{"id":41832,"date":"2025-12-29T19:32:39","date_gmt":"2025-12-29T11:32:39","guid":{"rendered":"https:\/\/www.zdsztech.com\/blog\/production-quality-deviation-corrective-prevention-measures\/"},"modified":"2025-12-29T19:32:39","modified_gmt":"2025-12-29T11:32:39","slug":"production-quality-deviation-corrective-prevention-measures","status":"publish","type":"post","link":"https:\/\/www.zdsztech.com\/blog\/production-quality-deviation-corrective-prevention-measures\/","title":{"rendered":"\u751f\u4ea7\u8d28\u91cf\u504f\u5dee\u5982\u4f55\u7ea0\u6b63\u9884\u9632\uff1f\u5b9e\u7528\u63aa\u65bd\u5927\u76d8\u70b9\uff01"},"content":{"rendered":"<p>\u4f5c\u4e3a\u9996\u5e2d\u884c\u4e1a\u5206\u6790\u5e08\uff0c\u5728\u670d\u52a1\u8d85\u8fc75000\u5bb6\u5236\u9020\u4f01\u4e1a\u7684\u8fc7\u7a0b\u4e2d\uff0c\u6211\u4eec\u53d1\u73b0\u4e00\u4e2a\u4e25\u5cfb\u7684\u73b0\u5b9e\uff1a\u751f\u4ea7\u8d28\u91cf\u504f\u5dee\u662f\u4fb5\u8680\u4f01\u4e1a\u5229\u6da6\u3001\u635f\u5bb3\u54c1\u724c\u58f0\u8a89\u3001\u524a\u5f31\u5e02\u573a\u7ade\u4e89\u529b\u7684\u201c\u9690\u5f62\u6740\u624b\u201d\u3002\u5b83\u4e0d\u50cf\u91cd\u5927\u5b89\u5168\u4e8b\u6545\u90a3\u6837\u5f15\u4eba\u6ce8\u76ee\uff0c\u5374\u4ee5\u4e00\u79cd\u6301\u7eed\u3001\u6e10\u8fdb\u7684\u65b9\u5f0f\u6d88\u8017\u7740\u4f01\u4e1a\u7684\u751f\u547d\u529b\u3002\u6839\u636e\u6211\u4eec\u5bf95000+\u5236\u9020\u4f01\u4e1a\u7684\u89c2\u5bdf\uff0c\u8d85\u8fc760%\u7684\u5229\u6da6\u4fb5\u8680\u4e0e\u672a\u53d7\u63a7\u7684\u8d28\u91cf\u504f\u5dee\u76f4\u63a5\u76f8\u5173\u3002\u8fd9\u4e9b\u504f\u5dee\u5bfc\u81f4\u4e86\u7269\u6599\u6d6a\u8d39\u3001\u4ea7\u7ebf\u505c\u5de5\u3001\u4ea7\u54c1\u8fd4\u5de5\u3001\u5ba2\u6237\u6295\u8bc9\u4e43\u81f3\u8ba2\u5355\u6d41\u5931\uff0c\u5176\u7d2f\u79ef\u6210\u672c\u89e6\u76ee\u60ca\u5fc3\u3002\u7136\u800c\uff0c\u8bb8\u591a\u4f01\u4e1a\u7ba1\u7406\u8005\u4ecd\u505c\u7559\u5728\u201c\u5934\u75db\u533b\u5934\u3001\u811a\u75db\u533b\u811a\u201d\u7684\u88ab\u52a8\u5e94\u5bf9\u6a21\u5f0f\uff0c\u7f3a\u4e4f\u7cfb\u7edf\u6027\u7684\u7ba1\u7406\u6846\u67b6\u3002\u672c\u6587\u65e8\u5728\u4e3a\u4f01\u4e1a\u51b3\u7b56\u8005\u63d0\u4f9b\u4e00\u4e2a\u7cfb\u7edf\u5316\u3001\u53ef\u6267\u884c\u7684\u7ea0\u6b63\u4e0e\u9884\u9632\u884c\u52a8\uff08CAPA\uff09\u6846\u67b6\uff0c\u8be6\u7ec6\u62c6\u89e3\u4ece\u504f\u5dee\u8bc6\u522b\u3001\u7ea0\u6b63\u5230\u9884\u9632\u7684\u5168\u6d41\u7a0b\uff0c\u5e76\u63a2\u8ba8\u5982\u4f55\u5229\u7528\u6570\u5b57\u5316\u5de5\u5177\u56fa\u5316\u7ba1\u7406\u4f53\u7cfb\u3002\u6211\u4eec\u7684\u76ee\u6807\u662f\u5e2e\u52a9\u4f01\u4e1a\u4ece\u88ab\u52a8\u5e94\u5bf9\u7684\u201c\u6551\u706b\u961f\u201d\u89d2\u8272\uff0c\u8f6c\u5411\u4e3b\u52a8\u9884\u9632\u7684\u201c\u67b6\u6784\u5e08\u201d\uff0c\u6784\u5efa\u7a33\u56fa\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u5c06\u8d28\u91cf\u8f6c\u5316\u4e3a\u771f\u6b63\u7684\u6838\u5fc3\u7ade\u4e89\u529b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%80%E3%80%81%E5%AE%9A%E4%B9%89%E4%B8%8E%E8%AF%86%E5%88%AB%EF%BC%9A%E4%BB%80%E4%B9%88%E6%98%AF%E7%94%9F%E4%BA%A7%E8%B4%A8%E9%87%8F%E5%81%8F%E5%B7%AE%EF%BC%9F\"><\/span>\u4e00\u3001\u5b9a\u4e49\u4e0e\u8bc6\u522b\uff1a\u4ec0\u4e48\u662f\u751f\u4ea7\u8d28\u91cf\u504f\u5dee\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u6df1\u5165\u63a2\u8ba8\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\u4e4b\u524d\uff0c\u51b3\u7b56\u8005\u5fc5\u987b\u9996\u5148\u5bf9\u201c\u751f\u4ea7\u8d28\u91cf\u504f\u5dee\u201d\u5efa\u7acb\u4e00\u4e2a\u6e05\u6670\u3001\u7ed3\u6784\u5316\u7684\u8ba4\u77e5\u3002\u751f\u4ea7\u8d28\u91cf\u504f\u5dee\uff08Production Quality Deviation\uff09\u662f\u6307\u5728\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u4efb\u4f55\u504f\u79bb\u65e2\u5b9a\u6807\u51c6\u3001\u89c4\u7a0b\u3001\u89c4\u8303\u6216\u9884\u671f\u7684\u4e8b\u4ef6\u3002\u5b83\u4e0d\u662f\u4e00\u4e2a\u6a21\u7cca\u7684\u6982\u5ff5\uff0c\u800c\u662f\u53ef\u4ee5\u88ab\u7cbe\u786e\u5206\u7c7b\u548c\u6eaf\u6e90\u7684\u7ba1\u7406\u5bf9\u8c61\u3002\u53ea\u6709\u51c6\u786e\u5730\u8bc6\u522b\u504f\u5dee\u7684\u4e25\u91cd\u7b49\u7ea7\u548c\u6f5c\u5728\u6765\u6e90\uff0c\u624d\u80fd\u8c03\u52a8\u9002\u5ea6\u7684\u8d44\u6e90\uff0c\u8fdb\u884c\u9ad8\u6548\u7684\u5904\u7f6e\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"11_%E5%81%8F%E5%B7%AE%E7%9A%84%E5%88%86%E7%B1%BB%EF%BC%9A%E5%85%B3%E9%94%AE%E3%80%81%E4%B8%BB%E8%A6%81%E4%B8%8E%E6%AC%A1%E8%A6%81%E5%81%8F%E5%B7%AE\"><\/span>1.1 \u504f\u5dee\u7684\u5206\u7c7b\uff1a\u5173\u952e\u3001\u4e3b\u8981\u4e0e\u6b21\u8981\u504f\u5dee<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e3a\u4e86\u5b9e\u73b0\u8d44\u6e90\u7684\u6709\u6548\u5206\u914d\u548c\u98ce\u9669\u7684\u7cbe\u51c6\u7ba1\u63a7\uff0c\u6211\u4eec\u5c06\u504f\u5dee\u6309\u7167\u5176\u53ef\u80fd\u4ea7\u751f\u7684\u5f71\u54cd\u4e25\u91cd\u7a0b\u5ea6\uff0c\u5212\u5206\u4e3a\u4e09\u4e2a\u7b49\u7ea7\uff1a\u5173\u952e\u504f\u5dee\u3001\u4e3b\u8981\u504f\u5dee\u548c\u6b21\u8981\u504f\u5dee\u3002\u8fd9\u79cd\u5206\u7c7b\u65b9\u6cd5\u662f\u5efa\u7acb\u79d1\u5b66\u8bc4\u4f30\u6807\u51c6\u7684\u7b2c\u4e00\u6b65\uff0c\u786e\u4fdd\u7ba1\u7406\u56e2\u961f\u80fd\u591f\u5bf9\u4e0d\u540c\u8b66\u62a5\u7ea7\u522b\u7684\u4e8b\u4ef6\u505a\u51fa\u6070\u5f53\u53cd\u5e94\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">\u504f\u5dee\u7b49\u7ea7<\/th>\n<th align=\"left\">\u5b9a\u4e49<\/th>\n<th align=\"left\">\u5bf9\u4ea7\u54c1\/\u5ba2\u6237\u7684\u5f71\u54cd<\/th>\n<th align=\"left\">\u5904\u7406\u4f18\u5148\u7ea7<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\"><strong>\u5173\u952e\u504f\u5dee (Critical Deviation)<\/strong><\/td>\n<td align=\"left\">\u6307\u504f\u79bb\u6cd5\u5b9a\u6cd5\u89c4\u3001\u6ce8\u518c\u6807\u51c6\u6216\u53ef\u80fd\u5bf9\u4ea7\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u4ea7\u751f\u91cd\u5927\u5f71\u54cd\u7684\u4e8b\u4ef6\u3002<\/td>\n<td align=\"left\">\u6781\u9ad8\uff1a\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u5b8c\u5168\u5931\u6548\u3001\u5f15\u53d1\u5b89\u5168\u4e8b\u6545\u3001\u5bf9\u4f7f\u7528\u8005\u9020\u6210\u4e25\u91cd\u4f24\u5bb3\u6216\u4e0d\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\uff0c\u5fc5\u987b\u53ec\u56de\u3002<\/td>\n<td align=\"left\"><strong>\u6700\u9ad8<\/strong>\uff1a\u9700\u7acb\u5373\u505c\u7ebf\uff0c\u9694\u79bb\u6240\u6709\u76f8\u5173\u6279\u6b21\uff0c\u5e76\u4e0a\u62a5\u81f3\u6700\u9ad8\u7ba1\u7406\u5c42\uff0c\u7acb\u5373\u542f\u52a8\u5168\u9762\u8c03\u67e5\u3002<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u4e3b\u8981\u504f\u5dee (Major Deviation)<\/strong><\/td>\n<td align=\"left\">\u6307\u504f\u79bb\u5df2\u9a8c\u8bc1\u7684\u5de5\u827a\u53c2\u6570\u6216\u8d28\u91cf\u6807\u51c6\uff0c\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u6027\u80fd\u3001\u7eaf\u5ea6\u3001\u8d28\u91cf\u6216\u7a33\u5b9a\u6027\u4e0b\u964d\uff0c\u4f46\u901a\u5e38\u4e0d\u6784\u6210\u76f4\u63a5\u5b89\u5168\u5a01\u80c1\u3002<\/td>\n<td align=\"left\">\u8f83\u9ad8\uff1a\u53ef\u80fd\u5bfc\u81f4\u4ea7\u54c1\u90e8\u5206\u529f\u80fd\u4e0d\u8fbe\u6807\u3001\u6279\u6b21\u4e0d\u5408\u683c\u3001\u5ba2\u6237\u6295\u8bc9\u7387\u663e\u8457\u4e0a\u5347\u6216\u9700\u8981\u8fdb\u884c\u8fd4\u5de5\u5904\u7406\u3002<\/td>\n<td align=\"left\"><strong>\u9ad8<\/strong>\uff1a\u9700\u7acb\u5373\u8bc4\u4f30\u98ce\u9669\uff0c\u9694\u79bb\u53d7\u5f71\u54cd\u6279\u6b21\uff0c\u5728\u9650\u5b9a\u65f6\u95f4\u5185\u5b8c\u6210\u6839\u672c\u539f\u56e0\u8c03\u67e5\u548c\u7ea0\u6b63\u63aa\u65bd\u3002<\/td>\n<\/tr>\n<tr>\n<td align=\"left\"><strong>\u6b21\u8981\u504f\u5dee (Minor Deviation)<\/strong><\/td>\n<td align=\"left\">\u6307\u8f7b\u5fae\u504f\u79bb\u64cd\u4f5c\u89c4\u7a0b\u6216\u6587\u4ef6\u8bb0\u5f55\u8981\u6c42\uff0c\u5bf9\u4ea7\u54c1\u6700\u7ec8\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u51e0\u4e4e\u6ca1\u6709\u53ef\u9884\u89c1\u7684\u5f71\u54cd\u3002<\/td>\n<td align=\"left\">\u8f83\u4f4e\uff1a\u901a\u5e38\u4e0d\u4f1a\u5f71\u54cd\u4ea7\u54c1\u653e\u884c\uff0c\u4f46\u53ef\u80fd\u53cd\u6620\u51fa\u6d41\u7a0b\u4e2d\u7684\u6f5c\u5728\u5f31\u70b9\u6216\u8bb0\u5f55\u4e0d\u89c4\u8303\u7684\u95ee\u9898\u3002<\/td>\n<td align=\"left\"><strong>\u4e2d<\/strong>\uff1a\u53ef\u5728\u5e38\u89c4\u751f\u4ea7\u6d3b\u52a8\u4e2d\u8fdb\u884c\u8c03\u67e5\u548c\u7ea0\u6b63\uff0c\u65e8\u5728\u6301\u7eed\u6539\u8fdb\uff0c\u9632\u6b62\u5c0f\u95ee\u9898\u6f14\u53d8\u4e3a\u5927\u95ee\u9898\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3><span class=\"ez-toc-section\" id=\"12_%E5%81%8F%E5%B7%AE%E7%9A%84%E6%9D%A5%E6%BA%90%EF%BC%9A%E4%BA%BA%E3%80%81%E6%9C%BA%E3%80%81%E6%96%99%E3%80%81%E6%B3%95%E3%80%81%E7%8E%AF%E3%80%81%E6%B5%8B%EF%BC%886M%EF%BC%89%E5%88%86%E6%9E%90%E6%B3%95\"><\/span>1.2 \u504f\u5dee\u7684\u6765\u6e90\uff1a\u4eba\u3001\u673a\u3001\u6599\u3001\u6cd5\u3001\u73af\u3001\u6d4b\uff086M\uff09\u5206\u6790\u6cd5<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8bc6\u522b\u504f\u5dee\u7684\u7b49\u7ea7\u540e\uff0c\u4e0b\u4e00\u6b65\u662f\u7cfb\u7edf\u6027\u5730\u8ffd\u6eaf\u5176\u6765\u6e90\u3002\u7ecf\u5178\u76846M\u5206\u6790\u6cd5\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5168\u9762\u7684\u6846\u67b6\uff0c\u5e2e\u52a9\u8c03\u67e5\u56e2\u961f\u4ece\u516d\u4e2a\u7ef4\u5ea6\u7cfb\u7edf\u6392\u67e5\u6839\u672c\u539f\u56e0\uff0c\u907f\u514d\u9057\u6f0f\u3002<\/p>\n<ul>\n<li><strong>\u4eba\uff08Man\/Manpower\uff09<\/strong>\uff1a\u4e0e\u4eba\u5458\u76f8\u5173\u7684\u56e0\u7d20\u3002\u8fd9\u5305\u62ec\u64cd\u4f5c\u4eba\u5458\u7684\u6280\u80fd\u719f\u7ec3\u5ea6\u3001\u57f9\u8bad\u60c5\u51b5\u3001\u8d23\u4efb\u5fc3\u3001\u75b2\u52b3\u72b6\u6001\u4ee5\u53ca\u662f\u5426\u9075\u5faa\u64cd\u4f5c\u89c4\u7a0b\u3002\n<ul>\n<li><em>\u4f8b\u5b50<\/em>\uff1a\u65b0\u5458\u5de5\u672a\u7ecf\u5145\u5206\u57f9\u8bad\u5373\u4e0a\u5c97\uff0c\u56e0\u64cd\u4f5c\u4e0d\u719f\u7ec3\u5bfc\u81f4\u8bbe\u5907\u53c2\u6570\u8bbe\u7f6e\u9519\u8bef\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u673a\uff08Machine\uff09<\/strong>\uff1a\u4e0e\u8bbe\u5907\u3001\u5de5\u88c5\u5939\u5177\u76f8\u5173\u7684\u56e0\u7d20\u3002\u8fd9\u5305\u62ec\u8bbe\u5907\u7cbe\u5ea6\u3001\u7ef4\u62a4\u4fdd\u517b\u72b6\u51b5\u3001\u6027\u80fd\u7a33\u5b9a\u6027\u3001\u5de5\u5177\u7684\u9002\u7528\u6027\u7b49\u3002\n<ul>\n<li><em>\u4f8b\u5b50<\/em>\uff1a\u751f\u4ea7\u8bbe\u5907\u7684\u4e00\u4e2a\u5173\u952e\u4f20\u611f\u5668\u8001\u5316\uff0c\u5bfc\u81f4\u6e29\u5ea6\u63a7\u5236\u51fa\u73b0\u6f02\u79fb\uff0c\u8d85\u51fa\u5de5\u827a\u7a97\u53e3\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u6599\uff08Material\uff09<\/strong>\uff1a\u4e0e\u539f\u6750\u6599\u3001\u8f85\u6599\u3001\u534a\u6210\u54c1\u76f8\u5173\u7684\u56e0\u7d20\u3002\u8fd9\u5305\u62ec\u7269\u6599\u7684\u89c4\u683c\u3001\u7eaf\u5ea6\u3001\u4f9b\u5e94\u5546\u8d28\u91cf\u3001\u5b58\u50a8\u6761\u4ef6\u3001\u6279\u6b21\u4e00\u81f4\u6027\u7b49\u3002\n<ul>\n<li><em>\u4f8b\u5b50<\/em>\uff1a\u67d0\u6279\u6b21\u4f9b\u5e94\u5546\u6765\u6599\u7684\u6742\u8d28\u542b\u91cf\u7565\u9ad8\u4e8e\u6807\u51c6\uff0c\u5bfc\u81f4\u6700\u7ec8\u4ea7\u54c1\u51fa\u73b0\u5fae\u5c0f\u7455\u75b5\