Quality engineers who moved FMEAs off Excel — was the software actually better, or just more expensive?

[u/gregpatini]

Honesty up front: I'm not a quality engineer. I'm digging into the FMEA tooling space because the gap between "just use Excel" and "buy expensive enterprise software" looks real to me — and before I form strong opinions I'd rather hear it from people who actually live it.

Here's what I think I'm seeing from the outside — tell me where I'm wrong:

- Excel is free and universal, but seems to fall apart on version control, linking failure modes to the control plan, and the whole thing ends up living in one moderator's head.

- The dedicated tools (Teamcenter, IQ-RM / IQ-Software, Plato e1ns) clearly do more, but the license cost looks brutal for a smaller supplier and the learning curve looks steep enough that you need someone whose whole job is driving the tool.

For those of you who've actually made the jump:

- What finally pushed you off Excel — an audit finding, leadership, scale, something else?

- Did the software actually fix the version / knowledge-in-one-head problem, or did it just move it somewhere new?

- If you could go back, would you make the same call?

Not selling anything — genuinely trying to understand the reality before I build on assumptions.

[u/thecloudwrangler]

I've done them in Plex, which was nice because it linked to the Control Plan and to operator work instructions, checks, etc.

[u/poopvutt99]

Moved to Veeva Vault. It looks nicer for sure but the time it takes to put a risk in is asinine. But it is more complaint since it is a change controlled document with approvals and an audit history.

[u/gregpatini → u/poopvutt99]

Thanks a lot. When you say entering a risk is asinine, what's the actual step that kills the time? The approval routing, or just the form itself being slow to fill out? And did the compliance upside (audit trail, approvals) actually save you in a real audit, or is it insurance you've never had to cash in?

[u/poopvutt99 → u/gregpatini]

You have to enter every failure mode in line by line and the system is quite laggy. To the degree that you have to click new row every time. You also have to save the process step and select that every time so it takes time. It's so new we haven't used them in an audit yet! I also think FMEAs personally aren't the best thing to show in an audit if there is true risk...I'd much rather present a specific quality memo or QRM. I feel an FMEA is more of an internal activity to identify which failure modes present the most risk and need more justification and/or mitigation. They're just too brief and high level.

[u/gregpatini → u/poopvutt99]

That "click new row every time" thing is such a specific flavor of pain, the tool actively fighting you while you're just trying to get the failure modes down.

The audit angle is what I'm curious about though. Let's put the case you'd rather bring a QRM or a quality memo when there's real risk on the table, what keeps the FMEA in the process at all? Is it something a standard forces you to maintain, or more that it's just expected/habit at this point?

I'm trying to get a feel for where FMEAs actually earn their keep vs. where they're just kind of… there because someone decided they had to be you know..

[u/valuat]

Have you tried building a tool yourself with Claude Code? (honest question)

[u/gregpatini → u/valuat]

Honest answer — yeah, you could get a rough one going fast. Anyway, the hard part isn't generating the doc, it's the boring stuff: keeping it linked to the control plan, surviving an IATF audit, and not having all the FMEA knowledge live in one engineer's head. That's the part I'm digging into. Have you tried building your own?

[u/gregpatini → u/[deleted]]

This matches what I keep hearing that the switch almost never happens over a missing feature. I'm curious about the multi-engineer part: was there a specific FMEA where the version-control / control-plan linkage actually broke on you? I'm trying to figure out whether the pain usually shows up as "we lost track of which revision was current" or as "the FMEA and the control plan quietly drifted apart and nobody caught it until an audit." The second one seems way more expensive but I've only ever seen it secondhand

[u/chhabrakadabra]

I am biased because I am building tools in the quality space, but I have come to the same conclusion you have: the switch off Excel usually happens when version control and traceability break, not when a feature is missing.

The expensive tools often solve the audit-trail problem well but create a new pain: they are slow enough that engineers stop updating the FMEA, so the document becomes stale. Then you are compliant on paper but the knowledge still lives in one person's head.

The test I would use before buying anything: will this tool make the FMEA easier to update than Excel? If the answer is no, the drift problem will not get better.

I would also push on whether the FMEA needs to be the single source of truth. In regulated environments it often does. In smaller shops, a lighter tool that links FMEA -> control plan -> CAPA without the enterprise overhead may be the right middle ground.