The five letters
Who did this?
Results, entries, and changes should be traceable to a person (and role where it matters) — not “the lab,” not an anonymous table, not a correction with no initials.
Can a second reader still read it?
Content should remain readable and its history preserved. Obliterated values, strikeouts with no replacement, or passages marked illegible in a transcription are signals — not footnotes to ignore.
Recorded when the work happened?
Records made long after the fact, “from memory,” or batched in a single sitting days later undermine the story. (A sign-off dated before the work is a different failure — date order — and should not be confused with late recording.)
Is this the real record (or a controlled true copy)?
Informal retypes, “summary instead of the raw chart,” or copies with no true-copy language are where Original breaks. Silence is not automatically a finding — only what the document exposes.
Complete as recorded, free of unexplained change
Amendments without reason, selective reporting the text itself admits, or derived values that contradict the stated raw value belong here — not every figure/table mismatch (those are consistency problems of their own).
What ALCOA is not
- Not a score. Five green checks do not mean “data integrity program healthy.”
- Not proof a signature is genuine — only that the record may show a signature block or owner.
- Not the whole of ALCOA+ (Complete, Consistent, Enduring, Available). Some of those need systems and retention, not a single uploaded document.
Correction: value overwritten, no initials or date.
“Recorded from notebook later the same week.”
Correction with strike-through, new value, initials, date, reason.
Entries tied to the time of performance (or an honest late-entry procedure).
Empty signature blocks are a special case. A tool can flag that a block looks empty or undated. It should not return PASS in a way a reviewer would read as “signature verified.” Presence is not authenticity.
How this shows up in inspection prep
Under deadline, people fix the narrative (root cause language, executive summary) and leave the record mechanics untouched: who entered the value, when, what was overwritten. Those mechanics are often faster to check than to re-investigate — and they are exactly what a second pair of eyes (human or assisted) can surface early.
Open ALCOA criteria → · Mechanical vs judgment →
See how findings are listed per criterion on sample data.