Five-minute self-check

Test One GMP Decision for Inspection Readiness

Choose one completed consequential GMP decision—such as a batch release, CAPA closure, deviation conclusion, OOS investigation, change-control approval, or supplier decision. Answer only from what the existing record demonstrates today.

Use the record as it exists.Do not give credit for what the team could reconstruct later.
01Evidence

Can the record show what was known when the decision was made?

The file identifies the evidence reviewed before authorization.

Critical attachments and source records are accessible from the decision record.

The record distinguishes facts available at the time from information learned later.

02Judgment

Can another qualified reviewer follow the reasoning, including credible alternatives considered?

The conclusion explains how the evidence supports the decision.

Credible alternative actions or conclusions are identified.

The record explains why the selected path was preferred over those alternatives.

03Risk

Is the accepted exposure explicit rather than implied?

Product, patient, process, data-integrity, and regulatory risks were considered where relevant.

Residual risk and the controls used to manage it are recorded.

The conditions that would have changed or reversed the decision are clear.

04Authorization

Is accountability preserved at the decision—not merely at workflow completion?

The accountable decision-maker is named and their authority is clear.

The authorization date reflects when the decision was actually made.

The approval preserves the rationale, not only an electronic signature or status change.

What the result means

The result identifies where the existing record depends most on reconstruction.

“Partly preserved,” “Not preserved,” and “Unsure” are treated differently. The result highlights the dimensions that merit a deeper look without declaring the decision compliant, noncompliant, inspection-ready, or not inspection-ready.

When all 12 responses are complete, the DDA is the single next step for this information-stage path.