C
catfish4862
Good morning.
Instructions we use to do testing at our facility are Customer Supplied documents. They issue, update, and control them. Is it acceptable for them to just email or send a typed "change" to the instruction (with signature and date) that we then attach to the instruction? I don't think this is right. It's like using post-it notes to give instruction - they are not properly controlled.
I'm new to all this, so maybe I'm wrong. We are not FDA compliant, but this same Customer would like us to strive to be (but only regarding a few clauses...training, calibration, and inspection).
We do not manufacture anything - we only test the product that they manufacture at their facilities (drapes/gowns used in surgery).
If I'm right - what clause should I site to them as to why we do not want to handle changes this way. We want them to update and re-issue the instruction. They claim the process at their company to submit and get changes is very lengthly and time consuming...which is not our problem.
I just need help in trying to defend ourselves on this.....but maybe I'm wrong. When I read 820.40, it doesn't give detail about how the change should be incorporated. So maybe I'm wrong!!
All help is greatly appreciated!!!
Instructions we use to do testing at our facility are Customer Supplied documents. They issue, update, and control them. Is it acceptable for them to just email or send a typed "change" to the instruction (with signature and date) that we then attach to the instruction? I don't think this is right. It's like using post-it notes to give instruction - they are not properly controlled.
I'm new to all this, so maybe I'm wrong. We are not FDA compliant, but this same Customer would like us to strive to be (but only regarding a few clauses...training, calibration, and inspection).
We do not manufacture anything - we only test the product that they manufacture at their facilities (drapes/gowns used in surgery).
If I'm right - what clause should I site to them as to why we do not want to handle changes this way. We want them to update and re-issue the instruction. They claim the process at their company to submit and get changes is very lengthly and time consuming...which is not our problem.
I just need help in trying to defend ourselves on this.....but maybe I'm wrong. When I read 820.40, it doesn't give detail about how the change should be incorporated. So maybe I'm wrong!!
All help is greatly appreciated!!!