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Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [1] outlining best practices regarding business process validation in the pharmaceutical ...
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.
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).
Appearance Approval Report A copy of the AAI (Appearance Approval Inspection) form signed by the customer. Applicable for components affecting appearance only. 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 ...
Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1]
In this stage all production processes and manufacturing equipment is proofed to confirm quality and output capabilities. Critical quality attributes are evaluated, and critical process parameters taken into account, to confirm product quality. Once the process qualification stage has been successfully accomplished, production can begin.
Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects. Application of statistical control came later as a result of World War production methods, which were advanced by the work done of W. Edwards Deming , a statistician , after whom the Deming Prize for ...
The purpose of a technical peer review is to remove defects as early as possible in the development process. By removing defects at their origin (e.g., requirements and design documents, test plans and procedures, software code, etc.), technical peer reviews prevent defects from propagating through multiple phases and work products and reduce the overall amount of rework necessary on projects.