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class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u5b9a\u4e49<\/strong>\uff1a\u6d89\u53ca\u5b89\u5168\u6cd5\u89c4\u3001\u5bfc\u81f4\u7cfb\u7edf\u6027\u762b\u75ea\u3001\u5df2\u9020\u6210\u91cd\u5927\u5ba2\u6237\u6295\u8bc9\u6216\u6279\u91cf\u9000\u8d27\u7684\u8d28\u91cf\u95ee\u9898\u3002<\/li>\n<li><strong>\u793a\u4f8b<\/strong>\uff1a\u4ea7\u54c1\u6f0f\u7535\u98ce\u9669\u3001\u6838\u5fc3\u90e8\u4ef6\u6279\u91cf\u6027\u5931\u6548\u3001\u53d1\u5f80\u5ba2\u6237\u7684\u4ea7\u54c1\u578b\u53f7\u5b8c\u5168\u9519\u8bef\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E4%BA%8C%E7%BA%A7%E5%BC%82%E5%B8%B8%EF%BC%88%E4%B8%BB%E8%A6%81_P2%EF%BC%89%EF%BC%9A%E9%87%8D%E5%A4%A7%E9%97%AE%E9%A2%98\"><\/span>\u4e8c\u7ea7\u5f02\u5e38\uff08\u4e3b\u8981 P2\uff09\uff1a\u91cd\u5927\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u5b9a\u4e49<\/strong>\uff1a\u672a\u89e6\u53ca\u5b89\u5168\u5e95\u7ebf\uff0c\u4f46\u5bfc\u81f4\u4ea7\u54c1\u4e3b\u8981\u529f\u80fd\u4e0d\u5408\u683c\u3001\u751f\u4ea7\u7ebf\u957f\u65f6\u95f4\u505c\u7ebf\u3001\u6216\u53ef\u80fd\u5f15\u53d1\u5ba2\u6237\u6279\u91cf\u62b1\u6028\u7684\u8d28\u91cf\u95ee\u9898\u3002<\/li>\n<li><strong>\u793a\u4f8b<\/strong>\uff1a\u4ea7\u54c1\u6027\u80fd\u53c2\u6570\u4e0d\u8fbe\u6807\u3001\u91cd\u8981\u7ec4\u4ef6\u5c3a\u5bf8\u8d85\u5dee\u5bfc\u81f4\u65e0\u6cd5\u88c5\u914d\u3001\u5916\u89c2\u4e25\u91cd\u6279\u91cf\u6027\u635f\u4f24\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E4%B8%89%E7%BA%A7%E5%BC%82%E5%B8%B8%EF%BC%88%E8%BD%BB%E5%BE%AE_P3%EF%BC%89%EF%BC%9A%E4%B8%80%E8%88%AC%E9%97%AE%E9%A2%98\"><\/span>\u4e09\u7ea7\u5f02\u5e38\uff08\u8f7b\u5fae P3\uff09\uff1a\u4e00\u822c\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u5b9a\u4e49<\/strong>\uff1a\u4e0d\u5f71\u54cd\u4ea7\u54c1\u4e3b\u8981\u529f\u80fd\u548c\u5b89\u5168\u6027\uff0c\u4ec5\u6d89\u53ca\u5916\u89c2\u3001\u88c5\u914d\u4fbf\u5229\u6027\u6216\u8f7b\u5fae\u6027\u80fd\u6ce2\u52a8\u7684\u8d28\u91cf\u95ee\u9898\u3002<\/li>\n<li><strong>\u793a\u4f8b<\/strong>\uff1a\u4ea7\u54c1\u8868\u9762\u8f7b\u5fae\u5212\u75d5\u3001\u6807\u7b7e\u7c98\u8d34\u4e0d\u89c4\u8303\u3001\u975e\u5173\u952e\u5c3a\u5bf8\u8f7b\u5fae\u504f\u5dee\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E8%A6%81