Document or Record?


Hi all,

We have had very hot discussion in our QMS department about documents and records.
I would like to ask you for opinion.

Is an internal audit report a document or record?


Involved In Discussions
Document = The base document (Revision info etc. the information contained guides on how things shall be done)
Record - How things were done. Recorded proof of activities that occurred.

Bev D

Heretical Statistician
Super Moderator
The better question here is “why does it matter?”. Not to be snarky but to get at the reason for this semantic argument.
Words do matter but twisting definitions or deliberately misinterpreting their meaning is usually a ‘hidden’ effort at advancing an agenda. It is a not so passive aggressive move at undermining something at worst or a diversionary waste of time at best.

Now to the posted question: ‘document’ and ‘record’ are words that are not unique from each other. A document is “a piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.” It ranges from a book to a notecard or post it that has written or photograph ‘stuff’ on it. A procedure, work instruction, blank form and a filled out form (aka record) are all documents. A record is a specific type of document. A report is a very wordy record; it is a document that documents - or records - the results of some type of investigation.

So what is the argument really about?

Ed Panek

QA RA Small Med Dev Company
Super Moderator
We have an SOP regarding internal audits and the int audit schedule. Our audit has a report we file on the controlled drive forever and ever under the 2023 Internal audit folder in the QA folder.

Thats it. An auditor asks "Did you perform your internal audit?" Answer: "Yes, per our audit schedule it was completed last May. Here is the report"

Next topic

Record or document? Thats a distinction without a difference. Its evidence.
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