Table 58.1 Steps in the corrective action process 表58.1 纠正措施过程的步骤 |
| | Clause 10.2.1 requirement |
1.
| Collect the nonconformity data and classify 收集不符合数据并进行分类 | Reviewing and analysing 评审和分析 |
2.
| Conduct Pareto analysis to identify the vital few and trivial many and evaluate the need for action进行 柏拉图分析，以确定重要的少数和琐碎的多数，并评估采取措施的必要性 |
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3.
| Organize a diagnostic team 组建一个诊断团队 | Determining the cause and extent of nonconformity (10.2.1b) 确定原因和不符合程度（10.2.1b） |
4.
| Postulate causes and test theories |
|
5.
| Determine the root cause of nonconformity 确定不符合的根本原因 |
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6.
| Determine if similar nonconformities exist or could exist elsewhere 确定其他地方是否存在或可能存在类似的不符合的情况 |
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7.
| Determine the effects of nonconformity and the need for action 确定不符合要求的影响和必要措施 | Implementing any action needed (10.2.1c) 执行必须的措施（10.2.1c） |
8.
| Determine the action needed to prevent nonconformity recurring 确定需要采取的措施，以防止不符合再次发生 |
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9.
| Organize an implementation team 组建一个执行团队 |
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10.
| Create or choose the conditions which will ensure effective implementation 创造或选择能确保有效实施的条件 |
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11.
| Implement the agreed action 实施商定的措施 |
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12.
| Record the nature of the nonconformities 记录不符合的性质 | Retain documented information (10.2.2) |
13.
| Record the results of Pareto analysis 记录柏拉图分析结果 |
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14.
| Record the causes of nonconformity 记录不符合原因 |
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15.
| Record the criteria for determining severity or priority
记录确定严重度或优先级的准则 |
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16.
| Record the proposed actions to be taken
记录采取的建议措施 |
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17.
| Record the actions actually taken 记录实际采取的措施 |
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18.
| Record the results of actions taken 记录采取措施的结果 |
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19.
| Assess the actions taken and determine if they were those required to be taken
评估所采取的措施，并确定这些措施是否是所需采取的行动 | Reviewing corrective actions (10.2.1.d) 评审纠正措施（10.2.1d） |
20.
| Determine whether the actions were performed in the best way 确定执行的措施是否是最佳方法 |
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21.
| Determine whether the nonconformity has recurred 确定不符合是否复发 |
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22.
| If nonconformity has recurred repeat steps 1–22 如果不符合复发，重复1−22步骤 |
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| Review risk assessments and opportunities and update if necessary | Update risks and opportunities determined during planning (10.2.1e) 更新策划期间确定的风险和机遇（10.2.1e） |
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