authoring vs transcribing/converting documents

I’m currently debating with a co-worker over the definition of authoring a document, say an SOP, vs transcribing and being able to audit that document later during an internal audit.

So lets say as a QA rep you are handed a new procedure written out on paper and asked to make it into an electronic version. My co-worker states that by doing so, it makes you the author of that document and therefore you cannot audit it later. He states that is stated in the ISO standards but I’ve never come across it or seen it followed like that at the other sites I’ve worked at within the company.

My view is that you are transcribing and converting the document into another format. You are not altering the content or intent of the procedure. Therefore you are then free to audit that procedure during an internal audit.



Any thoughts on how to interpret this type of situation?

 

Typically, the process owner authors his/her SOP. Whoever prepares the SOP for him/her, the process owner is still the SOP's author. In auditing, process owners are conventionally prohibited to audit their own SOP. This is due to the requirement of ISO 9001:2008 clause 8.2.2 that says "Auditors shall not audit their own work".

 

That's what I thinking as well. His expectation is that others will type up the SOP, form, manual, etc and all the QA responsibility will be is to upload it to the network and perform audits. Most of my coworkers don't have the experience writing up these documents or the skill set to properly format them and have them ready to be published. They need assistance or someone to polish the work for them. I don't see a conflict of interest in assisting them with the documents and typing them up that prevents me from then conducting an audit on the process and related documentation. I haven't written or changed the documentation, only transcribed from their rough written format to electronic format. In a perfect world, it would be done his way since everyone would have the required skills to complete the tasks. Unfortunately, it's a small work site where we have secondary duties assigned to us outside of our regular job functions.

 

I'm curious as to why this is even an issue. You will not be auditing the authors of procedures. You will be auditing the procedures themselves ... as in, are they working. It's not so much about who wrote it as it is about who is doing the work it describes.

 

It's not auditing the author but what my co-worker is saying is that by transcribing the document, you now become the author and therefore you cannot audit your own work. I'm disagreeing with that viewpoint in that if you are not changing the content or intent of the document you're transcribing, then you are not the author. You can then audit the document as part of your audit.

 

ChrisB

If you photocopied the document rather than transcribing it, would the photocopier become the author? Tell your colleague not to be daft!

 

So if I set the type on an old fashioned printing press and made some books in that manner, I'd be the author?

Our process documents have a field for author and reviewer. Depending on the point I'm making, and the responsibility I'm asserting/assigning, I may put my name in either one of those fields after I've interviewed somebody and turned their story into process documentation.

I can still audit that process - I'm not auditing the document, but how the work gets done, which is hopefully in accordance with the document.