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Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001 .
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 quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). [1]
A quality audit is a process that involves the systematic identification and examination of a production quality system. A Certified Quality Auditor must analyze all elements of a quality system and assess its degree of adherence to the applicable industry criteria. This is described in detail in Russell. [2]
Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome. Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome.
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. Process Performance Qualification [8] is the second phase of process validation.
The plan–do–check–act cycle is an example of a continual improvement process. The PDCA (plan, do, check, act) or (plan, do, check, adjust) cycle supports continuous improvement and kaizen. It provides a process for improvement which can be used since the early design (planning) stage of any process, system, product or service.
The suite of documents associated with a particular version of the CMMI includes a requirements specification called the Appraisal Requirements for CMMI (ARC), [2] which specifies three levels of formality for appraisals: Class A, B, and C. Formal (Class A) SCAMPIs are conducted by SEI-authorized Lead Appraisers who use the SCAMPI A Method Definition Document (MDD) [3] to conduct the appraisals.