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class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u7f5a\u6b3e\u8bb0\u5f55\u672c\u8d28\u4e0a\u662f\u4e00\u5806\u79bb\u6563\u7684\u3001\u6ede\u540e\u7684\u5386\u53f2\u6570\u636e\u3002\u5b83\u80fd\u544a\u8bc9\u4f60\u8fc7\u53bb\u53d1\u751f\u4e86\u4ec0\u4e48\uff0c\u4f46\u65e0\u6cd5\u544a\u8bc9\u4f60\u4e0b\u4e2a\u6708\u3001\u4e0b\u4e00\u6279\u6b21\u7684\u98ce\u9669\u6709\u591a\u5927\u3002\u5b83\u65e0\u6cd5\u63ed\u793a\u4f9b\u5e94\u5546\u5185\u90e8\u8fc7\u7a0b\u80fd\u529b\u7684\u7a33\u5b9a\u6027\u53d8\u5316\uff0c\u4e5f\u65e0\u6cd5\u4e3a\u4f01\u4e1a\u7684\u4f9b\u5e94\u5546\u51c6\u5165\u3001\u5ba1\u6838\u548c\u5206\u7ea7\u7ba1\u7406\u63d0\u4f9b\u4efb\u4f55\u6709\u4ef7\u503c\u7684\u524d\u77bb\u6027\u6307\u5f15\u3002\u4f9d\u8d56\u8fd9\u6837\u7684\u6570\u636e\u505a\u51b3\u7b56\uff0c\u65e0\u5f02\u4e8e\u770b\u7740\u540e\u89c6\u955c\u5f00\u8f66\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E5%85%B3%E9%94%AE%E7%82%B9%E5%9B%9E%E9%A1%BE\"><\/span>\u5173\u952e\u70b9\u56de\u987e<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u603b\u7ed3\u800c\u8a00\uff0c\u5355\u7eaf\u7684\u6263\u5206\u7ba1\u7406\u662f\u4e00\u79cd<strong>\u53cd\u5e94\u5f0f<\/strong>\u7684\u7ba1\u7406\uff0c\u5b83\u5728\u95ee\u9898\u53d1\u751f\u540e\u624d\u4ecb\u5165\uff1b\u5b83\u4f1a\u7834\u574f\u81f3\u5173\u91cd\u8981\u7684<strong>\u4f19\u4f34\u5173\u7cfb<\/strong>\uff0c\u5c06\u534f\u4f5c\u53d8\u4e3a\u5bf9\u6297\uff1b\u5e76\u4e14\uff0c\u5b83\u63d0\u4f9b\u7684\u6570\u636e\u7f3a\u4e4f<strong>\u9884\u6d4b\u6027<\/strong>\uff0c\u65e0\u6cd5\u6709\u6548\u6307\u5bfc\u672a\u6765\u7684\u98ce\u9669\u89c4\u907f\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%89%E3%80%81%E4%BB%8E%E2%80%9C%E4%BA%A4%E6%98%93%E5%AF%BC%E5%90%91%E2%80%9D%E5%88%B0%E2%80%9C%E5%8D%8F%E4%BD%9C%E5%AF%BC%E5%90%91%E2%80%9D%EF%BC%9A%E6%9E%84%E5%BB%BA%E9%97%AD%E7%8E%AF%E7%9A%84%E4%BE%9B%E5%BA%94%E5%95%86%E8%B4%A8%E9%87%8F%E6%94%B9%E8%BF%9B%E4%BD%93%E7%B3%BB\"><\/span>\u4e09\u3001\u4ece\u201c\u4ea4\u6613\u5bfc\u5411\u201d\u5230\u201c\u534f\u4f5c\u5bfc\u5411\u201d\uff1a\u6784\u5efa\u95ed\u73af\u7684\u4f9b\u5e94\u5546\u8d28\u91cf\u6539\u8fdb\u4f53\u7cfb<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u8981\u6253\u7834\u201c\u95ee\u9898-\u7f5a\u6b3e-\u518d\u53d1\u201d\u7684\u6076\u6027\u5faa\u73af\uff0c\u4f01\u4e1a\u9700\u8981\u5c06\u7ba1\u7406\u601d\u7ef4\u4ece\u201c\u4ea4\u6613\u5bfc\u5411\u201d\u5f7b\u5e95\u8f6c\u5411\u201c\u534f\u4f5c\u5bfc\u5411\u201d\uff0c\u642d\u5efa\u4e00\u4e2a\u4ee5\u8fc7\u7a0b\u7ba