Minimise technical risks – before they become costly.

FMEA for manufacturers and suppliers

Audit-ready. Practical. Structured.

Effective FMEA workshops

reliable audits

Compliant with AIAG & VDA

ISO 9001
Free initial consultation:

Answer from an expert. No obligation. Free of charge.

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Status Quo

Why FMEA often doesn’t work

Are you familiar with the following issue in your company?

A lot of effort for little benefit

FMEA is only carried out for audits

Results are not utilised consistently

Uncertainty regarding AIAG and VDA requirements

Missing links, unclear assessments or the scope of measures

FMEA as an effective management tool

The right starting point for your situation

No one-size-fits-all package – we start where your greatest needs lie.

Quick start

Package 1

FMEA Review &
Audit Check

For organisations that wish to have their existing FMEA documents reviewed – before the auditor does.

1–3 days remote work possible low risk
  • Analysis of existing FMEA documents for completeness and plausibility
  • Assessment in accordance with the AIAG/VDA standard
  • Clear recommendations for action, with priorities set
  • Written review report as a deliverable
A major project

Package 3

FMEA System Design & Implementation

For organisations wishing to introduce a standardised FMEA system across the organisation.

Several weeks in-house including training
  • Establishment of a company-wide FMEA system
  • Definition of roles, timings, templates and interfaces
  • Integration into APQP, IATF and mass production processes
  • In-house training courses & trainer accreditation
  • Sustainable implementation – not just a one-off workshop exercise

Your benefits at a glance

AIAG/VDA-compliant right from the start. All steps implemented in accordance with the methodology – with no need for rectification prior to audits.

Audit-proof documentation from step 1 onwards. All FMEA documents are produced in such a way that they stand up to external and internal audits.

Can be integrated directly into your development processes. FMEA becomes part of the process, not just a mandatory step.

Keeping OEM requirements in mind. Meets industry-standard specifications – leaving no room for interpretation.

Core tools seamlessly integrated. FMEA embedded in APQP, Control Plan, SPC and other processes.

Ready-to-use templates and processes – including practical implementation guides.

Our aim was to lay the groundwork in the infotainment sector so that we could demonstrate our development and manufacturing expertise to BMW. QMH Consulting provided us with crucial support in this regard – particularly with the system audit, which was essential for taking part in the tender process.

NOBO Technologies
Customer Testimonial | Automotive

About QMH Consulting

Why companies work with us

We have been supporting medium-sized companies and corporate groups since 2010. Whether it involves setting up new systems, providing support during demanding audits or the continuous optimisation of existing processes – we combine methodological rigour with practical applicability.

Our aim is not simply to get you onto a certification course, but to put systems in place that will ease your workload and empower you in the long term.

QMH Consulting, About us, Team photo

Projects

Practical expertise from the automotive, medtech, electronics and mechanical engineering sectors

Years of experience

in quality management consultancy

Certifications

successfully completed

Consultant

with a wide range of qualifications

FMEA system structure at an international Tier 1 supplier

Industry: Automotive
Standard: IATF 16949 / AIAG/VDA
Company: International Tier 1, ~3,200 employees
Services: System Setup & Training
Duration: 6 weeks

Initial situation

Inconsistent risk analyses, varying assessment criteria and a lack of consistent integration into development and production processes.

Challenge

Standardisation of the evaluation logic whilst integrating it into existing IATF structures across three plants.

Implementation

Introduction of the 7-step methodology in accordance with AIAG/VDA, facilitation of structured risk analyses, training programme for internal facilitators.

Result

A standardised, audit-ready FMEA system across all three plants
Audit successfully passed – with no non-conformities
In-house facilitators have received long-term training

FMEA review prior to an OEM customer audit in the mechanical engineering sector

Industry: Mechanical Engineering
Standard ISO 9001 / VDA
Company: SME, ~480 employees
Service: FMEA Review & Optimisation
Duration: 2.5 weeks

Initial situation

Existing FMEA documents were rejected by the OEM customer – methodological gaps in the assessment logic and unclear derivation of corrective actions.

Challenge

A last-minute review ahead of the upcoming client audit in less than three weeks.

Implementation

Structured FMEA review in accordance with AIAG/VDA, revision of the rating scales, and plausibility checks on all measures.

