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目的根据《药品生产质量管理规范(2010年版)》的要求,我公司供应商管理文件规定:“用于正式生产产品的主要原料、辅料、包装材料的供应商应进行审计批准。”在供应商审计前,我公司审核管理人员参照《管理体系审核指南》GB/T19011-2012中“5.4.5为审核组长分配每次的审核职责”的规定,分配供应商审计组的职责,确保有效地实施每次审核。方法基于《审核方案》和供应商信息,由质量管理部审核管理人员对供应商的资质、基本情况、质量保障情况,以及我厂审核期望的风险分析进行预识别和解读,并向审计组针对性地分配审核目标、审核准则和引用文件、审核范围,确定审核方法和程序、审核组的组成,确定为实施审核所配置的适当资源等,并在此过程中评价和关注识别达到审核目标的风险所需的信息。结果与结论增加供应商审计组实施审计之前的职责分配管理过程,识别了审计过程的风险点,并将我厂审核期望和被审计供应商的信息充分传达到审核组,便于针对性地完成整个审计过程;将供应商不符合风险降至可接受的水平。
Objective According to the requirements of the “Good Manufacturing Practice for Pharmaceuticals (2010 Edition)”, the company’s supplier management document stipulates: “The suppliers of the main raw materials, auxiliary materials and packaging materials used for the formal production of products shall be subject to audit and approval.” Supplier audit, the company audit management personnel refer to “Management System Audit Guide” GB / T19011-2012 in “5.4.5 audit team leader to assign each audit responsibility ” requirement, the responsibility of the supplier audit team assigned responsibility , To ensure effective implementation of each audit. Methods Based on the “audit plan” and supplier information, the quality management department audits the management personnel to pre-identify and interpret the supplier’s qualification, basic information, quality assurance and risk analysis of the factory’s audit expectation, Assign audit objectives, audit criteria and reference documents, scope of audit, determine audit methods and procedures, audit team composition, identify appropriate resources for the implementation of audit and so on, and in the process of evaluation and focus on the identification of audit objectives The information needed for risk. Results and Conclusions Increasing the process of responsibility assignment management before the supplier audit team implemented the audit, identified the risk points of the audit process, fully communicated the audit expectation of the factory and the information of the audited suppliers to the audit team, and facilitated the targeted completion of the whole Audit process; reduce supplier non-compliance risk to an acceptable level.