Solution
Risk analysis with FMEA
Design and process FMEA with control plans and actions that are followed up, instead of spreadsheets nobody opens.
The problem
FMEA is often done because the customer requires it, in a spreadsheet that is then not updated. The analysis then loses its value: preventing failures before they occur.
Relevant for: Quality
The context in production
Failure mode and effects analysis (FMEA) is used in product and process development to identify possible failures, their effects and causes in good time, and decide on preventive actions. Design FMEA (DFMEA) covers the product, process FMEA (PFMEA) covers manufacturing. The result leads on to control plans and inspections in production.
Why it matters
The later a failure is found, the more expensive it is: a failure found at the prototype stage costs a fraction of the same failure at the customer.
In the automotive industry, FMEA is part of the requirements in APQP and in production part approval for the customer.
In principle
From risk to inspection in production
FMEA links possible failures with effects, causes and actions. The control plan translates the risks into inspections: which characteristic, with which method, how often and what is done when the requirement is not met.
How does an FMEA work from failure to action?
IllustrationAn FMEA describes what can go wrong, what effect it has and why it happens, and rates the risk so that actions go where they do most good.
Step by step
- Failure mode: how the product or process can fail.
- Effect: what the customer or the next step notices. Rated as severity.
- Cause: why the failure occurs. Rated as occurrence.
- Action: prevent the cause or improve detection. Rated as detection.
- Actions are followed up and the analysis is updated.
How does a risk in the PFMEA become a check in production?
Illustration · Example dataThe control plan turns the risks into concrete checks: which characteristic, with which method and gauge, how often, and what happens when the requirement is not met.
Step by step
- A risk in the PFMEA concerns the length.
- The control plan specifies that the length is measured with a caliper on every part.
- The reaction plan says what is done if the length is outside: quarantine and sort.
From today to better
Common challenges, and what a better way of working looks like
What it often looks like
- FMEA in spreadsheets that are hard to keep consistent.
- Actions are decided but not followed up.
- The link to the control plan and inspections in production is missing.
- Analyses are not reused between similar products.
A better way of working
- A shared structure and method for all analyses.
- Actions with an owner and a status that are followed up.
- Control plans produced directly from the analysis.
- The option to copy and reuse analyses.
Rektron's approach
How we help
Rektron FMEA is a tool for DFMEA and PFMEA with method guidance, traceability and support for multiple users. Control plans and lists of prioritised actions are produced directly from the analysis. The tool has support for the AIAG & VDA methodology.
Capabilities used
DFMEA and PFMEA
FMEAStructured analyses with traceability, reuse and multiple users.
Read more →Control plans and action lists
FMEAControl plans and prioritised actions are produced directly from the analysis.
Read more →Support for the AIAG & VDA methodology
FMEAWorking according to AIAG & VDA, as requested in the automotive industry.
Read more →
The flow
How it works
- 01
Analyse
Functions, failures, effects and causes are structured.
- 02
Assess
Risks are assessed and prioritised according to the method.
- 03
Act
Actions are decided with an owner and followed up.
- 04
Control
Control plan and inspections are carried over to production.
What changes
- FMEA as a living tool instead of a box to tick.
- Actions that actually get done.
- A clear link from risk to inspection in production.
Read more
- Customers and references →
Companies that work with Rektron systems.
- The knowledge base →
The methods behind the solution, explained.
Technical information
- DFMEA and PFMEA.
- Formula validation, copying and reuse.
- Reports and control plans.
Knowledge
Concepts on this page
Related
Solutions that fit together
Next step
Want to see how risk analysis and FMEA can work for you?
Tell us about your process and your measurements. We will suggest a first step that suits your business.