%E7%82%B9%E5%9B%9E%E9%A1%BE\"><\/span>\u8981\u70b9\u56de\u987e<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5efa\u7acb\u5206\u7ea7\u6807\u51c6\u7684\u6838\u5fc3\u662f\u201c\u5171\u8bc6\u201d\u3002\u6211\u4eec\u5f3a\u70c8\u5efa\u8bae\u5c06\u6700\u7ec8\u786e\u5b9a\u7684\u6807\u51c6\u6253\u5370\u6210\u6d77\u62a5\uff0c\u5728\u8f66\u95f4\u3001\u4f1a\u8bae\u5ba4\u7b49\u573a\u6240\u8fdb\u884c\u516c\u793a\uff0c\u786e\u4fdd\u6bcf\u4e00\u4f4d\u5458\u5de5\u90fd\u4e86\u7136\u4e8e\u5fc3\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E6%80%8E%E4%B9%88%E5%81%9A%EF%BC%9A%E4%B8%8D%E5%90%8C%E7%BA%A7%E5%88%AB%E8%B4%A8%E9%87%8F%E5%BC%82%E5%B8%B8%E7%9A%84%E6%A0%87%E5%87%86%E5%8C%96%E5%BF%AB%E9%80%9F%E5%93%8D%E5%BA%94%E6%B5%81%E7%A8%8B\"><\/span>\u600e\u4e48\u505a\uff1a\u4e0d\u540c\u7ea7\u522b\u8d28\u91cf\u5f02\u5e38\u7684\u6807\u51c6\u5316\u5feb\u901f\u54cd\u5e94\u6d41\u7a0b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5b9a\u4e49\u4e86\u6807\u51c6\uff0c\u4e0b\u4e00\u6b65\u5c31\u662f\u5c06\u6807\u51c6\u4e0e\u884c\u52a8\u7ed1\u5b9a\u3002\u4e0d\u540c\u7ea7\u522b\u7684\u5f02\u5e38\uff0c\u5fc5\u987b\u89e6\u53d1\u4e0d\u540c\u901f\u5ea6\u548c\u529b\u5ea6\u7684\u54cd\u5e94\u6d41\u7a0b\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%B8%80%E7%BA%A7%E5%BC%82%E5%B8%B8%EF%BC%88%E4%B8%A5%E9%87%8D_P1%EF%BC%89%E7%9A%84%E5%93%8D%E5%BA%94%E5%8A%A8%E4%BD%9C%E6%B8%85%E5%8D%95\"><\/span>\u4e00\u7ea7\u5f02\u5e38\uff08\u4e25\u91cd P1\uff09\u7684\u54cd\u5e94\u52a8\u4f5c\u6e05\u5355<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u54cd\u5e94\u65f6\u95f4<\/strong>\uff1a\u7acb\u5373\u54cd\u5e94\uff08\u226415\u5206\u949f\uff09<\/li>\n<li><strong>\u904f\u5236\u63aa\u65bd<\/strong>\uff1a\n<ul>\n<li><strong>\u7acb\u5373\u505c\u6b62<\/strong>\u6240\u6709\u76f8\u5173\u751f\u4ea7\u6d3b\u52a8\u3002<\/li>\n<li><strong>\u7acb\u5373\u9694\u79bb<\/strong>\u6240\u6709\u7ebf\u4e0a\u3001\u5e93\u5b58\u53ca\u5f85\u53d1\u8fd0\u7684\u53ef\u7591\u54c1\u3002<\/li>\n<li><strong>\u7d27\u6025\u8ffd\u6eaf<\/strong>\u5df2\u53d1\u8fd0\u4ea7\u54c1\uff0c\u8bc4\u4f30\u53ec\u56de\u98ce\u9669\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u4e0a\u62a5\u673a\u5236<\/strong>\uff1a\n<ul>\n<li>\u73b0\u573a\u4eba\u5458\u7acb\u523b\u4e0a\u62a5\u751f\u4ea7\u4e3b\u7ba1\u4e0e\u8d28\