![]() ![]() A more critical thinking needs to take place when assessing risks and evaluating hazards behind a product, process, or system features. The “adjusting screws” that the quality system offers for risk-based approach should fully be exploited to gain efficiencies. With that, the test strategy is at a very early stage defined for each sprint, so that the preparation of test scripts can start immediately and in parallel to development. In an agile project it is recommended to conduct this assessment at the very start of each sprint for the defined SPIs in scope. The functional risk assessment is one other form of applying risk-based validation, by tailoring the validation test scope and test extent, where reasonable, to the risk-level of a function or feature. Depending on the outcome, the validation planning is regularly reviewed and CSV deliverables are added or changed as needed with justification. During the project this evaluation should be revisited on a more detailed level as recurring activity, e.g., as integral part of the backlog refinement or sprint planning process. with an assessment of the until then known high-level scope and critical key areas and capabilities. However, for agile endeavors this practice is even more important to handle changes that will occur over the time efficiently.įor applying risk-based approach, a system’s risk evaluation is recommended at project initiation, i.e. A risk-based approach is not new and is applied in “waterfall world” as well. At the same time, those parts of the quality system should be identified and adapted on a risk basis, which are flexible to be trimmed to agile project needs. The Validation Manager must know existing guardrails and constraints of the current quality system. The Validation Report then verifies and confirms whether the defined DoD criteria on release level were met.įor a system’s validation in an agile setting, the main CSV deliverables will mostly be the same compared to waterfall model. I recommend documentation of all DoR/DoD criteria with different levels needed in the Validation Plan. On release level, the DoD criteria should be defined as well. DoD is confirmed and approved in the Sprint Review meeting. This includes CSV related activities next to development work. Tasks to achieve DoD on sprint level are completed within the sprint. In the Sprint Planning Meeting, which kicks-off the next sprint, the DoR is officially confirmed by the team and product owner, then considered as sprint backlog item (SPI). ![]() DoR is elaborated for a product backlog item as part of the backlog refinement, prioritization, and sprint planning processes. For a closer integration of CSV with the agile development and to ensure that the validation activities are on track with the sprint-wise development, DoR and DoD should be extended with some CSV relevant criteria. ![]() In this context, the agile concepts of ‘Definition of Ready’ (DoR) and ‘Definition of Done’ (DoD) are also quality gates, i.e., a defined checklist for a common alignment on the status of product backlog items at a certain stage. Quality Gates are important for ensuring that a project is on track with the planned deliverables. The validation manager must work even closer together with the entire project team, e.g., by active participation in the scrum ceremonies or by parallelizing different CSV deliverables activities. In fact, as it is the agile nature that a product is evolving over time, an increased focus and effort on coordination, alignment, regular reviews, and impact analysis is needed from validation perspective. ![]() But this is not true, agile validation cannot compensate inefficient CSV processes per se, which are defined in the own Quality System. I have observed a general misconception that with agile validation less effort or less documentation is expected (compared to a waterfall CSV approach). This article shares best practices and observations and gives insights to some concrete activities that should be considered during the course of such a project. Likewise, the agile development approach is recommended to be described in the Validation Plan. Like the agile ceremonies and artifacts, the CSV tasks should be an integral part of the overall agile project planning. The first part of this series describes thorough preparation of some key topics before the start of the project to set a good foundation for this endeavor. Fitting an agile development project into a waterfall-driven CSV framework and quality system can be a challenge. ![]()
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