BV质量验厂清单
<p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">1.</font><span style="font:7pt 'times new roman'"> </span></span></span><font size="2"><span lang="EN-US" style="font-family:arial">Quality Manual (including quality policy, objectives, organization chart, job description, reference to / procedures for the Quality Management System)</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">品质手册（包括质量方针，质量目标，组织架构图，工作职责描述，及与品质管理体系相关的程序）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">2.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Management Review (procedure, agenda, report)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">管理评审（程序，议题，报告）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">3.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Internal audit documents (procedure, plan, audit report)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">内审文件（程序文件，计划，评审报告）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">4.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Supplier Control documents (supplier approval control procedure / criteria, list of approval supplier list, supplier evaluation records)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">供应商管控文件（供应商评估控制程序</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体">/</span><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">标准，合格供应商明细，供应商评估报告）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 27pt"><font size="2"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">5.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Document Control procedure (including that for record keeping)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">文件控制程序（包括记录文件）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">6.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Inspection Specification / Instruction (including IQC, In-process, Final)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">检验标准</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体">/</span><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">指导（包括来料检验，制成检验及终检）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">7.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Work Instruction for each manufacturing process<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">作业指导：所有生产工序的指导</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">8.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Procedure for definition and reporting of “incident” <p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">事故定义及报告程序</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">9.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Product recall procedure<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">产品招回程序</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">10.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Customer complaints procedure and complaint records<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">客户投诉程序及记录</span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">(发贴20可看以下内容)</span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">11.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Corrective Action reports (related to incident, internal audit, complaint, etc)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">改善措施报告（与事故，内审及投诉等相关的）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">12.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Test records on Traceability system<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">追溯体系的测试记录</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 27pt"><font size="2"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">13.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Equipment maintenance documents (plan, procedure, record)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt"><span lang="EN-US" style="font-family:arial"><p><font size="2"> </font></p></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">设备保养文件（保养计划，保养程序及保养记录）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">14.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Calibration of monitoring & measuring devices (plan, procedures, records)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">监控及测量仪器的校验（计划，程序文件，记录）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">15.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Written procedure for handling glass and hard clear plastic breakages Cleaning <p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 27pt"><font size="2"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial">schedule and procedure</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">书面玻璃及利器管控程序和清理安排</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p><font size="2"> </font></p></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">16.</font><span style="font:7pt 'times new roman'"> </span></span></span><font size="2"><span lang="EN-US" style="font-family:arial">Waste handling / storage procedure or record</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">废品控制</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体">/</span><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">存储程序及记录</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 45pt"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p><font size="2"> </font></p></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">17.</font><span style="font:7pt 'times new roman'"> </span></span></span><font size="2"><place wst="on"><span lang="EN-US" style="font-family:arial">Pest</span></place><span lang="EN-US" style="font-family:arial"> control documents (list of trained pest control staff, contract with external pest control agency, pest control inspection record, bait documentation)<p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">虫害控制文件（专业虫害控制人员名单，与外部虫害控制公司的合同书，虫害控制记录等）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 27pt"><font size="2"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">18.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Process flow documentation<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">工艺流程文件</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">19.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Record / plan for “Hazard Analysis” of the entire production processes<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">全部流程的风险评估计划及记录</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">20.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Hazards Assessment records during product design and development <p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">产品设计及开发过程中的风险评估记录</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">21.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Monitoring records of foreign body detectors (e.g. daily sensitivity records of metal detectors)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">外来物品探测器（比如：每日金属探测记录）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">22.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Broken needle procedure & records (if applicable)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">断针控制程序及记录（如果适用）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">23.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Sharp tool control procedure & records (if applicable)<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">利器控制程序及记录（如果适用）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">24.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Nonconforming product control procedure <p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">不良品控制程序</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">25.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Guidance on quantity checking<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">产品数量检查指导</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">26.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Approved reference samples<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">合格样品</span><span lang="EN-US" style="font-family:arial"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">27.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Control procedure for equipment failure and process deviation<p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">不良仪器的管控程序及隔离控制</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p><font size="2"> </font></p></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 27pt"><font size="2"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><span style="mso-spacerun:yes"> </span></span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt;text-indent:-21pt;mso-list:l0 level1 lfo1;tab-stops:list 48.0pt"><span lang="EN-US" style="font-family:arial;mso-fareast-font-family:arial"><span style="mso-list:ignore"><font size="2">28.</font><span style="font:7pt 'times new roman'"> </span></span></span><span lang="EN-US" style="font-family:arial"><font size="2">Factory’s own training program (plan, procedure, records) <p></p></font></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><font size="2"><span style="font-family:宋体;mso-bidi-font-family:arial;mso-fareast-language:zh-cn;mso-ascii-font-family:arial;mso-hansi-font-family:arial">工厂内部的培训计划（计划，程序，记录）</span><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p></p></span></font></p><p class="MsoNormal" style="margin:0cm 0cm 0pt 48pt"><span lang="EN-US" style="font-family:arial;mso-fareast-language:zh-cn;mso-fareast-font-family:宋体"><p><font size="2"> </font></p></span></p><p class="MsoNormal" style="margin:0cm 0cm 0pt"><span lang="EN-US" style="font-family:arial"><span style="mso-spacerun:yes"><font size="2"> </font></span><p></p></span></p> <p>简单的GMP要求文件，实际检查的不止这些。</p><p>但如果连这些都做不到，肯定会有很多问题。</p>
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