Risk management, thanks to the amendment of ISO 9001 in 2015, has become an element of organizational culture. This means, in practice, its translation into strategic, tactical and operational goals of the organization. It involves carefully defining risk management measures to take additional actions to manage and document risks. You can read more about risk management in the article here. Meanwhile, in this article, I would like us to answer one fundamental question: is FMEA in IATF 16949:2016 mandatory in the automotive industry, or does it result from other requirements, e.g. of the client?
What is the risk?
ISO 9000: 2015 in clause 3.7.9 defines risk as “the influence of uncertainty”. Further is this clause it is said that it is “the impact of uncertainty causing deviation from expectations”. Uncertainty, on the other hand, is defined as “a state, (…), lack of information related to the understanding or knowledge of an event, its consequences or probability”.
Therefore, risk is often presented as a combination of the event consequences and the associated probability of occurring.
FMEA in IATF 16949:2016 – why is it mandatory?
There is only one answer to the question posed in the introduction: FMEA in IATF 16949:2016 is mandatory to use in the automotive industry.
This is since this standard is based on risk, which appears in its content as many as 97 times! FMEA is a risk management tool, in particular product and process risk, from the design and development stage. Therefore, it must be a mandatory tool to even achieve the goal of the IATF 16949 standard, i.e. the elimination of defects and wastes in the supply chain.
In addition to the requirements of IATF 16949, FMEA is also required by OEMs, i.e. original equipment manufacturers in their specific customer requirements.
FMEA in IATF 16949:2016 – where can we find it specifically?
ATTENTION! Below, I present you only the 3 most important requirements about FMEA in IATF 16949. If you want to know more requirements that make FMEA mandatory, I invite you to the end of the article, where you can download the document with the full list of requirements.
126.96.36.199 Design and development outputs – supplemental
“(…) The product design output shall include but is not limited to the following, as applicable:
a) Design risk analysis (FMEA); (…).”
188.8.131.52 Manufacturing process design output
“(…) The manufacturing process design output shall include but is not limited to the following:
(…) g) manufacturing process FMEA; (…).”
184.108.40.206 Monitoring and measurement of manufacturing processes
“(…) The organizations shall maintain manufacturing process capability or performance results as specified by the customer’s part approval process requirements. The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented (…).”
Get the complete list of FMEA in IATF 16949:2016
I invite you to complete a quick survey. It is about “20 examples of incorrectly implemented FMEA according to AIAG-VDA causing nonconformity in IATF 16949 audits.”
In this survey I collected my experiences that I want to present to you. They can also be helpful for you in avoiding potential nonconformities during your IATF 16949 audit. However, I would like to hear from you if you have any other issues/observations while working with FMEA.
As a thank you gift I have prepared a complete list of FMEA in IATF 16949:2016 for you.
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Thank you for your presence.
Agata Lewkowska Ph.D.
PS. If I can help you with quality management issues, please contact me. You may also join me in my private group on Facebook: ISO 9001 & IATF 16949 QualityWise Group.
For people who want to know more:
IATF 16949: 2016 Requirements for quality management systems in serial production and the production of spare parts in the automotive industry, 1st edition, 2016
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
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 ISO 9000:2015 Quality management systems — Fundamentals and vocabulary, p.3.7.9