I'm wondering if anyone knows of an industry standard for correcting dates. For example, I recently dated a document with the year as "07" (I know I'm behind, but I had no idea that far!), and it wasn't caught until about a week later. What is the proper procedure for correcting the date on a date different from when the activity was actually performed? Thanks in advance for any assistance you can provide.

If you want to be clear of the correction, draw one line through the incorrect date so it is not obscured or unreadable. Then put in the correct date and initial.

I don't know of any industry standards. Someone else may be aware of one.

I don't know of an industry standard either. Industry expectations are to be able to see what was originally written. That would mean no whiteout, no blackouts and no scribbling allowed. In my experience, specifics are set out by the QMS.

While doing records for submarine inspections, the rule we followed for changes was: single line through the text, then initials of the correcting person (usually to the upper right) and the date correction was made.

I've always heard the single line with initials also. great minds think alike?:biglaugh:

Let's think about what the concern would be as an auditor - namely that someone is trying to hide / falsify / etc a record. For this reason any use of whiteout fluid or other opaque medium will get you into some interesting discussions.

The simple use of a one-line cross out so that the original text remains visible along with a correction and either initials or name of the corrector together with date the correction was made will show that someone made an error; someone spotted it and someone fixed it. The original inforation is visible so there is no question of impropriety. The name and date relating to the correction is recorded so we have traceability.

As a complete closed loop you can include the statement in your document management procedure that corrections are allowed with a single strike out with initials and dates being recoreded next to the correction.

Thank you all for your responses. I am very familiar with the standards for normal corrections. My question specifically applies to dates that are corrected on a different date. Once you cross out the incorrect date, do you replace it with the original date that the work was performed, or do you replace it with the current date? In either case, it would be accompanied by a note that says "for work performed on <original date>". However, while I argue that the first option seems like backdating, the other party is arguing that I didn't really perform the work today, so today's date would be incorrect.

What we've done / seen is cross out the original then annotate the change with something like "incorrect date originally entered, correct date is Mon-day-Yr" and then initial the annotation and date the annotation with the current date.

To generalize what Allan66 said: any appearance of date manipulation can get you into some interesting discussions. In this case, some added annotation is well worth the trouble.

What we've done / seen is cross out the original then annotate the change with something like "incorrect date originally entered, correct date is Mon-day-Yr" and then initial the annotation and date the annotation with the current date.

To generalize what Allan66 said: any appearance of date manipulation can get you into some interesting discussions. In this case, some added annotation is well worth the trouble.This solution has "legs" for me - the idea of full disclosure of what is going on goes a long way toward making life easier for everyone.

May be this is a good chance for me to post this procedure on "Good Documentation Practices" that I have written solely for the Pharmaceuticals / Medical devices background.

Btw, I received couple of requests from covers requesting me to give them my procedure.

Do let me know if you have any comments.

Ajit - your GDP SOP is very much like the one we use at my current employer.

Yodon - your description of error correction procedures is consistent with what I learned in an FDA/ISO9001 Internal Audit course earlier this year.

SZ