Index Quality audits consist of system audits Process Audits Audits in a QA system are known as quality audits. This is a systematic examination of a quality system carried out by an external quality auditor or audit team. The main purpose of which is to ensure that procedures correctly reflect documented standards. Audits are an important part of a quality system and are a key part of the ISO quality system standard ISO 9001. Say no to plagiarism. Get a tailor-made essay on "Why Violent Video Games Shouldn't Be Banned"? Get an Original Essay Quality audits are becoming more regular in today's pharmaceutical industry due to increasingly complex regulations and expanding globalization. Companies in the pharmaceutical industry are often subjected to developments and new research cycles for manufactured products, and as a result, these companies must establish quality assurance departments that ensure that the quality of the process is maintained efficiently. Regular quality audits of QA procedures provide an effective way for management to evaluate the efficiency of these procedures. Quality audits consist of system audits Process audits Product compliance audits System audits A quality system audit is defined by ISO 10011-1 (1990) as a "systematic and independent examination used to determine whether quality activities and the related results comply with the planned provisions and whether these provisions are implemented effectively and are suitable for achieving the objectives. It is "a documented activity performed to verify, through examination and evaluation of objective evidence, that the applicable quality system tests are adequate and have been developed, documented and effectively implemented in accordance with specific requirements." It is the role of the quality system audit to ask questions such as; How is the system defined? Who is the party responsible for producing the product? What is the degree of involvement of the management department in the daily management of a quality system Who is the responsible party for ensuring that the quality of the products produced conforms to the customer's standards? What type of direct and indirect processes are used in the production of the product(s). What procedures are in place to aid the organization's productive efforts. How are these procedures maintained and updated and by whom? Where can the procedures be found? Quality system audits tend to focus on the macro nature of a quality management system, i.e. the general and broad scope rather than a narrow and limited scope. Process audits Process audits are analytical in nature, unlike more general system audits which are much more easily defined and circumscribed. The central focus of these audits is to; people, materials and machines. You need to check how these factors are combined to produce a reliable product. It must compare and contrast the active processes in which products are made to those of written procedures. It is essentially a guide to the manufacturing process. Please note: this is just an example. Get a custom paper from our expert writers now. Get a Custom Essay It also focuses on the process itself. He must ask himself whether the process is valid and reliable or not. Does the process produce the expected results consistently? Processes need to be changed or updated to meet current and/or future customer needs.