Use of External Documents in Product Realization

Hello Everyone,
I've recently completed a renewal audit for API Q1 and the only thing I have left to address is a lack of procedure for section 4.4.4 of Q1 (Use of External Documents in Product Realization). I'm not sure why I just can't seem to get my brain wrap around this, but does anyone have any example of how they have covered this? Any help would be greatly appreciated.
Evidence- Performed a review of the Document Control procedure (QP-05, Rev. 9), performed a review of the Contract Review procedure (QP-3.0, Rev. 7). There was no evidence that the procedures described the integration of requirements from external documents into the product realization process.
Finding Description- The Document Control procedure (QP-05, Rev. 9) describes the control of external documents but does not describe the integration of the requirements in product realization.
Yes it is.
A little background info for you- We are a medium sized job shop only. We have no product line so i think not having a design and development section is throwing me off since we don't regularly revise parts due to industry standard changes. We are licensed as a 5CT threader though, so we must have a procedure to integrate external documents and that is where i'm hitting a roadblock. I'm not sure how to go about including it, (should it go in to Document control procedure, Contract review procedure, or become it's own separate procedure?) things like that.
I know there are more important things to do than help someone you don't know so i really appreciate the time you have already spent looking at this

Al Rosen

Staff member
Super Moderator
During Contract review you identify external documents referenced in the contract that you need and control as part of the contract.


Quality Manager
Notice that 4.4.4 says "...used in the design or manufacture...". API Q9 is more specific there. Although of course keep in mind it starts with "When API product or other external specifications....are used in the design or manufacture..." I think once you get that going it won't be hard to apply it to the 5.1 requirements.


Quality Manager
If your goal is to satisfy API then I think they give you the answer in their finding language. It looks like they say your QP-05, Rev 9 describes their control but doesn't describe the integration into product realization. So are they expecting it to be done in your QP-05?

But I'm a fan of looking at your organization and building the QMS around that, rather than looking at the QMS and building your organization around it. So I would rather look at how your organization is already handling this kind of thing and fulfill it there. But I also realize it's very different with API because it isn't like ISO or AS where there are 3rd party registrars. So their isn't as much room for interpretation.

Top Bottom