product

safety and test guidance and no viable

existing Australian or international

standard

MSBM (Standard)

MSBM (Standard)

The development stage of a MSBM document differs from

a traditional standard and handbook by using modules to

speed up the process and harmonise with components

of existing standards

The development stage of a MSBM document differs from

a traditional standard and handbook by using modules to

speed up the process and harmonise with components

of existing standards

MSBM – Standards development

Meta Data SearchMeta Data SearchSpecific Requirement Modules (SRM) Specific Requirement Modules (SRM)

Generic Requirements Modules (GRM)Generic Requirements Modules (GRM)•M

echa

nica

l•

Che

mic

al•

Bio

logi

cal

•T

herm

al•

Dro

wni

ng•

Oth

er

•M

echa

nica

l•

Che

mic

al•

Bio

logi

cal

•T

herm

al•

Dro

wni

ng•

Oth

er

Assemble a test methodology pulling together required

GRMs/SRMs and IGs

Assemble a test methodology pulling together required

GRMs/SRMs and IGs

Informative Guides (IG)Informative Guides (IG)

Output MSBM AS or HBOutput MSBM AS or HB

Regulator or SA establish a committee (may be a SDO)

Regulator or SA establish a committee (may be a SDO)

New GRMs/IGs may be required. If so they are submitted to SA for formal evaluation and approval. To ensure technically correct and harmonised.

Exam

ples o

f Gen

eric Req

uirem

ents M

od

ules

GRM-002 Visual & Tactile Examination of Components

GRM-003 Hazardous Sharp Points

GRM-004 Hazardous Sharp Edges

GRM-005 Requirements for Decoration

GRM-006 Product Safety Warning Labels and Markings

GRM-007 Scissoring, Shearing & Pinching

GRM-008 Small Objects Removal of Graspable Components

GRM-009 Straps & Stitching Strength of Baby Slings Harnesses etc

GRM-010 Volatile Compounds Content

GRM-011 Small Parts Released During Testing

GRM-040 Packaging Hazards

GRM-041 Cords & Elastics

GRM-043 Leakage from Liquid Filled Products

GRM-044 Thermal Hazards Flammability

GRM-046 Traps Cords & Elastics

GRM-047 Snagging Traps Protrusions and Gaps

GRM-048 Gaps & Openings Finger Entrapment

GRM-049 Gaps & Openings Limb Entrapment

GRM-050 Gaps & Openings Head Entrapment and Fall Through Hazard

Demonstration activity

Example of a MSBM as used by organisations in its native form

Industry trial and case studies

Example of the application of the MSBM

“Using the [MSBM] we identified potential finger entrapment hazards and a potential strangulation hazard that a coiled attachment presented as it could be wrapped around a child's neck. The [MSBM] helped us identify the hazards and we have consequently implemented changes to remove these hazards”

“The [MSBM] has been adopted as an alternative assessment process to ensure that products we offer, if not covered by a product specific standard, still have a logical process that can be applied, to ensure risks are identified and managed to improve the overall safety of products.”

Rob Wise - FuntasticSee HB295.2 and 3.19 and 3.21

Vision Case study

Manufactured since 1989 and 600,000 units sold.

“A number of potentially hazardous issues were identified, primarily to do with possible entrapment risks largely associated with the expandable nature of the product, the product’s stability as well as the physical nature and properties of the locking fixtures on the product.” (Target)

Vision Australia has been satisfied with the process in that it gave the organisation an opportunity to review the product, improve it and supply it back to the market place with safer features. The product is now selling nationwide in all Target stores.

See HB295.2 and 3.22

Worked example

• Getting to know the documentation• Complete a Hazard Control Checklist

Example of a MSBM to create a new standard

MSBM – ExampleVAG 001 - Infant Care Products

1. Introduction2. Scope3. Reference documents4. Definitions5. Product list and graphics showing products covered by VAG6. Generic Requirement Modules (complete and by product)7. Specific Requirement Modules (complete and by product)8. Information Guides (complete and by product)9. Guidance on risk assessment

Baby bottle

Legend

1.Protective cover

2.Locking ring

3.Feeding teat

4.Sealing disc

5.Feeding bottle

6.Feeding bag

7.Numbered graduations

8.Feeding bag holder

(Please note there is a separate section on teats)

GRMs

GRMRef

Topic

HB 295.3.1-2007 Visual and Tactile ExaminationHB 295.3.2-2007 Hazardous Sharp PointsHB 295.3.3-2007 Hazardous Sharp EdgesHB 295.3.4-2007 DecorationHB 295.3.5-2007 Product Safety Warning LabelsHB 295.3.8-2007 Volatile Compounds ContentHB 295.3.9-2007 Formaldehyde ReleaseHB 295.3.10-2007 Release of Bisphenol A HB 295.3.11-2007 Migration Of Certain ElementsHB 295.3.12-2007 Release of Nitrosamines & NitrosatablesHB 295.3.13-2007 Release of NickelHB 295.3.14-2007 Melting and Dissolving of Materials Dishwasher SafetyHB 295.3.15-2007 Melting and Dissolving of Materials Microwave SafetyHB 295.3.16-2007 Melting and Dissolving of Materials Washing by HandHB 295.3.17-2007 Phthalate ContentHB 295.3.21-2007 Finger EntrapmentHB 295.3.24-2007 Informative and Instructive MaterialHB 295.3.25-2007 Small Parts TestHB 295.3.27-2007 Requirement for Toys

MSBM GENERIC REQUIREMENTSThe following Generic Requirements are applicable to this product type:

SRMs

SRM Ref TopicVAG-001.1 Volumetric RequirementsVAG-001.2 Feeding Bottle Flow RatesVAG-001.7 Strength Rigidity Cutlery and Feeding UtensilsVAG-001.9 Drop Test Cutlery and Feeding UtensilsVAG-001.13 Preparation Conditioning Order of Testing Drinking EquipmentVAG-001.18 Leakage BottlesVAG-001.19 Compression Strength BottlesVAG-001.37 Hygiene Ease of CleaningVAG-001.38 Resistance to Boiling

FEEDING PRODUCTSPRODUCT TYPE 4FEEDING BOTTLES

SPECIFIC REQUIREMENTSThe following Specific Requirements are applicable to this product type:

Conclusions

• Combined the PCSMS and MSBM offer a good set of tools for supporting standards based product safety. This is particularly important in economies where a general provision for product safety is in place.

• The MSBM could radically improve an approach towards a harmonised set of international standards.

• We are looking for supporters in communicating the benefits of a MSBM approach so let me know if you are interested in becoming involved.

Contact Details:

Mark BezzinaPresentation on behalf of Standards AustraliaManaging Director, StanCert Email: bezzina@stancert.comMobile: +61 (0) 413 101 096Land line: +61 (2) 8721 6434