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Hi all!
I'm the Usability Engineer of my team, brand new to the industry, the company and the position, and we're currently designing a hand held and operated device. It has a simple interface with just a couple of buttons and two light bars, but it has some nice potential hazardous situations.
I've performed a function and task analysis and with the aid of a couple more analytical studies I've come with a comprehensive UFMEA that complies with our internal standards.
I'm starting to write the V&V plan for this project but I'm kind of lost on the process. The 62366 only says that a plan should be presented and then it starts talking about verification tests.
I've written usability test plans before, but as I understand this, the standard means that I need to write a project plan, which will also include the individual test plan or plans depending of how many tests I make. I've also written project plans before but for something completely different, so I don't know if that'd be the proper thing to do.
I hope you guys can help me here to learn more about what info or sections such plan should have.
Then, as part of such planning, I'm starting to write the Usability Specification, in which I understand I need to put the usability evaluation criteria. My problem here is that even though the standard (and other people in this forum) indicate that one should write Usability Goals, the FDA does not recognize such a thing as "Usability Goals". It doesn't even recognize the example shown in annex G (I'm new to the forum so I can't post links, but if you go to the FDA Recognized Consensus Standards Database and search for 62366 you'll see what I'm talking about).
So I'd really appreciate your advice on how to write my usability evaluation criteria, added to your kind advice on how to write the V&V plan.
Many thanks!!
Oscar
I'm the Usability Engineer of my team, brand new to the industry, the company and the position, and we're currently designing a hand held and operated device. It has a simple interface with just a couple of buttons and two light bars, but it has some nice potential hazardous situations.
I've performed a function and task analysis and with the aid of a couple more analytical studies I've come with a comprehensive UFMEA that complies with our internal standards.
I'm starting to write the V&V plan for this project but I'm kind of lost on the process. The 62366 only says that a plan should be presented and then it starts talking about verification tests.
I've written usability test plans before, but as I understand this, the standard means that I need to write a project plan, which will also include the individual test plan or plans depending of how many tests I make. I've also written project plans before but for something completely different, so I don't know if that'd be the proper thing to do.
I hope you guys can help me here to learn more about what info or sections such plan should have.
Then, as part of such planning, I'm starting to write the Usability Specification, in which I understand I need to put the usability evaluation criteria. My problem here is that even though the standard (and other people in this forum) indicate that one should write Usability Goals, the FDA does not recognize such a thing as "Usability Goals". It doesn't even recognize the example shown in annex G (I'm new to the forum so I can't post links, but if you go to the FDA Recognized Consensus Standards Database and search for 62366 you'll see what I'm talking about).
So I'd really appreciate your advice on how to write my usability evaluation criteria, added to your kind advice on how to write the V&V plan.
Many thanks!!
Oscar
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