Agile Methods for Safety-Critical Systems: A Primer Using Medical Systems
Nancy Van Schooenderwoert and Brian Shoemaker, CreateSpace Independent Publishing Platform, 2018, 130 pp., $40 (book).
Quality and safety are integral aspects of software-driven medical and diagnostic devices. The authors lament that ensuring quality, safety and performance through validation and documentation often is viewed by organizations as an unavoidable cost and not as a benefit. The authors saw an alternative to this outlook in an approach used by agile teams that integrated quality control activities into the development process leading to better and safer products.
The book is organized into 12 chapters. The first part of the book provides a detailed explanation of the agile method and its origins. The authors contend that agile is a mindset and, in the software world, is established through four values, grounded by 12 principles, and manifested through many different practices. The dual feedback loop comprised of agile management practices and agile technical practices is discussed.
The culture of learning and the ability to document incrementally is the benefits of agile. This helps fulfill legal and regulatory obligations pertaining to various aspects including traceability, safety, risk and design. The fourth chapter deals with applying agile principles. There is no one way of implementing agile and they share several agile implementation situations.
The book details forming agile teams, documentation and risk management. The rest of the book details agile project implementation, such as planning techniques, and impact and story-mapping techniques. The last part of the book discusses how to track progress and accelerate learning when using agile. The last chapter discusses maintaining agile.
This book is written in a simple and readable manner with emphasis on understanding and implementation. Theory is kept to a minimum. This book should be in the reading list of quality professionals and those appearing for the ASQ certification exams.
Alka Jarvis, Luis Morales, Johnson Jose, ASQ Quality Press, 2018, 204 pp., $45 member, $75 list (book).
The telemetry method to enhance customer satisfaction by proactively recognizing and addressing problems experienced by the end user throughout the product or service life cycle has been rarely used. Telemetry is “an automatic way of collecting data at remote sites or locations and transmitting the data to collectors at the receiving equipment for monitoring, analyzing, and taking appropriate actions based on the insights provided by the data analytics.” The insights gained through this adoptive method will result in more cost effective and efficient customer service.
The book is structured in six chapters. Chapter one provides a basic introduction to several topics, such as customer experience, technological tipping points for productivity and growth, proactive versus corrective and preventive actions, and change in management.
Chapter two provides a detailed overview of telemetry and telemetry structures and compares past and newly developed methods. Chapter three covers the use of data, its classification, quality, protection, security and storage, and the use of various databases. It also includes a case study on the use of automation leading to improved customer experience.
Chapters four and five focus on the application of telemetry in a software development organization and the required talent for successful integration. Also included is a list of risk factors considered in designing a telemetry-enabled system. In the concluding chapter the previous five chapters are summarized and include examples of the application.
This book is a valuable resource for those are tasked with development and implementation of a telemetry-based system in organizations with the capacity and desire for enhanced and sustainable customer loyalty programs beyond the use of traditional methods of measuring customer satisfaction.