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u6cd5\uff08Method\uff09<\/strong>\uff1a\u4e0e\u65b9\u6cd5\u3001\u5de5\u827a\u3001\u6d41\u7a0b\u76f8\u5173\u7684\u56e0\u7d20\u3002\u8fd9\u5305\u62ec\u4f5c\u4e1a\u6307\u5bfc\u4e66\uff08SOP\uff09\u7684\u6e05\u6670\u5ea6\u3001\u5de5\u827a\u53c2\u6570\u7684\u5408\u7406\u6027\u3001\u64cd\u4f5c\u6d41\u7a0b\u7684\u79d1\u5b66\u6027\u7b49\u3002\n<ul>\n<li><em>\u4f8b\u5b50<\/em>\uff1a\u4f5c\u4e1a\u6307\u5bfc\u4e66\uff08SOP\uff09\u66f4\u65b0\u4e0d\u53ca\u65f6\uff0c\u5bfc\u81f4\u5458\u5de5\u4ecd\u5728\u4f7f\u7528\u5df2\u88ab\u4f18\u5316\u7684\u8fc7\u65f6\u5de5\u827a\u8fdb\u884c\u751f\u4ea7\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u73af\uff08Environment\uff09<\/strong>\uff1a\u4e0e\u751f\u4ea7\u73af\u5883\u76f8\u5173\u7684\u56e0\u7d20\u3002\u8fd9\u5305\u62ec\u8f66\u95f4\u7684\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u6d01\u51c0\u5ea6\u3001\u5149\u7167\u3001\u632f\u52a8\u3001\u7535\u78c1\u5e72\u6270\u7b49\u3002\n<ul>\n<li><em>\u4f8b\u5b50<\/em>\uff1a\u96e8\u5b63\u8f66\u95f4\u6e7f\u5ea6\u8fc7\u9ad8\uff0c\u8d85\u51fa\u89c4\u5b9a\u8303\u56f4\uff0c\u5f71\u54cd\u4e86\u67d0\u79cd\u5bf9\u6e7f\u5ea6\u654f\u611f\u7684\u80f6\u6c34\u7684\u56fa\u5316\u6548\u679c\u3002<\/li>\n<\/ul>\n<\/li>\n<li><strong>\u6d4b\uff08Measurement\uff09<\/strong>\uff1a\u4e0e\u6d4b\u91cf\u7cfb\u7edf\u3001\u68c0\u9a8c\u65b9\u6cd5\u76f8\u5173\u7684\u56e0\u7d20\u3002\u8fd9\u5305\u62ec\u6d4b\u91cf\u8bbe\u5907\u7684\u6821\u51c6\u72b6\u6001\u3001\u6d4b\u91cf\u65b9\u6cd5\u7684\u51c6\u786e\u6027\uff08GR&amp;R\uff09\u3001\u68c0\u9a8c\u6807\u51c6\u662f\u5426\u660e\u786e\u7b49\u3002\n<ul>\n<li><em>\u4f8b\u5b50<\/em>\uff1a\u7528\u4e8e\u68c0\u6d4b\u4ea7\u54c1\u5c3a\u5bf8\u7684\u5361\u5c3a\u672a\u6309\u671f\u6821\u51c6\uff0c\u5bfc\u81f4\u6d4b\u91cf\u6570\u636e\u5931\u51c6\uff0c\u5c06\u5408\u683c\u54c1\u8bef\u5224\u4e3a\u4e0d\u5408\u683c\u54c1\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E4%BA%8C%E3%80%81%E7%BA%A0%E6%AD%A3%E6%8E%AA%E6%96%BD%EF%BC%88Correction%EF%BC%89%EF%BC%9A%E5%A6%82%E4%BD%95%E5%BF%AB%E9%80%9F%E5%93%8D%E5%BA%94%E5%B9%B6%E6%8E%A7%E5%88%B6%E5%81%8F%E5%B7%AE%E5%BD%B1%E5%93%8D%EF%BC%9F\"><\/span>\u4e8c\u3001\u7ea0\u6b63\u63aa\u65bd\uff08Correction\uff09\uff1a\u5982\u4f55\u5feb\u901f\u54cd\u5e94\u5e76\u63a7\u5236\u504f\u5dee\u5f71\u54cd\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5f53\u504f\u5dee\u53d1\u751f\u65f6\uff0c\u9996\u8981\u4efb\u52a1\u4e0d\u662f\u8ffd\u8d23\uff0c\u800c\u662f\u8fc5\u901f\u884c\u52a8\uff0c\u5c06\u504f\u5dee\u5e26\u6765\u7684\u8d1f\u9762\u5f71\u54cd\u63a7\u5236\u5728\u6700\u5c0f\u8303\u56f4\u3002\u4e00\u4e2a\u9ad8\u6548\u7684\u7ea0\u6b63\u6d41\u7a0b\u80fd\u591f\u4e3a\u540e\u7eed\u7684\u6839\u672c\u539f\u56e0\u5206\u6790\u548c\u9884\u9632\u63aa\u65bd\u8d62\u5f97\u5b9d\u8d35\u7684\u65f6\u95f4\u548c\u7a7a\u95f4\u3002\u8fd9\u4e2a\u9636\u6bb5\u7684\u6838\u5fc3\u662f\u201c\u63a7\u5236\u201d\u4e0e\u201c\u5206\u6790\u201d\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"21_%E6%AD%A5%E9%AA%A4%E4%B8%80%EF%BC%9A%E7%AB%8B%E5%8D%B3%E8%A1%8C%E5%8A%A8%E4%B8%8E%E9%A3%8E%E9%99%A9%E8%AF%84%E4%BC%B0\"><\/span>2.1 \u6b65\u9aa4\u4e00\uff1a\u7acb\u5373\u884c\u52a8\u4e0e\u98ce\u9669\u8bc4\u4f30<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u53d1\u73b0\u504f\u5dee\u540e\u7684\u7b2c\u4e00\u4e2a\u5c0f\u65f6\u81f3\u5173\u91cd\u8981\u3002\u6df7\u4e71\u7684\u5e94\u5bf9\u4f1a\u653e\u5927\u635f\u5931\uff0c\u800c\u6807\u51c6\u5316\u7684\u5e94\u6025\u54cd\u5e94\u6d41\u7a0b\u5219\u80fd\u786e\u4fdd\u884c\u52a8\u7684\u6709\u5e8f\u548c\u9ad8\u6548\u3002\u4f01\u4e1a\u5fc5\u987b\u5efa\u7acb\u5e76\u6f14\u7ec3\u4e00\u5957\u660e\u786e\u7684\u884c\u52a8\u6307\u5357\uff0c\u786e\u4fdd\u4efb\u4f55\u5458\u5de5\u5728\u53d1\u73b0\u95ee\u9898\u65f6\u90fd\u6e05\u695a\u8be5\u505a\u4ec0\u4e48\u3002<\/p>\n<ol>\n<li><strong>\u7acb\u5373\u9694\u79bb\u4e0e\u6807\u8bc6<\/strong>\uff1a\u4e00\u65e6\u786e\u8ba4\u504f\u5dee\uff0c\u73b0\u573a\u4eba\u5458\u7684\u9996\u8981\u804c\u8d23\u662f\u7acb\u5373\u505c\u6b62\u53d7\u5f71\u54cd\u7684\u751f\u4ea7\u6d3b\u52a8\u3002\u5bf9\u6240\u6709\u53ef\u80fd\u53d7\u5f71\u54cd\u7684\u7269\u6599\u3001\u534a\u6210\u54c1\u548c\u6210\u54c1\u8fdb\u884c\u7269\u7406\u9694\u79bb\uff0c\u5e76\u4f7f\u7528\u6e05\u6670\u3001\u9192\u76ee\u7684\u6807\u8bc6\uff08\u5982\u201c\u5f85\u5904\u7406\u201d\u3001\u201c\u4e0d\u5408\u683c\u201d\uff09\u8fdb\u884c\u6807\u8bb0\uff0c\u9632\u6b62\u5176\u610f\u5916\u6d41\u5411\u4e0b\u6e38\u5de5\u5e8f\u6216\u8fdb\u5165\u6210\u54c1\u5e93\u3002<\/li>\n<li><strong>\u8bc4\u4f30\u5f71\u54cd\u8303\u56f4<\/strong>\uff1a\u8d28\u91cf\u6216\u751f\u4ea7\u90e8\u95e8\u5e94\u8fc5\u901f\u7ec4\u7ec7\u8bc4\u4f30\u3002\u8bc4\u4f30\u9700\u8981\u56de\u7b54\u51e0\u4e2a\u5173\u952e\u95ee\u9898\uff1a\u504f\u5dee\u4ece\u4f55\u65f6\u5f00\u59cb\uff1f\u5f71\u54cd\u4e86\u54ea\u4e9b\u6279\u6b21\u6216\u8ba2\u5355\uff1f\u662f\u5426\u6709\u53d7\u5f71\u54cd\u7684\u4ea7\u54c1\u5df2\u7ecf\u51fa\u8d27\uff1f\u5bf9\u5df2\u653e\u884c\u4ea7\u54c1\u7684\u5f71\u54cd\u6709\u591a\u4e25\u91cd\uff1f\u8fd9\u9700\u8981\u5feb\u901f\u8ffd\u6eaf\u751f\u4ea7\u8bb0\u5f55\u3001\u7269\u6599\u6279\u53f7\u548c\u53d1\u8d27\u8bb0\u5f55\uff0c\u8bc4\u4f30\u6f5c\u5728\u7684\u5ba2\u6237\u98ce\u9669\u548c\u53ec\u56de\u5fc5\u8981\u6027\u3002<\/li>\n<li><strong>\u542f\u52a8\u504f\u5dee\u8c03\u67e5\u6d41\u7a0b<\/strong>\uff1a\u5728\u5b8c\u6210\u521d\u6b65\u63a7\u5236\u540e\uff0c\u5e94\u7acb\u5373\u6309\u7167\u9884\u8bbe\u7a0b\u5e8f\uff0c\u6b63\u5f0f\u542f\u52a8\u504f\u5dee\u8c03\u67e5\u6d41\u7a0b\u3002\u8fd9\u901a\u5