Can anyone tell where in the FDA regs it states that a design document, i.e. product definition, verification and validation results, FMEA, etc must be controlled with a ECN/ECO/DCN? I know they must be revision controlled and approved, but why must I go thru the hassle of filling out another piece of paper. We are a very small company where each person wears multiple hats. Seems ridiculous for me to request a change order and then approve it because I'm the only one to do it.

So that the doc is known to be current. Without updating the docs there is a chance of useing a old rev to make a part out of spec. Basicaly a headache today will save you days of headaches down the road. You could lean up the process change time, I use files in the computer with all supporting docs for each part number so I only have to go to one place to update all of them.

As you've indicated you already know they need to be controlled, I presume you have already addressed justncredible's concern that you know what is current.

The reg requires change control. This means that you have to show evidence of review (and approval). Further, from the reg:

Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

There is no requirement for HOW (ECN, etc.) you do this. As long as you can show that you comply with the requirement, you are fine. The thing you might run into is that the forms you list are rather de facto standards and some auditors tend to get uncomfortable or get inclined to dig deeper when someone deviates from what they are used to. So at this point, it's a matter of picking your battles. If you have solid doc / change control, then stick to your guns (process).

There's many ways you can do things.

We're a small company as well and I know your pain.

We've worked to combine as many things as possible, even when it made the followers of industry standards cringe.

Our design history file is an 8 page form (8 pages blank) that includes risk management and references to supporting documents. The second to last page lists all the DMR components and the last page is dedicated to design review.

Whenever there's a product change, the whole DHF is given a new revision. Changes and updates are always in italics. Its reviewed and approved much like an ECN.

There's a lot of reasons why we do this. I am not suggesting to take the same approach, just find what works for your company and meets regulatory requirements.

QA-Man,

So you review and sign off the document and give it a new Rev level but you don't do it via a change notice? That is what I am thinking of doing and it also makes sense to me.

Thx