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Recommended minimum process capability for two-sided specifications Recommended minimum process capability for one-sided specification Existing process 1.33 1.25 New process 1.50 1.45 Safety or critical parameter for existing process 1.50 1.45 Safety or critical parameter for new process 1.67 1.60 Six Sigma quality process 2.00 2.00
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. (ISO 7870-1) [1] The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line.
Sample Production Parts A sample from the same lot of initial production run. The PPAP package usually shows a picture of the sample and where it is kept (customer or supplier). Master Sample A sample signed off by customer and supplier, that usually is used to train operators on subjective inspections such as visual or for noise. Checking Aids
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
Today industry and ISO also do a lot of this standardization specification, freeing the U.S. DOD and military to do less of it (as explained at United States Military Standard > Origins and evolution), although many MIL standards are still current. (See also MS-and NAS.) ANN: anneal, annealed: ANSI: American National Standards Institute
A key aspect of specification by example is creating a single source of truth about required changes from all perspectives. When business analysts work on their own documents, software developers maintain their own documentation and testers maintain a separate set of functional tests, software delivery effectiveness is significantly reduced by the need to constantly coordinate and synchronise ...
A design specification (or product design specification) is a document which details exactly what criteria a product or a process should comply with. [1] If the product or its design are being created on behalf of a customer , the specification should reflect the requirements of the customer or client. [ 2 ]
Copies of Open Specifications are available free of charge or for a moderate fee and can be implemented under reasonable and non-discriminatory licensing (RAND) terms by all interested parties. Specifications should not be confused with standards. Many standards and specification are touted as open while falling short in practice.