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Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
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 process.
A process capability analysis may be performed on a stable process to predict the ability of the process to produce "conforming product" in the future. A stable process can be demonstrated by a process signature that is free of variances outside of the capability index. A process signature is the plotted points compared with the capability index.
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 ]
Manufacturing process management (MPM) is a collection of technologies and methods used to define how products are to be manufactured. MPM differs from ERP/MRP which is used to plan the ordering of materials and other resources, set manufacturing schedules, and compile cost data.
Margins can be narrowed through various process upgrades (i.e. equipment upgrades, enhanced control methods, etc.). Once margins are narrowed, an economic analysis can be done on the process to determine how the set point target is to be shifted. Less conservative process set points lead to increased economic efficiency. [11]
Layers of protection analysis (LOPA) is a technique for evaluating the hazards, risks and layers of protection associated with a system, such as a chemical process plant. . In terms of complexity and rigour LOPA lies between qualitative techniques such as hazard and operability studies (HAZOP) and quantitative techniques such as fault trees and event trees.
The process capability is a measurable property of a process to the specification, expressed as a process capability index (e.g., C pk or C pm) or as a process performance index (e.g., P pk or P pm). The output of this measurement is often illustrated by a histogram and calculations that predict how many parts will be produced out of ...