{"id":7580,"date":"2026-06-11T14:06:38","date_gmt":"2026-06-11T06:06:38","guid":{"rendered":"https:\/\/www.jodoo.com\/blog\/?p=7580"},"modified":"2026-07-13T11:06:10","modified_gmt":"2026-07-13T03:06:10","slug":"%e6%98%af%e6%ad%a3%e6%8e%aa%e7%bd%ae-%e4%ba%88%e9%98%b2%e6%8e%aa%e7%bd%ae","status":"publish","type":"post","link":"https:\/\/www.jodoo.com\/blog\/ja-jp\/corrective-action-preventive-action","title":{"rendered":"\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\uff1a\u88fd\u9020\u54c1\u8cea\u306e\u305f\u3081\u306eCAPA\u30d7\u30ed\u30bb\u30b9"},"content":{"rendered":"

<\/span>\u306f\u3058\u3081\u306b\uff1a\u88fd\u9020\u696d\u306b\u304a\u3051\u308b\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u304c\u91cd\u8981\u306a\u7406\u7531<\/span><\/h2>\n\n\n\n

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<\/span>\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\uff1a\u305d\u306e\u9055\u3044\u3068\u306f\uff1f<\/span><\/h2>\n\n\n\n

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<\/span>\u662f\u6b63\u63aa\u7f6e\u306f\u3001\u5b9f\u969b\u306b\u78ba\u8a8d\u3055\u308c\u305f\u554f\u984c\u306b\u5bfe\u51e6\u3059\u308b\u3082\u306e\u3067\u3059\u3002<\/span><\/h3>\n\n\n\n

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<\/span>\u4e88\u9632\u63aa\u7f6e\u306f\u3001\u5931\u6557\u304c\u7e70\u308a\u8fd4\u3055\u308c\u308b\u524d\u306b\u30ea\u30b9\u30af\u306b\u7126\u70b9\u3092\u5f53\u3066\u308b\u3002<\/span><\/h3>\n\n\n\n

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<\/span>\u88fd\u9020\u30c1\u30fc\u30e0\u306e\u305f\u3081\u306e\u4e26\u5217\u8868\u793a<\/span><\/h3>\n\n\n\n

\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3092\u533a\u5225\u3059\u308b\u6700\u3082\u7c21\u5358\u306a\u65b9\u6cd5\u306f\u3001 \u30c8\u30ea\u30ac\u30fc<\/strong>, \u30bf\u30a4\u30df\u30f3\u30b0<\/strong>, \u3001 \u305d\u3057\u3066 \u671f\u5f85\u3055\u308c\u308b\u7d50\u679c<\/strong>. \u662f\u6b63\u63aa\u7f6e\u306f\u300c\u3053\u306e\u5b9f\u969b\u306e\u554f\u984c\u306e\u539f\u56e0\u306f\u4f55\u3067\u3001\u3069\u3046\u3059\u308c\u3070\u518d\u767a\u3092\u9632\u3052\u308b\u306e\u304b\uff1f\u300d\u306b\u7b54\u3048\u307e\u3059\u3002\u4e88\u9632\u63aa\u7f6e\u306f\u300c\u73fe\u5728\u3069\u306e\u3088\u3046\u306a\u30ea\u30b9\u30af\u304c\u898b\u3089\u308c\u308b\u306e\u304b\u3001\u3069\u3046\u3059\u308c\u3070\u305d\u308c\u304c\u6b21\u306e\u554f\u984c\u306b\u306a\u3089\u306a\u3044\u3088\u3046\u306b\u3067\u304d\u308b\u306e\u304b\uff1f\u300d\u306b\u7b54\u3048\u307e\u3059\u3002\u3053\u306e\u533a\u5225\u306f\u3001 \u30ab\u30d1<\/strong><\/a> \u7ba1\u7406\u3001\u6240\u6709\u6a29\u3001\u627f\u8a8d\u30ed\u30b8\u30c3\u30af\u3001\u305d\u3057\u3066\u54c1\u8cea\u30a2\u30af\u30b7\u30e7\u30f3\u8ffd\u8de1\u306e\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u306e\u65b9\u6cd5\u3002.<\/p>\n\n\n\n

\"\u88fd\u9020\u696d\u306b\u304a\u3051\u308b\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u306e\u6bd4\u8f03\u30a4\u30f3\u30d5\u30a9\u30b0\u30e9\u30d5\u30a3\u30c3\u30af\"<\/figure>\n\n\n\n

\u98df\u54c1\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u660e\u78ba\u306a\u4e88\u9632\u63aa\u7f6e\u306e\u4e8b\u4f8b\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u30e9\u30d9\u30eb\u78ba\u8a8d\u30c1\u30a7\u30c3\u30af\u3067\u3001\u5207\u308a\u66ff\u3048\u6642\u306b\u985e\u4f3c\u3057\u305f2\u3064\u306e\u30d1\u30c3\u30b1\u30fc\u30b8SKU\u9593\u3067\u6df7\u4e71\u304c\u751f\u3058\u3066\u3044\u308b\u3053\u3068\u304c\u5224\u660e\u3057\u305f\u5834\u5408\u3067\u3082\u3001\u8aa4\u8868\u793a\u88fd\u54c1\u304c\u307e\u3060\u9867\u5ba2\u306b\u5c4a\u3044\u3066\u3044\u306a\u3044\u306e\u3067\u3042\u308c\u3070\u3001\u5de5\u5834\u306f\u5bfe\u7b56\u3092\u8b1b\u3058\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u306e\u624b\u9806\u3092\u66f4\u65b0\u3057\u3001\u30d0\u30fc\u30b3\u30fc\u30c9\u691c\u8a3c\u3092\u8ffd\u52a0\u3057\u3001\u4f5c\u696d\u54e1\u306e\u627f\u8a8d\u624b\u9806\u3092\u898b\u76f4\u3059\u3053\u3068\u306f\u3001\u5de5\u5834\u304c\u30ea\u30b3\u30fc\u30eb\u306b\u3064\u306a\u304c\u308b\u524d\u306b\u4e88\u898b\u53ef\u80fd\u306a\u30ea\u30b9\u30af\u3092\u7ba1\u7406\u3057\u3066\u3044\u308b\u305f\u3081\u3001\u4e88\u9632\u63aa\u7f6e\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u5b9f\u8df5\u306b\u304a\u3044\u3066\u305d\u306e\u9055\u3044\u304c\u91cd\u8981\u306a\u7406\u7531<\/span><\/h3>\n\n\n\n

\u30c1\u30fc\u30e0\u304c\u3053\u306e2\u3064\u3092\u6df7\u540c\u3059\u308b\u3068\u3001CAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306b\u4e00\u8cab\u6027\u304c\u306a\u304f\u306a\u308a\u307e\u3059\u3002\u30ea\u30b9\u30af\u30b7\u30b0\u30ca\u30eb\u3078\u306e\u5bfe\u5fdc\u306e\u307f\u3092\u884c\u3063\u3066\u3044\u308b\u5834\u5408\u3067\u3082\u3001\u3059\u3079\u3066\u306e\u4fee\u6b63\u3092\u662f\u6b63\u63aa\u7f6e\u3068\u307f\u306a\u3059\u5de5\u5834\u3082\u3042\u308c\u3070\u3001\u6b20\u9665\u304c\u518d\u767a\u3059\u308b\u307e\u3067\u6b63\u5f0f\u306a\u5bfe\u5fdc\u3092\u9045\u3089\u305b\u308b\u5de5\u5834\u3082\u3042\u308a\u307e\u3059\u3002\u660e\u78ba\u306a\u5206\u985e\u306f\u5831\u544a\u3092\u6539\u5584\u3057\u3001\u50be\u5411\u5206\u6790\u3092\u3088\u308a\u6709\u7528\u306a\u3082\u306e\u306b\u3057\u3001\u7ba1\u7406\u8005\u304c\u3001\u5de5\u5834\u304c\u6545\u969c\u3078\u306e\u5bfe\u5fdc\u306e\u307f\u3092\u884c\u3063\u3066\u3044\u308b\u306e\u304b\u3001\u305d\u308c\u3068\u3082\u30ea\u30b9\u30af\u3092\u7a4d\u6975\u7684\u306b\u4f4e\u6e1b\u3057\u3066\u3044\u308b\u306e\u304b\u3092\u628a\u63e1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\n\n\n

\u54c1\u8cea\u7ba1\u7406\u8cac\u4efb\u8005\u306b\u3068\u3063\u3066\u3001\u5b9f\u52d9\u4e0a\u306e\u5224\u65ad\u57fa\u6e96\u306f\u660e\u78ba\u3067\u3059\u3002\u554f\u984c\u304c\u65e2\u306b\u4e0d\u9069\u5408\u3001\u9867\u5ba2\u3078\u306e\u5f71\u97ff\u3001\u307e\u305f\u306f\u6587\u66f8\u5316\u3055\u308c\u305f\u9038\u8131\u3092\u5f15\u304d\u8d77\u3053\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u76e3\u8996\u3084\u5206\u6790\u306b\u3088\u3063\u3066\u554f\u984c\u304c\u4f9d\u7136\u3068\u3057\u3066\u6df1\u523b\u306a\u30ea\u30b9\u30af\u3068\u3057\u3066\u7279\u5b9a\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u4e88\u9632\u63aa\u7f6e\u3092\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u88fd\u9020\u696d\u306b\u304a\u3051\u308bCAPA\u30d7\u30ed\u30bb\u30b9\u306e\u958b\u59cb\u6642\u671f<\/span><\/h2>\n\n\n\n

\u3059\u3079\u3066\u306e\u54c1\u8cea\u554f\u984c\u306b\u6b63\u5f0f\u306a\u5bfe\u5fdc\u304c\u5fc5\u8981\u306a\u308f\u3051\u3067\u306f\u306a\u3044 \u30ab\u30d1<\/strong><\/a> \u30d7\u30ed\u30bb\u30b9\u3002\u30c1\u30fc\u30e0\u304c\u5c0f\u3055\u306a\u30df\u30b9\u3054\u3068\u306b\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u3092\u958b\u59cb\u3059\u308b\u3068\u3001\u7ba1\u7406\u4e0a\u306e\u8ca0\u62c5\u304c\u5897\u3048\u3001\u5bfe\u5fdc\u6642\u9593\u304c\u9577\u304f\u306a\u308a\u3001\u3088\u308a\u30ea\u30b9\u30af\u306e\u9ad8\u3044\u554f\u984c\u3078\u306e\u6ce8\u610f\u304c\u5206\u6563\u3055\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u5fdc\u6025\u51e6\u7f6e\u3068\u5c01\u3058\u8fbc\u3081\u3060\u3051\u306b\u983c\u308b\u3068\u3001\u540c\u3058\u554f\u984c\u304c\u518d\u767a\u3057\u3001\u76e3\u67fb\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u308a\u3001\u54c1\u8cea\u7ba1\u7406\u306e\u8ffd\u8de1\u304c\u4fe1\u983c\u6027\u3092\u5931\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

