Q9質(zhì)量風(fēng)險(xiǎn)管理中英文對照

1、.Contains Nonbinding Recommendations：.；薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁

2、羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅

3、蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆

4、螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇

5、羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻

6、蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂

7、螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅

8、羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇

9、蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈

10、裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁

11、羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃

12、蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆

13、襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇

14、羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁

15、螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂

16、袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃

17、羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇

18、螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈

19、袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂

20、羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃

21、螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄

22、袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈

23、羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿

24、螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃

25、袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄

26、肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿膈膅蒁羈袇莁莇羇羀膄蚅羆肂荿薁羅芄膂薇羄羄蕆蒃羄肆芀螂羃膈蒆蚈羂芁羋薄肁羀蒄蒀蚇肅芇莆蚇膅蒂螅蚆羅芅蟻蚅肇薁薇蚄腿莃蒃蚃節(jié)膆螁螞羈莂蚇螁肄膄薃螁膆莀葿螀袆膃蒞

27、蝿肈莈螄螈膀芁蝕螇節(jié)蕆薆螆羂艿蒂螆肄蒅莈裊膇羋蚆襖袆蒃薂袃罿芆蒈袂膁蒁蒄袁芃莄螃袀羃膇蠆袀肅莃薅衿 QUALITY RISK MANAGEMENTQ9工業(yè)指南Q9質(zhì)量風(fēng)險(xiǎn)管理美國安康與公眾效力部食品藥品監(jiān)視管理局FDA藥品評價(jià)與研討中心CDER生物評價(jià)與研討中心(CBER)2006年6月人用藥物注冊技術(shù)要求國際協(xié)調(diào)會議ICHTable of Contents目錄1. INTRODUCTION 引言2. SCOPE 范圍3. PRINCIPLES OF QUALITY RISK MANAGEMENT 質(zhì)量風(fēng)險(xiǎn)管理原理4. GENERAL QUALITY RISK MANAGEMENT PROCE

28、SS 質(zhì)量風(fēng)險(xiǎn)管理根本程序4.1 Responsibilities 職責(zé)分配4.2 Initiating a Quality Risk Management Process 質(zhì)量風(fēng)險(xiǎn)管理的啟動(dòng)4.3 Risk Assessment 風(fēng)險(xiǎn)評價(jià)4.4 Risk Control 風(fēng)險(xiǎn)控制4.5 Risk Communication 風(fēng)險(xiǎn)交流4.6 Risk Review 風(fēng)險(xiǎn)回想5. RISK MANAGEMENT METHODOLOGY 風(fēng)險(xiǎn)管理方法學(xué)6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPE

29、RATIONS 工業(yè)及監(jiān)管與質(zhì)量風(fēng)險(xiǎn)管理的整合7. DEFINITIONS 定義8. REFERENCES 參考資料Annex I: Risk Management Methods and Tools 附件 I:風(fēng)險(xiǎn)管理方法及工具I.1 Basic Risk Management Facilitation Methods I.1 根本風(fēng)險(xiǎn)管理簡易方法I.2 Failure Mode Effects Analysis (FMEA) I.2 失誤方式影響分析(FMEA)I.3 Failure Mode, Effects and Criticality Analysis (FMECA) I.3 失誤

30、方式影響及危險(xiǎn)程度分析 (FMECA)I.4 Fault Tree Analysis (FTA) I.4 缺點(diǎn)樹型分析(FTA)I.5 Hazard Analysis and Critical Control Points (HACCP) I.5 危害分析及關(guān)鍵控制點(diǎn)(HACCP)I.6 Hazard Operability Analysis (HAZOP) I.6 危害可操作性分析(HAZOP)I.7 Preliminary Hazard Analysis (PHA) I.7 初步危害分析(PHA)I.8 Risk Ranking and Filtering I.8 風(fēng)險(xiǎn)排序及濾除I.9 S

31、upporting Statistical Tools I.9 輔助統(tǒng)計(jì)工具Annex II: Potential Applications for Quality Risk Management 附件 II: 質(zhì)量風(fēng)險(xiǎn)管理潛在運(yùn)用前景.II.1 Quality Risk Management as Part of Integrated Quality Management II.1 綜合質(zhì)量管理中的質(zhì)量風(fēng)險(xiǎn)管理II.2 Quality Risk Management as Part of Regulatory Operations II.2 操作優(yōu)化中的運(yùn)用II.3 Quality Risk

32、 Management as Part of development II.3 研發(fā)中的運(yùn)用II.4 Quality Risk Management for Facilities, Equipment and Utilities II.4 對工具、設(shè)備和設(shè)備的質(zhì)量風(fēng)險(xiǎn)管理II.5 Quality Risk Management as Part of Materials Management II.5 物料管理中的運(yùn)用II.6 Quality Risk Management as Part of Production II.6 消費(fèi)中的運(yùn)用II.7 Quality Risk Management

33、 as Part of Laboratory Control and Stability Studies II.7 實(shí)驗(yàn)室控制及穩(wěn)定性研討中的運(yùn)用II.8 Quality Risk Management as Part of Packaging and Labelling II.8 標(biāo)簽及包裝中的運(yùn)用 1. INTRODUCTION引言Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupati

