Why did you believe this change was acceptable?

PDSLTell me, what’s going on?

PMI wanted to reach out for your input on this project.

PDSLOh, that one where you were changing the dimensions of the product? Yeah, I don’t have anything to assess.

PMHow? You never answer like that.

PDSLLet me explain. The intended use for this legacy product has never defined a specific need tied to the accessory. If you change a dimension there, that doesn’t necessarily mean that the product will stop working.

PMRight, but I don’t think that’s necessarily true.

PDSLTrue, but let me add something. Even though the design output is changing, it is not connected to a design input. So, what exactly should I send out for testing if I don’t have a defined change—at least on paper?

PMSo, another engineer told me that I had to test for shelf life.

PDSLYeah, but here the risk assessment is saying that this defect is caused by a material change. And as far as I know, that hasn’t happened, right?

PMRight.

PDSLI don’t agree with the conclusion provided. What I can say is that I also cannot determine whether the risk profile is changing. I could assume that it is, but I don’t know whether it is changing for better or worse.

PMSo, does that mean I don’t have to follow the product development process?

PDSLNot necessarily. It means that someone else needs to call out the decision. I’d rather have RA input on this because, if I follow the guidance, at least in my mind, I would have to perform some sort of assessment given that I don’t know how the risk profile is changing. What I can say is that RA would want evidence. But let RA decide.

PMI mean, if we didn’t have to follow the PDP, that’d be great; that reduces the timeline a lot…

PDSLNow, there’s another problem.

PMWhat is it?

PDSLIn sustaining, who would stop you from changing anything?

PMWhat do you mean?

PDSLSo, if I have an output that is not connected to an input, what would prevent anyone from changing anything?

PMI’m not following you.

PDSLSo, let’s say you transfer this to manufacturing. Right? If manufacturing suddenly finds that they’re unable to manufacture for whatever reason, anyone can come and say, “I need to change a dimension.” How could I constrain that change if I don’t have an input?

PMOh, I get it.

PDSLI’ll conclude with the following. I won’t redo the risk file just because you guys found a gap. I won’t necessarily ask you to test something you have not defined. But I’ll ask you to host a design review to decide, because in the end the question becomes: