登录查看更多内容

What are the best practices for conducting design FMEAs and updating them throughout the design process?

由人工智能和领英社区提供技术支持

Design FMEAs, or failure mode and effects analyses, are tools to identify and prioritize potential failures and their impacts on the performance and safety of a product or system. They are essential for design control, as they help to ensure that the design meets the requirements and specifications, and that the risks are reduced to acceptable levels. In this article, you will learn the best practices for conducting design FMEAs and updating them throughout the design process.

此文章中的业界达人

由社区从 7 条内容中精选。了解更多

DeVonnah Woodruff

Leading with a passion for Quality by Design, Risk Management and Design Controls

1 Define the scope and objectives

The first step in conducting a design FMEA is to define the scope and objectives of the analysis. This includes identifying the product or system to be analyzed, its functions, features, components, interfaces, and modes of operation. It also includes defining the criteria for evaluating the severity, occurrence, and detection of each failure mode, and the risk priority number (RPN) that combines these factors. The scope and objectives should be aligned with the design inputs, outputs, verification, and validation activities, and the reliability risk management plan.

添加您的观点

加载更多内容

2 Identify the failure modes and effects

The next step is to identify the possible failure modes and their effects on the product or system. A failure mode is a way that a component or function can fail to perform as intended or expected. An effect is the consequence of a failure mode on the product, system, user, or environment. To identify the failure modes and effects, you can use various sources of information, such as previous FMEAs, design reviews, customer feedback, testing results, standards, regulations, and best practices. You can also use brainstorming techniques, such as fishbone diagrams, to generate ideas.

添加您的观点

DeVonnah Woodruff

Leading with a passion for Quality by Design, Risk Management and Design Controls
举报内容
One thing I have found helpful, is if a top down analysis is used to comply with 14971, that external effects should link in some way to the hazards in the top down file. It could be something as the effect wording is similar to the hazard wording in the top down. This helps ensure no hazards have been missed.

已翻译

赞

3 Assess the severity, occurrence, and detection

The third step is to assess the severity, occurrence, and detection of each failure mode and effect. Severity is the degree of harm or impact that a failure mode can cause. Occurrence is the likelihood or frequency that a failure mode can happen. Detection is the ability or probability to identify or prevent a failure mode before it causes harm or impact. You can use rating scales, such as 1 to 10, to assign numerical values to each factor, based on predefined criteria. You can also use historical data, engineering judgment, or statistical methods to estimate the values.

添加您的观点

DeVonnah Woodruff

Leading with a passion for Quality by Design, Risk Management and Design Controls
举报内容
One thing I have seen that adds unnecessary confusion is having more than one severity scale. Have one severity scale with definitions to be used for all top downs and all FMECAs within a company. This creates alignment and less time trying to "convert" scales.

已翻译

赞

4 Calculate the risk priority number and prioritize the actions

The fourth step is to calculate the risk priority number (RPN) and prioritize the actions to reduce the risks. The RPN is the product of the severity, occurrence, and detection ratings, and it represents the relative risk of each failure mode and effect. The higher the RPN, the higher the risk. You can use the RPN to rank and prioritize the failure modes and effects, and to determine which ones need corrective or preventive actions. You can also use other criteria, such as regulatory requirements, customer expectations, or cost-benefit analysis, to prioritize the actions.

添加您的观点

DeVonnah Woodruff

Leading with a passion for Quality by Design, Risk Management and Design Controls
(已编辑)
举报内容
If using a top down as my source of risk to comply with 14971, I prefer renaming this to criticality priority number. The main reason is regulators are very narrowly focused when they talk about risk. Their definition of risk is severity of harm x occurrence of harm. When regulators say scale activity, e.g. V&V rigor, based on risk, it's typically the 14971 definition of risk that is implied. Often many xFMECAs do not include occurrence of harm.

已翻译

赞

5 Implement and verify the actions

The fifth step is to implement and verify the actions to reduce the risks. The actions can be design changes, process improvements, testing methods, control measures, or contingency plans, depending on the nature and cause of the failure modes and effects. You should document the actions, their rationale, their responsibility, their schedule, and their status. You should also verify that the actions are effective and do not introduce new or unintended failures or effects. You can use design reviews, testing results, feedback, or audits to verify the actions.

添加您的观点

6 Update the FMEA throughout the design process

The final step is to update the FMEA throughout the design process. The FMEA is not a one-time activity, but a living document that reflects the current state of the design and its risks. You should update the FMEA whenever there are changes in the design inputs, outputs, verification, validation, requirements, specifications, or assumptions. You should also update the FMEA when new information, data, or feedback becomes available, or when new failure modes or effects are identified or eliminated. You should review and revise the ratings, RPNs, actions, and status accordingly.

添加您的观点

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

添加您的观点

刘雨丝

Regulatory Affairs and Quality Assurance @BioIntellisense
举报内容
Need to add relation with other standards, such as iso 14971 in the context of medical devices. Not sure if this article, might be too generic?

已翻译

赞

Design Control

+ 关注

给文章评分

我们借助人工智能创建了此文章。您认为这篇文章怎么样？

很棒不太好

举报此文章

查看全部

What are the best practices for conducting design FMEAs and updating them throughout the design process?

1

2

3

4

5

6

7

1 Define the scope and objectives

2 Identify the failure modes and effects

3 Assess the severity, occurrence, and detection

4 Calculate the risk priority number and prioritize the actions

5 Implement and verify the actions

6 Update the FMEA throughout the design process

7 Here’s what else to consider

Design Control

给文章评分

感谢您的反馈

更多Design Control相关文章

更多相关阅读内容