34、onal safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In

35、addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system. 風(fēng)險(xiǎn)管理原理在商業(yè)和政府的許多領(lǐng)域都得到了有效運(yùn)用，如：金融、保險(xiǎn)、職業(yè)平安、公共衛(wèi)生、藥物監(jiān)測及相應(yīng)的監(jiān)管部門。如今質(zhì)量風(fēng)險(xiǎn)管理在藥企中雖有運(yùn)用，但范圍有限，并沒有發(fā)揚(yáng)出它的全部成效。

36、藥企曾經(jīng)認(rèn)識到了質(zhì)量體系的重要性，而質(zhì)量風(fēng)險(xiǎn)管理越來越明顯地成為有效質(zhì)量體系的重要組分。It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficul

37、t because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In relation to pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as wel

38、l as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance. 根據(jù)常規(guī)了解，風(fēng)險(xiǎn)被定義為損傷發(fā)生的能夠性及嚴(yán)重程度。然而，要在不同利益集團(tuán)之間尋求風(fēng)險(xiǎn)管理運(yùn)用方面的共同認(rèn)識是相當(dāng)困難的，由于他們認(rèn)識到的潛在危害、各危害發(fā)生的能夠性及嚴(yán)重程度都不同。藥品相關(guān)的利益集團(tuán)很多，如病人、醫(yī)療人員和政府企業(yè)，但是質(zhì)量風(fēng)險(xiǎn)管理的首要目的是維護(hù)病人。The manufacturing and use of

39、 a drug (medicinal) product, including its components, necessarily entail some degree of risk. The risk to its quality is just one component of the overall risk. It is important to understand that product quality should be maintained throughout the product lifecycle such that the attributes that are

40、 important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control

41、 potential quality issues during development and manufacturing. Additionally, use of quality risk management can improve the decision making if a quality problem arises. Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance

42、 of a companys ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight. 藥品消費(fèi)、運(yùn)用過程，包括藥品的成分，都會不可防止地引入一定的風(fēng)險(xiǎn)。質(zhì)量風(fēng)險(xiǎn)只是其中的一部分。在產(chǎn)品整個(gè)生命周期中，確保產(chǎn)品的質(zhì)量，使得藥質(zhì)量量方面的重要性質(zhì)與臨床研討中的一致，做到這些是非常重要的。一個(gè)有效的質(zhì)量風(fēng)險(xiǎn)管理方法能經(jīng)過提供前攝措施，確定控制研發(fā)和消費(fèi)中潛在的質(zhì)量問題，來進(jìn)一步確保藥質(zhì)量量。當(dāng)質(zhì)量問題出現(xiàn)時(shí)，運(yùn)用質(zhì)量風(fēng)險(xiǎn)管

43、理還能改善決策過程。有效進(jìn)展質(zhì)量風(fēng)險(xiǎn)管理能促使產(chǎn)生更好更正式?jīng)Q策，加強(qiáng)監(jiān)控者對公司處置潛在風(fēng)險(xiǎn)才干的自信心，積極影響直接監(jiān)理的程度和程度。The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing qu

44、ality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk based decisions, both by reg

45、ulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements. 此文件的目的是提供質(zhì)量風(fēng)險(xiǎn)管理方面的系統(tǒng)方法。作為一個(gè)根底性、資源性的文件，它獨(dú)立于卻又支持其它ICH質(zhì)量文件，補(bǔ)充藥企和監(jiān)管機(jī)構(gòu)內(nèi)已有的質(zhì)量措施、要求、規(guī)范和指南。

46、特別是它提供了一些質(zhì)量風(fēng)險(xiǎn)管理工具的原理指南，這些工具能促使監(jiān)管者和企業(yè)思索整個(gè)產(chǎn)品周期中藥用物質(zhì)和藥品的質(zhì)量，做出更有效、更延續(xù)的基于風(fēng)險(xiǎn)的決策，并不想在現(xiàn)有法規(guī)之外提出新的期望。It is neither always appropriate nor always necessary to use a formal risk management process (using recognized tools and/ or internal procedures e.g., standard operating procedures). The use of informal risk

47、management processes (using empirical tools and/ or internal procedures) can also be considered acceptable. Appropriate use of quality risk management can facilitate but does not obviate industrys obligation to comply with regulatory requirements and does not replace appropriate communications betwe

48、en industry and regulators. 運(yùn)用正式的風(fēng)險(xiǎn)管理程序并非總是適宜的或必要的用已成認(rèn)的工具或內(nèi)部程序，如規(guī)范操作規(guī)程。有時(shí)也允許運(yùn)用非正式的風(fēng)險(xiǎn)管理程序用閱歷工具或內(nèi)部程序。恰當(dāng)運(yùn)用風(fēng)險(xiǎn)管理能方便但不消除企業(yè)遵守法規(guī)要求的責(zé)任，也不能取代企業(yè)和監(jiān)管者之間必要的溝通交流。2. SCOPE 2. 范圍This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceut

