CQ Enterprise Quality Management System (EQMS) & Quality Audit Quality audit is a verification effort intended at evaluating the degree of conformance to meet a standard specification or procedure of the product, design, process, or system. The quality audit has two components: one is the analysis of the system within which the items of product or service are brought into being and is called the quality system audit. The other one is an analysis of the items themselves, which is called product or service quality audit Request a Demo Quality auditing is the systematic, independent, and documented review and evaluation of an organization’s quality management system (QMS) to determine whether quality activities and results comply with a strategic arrangement that is effectively implemented and appropriate to achieve the objectives. A quality audit is typically conducted by an internal or external quality auditor or audit team at agreed time intervals, ensuring that an organization has a clearly defined system for quality monitoring. It is an essential element of the ISO 9001 quality system standard. To ensure the greatest benefit for an organization, audits are crucial for assessing the success of processes, products, and systems whether it is existing or newly-implemented. This is an important tool for:
An auditor is a person who understands the business and industry standards and conducts an audit as per the standards. Quality auditors can be one of two categories, external or internal. An internal auditor is an employee of the company being audited whereas an external auditor is a third party hired from an approved agency, customer or client to evaluate the quality system or products. There are different types of quality audits, broadly categorized as follows:
First-party, second-party, and third-party audits
Audit is carried out either by trained members of an organization’s own staff (internal quality audit) or by hired professional auditors from outside the organization (external quality audit). The process of quality audits can be divided as follows: The initial step in the quality audit process is starting the quality audit. Initiating quality audits involves a preliminary discussion between the three parties concerned, the client, the auditee, and the auditing organization. The three parties discuss the objective of the proposed audit, the reference standards against which documentation and activities are compared, the auditors to be used, and the time of the audit. They can speak for and take decisions on behalf of the managers of their organization during the discussion. Mutual understanding and agreement will enable the auditee and the auditing organization to execute their activities efficiently. Audit planning by the auditing organization comprehends several activities by implying actions and reactions from the three involved parties in the audit including scheduling the audit, the number of resources needed for the audit, gathering working papers for the audit, reporting the results, determining the sampling procedures in the audit and following up on corrective actions. After the quality audit initiation and planning, the auditor starts to undertake various activities including evaluating process and system controls, interviewing employees, on-site audit management, and regular communication with other relevant parties within the organization. Audit execution is often called ‘fieldwork’ and it concludes with the final discussion between the auditor and the auditee. The audit report outlines the results of an auditor’s observation made, inspection, or test results obtained providing accurate data on management, conformances, and nonconformances found along with any recommended corrective actions that need to be taken. It also allows an organization to track performance and quality effectively, find out areas for continuous improvement, and emphasize any achievements. Organizations implement the ISO 9000 group of standards to achieve compliance for their commitment to quality management. Often, manufacturers, large and small-sized businesses, and other companies address potential quality gaps to provide the best possible product or service to customers and clients. While many companies are making the move towards compliance, many do not. Here are some of the most common reasons for quality audit failure:
Quality audit is an effective management tool conducted to check the causes of poor quality, corrective action taken, and the confirmation or verification activities undertaken related to quality. It not only detects the problems and defects in the quality management system but also helps improve and resolve them based on broad findings and recommendations. The principles behind quality audit are as follows:
Quality audit is an effective management tool conducted to check the causes of poor quality, corrective action taken, and the confirmation or verification activities undertaken related to quality. It not only detects the problems and defects in the quality management system but also helps improve and resolve them based on broad findings and recommendations. The principles behind quality audit are as follows:
Quality audit provides the objective evidence based on which decisions on the system and its implementation and improvements can be made effectively. Additionally, the management wants a quality audit to control operations and ensure that the policies and procedures are being followed and contribute to the health of the business. There are various advantages of implementing quality audits properly in organizations.
Auditors should have the knowledge and skills in audit principles, procedures and techniques, organizational understanding, quality management systems, and social interaction.
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