Release
Release and DHR refusals
Every message the system gives when it refuses an outgoing inspection, a retention sample, a lot release or a DHR step, and what to do.
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.
Outgoing inspection and lot release
For Inspect outgoing lots and release them.
Outgoing inspection (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. |
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
| 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
For Compile and approve the DHR.
| 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. |