u91cf\u7ecf\u7406\u3002<\/li>\n<li>1\u5c0f\u65f6\u5185\u542f\u52a8\u7531\u8d28\u91cf\u3001\u751f\u4ea7\u3001\u6280\u672f\u3001\u91c7\u8d2d\u7b49\u90e8\u95e8\u7ec4\u6210\u7684\u8de8\u90e8\u95e8\u5e94\u6025\u54cd\u5e94\u5c0f\u7ec4\uff08QRQC\uff09\u3002<\/li>\n<li>2\u5c0f\u65f6\u5185\u5fc5\u987b\u4e0a\u62a5\u81f3\u516c\u53f8\u6700\u9ad8\u7ba1\u7406\u8005\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u5904\u7406\u6d41\u7a0b<\/strong>\uff1a\n<ul>\n<li>24\u5c0f\u65f6\u5185\u8f93\u51fa\u521d\u6b65\u539f\u56e0\u5206\u6790\u53ca\u4e34\u65f6\u5bf9\u7b56\u3002<\/li>\n<li>3\u4e2a\u5de5\u4f5c\u65e5\u5185\u5b8c\u6210\u6839\u672c\u539f\u56e0\u5206\u6790\uff08RCA\uff09\u3002<\/li>\n<li>5\u4e2a\u5de5\u4f5c\u65e5\u5185\u5236\u5b9a\u5e76\u9a8c\u8bc1\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff08CAPA\uff09\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E4%BA%8C%E7%BA%A7%E5%BC%82%E5%B8%B8%EF%BC%88%E4%B8%BB%E8%A6%81_P2%EF%BC%89%E7%9A%84%E5%93%8D%E5%BA%94%E5%8A%A8%E4%BD%9C%E6%B8%85%E5%8D%95\"><\/span>\u4e8c\u7ea7\u5f02\u5e38\uff08\u4e3b\u8981 P2\uff09\u7684\u54cd\u5e94\u52a8\u4f5c\u6e05\u5355<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u54cd\u5e94\u65f6\u95f4<\/strong>\uff1a30\u5206\u949f\u5185<\/li>\n<li><strong>\u904f\u5236\u63aa\u65bd<\/strong>\uff1a\n<ul>\n<li>\u6682\u505c\u53d7\u5f71\u54cd\u7684\u5de5\u5e8f\u6216\u4ea7\u7ebf\u3002<\/li>\n<li>\u9694\u79bb\u7ebf\u4e0a\u53ca\u4ed3\u5e93\u5185\u7684\u6240\u6709\u53ef\u7591\u54c1\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u4e0a\u62a5\u673a\u5236<\/strong>\uff1a\n<ul>\n<li>\u73b0\u573a\u4eba\u5458\u4e0a\u62a5\u73ed\u7ec4\u957f\u4e0e\u73b0\u573a\u8d28\u91cf\u63a7\u5236\uff08QC\uff09\u3002<\/li>\n<li>2\u5c0f\u65f6\u5185\u901a\u77e5\u5230\u751f\u4ea7\u4e3b\u7ba1\u4e0e\u8d28\u91cf\u5de5\u7a0b\u5e08\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u5904\u7406\u6d41\u7a0b<\/strong>\uff1a\n<ul>\n<li>\u5f53\u5929\u5b8c\u6210\u95ee\u9898\u521d\u6b65\u5206\u6790\u4e0e\u56f4\u5835\u63aa\u65bd\u3002<\/li>\n<li>3\u4e2a\u5de5\u4f5c\u65e5\u5185\u5b8c\u6210\u6839\u672c\u539f\u56e0\u5206\u6790\u3002<\/li>\n<li>1\u5468\u5185\u5b8c\u6210\u7ea0\u6b63\u63aa\u65bd\u7684\u5b9e\u65bd\u4e0e\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E4%B8%89%E7%BA%A7%E5%BC%82%E5%B8%B8%EF%BC%88%E8%BD%BB%E5%BE%AE_P3%EF%BC%89%E7%9A%84%E5%93%8D%E5%BA%94%E5%8A%A8%E4%BD%9C%E6%B8%85%E5%8D%95\"><\/span>\u4e09\u7ea7\u5f02\u5e38\uff08\u8f7b\u5fae