Start small and let it spread organically. Allow master teams to customize it. Employ agile at the top. Destroy the barriers to agile behaviors. Agile innovation methods have revolutionized information technology. Over the past 2. 5 to 3. IT teams. Now agile methodologieswhich involve new values, principles, practices, and benefits and are a radical alternative to command and control style managementare spreading across a broad range of industries and functions and even into the C suite. National Public Radio employs agile methods to create new programming. John Deere uses them to develop new machines, and Saab to produce new fighter jets. Intronis, a leader in cloud backup services, uses them in marketing. C. H. Robinson, a global third party logistics provider, applies them in human resources. Mission Bell Winery uses them for everything from wine production to warehousing to running its senior leadership group. And GE relies on them to speed a much publicized transition from 2. By taking people out of their functional silos and putting them in self managed and customer focused multidisciplinary teams, the agile approach is not only accelerating profitable growth but also helping to create a new generation of skilled general managers. The spread of agile raises intriguing possibilities. What if a company could achieve positive returns with 5. What if marketing programs could generate 4. What if human resources could recruit 6. What if twice as many workers were emotionally engaged in their jobs Agile has brought these levels of improvement to IT. The opportunity in other parts of the company is substantial. But a serious impediment exists. When we ask executives what they know about agile, the response is usually an uneasy smile and a quip such as Just enough to be dangerous. They may throw around agile related terms sprints, time boxes and claim that their companies are becoming more and more nimble. But because they havent gone through training, they dont really understand the approach. Consequently, they unwittingly continue to manage in ways that run counter to agile principles and practices, undermining the effectiveness of agile teams in units that report to them. These executives launch countless initiatives with urgent deadlines rather than assign the highest priority to two or three. They spread themselves and their best people across too many projects. They schedule frequent meetings with members of agile teams, forcing them to skip working sessions or send substitutes. Many of them become overly involved in the work of individual teams. They talk more than listen. They promote marginal ideas that a team has previously considered and back burnered. They routinely overturn team decisions and add review layers and controls to ensure that mistakes arent repeated. With the best of intentions, they erode the benefits that agile innovation can deliver. Further Reading. Innovation. Digital Article. Darrell K. Rigby. Jeff Sutherland. Hirotaka Takeuchi. ITs most famous idea didnt start in IT. Innovation is what agile is all about. Although the method is less useful in routine operations and processes, these days most companies operate in highly dynamic environments. They need not just new products and services but also innovation in functional processes, particularly given the rapid spread of new software tools. Companies that create an environment in which agile flourishes find that teams can churn out innovations faster in both those categories. From our work advising and studying such companies, we have discerned six crucial practices that leaders should adopt if they want to capitalize on agiles potential. Learn How Agile Really Works. Some executives seem to associate agile with anarchy everybody does what he or she wants to, whereas others take it to mean doing what I say, only faster. But agile is neither. See the sidebar Agile Values and Principles. It comes in several varieties, which have much in common but emphasize slightly different things. They include scrum, which emphasizes creative and adaptive teamwork in solving complex problems lean development, which focuses on the continual elimination of waste and kanban, which concentrates on reducing lead times and the amount of work in process. One of us Jeff Sutherland helped develop the scrum methodology and was inspired to do so in part by The New New Product Development Game, a 1. HBR article coauthored by another of us Hirotaka Takeuchi. Because scrum and its derivatives are employed at least five times as often as the other techniques, we will use its methodologies to illustrate agile practices. The fundamentals of scrum are relatively simple. To tackle an opportunity, the organization forms and empowers a small team, usually three to nine people, most of whom are assigned full time. The team is cross functional and includes all the skills necessary to complete its tasks. It manages itself and is strictly accountable for every aspect of the work. The teams initiative owner also known as a product owner is ultimately responsible for delivering value to customers including internal customers and future users and to the business. The person in this role usually comes from a business function and divides his or her time between working with the team and coordinating with key stakeholders customers, senior executives, and business managers. The initiative owner may use a technique such as design thinking or crowdsourcing to build a comprehensive portfolio backlog of promising opportunities. Then he or she continually and ruthlessly rank orders that list according to the latest estimates of value to internal or external customers and to the company. The initiative owner doesnt tell the team who should do what or how long tasks will take. Rather, the team creates a simple road map and plans in detail only those activities that wont change before execution. Its members break the highest ranked tasks into small modules, decide how much work the team will take on and how to accomplish it, develop a clear definition of done, and then start building working versions of the product in short cycles less than a month known as sprints. A process facilitator often a trained scrum master guides the process. This person protects the team from distractions and helps it put its collective intelligence to work. The process is transparent to everyone. Team members hold brief daily stand up meetings to review progress and identify roadblocks. They resolve disagreements through experimentation and feedback rather than endless debates or appeals to authority. They test small working prototypes of part or all of the offering with a few customers for short periods of time. If customers get excited, a prototype may be released immediately, even if some senior executive isnt a fan, or others think it needs more bells and whistles. Innovation made by Talents INVENSITY Gmb. HMore and more medical devices depend on software. Therefore the number of reports about problems caused by software is rising dramatically Bf. Ar. M 2. 