e38\u610f\u5473\u7740\u7ec4\u5efa\u4e00\u4e2a\u8de8\u804c\u80fd\u7684\u8c03\u67e5\u5c0f\u7ec4\uff08\u5305\u62ec\u8d28\u91cf\u3001\u751f\u4ea7\u3001\u5de5\u7a0b\u7b49\u90e8\u95e8\uff09\uff0c\u5e76\u521b\u5efa\u4e00\u4efd\u504f\u5dee\u62a5\u544a\uff0c\u8bb0\u5f55\u504f\u5dee\u7684\u521d\u6b65\u63cf\u8ff0\u3001\u53d1\u73b0\u65f6\u95f4\u3001\u5730\u70b9\u4ee5\u53ca\u5df2\u91c7\u53d6\u7684\u5373\u65f6\u63aa\u65bd\u3002<\/li>\n<\/ol>\n<p>\u5efa\u7acb\u6807\u51c6\u5316\u7684\u5e94\u6025\u54cd\u5e94\u6d41\u7a0b\uff0c\u5e76\u5c06\u5176\u56fa\u5316\u5728\u7ba1\u7406\u4f53\u7cfb\u4e2d\uff0c\u662f\u786e\u4fdd\u4e0a\u8ff0\u6b65\u9aa4\u80fd\u591f\u88ab\u4e25\u683c\u3001\u8fc5\u901f\u6267\u884c\u7684\u5173\u952e\u3002\u5236\u5ea6\u4e0d\u80fd\u53ea\u6302\u5728\u5899\u4e0a\uff0c\u5fc5\u987b\u6210\u4e3a\u7ec4\u7ec7\u808c\u8089\u8bb0\u5fc6\u7684\u4e00\u90e8\u5206\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"22_%E6%AD%A5%E9%AA%A4%E4%BA%8C%EF%BC%9A%E6%A0%B9%E6%9C%AC%E5%8E%9F%E5%9B%A0%E5%88%86%E6%9E%90%EF%BC%88RCA%EF%BC%89%E7%9A%84%E5%AE%9E%E7%94%A8%E5%B7%A5%E5%85%B7\"><\/span>2.2 \u6b65\u9aa4\u4e8c\uff1a\u6839\u672c\u539f\u56e0\u5206\u6790\uff08RCA\uff09\u7684\u5b9e\u7528\u5de5\u5177<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u63a7\u5236\u4f4f\u5c40\u9762\u540e\uff0c\u5fc5\u987b\u6df1\u5165\u6316\u6398\u95ee\u9898\u7684\u6839\u6e90\u3002\u5982\u679c\u4ec5\u4ec5\u5904\u7406\u8868\u9762\u73b0\u8c61\uff0c\u504f\u5dee\u5fc5\u7136\u4f1a\u518d\u6b21\u53d1\u751f\u3002\u6839\u672c\u539f\u56e0\u5206\u6790\uff08Root Cause Analysis, RCA\uff09\u662f\u4ece\u4e8b\u540e\u8865\u6551\u8f6c\u5411\u4e8b\u524d\u9884\u9632\u7684\u8f6c\u6298\u70b9\u3002\u4ee5\u4e0b\u662f\u4e24\u79cd\u5728\u5236\u9020\u4e1a\u4e2d\u88ab\u5e7f\u6cdb\u5e94\u7528\u4e14\u884c\u4e4b\u6709\u6548\u7684RCA\u5de5\u5177\u3002<\/p>\n<ol>\n<li>\n<p><strong>\u9c7c\u9aa8\u56fe\uff08Ishikawa Diagram\uff09<\/strong>\uff1a<\/p>\n<ul>\n<li><strong>\u7b2c\u4e00\u6b65\uff1a\u660e\u786e\u95ee\u9898<\/strong>\u3002\u5c06\u504f\u5dee\u95ee\u9898\uff08\u201c\u9c7c\u5934\u201d\uff09\u6e05\u6670\u5730\u5199\u5728\u56fe\u8868\u7684\u53f3\u4fa7\uff0c\u4f8b\u5982\u201c\u7b2c3\u5b63\u5ea6A\u4ea7\u54c1\u8868\u9762\u5212\u4f24\u7387\u4e0a\u534720%\u201d\u3002<\/li>\n<li><strong>\u7b2c\u4e8c\u6b65\uff1a\u7ed8\u5236\u4e3b\u9aa8<\/strong>\u3002\u56f4\u7ed5\u95ee\u9898\uff0c\u5229\u7528\u524d\u8ff0\u7684\u201c6M\u201d\u65b9\u6cd5\u4f5c\u4e3a\u4e3b\u8981\u5206\u652f\uff08\u201c\u5927\u9c7c\u9aa8\u201d\uff09\uff0c\u5373\u4eba\u3001\u673a\u3001\u6599\u3001\u6cd5\u3001\u73af\u3001\u6d4b\u3002<\/li>\n<li><strong>\u7b2c\u4e09\u6b65\uff1a\u56e2\u961f\u5934\u8111\u98ce\u66b4<\/strong>\u3002\u7ec4\u7ec7\u8de8\u804c\u80fd\u56e2\u961f\uff0c\u9488\u5bf9\u6bcf\u4e2a\u201cM\u201d\u5206\u652f\uff0c\u8fdb\u884c\u5934\u8111\u98ce\u66b4\uff0c\u5c3d\u53ef\u80fd\u591a\u5730\u5217\u51fa\u53ef\u80fd\u5bfc\u81f4\u95ee\u9898\u7684\u6f5c\u5728\u539f\u56e0\uff08\u201c\u4e2d\u9c7c\u9aa8\u201d\u548c\u201c\u5c0f\u9c7c\u9aa8\u201d\uff09\u3002\u4f8b\u5982\uff0c\u5728\u201c\u673a\u201d\u5206\u652f\u4e0b\uff0c\u53ef\u80fd\u4f1a\u6709\u201c\u8bbe\u5907\u632f\u52a8\u8fc7\u5927\u201d\u3001\u201c\u5939\u5177\u78e8\u635f\u201d\u7b49\u3002<\/li>\n<li><strong>\u7b2c\u56db\u6b65\uff1a\u8bc6\u522b\u5173\u952e\u539f\u56e0<\/strong>\u3002\u5728\u6240\u6709\u5217\u51fa\u7684\u6f5c\u5728\u539f\u56e0\u4e2d\uff0c\u901a\u8fc7\u8ba8\u8bba\u3001\u6570\u636e\u9a8c\u8bc1\u6216\u73b0\u573a\u52d8\u67e5\uff0c\u5708\u5b9a\u51fa\u6700\u6709\u53ef\u80fd\u5bfc\u81f4\u95ee\u9898\u7684\u51e0\u4e2a\u5173\u952e\u539f\u56e0\uff0c\u4e3a\u4e0b\u4e00\u6b65\u6df1\u5165\u5206\u6790\u6307\u660e\u65b9\u5411\u3002<\/li>\n<\/ul>\n<\/li>\n<li>\n<p><strong>\u201c\u4e94\u4e2a\u4e3a\u4ec0\u4e48\u201d\uff085 Whys\uff09<\/strong>\uff1a<\/p>\n<ul>\n<li><strong>\u7b2c\u4e00\u6b65\uff1a\u4ece\u95ee\u9898\u5f00\u59cb<\/strong>\u3002\u9488\u5bf9\u9c7c\u9aa8\u56fe\u8bc6\u522b\u51fa\u7684\u67d0\u4e2a\u5173\u952e\u539f\u56e0\uff0c\u63d0\u51fa\u7b2c\u4e00\u4e2a\u201c\u4e3a\u4ec0\u4e48\u201d\u3002\u4f8b\u5982\uff0c\u95ee\u9898\u662f\u201c\u8bbe\u5907\u632f\u52a8\u8fc7\u5927\u201d\u3002<em>\u4e3a\u4ec0\u4e48\u8bbe\u5907\u4f1a\u632f\u52a8\u8fc7\u5927\uff1f<\/em><\/li>\n<li><strong>\u7b2c\u4e8c\u6b65\uff1a\u8fde\u7eed\u8ffd\u95ee<\/strong>\u3002\u5bf9\u4e0a\u4e00\u4e2a\u95ee\u9898\u7684\u56de\u7b54\uff0c\u7ee7\u7eed\u63d0\u51fa\u4e0b\u4e00\u4e2a\u201c\u4e3a\u4ec0\u4e48\u201d\u3002\u7b54\uff1a\u56e0\u4e3a\u5730\u811a\u87ba\u6813\u677e\u52a8\u4e86\u3002<em>\u4e3a\u4ec0\u4e48\u5730\u811a\u87ba\u6813\u4f1a\u677e\u52a8\uff1f<\/em><\/li>\n<li><strong>\u7b2c\u4e09\u6b65\uff1a\u5c42\u5c42\u6df1\u5165<\/strong>\u3002\u6301\u7eed\u8ffd\u95ee\uff0c\u76f4\u5230\u627e\u5230\u65e0\u6cd5\u518d\u95ee\u4e0b\u53bb\u7684\u6839\u672c\u539f\u56e0\uff0c\u8fd9\u901a\u5e38\u4f1a\u6307\u5411\u4e00\u4e2a\u6d41\u7a0b\u6216\u7ba1\u7406\u4e0a\u7684\u95ee\u9898\u3002\u7b54\uff1a\u56e0\u4e3a\u6ca1\u6709\u5b9a\u671f\u7684\u8bbe\u5907\u70b9\u68c0\u8ba1\u5212\u3002<em>\u4e3a\u4ec0\u4e48\u6ca1\u6709\u5b9a\u671f\u7684\u8bbe\u5907\u70b9\u68c0\u8ba1\u5212\uff1f<\/em> \u7b54\uff1a\u56e0\u4e3a\u8bbe\u5907\u7ef4\u62a4SOP\u4e2d\u9057\u6f0f\u4e86\u8fd9\u4e00\u9879\u3002<em>\u4e3a\u4ec0\u4e48SOP\u4f1a\u9057\u6f0f\uff1f<\/em> \u7b54\uff1a\u56e0\u4e3a\u5728\u5236\u5b9aSOP\u65f6\uff0c\u6ca1\u6709\u53c2\u8003\u8bbe\u5907\u5236\u9020\u5546\u7684\u7ef4\u62a4\u624b\u518c\u3002<\/li>\n<li><strong>\u7b2c\u56db\u6b65\uff1a\u627e\u5230\u6839\u6e90<\/strong>\u3002\u901a\u8fc7\u8fde\u7eed\u4e94\u4e2a\uff08\u6216\u66f4\u591a\