\u5b9f\u7528\u7684\u306a\u30eb\u30fc\u30eb\u306f\u5206\u96e2\u3059\u308b\u3053\u3068\u3067\u3059 \u4fee\u6b63<\/strong>, \u5c01\u3058\u8fbc\u3081<\/strong>, \u3001 \u305d\u3057\u3066 \u6b63\u5f0f\u306aCAPA\u7ba1\u7406<\/strong>. \u4fee\u6b63\u306f\u3001\u51fa\u8377\u524d\u306b\u30e9\u30d9\u30eb\u306e\u8aa4\u308a\u304c\u3042\u308b\u30ab\u30fc\u30c8\u30f3\u3092\u4ea4\u63db\u3059\u308b\u306a\u3069\u3001\u5dee\u3057\u8feb\u3063\u305f\u554f\u984c\u3092\u89e3\u6c7a\u3057\u307e\u3059\u3002\u5c01\u3058\u8fbc\u3081\u306f\u3001\u7279\u5b9a\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u30ed\u30c3\u30c8\u3092\u9694\u96e2\u3059\u308b\u306a\u3069\u3001\u7bc4\u56f2\u306e\u8a55\u4fa1\u304c\u884c\u308f\u308c\u3066\u3044\u308b\u9593\u3001\u9867\u5ba2\u307e\u305f\u306f\u6b21\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u4fdd\u8b77\u3057\u307e\u3059\u3002\u6b63\u5f0f\u306aCAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306f\u3001\u554f\u984c\u304c\u30b7\u30b9\u30c6\u30e0\u4e0a\u306e\u5f31\u70b9\u3001\u518d\u767a\u30ea\u30b9\u30af\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3078\u306e\u5f71\u97ff\u3001\u307e\u305f\u306f\u90e8\u9580\u6a2a\u65ad\u7684\u306a\u5bfe\u5fdc\u3092\u793a\u5506\u3059\u308b\u5834\u5408\u306b\u6b63\u5f53\u5316\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u6b20\u9665<\/span><\/h3>\n\n\n\n

\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u6b20\u9665\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u305f\u3081\u306e\u6700\u3082\u660e\u78ba\u306a\u304d\u3063\u304b\u3051\u306e\u4e00\u3064\u3067\u3059\u3002\u4f5c\u696d\u54e1\u304c\u8a2d\u5b9a\u3092\u8abf\u6574\u3057\u305f\u5f8c\u3067\u3082\u3001\u540c\u3058\u6eb6\u63a5\u6c17\u5b54\u6b20\u9665\u304c\u8907\u6570\u306e\u30b7\u30d5\u30c8\u3001\u30ed\u30c3\u30c8\u3001\u307e\u305f\u306f\u30e9\u30a4\u30f3\u306b\u308f\u305f\u3063\u3066\u767a\u751f\u3059\u308b\u5834\u5408\u3001\u305d\u306e\u554f\u984c\u306f\u3082\u306f\u3084\u65e5\u5e38\u7684\u306a\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u6700\u521d\u306e\u4fee\u6b63\u3067\u306f\u6839\u672c\u539f\u56e0\u304c\u89e3\u6d88\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

\u9069\u5207\u306a\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u57fa\u6e96\u306f\u3001\u6b20\u9665\u6570\u3060\u3051\u3067\u306a\u304f\u3001\u30d1\u30bf\u30fc\u30f3\u306e\u5b89\u5b9a\u6027\u3082\u8003\u616e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u96fb\u5b50\u6a5f\u5668\u5de5\u5834\u3067\u3001\u306f\u3093\u3060\u30d6\u30ea\u30c3\u30b8\u304c3\u65e5\u9593\u9023\u7d9a\u3067\u5185\u90e8\u8a31\u5bb9\u5024\u3092\u8d85\u3048\u305f\u5834\u5408\u3001\u305d\u308c\u306f\u5358\u306a\u308b\u4f5c\u696d\u8005\u306e\u30df\u30b9\u3067\u306f\u306a\u304f\u3001\u5de5\u7a0b\u7ba1\u7406\u4e0a\u306e\u554f\u984c\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u3001\u6b63\u5f0f\u306a\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u3063\u3066\u3001\u8cac\u4efb\u8005\u306e\u7279\u5b9a\u3001\u539f\u56e0\u7a76\u660e\u3001\u518d\u767a\u9632\u6b62\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u9867\u5ba2\u304b\u3089\u306e\u82e6\u60c5\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3088\u308b\u898f\u5236\u9055\u53cd<\/span><\/h3>\n\n\n\n

\u9867\u5ba2\u304b\u3089\u306e\u82e6\u60c5\u306f\u3001\u305f\u3068\u3048\u5185\u90e8\u4e0d\u826f\u4ef6\u6570\u304c\u5c11\u306a\u304f\u898b\u3048\u3066\u3082\u3001\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u306e\u5bfe\u8c61\u3068\u306a\u308b\u3053\u3068\u304c\u591a\u3044\u3002\u306a\u305c\u306a\u3089\u3001\u4e0d\u5177\u5408\u306f\u3059\u3067\u306b\u5de5\u5834\u306e\u5883\u754c\u3092\u8d8a\u3048\u3066\u767a\u751f\u3057\u3066\u3044\u308b\u304b\u3089\u3067\u3042\u308b\u3002\u4f8b\u3048\u3070\u3001\u81ea\u52d5\u8eca\u30e1\u30fc\u30ab\u30fc\u306e\u9867\u5ba2\u304b\u3089\u51fa\u8377\u30ad\u30c3\u30c8\u306b\u7570\u306a\u308b\u30b5\u30a4\u30ba\u306e\u30d5\u30a1\u30b9\u30ca\u30fc\u304c\u6df7\u5728\u3057\u3066\u3044\u308b\u3068\u306e\u5831\u544a\u304c\u3042\u3063\u305f\u5834\u5408\u3001\u554f\u984c\u306f\u30d4\u30c3\u30ad\u30f3\u30b0\u30ed\u30b8\u30c3\u30af\u3001\u6700\u7d42\u691c\u67fb\u3001\u68b1\u5305\u7ba1\u7406\u3001\u307e\u305f\u306f\u30d0\u30fc\u30b3\u30fc\u30c9\u691c\u8a3c\u306e\u3044\u305a\u308c\u304b\u306b\u95a2\u4fc2\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u5916\u90e8\u3078\u306e\u5f71\u97ff\u306f\u3001\u5546\u696d\u30ea\u30b9\u30af\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30b9\u30af\u306e\u4e21\u65b9\u3092\u9ad8\u3081\u308b\u3002.<\/p>\n\n\n\n

\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u3088\u308b\u898f\u5236\u9055\u53cd\u3082\u3001\u591a\u304f\u306e\u5834\u5408\u3001\u6b63\u5f0f\u306a\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002\u5165\u8377\u3057\u305f\u6a39\u8102\u304c\u53d7\u5165\u691c\u67fb\u3092\u901a\u904e\u3057\u305f\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u5f8c\u65e5\u6210\u5f62\u54c1\u306b\u5916\u89b3\u4e0a\u306e\u6b20\u9665\u304c\u751f\u3058\u305f\u5834\u5408\u3001\u554f\u984c\u306f\u53d7\u5165\u57fa\u6e96\u306e\u4e0d\u5099\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u5909\u66f4\u901a\u77e5\u306e\u4e0d\u5099\u3001\u307e\u305f\u306f\u6750\u6599\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u4e0d\u8db3\u306b\u3042\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002CAPA\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u5bfe\u5fdc\u306b\u5185\u90e8\u7d71\u5236\u3068\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u662f\u6b63\u63aa\u7f6e\u306e\u4e21\u65b9\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u306b\u9069\u5207\u3067\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u76e3\u67fb\u7d50\u679c\u3001\u9038\u8131\u4e8b\u9805\u3001\u304a\u3088\u3073\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u4e0a\u306e\u30ae\u30e3\u30c3\u30d7<\/span><\/h3>\n\n\n\n

\u76e3\u67fb\u7d50\u679c\u306f\u3059\u3079\u3066\u540c\u3058\u4fa1\u5024\u3092\u6301\u3064\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u554f\u984c\u3084\u91cd\u5927\u306a\u554f\u984c\u306f\u901f\u3084\u304b\u306b\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u7ba1\u7406\u306b\u79fb\u884c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u7d19\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306b\u7f72\u540d\u6f0f\u308c\u304c1\u4ef6\u3042\u308b\u5834\u5408\u3001\u3088\u308a\u5e83\u7bc4\u306a\u30d1\u30bf\u30fc\u30f3\u304c\u898b\u3089\u308c\u306a\u3044\u9650\u308a\u3001\u4fee\u6b63\u3068\u3057\u3066\u51e6\u7406\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u5185\u90e8\u76e3\u67fb\u3067\u8907\u6570\u306e\u30d0\u30c3\u30c1\u306b\u308f\u305f\u3063\u3066\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u8a18\u9332\u304c\u4e0d\u5b8c\u5168\u3067\u3042\u308b\u3053\u3068\u304c\u5224\u660e\u3057\u305f\u5834\u5408\u3001\u305d\u308c\u306f\u7ba1\u7406\u4f53\u5236\u306e\u4e0d\u5099\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306e\u4e0d\u8db3\u3001\u307e\u305f\u306f\u975e\u73fe\u5b9f\u7684\u306a\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff08SOP\uff09\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

