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In 21CFR820.3 (h), design review is described as "documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems". The FDA also specifies that a design review should include an independent reviewer.
The SDR is a technical review conducted to evaluate the manner in which a project's system requirements have been allocated to configuration items, manufacturing considerations, next phase planning, production plans, and the engineering process that produced the allocation. This review is conducted when the system definition is at a point where ...
Advanced product quality planning. Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation but has similarities to Design for Six Sigma (DFSS).
Business continuity planning life cycle. Business continuity may be defined as "the capability of an organization to continue the delivery of products or services at pre-defined acceptable levels following a disruptive incident", [1] and business continuity planning [2] [3] (or business continuity and resiliency planning) is the process of creating systems of prevention and recovery to deal ...
Constructability (or buildability) is a concept that denotes ease of construction. It can be central to project management techniques to review construction processes from start to finish during pre-construction phase. Buildability assessment is employed to identify obstacles before a project is actually built to reduce or prevent errors ...
Manufacturing readiness level. The manufacturing readiness level (MRL) is a measure to assess the maturity of manufacturing readiness, similar to how technology readiness levels (TRL) are used for technology readiness. They can be used in general industry assessments, [1] or for more specific application in assessing capabilities of possible ...
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. [1] The ultimate design review, if successful, therefore triggers the ...
Assumption-based planning. Assumption-based planning in project management is a post-planning method that helps companies to deal with uncertainty. It is used to identify the most important assumptions in a company's business plans, to test these assumptions, and to accommodate unexpected outcomes.