Recording a deviation isn't justifying one

This week's notes on how an OOS result opens an investigation and how a change control has to clear review before it runs cover two different kinds of trouble a batch record can carry: a test result that falls outside its own specification, and a change nobody approved yet. A third document sits in the gap between them — the deviation, an unplanned departure from a written procedure that happens in real time, on the floor, with nobody retesting their way out of it. 21 CFR 211.100(b) states its duty in a single sentence, and that sentence actually names two different jobs, not one.

One sentence, two verbs

21 CFR 211.100(b) requires written production and process control procedures to be followed and documented at the time of performance, then adds a clause that gets read as an afterthought: “Any deviation from the written procedures shall be recorded and justified.” Recorded and justified are two different verbs doing two different kinds of work, and the regulation asks for both in the same sentence — not a record that implies its own justification, and not a justification that skips stating what actually happened. A form that collapses the two into a single free-text box invites whoever fills it out to pick one and stop.

A record states a fact; a justification defends a decision

A record answers what happened: which step, which procedure, what was done instead of what the document called for, who did it, and when. A justification answers a different question — why the departure didn't put product quality at risk, and why the deviation is still acceptable despite not matching the written procedure. A log that lists ten deviations with a one-line description of each has written ten records. Unless each line also says why the departure didn't compromise the batch, the log has met half of what 211.100(b) actually asks for. The distinction matters most on inspection, where a reviewer reading the same log looks for the reasoning, not just the roster of what went wrong.

211.111 draws the same line around one specific case

21 CFR 211.111 takes the general duty in 211.100(b) and applies it to a narrower fact pattern: missing an established time limit between process steps. Its text keeps the same two-part shape — “Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.” FDA didn't need a separate rule to create a different duty for hold-time deviations; it needed one to make sure the same duty got applied to a departure that's easy to treat as a scheduling problem rather than a quality one. A line that sat idle four hours past its written hold time isn't a paperwork lapse until someone writes down why the extra time didn't change the product; before that, it's just a fact nobody has accounted for yet.

An unjustifiable deviation isn't a deviation anymore

The two-part duty assumes someone can name why a departure happened and why it was still acceptable at the time. When nobody can — when the departure surfaces only because a downstream check caught something odd, with no assignable cause to explain it — the document stops being a deviation in the 211.100(b) sense and becomes the unexplained discrepancy 21 CFR 211.192 governs, the same provision behind the OOS investigation this blog covered earlier this week. That record widens into a full investigation precisely because the justification that would have closed it out at the time was never available. A deviation log that quietly reclassifies unexplained problems as justified ones to avoid opening an investigation isn't keeping two duties straight; it's making one of them disappear, and leaving a record that reads as closed when the underlying question never actually got answered.

Where this meets the file

A deviation report that keeps the justification in its own required field — separate from the narrative of what happened, and not satisfied by the narrative alone — is previewed in the launch catalog alongside this week's other quality-investigation templates. If your site splits recorded from justified a different way, the shelf takes that correction directly.