\u627f\u8a8d\u3055\u308c\u305f\u624b\u9806\u304b\u3089\u306e\u9038\u8131\u306b\u3064\u3044\u3066\u3082\u3001\u540c\u69d8\u306e\u8ad6\u7406\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u98df\u54c1\u88fd\u9020\u306b\u304a\u3044\u3066\u3001\u751f\u7523\u30e9\u30a4\u30f3\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u304c\u903c\u8feb\u3057\u3066\u3044\u308b\u305f\u3081\u306b\u5207\u308a\u66ff\u3048\u6642\u306b\u30e9\u30d9\u30eb\u78ba\u8a8d\u3092\u7701\u7565\u3057\u305f\u5834\u5408\u3001\u305d\u308c\u306f\u5358\u306a\u308b\u4e00\u6642\u7684\u306a\u30df\u30b9\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u9038\u8131\u304c\u88fd\u54c1\u306e\u540c\u4e00\u6027\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u307e\u305f\u306f\u898f\u5236\u9075\u5b88\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5834\u5408\u3001\u6b63\u5f0f\u306a\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u65b9\u304c\u3088\u308a\u5b89\u5168\u306a\u9053\u3067\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u5371\u6a5f\u767a\u751f\u524d\u306b\u30c8\u30ec\u30f3\u30c9\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3059\u308b<\/span><\/h3>\n\n\n\n

\u91cd\u5927\u306a\u4e0d\u9069\u5408\u304c\u767a\u751f\u3059\u308b\u307e\u3067\u767a\u58f2\u3092\u5f85\u3064\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093 \u30ab\u30d1<\/a><\/strong>. \u54c1\u8cea\u306b\u304a\u3051\u308b\u4e88\u9632\u63aa\u7f6e\u306f\u3001\u9867\u5ba2\u3078\u306e\u5f71\u97ff\u304c\u307e\u3060\u767a\u751f\u3057\u3066\u3044\u306a\u304f\u3066\u3082\u3001\u30c7\u30fc\u30bf\u304c\u30ea\u30b9\u30af\u306e\u4e0a\u6607\u3092\u793a\u3057\u3066\u3044\u308b\u5834\u5408\u306b\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u4e0d\u826f\u54c1\u306e\u50be\u5411\u3001\u518d\u52a0\u5de5\u7387\u3001\u6821\u6b63\u306e\u305a\u308c\u3001\u30cb\u30a2\u30df\u30b9\u3001\u691c\u67fb\u6f0f\u308c\u306a\u3069\u306f\u3001\u6b63\u5f0f\u306a\u30ec\u30d3\u30e5\u30fc\u3092\u884c\u3046\u6b63\u5f53\u306a\u7406\u7531\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u4f8b\u3048\u3070\u3001\u5305\u88c5\u30e9\u30a4\u30f3\u306f\u51fa\u8377\u54c1\u8cea\u76ee\u6a19\u306f\u9054\u6210\u3057\u3066\u3044\u308b\u3082\u306e\u306e\u3001\u30b7\u30fc\u30eb\u5f37\u5ea6\u306e\u3070\u3089\u3064\u304d\u304c4\u9031\u9593\u9023\u7d9a\u3067\u62e1\u5927\u3057\u3001\u6a5f\u68b0\u306e\u505c\u6b62\u56de\u6570\u304c\u5897\u52a0\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u82e6\u60c5\u304c\u767a\u751f\u3059\u308b\u524d\u306b\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u30d7\u30ed\u30bb\u30b9\u3092\u958b\u59cb\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u5146\u5019\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u52b9\u679c\u7684\u306a\u4e88\u9632\u63aa\u7f6e\u306e\u8cea\u306f\u3001\u50be\u5411\u30b7\u30b0\u30ca\u30eb\u3092\u5358\u306a\u308b\u30ce\u30a4\u30ba\u3067\u306f\u306a\u304f\u3001\u904b\u7528\u4e0a\u306e\u8a3c\u62e0\u3068\u3057\u3066\u6271\u3046\u3053\u3068\u306b\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>CAPA\u306e\u904e\u5270\u4f7f\u7528\u3084\u904e\u5c11\u4f7f\u7528\u3092\u907f\u3051\u308b\u65b9\u6cd5<\/span><\/h3>\n\n\n\n

CAPA\u3092\u904e\u5270\u306b\u4f7f\u7528\u3059\u308b\u3068\u3001\u5b8c\u4e86\u307e\u3067\u306e\u30b5\u30a4\u30af\u30eb\u304c\u9045\u304f\u306a\u308a\u3001\u30ed\u30b0\u304c\u81a8\u308c\u4e0a\u304c\u308a\u3001\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u304c\u4e0d\u5341\u5206\u306b\u306a\u308b\u3002\u3053\u308c\u306f\u3001\u30c1\u30fc\u30e0\u304c\u30ea\u30b9\u30af\u306e\u4f4e\u3044\u554f\u984c\u306e\u6587\u66f8\u5316\u306b\u6642\u9593\u3092\u304b\u3051\u3059\u304e\u3066\u3044\u308b\u305f\u3081\u3060\u3002\u5c0f\u3055\u306a\u50b7\u3001\u6a5f\u68b0\u306e\u505c\u6b62\u3001\u3042\u308b\u3044\u306f\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u3061\u3087\u3063\u3068\u3057\u305f\u30df\u30b9\u306a\u3069\u3001\u3042\u3089\u3086\u308b\u4e8b\u8c61\u306b\u5bfe\u3057\u3066CAPA\u3092\u5168\u9762\u7684\u306b\u5b9f\u65bd\u3059\u308b\u5de5\u5834\u3067\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u3092\u671f\u65e5\u307e\u3067\u306b\u5b8c\u4e86\u3055\u305b\u308b\u306e\u306f\u56f0\u96e3\u306b\u306a\u308b\u3002\u7d50\u679c\u3068\u3057\u3066\u3001\u66f8\u985e\u4e0a\u306f\u6d3b\u767a\u306b\u898b\u3048\u308b\u3082\u306e\u306e\u3001\u5b9f\u969b\u306b\u306f\u307b\u3068\u3093\u3069\u5236\u5fa1\u52b9\u679c\u306e\u306a\u3044\u30b7\u30b9\u30c6\u30e0\u306b\u306a\u3063\u3066\u3057\u307e\u3046\u3002.<\/p>\n\n\n\n

CAPA\uff08\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff09\u3092\u5341\u5206\u306b\u6d3b\u7528\u3057\u306a\u3044\u3053\u3068\u306f\u3001\u901a\u5e38\u3001\u3088\u308a\u30b3\u30b9\u30c8\u304c\u304b\u304b\u308a\u307e\u3059\u3002\u30c1\u30fc\u30e0\u304c\u6162\u6027\u7684\u306a\u30b7\u30b9\u30c6\u30e0\u505c\u6b62\u3001\u7e70\u308a\u8fd4\u3055\u308c\u308b\u9867\u5ba2\u30af\u30ec\u30fc\u30e0\u3001\u307e\u305f\u306f\u76e3\u67fb\u6307\u6458\u306b\u5bfe\u3057\u3066\u975e\u516c\u5f0f\u306a\u4fee\u6b63\u3092\u7e70\u308a\u8fd4\u3057\u9069\u7528\u3059\u308b\u3068\u3001\u77ed\u671f\u7684\u306a\u5fa9\u65e7\u306e\u9670\u306b\u30b7\u30b9\u30c6\u30e0\u4e0a\u306e\u6b20\u9665\u304c\u96a0\u3055\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002\u6700\u9069\u306a\u5224\u65ad\u57fa\u6e96\u306f\u30b7\u30f3\u30d7\u30eb\u3067\u3059\u3002\u554f\u984c\u304c\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u5834\u5408\u3001\u30ea\u30b9\u30af\u304c\u9ad8\u3044\u5834\u5408\u3001\u5916\u90e8\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u5834\u5408\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u95a2\u9023\u3059\u308b\u5834\u5408\u3001\u307e\u305f\u306f\u3088\u308a\u5e83\u7bc4\u306a\u7d71\u5236\u4e0a\u306e\u6b20\u9665\u3092\u793a\u5506\u3059\u308b\u8ca0\u306e\u50be\u5411\u304c\u898b\u3089\u308c\u308b\u5834\u5408\u306f\u3001\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u884c\u3046\u3079\u304d\u3067\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u691c\u51fa\u304b\u3089\u6709\u52b9\u6027\u691c\u8a3c\u307e\u3067\u306e\u5b9f\u8df5\u7684\u306aCAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc<\/span><\/h2>\n\n\n\n

<\/span>1) \u554f\u984c\u3092\u691c\u51fa\u3057\u3001\u521d\u671f\u62c5\u5f53\u8005\u3092\u5272\u308a\u5f53\u3066\u308b<\/span><\/h3>\n\n\n\n

\u5b9f\u7528\u7684 \u30ab\u30d1<\/a><\/strong> \u54c1\u8cea\u554f\u984c\u304c\u6587\u66f8\u5316\u3001\u30eb\u30fc\u30c6\u30a3\u30f3\u30b0\u3001\u304a\u3088\u3073\u30ec\u30d3\u30e5\u30fc\u53ef\u80fd\u306a\u65b9\u6cd5\u3067\u691c\u51fa\u3055\u308c\u305f\u6642\u70b9\u3067\u3001\u30d7\u30ed\u30bb\u30b9\u304c\u958b\u59cb\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u4f8b\u3067\u306f\u3001\u96fb\u5b50\u6a5f\u5668\u5de5\u5834\u304cPCB\u7d44\u7acb\u30e9\u30a4\u30f3\u306e\u6700\u7d42\u691c\u67fb\u4e2d\u306b\u3001\u540c\u3058\u30b3\u30fc\u30eb\u30c9\u30b8\u30e7\u30a4\u30f3\u30c8\u30d1\u30bf\u30fc\u30f3\u304c1\u9031\u9593\u306b3\u3064\u306e\u751f\u7523\u30ed\u30c3\u30c8\u3067\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u306f\u3093\u3060\u4ed8\u3051\u4e0d\u826f\u3092\u767a\u898b\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u554f\u984c\u306f\u5358\u767a\u7684\u306a\u3082\u306e\u3067\u306f\u306a\u304f\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u305f\u3081\u3001\u30c1\u30fc\u30e0\u306f\u5358\u7d14\u306a\u4fee\u6b63\u306b\u3068\u3069\u307e\u3089\u305a\u3001\u56fa\u6709\u306eID\u3001\u62c5\u5f53\u8005\u3001\u671f\u65e5\u3001\u304a\u3088\u3073\u5f71\u97ff\u3092\u53d7\u3051\u308b\u90e8\u54c1\u756a\u53f7\u3092\u542b\u3080\u6b63\u5f0f\u306aCAPA\u30ec\u30b3\u30fc\u30c9\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u3053\u3053\u304b\u3089\u54c1\u8cea\u30a2\u30af\u30b7\u30e7\u30f3\u8ffd\u8de1\u304c\u59cb\u307e\u308a\u307e\u3059\u3002\u7d44\u7e54\u306f\u3001\u554f\u984c\u306e\u767a\u898b\u304b\u3089\u691c\u8a3c\u6e08\u307f\u306e\u89e3\u6c7a\u307e\u3067\u3092\u8ffd\u8de1\u3059\u308b\u5358\u4e00\u306e\u30ec\u30b3\u30fc\u30c9\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

