Documents Identification in QMS

[Jeevan Jyoti]

Hi, We are using Qualio as eQMS tool and want to control all documents through it. We have Aligned Elements which generates documents for Design and development. The documents generated within Aligned when released through Qualio does not match with the auto identification generated within the Qualio.

Can some one please suggest and share thoughts that is it mandatory that the document identification should remain consistent across the document if we have added that document as an attachment?

 

[Jen Kirley]

Welcome Jeevan!

There is no requirement - nothing is mandatory in methods for documentation identification consistency. Control of documents is mandatory so as to enable consistent and timely awareness of correct process performance so as to result in expected outcomes.

I very often see Attachment A/B/C or I/II/III used to identify attachments. If an attachment is referenced within a "parent" document in more than one place, I would expect to see that attachment identified in a consistent manner so as to avoid confusion. That is, if it is called by its title in one place and Attachment A in another, the reader might not understand it is the same document so that practice should be avoided. However, I have never seen a requirement for this specified in any standard I have used.

I hope I answered your question.

 

[Jeevan Jyoti]

Thanks Jen for providing your inputs. Agreed