FMEA，是时候告别RPN风险评分了！

新版FMEA发布已有一年多时间，其中取消了传统的RPN评分方法，而用AP（风险控制行动优先级）值来代替，但是并未给出在制药领域的应用。近日，在PharmaceuticalOnline上发布了题为“Is It Time To Say Goodbye To FMEA Risk Priority Number (RPN) Scores?（是时候告别FMEA风险优先级（RPN）分数了吗？）”的文章，作者给出了使用FMEA中AP值的在制药领域的应用示例，并表示：现在是时候考虑取消使用传统的 RPN 评分并过渡到使用 AP 评级。AP 评级使用简单得多，不需要计算（无需验证电子表格），并提供独立简单的参照表来确定适当的操作级别。翻译如下：Example: A process FMEA has been developedfor a new product using Table 4. A certain characteristic has acriticality/severity of moderate, a probabilityof occurrence of moderate, and aprobability of detection of adequate.示例：对一个新产品进行了工艺FMEA评估。某一特征具有中度严重性、中度发生概率和充分检测概率。Table 4: ExampleCriticality/Severity, Occurrence, and Detection Ratings表 4：严重性/关键性、可能性和可探测性评分示例Criticality/Severity严重性Definition界定Catastrophic高Moderate中Minor低Occurrence发生频率（可能性）Certain. 1 failure / hour高：每小时失效1次Moderate. 1 failure / week中：每周失效1次Remote. 1 failure / year低：每年失效1次Detection检测能力Slight弱Adequate中等Excellent良好Using Table 5, a criticality/severity of moderate, a probability of occurrenceof moderate, and a probability of detection of adequate produce an ActionPriority of high. This requiresthe FMEA team to identify appropriate actions or improve the prevention ordetection controls or reduce the probability of occurrence.使用表 5，中等严重性、中等可能性和中等的检测能力会产生高行动优先级。这要求 FMEA 团队制定适当的措施或改进预防措施或检测控制或降低发生的可能性。Table 5: ActionPriority Ratings优先级评分SeverityCriticality严重性关键性Occurrence可能性（发生频率）Detection可探测性ActionPriority优先级（AP值）Catastrophic高Certain高Slight弱High高Adequate中等High高Excellent良好High高Moderate中Slight弱High高Adequate中等High高Excellent良好High高Remote低Slight弱High高Adequate中等High高Excellent良好Medium中Moderate中Certain高Slight弱High高Adequate中等High高Excellent良好Medium中Moderate中Slight弱High高Adequate中等High高Excellent良好Medium中Remote低Slight弱Medium中Adequate中等Medium中Excellent良好Low低Minor低Certain高Slight弱Medium中Adequate中等Medium中Excellent良好Low低Moderate中Slight弱Low低Adequate中等Low低Excellent良好Low低Remote低Slight弱Low低Adequate中等Low低Excellent良好Low低Conclusion结论It may be time to consider eliminating theuse of the traditional RPN score and transitioning to the use of AP ratings. APratings are much simpler to use, do not require a calculation (eliminating thevalidation of a spreadsheet), and provides a single simple table reference todetermine the appropriate level of action.现在是时候考虑取消使用传统的 RPN 评分并过渡到使用 AP 评级。AP 评级使用简单得多，不需要计算（无需验证电子表格），并提供独立简单的参照表来确定适当的操作级别。

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