a testing facility perspective on harmonized ee risk...

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2012/SCSC/WKSP/011

A Testing Facility Perspective on Harmonized EE Risk Assessment

Submitted by: Dekra

Workshop on Developing a Harmonised Electrical Equipment Regulatory Risk

Assessment ToolSingapore

15-16 May 2012

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APEC Workshop Singapore May 2012

A Testing Facility Perspective on Harmonized EE Risk Assessment

Dr. Michael Siedentop

APEC Joint Regulatory Advisory Committee

Page 1 © 2012 DEKRA

APEC Joint Regulatory Advisory CommitteeElectrical and Electronic Equipment Workshop

Developing a Harmonised Electrical Equipment Regulatory Risk Assessment ToolSingapore, 15th – 16th May 2012


Contents

Benefits of Harmonized Standards Global vs. European Standardization Standardization and Certification in the P. R. China A View on Risk Assessment and Tools Conclusion

© 2012 DEKRA

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What are the economic benefits of standardization?

© 2012 DEKRA

(as per DIN study "Economic Benefits of Standardization", updated 2011).


How does harmonization of standards help businesses?

R&D investment

Mass productionGlobal purchasing Lower transaction costs Reduced adjustment costs Shorter development timesCompany

success

investment success

Cost reduction

Improved image in

Lower liability

Access to new

markets


image in general

Improved customer relations

liability exposure

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Cornerstones of Export Strategy

What are the cornerstones of export strategy (business survey results from the joint research project “Economic benefits of standards”)?• Use European and International standards (84%)• Set up factories in the economy of importation (13 %)Set up factories in the economy of importation (13 %) • Conclude delivery contracts in the economy of importation (7 %).

Michael Glos, Federal Minister, Federal Ministry of Economics and Technology (until 2009)


Dr. Thomas Enders, European Aeronautic Defenceand Space Company (EADS)


Perspective of Testing Facilities

Harmonized standards and conformance procedures improve the efficiency of testing and certification

Factory AuditsTesting Certification

Administration, IT SystemsCost DriversWorkgroups


Accreditation Accreditation Audits

Training of Employees

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Global Standards Organizations

Standardization System in Europe

SO C

WTO

ITURecognizes

RecommendsPractices

European Standards Organizations (ESO)

CENELEC ETSICEN

ISO IECUN ITU

EU

National Standards Bodies: DIN, AFNOR, BSI, …

Vienna Agreement, Dresden Agreement

Recognizes

Recognizes

ReleasesDirectives


National Standards Bodies: DIN, AFNOR, BSI, …Nat. Committees: DKE (DIN/VDE), UTE, BSI, …

Members (companies, associations, public authorities)


CEN Member States


MembersAffiliatesPartner standardization bodies

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CENELEC Member States


MembersAffiliates


ETSI Member States


Full MembersAssociate MembersObservers

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China-EU/EFTA Standardization Information Platform (CESIP)

In 2009 CEN, CENELEC and ETSI signed a Memorandum of Understanding (MoU) with the Standardization Administration of the People’s Republic of China (SAC)China (SAC).

This agreement provides a framework for regular and coordinated exchange of information at corporate and technical level.

CESIP launched in 2009. Information tool that aims at strengthening the mutual trade

between Europe and China Website with information in English and Chinese Current and upcoming standards and related technical regulations


p g g Sectors:

• electrical equipment• medical devices• Machinery• environmental protection.

The platform is available at http://www.eu-china-standards.eu/.


Standards System and Policy in China

Classification of standards for the Chinese electrical industry

N ti l t d d• National standards• Professional standards• Provincial standards • Enterprise standards

For the electrical industry, the national and professional standards are applicable and have binding effect on the entire industry.


The national standards (GB) are administrated by the Standardization Administration of China (SAC) and developed by the National Professional Standardization Techniques Commission whose establishment was approved by SAC.

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Standards System and Policy in China

National standards (GB) can be further divided into three categories.

There are two major standardization administration bodies associated with the electrical industry: • China Machinery Industry Federation (CMIF)• China Electrical Equipment Industry Association

Mandatory standards(GB)

Recommended standards (GB/T)


q p y(CEEIA).

Technical guides for national standards (GB/Z).


Adoption of International Standards in China

Target 2020:Adopting international standards at a rate of over 90%

Feb. 2011 (End of the “11th five-year” planning period):Adopting international standards at a rate of 85%

End of 2007 (electrical industry):1,222 national standards, thereof 890 standards had adopted the international standards


had adopted the international standards

End of 2001 (electrical industry): 1,097 national standards, thereof 661 standards had adopted the international standard

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Compulsory Certification System in China

• Products related to

h man health and sec rit• human health and security• life and health of animals and plants • environmental protection • public security.

• AQSIQ formulates national rules and regulations

• Catalogue of Products issued by AQSIQ


Catalogue of Products issued by AQSIQ

• CNCA manages and organizes the implementation


Risk Assessment and Conformity

Explosive

Specific areas with high risk potential require specific risk assessment methods

ExplosiveEnvironment

NuclearTechnology

Trans-portation

Machinery Medical

Specific Risk Assessment


Machinery Devices

…

Essential health and safety requirements are given in harmonized standards

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Risk Assessment and Harmonized Standards


Guide to application of the Machinery Directive 2006/42/EC 2nd Edition June 2010: Excerpt from §159


Risk Assessment According to MD 2006/42/EC 1)

Can a tool help?

• determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,

• identify the hazards that can be generated by the machinery and the associated hazardous situations,

• estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,

• evaluate the risks, with a view to determining whether risk reduction is i d i d i h h bj i f hi Di i


required, in accordance with the objective of this Directive, • eliminate the hazards or reduce the risks associated with these hazards

by application of protective measures.

1) MD = Machinery Directive

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Risk Analysis Methodologies

Failure Mode and Effects Analysis (FMEA)

Fault Tree Analysis (FTA)■ Fault Tree Analysis (FTA)

■ Others



Risk Assessment Calculation (Example)

LO (Likelihood of Occurrence) FE (Frequency of Exposure) HRN Risk0.033 Almost impossible Only in extreme circumstances 0.5 Annually 0-5 Negligible1 Highly unlikely Though conceivable 1 Monthly 5-50 Low, significantg y y g y , g1.5 Unlikely But could occur 1.5 Weekly 50-500 High2 Possible But unusual 2.5 Daily Over 500 Unacceptable5 Even chance Could happen 4 Hourly HRN = LO x FE x DPH x NP8 Probable Not surprising 5 Constantly10 Likely To be expected15 Certain No doubt

DPH (Degree of Possible Harm) NP (Number of Persons at risk)0 1 S t h b i 1 1 2

(Hazard Rating Number)


0.1 Scratch or bruise 1 1-2 persons0.5 Laceration or mild ill-effect 2 3-7 persons2 Break of minor bone or minor illness (temporary) 4 8-15 persons4 Break of major bone or major illness (temporary) 8 16-50 persons6 Loss of one limb, eye, hearing (permanent) 12 50+ persons10 Loss of two limbs or eyes (permanent)15 Fatality

Source: Pilz Guide to Machinery Safety, 6th Edition

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Problems with Numerical Risk Assessments (Risk Matrix)

Poor Resolution

Typical risk matrices can correctly and unambiguously compare only a small fraction (e.g., less than 10%) of randomly selected pairs of hazards. They can assign identical ratings to quantitatively very different risks (“range compression”).

Errors Risk matrices can mistakenly assign higher qualitative ratings to quantitatively smaller risks. For risks with negatively correlated frequencies and severities, they can be “worse than useless,” leading to worse-than-random decisions.

Suboptimal Resource Allocation

Effective allocation of resources to risk-reducing countermeasures cannot be based on the categories provided by risk matrices.


Ambiguous Inputs and Outputs

Categorizations of severity cannot be made objectively for uncertain consequences. Inputs to risk matrices (e.g., frequency and severity categorizations) and resulting outputs (i.e., risk ratings) require subjective interpretation, and different users may obtain opposite ratings of the same quantitative risks. These limitations suggest that risk matrices should be used with caution, and only with careful explanations of embedded judgments.

Cox, L.A. Jr., 'What's Wrong with Risk Matrices?', Risk Analysis, Vol. 28, No. 2, 2008


Criticisms of Quantitative Risk Assessment

Risk assessment tends to be overly quantitative and reductive (Barry Commoner Brian Wynne)(Barry Commoner, Brian Wynne).

Risk assessments ignore qualitative differences among risks.

Assessments may drop out important non-quantifiable or inaccessible information, such as variations among the classes of people exposed to hazards.

Quantitative approaches divert attention from precautionary or preventative


pp p y pmeasures (Barry Commoner, Mary O'Brien).

Risk managers are a little more than "blind users" of statistical tools and methods (Nassim Nicholas Taleb).

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Conclusion

Risk assessment and respective tools shall

always be based on relevant (harmonized) standards, reflect specific requirements, be systematic and transparent, easy to apply,


y pp y, easy to maintain.


Electrical and Electronic Equipment Mutual Recognition Arrangement (EE MRA)

Part I: Information interchange

Economy EEMRA - Part 1 Date

Australia Yes 2006

Brunei Darussalam Yes 2006

Information about a participating APEC Member Economy's mandatory requirements on regulated electrical and electronic products is provided in a standardized format to assist those in other APEC Member Economies who may wish to export electrical and electronic products to that economy. At present, 17 Member Economies are participants in P t I f th MRA

Canada No Chile Yes June 2007 China Yes 2006

Hong Kong, China Yes May 2007

Indonesia Yes 2006 Japan Yes May 2007Korea Yes 2006 Malaysia Yes 2006 Mexico No New Zealand Yes 2006


Part I of the MRA.Papua New Guinea Yes

Peru YesPhilippines Yes 2006 Russia YesSingapore Yes May 2007 Chinese Taipei Yes June 2007 Thailand Yes Oct 2008 United States No Viet Nam Yes 2006

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Part II: Acceptance of test reportsPart II of the MRA commits participating

Economy EEMRA - Part 2

Australia Yes Brunei Darussalam Yes C d NPart II of the MRA commits participating

APEC Member Economies to mutually accept test reports produced by testing facilities designated by participating economies in accordance with the designation requirements of the EE MRA. The designation requirements are in accordance with the relevant ISO/IEC Standards and do not require re-testing.

Canada No Chile No China No Hong Kong, China No Indonesia No Japan No Korea No Malaysia Yes Mexico No New Zealand Yes


Papua New Guinea No Peru No Philippines No Russia No Singapore Yes Chinese Taipei No Thailand No United States No Viet Nam No



Part III: Acceptance of certificationPart III commits a participating importing APEC

Economy EEMRA - Part 3

Australia Yes Brunei Darussalam Yes

economy to accept product certification (including batch testing) produced by certification bodies designated by participating exporting economies in accordance with the designation requirements of the EE MRA. The designation requirements are in accordance with the relevant ISO/IEC Guide. Certification bodies may issue product certificates (Certificate of Conformity), which are acceptable in participating importing

Canada No Chile No China No Hong Kong, China No Indonesia No Japan No Korea No Malaysia No Mexico No New Zealand Yes


acceptable in participating importing economies, thus negating the need to re-certify the product.

Papua New Guinea No Peru No Philippines No Russia No Singapore Yes Chinese Taipei No Thailand No United States No Viet Nam No

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