© 2011 Underwriters Laboratories Inc. All rights reserved. This document may not be reproduced or...

© 2011 Underwriters Laboratories Inc. All rights reserved. This document may not be reproduced or distributed without authorization.

ASSET Safety Management Process

Thomas Lanzisero

1 November 2011

Perspective

ICPHSO Asia-Pacific Consumer Product Safety Symposium 2011Toward Global Best Practices in Product Safety and Consumer Protection

Segment II – A Closer Look at Sectors

Sector 1 – Electrical/Electronics

How to Improve Information Sharing to Help Harmonize Regulations:

This panel will explore the ways that manufacturers, testing/consulting organizations, and regulators can work together to harmonize regulations, or notify interested stakeholders in the Asia-Pacific region

Slide 2© 2011 Underwriters Laboratories Inc.

Objective


Improve information sharing – work together to harmonize regulations or notify interested stakeholders

Need Common BasisSafety

(freedom from unacceptable risk)

Need Common MeansManagement

(meet objectives)

Safety ManagementCan support basis & means to meet objectives

ASSET Safety Management ProcessCommon framework for basis & means to meet safety objectives

and other multiple, mutual objectives of stakeholders

ASSET™ Objective


ASSET ™ is a trademark of Underwriters Laboratories Inc.

* Subject of new UL University 2-day ASSET workshop applying and expanding principles of HBSE (Hazard Based Safety Engineering)

To utilize Applied Safety Science and Engineering Techniques* and the ASSET Safety Management Process*

For informed decisions to achieve, maintain and continuously improve the safety of products, processes and services

• By assessment of best available data / information

• With greatest degree of confidence

• Together with existing standards, codes and regulations

ASSET Applications – General

Safety Management

• Design

• Evaluation• Compliance / Certification

• Harmonization of safety standards, codes, and regulations*• Development / Implementation / Enforcement)

• Information Sharing on safety• Effective planning, communication, documentation, reporting


* - Hazard-based, Risk-based requirements Safety objectives based on performance, not prescriptive construction e.g., IEC 62368: Information Communication Technology Equipment

Scope of Product / Process / Service

Slide 6

ASSET Applications – Detailed

Scope of Standards /

Codes / Regulations

Applicable in-scope safety requirements

© 2011 Underwriters Laboratories Inc.

Product / Process / Service: not within the scope of existing safety standards

Product / Process / Service: within scope of a safety standard, but involves features (functions, technologies, applications) that may (1) introduce or reduce a safety hazard, (2) not be anticipated or addressed by requirements in the standard

Standards / Codes / Regulations: do not address features involving hazards or alternative protective measures

ASSET provides a process and methodology to:

• Help address hazards not anticipated or covered by existing standards and the need for additional requirements to meet the safety objective (intent) of the standards

• Help address alternative protective measures not anticipated by the standard, but which can achieve an equivalent level of safety to the protective measures specified in the standard, thereby meeting the safety objective (intent) of the standard

In a uniform, consistent mannerEqualize the playing field Balance multiple stakeholders and needs

Slide 7

ASSET and Standards


ASSET Process

The evolution of hazard-based safety engineering principles1 and safety science into an overall framework of a safety management process based on risk management / risk assessment2 by

• Formulating types of questions to identify scope of the product, system or service to be evaluated for potential harm

• Identifying and analyzing hazards (potential sources of harm)

• Identifying, analyzing and evaluating protective measures to reduce the risk of harm

• Assisting in the determination of whether or not an acceptable level of safety is achieved

• Understanding and applying methods to maintain and continuously improve safety

Slide 8

1. Hazard Based Safety Engineering (HBSE), originally conceived by HP/Agilent, targeted typical types of hazards and forms of injury involving electronics products, such as information technology and office equipment

2. E.g., ISO/IEC Guide 51, IEC Guide 116, ISO 31000, ISO/IEC 31010, ISO 14121, ISO 14971, IEC 60300-3-9, ANSI Z690


Assess / Decide on Action Evaluate Protective Measures

Acceptable Level of Safety Achieved?

Control / Monitor / Review

Y

N

Present Level of Safety Maintained?