00. 7. It is necessary to develop software which is error free and safe from the beginning as well as to consider all risks and hazards. A structured and traceable development is essential, because even the smallest mistake during the development of medical devices can result in fatal consequences. For the software development there are no safety instructions and the software for medical devices can be a very complex system. The Assurance Case is used to structure and divide this complex system in parts that are easier to handle. The Assurance Case is a documented line of evidence method which uses a convincing and valid argument to proof the accumulation of critical claims by significant evidences. The structured argumentation and evidence support the reliability of the main claim e. The device is safe. If the main claim refers to the safety of the device like in the given example the Assurance Case can be called Safety Case. Assurance Cases were initially used in the nuclear technology, aerospace engineering and the defense industry where they are mainly used as Safety Cases. The Assurance Case is sub divided in three main categories which are characterized by symbols Claims. The claims have to be in a specific context, which can be in relation to the environment, application, behavior, risks or hazards. The main claim The device is safe, is on the top level. Sub claims which are built hierarchically can characterize the claim further and have to be argued and proven as well. Arguments. Arguments are the link between claim and proof. There are three kinds of arguments Deterministic predetermined rules are applied for a truefalse claim e. Probabilistic quantitative statistical reasoning in order to establish a numerical level e. Qualitative observation of rules that have an indirect link to the desired feature e. QMS standards. Evidence. Evidence can be based on product analysis, on development processes and reliability testing for a new design, field experience for an established design or product review. Assurance Cases are illustrated as diagrams with specific symbols. Like mentioned above, every symbol is assigned to a certain level. This graphical illustration is called Goal Structuring Notation GSN T. Kelly, 1. 99. 8. Thereby goal is used simultaneous for claim. In its simplest form the Assurance Case consists of the three main levels The advantage over other procedure models is its easy traceability due to the graphical illustration. This kind of graphical demonstration can refer to the principle of the software modeling language UML unified modeling language or Sys. ML system modeling language respectively. UML is a standardized graphic modeling language which is used for graphic construction and specification of software parts, but also other types of systems can be represented. Notations which are language elements that are demonstrated as symbols are used. An advanced modeling language for more general systems is Sys. ML, which is more flexible and variable in its appearance than UML. It can be used for analysis, specification, verification and validation of many systems. Next figure shows an example of a typical structure of an Assurance Case Assurance Case application for medical devices. In the field of medical technology the Assurance Case has been developed for generic infusion pumps GIP Figure 3. GIPs belong to the risk class II and III, depending on their usage. Therefore they have very high security and safety requirements. In the US alone, 5. January 2. 00. 5 and December 2. FDA, 2. 01. 0. Due to this enormous error rate the FDA has chosen the Assurance Case as a process model in order to minimize the risk and afford better safety quality. The FDA report 5. Working Group Preliminary Report and Recommendations released in August 2. Assurance Case for premarket notification 5. FDA division CDRH Center for Devices and Radiological Health. II products, which have to be tested by a premarket review before market launch. The CDRH expects a better traceability of the development and safety examination due to application of the Assurance Cases and therefore a faster approval time. In the case of infusion pumps belonging to class II all risks and hazards as well as safety implementation have been described and demonstrated for Assurance Cases. For other medical devices the CDRH has to determine the conditions how to develop the Assurance Case and what is needed to guarantee a good comparability and simplified management. The guidelines have to contain detailed product descriptions of all medical devices with requested approvals and also user descriptions. Furthermore, all modifications since the first release have to be described again. Additional the CDRH has to tutor its reviewers and managers for evaluation of Assurance Cases. This shows some of the challenges for the introduction of Assurance Cases. The Assurance Case refers to very complex systems and the demonstration of evidence is very work intensive. Further it is hard to generalize or reuse the case for different medical devices. The creation of the Assurance Cases and its handling is very labor and time intensive, but on the other hand safety and elimination of errors are the greatest challenges and should have highest priority. It has to be considered that recalls and error reports are not only cost intensive, but also cause damage of the companys image. Assurance Cases are an efficient process model, which in the future can speed up the process of approval and assure highest safety standards at the same time. INVENSITY would like to support and advice you in introduction and implementation of Assurance Cases for your medical device and questions on functional safety. Example of an Assurance Case. The claim described on the top level is The GIP is safe for the patient C1. A strategy that results from this assumption could be to argue all risks and hazards S1. This strategy can be considered in different contexts, for example risks due to user errors by programming Ct. Ct. 4 or wrong application to patients Ct. Ct. 3. Due to the different sub claims and contexts, more and more specific sub claims C1. On the second level the GIP is categorized in different hazards operational hazard, environment hazards, electrical hazards, hardware hazards, software hazards, mechanical hazards, biological and chemicals hazards as well as use hazards. Those categories divide in more detailed sub claims. Sad Rap Beats Mp3 Download. All sub claims have to be proven E1 1. The evidence can be performed in different ways user testing E1. E1. 3 or it can be addressed to documentation E3.