© 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 2011 Toward 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 Slide 3 © 2011 Underwriters Laboratories Inc. Improve information sharing – work together to harmonize regulations or notify interested stakeholders Need Common Basis Safety (freedom from unacceptable risk) Need Common Means Management (meet objectives) Safety Management Can support basis & means to meet objectives ASSET Safety Management Process Common framework for basis & means to meet safety objectives and other multiple, mutual objectives of stakeholders

ASSET™ Objective Slide 4 © 2011 Underwriters Laboratories Inc. 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 Slide 5 © 2011 Underwriters Laboratories Inc. * - 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 manner  Equalize the playing field  Balance multiple stakeholders and needs Slide 7 ASSET and Standards © 2011 Underwriters Laboratories Inc.

ASSET Process The evolution of hazard-based safety engineering principles 1 and safety science into an overall framework of a safety management process based on risk management / risk assessment 2 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 , ANSI Z690 © 2011 Underwriters Laboratories Inc.

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 Opportunities For Improvement Specify / Identify / Design Protective Measures ASSET™ Safety Management Process Slide 9 © 2011 Underwriters Laboratories Inc.

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 Opportunities For Improvement Specify / Identify / Design Protective Measures Managing the Process & Interactions Slide 10 © 2011 Underwriters Laboratories Inc. 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 Slide 11 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

Determine Scope / Context 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) © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

Identify / Analyze Hazards 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 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

Specify / Identify / Design Protective Measures 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 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

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 Slide 15 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

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 Slide 16 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

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 Slide 17 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

Present Level of Safety Maintained? 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 Slide 18 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures 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 Slide 19 © 2011 Underwriters Laboratories Inc. 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 Opportunities For Improvement Specify / Identify / Design Protective Measures

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 Opportunities For Improvement Specify / Identify / Design Protective Measures 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 © 2011 Underwriters Laboratories Inc. Application Examples

Meeting the Objective Slide 21 © 2011 Underwriters Laboratories Inc. Improve information sharing – work together to harmonize regulations or notify interested stakeholders Need Common Basis Safety (freedom from unacceptable risk) Need Common Means Management (meet objectives) Safety Management Can support basis & means to meet objectives ASSET Safety Management Process Common framework for basis & means to meet safety objectives and other multiple, mutual objectives of stakeholders

Slide 22 © 2011 Underwriters Laboratories Inc. Working Together to Close the Loop

Questions / Comments Slide 23

ASSET Safety Management Process Tom Lanzisero END Thank You