Block Diagram - Requirements for a Block Diagram

K

KAMay

Hi Guys

I am currently working through my company's Technical File for a class II b medical device that we design and manufacture on site. We have had a CE mark on this product since 1995.

I am currently going through Technical File, 'tidying it up' and fixing some errors that were flagged as part of our audit's observations.

I have stumbled upon our 'block diagram' which is the most amazing mixture of different cliparts, over-sized arrows and random rectangles - it is so bad I'm actually quite amused (I wish I could post it for you to see) :lol:

ANYWAY, the point of my post - obviously we have received our CE mark despite this glorious picture for the past 15 years and it therefore it isn't an issue, but an outside customer has requested to see it and I would prefer it was redone before it was sent out (purely from a professional point of view) - obviously if I redesign it, I want it to be professional looking but also it has to have everything it is meant to have in it - Does anyone know what the requirements for the Block Diagram are? - does it need to have pictures/diagrams etc?

Thanks :)
 

Stijloor

Leader
Super Moderator
Re: Block Diagram

Hi Guys

I am currently working through my company's Technical File for a class II b medical device that we design and manufacture on site. We have had a CE mark on this product since 1995.

I am currently going through Technical File, 'tidying it up' and fixing some errors that were flagged as part of our audit's observations.

I have stumbled upon our 'block diagram' which is the most amazing mixture of different cliparts, over-sized arrows and random rectangles - it is so bad I'm actually quite amused (I wish I could post it for you to see) :lol:

ANYWAY, the point of my post - obviously we have received our CE mark despite this glorious picture for the past 15 years and it therefore it isn't an issue, but an outside customer has requested to see it and I would prefer it was redone before it was sent out (purely from a professional point of view) - obviously if I redesign it, I want it to be professional looking but also it has to have everything it is meant to have in it - Does anyone know what the requirements for the Block Diagram are? - does it need to have pictures/diagrams etc?

Thanks :)

What will be the purpose of the block diagram? Who will be the intended users/recipients?

Stijloor.
 
D

DrM2u

From what I recall, a block diagram (a.k.a. flow diagram) depicts the flow of information, the sequence of process steps, interaction among processes & departments, etc. There are no specific 'rules' or 'standards' that I am aware of. I do know that certain sectors (i.e. IT, electrical, mechanical, etc) use certain 'images' and symbols in their diagrams. If this a general, business block diagram (your process interractions diagram?) then there are no specific guidelines. Most flow charting software (i.e. Visio) has a description for its symbols. There is nothing prohibiting you from customizing the diagram as you wish by using pictures, graphics, etxt, etc. The important thing is for the diagram to be clear and easy to follow by the reader, be accurate in what it depicts, and hopefully be usefull for the organization.

Other Covers please correct or expand on my statement to give a more accurate answer.
 
I

itay26

Re: Block Diagram

Hallo
There are no specific rules or requirements for a block diagram. The block diagram's objective is to present the process elements: participants, activities, information, inputs, outputs, and other related technical elements related to the nature of the process. When you plan your block diagram, include these elements. If you are still not satisfied, you may ask your customer whether he expects something in particular.
Hope it helps
Itay
 
K

KAMay

Re: Block Diagram

Hi all
Thanks for your input!

The diagram is in the technical file and currently seems to be describing the function of our medical device - eg, when this button is pushed an alarm sounds etc

I had assumed it was a requirement to have it in the Tech File but I can't find my checklist just now to confirm
 
D

DrM2u

Re: Block Diagram

Hi all
Thanks for your input!

The diagram is in the technical file and currently seems to be describing the function of our medical device - eg, when this button is pushed an alarm sounds etc

I had assumed it was a requirement to have it in the Tech File but I can't find my checklist just now to confirm
If the diagram is not specified or required by customer(s) then it might not be a requirement. I am almost 100% sure it is not requried by any QMS standards either, unles there are product-specific standards that are applicable. First of all, do not delete or erase the file since it is part of the device record. If you don't need it then just make it obsolete and retain it as a record for the required/established period. If you decide to update the diagram then I suggest that you get with the 'tech guys' and get their input on the accuracy of the diagram and the symbols used. After that you can arrange the images on paper to improve ease of reading and following the diagram.:agree1:
 

Stijloor

Leader
Super Moderator
Re: Block Diagram

Hi all
Thanks for your input!

The diagram is in the technical file and currently seems to be describing the function of our medical device - eg, when this button is pushed an alarm sounds etc

I had assumed it was a requirement to have it in the Tech File but I can't find my checklist just now to confirm

In that context, the Block Diagram may have been used to establish the scope of a Design FMEA. (Same term different meanings.)

Stijloor.
 
U

Umang Vidyarthi

Hi Guys

.....- Does anyone know what the requirements for the Block Diagram are? - does it need to have pictures/diagrams etc?

Thanks :)

'Block diagram' is a diagram of a system, in which the functions are represented by blocks connected by lines, that show the relationships between the blocks. Block diagrams are like the 'Black boxes' where the contents are hidden from view. You know what 'goes in' and what 'goes out', but don't know the details of happening inside the box.

Hi all
Thanks for your input!

The diagram is in the technical file and currently seems to be describing the function of our medical device - eg, when this button is pushed an alarm sounds etc
I had assumed it was a requirement to have it in the Tech File but I can't find my checklist just now to confirm

'When this button is pushed an alarm sounds', but why/what for/how is hidden from view. It is describing the function of medical device, hiding the technical details of the function. That is the essential purpose of a block diagram.

Hope this helps

Umang :D
 
Top Bottom