\u6700\u521d\u306e\u6c7a\u5b9a\u306f\u6839\u672c\u539f\u56e0\u3067\u306f\u306a\u304f\u3001 \u30b3\u30f3\u30c8\u30ed\u30fc\u30eb<\/strong>. \u54c1\u8cea\u30a8\u30f3\u30b8\u30cb\u30a2\u306f\u3001\u6b20\u9665\u30c7\u30fc\u30bf\u3092\u8a18\u9332\u3057\u3001\u691c\u67fb\u5199\u771f\u3092\u6dfb\u4ed8\u3057\u3001\u30ed\u30c3\u30c8\u3054\u3068\u306e\u6b20\u9665\u6570\u3092\u8a18\u9332\u3057\u3001CAPA\u62c5\u5f53\u8005\uff08\u901a\u5e38\u306f\u90e8\u9580\u6a2a\u65ad\u7684\u306a\u6d3b\u52d5\u3092\u8abf\u6574\u3059\u308b\u6a29\u9650\u3092\u6301\u3064\u54c1\u8cea\u30a8\u30f3\u30b8\u30cb\u30a2\u307e\u305f\u306f\u30d7\u30ed\u30bb\u30b9\u30a8\u30f3\u30b8\u30cb\u30a2\uff09\u3092\u5272\u308a\u5f53\u3066\u307e\u3059\u3002\u3053\u306e\u6bb5\u968e\u3067\u3001\u76e3\u7763\u8005\u3001\u88fd\u9020\u90e8\u9580\u3001\u304a\u3088\u3073\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u9580\u306f\u3001\u8ab0\u304c\u8cac\u4efb\u8005\u3067\u3042\u308b\u304b\u3001\u3069\u306e\u88fd\u54c1\u304c\u5f71\u97ff\u3092\u53d7\u3051\u308b\u304b\u3001\u305d\u3057\u3066\u6b21\u306e\u30ec\u30d3\u30e5\u30fc\u6c7a\u5b9a\u304c\u3044\u3064\u884c\u308f\u308c\u308b\u304b\u3092\u628a\u63e1\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u8cac\u4efb\u8005\u306e\u660e\u78ba\u5316\u304c\u306a\u3051\u308c\u3070\u3001CAPA\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306f\u8abf\u67fb\u958b\u59cb\u524d\u306b\u505c\u6ede\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>2\uff09\u554f\u984c\u3092\u76f4\u3061\u306b\u5c01\u3058\u8fbc\u3081\u308b<\/span><\/h3>\n\n\n\n

\u8abf\u67fb\u304c\u5b8c\u4e86\u3059\u308b\u307e\u3067\u306e\u9593\u3001\u76f4\u3061\u306b\u5c01\u3058\u8fbc\u3081\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u3053\u3068\u3067\u9867\u5ba2\u3092\u4fdd\u8b77\u3057\u3001\u4e0d\u9069\u5408\u54c1\u306e\u767a\u751f\u3092\u9632\u6b62\u3057\u307e\u3059\u3002\u306f\u3093\u3060\u4e0d\u826f\u306e\u5834\u5408\u3001\u5de5\u5834\u306f\u8a72\u5f53\u30ed\u30c3\u30c8\u306e\u51fa\u8377\u3092\u505c\u6b62\u3057\u3001\u540c\u3058\u30e9\u30a4\u30f3\u306e\u4ed5\u639b\u54c1\u3092\u9694\u96e2\u3057\u3001\u5f8c\u7d9a\u30d0\u30c3\u30c1\u306e\u691c\u67fb\u983b\u5ea6\u3092\u5897\u3084\u3057\u307e\u3059\u3002\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u30ea\u30b9\u30af\u304c\u660e\u78ba\u306b\u306a\u308b\u307e\u3067\u3001\u4f5c\u696d\u54e1\u306f\u30ea\u30d5\u30ed\u30fc\u51fa\u53e3\u3067100%\u76ee\u8996\u691c\u67fb\u306b\u5207\u308a\u66ff\u3048\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u63aa\u7f6e\u306f\u4e00\u6642\u7684\u306a\u3082\u306e\u3067\u3059\u304c\u3001\u5de5\u5834\u304c\u4f55\u3092\u3001\u3044\u3064\u3001\u8ab0\u306b\u3088\u3063\u3066\u884c\u3063\u305f\u304b\u3092\u8a3c\u660e\u3067\u304d\u308b\u3088\u3046\u3001\u660e\u78ba\u306b\u6587\u66f8\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u3088\u304f\u3042\u308b\u9593\u9055\u3044\u306f\u3001\u5c01\u3058\u8fbc\u3081\u63aa\u7f6e\u3092\u662f\u6b63\u63aa\u7f6e\u305d\u306e\u3082\u306e\u3068\u307f\u306a\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u3067\u3059\u3002\u5c01\u3058\u8fbc\u3081\u63aa\u7f6e\u306f\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u307e\u3059\u304c\u3001\u6b20\u9665\u304c\u767a\u751f\u3057\u305f\u6839\u672c\u539f\u56e0\u3092\u53d6\u308a\u9664\u304f\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u9069\u5207\u306b\u5b9f\u65bd\u3055\u308c\u305fCAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3067\u306f\u3001\u8a18\u9332\u306b\u306f\u66ab\u5b9a\u7684\u306a\u5bfe\u7b56\u3001\u8cac\u4efb\u8005\u3001\u5b9f\u65bd\u65e5\u3001\u304a\u3088\u3073\u7ba1\u7406\u3055\u308c\u305f\u6761\u4ef6\u4e0b\u3067\u306e\u751f\u7523\u306e\u30ea\u30ea\u30fc\u30b9\u307e\u305f\u306f\u7d99\u7d9a\u306e\u627f\u8a8d\u306b\u95a2\u3059\u308b\u9805\u76ee\u304c\u305d\u308c\u305e\u308c\u5225\u3005\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u533a\u5225\u306f\u3001\u30c1\u30fc\u30e0\u304c\u771f\u306e\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u304c\u52b9\u679c\u7684\u3067\u3042\u3063\u305f\u304b\u3069\u3046\u304b\u3092\u5f8c\u3005\u8a55\u4fa1\u3059\u308b\u969b\u306b\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>3) \u6545\u969c\u306e\u539f\u56e0\u3092\u8abf\u67fb\u3057\u3001\u6839\u672c\u539f\u56e0\u3092\u78ba\u8a8d\u3059\u308b<\/span><\/h3>\n\n\n\n

\u30e9\u30a4\u30f3\u304c\u5b89\u5b9a\u3057\u305f\u3089\u3001\u30c1\u30fc\u30e0\u306f\u751f\u7523\u3001\u4fdd\u5b88\u3001\u6750\u6599\u3001\u691c\u67fb\u304b\u3089\u306e\u8a3c\u62e0\u3092\u7528\u3044\u3066\u8abf\u67fb\u3092\u884c\u3044\u307e\u3059\u3002\u3053\u306e\u30b1\u30fc\u30b9\u3067\u306f\u3001CAPA\u62c5\u5f53\u8005\u304c\u30ea\u30d5\u30ed\u30fc\u7089\u306e\u6e29\u5ea6\u30ed\u30b0\u3001\u30b9\u30c6\u30f3\u30b7\u30eb\u6d17\u6d44\u983b\u5ea6\u3001\u306f\u3093\u3060\u30da\u30fc\u30b9\u30c8\u306e\u7d4c\u904e\u6642\u9593\u3001\u6a5f\u68b0\u306e\u4fdd\u5b88\u5c65\u6b74\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u30b7\u30d5\u30c8\u3001PCB\u4e0a\u306e\u6b20\u9665\u4f4d\u7f6e\u30d1\u30bf\u30fc\u30f3\u306a\u3069\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u8abf\u67fb\u306e\u7d50\u679c\u3001\u7279\u306b\u30b9\u30c6\u30f3\u30b7\u30eb\u6d17\u6d44\u3092\u884c\u308f\u305a\u306b\u9577\u6642\u9593\u7a3c\u50cd\u3057\u305f\u5f8c\u3001\u591a\u54c1\u7a2e\u5c11\u91cf\u751f\u7523\u306e\u5207\u308a\u66ff\u3048\u6642\u306b\u3001\u4e3b\u306b\u30e9\u30a4\u30f32\u3067\u6b20\u9665\u304c\u5897\u52a0\u3059\u308b\u3053\u3068\u304c\u5224\u660e\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5e83\u7bc4\u306a\u306f\u3093\u3060\u4ed8\u3051\u306e\u554f\u984c\u304b\u3089\u3001\u3088\u308a\u5177\u4f53\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u5236\u5fa1\u306e\u554f\u984c\u3078\u3068\u8abf\u67fb\u7bc4\u56f2\u304c\u7d5e\u308a\u8fbc\u307e\u308c\u307e\u3057\u305f\u3002.<\/p>\n\n\n\n

