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Process performance qualification protocol. Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production ...
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). According to the Automotive Industry Action Group ...
Production part approval process. Production Part Approval Process (PPAP) is used in the Aerospace or automotive supply chain for establishing confidence in suppliers and their production processes. Actual measurements are taken from the parts produced and are used to complete the various test sheets of PPAP.
First article inspection. A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [1] The purpose of process validation is to ensure ...
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap. SPC can be applied to any process where ...
Condition monitoring (colloquially, CM) is the process of monitoring a parameter of condition in machinery (vibration, temperature etc.), in order to identify a significant change which is indicative of a developing fault. It is a major component of predictive maintenance.
The positive predictive value (PPV), or precision, is defined as = + = where a "true positive" is the event that the test makes a positive prediction, and the subject has a positive result under the gold standard, and a "false positive" is the event that the test makes a positive prediction, and the subject has a negative result under the gold standard.