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Showing content with the highest reputation on 09/03/2019 in all areas

  1. In DMADV, focus is on new product/service design, unlike for existing product/service in DMAIC, during the last phase of DMADV, verification of design is performed and whether the design is capable of meeting needs of the customer is validated. Numerous pilot runs will be required to validate and verify the design outcomes. Major aspect of this phase to check whether all metrics which are designed are performing as expected. Conformance to Specification. Some of the common used tools in verify phase includes Control charts, control plans, Flagging, Poka Yoke, check sheets, SOP’s and work instructions. Software Application Design: In a new design viewpoint, Verification is whether Software Application developed in right way & Validation is whether Right Software Application is being produced In simple terms, verification is checking whether the application works perfectly without any errors/bugs and validation is checking whether the application is meeting the requirement and expectation Verification Validation Application and design review, code walk through, code inspection Black Box and White box testing It is static testing It is dynamic testing Performed first Usually performed post verification Verification done without software execution Validation done with software execution Automotive Manufacturing: Reference to a gearbox manufacturing, as per the new design in DMADV process, in actual manufacturing high level steps include preforming, annealing, machining, producing teeth, shaving, grinding and inspection. Here verification is, comparing the gearbox to design requirement of material, dimension, tolerance etc., that is all specs are verified Whereas, in validation, post inspection assembling gearbox and doing a dry run, test it to check whether it runs as expected. Verification Validation Done during development, review and inspection, production and scaleup Usually done before scaleup and after the actual production Random inspection can be done for verification Stringent checks are done during validation Validation can be done directly by skipping verification in some scenarios, especially when we are not able to measure component outcomes or when cost of verification is very high. Medical Devices: Verification usually done on the design: design input, process and the output. It is done by test, inspections and analysis. Validation is checking whether the intended need of the medical device is met Source: U.S. Food and Drug Administration (FDA)
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