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.

If the instructions are from your customer, they would fall under 4.2.3 f) of ISO 9001, and 820.40 in GMP. I am not sure where else.

You raise an interesting and important point. Even though they are documents of external origin, you must still make sure you have the right information when conducting the tests. And as you say, using post-it notes for instructions sounds like high risk for variation. But even post-it notes can meet the requirements if they are handled properly (there is no requirement on what a work instruction must look like -- that I am aware of). The bottom line is that someone has to be responsible to ensure that changes make it to where they need to be. If a work instruction is changed, someone must ensure that the updated information is distributed and the old information is kept from being used.

Ugh. talk about your rock / hard place!

Given that you have no real leverage to make them change, have you considered options to control internally? For example, you could have your own internal numbering for the document and every change submitted revs your internal number. You could then show that product x was tested against rev y of the instruction which contained this set of change pages.

I'm just brainstorming. I don't envy your position at all. Good luck.