Risk and quality planning

Process FMEA Risk Analysis

Connect process functions, failure modes, effects, causes and current controls, then prioritise prevention and detection improvements with accountable actions.

Purpose and method

Evaluate potential failures, effects, causes, controls and required risk-reduction actions.

When to use it

Use FMEA before launch and during process, product or equipment changes to prevent failures proactively.

Core principle

FMEA is a living preventive analysis, not only a score table. Severity belongs to the effect, occurrence to the cause and detection to the current control capability.

What the interactive module provides

  • Failure-mode table
  • Risk priority evaluation
  • Action ownership and reassessment
  • structured PFMEA, risk priorities, action plan and revised residual risk
Professional verification: The module supports learning, analysis and documentation. Verify results against actual process conditions, internal standards, safety requirements and competent professional judgement before implementation.
01

Recommended workflow

Connect process functions, failure modes, effects, causes and current controls, then prioritise prevention and detection improvements with accountable actions.

  1. 1

    Define process functions and measurable requirements

  2. 2

    Identify failure modes and credible effects

  3. 3

    Analyse causes and current prevention/detection controls

  4. 4

    Rate risk consistently and select priority actions

  5. 5

    Implement actions, verify them and update the FMEA

02

Practical example

A missing projection weld can reduce structural strength. The team separates the cause “nut not seated” from the failure mode and adds part presence prevention plus force monitoring.

Calculation or verification principle

Traditional RPN = severity × occurrence × detection. Use the organisation’s approved scales and action-priority logic; identical RPN values can represent very different risks.

Required inputs → Expected outputs

Required inputs
process steps, functions, requirements, failure modes, effects, causes, controls, ratings, actions and responsibility
Expected outputs
structured PFMEA, risk priorities, action plan and revised residual risk
03

Common mistakes to avoid

×

Writing a cause as a failure mode

×

Reducing severity without changing the effect

×

Crediting an inspection that cannot detect the cause or mode

×

Re-scoring before the action is implemented and verified

04

Frequently asked questions

What data do I need to use this tool?

Prepare process steps, functions, requirements, failure modes, effects, causes, controls, ratings, actions and responsibility.

What result does the module produce?

The module produces structured PFMEA, risk priorities, action plan and revised residual risk.

Can I implement the result without further review?

No. Treat the output as a structured engineering and improvement aid. Verify source data, assumptions, safety, quality, legal requirements and local process conditions with competent responsible people before implementation.