Was the work performed?

Start with the question

A batch record requires an independent verification before the next process step. The field is blank. What does that establish?

By the end of this lesson you should be able to:

• Distinguish an observed documentation gap from an established execution failure.
• Identify the evidence needed to evaluate whether a required activity occurred.
• Explain why retraining is not automatically a sufficient corrective action.
• Describe an appropriately qualified conclusion when the evidence is incomplete.

Watch

Transcript

A missing entry tells you something about the record. It does not, by itself, tell you everything about the work.

Picture a batch record that requires an independent verification. The field is blank. The supervisor proposes retraining the operator for incomplete documentation.

There are at least three competing explanations. The verification occurred, but the entry was omitted. Or the verification did not occur. Or a check occurred, but its scope or timing cannot be established. They need different attention.

Evidence that is specific to the event, attributable, and contemporaneous can support some interpretations without resolving every question. A person being in the room is consistent with a check. It is not a record of one.

So what would you need to see before agreeing that retraining is an adequate response?

Examine what the evidence establishes before deciding how the gap should be addressed.

Apply it

Take one blank entry you have seen, or imagine one. Write down three things before you decide what to do about it:

• What exactly is missing from the record?
• What independent evidence establishes what occurred?
• What remains uncertain after that evidence is examined?

Next: What would establish performance?, where you work through a synthetic case and make the judgments yourself.

If you want to go further

These already exist on this site. You do not need them to continue the lessons.