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class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5408\u683c\u7684\u4eba\u5458\u662fQMS\u80fd\u591f\u6709\u6548\u8fd0\u884c\u7684\u524d\u63d0\u3002\u4eba\u5458\u8d4b\u80fd\u7684\u6838\u5fc3\u5728\u4e8e\u4e00\u4e2a\u52a8\u6001\u4e14\u95ed\u73af\u7684\u57f9\u8bad\u7ba1\u7406\u7cfb\u7edf\u3002<\/p>\n<p>\u8fd9\u5957\u7cfb\u7edf\u59cb\u4e8e\u4e00\u4efd\u6e05\u6670\u7684\u5c97\u4f4d\u804c\u8d23\u8bf4\u660e\u4e0e\u57f9\u8bad\u9700\u6c42\u77e9\u9635\uff0c\u5b83\u660e\u786e\u5b9a\u4e49\u4e86\u201c\u4ec0\u4e48\u5c97\u4f4d\u7684\u4eba\u9700\u8981\u638c\u63e1\u54ea\u4e9b\u77e5\u8bc6\u548c\u6280\u80fd\u201d\u3002\u57fa\u4e8e\u8fd9\u4efd\u77e9\u9635\uff0c\u4f01\u4e1a\u5e94\u4e25\u683c\u6267\u884c\u5e76\u5b8c\u6574\u8bb0\u5f55\u6240\u6709\u7c7b\u578b\u7684\u57f9\u8bad\uff0c\u5305\u62ec\u65b0\u5458\u5de5\u7684\u5c97\u524d\u57f9\u8bad\u548c\u5728\u804c\u5458\u5de5\u7684\u6301\u7eed\u57f9\u8bad\u3002<\/p>\n<p>\u66f4\u5173\u952e\u7684\u662f\uff0c\u57f9\u8bad\u5e76\u975e\u7ec8\u70b9\u3002\u5fc5\u987b\u5b9a\u671f\u8fdb\u884c\u57f9\u8bad\u6548\u679c\u7684\u8bc4\u4f30\uff0c\u5e76\u901a\u8fc7\u8003\u6838\u6216\u73b0\u573a\u64cd\u4f5c\u786e\u8ba4\u7b49\u65b9\u5f0f\uff0c\u5bf9\u5173\u952e\u5c97\u4f4d\u4eba\u5458\u8fdb\u884c\u4e0a\u5c97\u8d44\u8d28\u786e\u8ba4\uff0c\u786e\u4fdd\u57f9\u8bad\u771f\u6b63\u8f6c\u5316\u4e3a\u4e86\u7b26\u5408\u8981\u6c42\u7684\u64cd\u4f5c\u80fd\u529b\u3002<\/p>\n<blockquote>\n<p>\u9636\u6bb5\u5c0f\u7ed3\uff1a\u7a33\u56fa\u7684\u201c\u6587\u4ef6\u201d\u548c\u5408\u683c\u7684\u201c\u4eba\u5458\u201d\u662fQMS\u6709\u6548\u8fd0\u884c\u7684\u57fa\u77f3\u3002\u8fd9\u4e24\u4e2a\u6b65\u9aa4\u7684\u5b8c\u6210\u8d28\u91cf\uff0c\u76f4\u63a5\u51b3\u5b9a\u4e86\u540e\u7eed\u6240\u6709\u8d28\u91cf\u6d3b\u52a8\u7684\u53ef\u9760\u6027\u3002<\/p>\n<\/blockquote>\n<h3><span class=\"ez-toc-section\" id=\"%E6%AD%A5%E9%AA%A4%E4%B8%89%EF%BC%9A%E6%BA%90%E5%A4%B4%E6%8E%A7%E5%88%B6_-_%E4%B8%A5%E6%A0%BC%E7%9A%84%E4%BE%9B%E5%BA%94%E5%95%86%E4%B8%8E%E7%89%A9%E6%96%99%E7%AE%A1%E7%90%86\"><\/span>\u6b65\u9aa4\u4e09\uff1a\u6e90\u5934\u63a7\u5236 - \u4e25\u683c\u7684\u4f9b\u5e94\u5546\u4e0e\u7269\u6599\u7ba1\u7406<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u836f\u54c1\u7684\u8d28\u91cf\u98ce\u9669\u5f88\u5927\u4e00\u90e8\u5206\u6765\u6e90\u4e8e\u4f9b\u5e94\u94fe\u4e0a\u6e38\u3002\u56e0\u6b64\uff0c\u5bf9\u4f9b\u5e94\u5546\u548c\u7269\u6599\u7684\u4e25\u683c\u63a7\u5236\u662f\u9884\u9632\u8d28\u91cf\u95ee\u9898\u7684\u5173\u952e\u7b2c\u4e00\u9053\u9632\u7ebf\u3002<\/p>\n<p>\u8fd9\u9700\u8981\u5efa\u7acb\u4e00\u5957\u5b8c\u6574\u7684\u5408\u683c\u4f9b\u5e94\u5546\u51c6\u5165\u4e0e\u7ba1\u7406\u6d41\u7a0b\uff0c\u5305\u62ec\u660e\u786e\u7684\u51c6\u5165\u6807\u51c6\u3001\u73b0\u573a\u5ba1\u8ba1\u7a0b\u5e8f\u4ee5\u53ca\u5b9a\u671f\u7684\u7ee9\u6548\u8bc4\u4f30\u3002\u5bf9\u4e8e\u8fdb\u5165\u5de5\u5382\u7684\u6bcf\u4e00\u6279\u7269\u6599\uff0c\u90fd\u5fc5\u987b\u5236\u5b9a\u5e76\u6267\u884c\u4e25\u683c\u7684\u6807\u51c6\u64cd\u4f5c\u7a0b\u5e8f\uff08SOP\uff09\uff0c\u8986\u76d6\u4ece\u63a5\u6536\u3001\u9694\u79bb\u3001\u53d6\u6837\u3001\u68c0\u9a8c\u5230\u6700\u7ec8\u6279\u51c6\u653e\u884c\u7684\u5168\u8fc7\u7a0b\u3002<\/p>\n<p>\u57fa\u4e8e\u6211\u4eec\u7684\u89c2\u5bdf\uff0c\u9886\u5148\u7684\u4f01\u4e1a\u5df2\u4e0d\u518d\u662f\u9759\u6001\u5730\u7ba1\u7406\u4f9b\u5e94\u5546\uff0c\u800c\u662f\u5b9e\u65bd\u57fa\u4e8e\u98ce\u9669\u7684\u6301\u7eed\u8bc4\u4f30\u4e0e\u52a8\u6001\u7ba1\u7406\uff0c\u5c06\u8d44\u6e90\u66f4\u591a\u5730\u6295\u5165\u5230\u9ad8\u98ce\u9669\u7684\u4f9b\u5e94\u5546\u4e0e\u7269\u6599\u4e0a\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E6%AD%A5%E9%AA%A4%E5%9B%9B%EF%BC%9A%E8%BF%87%E7%A8%8B%E4%BF%9D%E9%9A%9C_-_%E7%B2%BE%E7%BB%86%E5%8C%96%E7%9A%84%E7%94%9F%E4%BA%A7%E4%B8%8E%E6%93%8D%E4%BD%9C%E6%8E%A7%E5%88%B6\"><\/span>\u6b65\u9aa4\u56db\uff1a\u8fc7\u7a0b\u4fdd\u969c - \u7cbe\u7ec6\u5316\u7684\u751f\u4ea7\u4e0e\u64cd\u4f5c\u63a7\u5236<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5f53\u5408\u683c\u7684\u7269\u6599\u8fdb\u5165\u751f\u4ea7\u73af\u8282\u540e\uff0c\u7cbe\u7ec6\u5316\u7684\u8fc7\u7a0b\u63a7\u5236\u6210\u4e3a\u4fdd\u969c\u6279\u6b21\u8d28\u91cf\u7a33\u5b9a\u6027\u7684\u6838\u5fc3\u3002<\/p>\n<p>\u8fd9\u5305\u62ec\u5bf9\u6240\u6709\u5df2\u9a8c\u8bc1\u7684\u5173\u952e\u5de5\u827a\u53c2\u6570\uff08CPP\uff09\u8fdb\u884c\u6301\u7eed\u7684\u76d1\u63a7\u4e0e\u8bb0\u5f55\uff0c\u786e\u4fdd\u751f\u4ea7\u8fc7\u7a0b\u59cb\u7ec8\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\u3002\u6bcf\u4e00\u6279\u4ea7\u54c1\u7684\u6279\u751f\u4ea7\u8bb0\u5f55\uff08BPR\uff09\u90fd\u9700\u8981\u88ab\u89c4\u8303\u5730\u5b9e\u65f6\u586b\u5199\uff0c\u5e76\u5728\u751f\u4ea7\u7ed3\u675f\u540e\u7531\u591a\u7ea7\u4eba\u5458\u8fdb\u884c\u4e25\u683c\u590d\u6838\u4e0e\u6279\u51c6\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u5bf9\u751f\u4ea7\u73af\u5883\uff08\u5982\u6d01\u51c0\u533a\u7684\u6e29\u6e7f\u5ea6\u3001\u538b\u5dee\u3001\u5c18\u57c3\u7c92\u5b50\uff09\u548c\u4ed3\u50a8\u73af\u5883\u7684\u6301\u7eed\u76d1\u6d4b\uff0c\u4ee5\u53ca\u5bf9\u6240\u6709\u4eea\u5668\u8bbe\u5907\u7684\u5b9a\u671f\u6821\u9a8c\u4e0e\u9884\u9632\u6027\u7ef4\u62a4\uff0c\u90fd\u662f\u786e\u4fdd\u8fc7\u7a0b\u7a33\u5b9a\u4e0d\u53ef\u6216\u7f3a\u7684\u7ec4\u6210\u90e8\u5206\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E6%AD%A5%E9%AA%A4%E4%BA%94%EF%BC%9A%E5%BC%82%E5%B8%B8%E5%93%8D%E5%BA%94_-_%E8%A7%84%E8%8C%83%E5%8C%96%E7%9A%84%E5%81%8F%E5%B7%AE%E5%A4%84%E7%90%86%E4%B8%8E%E5%8F%98%E6%9B%B4%E6%8E%A7%E5%88%B6\"><\/span>\u6b65\u9aa4\u4e94\uff1a\u5f02\u5e38\u54cd\u5e94 - \u89c4\u8303\u5316\u7684\u504f\u5dee\u5904\u7406\u4e0e\u53d8\u66f4\u63a7\u5236<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6ca1\u6709\u4e00\u4e2a\u751f\u4ea7\u7cfb\u7edf\u662f\u5b8c\u7f8e\u65e0\u7f3a\u7684\uff0c\u5173\u952e\u5728\u4e8e\u5982\u4f55\u7cfb\u7edf\u6027\u5730\u54cd\u5e94\u5f02\u5e38\u3002\u504f\u5dee\u5904\u7406\u4e0e\u53d8\u66f4\u63a7\u5236\uff0c\u662f\u8861\u91cf\u4e00\u4e2aQMS\u6210\u719f\u5ea6\u7684\u91cd\u8981\u6807\u5fd7\u3002<\/p>\n<ul>\n<li><strong>\u504f\u5dee\u5904\u7406\u6d41\u7a0b<\/strong>\uff1a\u5f53\u51fa\u73b0\u4efb\u4f55\u504f\u79bb\u65e2\u5b9a\u89c4\u7a0b\u6216\u6807\u51c6\u7684\u60c5\u51b5\u65f6\uff0c\u5fc5\u987b\u542f\u52a8\u7ed3\u6784\u5316\u7684\u5904\u