Correct a record

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When this applies

Record corrections are enabled per organization. Where enabled, Administrators and QA Managers see a Correct record control on the detail page of an open complaint, deviation, or CAPA. Other roles see no change. If your organization has not been enabled, the control does not appear and the underlying action is refused. A correction is for a recorded error: a mistyped title, a wrong lot number, a received date entered a day off, the wrong person recorded as detector. It is not a way to change a quality decision. See Correct or reopen? before you start.

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Correct an open record

1. Open the complaint, deviation, or CAPA and find the Correct record section.
2. Select Correct record. The form shows the current recorded values.
3. Change only the fields that are wrong. Leave every other field as it is.
4. Enter a Reason for change (10 to 1000 characters). State what was wrong, what is right, and where the correct value came from. For example: Lot number typed as 24-118; batch record shows 24-181.
5. Select Save correction. The record refreshes with the corrected values.

The form refuses a save that changes nothing, a required field left blank, or a reason outside the length limits. Read the message, fix the form, and save again. A failed save records nothing.

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What can be corrected

Notes on specific fields:

• Recorded detector (deviation) identifies who detected the event. It may be a user who is now inactive, because it records history. Changing it does not change who created the record.
• Recorded target date (CAPA) is the target written on the record. Correcting it, or the priority, does not move the SLA deadline or any approved extension. Those follow their own controlled paths.
• Deviation severity and classification are deliberately excluded. Severity drives the SLA clock and classification is signed, so each keeps its own controlled path.
• Status is never corrected. Use the lifecycle actions (start investigation, close, reopen).

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What the audit trail records

Every saved correction writes one entry to the tamper-evident audit trail containing:

• the previous and corrected values of the changed fields only,
• the reason for change exactly as entered,
• who made the correction and when,
• a marker that the entry is a correction.

The entry is part of the hash chain, so it can be verified and exported with the rest of the record’s history. Nothing is overwritten in the trail. The record shows the corrected values; the trail shows how they got there.

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Signatures and independence

Existing signatures are not changed. They remain historical evidence of the values that were signed at that time and they do not attest to the correction. When a record carries signatures, the form says so. Correcting a deviation or CAPA makes you an author of its content. The independence check that governs closure and effectiveness signatures treats a correction like any other content change. If you correct a deviation or CAPA, plan for a different QA Manager to sign its closure. In a small QA team, decide who will correct and who will sign before you start.

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Correct or reopen?

Use a correction when all of the following are true:

• the record is open (not closed, and for a CAPA not completed or effectiveness-verified),
• the change fixes a recording error, and
• the change does not alter a decision or outcome: classification, severity, root cause, disposition, effectiveness result, closure rationale.

Use the signed reopen workflow instead when any of these is true:

• the record is closed, completed, or carries a signature over the value you need to change,
• the change alters a quality decision or outcome, or
• you are unsure. Reopening is reversible in process terms; a correction to the wrong thing is not something you can undo, only document.

Reopening needs a reason for change and an independent signer (Reopen complaint, Sign & reopen on a deviation, Sign & Reopen on a CAPA). After reopening, make the change through its normal controlled path, then close again with a new signature. If you try to correct a closed record, the save is refused with a message telling you to reopen first.