# Release and DHR refusals (/docs/quality-release/refusals) When the system refuses a step, it shows the message and changes nothing. Find the message below. Placeholders such as `{lot}` stand for the real value. Messages shared by every flow (signature authority, missing reason, access letters, the training gate, signed-record locks) are explained in [Signatures and refusals](/docs/get-started/signatures-and-refusals). ## Outgoing inspection and lot release [#outgoing-inspection] For [Inspect outgoing lots and release them](/docs/quality-release/outgoing-inspection-and-lot-release). ### Outgoing inspection (OQC) [#oqc] | Message | When | What to do | |---|---|---| | `Enter the number of critical, major and minor defects found in the sample.` | **Sign · Accept lot** or **Hold lot and raise NCR** with a defect count blank. | Enter all three counts. Use 0 where none was found. | | `A defect count cannot be above the sample size (n = {n}). Check the counts entered.` | A count is higher than the pieces sampled. | Correct the count. | | `Enter the measured value of each critical characteristic of the inspection plan.` | **Sign · Accept lot** with a CTQ of the plan not measured. | Measure each CTQ on the sample and type the value. | | `{id} is out of tolerance on the sample. Hold the lot and raise an NCR instead.` | **Sign · Accept lot** with a CTQ reading outside the plan. | Choose **Hold lot and raise NCR**. | | `Verify the UDI labels, lot number and pouch count on the sampled cartons first.` | **Sign · Accept lot** with the label box not ticked. | Check the cartons, then tick the box. | | `The sample is above an accept number. Hold the lot and raise an NCR instead.` | **Sign · Accept lot** when a class shows **Reject**. | Choose **Hold lot and raise NCR**. | | `Give the reason the lot fails` | **Hold lot and raise NCR** with no reason. | Write why the lot fails. | | `Finished lot {lot} not found` | The order has no finished lot in stock. | Complete the production run first. | | `Lot {lot} is on hold. Clear the hold first.` | **Sign · Accept lot** on a lot on hold. | Clear the hold where it was placed. | | `Lot {lot} is on hold under {ncr}. Close the NCR with its disposition before releasing or re-inspecting.` | Any outgoing decision while the NCR is open. | Close the NCR. | | `{key} is not at QA Final, so its lot has no outgoing hold to clear.` | **Clear hold** on an order that is not at **QA Final**. | None needed. | | `Lot {lot} is not on hold.` | **Clear hold** on a lot that is not on hold. | None needed. | | `Lot {lot} is on hold, but not under an outgoing inspection NCR of this order. Clear it where the hold was placed.` | **Clear hold** when the hold came from somewhere else. | Clear the hold where it was placed. | | `{ncr} was closed as scrap, so lot {lot} cannot go back to inspection.` | **Clear hold** after an NCR closed as **Scrap**. | The lot cannot be inspected again. | | `STOP · {reason}` | A gauge in the inspection is not calibrated or is locked. | Use a gauge that is in calibration. See [Gauges and calibration](/docs/quality/gauges-and-calibration). | ### Retention samples [#retention-samples] | Message | When | What to do | |---|---|---| | `Enter the withdrawal reason and reference (complaint, investigation)` | **Withdraw sample** with either blank. | Fill in both. | | `Enter the quantity withdrawn (1–{qty})` | **Qty withdrawn** is 0, negative or above the quantity retained. | Enter a quantity in range. | | `{key} must be kept until {date}` | **Dispose** before **Retain until**. | Wait until that date. | ### Release checks [#release-checks] | Message | When | What to do | |---|---|---| | `Release refused · {first blocker}` | **Sign · release lot** while any check fails. The status goes to **Blocked**, and the attempt is logged without a signature. | Fix the blockers listed on the record. See the table in the task page. | | `The releaser must be someone other than the requester` | The person who requested the release tried to sign it. | Ask the QA manager. | | `Your account is not linked to an employee, so it cannot be shown that you are not the requester. Link it to an employee first.` | The signer's login has no employee. | Ask the administrator to link an employee. | | `{key} names no requester, so the releaser cannot be shown to differ. Create a new release check.` | The record has no **Requested by**. | Create a new release check. | | `Requested by is set from the signed-in person and cannot be changed.` | Editing **Requested by**. | Leave it. | | `No free number is left for this prefix.` | Numbering ran out for the prefix. | Ask the administrator. | ## Device history records [#device-history-records] For [Compile and approve the DHR](/docs/quality-release/device-history-records). | Message | When | What to do | |---|---|---| | `Order {mo} not found` | **Compile DHR** or **Review · approve DHR** on a record whose order is missing or blank. | Pick a manufacturing order. | | `Manufacturing order is required.` | Saving a DHR with no order. | Pick the order. | | `{other} is already the device history record of {lot or order}. A lot has one record.` | Saving a second DHR for the same lot. | Use the existing record. | | `{key} is approved for lot {lot}. Its lot and order cannot change.` | Editing the lot or order of an approved DHR. | Leave it. | | `Approval refused · {first open item}` | **Review · approve DHR** while items are open. The record goes back to **Incomplete** and the attempt is logged without a signature. | Close the open items, then **Re-compile**. | | `The reviewer must be someone other than the compiler` | The compiler tried to approve their own DHR. | Ask the QA manager. | | `Your account is not linked to an employee, so it cannot be shown that you are not the compiler. Link it to an employee first.` | The reviewer's login has no employee. | Ask the administrator. | | `{key} names no compiler, so the reviewer cannot be shown to differ. Have it compiled again by a person linked to an employee.` | The record has no **Compiled by**. | Compile it again. | | `Compiled by is set from the signed-in person and cannot be changed.` | Editing **Compiled by**. | Leave it. | | `Lot {lot} was not produced by order {mo}` | The lot named is not one the order made. | Check the lot and order. | | `Device history records apply while ISO 13485 is on.` | Opening the DHR screen with ISO 13485 switched off. | None needed. | | `The device history record is part of Production and Quality. Ask an administrator for access to see it.` | Your role has no access to either module. | Ask an administrator. |