The new FMEA standard is a reality: here’s what’s changing for your organization

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Change 1: the 7-step method including Planning & Preparation

The new directive differs from the old directive in a few key ways. The first salient change is that a so-called 7-step method is very explicitly used to prepare an FMEA. The seven steps provide a more structured, as well as a more effective and efficient approach to FMEA within your multidisciplinary team. And the first step it mentions is particularly notable: Planning & Preparation. The fact that this is named as the first step – as well as indicating the importance of that step – is a big step forward. Still many organizations want to start an FMEA from scratch, whereas planning and preparation is essential. With the new directive, this is tackled – but it is still something to consider.

Change 2: the five T’s, baseline FMEAs and roles

In addition to that planning and preparation, the guideline also pays attention to how to do it. Thus, the guideline launches five T’s: InTent, Timing, Team, Tasks and Tools. Next, the new directive directs working with so-called foundation FMEAs. This involves preparing a basic FMEA for a particular family of products. You keep these up-to-date by continuously making the latest changes (aka: lessons learned) to them. If you then start a new FMEA within this product family, take the foundation FMEA as a starting point. The new guideline also addresses the roles that different people within your organization should play to make it easier to create better FMEAs. Four different roles are distinguished, namely management, technical lead, facilitator and team members. For all these roles, the new guideline provides “tips and tricks,” for example, on how management can provide the right framework conditions.

Change 3: the disappearance of the RPN

Also disappearing is the Risk Priority Number (RPN) as an assessment criterion for risks. Three criteria were previously used to weigh the risks relative to each other: Severity, Occurence and Detection. The rating of those three was multiplied together to a number between 1 and 1000 – the higher the number, the higher the risk. This method had drawbacks, including that all three numbers weighed equally. However, the industry – that is, your customer base – places more value on preventing problems (Occurence) than detecting problems (Detection). After all, the moment an error is discovered, there is already a lot of value in the product. This results in a higher cost of the product, since that error must be adjusted. The new guideline responds to industry demand to place more value on low Occurrence than good Detection. How? By adding a fourth table: Action Priority. From this table rolls…

• H: high priority (something must be done or you must justify why you choose not to do anything about it),
• M: a medium priority (preferably you take action, but if you choose to do nothing about it then you decide whether to write a justification for this) or
• L: a low priority (action may be taken, but the choice is yours).

Change 4: an updated FMEA form

Following this, the valuation tables for Severty, Occurence and Detection were also adjusted. Specifically, the interpretation of some terms has changed, as has the format of the FMEA form. Therein also lies an immediate disadvantage, as the form goes from about twenty to more than thirty columns. That doesn’t make it any easier, especially when creating FMEAs with Excel.

FMEA in Excel

A tip in between: does your organization also use Excel instead of dedicated software to perform FMEAs? Symbol is busy finding a practical approach for anyone who would like to continue working in Excel and not make the switch to software. Please feel free to contact us so we can work with you on a solution.

Change 5: FMEA-MSR

Finally, in addition to the Design FMEA and the Process FMEA, the FMEA-MSR is now described in the guideline. Here, MSR stands for Monitoring and System Response. The FMEA now also considers how the system (car) handles the potential faults identified in the DFMEA and the extent to which these faults can be detected in a timely manner. The FMEA MSR is an important addition to the functional safety guideline: ISO 26262.

The new FMEA standard: do you delve deeper into it or not?

You read it: a lot is changing. A lot. Of course, you can choose not to delve further into these changes – meeting the AIAG-VDA FMEA standard is not mandatory, the IATF16949 directive does not specifically require it. But not delving into it is unwise. Your customers expect you to implement the new directive, and so you still have to comply with it via customer specific requirements. It is therefore essential that you know the new guideline well, because sooner or later you will be confronted with it.

This blog was written by FMEA specialist Nicole Mak, owner of smartFMEA and experienced trainer at Symbol.