1\u63a7\u548c\u6570\u636e\u9a71\u52a8\u4e3a\u6838\u5fc3\u7684\u95ed\u73af\u6539\u8fdb\u4f53\u7cfb\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E4%B8%80%E6%AD%A5%EF%BC%9A%E5%BB%BA%E7%AB%8B%E9%80%8F%E6%98%8E%E7%9A%84%E3%80%81%E7%BB%9F%E4%B8%80%E7%9A%84%E8%B4%A8%E9%87%8F%E6%A0%87%E5%87%86%E4%B8%8E%E6%95%B0%E6%8D%AE%E7%9C%8B%E6%9D%BF\"><\/span>\u7b2c\u4e00\u6b65\uff1a\u5efa\u7acb\u900f\u660e\u7684\u3001\u7edf\u4e00\u7684\u8d28\u91cf\u6807\u51c6\u4e0e\u6570\u636e\u770b\u677f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8fd9\u662f\u6240\u6709\u534f\u4f5c\u7684\u57fa\u7840\u3002\u5fc5\u987b\u786e\u4fdd\u91c7\u8d2d\u65b9\u548c\u4f9b\u5e94\u65b9\u5bf9\u4e8e\u201c\u597d\u201d\u4e0e\u201c\u4e0d\u597d\u201d\u7684\u5b9a\u4e49\u3001\u68c0\u9a8c\u6807\u51c6\u3001\u5141\u6536\u8303\u56f4\u7b49\u62e5\u6709\u4e00\u81f4\u7684\u7406\u89e3\u3002\u66f4\u91cd\u8981\u7684\u662f\uff0c\u8fd9\u4e9b\u6807\u51c6\u548c\u76f8\u5e94\u7684\u68c0\u9a8c\u6570\u636e\u9700\u8981\u5728\u4e00\u4e2a\u53cc\u65b9\u5171\u4eab\u7684\u5e73\u53f0\u4e0a\u5b9e\u73b0\u900f\u660e\u5316\uff0c\u6d88\u9664\u56e0\u4fe1\u606f\u5dee\u5bfc\u81f4\u7684\u8bef\u5224\u548c\u4e89\u6267\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E4%BA%8C%E6%AD%A5%EF%BC%9A%E5%AE%9E%E6%96%BD%E5%9F%BA%E4%BA%8E%E8%BF%87%E7%A8%8B%E7%9A%84%E4%BE%9B%E5%BA%94%E5%95%86%E7%BB%A9%E6%95%88%E8%80%83%E6%A0%B8%E6%8C%87%E6%A0%87\"><\/span>\u7b2c\u4e8c\u6b65\uff1a\u5b9e\u65bd\u57fa\u4e8e\u8fc7\u7a0b\u7684\u4f9b\u5e94\u5546\u7ee9\u6548\u8003\u6838\u6307\u6807<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u7528\u80fd\u591f\u53cd\u6620\u8fc7\u7a0b\u7a33\u5b9a\u6027\u548c\u9884\u9632\u80fd\u529b\u7684\u5148\u884c\u6307\u6807\uff0c\u9010\u6b65\u66ff\u4ee3\u6ede\u540e\u7684\u7ed3\u679c\u6307\u6807\u3002\u6211\u4eec\u5efa\u8bae\u4f01\u4e1a\u5173\u6ce8\u4ee5\u4e0b\u51e0\u7c7b\u6570\u636e\uff1a<\/p>\n<ul>\n<li><strong>\u66ff\u4ee3\u6307\u68071\uff1a\u8fc7\u7a0b\u80fd\u529b\u6307\u6570 (Cpk)<\/strong>\uff1a\u76f4\u63a5\u53cd\u6620\u4f9b\u5e94\u5546\u751f\u4ea7\u8fc7\u7a0b\u7684\u7a33\u5b9a\u6027\u548c\u4e00\u81f4\u6027\uff0c\u662f\u8861\u91cf\u5176\u80fd\u5426\u6301\u7eed\u4ea7\u51fa\u5408\u683c\u54c1\u7684\u6838\u5fc3\u6307\u6807\u3002<\/li>\n<li><strong>\u66ff\u4ee3\u6307\u68072\uff1a\u9996\u4ef6\u68c0\u9a8c\u5408\u683c\u7387 (FAI)<\/strong>\uff1a\u8861\u91cf\u4f9b\u5e94\u5546\u5728\u65b0\u4ea7\u54c1\u6216\u6d41\u7a0b\u53d8\u66f4\u540e\uff0c\u80fd\u5426\u5feb\u901f\u8fbe\u5230\u8d28\u91cf\u8981\u6c42\u7684\u80fd\u529b\uff0c\u662f\u9884\u9632\u6279\u91cf\u6027\u95ee\u9898\u7684\u5173\u952e\u63a7\u5236\u70b9\u3002<\/li>\n<li><strong>\u66ff\u4ee3\u6307\u68073\uff1a\u8d28\u91cf\u6539\u8fdb\u8ba1\u5212 (CAPA) \u5b8c\u6210\u7387<\/strong>\uff1a\u5f53\u95ee\u9898\u53d1\u751f\u540e\uff0c\u8861\u91cf\u4f9b\u5e94\u5546\u5b9a\u4f4d\u6839\u672c\u539f\u56e0\u3001\u5236\u5b9a\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u5e76\u6309\u65f6\u5b8c\u6210\u7684\u80fd\u529b\u3002\u8fd9\u6bd4\u7f5a\u6b3e\u66f4\u80fd\u4f53\u73b0\u5176\u8d28\u91cf\u6539\u8fdb\u7684\u610f\u613f\u548c\u6267\u884c\u529b\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E7%AC%AC%E4%B8%89%E6%AD%A5%EF%BC%9A%E4%BB%8E%E2%80%9C%E6%83%A9%E7%BD%9A%E2%80%9D%E8%BD%AC%E5%90%91%E2%80%9C%E4%BE%9B%E5%BA%94%E5%95%86%E8%B5%8B%E8%83%BD%E2%80%9D%E4%B8%8E%E5%8D%8F%E5%90%8C%E6%94%B9%E8%BF%9B\"><\/span>\u7b2c\u4e09\u6b65\uff1a\u4ece\u201c\u60e9\u7f5a\u201d\u8f6c\u5411\u201c\u4f9b\u5e94\u5546\u8d4b\u80fd\u201d\u4e0e\u534f\u540c\u6539\u8fdb<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5c06\u7ba1\u7406\u7684\u5173\u6ce8\u70b9\u4ece\u201c\u8c01\u72af\u4e86\u9519\u201d\u5f7b\u5e95\u8f6c\u79fb\u5230\u201c\u5982\u4f55\u5171\u540c\u89e3\u51b3\u95ee\u9898\u5e76\u9632\u6b62\u518d\u53d1\u201d\u3002\u8fd9\u610f\u5473\u7740\u5f53\u8d28\u91cf\u5f02\u5e38\u51fa\u73b0\u65f6\uff0c\u9996\u8981\u52a8\u4f5c\u4e0d\u662f\u5f00\u7f5a\u5355\uff0c\u800c\u662f\u542f\u52a8\u4e00\u4e2a\u7ed3\u6784\u5316\u7684\u534f\u540c\u6539\u8fdb\u6d41\u7a0b\u3002<\/p>\n<p>\u5728\u6211\u4eec\u7684\u5b9e\u8df5\u4e2d\uff0c\u4f01\u4e1a\u53ef\u4ee5\u501f\u52a9\u50cf\u300c\u652f\u9053\u300d\u8fd9\u6837\u7684\u6570\u5b57\u5316\u4f9b\u5e94\u94fe\u534f\u4f5c\u5e73\u53f0\uff0c\u5c06\u8d28\u91cf\u95ee\u9898\u7684\u63d0\u62a5\u3001\u6839\u672c\u539f\u56e0\u7684\u5206\u6790\uff08\u59828D\u62a5\u544a\uff09\u3001\u6539\u8fdb\u4efb\u52a1\u7684\u5206\u914d\u4e0e\u8ddf\u8fdb\u3001\u4ee5\u53ca\u6700\u7ec8\u6548\u679c\u7684\u9a8c\u8bc1\uff0c\u5168\u90e8\u5728\u7ebf\u5316\u3001\u53ef\u89c6\u5316\u5730\u8fdb\u884c\u95ed\u73af\u7ba1\u7406\u3002\u5e73\u53f0\u8bb0\u5f55\u4e86\u4ece\u95ee\u9898\u53d1\u751f\u5230\u89e3\u51b3\u7684\u5168\u8fc7\u7a0b\uff0c\u6570\u636e\u548c\u8d23\u4efb\u6e05\u6670\u660e\u786e\uff0c\u53cc\u65b9\u56e2\u961f\u80fd\u771f\u6b63\u805a\u7126\u4e8e\u89e3\u51b3\u95ee\u9898\u672c\u8eab\uff0c\u800c\u4e0d\u662f\u76f8\u4e92\u6307\u8d23\u3002\u8fd9\u624d\u662f\u5bf9\u4f9b\u5e94\u5546\u771f\u6b63\u7684\u8d4b\u80fd\uff0c\u4e5f\u662f\u6784\u5efa\u957f\u671f\u7a33\u5b9a\u4f9b\u5e94\u94fe\u5173\u7cfb\u7684\u57fa\u77f3\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%9B%9B%E3%80%81%E6%89%A3%E5%88%86%E7%AE%A1%E7%90%86_vs_%E5%8D%8F%E5%90%8C%E7%AE%A1%E7%90%86%EF%BC%9A%E4%B8%80%E5%BC%A0%E8%A1%A8%E7%9C%8B%E6%87%82%E6%A0%B9%E6%9C%AC%E5%8C%BA%E5%88%AB\"><\/span>\u56db\u3001\u6263\u5206\u7ba1\u7406 