Audit personnel consist of the audit team leader and auditors. The audit team leader is responsible for overseeing all activities throughout the audit process. The QA department selects the audit team leader and auditors based on requirements, which are then approved by the QA manager. The audit team leader and auditors must have received internal quality audit training, possess relevant regulatory and professional knowledge, and have sufficient practical experience and ability in quality assessment and on-site quality audits.
The QA supplier administrator is responsible for preparing the annual audit plan, which is approved by the QA manager. The supplier audit team consists of members from QA, QC, supply chain department, technical department, production department, production management, and quality management. Each audit will have corresponding auditors arranged based on the audit plan and the product characteristics of the supplier.
Based on the approved "Supplier Audit Plan," supply chain personnel will notify suppliers in writing through a "Supplier Audit Notification." The audit team must contact the supplier to clarify the purpose and scope of the audit (including materials and/or services to be audited), audit dates, documented audit schedule, location of the audited supplier, audited regions and quality systems.
For on-site audits of various materials, refer to the Supplier Quality Audit Requirements and various types of material audit checklists. Prior to auditing, the audit team leader will draft an audit plan based on specific requirements for each auditing object. The plan will then be reviewed by QA director, QC department head, manufacturing department head, technical department manager and QA manager before being finally approved by the quality manager.
The coding rules for the audit plan are in accordance with document classification and coding management procedures.
The audit team holds an initial meeting with the supplier's management and discusses the purpose, scope, time frame, and audit content (both software and hardware on-site). The audited company may provide a basic introduction, usually through a PowerPoint presentation or direct communication. The audit team leader assigns audit tasks to members (which can be divided into six modules: quality, manufacturing, packaging labeling, materials, QC, and facilities/equipment) while the other party selects accompanying personnel for the review.
Regulatory registration certificates from the FDA; previous regulatory inspections; sterile validation; supply chain activities/supplier qualifications; any significant changes or critical process parameters; implementation of corrective actions from previous audits or complaint reviews. The audit team members compare actual operations with regulatory requirements through interviews, document reviews, and behavioral observations according to the audit plan.
At the end of the audit, a closing meeting is held with the supplier's management to discuss findings such as identified issues during the audit process; assurance of audit report generation time and supplier response time (if applicable); requirements for closing out non-conformances or observations such as root cause analysis, implementation of corrective actions, confirmation of their effectiveness.
The auditor should issue a supplier audit report, highlighting the defects and observations found during the audit process. The audit report should be issued within two weeks of completing the audit, and any delay due to legitimate reasons must be requested in writing and approved by the QA manager.
The audit report includes: supplier name; audit location and date; audit objectives (including identification of supplier materials and/or services); supplier background and history (initial review); participants in the audit; identification of applicable requirements and standards;
a complete list of defects and observations from the audit, with each defect classified as severe, major, or minor; objective evidence supporting each item; completion of corrective actions or CAPA plan reports by the supplier; summary and handling of the audit (conclusion); signatures and dates from the auditor, audit manager, QA manager, and quality manager. The "Supplier Audit Report" should be promptly filed for safekeeping after completion.
Feedback is required within two weeks of the final report issuance, with a maximum deadline of one month.
Corrective measures submitted should be archived and maintained in the supplier's records. If submitted corrective measures are deemed unacceptable, the auditor should communicate with the supplier to obtain sufficient corrective measures.
The audit can be closed once all the corrective actions, CAPA plans, and objective evidence are accepted by the QA department. The auditor should submit the relevant documents to be stored in the supplier's documentation.
The supplier's written audit is initiated by providing the "Supplier Survey Form" to the supplier administrator. The supplier should fill it out truthfully and provide all relevant documentation along with the completed form. After evaluating and reviewing the information, the supplier administrator should complete the "Supplier Audit Report Form" for review by the audit manager and approval by the QA manager.