P3\uff09\u7684\u54cd\u5e94\u52a8\u4f5c\u6e05\u5355<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><strong>\u54cd\u5e94\u65f6\u95f4<\/strong>\uff1a2\u5c0f\u65f6\u5185<\/li>\n<li><strong>\u904f\u5236\u63aa\u65bd<\/strong>\uff1a\n<ul>\n<li>\u5bf9\u53d1\u73b0\u7684\u53ef\u7591\u54c1\u8fdb\u884c\u6709\u6548\u6807\u8bc6\u548c\u7269\u7406\u9694\u79bb\u3002<\/li>\n<li>\u5728\u5f53\u524d\u73ed\u6b21\u5185\uff0c\u52a0\u5f3a\u5bf9\u8be5\u95ee\u9898\u7684\u81ea\u68c0\u4e0e\u4e92\u68c0\u9891\u7387\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u4e0a\u62a5\u673a\u5236<\/strong>\uff1a\n<ul>\n<li>\u8be6\u7ec6\u8bb0\u5f55\u4e8e\u751f\u4ea7\u65e5\u62a5\u6216\u8d28\u91cf\u5f02\u5e38\u5904\u7406\u5355\u4e2d\u3002<\/li>\n<li>\u7531QC\u548c\u751f\u4ea7\u73ed\u7ec4\u957f\u8fdb\u884c\u6bcf\u65e5\u6216\u5b9a\u671f\u7684\u56de\u987e\u5206\u6790\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u5904\u7406\u6d41\u7a0b<\/strong>\uff1a\n<ul>\n<li>\u73b0\u573a\u7531\u73ed\u7ec4\u957f\u6216\u6280\u672f\u5458\u8fdb\u884c\u5feb\u901f\u5206\u6790\u548c\u5904\u7f6e\u3002<\/li>\n<li>\u5982\u6709\u5fc5\u8981\uff0c\u5bf9\u4f5c\u4e1a\u6307\u5bfc\u4e66\uff08SOP\uff09\u8fdb\u884c\u5fae\u8c03\u3002<\/li>\n<li>\u6570\u636e\u7eb3\u5165\u957f\u671f\u7684\u8d28\u91cf\u6539\u8fdb\u8d8b\u52bf\u5206\u6790\uff0c\u7528\u4e8e\u8bc6\u522b\u7cfb\u7edf\u6027\u98ce\u9669\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E5%A6%82%E4%BD%95%E7%94%A8%EF%BC%9A%E6%88%90%E5%8A%9F%E8%90%BD%E5%9C%B0%E8%B4%A8%E9%87%8F%E5%BC%82%E5%B8%B8%E5%88%86%E7%BA%A7%E5%A4%84%E7%90%86%E6%A0%87%E5%87%86%E7%9A%843%E4%B8%AA%E5%BB%BA%E8%AE%AE\"><\/span>\u5982\u4f55\u7528\uff1a\u6210\u529f\u843d\u5730\u8d28\u91cf\u5f02\u5e38\u5206\u7ea7\u5904\u7406\u6807\u51c6\u76843\u4e2a\u5efa\u8bae<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6709\u4e86\u6807\u51c6\u548c\u6d41\u7a0b\uff0c\u5982\u4f55\u786e\u4fdd\u5176\u6709\u6548\u843d\u5730\uff1f\u57fa\u4e8e\u5bf9\u8d85\u8fc75000\u5bb6\u5236\u9020\u4f01\u4e1a\u7684\u670d\u52a1\u7ecf\u9a8c\uff0c\u6211\u4eec\u63d0\u70bc\u51fa\u4ee5\u4e0b\u4e09\u4e2a\u5173\u952e\u5efa\u8bae\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