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THE PHARMA REVIEW (MAY 2009)

Quality Audit: A Tool to Review Quality System

Rashmin B. Patel, Mrunali R. Patel

Abstract: Quality audit is a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. 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 organization’s quality management system and is a key element in the ISO quality system standard. Quality audits are typically performed at predefined time intervals and ensure that the organization has clearly-defined internal quality monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria. With the upgrade of the ISO series of standards from the 1994 to 2000 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS. Quality audits can be an integral part of compliance or regulatory requirements. Audits can also be used for safety purposes. Quality Audit can save organizations from quality disasters. The goal of this article is to provide brief information regarding quality audit and it’s importance in continuous improvement of any quality system.
 
Introduction
A major development in Operations Management over the past two decades has been the use of quality audits to gauge the effectiveness of quality management systems in manufacturing and service organizations. Quality is defined as the ensemble of features and attributes which characterize a product or a service, and indicate its capacity to provide an implicit or explicit need (Quality means degree or level of excellence). The word ‘‘audit’’ comes from the Latin and means ‘‘the act of hearing.’’ The contemporary dictionary definition includes ‘‘formal or official examination or verification’’ and ‘‘methodical examination and review.’’ The word ‘‘inspection’’ also comes from the Latin, means to look. Audit and inspection are often used interchangeably; both convey that organizational activities are subject to on-site, external, review. Audits can be internal, but are most often a part of an external certification process conducted by national governmental or professional bodies. The contemporary definition of audit is ‘‘to examine officially or to test against established standards. The International Standard ISO 10011-1 (1990) defines the ‘‘Quality Audit’’ as: ‘‘. . . a systematic and independent examination to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives’’. These audits provide an independent assessment of conformance and the effectiveness of the organization’s operating systems against predefined standards such as the ISO 9001–2000 quality standard. According to Quality Systems used in organization, Quality Audit is a continuing process of testing the Quality Systems in use in the organization to check if the systems are effective, documented and being adhered to by the working staff.4 It consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it. 

 

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