Using a Kanban Lifecycle for the Software Development

M

Marc_G

#1
Hello,

I am new in the field of medical software. My company manufacture software for in vitro diagnostic device.

We are thinking about using a kanban lifecycle for the software development, but it seems to be difficult to use it with 62304 and 21 CFR part 820.

Do you have any experience that could help me in the decision of using kanban or not ?

Thanks
 
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sagai

Quite Involved in Discussions
#2
i think you can forget it.
tasks can not be unified into the same size in sw developement, however it is a cornerstone in kanban.
moreover kanban is simply a cycle time optimization for discrete manufacturing. sw development is a non deterministic process.
br
Sz.
 
Last edited:

sagai

Quite Involved in Discussions
#4
it could be really deep :)

the result of the sw development is a source code (i mean what really touches the customer's wallet).
mostly it is distinguished from requirement engineering and treated differently than a requirement.
But in the reality the code itself nothing else than design documentation, more surprisingly it is also a specification, a specification for the compiler or a specification (for low level coding when using 0 and 1 only) for the microprocessor.
Okay, than coming back to more specifically to your question.
The sw development, which results the code, is non deterministic, because 1oo% surely if you give companies the same specification, they will not produce the same source code or the same specification for the microprocessor.
In contrast, when there is a discrete manufacturing specification, surely the end product will be the same. (or you can fire the one creating something else :) )
br
Szabolcs
 
Last edited:

michellemmm

Quest For Quality
#5
it could be really deep :)

the result of the sw development is a source code (i mean what really touches the customer's wallet).
mostly it is distinguished from requirement engineering and treated differently than a requirement.
But in the reality the code itself nothing else than design documentation, more surprisingly it is also a specification, a specification for the compiler or a specification (for low level coding when using 0 and 1 only) for the microprocessor.
Okay, than coming back to more specifically to your question.
The sw development, which results the code, is non deterministic, because 1oo% surely if you give companies the same specification, they will not produce the same source code or the same specification for the microprocessor.
In contrast, when there is a discrete manufacturing specification, surely the end product will be the same. (or you can fire the one creating something else :) )
br
Szabolcs
Thank you.
Currently, I am involved with documentation of a project in accordance with DO178B. The guideline that was given to us by our customer for SDD is : the document to be written in such a manner so that...for two programmers develop almost identical source code as long as they follow the software standards. I am not sure if this is practical or possible or deterministic?
 

sagai

Quite Involved in Discussions
#6
Hi Michelle,
I do not think when there is a common programming guideline the two developer will develop the same source code. Surely they have different resolution patterns in their mind due to different education, culture, etc., and grow up background. Even twins not likely develop the same source code regardless they had the same environment and education background.
In your case the reason could be the voting approach.
When there are two (our even more) source code developed based on the same requirement set but by entirely separated developers (or companies), than the verification of proper operation above of the "traditional" verification way could be that these programs (with the same functionality) incorporated into a framework program and typically in real time decision system, all the individual program proposes a decision but the final accepted decision will be the majority decision of the proposed ones.
I do believe sw development is non deterministic as long as human does that.
br
Sz.
 
Last edited:
M

Marc_G

#7
My point about kanban is more about using lean and agile software development practicies and not to have the capacity to reproduce the same software.



But seeing the 62304 added with the part 820 prescriptions, it seems difficult to manage project with these practicies.




I found an interesting link from at the bottom of the kanban wikipedia page.


"Software Engineering Radio, Episode 156: Kanban with David Anderson"
 

sagai

Quite Involved in Discussions
#8
IEC62304 and 21CFR820 is not about project management. (there are very minimal requirements for that, mainly on the area of planning)
Project management can be any method, waterfall, agile, etc.
br
Sz.
 
A

ab001

#9
My point about kanban is more about using lean and agile software development practicies and not to have the capacity to reproduce the same software.



But seeing the 62304 added with the part 820 prescriptions, it seems difficult to manage project with these practicies.




I found an interesting link from at the bottom of the kanban wikipedia page.


"Software Engineering Radio, Episode 156: Kanban with David Anderson"
The way I understand Kanban is
A Kanban is a standing order used to make only the right amount of widgets at the right time. For example, please make 100 widgets to refill this bin. (where having a full bin means production can continue)
Well-planned, properly designed Kanbans have very little management overhead and very little time delays.
Please make 100 lines of code doesn’t quite make sense.

I thought Agile/Scrum had the concept of a working build. This working build is similar to a Kanban (as sagai said earlier, code is different to widgets)
Please make a working build that satisfies requirement 1
Please make a working build that satisfies requirement 1 and 2
Etc.

Keep using the local terminology. Adding another Japanese word won’t necessarily help.
If you want Lean in software development, look for Seven Wastes in Services.
 
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