\u6839\u672c\u539f\u56e0\u5206\u6790\u306f\u3001\u75c7\u72b6\u304b\u3089\u691c\u8a3c\u6e08\u307f\u306e\u539f\u56e0\u3078\u3068\u9032\u3080\u3079\u304d\u3067\u3042\u308a\u3001\u61b6\u6e2c\u306b\u57fa\u3065\u304f\u3082\u306e\u3067\u3042\u3063\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u30c1\u30fc\u30e0\u306f 5\u3064\u306e\u7406\u7531<\/a><\/strong> \u30d7\u30ed\u30bb\u30b9\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u305f\u691c\u8a3c\u306e\u7d50\u679c\u3001\u6839\u672c\u539f\u56e0\u3068\u3057\u3066\u3001\u30b9\u30c6\u30f3\u30b7\u30eb\u6d17\u6d44\u9593\u9694\u306e\u3070\u3089\u3064\u304d\u3068\u3001\u88fd\u54c1\u5207\u308a\u66ff\u3048\u5f8c\u306e\u30ea\u30d5\u30ed\u30fc\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u8a2d\u5b9a\u306e\u305a\u308c\u3068\u3044\u30462\u70b9\u304c\u78ba\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002\u539f\u56e0\u306e\u4e00\u3064\u3068\u3057\u3066\u3001\u30e9\u30a4\u30f3\u8a2d\u5b9a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306b\u3001\u7279\u5b9a\u306e\u88fd\u54c1\u30d5\u30a1\u30df\u30ea\u30fc\u306e\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u691c\u8a3c\u306b\u95a2\u3059\u308b\u627f\u8a8d\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u30d7\u30ed\u30bb\u30b9\u5168\u4f53\u304c\u5b9f\u884c\u53ef\u80fd\u3068\u306a\u308a\u307e\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u3069\u306e\u30d7\u30ed\u30bb\u30b9\u4e0a\u306e\u4e0d\u5177\u5408\u3092\u4fee\u6b63\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3001\u307e\u305f\u3069\u306e\u7ba1\u7406\u4e0a\u306e\u30ae\u30e3\u30c3\u30d7\u306b\u5bfe\u3057\u3066\u4e88\u9632\u63aa\u7f6e\u3092\u8b1b\u3058\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u304c\u3001\u5de5\u5834\u5074\u3067\u660e\u78ba\u306b\u306a\u3063\u305f\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n

\u5168\u4f53\u306e\u6d41\u308c\u306f\u5358\u7d14\u660e\u5feb\u3067\u3059\u3002\u554f\u984c\u306e\u691c\u51fa\u3001\u30ea\u30b9\u30af\u306e\u5c01\u3058\u8fbc\u3081\u3001\u969c\u5bb3\u306e\u8abf\u67fb\u3001\u6839\u672c\u539f\u56e0\u306e\u691c\u8a3c\u3001\u5bfe\u7b56\u306e\u7b56\u5b9a\u3001\u5909\u66f4\u306e\u5b9f\u65bd\u3001\u6709\u52b9\u6027\u306e\u78ba\u8a8d\u3001\u305d\u3057\u3066\u627f\u8a8d\u3068\u8a3c\u62e0\u306e\u4fdd\u7ba1\u3092\u3082\u3063\u3066\u5b8c\u4e86\u3067\u3059\u3002\u5b9f\u969b\u306b\u306f\u3001\u3053\u306e\u624b\u9806\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u9375\u306f\u3001\u624b\u9806\u305d\u306e\u3082\u306e\u3088\u308a\u3082\u3001\u5404\u6bb5\u968e\u306b\u304a\u3051\u308b\u62c5\u5f53\u8005\u3001\u671f\u65e5\u3001\u8a3c\u62e0\u3001\u610f\u601d\u6c7a\u5b9a\u306e\u30b2\u30fc\u30c8\u3068\u3044\u3063\u305f\u8981\u7d20\u3092\u304d\u3061\u3093\u3068\u7ba1\u7406\u3059\u308b\u3053\u3068\u306b\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\"\u88fd\u9020\u696d\u306b\u304a\u3051\u308bCAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306e\u30a4\u30f3\u30d5\u30a9\u30b0\u30e9\u30d5\u30a3\u30c3\u30af\uff1a\u691c\u51fa\u3068\u5c01\u3058\u8fbc\u3081\u304b\u3089\u691c\u8a3c\u3068\u5b8c\u4e86\u307e\u3067\"<\/figure>\n\n\n\n

<\/span>4\uff09\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3092\u5b9a\u7fa9\u3059\u308b<\/span><\/h3>\n\n\n\n

\u6839\u672c\u539f\u56e0\u304c\u7279\u5b9a\u3055\u308c\u305f\u5f8c\u3001\u30c1\u30fc\u30e0\u306f\u76ee\u7684\u5225\u306b\u5bfe\u7b56\u3092\u5206\u3051\u307e\u3059\u3002\u662f\u6b63\u63aa\u7f6e\u306f\u73fe\u5728\u306e\u4e0d\u5177\u5408\u30e1\u30ab\u30cb\u30ba\u30e0\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u5de5\u5834\u306f\u88fd\u9020\u5de5\u7a0b\u306e\u9577\u3055\u306b\u57fa\u3065\u3044\u3066\u30b9\u30c6\u30f3\u30b7\u30eb\u6d17\u6d44\u306e\u5fc5\u9808\u9593\u9694\u3092\u8a2d\u5b9a\u3057\u3001\u5f71\u97ff\u3092\u53d7\u3051\u308b\u88fd\u54c1\u306e\u30ea\u30d5\u30ed\u30fc\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u518d\u691c\u8a3c\u3057\u3001\u30e9\u30a4\u30f3\u6280\u8853\u8005\u306b\u6bb5\u53d6\u308a\u66ff\u3048\u8a2d\u5b9a\u306b\u95a2\u3059\u308b\u518d\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002\u4e88\u9632\u63aa\u7f6e\u306f\u3088\u308a\u5e83\u7bc4\u306a\u30ea\u30b9\u30af\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u9580\u306f\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u66f4\u65b0\u3057\u3001\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u306f\u7ba1\u7406\u8a08\u753b\u3092\u6539\u8a02\u3057\u3001\u4fdd\u5b88\u90e8\u9580\u306f\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u4e00\u8cab\u6027\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u5b9a\u671f\u7684\u306a\u691c\u8a3c\u30dd\u30a4\u30f3\u30c8\u3092\u8ffd\u52a0\u3057\u307e\u3059\u3002\u3053\u306e\u533a\u5225\u306f\u3001\u88fd\u9020\u696d\u306b\u304a\u3051\u308b\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u306e\u6700\u3082\u6709\u7528\u306a\u4f8b\u306e\u4e00\u3064\u3067\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u4eca\u65e5\u306e\u4e0d\u5177\u5408\u3092\u4fee\u6b63\u3059\u308b\u3053\u3068\u3068\u5c06\u6765\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u3053\u3068\u306f\u95a2\u9023\u3057\u3066\u3044\u308b\u3082\u306e\u306e\u3001\u540c\u4e00\u3067\u306f\u306a\u3044\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u308b\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n

\u5404\u30a2\u30af\u30b7\u30e7\u30f3\u306f\u3001\u5f8c\u3067\u76e3\u67fb\u3067\u304d\u308b\u3088\u3046\u306b\u5341\u5206\u306b\u5177\u4f53\u7684\u3067\u3042\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u300c\u30d7\u30ed\u30bb\u30b9\u7ba1\u7406\u3092\u6539\u5584\u3059\u308b\u300d\u3068\u3044\u3063\u305f\u66d6\u6627\u306a\u9805\u76ee\u3092\u66f8\u304f\u306e\u3067\u306f\u306a\u304f\u3001\u5404\u30bf\u30b9\u30af\u306b\u3064\u3044\u3066\u3001\u62c5\u5f53\u8005\u3001\u5fc5\u8981\u306a\u8a3c\u62e0\u3001\u671f\u65e5\u3001\u627f\u8a8d\u7d4c\u8def\u3092\u660e\u78ba\u306b\u5b9a\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u300c\u30b9\u30c6\u30f3\u30b7\u30eb\u6d17\u6d44SOP\u3092\u66f4\u65b0\u3057\u30015\u670815\u65e5\u307e\u3067\u306b\u3059\u3079\u3066\u306eSMT\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3092\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3059\u308b\u300d\u306f\u7ba1\u7406\u3057\u3084\u3059\u3044\u3067\u3059\u304c\u3001\u300c\u306f\u3093\u3060\u4ed8\u3051\u30d7\u30ed\u30bb\u30b9\u3092\u898b\u76f4\u3059\u300d\u306f\u305d\u3046\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u52b9\u679c\u7684\u306aCAPA\u7ba1\u7406\u306f\u3001\u5206\u6790\u3092\u5b9f\u884c\u304a\u3088\u3073\u691c\u8a3c\u53ef\u80fd\u306a\u30bf\u30b9\u30af\u306b\u5909\u63db\u3059\u308b\u3053\u3068\u306b\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>5) \u5909\u66f4\u306e\u5b9f\u88c5\u3068\u5b9f\u884c\u306e\u7ba1\u7406<\/span><\/h3>\n\n\n\n

\u5b9f\u88c5<\/strong> \u591a\u304f\u306e\u4eba\u304c \u30ab\u30d1<\/a><\/strong> \u7279\u306b\u3001\u4f5c\u696d\u304c\u54c1\u8cea\u3001\u751f\u7523\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3001\u4fdd\u5b88\u306b\u307e\u305f\u304c\u308b\u5834\u5408\u3001\u52e2\u3044\u304c\u5931\u308f\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u306f\u3093\u3060\u4e0d\u826f\u306e\u5834\u5408\u3001\u751f\u7523\u90e8\u9580\u306f\u65b0\u3057\u3044\u6d17\u6d44\u9593\u9694\u3092\u5b9f\u884c\u3057\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u9580\u306f\u691c\u8a3c\u6e08\u307f\u306e\u30ea\u30d5\u30ed\u30fc\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3057\u3001\u4fdd\u5b88\u90e8\u9580\u306f\u6a5f\u68b0\u306e\u70b9\u691c\u3092\u5b8c\u4e86\u3057\u3001\u54c1\u8cea\u90e8\u9580\u306f\u6539\u8a02\u3055\u308c\u305f\u6587\u66f8\u304c\u30e9\u30a4\u30f3\u3067\u6709\u52b9\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u5b8c\u4e86\u3057\u305f\u5404\u30bf\u30b9\u30af\u306b\u306f\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u8a18\u9332\u3001\u66f4\u65b0\u3055\u308c\u305fSOP\u3001\u6a5f\u68b0\u30ed\u30b0\u3001\u627f\u8a8d\u6e08\u307f\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306a\u3069\u306e\u5ba2\u89b3\u7684\u306a\u8a3c\u62e0\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8a3c\u62e0\u304c\u6b20\u3051\u3066\u3044\u308b\u5834\u5408\u3001\u4f5c\u696d\u304c\u5b8c\u4e86\u3057\u305f\u3068\u5831\u544a\u3055\u308c\u3066\u3044\u3066\u3082\u3001\u30a2\u30af\u30b7\u30e7\u30f3\u306f\u5b8c\u4e86\u3057\u3066\u3044\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u627f\u8a8d\u306f\u3053\u3053\u3067\u91cd\u8981\u3067\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u5b8c\u4e86\u3057\u305f\u30bf\u30b9\u30af\u304c\u3059\u3079\u3066\u81ea\u52d5\u7684\u306b\u6b21\u306e\u6bb5\u968e\u306b\u9032\u3080\u3079\u304d\u3067\u306f\u306a\u3044\u304b\u3089\u3067\u3059\u3002\u30d7\u30ed\u30bb\u30b9\u30a8\u30f3\u30b8\u30cb\u30a2\u304c\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306e\u66f4\u65b0\u3092\u5b8c\u4e86\u3057\u3066\u3082\u3001CAPA\u304c\u691c\u8a3c\u6bb5\u968e\u306b\u9032\u3080\u524d\u306b\u3001\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u307e\u305f\u306f\u62c5\u5f53\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u304c\u66f4\u65b0\u5185\u5bb9\u304c\u7ba1\u7406\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u6642\u671f\u5c1a\u65e9\u306a\u5b8c\u4e86\u3092\u9632\u304e\u3001CAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5358\u306a\u308b\u30bf\u30b9\u30af\u5b8c\u4e86\u3067\u306f\u306a\u304f\u3001\u5b9f\u969b\u306e\u30d7\u30ed\u30bb\u30b9\u5909\u66f4\u306b\u7d50\u3073\u4ed8\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u5de5\u5834\u8cac\u4efb\u8005\u306f\u3001\u671f\u9650\u5207\u308c\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u3084\u54c1\u8cea\u30a2\u30af\u30b7\u30e7\u30f3\u8ffd\u8de1\u306b\u304a\u3051\u308b\u30dc\u30c8\u30eb\u30cd\u30c3\u30af\u3092\u3088\u308a\u660e\u78ba\u306b\u628a\u63e1\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>6) \u9589\u9396\u524d\u306b\u6709\u52b9\u6027\u3092\u78ba\u8a8d\u3059\u308b<\/span><\/h3>\n\n\n\n

