Failure mode and effects analysis (FMEA)

FMEA has become increasingly important in modern industrial companies due to the growing complexity and networking of products, processes and systems. New technologies require even more careful risk analysis and assessment. By understanding potential risks that FMEA uncovers and taking corrective action, companies can develop innovative products and processes that meet customer requirements and expectations.

FMEA - An indispensable tool for systematic error prevention

A failure mode and effects analysis (FMEA) is a quality management tool. It is carried out during development and aims to systematically identify, evaluate and ultimately avoid possible errors. There are different focal points and variants of an FMEA. As a rule, a distinction is made between design FMEA, process FMEA and, if applicable, system FMEA.

While the D-FMEA considers product risks from a conceptual perspective (design) as early as possible, the P-FMEA focuses on the process side of production. Therefore, the P-FMEA can usefully build on the D-FMEA. On the one hand, the D-FMEA provides the basis for early and continuous reduction of product risks on the part of development and, on the other hand, for the selection of suitable quality assurance measures such as end-of-line tests in production as part of the P-FMEA. An S-FMEA, on the other hand, focusses on the system with regard to the interaction of its system elements, the interfaces between them and the system in the context of its environment.

FMEA - An indispensable tool for systematic error prevention

A failure mode and effects analysis (FMEA) is a quality management tool. It is carried out during development and aims to systematically identify, evaluate and ultimately avoid possible errors. There are different focal points and variants of an FMEA. As a rule, a distinction is made between design FMEA, process FMEA and, if applicable, system FMEA.

While the D-FMEA considers product risks from a conceptual perspective (design) as early as possible, the P-FMEA focuses on the process side of production. Therefore, the P-FMEA can usefully build on the D-FMEA. On the one hand, the D-FMEA provides the basis for early and continuous reduction of product risks on the part of development and, on the other hand, for the selection of suitable quality assurance measures such as end-of-line tests in production as part of the P-FMEA. An S-FMEA, on the other hand, focusses on the system with regard to the interaction of its system elements, the interfaces between them and the system in the context of its environment.

Each indicator has its own scale of 1...10 points, with a high value indicating a particularly severe impact, a high probability of occurrence or a low probability of detection. In order to objectify the classification, evaluation catalogues are used or reference statements on the respective scores are defined in advance.

The risks can be prioritised on the basis of these assessments. By defining measures, implementing them and adapting concepts or gaining experience, the risks can be gradually reduced. This is reflected in the updated status of measures and a correspondingly adjusted assessment. It is therefore a ‘living document’.

The composition of an FMEA team

A successful FMEA team should consist of different roles and functions to ensure a holistic perspective and the necessary expertise. The typical composition includes the following members:

Wiki FMEA final Figure
Figure: Crossfunctional FMEA team

Core team

  • Project manager: Initiates the FMEA, plans and coordinates the activities, provides resources
  • Responsible for implementation (e.g. developer, designer): Procures documents, organizes processes, defines topic boundaries and interfaces, bears responsibility for the result
  • Moderator/method specialist: Leads the meetings, ensures the correct application of the FMEA methodology, trains the team
  • 4-6 core team members: Contribute product, process and FMEA experience, collect information, work on profitability calculations

Extended team

  • Specialist experts from relevant areas such as engineering, production, service, purchasing, customers, etc. with specific expertise

The core team carries out the system analysis, while the extended team is called in as required to provide additional expertise. The multidisciplinary composition ensures that all necessary competences and perspectives are represented in the risk analysis process.

Why is an external moderator so important when conducting an FMEA?

An external moderator brings an unbiased and neutral perspective to the process. He is not part of the actual project team within the company, but can also be provided from outside the company. This enables them to carry out an open analysis, promotes open discussions and prevents personal preferences or conflicts of interest from influencing the results.

Internal employees are often busy with their regular tasks. An external moderator can concentrate fully on the FMEA and drive the process forward quickly. This saves time and resources as no internal capacities are tied up.

The external moderator acts as a neutral authority and can steer discussions, defuse conflicts and promote constructive collaboration in the multidisciplinary team. He asks the right questions, brings in new perspectives and integrates the knowledge of all those involved.

Overall, the use of an external FMEA moderator helps to increase the quality and effectiveness of the risk analysis and ultimately to develop more robust products and processes.

Blocks

Meaning

The significance (S) in an FMEA assesses the severity of the impact that a potential failure can have in terms of functional fulfilment, safety, conformity and impact on the customer. It helps to prioritize failure handling and focus resources on the most critical failures. It is typically rated on a scale from 1 (very low impact) to 10 (catastrophic impact). The higher the importance rating, the more critical the consequences of the error.

Probability of occurrence

The probability of occurrence (O) in an FMEA assesses how often a potential cause of failure can occur. It is typically rated on a scale from 1 (very low probability of occurrence) to 10 (very high probability of occurrence). For example, a low rating indicates a low risk of error due to known and robust concepts or well-controlled processes. For a more objective assignment of the respective risk to a key figure, reference statements are formulated in an evaluation catalogue or failure figures are assigned to the points.

Probability of detection

The probability of detection (D) indicates the probability of a defect being detected before it reaches the customer. It depends on the defined detection measures and their effectiveness. It is therefore not a question of whether the customer himself would notice a defective component or a malfunction, for example, but how effective the detection measures of development (validation, testing, etc.) or production (production-side quality assurance mechanisms) are.

Risk priority number

The risk priority number (RPN) is calculated by multiplying the three values B, O and D. It is therefore between 1 and 1000. As the RPN alone is only suitable for comparing individual risks with each other to a limited extent, risk matrices with a traffic light system for the resulting fields from the respective combinations (S-O; S-D; D-O) are often used as a reference (green, yellow and red area - depending on the value of the key figures). Based on this, the so-called action priority (AP) can also be determined in accordance with AIAG and VDA.

Action priority

The action priority (AP) is used to prioritize the risks among themselves and assign a recommendation as to whether measures must, should or can be taken. The individual coordinates of the three possible risk matrices (S-O; S-D; D-O) are colored red, yellow or green according to a traffic light logic. This results in one color per matrix for each risk. All possible color combinations are listed in the risk matrix table and assigned a risk matrix rank between 1...27 and a task priority (low, moderate or high).

Conclusion

As a result, an FMEA is a living instrument that is used during development. The technical risks are made more transparent and thus more manageable. Product safety is systematically increased with the consistent implementation of detection and avoidance measures based on it.

Your benefit

  • Early error detection and avoidance
  • Improvement of product and process quality
  • Increased safety, especially in safety-critical industries
  • Cost savings by avoiding rework, downtime, etc.
  • Proof of adherence to regulatory compliance standards
  • Competitive advantages through high-quality products and customer satisfaction
  • Enabling innovation by understanding potential risks
  • Systematic risk analysis and assessment for complex systems
  • Avoidance of reputational damage through error prevention
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