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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 ...
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 ...
The process specification defines what must be done to transform inputs into outputs. It is a detailed set of instructions outlining a business procedure that each elementary level business activity is expected to carry out. Process specifications are commonly included as integral components of requirements documents in systems development.
A Publicly Available Specification or PAS is a standardization document that closely resembles a formal standard in structure and format but which has a different development model. [1] The objective of a Publicly Available Specification is to speed up standardization. PASs are often produced in response to an urgent market need. [2]
An open specification is a specification created and controlled, in an open process, by an association or a standardization body intending to achieve interoperability and interchangeability. An open specification is not controlled by a single company or individual or by a group with discriminatory membership criteria.