\u6709\u52b9\u6027\u691c\u8a3c<\/strong> \u3053\u308c\u306f\u300c\u5bfe\u7b56\u306f\u5b8c\u4e86\u3057\u305f\u304b\uff1f\u300d\u3068\u3044\u3046\u8cea\u554f\u3088\u308a\u3082\u3055\u3089\u306b\u53b3\u5bc6\u306a\u8cea\u554f\u3067\u3059\u3002\u5bfe\u7b56\u306b\u3088\u3063\u3066\u3001\u901a\u5e38\u306e\u7a3c\u50cd\u6761\u4ef6\u4e0b\u3067\u5143\u306e\u554f\u984c\u304c\u8efd\u6e1b\u307e\u305f\u306f\u89e3\u6d88\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u3092\u554f\u3046\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u4f8b\u3067\u306f\u3001\u30c1\u30fc\u30e0\u306f\u7b2c2\u30e9\u30a4\u30f3\u306e\u6b21\u306e6\u9031\u9593\u306e\u751f\u7523\u3092\u76e3\u8996\u3057\u3001\u5bfe\u7b56\u524d\u306e\u57fa\u6e96\u5024\u3068\u6bd4\u8f03\u3057\u3066\u3001\u306f\u3093\u3060\u4e0d\u826f\u7387\uff08ppm\uff09\u3001\u521d\u56de\u5408\u683c\u7387\u3001\u518d\u52a0\u5de5\u7387\u3001\u9867\u5ba2\u30af\u30ec\u30fc\u30e0\u30c7\u30fc\u30bf\u306a\u3069\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u4e0d\u826f\u7387\u304c\u5927\u5e45\u306b\u4f4e\u4e0b\u3057\u3001\u8907\u6570\u56de\u306e\u5207\u308a\u66ff\u3048\u671f\u9593\u306b\u308f\u305f\u3063\u3066\u5b89\u5b9a\u3057\u305f\u72b6\u614b\u304c\u7dad\u6301\u3055\u308c\u308c\u3070\u3001\u662f\u6b63\u63aa\u7f6e\u306f\u6709\u52b9\u3067\u3042\u3063\u305f\u3068\u5224\u65ad\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

\u691c\u8a3c\u306f\u3001\u4e3b\u89b3\u7684\u306a\u5224\u65ad\u3067\u306f\u306a\u304f\u3001\u4e8b\u524d\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u57fa\u6e96\u3092\u7528\u3044\u308b\u3079\u304d\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u3067\u306f\u3001\u30b3\u30fc\u30eb\u30c9\u30b8\u30e7\u30a4\u30f3\u30c8\u306e\u30d1\u30bf\u30fc\u30f3\u304c\u7e70\u308a\u8fd4\u3055\u308c\u306a\u30443\u30ed\u30c3\u30c8\u9023\u7d9a\u306e\u30ed\u30c3\u30c8\u3001\u76ee\u6a19\u3068\u3059\u308b\u521d\u56de\u5408\u683c\u7387\u3078\u306e\u56de\u5fa9\u3001\u65b0\u3057\u3044\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3068\u6d17\u6d44\u9593\u9694\u3078\u306e\u6e96\u62e0\u306e\u6587\u66f8\u5316\u306a\u3069\u304c\u6c42\u3081\u3089\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u4e88\u9632\u63aa\u7f6e\u306e\u8cea\u304c\u660e\u3089\u304b\u306b\u306a\u308b\u306e\u3082\u3053\u306e\u6bb5\u968e\u3067\u3059\u3002\u6b20\u9665\u304c1\u3064\u306e\u88fd\u54c1\u3067\u306e\u307f\u89e3\u6d88\u3055\u308c\u3001\u305d\u306e\u5f8c\u540c\u69d8\u306e\u7d44\u7acb\u54c1\u3067\u518d\u3073\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u3088\u308a\u5e83\u7bc4\u306a\u4e88\u9632\u7ba1\u7406\u304c\u5341\u5206\u3067\u306f\u306a\u304b\u3063\u305f\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u5de5\u5834\u304c\u5b9f\u65bd\u8a3c\u62e0\u3068\u6027\u80fd\u8a3c\u62e0\u306e\u4e21\u65b9\u3092\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u305f\u5834\u5408\u306b\u306e\u307f\u3001\u662f\u6b63\u63aa\u7f6e\u306e\u5b8c\u4e86\u3068\u307f\u306a\u3059\u3079\u304d\u3067\u3059\u3002.<\/p>\n\n\n\n

\"CAPA\u6709\u52b9\u6027\u691c\u8a3c\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9\uff08\u88fd\u9020\u54c1\u8cea\u6307\u6a19\u306e\u524d\u5f8c\u6bd4\u8f03\uff09\"<\/figure>\n\n\n\n

<\/span>7) CAPA\u3092\u5b8c\u4e86\u3057\u3001\u305d\u3053\u304b\u3089\u5f97\u3089\u308c\u305f\u6559\u8a13\u3092\u8a18\u9332\u3059\u308b<\/span><\/h3>\n\n\n\n

\u6b63\u5f0f\u306a\u30af\u30ed\u30fc\u30ba\u306b\u306f\u3001\u6839\u672c\u539f\u56e0\u3001\u5b8c\u4e86\u3057\u305f\u5bfe\u7b56\u3001\u691c\u8a3c\u7d50\u679c\u3001\u304a\u3088\u3073\u6b8b\u308a\u306e\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u9805\u76ee\u306e\u6700\u7d42\u30ec\u30d3\u30e5\u30fc\u304c\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3059\u3002\u306f\u3093\u3060\u4e0d\u826f\u306e\u30b1\u30fc\u30b9\u3067\u306f\u3001CAPA\u306e\u62c5\u5f53\u8005\u306f\u3001\u8a18\u9332\u3092\u30af\u30ed\u30fc\u30ba\u3059\u308b\u524d\u306b\u3001\u8abf\u67fb\u6982\u8981\u3001\u88cf\u4ed8\u3051\u3068\u306a\u308b\u8a18\u9332\u3001\u50be\u5411\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u54c1\u8cea\u90e8\u9580\u3068\u904b\u7528\u90e8\u9580\u304b\u3089\u306e\u627f\u8a8d\u7f72\u540d\u3092\u307e\u3068\u3081\u307e\u3059\u3002\u5de5\u5834\u306e\u624b\u9806\u3067\u8981\u6c42\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u30c1\u30fc\u30e0\u306fCAPA\u3092\u6539\u8a02\u7248PFMEA\u3001\u7ba1\u7406\u8a08\u753b\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u306a\u3069\u306e\u95a2\u9023\u6587\u66f8\u306b\u30ea\u30f3\u30af\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30d0\u30e9\u30d0\u30e9\u306e\u30e1\u30fc\u30eb\u3084\u30d5\u30a1\u30a4\u30eb\u3067\u306f\u306a\u304f\u3001\u76e3\u67fb\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u5c65\u6b74\u304c\u4f5c\u6210\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u5b8c\u4e86\u3057\u305fCAPA\u306f\u3001\u5358\u306b\u524d\u56de\u306e\u5bfe\u5fdc\u3092\u8a18\u9332\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u6b21\u56de\u306e\u5bfe\u5fdc\u306e\u6539\u5584\u306b\u3082\u3064\u306a\u304c\u308b\u3079\u304d\u3067\u3059\u3002\u306f\u3093\u3060\u4ed8\u3051\u95a2\u9023\u306eCAPA\u304c\u8907\u6570\u767a\u751f\u3057\u3001\u6bb5\u53d6\u308a\u66ff\u3048\u6642\u306e\u898f\u5f8b\u306b\u554f\u984c\u304c\u3042\u308b\u3053\u3068\u304c\u793a\u5506\u3055\u308c\u308b\u5834\u5408\u3001\u305d\u306e\u50be\u5411\u306f\u4eca\u5f8c\u306e\u76e3\u67fb\u3001\u968e\u5c64\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u30c1\u30a7\u30c3\u30af\u3001\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u8a08\u753b\u306b\u53cd\u6620\u3055\u308c\u308b\u3079\u304d\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u6210\u719f\u3057\u305fCAPA\u7ba1\u7406\u3067\u306f\u3001\u5b8c\u4e86\u3092\u4e00\u3064\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306e\u7d42\u4e86\u3068\u3001\u3088\u308a\u512a\u308c\u305f\u7d44\u7e54\u7684\u7d71\u5236\u306e\u59cb\u307e\u308a\u3068\u6349\u3048\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u3092\u8d85\u3048\u305f\u3001\u5f37\u529b\u306aCAPA\u7ba1\u7406\u3068\u306f\u3069\u306e\u3088\u3046\u306a\u3082\u306e\u304b<\/span><\/h2>\n\n\n\n

