(a) Do you have an SOP describing the responsibilities of the person who signs:
– performed by
– verified by
– checked or reviewed or approved by
When I ask this, the answer is usually “no.” Employees aren’t necessarily clear that if they sign “verified by,” they need to have been physically present throughout the step and to have observed every part of the activity as if performed themselves. Whereas “checked” “reviewed” or “approved by” is a data review in which case you must be provided sufficient information to make a reliable assessment of the data before signing.
(b) Having understood your responsibility, a person reviewing a batch record is assessing the reliability of the data. Therefore, one Contractor who told me I couldn’t see my client’s batch record at an audit three weeks after manufacture because their VP Operations hadn’t yet reviewed it was essentially telling me straight out that their data was not very reliable. They were also giving a sub-conscious message to the production employees that filling in the batch record on real time was not all that important. The mentality was to keep moving product and to fill in any missing information in the record…LATER. This type of practice is at the heart of data integrity issues. If the batch record review has to be completed within 48 hours of performing the step, the record has to be filled immediately and any missing information will be rapidly challenged. This is a cultural issue.