7406\u6d41\u7a0b\u3002\u8fd9\u5305\u62ec\uff1a\u4e8b\u4ef6\u7684\u53ca\u65f6\u4e0a\u62a5\u4e0e\u98ce\u9669\u7684\u521d\u6b65\u8bc4\u4f30\uff1b\u6df1\u5165\u7684\u6839\u672c\u539f\u56e0\u8c03\u67e5\uff08RCA\uff09\u4ee5\u627e\u5230\u95ee\u9898\u672c\u8d28\uff1b\u4ee5\u53ca\u57fa\u4e8e\u6839\u672c\u539f\u56e0\u5236\u5b9a\u5e76\u5b9e\u65bd\u6709\u6548\u7684\u7ea0\u6b63\u63aa\u65bd\u3002<\/li>\n<li><strong>\u53d8\u66f4\u63a7\u5236\u6d41\u7a0b<\/strong>\uff1a\u4efb\u4f55\u5bf9\u5df2\u9a8c\u8bc1\u7684\u5de5\u827a\u3001\u8bbe\u5907\u3001\u7269\u6599\u6216\u6587\u4ef6\u7684\u53d8\u66f4\uff0c\u90fd\u53ef\u80fd\u5f15\u5165\u65b0\u7684\u98ce\u9669\u3002\u56e0\u6b64\uff0c\u5fc5\u987b\u901a\u8fc7\u4e25\u683c\u7684\u53d8\u66f4\u63a7\u5236\u6d41\u7a0b\u8fdb\u884c\u7ba1\u7406\uff1a\u9996\u5148\u53d1\u8d77\u53d8\u66f4\u7533\u8bf7\u5e76\u8fdb\u884c\u5168\u9762\u7684\u5f71\u54cd\u8bc4\u4f30\uff1b\u7ecf\u76f8\u5173\u65b9\u6279\u51c6\u540e\u5236\u5b9a\u8be6\u7ec6\u7684\u5b9e\u65bd\u8ba1\u5212\uff1b\u6700\u540e\uff0c\u5728\u53d8\u66f4\u5b8c\u6210\u540e\u8fdb\u884c\u6548\u679c\u9a8c\u8bc1\uff0c\u786e\u4fdd\u53d8\u66f4\u8fbe\u5230\u4e86\u9884\u671f\u76ee\u7684\u4e14\u672a\u5f15\u5165\u65b0\u7684\u8d1f\u9762\u5f71\u54cd\u3002<\/li>\n<\/ul>\n<blockquote>\n<p>\u9636\u6bb5\u5c0f\u7ed3\uff1a\u6709\u6548\u7684\u8fc7\u7a0b\u63a7\u5236\u4e0e\u5f02\u5e38\u54cd\u5e94\u673a\u5236\uff0c\u6784\u6210\u4e86\u8d28\u91cf\u7ba1\u7406\u7684\u6267\u884c\u95ed\u73af\u3002\u524d\u8005\u786e\u4fdd\u65e5\u5e38\u8fd0\u884c\u7684\u7a33\u5b9a\uff0c\u540e\u8005\u5219\u4fdd\u8bc1\u4e86\u7cfb\u7edf\u5728\u9762\u5bf9\u53d8\u5316\u4e0e\u610f\u5916\u65f6\u7684\u97e7\u6027\u3002<\/p>\n<\/blockquote>\n<h3><span class=\"ez-toc-section\" id=\"%E6%AD%A5%E9%AA%A4%E5%85%AD%EF%BC%9A%E6%8C%81%E7%BB%AD%E6%94%B9%E8%BF%9B_-_%E8%BF%90%E8%A1%8C%E9%AB%98%E6%95%88%E7%9A%84CAPA%E7%B3%BB%E7%BB%9F\"><\/span>\u6b65\u9aa4\u516d\uff1a\u6301\u7eed\u6539\u8fdb - \u8fd0\u884c\u9ad8\u6548\u7684CAPA\u7cfb\u7edf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>CAPA\uff08\u7ea0\u6b63\u63aa\u65bd\u548c\u9884\u9632\u63aa\u65bd\uff09\u662fQMS\u7684\u201c\u5927\u8111\u201d\uff0c\u662f\u9a71\u52a8\u7cfb\u7edf\u81ea\u6211\u5b8c\u5584\u7684\u6838\u5fc3\u5f15\u64ce\u3002\u4e00\u4e2a\u9ad8\u6548\u7684CAPA\u7cfb\u7edf\u80fd\u591f\u4ece\u5404\u7c7b\u4fe1\u606f\u6e90\u4e2d\u8bc6\u522b\u6539\u8fdb\u673a\u4f1a\u3002<\/p>\n<ul>\n<li><strong>CAPA\u7684\u6765\u6e90<\/strong>\uff1a\u95ee\u9898\u7ebf\u7d22\u53ef\u4ee5\u6765\u81ea\u504f\u5dee\u8c03\u67e5\u3001\u5185\u90e8\u6216\u5916\u90e8\u7684\u5ba1\u8ba1\u53d1\u73b0\u3001\u5ba2\u6237\u6295\u8bc9\u3001\u7a33\u5b9a\u6027\u8003\u5bdf\u7ed3\u679c\uff0c\u751a\u81f3\u662f\u524d\u77bb\u6027\u7684\u98ce\u9669\u8bc4\u4f30\u6d3b\u52a8\u3002<\/li>\n<li><strong>CAPA\u7684\u6267\u884c<\/strong>\uff1a\u7cfb\u7edf\u9700\u8981\u6e05\u6670\u5730\u533a\u5206\u4e24\u7c7b\u63aa\u65bd\u3002**\u7ea0\u6b63\u63aa\u65bd\uff08Corrective Action\uff09<strong>\u65e8\u5728\u89e3\u51b3\u5df2\u7ecf\u53d1\u751f\u7684\u95ee\u9898\uff0c\u6d88\u9664\u5176\u6839\u672c\u539f\u56e0\uff0c\u9632\u6b62\u5176\u518d\u6b21\u53d1\u751f\u3002\u800c<\/strong>\u9884\u9632\u63aa\u65bd\uff08Preventive Action\uff09**\u5219\u66f4\u8fdb\u4e00\u6b65\uff0c\u65e8\u5728\u8bc6\u522b\u6f5c\u5728\u7684\u8d28\u91cf\u98ce\u9669\uff0c\u5e76\u63d0\u524d\u91c7\u53d6\u63aa\u65bd\u9632\u6b62\u5176\u53d1\u751f\u3002<\/li>\n<li><strong>CAPA\u7684\u9a8c\u8bc1<\/strong>\uff1a\u5b8c\u6210\u63aa\u65bd\u7684\u5b9e\u65bd\u53ea\u662fCAPA\u6d41\u7a0b\u7684\u4e00\u534a\u3002\u5fc5\u987b\u5bf9\u63aa\u65bd\u7684\u6709\u6548\u6027\u8fdb\u884c\u6301\u7eed\u8ddf\u8e2a\u548c\u9a8c\u8bc1\uff0c\u901a\u8fc7\u6570\u636e\u8bc1\u660e\u95ee\u9898\u5f97\u5230\u4e86\u6839\u672c\u89e3\u51b3\u4e14\u6ca1\u6709\u590d\u53d1\uff0c\u624d\u7b97\u771f\u6b63\u5173\u95ed\u4e00\u4e2aCAPA\u5faa\u73af\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"%E6%AD%A5%E9%AA%A4%E4%B8%83%EF%BC%9A%E7%B3%BB%E7%BB%9F%E4%BD%93%E6%A3%80_-_%E5%AE%9A%E6%9C%9F%E5%AE%A1%E8%AE%A1%E4%B8%8E%E7%AE%A1%E7%90%86%E8%AF%84%E5%AE%A1\"><\/span>\u6b65\u9aa4\u4e03\uff1a\u7cfb\u7edf\u4f53\u68c0 - \u5b9a\u671f\u5ba1\u8ba1\u4e0e\u7ba1\u7406\u8bc4\u5ba1<span 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