<\/span>\u56de\u7b54\u3060\u3051\u3067\u306a\u304f\u3001\u8a18\u9332\u3082\u6a19\u6e96\u5316\u305b\u3088<\/span><\/h3>\n\n\n\n

\u5f37\u3044 \u30ab\u30d1<\/a><\/strong> \u7ba1\u7406\u306f\u3001\u4e00\u8cab\u6027\u306e\u3042\u308b\u30c7\u30fc\u30bf\u69cb\u9020\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002CAPA\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u8a18\u9332\u306b\u306f\u3001\u554f\u984c\u306e\u767a\u751f\u6e90\u3001\u5f71\u97ff\u3092\u53d7\u3051\u308b\u88fd\u54c1\u307e\u305f\u306f\u30d7\u30ed\u30bb\u30b9\u3001\u5c01\u3058\u8fbc\u3081\u63aa\u7f6e\u3001\u4f7f\u7528\u3055\u308c\u305f\u6839\u672c\u539f\u56e0\u5206\u6790\u65b9\u6cd5\u3001\u62c5\u5f53\u8005\u3001\u671f\u65e5\u3001\u691c\u8a3c\u8a08\u753b\u3001\u304a\u3088\u3073\u5b8c\u4e86\u306e\u8a3c\u62e0\u3068\u3044\u3063\u305f\u3001\u540c\u3058\u30b3\u30a2\u30d5\u30a3\u30fc\u30eb\u30c9\u3092\u8a18\u9332\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u69cb\u9020\u304c\u306a\u3051\u308c\u3070\u3001\u30c1\u30fc\u30e0\u306f\u4e8b\u4f8b\u3092\u6bd4\u8f03\u3057\u305f\u308a\u3001\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u539f\u56e0\u3092\u7279\u5b9a\u3057\u305f\u308a\u3001\u30e9\u30a4\u30f3\u3001\u5de5\u5834\u3001\u307e\u305f\u306f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u6a2a\u65ad\u3057\u3066\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u54c1\u8cea\u30a2\u30af\u30b7\u30e7\u30f3\u8ffd\u8de1\u3092\u7dad\u6301\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u6a19\u6e96\u5316\u3055\u308c\u305f\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u5404\u90e8\u9580\u304c\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3092\u7570\u306a\u308b\u5f62\u5f0f\u3067\u6587\u66f8\u5316\u3059\u308b\u3068\u3044\u3046\u3001\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u306b\u3088\u304f\u3042\u308b\u554f\u984c\u3082\u8efd\u6e1b\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306b\u5236\u5fa1\u6a5f\u80fd\u3092\u7d44\u307f\u8fbc\u3080<\/span><\/h3>\n\n\n\n

\u4fe1\u983c\u6027\u306e\u9ad8\u3044CAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306b\u306f\u3001\u5171\u6709\u30d5\u30a1\u30a4\u30eb\u3084\u30e1\u30fc\u30eb\u306b\u3088\u308b\u30ea\u30de\u30a4\u30f3\u30c0\u30fc\u4ee5\u4e0a\u306e\u3082\u306e\u304c\u5fc5\u8981\u3067\u3059\u3002\u5f79\u5272\u3054\u3068\u306b\u30bf\u30b9\u30af\u3092\u30eb\u30fc\u30c6\u30a3\u30f3\u30b0\u3057\u3001\u9069\u5207\u306a\u7ba1\u7406\u30dd\u30a4\u30f3\u30c8\u3067\u627f\u8a8d\u3092\u5fc5\u9808\u3068\u3057\u3001\u30a2\u30af\u30b7\u30e7\u30f3\u306e\u671f\u9650\u304c\u904e\u304e\u305f\u5834\u5408\u3084\u8a3c\u62e0\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u30ea\u30de\u30a4\u30f3\u30c0\u30fc\u3084\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u30c8\u30ea\u30ac\u30fc\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5b9f\u969b\u306b\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u90e8\u9580\u304c\u30b1\u30fc\u30b9\u3092\u8d77\u7968\u3057\u3001\u88fd\u9020\u90e8\u9580\u304c\u5c01\u3058\u8fbc\u3081\u3092\u5b9f\u65bd\u3057\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u9580\u304c\u6839\u672c\u539f\u56e0\u5206\u6790\u3092\u4e3b\u5c0e\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u90e8\u9580\u307e\u305f\u306f\u5de5\u5834\u7ba1\u7406\u90e8\u9580\u304c\u6709\u52b9\u6027\u306e\u7d50\u679c\u306b\u57fa\u3065\u3044\u3066\u5b8c\u4e86\u3092\u627f\u8a8d\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u306e\u5f79\u5272\u30d9\u30fc\u30b9\u306e\u69cb\u9020\u304c\u91cd\u8981\u306a\u306e\u306f\u3001\u5f15\u304d\u7d99\u304e\u306e\u9045\u5ef6\u304cCAPA\u5b8c\u4e86\u304c\u76ee\u6a19\u671f\u9593\u3092\u8d85\u904e\u3059\u308b\u4e3b\u306a\u539f\u56e0\u306e1\u3064\u3060\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u6587\u66f8\u7ba1\u7406\u3068\u76e3\u67fb\u8a3c\u8de1\u3067\u8a3c\u62e0\u3092\u4fdd\u8b77\u3059\u308b<\/span><\/h3>\n\n\n\n

\u898f\u5236\u5bfe\u8c61\u3067\u9867\u5ba2\u76e3\u67fb\u3092\u53d7\u3051\u305f\u88fd\u9020\u74b0\u5883\u3067\u306f\u3001CAPA\u8a18\u9332\u306f \u8ffd\u8de1\u53ef\u80fd<\/strong>. \u691c\u67fb\u5199\u771f\u3001\u8a66\u9a13\u5831\u544a\u66f8\u3001\u9038\u8131\u8a18\u9332\u30018D\u30ec\u30dd\u30fc\u30c8\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u306e\u56de\u7b54\u306a\u3069\u306e\u95a2\u9023\u30d5\u30a1\u30a4\u30eb\u306f\u3001\u30b1\u30fc\u30b9\u306b\u76f4\u63a5\u30ea\u30f3\u30af\u3055\u305b\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u7ba1\u7406\u3092\u884c\u3044\u3001\u30bf\u30a4\u30e0\u30b9\u30bf\u30f3\u30d7\u3092\u4ed8\u4e0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u76e3\u67fb\u8a3c\u8de1\u306b\u306f\u3001\u8ab0\u304c\u4f55\u3092\u3044\u3064\u5909\u66f4\u3057\u305f\u304b\u3001\u627f\u8a8d\u304c\u3044\u3064\u4e0e\u3048\u3089\u308c\u305f\u304b\u3001\u671f\u9650\u304c\u5ef6\u9577\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306a\u30ec\u30d9\u30eb\u306e\u7ba1\u7406\u306f\u3001\u7279\u306b\u30d5\u30a1\u30a4\u30eb\u304c\u5171\u6709\u30c9\u30e9\u30a4\u30d6\u3001\u30e1\u30fc\u30eb\u30b9\u30ec\u30c3\u30c9\u3001\u30ed\u30fc\u30ab\u30eb\u30d5\u30a9\u30eb\u30c0\u306b\u5206\u6563\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u3067\u306f\u7dad\u6301\u304c\u56f0\u96e3\u3067\u3059\u3002.<\/p>\n\n\n\n

<\/span>CAPA\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9\u3067\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u53ef\u8996\u5316<\/span><\/h3>\n\n\n\n

\u52b9\u679c\u7684\u306a\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u30b7\u30b9\u30c6\u30e0\u304c\u5358\u306b\u5b8c\u4e86\u3057\u305f\u8a18\u9332\u3092\u84c4\u7a4d\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u5b9f\u969b\u306b\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6700\u4f4e\u9650\u3001\u54c1\u8cea\u8cac\u4efb\u8005\u306f\u3001\u672a\u5b8c\u4e86\u306e\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u3092\u6240\u6709\u8005\u5225\u304a\u3088\u3073\u7d4c\u904e\u65e5\u6570\u5225\u306b\u3001\u671f\u9650\u5207\u308c\u306e\u63aa\u7f6e\u3001\u5e73\u5747\u5b8c\u4e86\u6642\u9593\u3001\u6b20\u9665\u307e\u305f\u306f\u30d7\u30ed\u30bb\u30b9\u5225\u306e\u518d\u767a\u7387\u3001\u6839\u672c\u539f\u56e0\u306e\u50be\u5411\u3001\u304a\u3088\u3073\u6709\u52b9\u6027\u691c\u8a3c\u306e\u5408\u683c\u7387\u3092\u78ba\u8a8d\u3067\u304d\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30d3\u30e5\u30fc\u306f\u3001\u7279\u306b\u3042\u308b\u62e0\u70b9\u3067\u30b1\u30fc\u30b9\u304c\u8fc5\u901f\u306b\u5b8c\u4e86\u3057\u3066\u3044\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4f9d\u7136\u3068\u3057\u3066\u4e0d\u5177\u5408\u304c\u7e70\u308a\u8fd4\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306a\u3069\u306b\u3001\u7ba1\u7406\u4e0a\u306e\u5b8c\u4e86\u3068\u771f\u306e\u4e88\u9632\u63aa\u7f6e\u306e\u54c1\u8cea\u3092\u533a\u5225\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u8907\u6570\u306e\u5de5\u5834\u3067\u64cd\u696d\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9\u306e\u53ef\u8996\u6027\u306f\u3001\u540c\u3058\u6839\u672c\u539f\u56e0\u304c\u7570\u306a\u308b\u65bd\u8a2d\u3067\u7570\u306a\u308b\u30e9\u30d9\u30eb\u3067\u8868\u793a\u3055\u308c\u3066\u3044\u306a\u3044\u304b\u3069\u3046\u304b\u3092\u7279\u5b9a\u3059\u308b\u306e\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\n\n\n

\"\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u76e3\u67fb\u8a3c\u8de1\u3001\u6587\u66f8\u7ba1\u7406\u3001\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9\u3092\u542b\u3080\u30c7\u30b8\u30bf\u30ebCAPA\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u30a4\u30f3\u30d5\u30a9\u30b0\u30e9\u30d5\u30a3\u30c3\u30af\"<\/figure>\n\n\n\n

<\/span>\u624b\u4f5c\u696d\u306b\u3088\u308b\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3092\u30c7\u30b8\u30bf\u30eb\u5b9f\u884c\u306b\u7f6e\u304d\u63db\u3048\u308b<\/span><\/h3>\n\n\n\n

