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Document review is a kind of verification?

ltcmff

Starting to get Involved
#1
hello,
I have a quesiton about verification method. Is the reviewing of doucment an approach of verification?
for example , certain content of an identification label of system is changed, the drawing of the lable will be reviewed as DMR documents.
Is the reviewing process as design verification for the lable change?
can anyone help to clarify?
thank you .
 
Last edited:

yodon

Staff member
Super Moderator
#2
I've successfully verified certain requirements through document review; however, I didn't bundle it with the change review. The latter should be just part of the standard change controls process. I put all the document review type verification 'tests' in a separate protocol or section. For example, if I had a requirement that the IFU include some specific text or warning or something, the test would require that the tester cite the released version of the document reviewed and a page / section number where found. For labels, I would use something as close to the actual label (if not the printed label itself) - maybe the label master (and, of course, have the tester record the revision of the released item).
 

ltcmff

Starting to get Involved
#3
Dear yodon ,
Thank you for your reply. I think you provide a good example. IFU must be reviewed and approved as it is document.
as far as i am concerned, if the IFU changed,is it required to be verified except for document review and approval ,or to establish the verification records?

Thank you.
 
#4
I've successfully verified certain requirements through document review; however, I didn't bundle it with the change review. The latter should be just part of the standard change controls process. I put all the document review type verification 'tests' in a separate protocol or section. For example, if I had a requirement that the IFU include some specific text or warning or something, the test would require that the tester cite the released version of the document reviewed and a page / section number where found. For labels, I would use something as close to the actual label (if not the printed label itself) - maybe the label master (and, of course, have the tester record the revision of the released item).
in the spirit of "verification", shouldn't it involve certain more details of such documents; i.e., 'adequacy' or 'suitability' of the such text/warning/directions etc?

the point is., document-review is different than 'verification of action plan implemented through document"
 

yodon

Staff member
Super Moderator
#5
in the spirit of "verification", shouldn't it involve certain more details of such documents; i.e., 'adequacy' or 'suitability' of the such text/warning/directions etc?"
For something like IFU content where adequacy or suitability is a consideration, I see that as a validation exercise and cover it in summative studies. That requires actual users to make a qualitative assessment.
 
#6
Any verification is a form of checking activity. It would require some clearly defined criteria against which the checking is performed, but yes, a document review can be verified through a review.
 
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