vs. \u534f\u540c\u7ba1\u7406\uff1a\u4e00\u5f20\u8868\u770b\u61c2\u6839\u672c\u533a\u522b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u4e3a\u4e86\u66f4\u6e05\u6670\u5730\u5c55\u793a\u4e24\u79cd\u6a21\u5f0f\u7684\u5dee\u5f02\uff0c\u6211\u4eec\u5c06\u5176\u6838\u5fc3\u8981\u7d20\u8fdb\u884c\u4e86\u5bf9\u6bd4\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">\u7ef4\u5ea6<\/th>\n<th align=\"left\">\u4f20\u7edf\u6263\u5206\u7ba1\u7406<\/th>\n<th align=\"left\">\u73b0\u4ee3\u534f\u540c\u7ba1\u7406<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>\u6838\u5fc3\u903b\u8f91<\/strong><\/td>\n<td align=\"left\">\u7ed3\u679c\u60e9\u7f5a\uff0c\u4e8b\u540e\u8ffd\u8d23<\/td>\n<td align=\"left\">\u8fc7\u7a0b\u9884\u9632\uff0c\u4e8b\u524d\u9884\u8b66<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u5173\u7cfb\u5b9a\u4f4d<\/strong><\/td>\n<td align=\"left\">\u4ea4\u6613\u5bf9\u624b\uff0c\u96f6\u548c\u535a\u5f08<\/td>\n<td align=\"left\">\u6218\u7565\u4f19\u4f34\uff0c\u4ef7\u503c\u5171\u521b<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u6c9f\u901a\u6a21\u5f0f<\/strong><\/td>\n<td align=\"left\">\u5bf9\u6297\u626f\u76ae\uff0c\u8d23\u4efb\u754c\u5b9a<\/td>\n<td align=\"left\">\u900f\u660e\u534f\u4f5c\uff0c\u95ee\u9898\u89e3\u51b3<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u6570\u636e\u4f5c\u7528<\/strong><\/td>\n<td align=\"left\">\u5386\u53f2\u7f5a\u5355\uff0c\u8d22\u52a1\u8bb0\u5f55<\/td>\n<td align=\"left\">\u5b9e\u65f6\u6570\u636e\uff0c\u9a71\u52a8\u6539\u8fdb<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u957f\u671f\u6548\u679c<\/strong><\/td>\n<td align=\"left\">\u5173\u7cfb\u6076\u5316\uff0c\u8d28\u91cf\u505c\u6ede<\/td>\n<td align=\"left\">\u6301\u7eed\u6539\u8fdb\uff0c\u4f9b\u5e94\u94fe\u7a33\u5b9a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%BA%94%E3%80%81%E6%80%BB%E7%BB%93%EF%BC%9A%E5%81%9C%E6%AD%A2%E6%97%A0%E6%95%88%E6%89%A3%E5%88%86%EF%BC%8C%E7%AB%8B%E5%8D%B3%E5%90%AF%E5%8A%A8%E4%BD%A0%E7%9A%84%E4%BE%9B%E5%BA%94%E9%93%BE%E8%B4%A8%E9%87%8F%E6%94%B9%E8%BF%9B%E8%AE%A1%E5%88%92\"><\/span>\u4e94\u3001\u603b\u7ed3\uff1a\u505c\u6b62\u65e0\u6548\u6263\u5206\uff0c\u7acb\u5373\u542f\u52a8\u4f60\u7684\u4f9b\u5e94\u94fe\u8d28\u91cf\u6539\u8fdb\u8ba1\u5212<span 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