Design Input & Output in Stages - Overkill?

sagai

Quite Involved in Discussions
#11
Hi Mike,

i am not really understand this problem.
DI/DO clearly defined in ISO13485 and ISO/TR 14969, and for US in the Design Control Guidance.

br
Sz.
 
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K

kgott

#12
I happen to agree with you. The ISO 9001 standard is written in cryptic language in some regards and I find your translation of the design requirements to be very usefulll, unless I too have failed to understand the design process.
 
M

mr.mike

#14
Hi Sagai,
The question stems from what the intended purpose of DI/DO is. In otherwords, not just to fulfill ISO13485 requirements, but to actually have a document that traces design decisions in a meaningful way.

Basically, I'm just proposing a modified DI/DO document format that actually traces how outputs from one stage of the design process feed into the next stage's inputs (rather than just have the initial inputs, and final outputs as would be in a typical DI/DO doc).

To me, this would be a much more meaningful design document...
 

sagai

Quite Involved in Discussions
#15
Actually I do not think the DI/DO definition makes too much practical benefit for the company, well, if there was not even a recognition of these principles than certainly does, but not even in a medium term. So basically it is a regulatory thing for me.
However, more useful guidance I had found for requirement engineering is in CMMI, you also can have it for free @ http://www.sei.cmu.edu/library/abstracts/reports/10tr033.cfm
I would suggest, in case already it was not know, the Requirement Development and Requirement Management process area defined in that book.
br
Sz.
 

somashekar

Staff member
Super Moderator
#16
Hi Sagai,
The question stems from what the intended purpose of DI/DO is. In otherwords, not just to fulfill ISO13485 requirements, but to actually have a document that traces design decisions in a meaningful way.

Basically, I'm just proposing a modified DI/DO document format that actually traces how outputs from one stage of the design process feed into the next stage's inputs (rather than just have the initial inputs, and final outputs as would be in a typical DI/DO doc).

To me, this would be a much more meaningful design document...
Each of the design and development sub processes have input and output that feed further in the direction of design completion to become design deliverables.
This has to be mapped in the 7.3.1 - The design and development planning
7.3.2. (input) >>> design and development core process per plan >>> 7.3.3 (provisional output)
7.3.3 (provisional output) >>> 7.3.4 >>> 7.3.5 >>> 7.3.6 (loop many times) >>> 7.3.3 (Release output)
7.3.3 (Release output) >>> changes input > review > verify > validate per 7.3.7 >>> 7.3.3 (Changed release output)
 

sagai

Quite Involved in Discussions
#17
It becomes a complete chaos when you are about to have an iterative development method like Agile and Scrum or XP, there is no exact definition how you should define DI/DO from regulatory sources in that case, and at the end of day we can be happy to have a partial agreement on that subject.
br
Sz.
 
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