uff09\u201c\u4e3a\u4ec0\u4e48\u201d\uff0c\u6211\u4eec\u4ece\u201c\u8bbe\u5907\u632f\u52a8\u201d\u8fd9\u4e2a\u6280\u672f\u8868\u8c61\uff0c\u6700\u7ec8\u8ffd\u6eaf\u5230\u201cSOP\u5236\u5b9a\u6d41\u7a0b\u5b58\u5728\u7f3a\u9677\u201d\u8fd9\u4e2a\u7ba1\u7406\u6839\u6e90\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>\u5728\u8fd0\u7528\u8fd9\u4e9b\u5de5\u5177\u65f6\uff0c\u5fc5\u987b\u5f3a\u8c03\u6570\u636e\u8bb0\u5f55\u7684\u5ba2\u89c2\u6027\u3002\u6240\u6709\u5206\u6790\u90fd\u5e94\u57fa\u4e8e\u4e8b\u5b9e\u548c\u6570\u636e\uff08\u5982\u751f\u4ea7\u8bb0\u5f55\u3001\u8bbe\u5907\u65e5\u5fd7\u3001\u68c0\u6d4b\u62a5\u544a\uff09\uff0c\u800c\u975e\u4e3b\u89c2\u81c6\u65ad\u3002\u8fd9\u6b63\u662f\u5206\u6790\u6210\u529f\u7684\u5173\u952e\u6240\u5728\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%89%E3%80%81%E9%A2%84%E9%98%B2%E6%8E%AA%E6%96%BD%EF%BC%88Prevention%EF%BC%89%EF%BC%9A%E5%A6%82%E4%BD%95%E4%BB%8E%E6%A0%B9%E6%BA%90%E4%B8%8A%E6%9D%9C%E7%BB%9D%E5%81%8F%E5%B7%AE%E5%A4%8D%E5%8F%91%EF%BC%9F\"><\/span>\u4e09\u3001\u9884\u9632\u63aa\u65bd\uff08Prevention\uff09\uff1a\u5982\u4f55\u4ece\u6839\u6e90\u4e0a\u675c\u7edd\u504f\u5dee\u590d\u53d1\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u627e\u5230\u6839\u672c\u539f\u56e0\u53ea\u662f\u5b8c\u6210\u4e86\u4e00\u534a\u7684\u5de5\u4f5c\u3002\u66f4\u5173\u952e\u7684\u53e6\u4e00\u534a\uff0c\u662f\u5c06\u5206\u6790\u7ed3\u679c\u8f6c\u5316\u4e3a\u80fd\u591f\u5f7b\u5e95\u89e3\u51b3\u95ee\u9898\u5e76\u9632\u6b62\u5176\u518d\u6b21\u53d1\u751f\u7684\u5177\u4f53\u884c\u52a8\u3002\u8fd9\u4e00\u9636\u6bb5\u7684\u76ee\u6807\u662f\u4ece\u6839\u672c\u4e0a\u4fee\u590d\u7cfb\u7edf\u6f0f\u6d1e\uff0c\u5b9e\u73b0\u4ece\u201c\u7ea0\u6b63\u201d\u5230\u201c\u9884\u9632\u201d\u7684\u8d28\u53d8\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"31_%E5%88%B6%E5%AE%9A%E5%B9%B6%E5%AE%9E%E6%96%BDCAPA%E8%AE%A1%E5%88%92\"><\/span>3.1 \u5236\u5b9a\u5e76\u5b9e\u65bdCAPA\u8ba1\u5212<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u7ea0\u6b63\u4e0e\u9884\u9632\u884c\u52a8\uff08Corrective and Preventive Action, CAPA\uff09\u8ba1\u5212\u662f\u8fde\u63a5\u201c\u95ee\u9898\u5206\u6790\u201d\u4e0e\u201c\u95ee\u9898\u89e3\u51b3\u201d\u7684\u6865\u6881\u3002\u5b83\u662f\u4e00\u4efd\u6b63\u5f0f\u7684\u3001\u7ed3\u6784\u5316\u7684\u884c\u52a8\u65b9\u6848\uff0c\u660e\u786e\u4e86\u8c01\uff08Who\uff09\u3001\u5728\u4f55\u65f6\uff08When\uff09\u3001\u505a\u4ec0\u4e48\uff08What\uff09\u4ee5\u53ca\u5982\u4f55\u9a8c\u8bc1\uff08How\uff09\u3002\u4e00\u4efd\u6709\u6548\u7684CAPA\u8ba1\u5212\u5e94\u5305\u542b\u4ee5\u4e0b\u6838\u5fc3\u8981\u7d20\uff0c\u53ef\u4ee5\u901a\u8fc7\u8868\u683c\u5f62\u5f0f\u8fdb\u884c\u6807\u51c6\u5316\u7ba1\u7406\u3002<\/p>\n<p><strong>CAPA\u8ba1\u5212\u8868\u793a\u4f8b<\/strong><\/p>\n<table>\n<thead>\n<tr>\n<th align=\"left\">\u95ee\u9898\u63cf\u8ff0<\/th>\n<th align=\"left\">\u6839\u672c\u539f\u56e0<\/th>\n<th align=\"left\">\u7ea0\u6b63\/\u9884\u9632\u63aa\u65bd<\/th>\n<th align=\"left\">\u8d23\u4efb\u4eba<\/th>\n<th align=\"left\">\u5b8c\u6210\u65f6\u9650<\/th>\n<th align=\"left\">\u9a8c\u8bc1\u65b9\u6cd5<\/th>\n<th align=\"left\">\u72b6\u6001<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td align=\"left\">\u7b2c3\u5b63\u5ea6A\u4ea7\u54c1\u8868\u9762\u5212\u4f24\u7387\u4e0a\u534720%<\/td>\n<td align=\"left\">\u8bbe\u5907\u7ef4\u62a4SOP\u4e2d\u672a\u5305\u542b\u5730\u811a\u87ba\u6813\u7684\u5b9a\u671f\u7d27\u56fa\u8981\u6c42\u3002<\/td>\n<td align=\"left\"><strong>\u7ea0\u6b63\u63aa\u65bd<\/strong>\uff1a\u7acb\u5373\u68c0\u67e5\u5e76\u7d27\u56fa\u6240\u6709\u540c\u578b\u53f7\u8bbe\u5907\u7684\u5730\u811a\u87ba\u6813\u3002<strong>\u9884\u9632\u63aa\u65bd<\/strong>\uff1a\u4fee\u8ba2\u300a\u8bbe\u5907\u7ef4\u62a4SOP-XXX\u300b\uff0c\u589e\u52a0\u201c\u6bcf\u5b63\u5ea6\u68c0\u67e5\u5e76\u7d27\u56fa\u5730\u811a\u87ba\u6813\u201d\u6761\u6b3e\uff0c\u5e76\u91cd\u65b0\u57f9\u8bad\u6240\u6709\u7ef4\u62a4\u4eba\u5458\u3002<\/td>\n<td align=\"left\">\u5f20\u5de5\uff08\u7ef4\u62a4\u90e8\uff09<\/td>\n<td align=\"left\">2023-10-15<\/td>\n<td align=\"left\">1. \u68c0\u67e5\u6240\u6709\u8bbe\u5907\u87ba\u6813\u7684\u7d27\u56fa\u8bb0\u5f55\u30022. \u5ba1\u6838\u65b0\u7248SOP\u6587\u4ef6\u30023. \u62bd\u67e5\u7ef4\u62a4\u4eba\u5458\u57f9\u8bad\u8bb0\u5f55\u4e0e\u73b0\u573a\u64cd\u4f5c\u3002<\/td>\n<td align=\"left\">\u8fdb\u884c\u4e2d<\/td>\n<\/tr>\n<tr>\n<td align=\"left\">\u67d0\u6279\u6b21\u539f\u6599\u5bfc\u81f4\u4ea7\u54c1\u6027\u80fd\u4e0d\u8fbe\u6807<\/td>\n<td align=\"left\">\u4f9b\u5e94\u5546\u7ba1\u7406\u6d41\u7a0b\u4e2d\uff0c\u5bf9\u6b21\u8981\u4f9b\u5e94\u5546\u7684\u6765\u6599\u68c0\u9a8c\u9891\u7387\u8fc7\u4f4e\u3002<\/td>\n<td align=\"left\"><strong>\u7ea0\u6b63\u63aa\u65bd<\/strong>\uff1a\u5bf9\u5e93\u5b58\u4e2d\u6240\u6709\u8be5\u4f9b\u5e94\u5546\u7684\u539f\u6599\u8fdb\u884c\u5168\u68c0\u3002<strong>\u9884\u9632\u63aa\u65bd<\/strong>\uff1a\u4fee\u8ba2\u300a\u4f9b\u5e94\u5546\u7ba1\u7406\u89c4\u7a0b\u300b\uff0c\u5c06\u8be5\u539f\u6599\u7684\u68c0\u9a8c\u9891\u7387\u4ece\u201c\u6bcf5\u6279\u68c01\u6279\u201d\u63d0\u5347\u81f3\u201c\u6bcf\u6279\u5fc5\u68c0\u201d\uff0c\u5e76\u91cd\u65b0\u8bc4\u4f30\u8be5\u4f9b\u5e94\u5546\u7684\u8d44\u8d28\u3002<\/td>\n<td align=\"left\">\u674e\u7ecf\u7406\uff08\u8d28\u91cf\u90e8\uff09<\/td>\n<td align=\"left\">2023-10-20<\/td>\n<td align=\"left\">1. \u68c0\u67e5\u5e93\u5b58\u539f\u6599\u7684\u5168\u68c0\u62a5\u544a\u30022. \u5ba1\u6838\u65b0\u7248\u7ba1\u7406\u89c4\u7a0b\u30023. \u68c0\u67e5\u540e\u7eed\u6279\u6b21\u7684\u6765\u6599\u68c0\u9a8c\u8bb0\u5f55\u3002<\/td>\n<td