Internal Audit Procedure for Quality Management System

Contract//n//nPurpose: To determine whether the quality management system conforms to the requirements of standards and regulations, and to ensure the effective implementation, maintenance, and continuous improvement of the quality management system.//n//nScope: Applicable to the internal audits of the company, including audits of the quality management system, manufacturing processes, and products.//n//nDefinitions://n3.1 Non-conformity://n3.1.1 Documents that do not conform to the requirements of standards and regulations.//n3.1.2 The quality management system does not conform to the provisions of the quality management system documents.//n3.1.3 The operational results of the quality management system do not meet the objectives.//n3.2 Major non-conformity://n3.2.1 Systemic failure in the operation of the quality management system.//n3.2.2 Regional failure in the operation of the quality management system.//n3.2.3 Non-conformities that would result in serious consequences for product quality or the operation of the quality management system.//n3.3 Minor non-conformity://n3.3.1 Non-conformities other than those mentioned in 3.2.//n//nResponsibilities://n4.1 The management representative is responsible for the management of internal quality management system audits.//n4.2 The quality department is responsible for organizing and implementing internal quality system audits, and developing internal audit plans.//n4.3 Each relevant department is responsible for accepting and cooperating with internal quality management system audits.//n//nProcedure Content://n5.1 The scope of internal quality management system audits covers all processes, sites, and implementing departments of the company related to quality management systems.//n5.2 Internal quality management system audits shall be conducted once a year (every 12 months), and must cover all elements, processes, activities, and shifts related to quality management. The audits must be scheduled according to the annual plan. The audit frequency should be appropriately increased when serious non-conformities occur internally/externally or when customer complaints are received, as proposed by the management representative.//n5.3 The quality department shall develop the annual plan and implementation plan for internal quality audits, including audits of the quality management system, product audits, and process audits. The audit plan shall be approved by the management representative. A prescribed checklist should be used for each audit.//n5.4 The quality department shall determine the auditors and recommend the audit team leader based on the requirements of the audit work, and submit it for approval by the management representative. Auditors should not audit their own department.//n5.5 Auditors must meet the following requirements://n5.5.1 They should be qualified and trained auditors, holding an internal auditor certificate or having the ability approved by the general manager, and be familiar with and understand the requirements of the standards. They should possess planning, organizing, communication, and leadership skills required for quality audits. They should be able to demonstrate auditing techniques through investigation, questioning, evaluation, and reporting methods. They should have experience in quality management and quality technology. They should be honest, upright, have judgment and analytical abilities, and be open to new knowledge.//nThe audit team leader shall develop the implementation plan for the audit, which should include the audit purpose, scope, basis, content, time, relevant departments involved, and audit team member arrangements. The audit plan shall be approved by the management representative and distributed to the relevant departments three days before the audit begins. The audit plan should consider the results of previous audits and track and inspect non-conformities and deficiencies. Before implementing the audit, auditors should study the relevant documents, prepare necessary materials, and develop checklists. The audit team leader shall chair the first meeting before the audit starts. The purpose, scope, and importance of the audit should be clarified in the first meeting, and records and attendance signatures should be made. During the on-site audit, auditors should follow the audit plan. The content of the developed checklist should serve as a guide for the audit. Auditors should conduct audits by interviewing the auditee, reviewing documents, conducting on-site inspections, collecting evidence, and making records. In case of non-conformities, timely oral feedback should be provided to accompanying personnel. After the on-site audit, auditors should issue non-conformity reports. After review by the audit team, the reports should be signed by the auditors and confirmed by the head of the audited department. The audit team leader shall chair the final meeting after the audit ends. The purpose and scope of the audit should be reiterated in the final meeting, and the audit results (including non-conformities) and conclusions should be announced. After confirming the non-conformities in each relevant department, written feedback should be provided within seven working days. The causes of non-conformities should be identified, corrective measures and deadlines should be determined, and implementation should be approved by the auditor. Within one week after the audit ends, the audit team leader should prepare the audit report, which should be approved by the management representative and distributed to the general manager, management representative, and the audited department. Distribution should be recorded, and the audit results should be used as input for management review. Each relevant department should complete the implementation of corrective measures within the agreed timeframe. The quality department should organize auditors to track the implementation of corrective measures, including verifying the measures taken and reporting the verification results. The execution of corrective measures shall be in accordance with the /'Continuous Improvement Control Specification./'//n//nRelated Documents://n6.1 QD10.1.1-2021 /'Continuous Improvement Control Specification/'/n6.2 QD9.2.2-2021 /'Process Audit Control Specification/'/n6.3 QD9.2.3-2021 /'Product Audit Control Specification/'/n//nRelated Records://n6.4 QR9.2-01 /'Internal Audit Plan/'/n6.5 QR9.2-02 /'Internal Audit Schedule/' (annual and daily)/n6.6 QR9.2-03 /'Internal Audit Checklist/'/n6.7 QR9.2-04 /'Internal Audit Report/'/n6.8 QR9.2-05 /'Non-conformity Report for Internal Audit/'/n6.9 QR9.2-06 /'First and Final Meeting Records/