49、ical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients,

50、 packaging and labeling materials in drug (medicinal) products, biological and biotechnological products). 本指南給出了質(zhì)量風(fēng)險(xiǎn)管理工具的原理和運(yùn)用實(shí)例，這些工具可用于藥質(zhì)量量各方面，即藥用物質(zhì)、藥品、生物和生物技術(shù)產(chǎn)品包括藥品中用到的原料、溶劑、賦形劑、包裝標(biāo)簽資料等生命周期中的研發(fā)、消費(fèi)、銷售、檢察、提交和復(fù)審各過程。3. PRINCIPLES OF QUALITY RISK MANAGEMENT 3.質(zhì)量風(fēng)險(xiǎn)管理原理Two primary principles of quality

51、risk management are: The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient; and The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. 質(zhì)量風(fēng)險(xiǎn)管理的兩

52、條根本原理是：1. 評價(jià)質(zhì)量風(fēng)險(xiǎn)應(yīng)基于科學(xué)知識并最終同對病人的維護(hù)聯(lián)絡(luò)起來。2. 投入的努力程度、管理的正式程度及文件管理程度應(yīng)與風(fēng)險(xiǎn)程度相順應(yīng)。4. GENERAL QUALITY RISK MANAGEMENT PROCESS 4. 質(zhì)量風(fēng)險(xiǎn)管理根本過程Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the pr

53、oduct lifecycle. A model for quality risk management is outlined in the diagram (Figure 1). Other models could be used. The emphasis on each component of the framework might differ from case to case but a robust process will incorporate consideration of all the elements at a level of detail that is

54、commensurate with the specific risk. 質(zhì)量風(fēng)險(xiǎn)管理是對藥質(zhì)量量風(fēng)險(xiǎn)進(jìn)展評價(jià)，控制，交流和審查的系統(tǒng)過程，這一過程貫穿藥品整個(gè)生命周期。圖1給出了這方面的一個(gè)模型，其他模型也有運(yùn)用。詳細(xì)情況不同，框架中各組分受注重程度會各有差別，可是一個(gè)有效的管理過程會將一切要素納入思索，各要素受關(guān)注程度會因風(fēng)險(xiǎn)的特異而各有區(qū)別。Figure 1:典型質(zhì)量風(fēng)險(xiǎn)管理過程簡介啟動(dòng)質(zhì)量風(fēng)險(xiǎn)管理風(fēng)險(xiǎn)鑒定風(fēng)險(xiǎn)分析風(fēng)險(xiǎn)評價(jià)風(fēng)險(xiǎn)評價(jià)風(fēng)險(xiǎn)質(zhì)量管理的效果/結(jié)果風(fēng)險(xiǎn)降低風(fēng)險(xiǎn)接受風(fēng)險(xiǎn)控制事件審核風(fēng)險(xiǎn)交流風(fēng)險(xiǎn)管理工具不合格Decision nodes are not shown in the dia

55、gram above because decisions can occur at any point in the process. These decisions might be to return to the previous step and seek further information, to adjust the risk models or even to terminate the risk management process based upon information that supports such a decision. Note: “unacceptab

56、le in the flowchart does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process. 由于決策行為隨時(shí)都能夠發(fā)生，上圖就沒有顯示決策點(diǎn)。這些決策有能夠被反響到上一步以尋求更多信息，這些信息可用于調(diào)整風(fēng)險(xiǎn)模型；也能夠用于管理過程的終止。注解：圖中的“不可接受項(xiàng)不僅指違背了法令法規(guī)要求，也表示風(fēng)險(xiǎn)管理過程需求重頭再來。4.1 Responsibilities 4.1. 職責(zé)分配

57、 Quality risk management activities are usually, but not always, undertaken by interdisciplinary teams. When teams are formed, they should include experts from the appropriate areas (e.g., quality unit, business development, engineering, regulatory affairs, production operations, sales and marketing

58、, legal, statistics and clinical) in addition to individuals who are knowledgeable about the quality risk management process. Decision makers should take responsibility for coordinating quality risk management across various functions and departments of their organization; and assure that a quality

59、risk management process is defined, deployed and reviewed and that adequate resources are available. 質(zhì)量風(fēng)險(xiǎn)管理經(jīng)常是但也不總是由交叉學(xué)科團(tuán)隊(duì)執(zhí)行。除了要有風(fēng)險(xiǎn)管理方面的閱歷人士，團(tuán)隊(duì)還應(yīng)包括相關(guān)領(lǐng)域的專家 例如：質(zhì)量小組、事業(yè)開展、工程、管理，消費(fèi)、行銷、法律、統(tǒng)計(jì)和臨床方面等。決策者必需擔(dān)任組織協(xié)調(diào)各部門之間的關(guān)系，保證團(tuán)隊(duì)各項(xiàng)功能的有效發(fā)揚(yáng)，確保整個(gè)管理過程得以合理展開、不斷完善、反復(fù)審查，保證有足夠的資源供團(tuán)隊(duì)運(yùn)用。4.2 Initiating a Quality Risk Manag

60、ement Process 4.2 質(zhì)量風(fēng)險(xiǎn)管理的啟動(dòng)Quality risk management should include systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process might include the following: Define the