align=\"left\">\u5f85\u9a8c\u8bc1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u901a\u8fc7\u8fd9\u6837\u7684\u7ed3\u6784\u5316\u8ba1\u5212\uff0c\u7ba1\u7406\u5c42\u53ef\u4ee5\u6e05\u6670\u5730\u8ffd\u8e2a\u6bcf\u4e2a\u95ee\u9898\u7684\u89e3\u51b3\u8fdb\u5ea6\uff0c\u786e\u4fdd\u6240\u6709\u63aa\u65bd\u90fd\u843d\u5230\u5b9e\u5904\uff0c\u5e76\u4e14\u5176\u6709\u6548\u6027\u5f97\u5230\u9a8c\u8bc1\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"32_%E6%95%B0%E5%AD%97%E5%8C%96%E5%B7%A5%E5%85%B7%E5%A6%82%E4%BD%95%E8%B5%8B%E8%83%BDCAPA%E6%B5%81%E7%A8%8B%E9%97%AD%E7%8E%AF\"><\/span>3.2 \u6570\u5b57\u5316\u5de5\u5177\u5982\u4f55\u8d4b\u80fdCAPA\u6d41\u7a0b\u95ed\u73af<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5728\u5b9e\u8df5\u4e2d\uff0c\u8bb8\u591a\u4f01\u4e1a\u4f9d\u8d56\u7eb8\u8d28\u6587\u4ef6\u6216Excel\u8868\u683c\u6765\u7ba1\u7406CAPA\u6d41\u7a0b\u3002\u8fd9\u79cd\u4f20\u7edf\u65b9\u5f0f\u5b58\u5728\u8bf8\u591a\u5f0a\u7aef\uff1a\u504f\u5dee\u62a5\u544a\u63d0\u4ea4\u4e0d\u4fbf\uff0c\u5bfc\u81f4\u95ee\u9898\u4e0a\u62a5\u5ef6\u8fdf\uff1b\u5ba1\u6279\u6d41\u7a0b\u4f9d\u8d56\u7ebf\u4e0b\u4f20\u9012\uff0c\u8fc7\u7a0b\u4e0d\u900f\u660e\uff0c\u8017\u65f6\u5197\u957f\uff1b\u4efb\u52a1\u5206\u914d\u5230\u4eba\u540e\uff0c\u8ddf\u8fdb\u56f0\u96be\uff0c\u5bb9\u6613\u77f3\u6c89\u5927\u6d77\uff1b\u5927\u91cf\u7684\u504f\u5dee\u6570\u636e\u4ee5\u975e\u7ed3\u6784\u5316\u5f62\u5f0f\u6563\u843d\u5728\u5404\u4e2a\u6587\u4ef6\u4e2d\uff0c\u5f62\u6210\u201c\u6570\u636e\u5b64\u5c9b\u201d\uff0c\u65e0\u6cd5\u7528\u4e8e\u8d8b\u52bf\u5206\u6790\u548c\u7cfb\u7edf\u6027\u6539\u8fdb\u3002<\/p>\n<p>\u4f5c\u4e3a\u884c\u4e1a\u5206\u6790\u5e08\uff0c\u6211\u4eec\u89c2\u5bdf\u5230\uff0c\u65b0\u4e00\u4ee3\u7684\u6570\u5b57\u5316\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\uff08QMS\uff09\u6b63\u5728\u4ece\u6839\u672c\u4e0a\u89e3\u51b3\u8fd9\u4e9b\u75db\u70b9\u3002\u7279\u522b\u662f\u50cf**\u300c\u652f\u9053\u5e73\u53f0\u300d**\u8fd9\u6837\u7684<span class=\"xintheme_keyword_link\"><a href=\"https:\/\/www.zdsztech.com\/engine\" target=\"_blank\" title=\"\u65e0\u4ee3\u7801\u5e73\u53f0\">\u65e0\u4ee3\u7801\u5e73\u53f0<\/a><\/span>\uff0c\u4e3a\u4f01\u4e1a\u63d0\u4f9b\u4e86\u4e00\u79cd\u9ad8\u6027\u4ef7\u6bd4\u4e14\u9ad8\u5ea6\u7075\u6d3b\u7684\u89e3\u51b3\u65b9\u6848\uff0c\u80fd\u591f\u5b8c\u7f8e\u8d4b\u80fdCAPA\u6d41\u7a0b\u7684\u95ed\u73af\u7ba1\u7406\u3002<\/p>\n<ul>\n<li><strong>\u6d41\u7a0b\u56fa\u5316\u4e0e\u6807\u51c6\u5316<\/strong>\uff1a\u501f\u52a9\u300c\u652f\u9053\u5e73\u53f0\u300d\u7684**\u3010\u6d41\u7a0b\u5f15\u64ce\u3011**\uff0c\u4f01\u4e1a\u53ef\u4ee5\u5c06\u6807\u51c6\u5316\u7684CAPA\u6d41\u7a0b\u2014\u2014\u4ece\u504f\u5dee\u62a5\u544a\u3001\u539f\u56e0\u8c03\u67e5\u3001\u63aa\u65bd\u5236\u5b9a\u3001\u5ba1\u6279\u5230\u4efb\u52a1\u6267\u884c\u548c\u6548\u679c\u9a8c\u8bc1\u2014\u2014\u5b8c\u6574\u5730\u56fa\u5316\u5230\u7ebf\u4e0a\u3002\u6bcf\u4e2a\u8282\u70b9\u7684\u8d1f\u8d23\u4eba\u3001\u5904\u7406\u65f6\u9650\u548c\u64cd\u4f5c\u6743\u9650\u90fd\u88ab\u9884\u8bbe\u5728\u7cfb\u7edf\u4e2d\uff0c\u6d41\u7a0b\u81ea\u52a8\u6d41\u8f6c\uff0c\u786e\u4fdd\u4e86\u5236\u5ea6\u7684\u4e25\u683c\u843d\u5730\uff0c\u675c\u7edd\u4e86\u7ebf\u4e0b\u6267\u884c\u65f6\u7684\u4eba\u4e3a\u5ef6\u8bef\u6216\u9057\u5fd8\u3002<\/li>\n<li><strong>\u6570\u636e\u7ed3\u6784\u5316\u4e0e\u8ffd\u6eaf<\/strong>\uff1a\u901a\u8fc7**\u3010\u8868\u5355\u5f15\u64ce\u3011**\uff0c\u4f01\u4e1a\u53ef\u4ee5\u8f7b\u677e\u521b\u5efa\u6807\u51c6\u5316\u7684\u504f\u5dee\u62a5\u544a\u3001\u8c03\u67e5\u8bb0\u5f55\u548cCAPA\u8ba1\u5212\u8868\u5355\u3002\u6240\u6709\u4fe1\u606f\uff0c\u4ece\u504f\u5dee\u63cf\u8ff0\u5230\u6839\u672c\u539f\u56e0\u5206\u6790\uff0c\u518d\u5230\u5177\u4f53\u7684\u9884\u9632\u63aa\u65bd\uff0c\u90fd\u4ee5\u7ed3\u6784\u5316\u7684\u6570\u636e\u5f62\u5f0f\u88ab\u8bb0\u5f55\u4e0b\u6765\u3002\u8fd9\u4e0d\u4ec5\u4fdd\u8bc1\u4e86\u4fe1\u606f\u7684\u5b8c\u6574\u6027\uff0c\u66f4\u4e3a\u540e\u7eed\u7684\u6570\u636e\u8ffd\u6eaf\u548c\u5206\u6790\u5960\u5b9a\u4e86\u575a\u5b9e\u57fa\u7840\u3002<\/li>\n<li><strong>\u51b3\u7b56\u53ef\u89c6\u5316\u4e0e\u9a71\u52a8<\/strong>\uff1a\u8fd9\u6b63\u662f\u6570\u5b57\u5316\u5de5\u5177\u6700\u5177\u4ef7\u503c\u7684\u5730\u65b9\u3002\u300c\u652f\u9053\u5e73\u53f0\u300d\u7684**\u3010\u62a5\u8868\u5f15\u64ce\u3011**\u80fd\u591f\u81ea\u52a8\u6293\u53d6\u548c\u6574\u5408\u6240\u6709CAPA\u6d41\u7a0b\u4e2d\u7684\u6570\u636e\uff0c\u5c06\u5176\u8f6c\u5316\u4e3a\u76f4\u89c2\u7684\u7ba1\u7406\u770b\u677f\u3002\u7ba1\u7406\u8005\u53ef\u4ee5\u4e00\u76ee\u4e86\u7136\u5730\u770b\u5230\uff1a\u5f53\u524d\u5f85\u5904\u7406\u7684\u504f\u5dee\u6570\u91cf\u3001\u5404\u90e8\u95e8CAPA\u4efb\u52a1\u7684\u5b8c\u6210\u7387\u3001\u7279\u5b9a\u4ea7\u54c1\u6216\u5de5\u5e8f\u7684\u504f\u5dee\u8d8b\u52bf\u3001\u6700\u5e38\u89c1\u7684\u504f\u5dee\u7c7b\u578b\u7b49\u3002\u8fd9\u4e9b\u6570\u636e\u6d1e\u5bdf\u4e0d\u518d\u9700\u8981\u4eba\u5de5\u82b1\u8d39\u6570\u5929\u65f6\u95f4\u6574\u7406Excel\uff0c\u800c\u662f\u5b9e\u65f6\u5448\u73b0\u5728\u7ba1\u7406\u8005\u9762\u524d\uff0c\u4e3a\u4ed6\u4eec\u8fdb\u884c\u6570\u636e\u51b3\u7b56\u3001\u8bc6\u522b\u7cfb\u7edf\u6027\u98ce\u9669\u3001\u6301\u7eed\u4f18\u5316\u6574\u4e2a\u8d28\u91cf\u4f53\u7cfb\u63d0\u4f9b\u4e86\u5f3a\u6709\u529b\u7684\u652f\u6301\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E5%9B%9B%E3%80%81%E6%9E%84%E5%BB%BA%E9%95%BF%E6%9C%9F%E6%9C%89%E6%95%88%E7%9A%84%E8%B4%A8%E9%87%8F%E5%81%8F%E5%B7%AE%E7%AE%A1%E7%90%86%E4%BD%93%E7%