Quality system
Complaints and recalls refusals
Every message the system gives when it refuses a step on a customer complaint, an advisory notice or the trace screen, and what to do.
When the system refuses a step, it shows the message and changes nothing. Find the message below.
Placeholders such as {key} 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.
Customer complaints
For Handle a customer complaint.
| Message | When | What to do |
|---|---|---|
Edit the complaint and set Reportability first | Record reportability decision with Reportability blank or Not assessed. | Edit the complaint and choose Not reportable or Reportable. |
Establish whether death or serious injury was involved before deciding | Death or serious injury involved is Unknown. | Find out, then set No or Yes. |
Death or serious injury involved: the complaint must be reported | Harm is Yes but the decision is not Reportable. | Set Reportable. |
Add the reportability rationale | Reportability rationale is blank. | Write the rationale. |
Edit the complaint and write the response to customer first | Send response with Response to customer blank. | Write the response. |
Reportable complaint: enter the authority report reference first | Send response on a reportable complaint with no Authority report ref.. | Report to the authority and enter the reference. |
Link an NCR or CAPA, or record why none is needed in the rationale, before closing | Close complaint with no NCR, no CAPA and a rationale that does not say "no NCR", "no CAPA" or "no action". | Raise or link one, or write why none is needed. |
{key} already linked to {ncr} | Raise NCR on a complaint that has an NCR. | Open the linked NCR. |
{key} already linked to {capa} | Raise CAPA on a complaint that has a CAPA. | Open the linked CAPA. |
Advisory notices and recalls
For Issue an advisory notice or recall.
Trace, approve, notify, close
| Message | When | What to do |
|---|---|---|
Enter the affected lots first | Trace shipped lots with Lots affected blank. | Enter the lots. |
Lot {lot} is not in stock, stock movements or goods receipts. Check the lot number. (or Lots {a, b} are not ...) | A lot number is unknown to the system. | Correct the lot number. |
Trace shipped lots before approving | Approve notice or Customers notified with no trace. | Choose Trace shipped lots. |
Trace shipped lots first | Confirm no customers affected with no trace. | Trace first. |
The lots changed after the trace. Trace shipped lots again | Lots affected was edited after the trace. | Trace again. |
The trace found no shipped delivery orders. Check the lot numbers, or confirm that no customers are affected, first | Approve or notify when the trace found nothing and nobody confirmed. | Check the lots, or use Confirm no customers affected. |
The trace found {n} shipped delivery order(s). Those customers must be notified: there is nothing to confirm. | Confirm no customers affected when the trace did find deliveries. | Notify the customers. |
Set whether the authority must be notified | Approve notice with Authority notified blank. | Choose Not required, Pending or Notified. |
Notify the authority and enter its reference first | Customers notified with Authority notified at Pending, or Notified with no Authority ref.. | Notify the authority and enter the reference. |
Record the effectiveness check (replies received, stock returned or corrected) first | Close notice with Effectiveness check blank. | Write the check. |
Trace screen
| Message | When | What to do |
|---|---|---|
Lot {lot} not found | Start recall or notice for an unknown lot. | Pick a lot from the list. |
{lot} has no shipped product to trace. | Start recall or notice for a lot nobody shipped. | None needed. |
{mo} has no suspect range. | Place on hold on an order with no suspect range. | None needed. |
{id} is not part of the suspect range of {mo}. | Place on hold on a line outside the range. | Pick a line in the range. |
{notice} is {status}. A customer can acknowledge it only after the customers are notified. | Record acknowledgement before Customers notified. | Notify the customers first. |
{delivery} has not shipped, so it cannot acknowledge {notice}. | Record acknowledgement for a delivery that has not shipped. | Pick a shipped delivery. |
{delivery} does not carry a lot of {notice}. | The delivery has none of the notice's lots. | Pick a delivery that carries the lot. |
Notice {key} not found or Delivery order {key} not found | The record was deleted. | Reload the screen. |
Next steps
Handle a customer complaintThe complaint task.NCR and CAPA refusals
Every message the system gives when it refuses a step on a nonconformance, a CAPA or a trend review, and what to do.
Training and gauges refusals
Every message the system gives when it refuses a training record, a training requirement, a calibration, a gauge or a gauge R&R step, and what to do.