About This Book If you want to achieve functional safety on a project, technically, the hardware and software must be SIL-compliant. But how do you achieve that? With functional safety management. FSM is at the heart of all SIL projects. If you understand FSM and you apply it correctly, every project will achieve compliance and, thus, SIL. In this book, the author explains the five core concepts that are at the basis of achieving functional safety. If you master these five concepts, your SIL projects will: - Will be completed faster. - Will be completed within budget. - Lead to profitable products and services. - Have more competent employees. Functional safety management is a requirement in all functional safety standards. Your product, service, solution, operation, maintenance and repair depend on it. You could not claim compliance with the standards if you did not implement functional safety management. Yet many companies do. This is no problem as long as no accidents happen. Table of Contents Terms and Definitions 9 Preface 11 Introduction 13 Who is this book for? 13 Functional safety management as a strategy 14 Laws, standards and functional safety management 16 How to Read This Book 17 What is functional safety? 21 Three types of failures 22 What it means to be functionally safe 24 Measuring functional safety 25 What does functional safety mean in practice? 26 Functional safety management 29 Why do we need functional safety management? 29 Innovation is not our problem, (lack of) management is 34 QM, PM, and now FSM? 35 History of functional safety management 37 Objectives of functional safety management 43 Who implements functional safety management? 43 Who manages functional safety management? 44 Five Core Functional Safety Management Concepts 46 Core concept #1 - Safety Life Cycle 48 Companies often have no clue 48 A safety life Cycle Is a management tool 49 Focus the work 50 One safety life cycle Template 55 Example Safety life cycle phase - Safety requirements specification 56 The Safety life cycle as a Planning and Management tool 60 The IEC 61508 overall life cycle explained 62 A safety life cycle for every stakeholder 70 Examples of Different safety life cycle models 72 What (Functional Safety) managers need to know about safety life cycles 79 What professionals need to know 81 Core concept #2 - Competency 82 Smart but incompetent is Lethal combination 82 Work needs to be carried out by competent professionals 84 Competence versus competency 85 Four pillars of competency 86 Who should be competent in what? 91 Proving competency 93 Roles and Role Definitions 96 Certification of people 99 Safety passport® 112 What managers need to know 114 What Professionals need to know 116 Core concepts #3 Verification, Validation, Assessment & Audit 118 Testing made the difference 118 Competent professionals can make mistakes 120 Verification 121 Verification Report 128 What managers need to know 129 What Professionals need to know 130 Validation 131 Validation Test Report 137 Verification versus validation 139 What managers need to know 140 What professionals need to know 141 Assessment 142 Assessment Report 145 What managers need to know 147 What professionals need to know 148 Audits 149 The functional safety audit report 154 No assessments in the operational phase? 155 What managers need to know 155 What professionals need to know 157 Core concept #4 - Documentation 159 Documentation matters 159 Documentation, the necessary evil 162 Keep in mind 166 Quality matters, not quantity 168 Technically correct and formally correct 169 What managers need to know 170 What Professionals need to know 172 Core concept #5 - Procedures 173 Procedures can make you or Break you 173 Phase One Functional Safety Management System 175 Competency Procedure 176 Supplier procedure 178 Tools procedure 180 Configuration Management procedure 182 Modification procedure 185 Communication Procedure 191 Phase Two Functional safety management System 193 What managers need to know 195 What Professionals need to know 197 What is next? 198 About The Author 203