B3%BB\"><\/span>\u56db\u3001\u6784\u5efa\u957f\u671f\u6709\u6548\u7684\u8d28\u91cf\u504f\u5dee\u7ba1\u7406\u4f53\u7cfb<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u89e3\u51b3\u5355\u4e2a\u504f\u5dee\u95ee\u9898\u662f\u6218\u672f\u5c42\u9762\u7684\u6210\u529f\uff0c\u800c\u6784\u5efa\u4e00\u4e2a\u80fd\u591f\u6301\u7eed\u81ea\u6211\u5b8c\u5584\u7684\u8d28\u91cf\u504f\u5dee\u7ba1\u7406\u4f53\u7cfb\uff0c\u624d\u662f\u6218\u7565\u5c42\u9762\u7684\u80dc\u5229\u3002\u8fd9\u610f\u5473\u7740\u4f01\u4e1a\u9700\u8981\u5c06\u6bcf\u4e00\u6b21\u504f\u5dee\u5904\u7406\u7684\u7ecf\u9a8c\u8f6c\u5316\u4e3a\u7ec4\u7ec7\u80fd\u529b\uff0c\u5e76\u5229\u7528\u6570\u636e\u9a71\u52a8\u6574\u4e2a\u4f53\u7cfb\u7684\u6301\u7eed\u6539\u8fdb\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"41_%E5%BB%BA%E7%AB%8B%E7%9F%A5%E8%AF%86%E5%BA%93%E4%B8%8E%E6%8C%81%E7%BB%AD%E5%9F%B9%E8%AE%AD\"><\/span>4.1 \u5efa\u7acb\u77e5\u8bc6\u5e93\u4e0e\u6301\u7eed\u57f9\u8bad<span 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class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6211\u4eec\u5fc5\u987b\u6e05\u9192\u5730\u8ba4\u8bc6\u5230\uff0c\u751f\u4ea7\u8d28\u91cf\u504f\u5dee\u7ba1\u7406\u7684\u6838\u5fc3\uff0c\u7edd\u975e\u4ec5\u4ec5\u662f\u5904\u7406\u5df2\u7ecf\u53d1\u751f\u7684\u95ee\u9898\uff0c\u800c\u662f\u8981\u5b9e\u73b0\u4ece\u88ab\u52a8\u7ea0\u6b63\u5230\u4e3b\u52a8\u9884\u9632\u7684\u6839\u672c\u6027\u8f6c\u53d8\u3002\u4e00\u4e2a\u53ea\u61c2\u5f97\u5728\u706b\u707e\u53d1\u751f\u540e\u75b2\u4e8e\u5954\u547d\u7684\u201c\u6551\u706b\u961f\u201d\uff0c\u6c38\u8fdc\u65e0\u6cd5\u5efa\u6210\u4e00\u5ea7\u575a\u56fa\u7684\u5927\u53a6\u3002\u771f\u6b63\u7684\u667a\u8005\uff0c\u662f\u90a3\u4e9b\u61c2\u5f97\u5206\u6790\u6bcf\u4e00\u6b21\u5fae\u5c0f\u88c2\u75d5\u3001\u52a0\u56fa\u6bcf\u4e00\u4e2a\u8584\u5f31\u7ed3\u6784\u3001\u6700\u7ec8\u6784\u5efa\u8d77\u9632\u706b\u9632\u9707\u4f53\u7cfb\u7684\u201c\u5efa\u7b51\u5e08\u201d\u3002<\/p>\n<p>\u5bf9\u4e8e\u8eab\u5904\u6fc0\u70c8\u5e02\u573a\u7ade\u4e89\u4e2d\u7684\u4f01\u4e1a\u51b3\u7b56\u8005\u800c\u8a00\uff0c\u8fd9\u4e0d\u4ec5\u662f\u4e00\u6b21\u7ba1\u7406\u7406\u5ff5\u7684\u5347\u7ea7\uff0c\u66f4\u662f\u4e00\u6b21\u5173\u4e4e\u4f01\u4e1a\u6838\u5fc3\u7ade\u4e89\u529b\u7684\u91cd\u5851\u3002\u901a\u8fc7\u91c7\u7eb3\u7cfb\u7edf\u5316\u7684\u65b9\u6cd5\u8bba\uff0c\u59826M\u5206\u6790\u3001RCA\u5de5\u5177\u548c\u7ed3\u6784\u5316\u7684CAPA\u8ba1\u5212\uff0c\u60a8\u53ef\u4ee5\u4e3a\u8d28\u91cf\u7ba1\u7406\u5efa\u7acb\u79d1\u5b66\u7684\u9aa8\u67b6\u3002\u800c\u501f\u52a9\u73b0\u4ee3\u5316\u7684\u6570\u5b57\u5316\u5de5\u5177\uff0c\u5219\u80fd\u4e3a\u8fd9\u526f\u9aa8\u67b6\u6ce8\u5165\u5f3a\u5927\u7684\u795e\u7ecf\u7cfb\u7edf\uff0c\u786e\u4fdd\u6d41\u7a0b\u7684\u987a\u7545\u6267\u884c\u3001\u6570\u636e\u7684\u5b9e\u65f6\u6d41\u52a8\u548c\u51b3\u7b56\u7684\u667a\u80fd\u9ad8\u6548\u3002<\/p>\n<p>\u662f\u65f6\u5019\u8ba9\u60a8\u7684\u8d28\u91cf\u7ba1\u7406\u90e8\u95e8\u4ece\u201c\u6551\u706b\u961f\u201d\u7684\u89d2\u8272\u4e2d\u89e3\u653e\u51fa\u6765\uff0c\u8ba9\u4ed6\u4eec\u6210\u4e3a\u4f01\u4e1a\u6838\u5fc3\u7ade\u4e89\u529b\u7684\u201c\u5efa\u7b51\u5e08\u201d\uff0c\u4e3a\u4f01\u4e1a\u7684\u57fa\u4e1a\u957f\u9752\u6784\u7b51\u6700\u575a\u5b9e\u7684\u8d28\u91cf\u57fa\u77f3\u3002<\/p>\n<p>\u7acb\u5373\u5f00\u59cb\u6784\u5efa\u60a8\u7684\u6570\u5b57\u5316\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u4f53\u9a8c\u300c\u652f\u9053\u5e73\u53f0\u300d\u5982\u4f55\u5c06\u590d\u6742\u7684CAPA\u6d41\u7a0b\u53d8\u5f97\u7b80\u5355\u3001\u9ad8\u6548\u3002\u70b9\u51fb\u3010<a href=\"https:\/\/user.zdsztech.com\/toWorkbench?index=2\">\u514d\u8d39\u8bd5\u7528\uff0c\u5728\u7ebf\u76f4\u63a5\u8bd5\u7528<\/a>\u3011\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%85%B3%E4%BA%8E%E8%B4%A8%E9%87%8F%E5%81%8F%E5%B7%AE%E7%AE%A1%E7%90%86%E7%9A%84%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98%EF%BC%88FAQ%EF%BC%89\"><\/span>\u5173\u4e8e\u8d28\u91cf\u504f\u5dee\u7ba1\u7406\u7684\u5e38\u89c1\u95ee\u9898\uff08FAQ\uff09<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_%E7%BA%A0%E6%AD%A3%EF%BC%88Correction%EF%BC%89%E5%92%8C%E7%BA%A0%E6%AD%A3%E6%8E%AA%E6%96%BD%EF%BC%88Corrective_Action%EF%BC%89%E6%9C%89%E4%BB%80%E4%B9%88%E5%8C%BA%E5%88%AB%EF%BC%9F\"><\/span>1. \u7ea0\u6b63\uff08Correction\uff09\u548c\u7ea0\u6b63\u63aa\u65bd\uff08Corrective Action\uff09\u6709\u4ec0\u4e48\u533a\u522b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u8fd9\u662f\u4e24\u4e2a\u5728\u8d28\u91cf\u7ba1\u7406\u4e2d\u6781\u6613\u88ab\u6df7\u6dc6\u4f46\u610f\u4e49\u622a\u7136\u4e0d\u540c\u7684\u672f\u8bed\u3002\u7b80\u5355\u6765\u8bf4\uff0c\u201c\u7ea0\u6b63\u201d\u662f\u6cbb\u6807\uff0c\u201c\u7ea0\u6b63\u63aa\u65bd\u201d\u662f\u6cbb\u672c\u3002<\/p>\n<ul>\n<li><strong>\u7ea0\u6b63\uff08Correction\uff09<\/strong>\uff1a\u6307\u4e3a\u4e86\u6d88\u9664\u5df2\u53d1\u73b0\u7684\u4e0d\u5408\u683c\u800c\u91c7\u53d6\u7684\u7acb\u5373\u884c\u52a8\u3002\u5b83\u7684\u76ee\u6807\u662f\u5904\u7406\u4e0d\u5408\u683c\u54c1\u672c\u8eab\uff0c\u4f7f\u5176\u7b26\u5408\u8981\u6c42\u6216\u5f97\u5230\u59a5\u5584\u5904\u7f6e\u3002\u4f8b\u5982\uff1a\u5bf9\u4e00\u6279\u5c3a\u5bf8\u8d85\u5dee\u7684\u4ea7\u54c1\u8fdb\u884c\u8fd4\u5de5\u3001\u5c06\u53d7\u6c61\u67d3\u7684\u7269\u6599\u8fdb\u884c\u62a5\u5e9f\u3001\u7b5b\u9009\u51fa\u4e0d\u5408\u683c\u54c1\u3002\u8fd9\u4e9b\u884c\u52a8\u662f\u53cd\u5e94\u6027\u7684\uff0c\u65e8\u5728\u63a7\u5236\u5f53\u524d\u635f\u5931\u3002<\/li>\n<li><strong>\u7ea0\u6b63\u63aa\u65bd\uff08Corrective