Design Input/Output Form - Your feedback appreciated

R

Randy-BCEC

#1
I am in the process of revamping our design controls and I want to get feedback on a format that I have used in the past. I like this format because it allows me to match my design input to the source of the input to the design output and finally to the verification record. And by adding a letter at the end of the design input number, I can track changes made at each design review.

I am hoping to get some feedback on the categories. I really like breaking the design inputs down into general categories to make it easier to complete fully. Since I don't have any copies of previous design input forms, I am not sure if I have enough or the right categories on the list. Please let me know what you think.

Randy
 

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Marcelo

Inactive Registered Visitor
#2
Re: Design Input/Output Form

Hello Randy, and welcome to the Cove.

You might try to look at the example catrgorization of hazards as decribed in table E.1 of ISo 14971:2007. Although it was created with hazards in mind, it also can be used as requirements. I´m using tjem as a way to facilitate the interaction betrween product requirements and risk management.

By the way, how do you make this interaction?
 

jkuil

Quite Involved in Discussions
#3
Looks clean and simple. :applause:

You indicate drawings at verification records, however they are design output records.
For medical devices you also need to validate the design in addition to verification, especially when the design input requirement is indicated by your customer as critical to quality.
For the pad sizes you match them with competitor products. That comparison is your verification record. The pad sizes must also match the body surface to which your device will be applied. That is something you can validate: are users satisfied with the selected sizes.
 
S

sshankle

#4
I know I'm a few days late here, forgive me...

Nice job on the IOVV table. You should consider adding a column that is a simple checkbox or yes/no to indicate whether each output is essential or not... See 820.30(d):

"Design output procedures shall contain or make reference to acceptance criteria and ensure that those design outputs that are essential for the proper functioning of the device are identified."

Hope that helps. Good luck!

Scott
 
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