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ISO 13485 - Assembly instructions written vs. online

Thomas Dorner

Starting to get Involved
#1
Hi,

I am not deeply familiar with ISO 13485, therefore I ask the professionals;)

Our production want to move away from written assembly instructions to videos that show the assembly process. This will help, making training easier and help improve production in a number of categories.

Now, my question is: What documentation do we need to be compliant with ISO 13485. Is it enough to have a SOP that points out we are have all instructions in form of an video and where they located?

Every input in this case would very much appreciated.

Thank you in advance,
Thomas
 
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indubioush

Quite Involved in Discussions
#2
Information needs to be available at points of use. When I do manufacturing line audits, I want to see that the operators have their instruction binder open and follow along with the instruction even if they have done the same process many times over. Do you want the video to be playing as they perform their assembly processes? If they want to review a specific process, will they have to spend time rewinding/fast forwarding? I think the better option would be to have some kind of reference document that shows the assembly standards for daily use, and but the video is available any time when needed and is required for initial training and periodic retraining.

Your video will need to undergo an approval process, have revision control, be stored and protected from loss, have distribution controls. In other words, all the requirements that apply to documents would apply to your videos.
 

yodon

Staff member
Super Moderator
#3
Good points by @indubioush - I might just add that revision identification will be important (how do you know you're looking at rev x of the video). As pointed out, a running video doesn't seem all that appropriate for the assembly line but certainly good for training.
 

Jim Wynne

Staff member
Admin
#4
Information needs to be available at points of use. When I do manufacturing line audits, I want to see that the operators have their instruction binder open and follow along with the instruction even if they have done the same process many times over.
What does this accomplish, other than potentially slowing things down? In point of fact, unless there's a documented requirement for operators to do as you describe, it shouldn't make any difference at all what an auditor "wants" to see.
 

indubioush

Quite Involved in Discussions
#5
I understand that they wont always follow along during their routine operations, but they need to show me that they are aware of the procedure, understand its contents, and know what section of the procedure corresponds to what they are doing. Process drift happens, and this can create risks for a class III implantable device.
 

Jim Wynne

Staff member
Admin
#6
I understand that they wont always follow along during their routine operations, but they need to show me that they are aware of the procedure, understand its contents, and know what section of the procedure corresponds to what they are doing. Process drift happens, and this can create risks for a class III implantable device.
If this is the case, IMO, the auditor should have the process instructions in hand while observing the operation. Of course, the operators should be able to demonstrate that they can readily access the current documentation if needed.
 
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