Y

N

Identify / Analyze Hazards

Start

Determine Scope / Context

Identify OpportunitiesFor Improvement

Specify / Identify / Design Protective Measures

ASSET™ Safety Management Process





Y

N


Y

N


Start




Managing the Process & Interactions


Plan

Prepare

Consult

Communicate

Document

Record

Address relevant stakeholder

interests, views, values, perceptions,

criteria

Including appropriate expertise,

endorsement, support

Regarding the existence, nature, form, likelihood,

significance, evaluation and

treatment of risk, and the

acceptability of the level of safety and its management

A Brief Look at Each Stage: Goals / Outcomes





Y

N


Y

N


Start





Goals

Slide 12

Determine the scope of the product, process or service to be assessed and the context for the assessment

• System approach

• Subject of the assessment

• Intended use

• Reasonably foreseeable misuse

• Other conditions or factors throughout lifecycle

• Applicable standards, codes and/or regulations (initial)





Y

N


Y

N


Start





Goals

Slide 13

• Identify potential types and sources of harm, and entities subject to harm

• Determine how harm can occur and the severity of the harm (tools, techniques)

• Sort consequences initially by the level of severity

• Determine if the applicable standards, codes and/or regulations address the identified hazards





Y

N


Y

N


Start





Goals

Slide 14

• Establish the safety objective(s)

• Determine the need for protective measures

• Identify the potential protective measure strategies, categories and mechanisms

• Analyze and prioritize protective measures

• Specify, identify, design and then implement the protective measures





Y

N


Y

N


Start




Evaluate Protective Measures

Goals

Determine whether protective measures are adequate and effective by

• Assessing whether and how protective measures meet specific safety objectives

• Identifying safety attributes that are being relied upon and need to be controlled

• Evaluating those safety attributes





Y

N


Y

N


Start




• If acceptable level of safety has been achieved, control, monitor, and review to maintain safety

• If acceptable level of safety has not been achieved, assess and decide on action

Acceptable Level of Safety Achieved? Safety Decision

Outcomes





Y

N


Y

N


Start




Control / Monitor / Review to Maintain Safety

Goals

Ensure that safety is maintained by

• Establishing controls throughout the life cycle to ensure that safety is maintained

• Monitoring field performance and factors that may impact safety by means of surveillance and follow up

• Periodically reviewing and assessing results and deciding on appropriate actions





Y

N


Y

N


Start





• If present level of safety is being maintained, continue to control, monitor, and review

• If present level of safety is not being maintained, assess and decide on action





Y

N


Y

N


Start




Safety Decision Outcomes

Monitor / Assess Opportunities for Improvement

Goals

Identify, review and assess the need or the opportunity for improvement in

• Safety & safety standards

− Increase level of safety and/or confidence

− Evolving demand (drivers) and/or capabilities

• Processes, methods and tools used to determine whether and how safety is achieved and maintained

− Reduce variations / defects

− Increase consistency





Y

N


Y

N


Start







Y

N


Y

N


Start




• Hazard-Based Safety Engineering• Safety Research• Safety Design• Conformity Assessment• New standards development

• Certification• Market and Conformity Surveillance• Follow-up for Certification Mark Integrity• Updates in regulations, codes, standards • New / emerging technologies that may

benefit / threaten safety

Safety Designers Regulatory Compliance Product Safety Certifiers Standards/Codes Developers Product and Program Safety Managers

Slide 20

• Improvements in regulations, standards, codes

• Improvements in safety assessment processes, methods and tools

• Conformance, Compliance


Application Examples

Meeting the Objective


Improve information sharing – work together to harmonize regulations or notify interested stakeholders

Need Common BasisSafety

(freedom from unacceptable risk)

Need Common MeansManagement

(meet objectives)

Safety ManagementCan support basis & means to meet objectives

ASSET Safety Management ProcessCommon framework for basis & means to meet safety objectives

and other multiple, mutual objectives of stakeholders


Working Together to Close the Loop

Questions / Comments

Slide 23

ASSETSafety Management

Process

Tom Lanzisero

ENDThank You

© 2011 Underwriters Laboratories Inc. All rights reserved. This document may not be reproduced or...

Documents

Transcript of © 2011 Underwriters Laboratories Inc. All rights reserved. This document may not be reproduced or...