Result

Customer audit successful – FMEA accepted without any objections
Valuation logic standardised on a long-term basis
Complaints rate reduced by 40 per cent in the following period

FMEA facilitation for a new medical device (Class IIb)

Sector: Medical Technology
Standard ISO 13485 / ISO 14971
Company: Scale-up, ~120 employees
Service: FMEA facilitation
Duration: 4 months

Initial situation

Development project for a regulated medical device without an established FMEA methodology – internal team with no experience of facilitating meetings.

Challenge

Development of a comprehensive design and process FMEA in parallel with the ongoing development process, under time pressure.

Implementation

External facilitation of all FMEA workshops, development of a systematic approach in accordance with ISO 14971, and close integration with the risk management file.

Result

Complete design and process FMEA for approval
Passed the regulatory audit without any additional claims
In-house team equipped to tackle future projects
1 / 3

Your guide to an audit that’s more than just a formality

1

Getting in touch

Personal

Please get in touch by email or telephone. We will clarify the key details, review your requirements and arrange an in-depth initial consultation.

Qualified & Free of charge

Together, we analyse your current situation: maturity level, existing FMEA analyses, software usage and objectives. On this basis, we determine which services will best help you achieve your goals.

Expert consultation & needs assessment

2

3

Project implementation & support

Audit-proof, practical & structured

Whether it’s facilitation, system implementation, review or training, when you choose to work with us, we’ll start with a agreed roadmap, clear responsibilities and a documented methodology.

FAQ – Frequently asked questions about collaboration in the field of FMEA

We already have FMEA documents. Could you review them?
Why have FMEAs facilitated by an external party rather than in-house?
How are standards maintained after the project is completed?
What software can you work with?
Can international teams take part in training courses?

We already have FMEA documents. Could you review them?

Yes – our audit services can be booked independently. Whether you have set up the system in-house, are working with another partner, or wish to maintain an existing certificate: we step in as and when required and carry out audits professionally, impartially and in accordance with the relevant standards.

Why should I have FMEA facilitated externally instead of internally?

Facilitating an FMEA requires methodological rigour, impartiality and experience – particularly when dealing with complex processes or diverse teams. External facilitation minimises friction, keeps the analysis on track and produces transparent results that stand up to both audit scrutiny and practical application.

How do standards remain in place after the project?

We provide targeted training for your FMEA cosultants. Our training courses are structured around specific roles: developers, quality managers, facilitators and managers each receive the content they actually need – highly relevant to their own day-to-day work and with a focus on practical application rather than theory.

What software solution can you work with?

Our consultants are well-versed in a wide variety of tool environments, including not only standard tools such as APIS and PLATO but also OEM-specific solutions. We adapt to your software structure, provide expert feedback on usability and, if required, also support you through tool changes or implementations.

Can international teams take part in training?

Yes. We offer training courses in German or English, including remote or hybrid options. We tailor the materials, practical examples and case studies to your target audience – suitable for use worldwide and consistent in their approach.

We already have FMEA reports. Could you review them? +
Yes – our audit services can be booked independently. Whether you have set up the system in-house, are working with another partner, or wish to maintain an existing certificate: we step in as and when required and carry out audits professionally, impartially and in accordance with the relevant standards.
Why should I have FMEA sessions facilitated by an external party rather than conducting them in-house? +
Facilitating an FMEA requires methodological rigour, impartiality and experience – particularly when dealing with complex processes or diverse teams. External facilitation minimises friction, keeps the analysis on track and produces transparent results that stand up to both audit scrutiny and practical application.
How are standards maintained after the project is completed? +
We provide targeted training for your FMEA leads. Our training courses are structured around specific roles: developers, quality managers, facilitators and managers each receive the content they actually need – highly relevant to their own day-to-day work and with a focus on practical application rather than theory.
Which software solution can you work with? +
Our consultants are well-versed in a wide variety of tool environments, including not only standard tools such as APIS and PLATO but also OEM-specific solutions. We adapt to your software structure, provide expert feedback on usability and, if required, also support you through tool changes or implementations.
Can international teams take part in training courses? +
Yes. We offer training courses in German or English, including remote or hybrid options. We tailor the materials, practical examples and case studies to your target audience – suitable for use worldwide and consistent in their approach.

Contact QMH Consulting

Request a consultation now

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Your QMH contact

Tim Wedel, Senior Consultant & Sales Tim Wedel
Senior Consultant

tim.wedel@qmh-group.com

The benefits of QMH

Industry expertise: Automotive & Manufacturing

Extensive industry knowledge and international experience

no freelancers or external service providers

Everything under one roof: preparation and follow-up

Over 20 years in business

Over 250 FMEA projects successfully supported