ComplianceOnline

Design for Safety

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Manufacturers of any product—from medical devices to automobiles—must create items that are, above all else, safe to use. Not only is this essential to long-term brand value and corporate success, but it’s also required by law. But while perfection is the goal, defects are bound to occur, especially in advanced products such as automobiles. When a safety defect does occur, auto manufacturers must initiate some form of recall to address the problem. Since 2013, the number of automotive recalls climbed to an average of 177 per year, up 86% from the prior experience around 1980. Product liability from negligence can present a substantial problem for organizations.

Event Type:
Conference/Seminar
Date:
May 14-15, 2020
Location:
Detroit , MI , USA

They can result in liability of the manufacturerfor deaths, injuries, fatalities, or property damagecaused by its products. They can save millions of dollars by preventing recalls of their products proactively. The automotive component suppliers are also responsible for safety if they design the components and subsystems.

The aerospace industry needs to improve also. A poll conducted by the Performance Review Institute (PRI) in January 2010 showed that 88% of respondents felt that their company could do a better job of measuring escapes. An escape is where defective product has been shipped to the customer prior to being identified as faulty, hence it has “escaped”.

Aerospace escapes need to be taken very seriously. When they are not recognized, escapes can cause fatalities. Flawed parts have been fitted in commercial planes without anyone realizing or recognizing them as flawed parts. As a result, a number of airline crashes have occurred due to faulty fuel lines or hydraulic fittings. In another case, 20,000 parts processed improperly had to be recalled at a cost of $20,000,000. A good example of an escape is Boeing 737 Max.

This seminar is for all the industries, all suppliers of components in any industry developing software, consumer products and services.

  • Learn the art of risk prediction
  • Risk Management Methods
  • Understand different risk analysis tools
  • Learn how to write robust safety specifications
  • Understand the art of aiming at zero accidents by using the knowledge of High Reliability
  • Understand that we are now dealing with complex systems called System of Systems
  • Developing checklists for developers and auditors
  • Operating & Support Hazard Analysis
  • Accelerated life testing
  • Hazards tracking
  • Complying with regulations
  • Verification techniques
  • Validation process
  • Senior Management responsibility

The topics of the seminar are from the most reputable organizations for safety. They are:

  • How to avoid writing vague, and incomplete specification
  • How to develop robust performance requirements to meet customer expectations for zero accidents
  • System safety concepts
  • New paradigms for avoiding liability
  • How to prevent scope creeps resulting in requirements volatility and design instability
  • Functional Hazard Analysis to prevent hazards
  • Functional process maps, activity diagrams, and sequence diagrams to prevent accidents
  • Preliminary hazard analysis
  • Subsystems hazard analysis
  • Interface hazard analysis
  • Operations & Support Hazard Analysis
  • Safety requirements for manufacturing, maintenance and repair
  • Human systems integration and accountability
  • Software safety analysis tools
  • How Subject Matter Experts work and brainstorm together for safety verification and validation
  • Management policy and accountability for product safety

This is a hands-on seminar. You can bring your company concerns and get solutions from your fellow attendees and the instructor who has 30 years of consulting experience worldwide.

  • Top management
  • Chief engineers in design and manufacturing
  • R&D staff
  • Design Engineers
  • Manufacturing managers and engineers
  • Safety staff
  • Quality Assurance staff
  • Marketing staff

Day 01(8:30 AM - 4:30 PM)
  • 08:30 am - 09:00 am - Registration
  • 9:00 AM -10:00 AM
    • Why Design for Safety?
    • What is a System?
    • What is System Safety?
    • Reflections on the Current State of the Art
  • 10:00 AM -11:00 AM
    • Ten Paradigms for Design for Safety
    • Develop a Comprehensive Safety Training y Operators and
    • Maintainers
    • Create Your Own Paradigms
  • 11:00 AM -12:00 Noon
    • Tools of the Trade
    • Benefits of System Safety
    • System Safety Management
    • Integrating System Safety into the Business Process
  • 12:00 NOON -1:00 PM Lunch
  • 1:00 PM-2:00 PM
    • Management Methods and Concepts
    • Software Tools
    • Design Concepts and Strategy
  • 2:00 PM-3:00 PM
    • Systems Engineering V-Model
    • Writing good performance specifications
    • System Testing
    • Risk Management
  • 3:00 PM - 4:00 PM
    • Safety Integrated in Systems Engineering
    • Key Interfaces
    • System Safety Program Plan
    • Safety Assessment Report
  • 4:00 PM -4:30 PM
    • Safety Tasks
    • An Introduction to Product Liability Law
    • Negligence
    • Warnings
Day 02(8:30 AM - 04:30 PM)
  • 8:30 AM-8:59 AM Registration Meet & Greet.
  • 9:00 AM -10:00 AM
    • Seminar objectives review, expectations and scope.
    • The Rush to Market and the Risk of Unknown Hazards
    • Warranty
    • Safety Requirement Specification
  • 10:00 AM -11:00 AM
    • Hazard Control Requirements
    • Negative versus Positive Requirements
    • Types of Checklists
    • Use of Checklists
  • 11:00 AM -12:00 NOON
    • Hazard Analysis Tools
    • Preliminary Hazard List
    • Preliminary Hazard Analysis8
    • Subsystem Hazard Analysis)
    • System Hazard Analysis
  • 12:00 NOON -1:00 PM Lunch
  • 1:00 PM-2:00 PM
    • The Design FMECA
    • How Are Single Point Failures Eliminated or Avoided
    • Software Design FMECA
    • Process FMECA?
  • 2:00 PM-3:00 PM
    • Fault Tree Analysis for System Safety
    • Event Tree Analysis
    • Sneak Circuit Analysis
    • Management Oversight Risk Tree (MORT)
  • 3:00 PM-4:00 PM
    • Safety Testing
    • Test Strategy and Test Architecture
    • Develop System Safety Test Plans
    • The Value of PHM for System Safety Testing
  • 4:00 PM-4:30 PM
    • Key Interfaces for Safety Engineering
    • Design for Reliability Integrated with Safety
    • Conclusions

Dev Raheja, MS, CSP, author of the books Design for Reliability, Assurance Technologies Principles and Practices, and Preventing Medical Device Recalls, is an international risk management, reliability, and system safety consultant for government, commercial and aerospace industry for over 30 years. His clients include Army, Navy, Air Force, NASA, Siemens, Eaton, Boeing, Lockheed, Northrup Grumman, General Motors, Prior to becoming a consultant in 1982 he worked at GE as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries. He teaches “Design for Reliability and “Design for Safert” courses at the University of Maryland for degree programs in Mechanical Engineering and Reliability Engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, and former chair of the Reliability Division. He is a Senior Member of IEEE. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. His served as Vice president of the International System Safety Society where he received the Scientific Achievement Award and the Educator-of-the-Year Award. He served on the Board of Directors for the Annual Reliability and Maintainability Symposium for more than 10 years.

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