Action\uff09<\/strong>\uff1a\u6307\u4e3a\u4e86\u6d88\u9664\u5df2\u53d1\u73b0\u7684\u4e0d\u5408\u683c\u7684\u201c\u6839\u672c\u539f\u56e0\u201d\u800c\u91c7\u53d6\u7684\u884c\u52a8\u3002\u5b83\u7684\u76ee\u6807\u662f\u9632\u6b62\u540c\u6837\u7684\u95ee\u9898\u518d\u6b21\u53d1\u751f\u3002\u4f8b\u5982\uff1a\u5728\u53d1\u73b0\u5c3a\u5bf8\u8d85\u5dee\u662f\u7531\u4e8e\u8bbe\u5907\u53c2\u6570\u6f02\u79fb\u540e\uff0c\u4fee\u8ba2\u8bbe\u5907\u7ef4\u62a4\u89c4\u7a0b\uff0c\u589e\u52a0\u6821\u51c6\u9891\u7387\u3002\u8fd9\u662f\u57fa\u4e8e\u6839\u672c\u539f\u56e0\u5206\u6790\u7684\u3001\u5177\u6709\u9884\u9632\u590d\u53d1\u6027\u8d28\u7684\u884c\u52a8\u3002<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"2_%E5%B0%8F%E5%85%AC%E5%8F%B8%E8%B5%84%E6%BA%90%E6%9C%89%E9%99%90%EF%BC%8C%E5%A6%82%E4%BD%95%E6%9C%89%E6%95%88%E5%AE%9E%E6%96%BD%E5%81%8F%E5%B7%AE%E7%AE%A1%E7%90%86%EF%BC%9F\"><\/span>2. \u5c0f\u516c\u53f8\u8d44\u6e90\u6709\u9650\uff0c\u5982\u4f55\u6709\u6548\u5b9e\u65bd\u504f\u5dee\u7ba1\u7406\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e2d\u5c0f\u4f01\u4e1a\u8d44\u6e90\u6709\u9650\u662f\u5ba2\u89c2\u4e8b\u5b9e\uff0c\u4f46\u8fd9\u5e76\u4e0d\u610f\u5473\u7740\u65e0\u6cd5\u8fdb\u884c\u6709\u6548\u7684\u504f\u5dee\u7ba1\u7406\u3002\u5173\u952e\u5728\u4e8e\u52a1\u5b9e\u548c\u805a\u7126\u3002\u9996\u5148\uff0c\u4e0d\u5fc5\u8ffd\u6c42\u4e00\u6b65\u5230\u4f4d\u3001\u6602\u8d35\u590d\u6742\u7684\u7cfb\u7edf\u3002\u53ef\u4ee5\u4ece\u6700\u57fa\u7840\u4e5f\u662f\u6700\u6838\u5fc3\u7684\u73af\u8282\u505a\u8d77\uff1a\u5efa\u7acb\u6807\u51c6\u5316\u7684\u64cd\u4f5c\u89c4\u7a0b\uff08SOP\uff09\u548c\u8bb0\u5f55\u6d41\u7a0b\u3002\u786e\u4fdd\u6bcf\u4e00\u6b21\u504f\u5dee\u90fd\u6709\u4e66\u9762\u8bb0\u5f55\uff0c\u6bcf\u4e00\u6b21\u5904\u7406\u90fd\u6709\u660e\u786e\u7684\u7ed3\u8bba\u3002\u5176\u6b21\uff0c\u53ef\u4ee5\u4f18\u5148\u805a\u7126\u4e8e\u5173\u952e\u548c\u4e3b\u8981\u504f\u5dee\u7684\u7ba1\u7406\uff0c\u5c06\u6709\u9650\u7684\u8d44\u6e90\u6295\u5165\u5230\u5bf9\u8d28\u91cf\u5f71\u54cd\u6700\u5927\u7684\u95ee\u9898\u4e0a\u3002\u6700\u540e\uff0c\u53ef\u4ee5\u8003\u8651\u91c7\u7528\u50cf**\u300c\u652f\u9053\u5e73\u53f0\u300d**\u8fd9\u7c7b\u9ad8\u6027\u4ef7\u6bd4\u7684\u65e0\u4ee3\u7801\u5de5\u5177\u3002\u8fd9\u7c7b\u5e73\u53f0\u5141\u8bb8\u4f01\u4e1a\u4ee5\u8f83\u4f4e\u7684\u521d\u59cb\u6210\u672c\uff0c\u6839\u636e\u81ea\u8eab\u6700\u8feb\u5207\u7684\u9700\u6c42\uff0c\u5feb\u901f\u642d\u5efa\u8d77\u4e2a\u6027\u5316\u7684\u504f\u5dee\u62a5\u544a\u548cCAPA\u8ddf\u8fdb\u6d41\u7a0b\uff0c\u7528\u201c\u5c0f\u6b65\u5feb\u8dd1\u201d\u7684\u65b9\u5f0f\uff0c\u4f4e\u6210\u672c\u3001\u9ad8\u6548\u7387\u5730\u5b9e\u73b0\u6570\u5b57\u5316\u8f6c\u578b\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_%E5%81%8F%E5%B7%AE%E8%B0%83%E6%9F%A5%E6%8A%A5%E5%91%8A%EF%BC%88Deviation_Investigation_Report%EF%BC%89%E5%BA%94%E8%AF%A5%E5%8C%85%E5%90%AB%E5%93%AA%E4%BA%9B%E6%A0%B8%E5%BF%83%E5%86%85%E5%AE%B9%EF%BC%9F\"><\/span>3. \u504f\u5dee\u8c03\u67e5\u62a5\u544a\uff08Deviation Investigation Report\uff09\u5e94\u8be5\u5305\u542b\u54ea\u4e9b\u6838\u5fc3\u5185\u5bb9\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e00\u4efd\u5b8c\u6574\u3001\u89c4\u8303\u7684\u504f\u5dee\u8c03\u67e5\u62a5\u544a\u662f\u95ee\u9898\u8ffd\u6eaf\u548c\u77e5\u8bc6\u6c89\u6dc0\u7684\u5173\u952e\u8f7d\u4f53\uff0c\u5b83\u5e94\u5f53\u81f3\u5c11\u5305\u542b\u4ee5\u4e0b\u6838\u5fc3\u8981\u7d20\uff1a<\/p>\n<ul>\n<li><strong>\u57fa\u672c\u4fe1\u606f<\/strong>\uff1a\u504f\u5dee\u7684\u552f\u4e00\u7f16\u53f7\u3001\u6807\u9898\u3001\u6d89\u53ca\u7684\u4ea7\u54c1\/\u7269\u6599\u540d\u79f0\u53ca\u6279\u53f7\u3002<\/li>\n<li><strong>\u504f\u5dee\u63cf\u8ff0<\/strong>\uff1a\u6e05\u6670\u3001\u5ba2\u89c2\u5730\u63cf\u8ff0\u53d1\u751f\u4e86\u4ec0\u4e48\uff0c\u5305\u62ec\u53d1\u73b0\u7684\u65f6\u95f4\u3001\u5730\u70b9\u3001\u5177\u4f53\u73b0\u8c61\u548c\u53d1\u73b0\u4eba\u3002<\/li>\n<li><strong>\u5373\u65f6\u63aa\u65bd\u4e0e\u98ce\u9669\u8bc4\u4f30<\/strong>\uff1a\u8bb0\u5f55\u4e86\u54ea\u4e9b\u5373\u65f6\u7ea0\u6b63\u884c\u52a8\uff08\u5982\u9694\u79bb\u3001\u505c\u7ebf\uff09\uff0c\u4ee5\u53ca\u5bf9\u4ea7\u54c1\u548c\u5ba2\u6237\u7684\u6f5c\u5728\u98ce\u9669\u8bc4\u4f30\u7ed3\u679c\u3002<\/li>\n<li><strong>\u6839\u672c\u539f\u56e0\u5206\u6790\uff08RCA\uff09<\/strong>\uff1a\u8be6\u7ec6\u8bb0\u5f55\u6240\u4f7f\u7528\u7684\u5206\u6790\u5de5\u5177\uff08\u5982\u9c7c\u9aa8\u56fe\u30015 Whys\uff09\u548c\u5206\u6790\u8fc7\u7a0b\uff0c\u5e76\u660e\u786e\u6700\u7ec8\u8bc6\u522b\u51fa\u7684\u4e00\u4e2a\u6216\u591a\u4e2a\u6839\u672c\u539f\u56e0\u3002<\/li>\n<li><strong>\u7ea0\u6b63\u4e0e\u9884\u9632\u884c\u52a8\uff08CAPA\uff09\u8ba1\u5212<\/strong>\uff1a\u5217\u51fa\u9488\u5bf9\u6839\u672c\u539f\u56e0\u5236\u5b9a\u7684\u5177\u4f53\u7ea0\u6b63\u63aa\u65bd\u548c\u9884\u9632\u63aa\u65bd\uff0c\u5305\u62ec\u6bcf\u9879\u4efb\u52a1\u7684\u8d23\u4efb\u4eba\u3001\u5b8c\u6210\u65f6\u9650\u3002<\/li>\n<li><strong>\u6709\u6548\u6027\u9a8c\u8bc1<\/strong>\uff1a\u660e\u786e\u5982\u4f55\u9a8c\u8bc1CAPA\u63aa\u65bd\u662f\u5426\u6709\u6548\uff0c\u4ee5\u53ca\u9a8c\u8bc1\u7684\u7ed3\u679c\u548c\u76f8\u5173\u6570\u636e\u652f\u6301\u3002<\/li>\n<li><strong>\u5ba1\u6279\u4e0e\u5173\u95ed<\/strong>\uff1a\u76f8\u5173\u7684\u8d1f\u8d23\u4eba\uff08\u5982\u8d28\u91cf\u3001\u751f\u4ea7\u90e8\u95e8\u7ecf\u7406\uff09\u7684\u5ba1\u6279\u7b7e\u540d\u548c\u65e5\u671f\uff0c\u6807\u5fd7\u7740\u8be5\u504f\u5dee\u4e8b\u4ef6\u7684\u6b63\u5f0f\u5173\u95ed\u3002<\/li>\n<\/ul>\n<h3><span 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