Die Fmeadie Method of error and analysis of the effect (in German “possible error and influenza analysis”) is a procedure to examine unknown effects known as known causes.

For medical devices, FMEA is used, for example, in the analysis of the risk to analyze the consequences of a defective component, in particular the resulting danger.

1. How to use the FMEA

a) in development

Use the analysis of fashion and bankruptcy effects to identify previously unknown dangers that derive from hypothetical errors:

1. Start in this analysis with the inputs and components of the product.
2. Notes possible states of error in these inputs and components.
3. Discover what unknown effects (e.g. must of product or danger) can have these states of error.

Because of the way, the method is called the bottom-up process.

b) when replacing or changing the components

As a manufacturer of medical devices, it is always necessary to use FMEA as a favorite procedure for risk analysis (more precisely: risk analysis) in order to analyze the effects that may involve the exchange or modification of a component.

It is possible to apply the FMEA to individual components consisting of subcomponents.

Famea components is not a risk analysis!

However, this form of FMEA does not need risk or risk analysis because the “FMEA component” does not discuss threats as an impact, but the bad conduct of the component on its “external edge”. As for the medical device, this bad conduct can be caused by an error within the component or by a defective input on this component.

In other words, the FMEA component is not a risk analysis because it does not examine the consequences in the sense of dangers or damage, but in the sense of a defective component. So it can only analyze the bad external conduct and their probability – that is, the (unwanted) effects. Therefore the analysis of the effect of the error mode of the name.

c) in production

The same applies to the analysis of bankruptcy and effects in production: this is not a risk analysis procedure because it does not study any damage or probability following production errors, but errors in the product produced or in a component of the product (following a production error).

In the process or in the production FMEA, the manufacturer examines the process or production phase for the process or production phase. The effects of possible errors are analyzed for each of these steps. Possible “visible” errors are:

• Physical nature, chemistry or incorrect biological of the component
• The components transmit information or data (too little, too, too early, too late, wrong order, etc.)
• The components release energy or materials (too little, too much, too late, a wrong place, etc.)

Knowing the probability of which errors in the product lead to incorrect production helps to precisely estimate the probability of the error in a component in a component.

d) as part of the QM system

In addition to the production, the QM system determines further processes and procedures with which organizations develop products and services and make it available for customers. Consequently, the analysis of fashion and the effect of bankruptcy can be transferred to other processes.

She answers the question “What happens if …?” That is, if a process phase or activity does not take place in accordance with the specifications or does not provide the desired result for another reason.

The method continues to pursue the chain of causes up to the result of the process, possibly even up to the risks for patients, users and third parties or risks for the compliance of the company.

2. Suggestions for the use of FMEA

a) fulfill the essential prerequisite: a documented system or software architecture

Contrary to the PHA, the FMEA requires system architecture or software architecture. Only when you documented these architecture, you know the individual components. Only with an architecture can you understand how a mistake in one of these components affects the general system (medical device).

The architectures should not only show which other components have interacted a component, but also how this interaction takes place. In order to apply a FMEA, you must know which one

• Data/information,
• Materials or fabrics or
• Energy

It can transmit a component to the next. At the “data interfaces” you should be able to find this information on the specification of the component.

b) Documes the results in the Tabular

The manufacturers of medical products usually document the risks in a tabular way and do not correctly call this “FMEA table” table. This term is misleading because the table is suitable for the results go Document the risk analysis procedure (e.g. that of the analysis of the failure, FTA). This table regularly has the following columns:

• Id
• Component/input
• Error in the component/input
• Inner chain of causes
• Misconduct external conduct
• Extinction
• Probability of the damage
• Gravity of the damage
• Risk before measures
• etc.

Also in this table, producers usually also document measures to take risks.

c) combine fmea with hazop

In order to systematically identify a possible poor input or components, the FMEA can be combined with the Hazop analysis. IEC 61882 describes this procedure. Does it work with key questions like “too early?” “Wrong order?” “Too fast?” etc.

3. Advantages and disadvantages of the FMEA

a) Advantages

Fmea has the advantage of being a very systematic process. With a given system or software architecture, it is possible to examine each component and therefore “check off”.

This process is easy to understand and corresponds to the way of thinking about many developers who can start with “their” component.

b) Disadvantages

The FMEA is not suitable for examining and describing the logical connections many errors. The analysis of the faults (FTA) is suitable for this.

Based on a FMEA, it cannot be evaluated how granular components should be analyzed. Many producers of medical devices suffocate in “risk tables” with hundreds and thousands of lines.

Since developers can use this method well, they are often transferred to the analysis at a complete risk. However, the developers – in their role as a developer – are neither qualified nor suitable.

Many manufacturers apply FMEA using the RPZ risk priority number. This definition of the term risk does not correspond to that of ISO 14971. Read more about this problem here.

4. Conclusion and summary

The error mode and effect analysis is a method that should be used in risk management. ISO 14971 presents this method as one of the most important.

In different sectors, the FMEA is used and indicated in a different way. In the automotive sector, the “bankruptcy methods” identified act as input for the actual risk analysis. On the contrary, FMEA is often used as a method in the medical world to identify risks and not only the “bankruptcy methods”.

Regardless of the approach that the producers are pursuing: they must keep track of the chains of the causes up to the actual damage and estimate their potential difficulty and probability. This is exactly what the risks are.

Change the story

• 2025-05-14: only small editorial changes such as integrated missing connections
• 2023-10-02: example in chapter 1, chapter 1.d) and summary (chapter 4). Editorial changes.
• 2020-10-20: first version created

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