Does FDA consider Flow Charts sufficient instruction for SOPs?

T

tdb17

#1
Example: The flow chart for Software Development Life Cycle has one block for 'Requirements Written' and the next block 'Review Requirements'.

Would the FDA consider this a documented procedure without additional work instructions?
 
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yodon

Staff member
Super Moderator
#2
I'd say that's probably going to be viewed as a bit too minimalistic.

Keep in mind that your procedures have to address the regulations and then you have to show that you are complying with the procedures. Given JUST what you described, I would expect you would get some, um, negative feedback on showing compliance to (from 21 CFR 820.30):

(e)Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

Where, for example, do you define responsibility, scheduling, documenting, etc.

As far as I know, flow charts ARE acceptable as SOPs as long as they provide sufficient instructions.
 
M

MIREGMGR

#3
If your procedure includes task assignments to specific individuals or job slots, and you conduct training from your flowcharts, and the trainer's materials provide for a substantial discussion of the non-chartable issues, and if the trainees then are tested on their comprehension and ability to implement, you may be OK. Otherwise, my guess is no.
 
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