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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
Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete.
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 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 ]
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.
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.