Actually, I am never asked that question. Instead, when during an audit I challenge corrections missing the reason for the change in information I am regularly told “the error is initialed and dated and that’s our SOP.”
This too is cultural. We shouldn’t hide behind an SOP. If a number, or any other piece of information is altered from the original paper record (if computer, there should be an audit trail and the audit trail should be provided – electronically or as a printout, with the record), the reason should always be documented. If I need to release a batch, and someone altered a yield calculation or a time or date on an entry and I don’t know why they did that or on what data they relied…I have a data integrity issue.