Functional Safety Management

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

There is no shortage of material that expounds the theory of functional safety, but precious little about the practice i.e. actual implementation in what is sometimes called the 'real world', where we routinely meet a variety of constraints that do not allow the theoretical model to be fully realised. This book is intended to bridge that gap. Readers are provided with the considerations that should inform their choices and judgements. The focus is on the process industries, but most of the material will have a direct 'read across' to other sectors. Questions considered include: * Functional safety misrepresentations and misunderstandings * Disconnects between theory & practice * SIL determination issues and ALARP considerations * How and when to use engineering judgement * How to manage competence * How to address systematic capability * How to handle legacy plant * Trip setting nomination & process safety time * Certification v 'Prior-Use' * How to validate failure rates during operation * How to manage useful life expiry * How to manage proof testing * What to expect from the regulator

Safety Critical Systems Handbook: A Straightfoward Guide to Functional Safety, IEC 61508 (2010 Edition) and Related Standards, Including Process IEC 61511 and Machinery IEC 62061 AND ISO 13849, Third Edition, offers a practical guide to the functional safety standard IEC 61508. The book is organized into three parts. Part A discusses the concept of functional safety and the need to express targets by means of safety integrity levels. It places functional safety in context, along with risk assessment, likelihood of fatality, and the cost of conformance. It also explains the life-cycle approach, together with the basic outline of IEC 61508 (known as BS EN 61508 in the UK). Part B discusses functional safety standards for the process, oil, and gas industries; the machinery sector; and other industries such as rail, automotive, avionics, and medical electrical equipment. Part C presents case studies in the form of exercises and examples. These studies cover SIL targeting for a pressure let-down system, burner control system assessment, SIL targeting, a hypothetical proposal for a rail-train braking system, and hydroelectric dam and tidal gates. The only comprehensive guide to IEC 61508, updated to cover the 2010 amendments, that will ensure engineers are compliant with the latest process safety systems design and operation standards Helps readers understand the process required to apply safety critical systems standards Real-world approach helps users to interpret the standard, with case studies and best practice design examples throughout

This book explains the decision-making processes for the management of instrumented protective systems (IPS) throughout a project's life cycle. It uses the new IEC 61511 standard as a basis for the work processes used to achieve safe and reliable process operation. By walking the reader through a project's life cycle, engineering, maintenance, and operations, the information allows users to easily focus on their responsibilities and duties. Using this approach, the book is useful as a primer, guidelines reference, and resource manual. Examples provide the added "real-world" experience applications.

This book aims to facilitate and improve development work related to all documents and information required by functional safety standards. Proof of Compliance (PoC) is important for the assessor and certification bodies when called up to confirm that the manufacturer has developed a software system according to the required safety standards. While PoC documents add functionality to the product neither for the developer nor for the customer, they do add confidence and trust to the product and ease certification, and as such are important for the product’s value. In spite of this added value, the documentation needed for PoC is often developed late in the project and in a haphazard manner. This book aims at developers, assessors, certification bodies, and purchasers of safety instrumented systems and informs the reader about the most important PoC documents. A typical PoC documentation encompasses 50 to 200 documents, several of which are named in the safety standards (e.g., 82 documents in IEC 61508:2010 series, 101 documents in EN 5012X series and 106 work products in ISO 26262:2018 series). These documents also include further references, typically one to twenty of them, and the total number of pages developed by the manufacturer varies between 2000 and 10000 pages. The book provides guidance and examples what to include in the relevant plans and documents.

Contains practical insights into automotive system safety with a focus on corporate safety organization and safety management Functional Safety has become important and mandated in the automotive industry by inclusion of ISO 26262 in OEM requirements to suppliers. This unique and practical guide is geared toward helping small and large automotive companies, and the managers and engineers in those companies, improve automotive system safety. Based on the author’s experience within the field, it is a useful tool for marketing, sales, and business development professionals to understand and converse knowledgeably with customers and prospects. Automotive System Safety: Critical Considerations for Engineering and Effective Management teaches readers how to incorporate automotive system safety efficiently into an organization. Chapters cover: Safety Expectations for Consumers, OEMs, and Tier 1 Suppliers; System Safety vs. Functional Safety; Safety Audits and Assessments; Safety Culture; and Lifecycle Safety. Sections on Determining Risk; Risk Reduction; and Safety of the Intended Function are also presented. In addition, the book discusses causes of safety recalls; how to use metrics as differentiators to win business; criteria for a successful safety organization; and more. Discusses Safety of the Intended Function (SOTIF), with a chapter about an emerging standard (SOTIF, ISO PAS 21448), which is for handling the development of autonomous vehicles Helps safety managers, engineers, directors, and marketing professionals improve their knowledge of the process of FS standards Aimed at helping automotive companies—big and small—and their employees improve system safety Covers auditing and the use of metrics Automotive System Safety: Critical Considerations for Engineering and Effective Management is an excellent book for anyone who oversees the safety and development of automobiles. It will also benefit those who sell and market vehicles to prospective customers.

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.

This book highlights the current challenges for engineers involved in product development and the associated changes in procedure they make necessary. Methods for systematically analyzing the requirements for safety and security mechanisms are described using examples of how they are implemented in software and hardware, and how their effectiveness can be demonstrated in terms of functional and design safety are discussed. Given today’s new E-mobility and automated driving approaches, new challenges are arising and further issues concerning “Road Vehicle Safety” and “Road Traffic Safety” have to be resolved. To address the growing complexity of vehicle functions, as well as the increasing need to accommodate interdisciplinary project teams, previous development approaches now have to be reconsidered, and system engineering approaches and proven management systems need to be supplemented or wholly redefined. The book presents a continuous system development process, starting with the basic requirements of quality management and continuing until the release of a vehicle and its components for road use. Attention is paid to the necessary definition of the respective development item, the threat-, hazard- and risk analysis, safety concepts and their relation to architecture development, while the book also addresses the aspects of product realization in mechanics, electronics and software as well as for subsequent testing, verification, integration and validation phases. In November 2011, requirements for the Functional Safety (FuSa) of road vehicles were first published in ISO 26262. The processes and methods described here are intended to show developers how vehicle systems can be implemented according to ISO 26262, so that their compliance with the relevant standards can be demonstrated as part of a safety case, including audits, reviews and assessments.

This ebook explains what SIL and functional safety means in a nutshell. The book is intended for everybody who is new to functional safety and SIL and wants to have a full overview without being lost in the details. It is excellent for managers that need to understand quickly what functional safety is all about and how it will influence the work of their employees and their products and/or services. It is excellent for engineers and professionals that want to get started with functional safety and understand the big picture before going into detail. Many standards, guidelines and other publications exist that talk about functional safety. All of them with their own level of detail. This book does not to go into the details of what has to be done according to what standard and what not. It explains main functional safety concepts so that you know everything you need to know to get started. Functional safety is not rocket science and once you understand it and applied it a few times in practice you will notice it is just good engineering practice. This book tries to explain that good engineering practice. Functional safety standards can be confusing and contradicting at times and sometimes they require things that make no sense. You do not need to understand the standards in order to apply and be good at functional safety. If you understand the concepts explained in this book you can apply functional safety into your organisation and to your products, with or without following the exact requirements of standards. Actually once you understand how functional safety works you most likely will go beyond what standards say and create your own functional safety organisation of excellence. And if you do that, well then you are well on your way in becoming a longtime winner as suppose to a short term fuse.