Internal audit The manufacturer shall conduct internal audits at planned intervals to determine whether the quality management system— (a) conforms to the planned arrangements, to the requirements of this Schedule and to the quality management system requirements established by the manufacturer; and (b) is effectively implemented and maintained. An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes. Followup activities shall include the verification of the actions taken and the reporting of verification results. 8.2.3 Monitoring and measurement of processes: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 155 of 248 The manufacturer shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.