\u624b\u52d5\u306b\u3088\u308b\u8ffd\u8de1\u3068\u30c7\u30b8\u30bf\u30eb\u306b\u3088\u308b\u5b9f\u884c\u306e\u4e3b\u306a\u9055\u3044\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304c\u6b21\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u3092\u6307\u793a\u3059\u308b\u70b9\u3067\u3042\u308a\u3001\u4eba\u304c\u8a18\u61b6\u3057\u3066\u304a\u304f\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30b9\u30d7\u30ec\u30c3\u30c9\u30b7\u30fc\u30c8\u30d9\u30fc\u30b9\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u30b9\u30c6\u30fc\u30bf\u30b9\u306e\u66f4\u65b0\u304c\u9045\u308c\u305f\u308a\u3001\u62c5\u5f53\u8005\u304c\u4e0d\u660e\u78ba\u3060\u3063\u305f\u308a\u3001\u671f\u9650\u5207\u308c\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u304c\u30ec\u30d3\u30e5\u30fc\u4f1a\u8b70\u3084\u76e3\u67fb\u6642\u306b\u521d\u3081\u3066\u660e\u3089\u304b\u306b\u306a\u3063\u305f\u308a\u3059\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u30c7\u30b8\u30bf\u30ebCAPA\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u671f\u65e5\u3001\u901a\u77e5\u3001\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u30d1\u30b9\u3001\u627f\u8a8d\u30eb\u30fc\u30eb\u3001\u8a3c\u62e0\u8981\u4ef6\u306a\u3069\u304c\u30d7\u30ed\u30bb\u30b9\u81ea\u4f53\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5b8c\u4e86\u307e\u3067\u306e\u898f\u5f8b\u304c\u5411\u4e0a\u3057\u3001\u7ba1\u7406\u8005\u306f\u30d7\u30ed\u30bb\u30b9\u306e\u9045\u5ef6\u7b87\u6240\u3092\u3088\u308a\u660e\u78ba\u306b\u628a\u63e1\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

<\/span>\u5358\u306a\u308b\u4e8b\u4ef6\u89e3\u6c7a\u3067\u306f\u306a\u304f\u3001\u30c8\u30ec\u30f3\u30c9\u5206\u6790\u306e\u305f\u3081\u306e\u8a2d\u8a08<\/span><\/h3>\n\n\n\n

\u6210\u719f\u3057\u305f\u88fd\u9020\u696d\u8005\u306f\u3001CAPA\u30c7\u30fc\u30bf\u3092\u5358\u306a\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a18\u9332\u3068\u3057\u3066\u3067\u306f\u306a\u304f\u3001\u6539\u5584\u306e\u6307\u6a19\u3068\u3057\u3066\u6d3b\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u8a18\u9332\u304c\u9069\u5207\u306b\u69cb\u9020\u5316\u3055\u308c\u3066\u3044\u308c\u3070\u3001\u5de5\u7a0b\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u6a5f\u68b0\u306e\u7a2e\u985e\u3001\u30b7\u30d5\u30c8\u3001\u88fd\u54c1\u30bf\u30a4\u30d7\u3054\u3068\u306b\u6839\u672c\u539f\u56e0\u3092\u5206\u6790\u3057\u3001\u305d\u306e\u60c5\u5831\u306b\u57fa\u3065\u3044\u3066\u3088\u308a\u5e83\u7bc4\u306a\u4e88\u9632\u63aa\u7f6e\u306e\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u591a\u304f\u306e\u662f\u6b63\u63aa\u7f6e\u3084\u4e88\u9632\u63aa\u7f6e\u306e\u4e8b\u4f8b\u304c\u904b\u7528\u4e0a\u5f79\u7acb\u3064\u306e\u306f\u3001\u307e\u3055\u306b\u3053\u306e\u70b9\u3067\u3059\u3002\u500b\u5225\u306e\u4e8b\u4f8b\u3068\u3057\u3066\u3067\u306f\u306a\u304f\u3001\u540c\u3058\u6545\u969c\u30e1\u30ab\u30cb\u30ba\u30e0\u304c\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3057\u3066\u3044\u308b\u7b87\u6240\u3092\u793a\u3059\u50be\u5411\u30c7\u30fc\u30bf\u3068\u3057\u3066\u6d3b\u7528\u3067\u304d\u308b\u306e\u3067\u3059\u3002\u3082\u3057\u30b7\u30b9\u30c6\u30e0\u304c\u3053\u306e\u30ec\u30d9\u30eb\u306e\u5206\u6790\u3092\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u306a\u3044\u5834\u5408\u3001\u305d\u308c\u306f\u88fd\u9020\u30ea\u30b9\u30af\u7ba1\u7406\u3068\u3044\u3046\u3088\u308a\u3082\u3001\u4e8b\u52d9\u51e6\u7406\u306b\u7d42\u59cb\u3057\u3066\u3044\u308b\u3068\u8a00\u3048\u308b\u3067\u3057\u3087\u3046\u3002.<\/p>\n\n\n\n

<\/span>\u7d50\u8ad6\uff1a\u67d4\u8edf\u306aCAPA\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3059\u308b Jodoo<\/a><\/span><\/h2>\n\n\n\n

\u5f37\u3044 \u30ab\u30d1<\/strong><\/a> \u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u308a\u3001\u500b\u3005\u306e\u54c1\u8cea\u554f\u984c\u3092\u6539\u5584\u306e\u305f\u3081\u306e\u518d\u73fe\u53ef\u80fd\u306a\u30b7\u30b9\u30c6\u30e0\u3078\u3068\u5909\u63db\u3067\u304d\u307e\u3059\u3002\u4e00\u6642\u7684\u306a\u5bfe\u51e6\u3067\u554f\u984c\u3092\u89e3\u6c7a\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u30c1\u30fc\u30e0\u306f\u554f\u984c\u306e\u691c\u51fa\u3068\u5c01\u3058\u8fbc\u3081\u304b\u3089\u6839\u672c\u539f\u56e0\u306e\u7279\u5b9a\u3001\u62c5\u5f53\u8005\u306e\u7279\u5b9a\u3001\u691c\u8a3c\u3001\u305d\u3057\u3066\u6587\u66f8\u5316\u3055\u308c\u305f\u89e3\u6c7a\u306b\u81f3\u308b\u307e\u3067\u306e\u660e\u78ba\u306a\u9053\u7b4b\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u88fd\u9020\u696d\u306b\u304a\u3044\u3066\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u88fd\u9020\u696d\u3067\u306f\u3001\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u6b20\u9665\u3001\u76e3\u67fb\u7d50\u679c\u3001\u305d\u3057\u3066\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u306e\u9045\u308c\u304c\u3001\u4e0d\u826f\u54c1\u306e\u767a\u751f\u7387\u3001\u7d0d\u671f\u9075\u5b88\u7387\u3001\u305d\u3057\u3066\u9867\u5ba2\u306e\u4fe1\u983c\u306b\u3059\u3050\u306b\u60aa\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n

\u305d\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u30b7\u30d5\u30c8\u3001\u30e9\u30a4\u30f3\u3001\u5de5\u5834\u3092\u554f\u308f\u305a\u4e00\u8cab\u3057\u3066\u6a5f\u80fd\u3055\u305b\u305f\u3044\u306e\u3067\u3042\u308c\u3070\u3001\u305d\u306e\u80cc\u5f8c\u306b\u3042\u308b\u30b7\u30b9\u30c6\u30e0\u306f\u65b9\u6cd5\u305d\u306e\u3082\u306e\u3068\u540c\u3058\u304f\u3089\u3044\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002. Jodoo<\/strong><\/a> \u88fd\u9020\u696d\u8005\u306f\u3001\u30ab\u30b9\u30bf\u30e0\u958b\u767a\u3092\u5f85\u3063\u305f\u308a\u3001\u6e96\u5099\u304c\u6574\u3046\u524d\u306b\u5927\u898f\u6a21\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u3092\u5c0e\u5165\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u30b3\u30fc\u30c9\u4e0d\u8981\u3067CAPA\u30d5\u30a9\u30fc\u30e0\u3001\u627f\u8a8d\u30d5\u30ed\u30fc\u3001\u30ea\u30de\u30a4\u30f3\u30c0\u30fc\u30eb\u30fc\u30eb\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u30ec\u30dd\u30fc\u30c8\u3092\u4f5c\u6210\u3067\u304d\u307e\u3059\u3002\u30c1\u30fc\u30e0\u306f\u3001\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306b\u6cbf\u3063\u305f\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u306e\u8a18\u9332\u3001\u8abf\u67fb\u3001\u5272\u308a\u5f53\u3066\u3001\u8ffd\u8de1\u65b9\u6cd5\u3092\u6a19\u6e96\u5316\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

CAPA\u7ba1\u7406\u3092\u3088\u308a\u8fc5\u901f\u306b\u3001\u3088\u308a\u8ffd\u8de1\u53ef\u80fd\u306b\u3001\u305d\u3057\u3066\u3088\u308a\u62e1\u5f35\u3057\u3084\u3059\u304f\u3059\u308b\u6e96\u5099\u304c\u3067\u304d\u3066\u3044\u308b\u306a\u3089\u3001 \u7121\u6599\u30c8\u30e9\u30a4\u30a2\u30eb\u3092\u958b\u59cb\u3059\u308b<\/a><\/strong> \u307e\u305f\u306f \u30c7\u30e2\u3092\u4e88\u7d04\u3059\u308b<\/a><\/strong> Jodoo\u3092\u4f7f\u3063\u3066\u3002.<\/p>","protected":false},"excerpt":{"rendered":"

\u88fd\u9020\u696d\u306b\u304a\u3051\u308b\u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u306b\u3064\u3044\u3066\u5b66\u3073\u3001\u3088\u308a\u5f37\u56fa\u306aCAPA\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u69cb\u7bc9\u3057\u307e\u3057\u3087\u3046\u3002Jodoo\u306e\u7121\u6599\u30c8\u30e9\u30a4\u30a2\u30eb\u3092\u958b\u59cb\u3059\u308b\u304b\u3001\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>","protected":false},"author":1,"featured_media":7376,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-7580","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-solutions"],"blocksy_meta":[],"yoast_head":"\nCorrective and Preventive Action: CAPA Process for Manufacturing Quality - Jodoo Blog<\/title>\n<meta name=\"description\" content=\"Learn corrective action and preventive action in manufacturing and build a stronger CAPA workflow. 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