E5%BB%BA%E8%AE%AE%E4%B8%80%EF%BC%9A%E4%BB%8E%E7%AE%80%E5%BC%80%E5%A7%8B%EF%BC%8C%E5%85%88%E8%B7%91%E8%B5%B7%E6%9D%A5\"><\/span>\u5efa\u8bae\u4e00\uff1a\u4ece\u7b80\u5f00\u59cb\uff0c\u5148\u8dd1\u8d77\u6765<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8bb8\u591a\u4f01\u4e1a\u5728\u521d\u6b21\u5c1d\u8bd5\u65f6\uff0c\u5bb9\u6613\u9677\u5165\u8fc7\u5ea6\u8bbe\u8ba1\u7684\u9677\u9631\uff0c\u8bd5\u56fe\u5b9a\u4e49\u4e00\u4e2a\u6db5\u76d6\u6240\u6709\u60c5\u51b5\u7684\u590d\u6742\u6a21\u578b\u3002\u6211\u4eec\u7684\u5efa\u8bae\u662f\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u521d\u521b\u4f01\u4e1a\u6216\u9996\u6b21\u63a8\u884c\u6807\u51c6\u5316\u7684\u56e2\u961f\uff0c\u53ef\u4ee5\u76f4\u63a5\u91c7\u7528\u4e0a\u8ff0\u7684\u4e09\u7ea7\u6a21\u578b\u3002\u5148\u8ba9\u6807\u51c6\u5728\u5b9e\u9645\u5de5\u4f5c\u4e2d\u8fd0\u8f6c\u8d77\u6765\uff0c\u5728\u5b9e\u8df5\u4e2d\u6839\u636e\u81ea\u8eab\u4e1a\u52a1\u7279\u70b9\u518d\u8fdb\u884c\u8fed\u4ee3\u4f18\u5316\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E5%BB%BA%E8%AE%AE%E4%BA%8C%EF%BC%9A%E4%B8%80%E4%BA%BA%E8%B4%9F%E8%B4%A3%EF%BC%8C%E6%98%8E%E7%A1%AE%E6%8E%88%E6%9D%83\"><\/span>\u5efa\u8bae\u4e8c\uff1a\u4e00\u4eba\u8d1f\u8d23\uff0c\u660e\u786e\u6388\u6743<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6807\u51c6\u9700\u8981\u4e00\u4e2a\u660e\u786e\u7684\u4e3b\u5bfc\u8005\u548c\u7ef4\u62a4\u8005\uff0c\u901a\u5e38\u8fd9\u4e2a\u89d2\u8272\u7531\u8d28\u91cf\u90e8\u95e8\u627f\u62c5\u3002\u66f4\u91cd\u8981\u7684\u662f\uff0c\u5fc5\u987b\u6388\u4e88\u8be5\u90e8\u95e8\u76f8\u5e94\u7684\u6743\u9650\uff0c\u4f8b\u5982\u5728\u53d1\u73b0\u4e25\u91cd\u95ee\u9898\u65f6\uff0c\u6709\u6743\u5728\u672a\u7ecf\u751f\u4ea7\u90e8\u95e8\u540c\u610f\u7684\u60c5\u51b5\u4e0b\uff0c\u76f4\u63a5\u53eb\u505c\u751f\u4ea7\u3001\u9694\u79bb\u4ea7\u54c1\u3002\u6743\u8d23\u5bf9\u7b49\uff0c\u662f\u6d41\u7a0b\u5f97\u4ee5\u4e25\u683c\u6267\u884c\u7684\u5236\u5ea6\u4fdd\u969c\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E5%BB%BA%E8%AE%AE%E4%B8%89%EF%BC%9A%E5%B7%A5%E5%85%B7%E8%BE%85%E5%8A%A9%EF%BC%8C%E6%95%B0%E6%8D%AE%E9%A9%B1%E5%8A%A8\"><\/span>\u5efa\u8bae\u4e09\uff1a\u5de5\u5177\u8f85\u52a9\uff0c\u6570\u636e\u9a71\u52a8<span 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