Challenges in practise
Consistently conducted FMEAs are required in many areas and are subject to various regulations, in particular the harmonised AIAG-VDA method description. FMEAs are mandatory in the automotive, aerospace and GxP industries in particular, as well as for defence equipment and medical products - in some cases at every delivery stage.
Today, the specifications according to the FMEA harmonisation of the German Association of the Automotive Industry VDA and the Automotive Industry Action Group AIAG have become established as the standard.
Solution QS1
In principle, FMEA is useful for every company: Failure modes and their possible effects can be recognised at an early stage and allow you to react to the possible causes during your inspection planning. QS1 allows you to map production control plans / FMEAs and inspection plans in any modular form without redundancy: FMEA sub-trees = inspection plans.
At part number level, all FMEA sub-trees are cumulated in a central knowledge database. Based on this ‘single-circuit system’, actual failure from the failure analyses (CAPA) of deviation management are of course automatically compared with the knowledge database or mirrored in your existing FMEAs - and this is also the case for the FMEA sub-trees.
The ERP production structure data such as parts lists/recipes and operations/activities are available to you online and allow you to carry out the individual FMEA steps directly at the level of this ERP structure data for both design FMEAs and process FMEAs.
- Redundancy-free: Recurring FMEA structures are managed redundancy-free as a subtree and assigned to processes and/or part numbers. (‘modular system’)
- At part number level, all sub-trees are cumulated in a central ‘knowledge database’.
- Integration of inspection planning: Joint assignment - inspection plan and FMEA can be assigned to processes and/or part numbers in a joint process.
- Monitoring and system response (‘FMEA-MSR’)
- Comprehensive options for failure analysis (optionally with failure network or failure tree)
- Failure tree calculation
- Variant matrix
- Documentation of cause/effect relationships
- Risk assessment according to various methods
- Version management and historisation
- Comprehensive risk assessment including measure management
- Support for the component function matrix
- FMEA cover sheets as management information
- Comprehensive statistical analyses (Pareto analysis, difference analysis, frequency analysis, completion analysis)