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.

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.

Nonconformance reports

For Handle nonconformances and CAPA.

Close NCR

Message	When	What to do
`An NCR is closed with Close NCR.`	You changed Status by editing the NCR.	Use Close NCR.
`Select a disposition before closing the NCR.`	Close NCR with Disposition blank.	Choose a disposition and save, then close.
`{key} is closed. Only an open NCR can be closed.`	Close NCR on a closed NCR.	None needed.
`Closing an NCR needs the signature of a QA engineer or QA manager.`	A role without that authority tried to close.	Ask the QA engineer.
`A Use as is NCR is closed by the QA manager named as approver, who signs the close.`	Someone other than the named approver (or their delegate) signed a Use as is close.	Ask the QA manager named in Concession approved by.
`NCR {key} not found`	The NCR was deleted or the link is old.	Reopen it from the list.

Concession (Use as is)

Message	When	What to do
`Use as is is a concession. Enter the justification before closing.`	Concession justification is blank.	Write the justification.
`Select the QA manager approving the concession.`	Concession approved by is blank.	Choose the approver.
`Concessions are approved by the QA manager.`	The approver is not the QA manager or an organization admin.	Choose the QA manager.
`The concession approver must be someone other than the NCR owner.`	The approver is also the Owner.	Choose another approver.
`Select whether customer approval is required.`	Customer approval is blank.	Choose an option.
`Enter the customer approval reference.`	Customer approval is Obtained with no reference.	Enter Customer approval ref..

CAPA

Stage steps

Message	When	What to do
`Set the risk level first`	Containment done · investigate with Risk blank.	Choose the risk.
`Record the containment taken, or why none is needed`	Containment done · investigate with Containment blank.	Write it.
`Missing: {investigation method, root cause, action, effectiveness criteria}`	Approve action plan with those fields blank. The message lists the blank ones.	Fill them in.
`Record the effectiveness evidence against the criteria first`	Close · effective with Effectiveness evidence blank.	Write the evidence.
`Record the evidence showing the action was not effective`	Not effective · reopen with Effectiveness evidence blank.	Write the evidence.
`The effectiveness must be verified by someone other than the CAPA owner`	The owner tried to close their own CAPA.	Ask another QA person.
`The effectiveness must be verified by someone other than the CAPA owner. You sign for the owner, so you cannot verify their CAPA`	You signed as a delegate of the owner.	Ask another QA person.
`Name the CAPA owner before closing it as effective`	Owner is blank.	Set the owner first.
`Your account is not linked to an employee, so it cannot be shown that you are not the CAPA owner. Link it to an employee first.`	The closer's login has no employee.	Ask the administrator.

Editing a CAPA

Message	When	What to do
`The due date of {key} moves later ({old} → {new}). Write a new Due date extension reason first.`	Due was moved later or cleared.	Write a new Due date extension reason.
`{key} is {status}. Its owner cannot change.`	Owner edited after the investigation started.	Leave the owner.

Trend reviews

Message	When	What to do
`Set the period from and to dates`	Run analysis, Raise CAPA from top signal or Approve review with From or To blank or reversed.	Set both dates.
`No signals to act on`	Raise CAPA from top signal with no signals.	None needed.
`{capa} already raised from this review`	Raise CAPA from top signal twice.	Open the CAPA.
`Record the decision and actions for this period`	Approve review with Decision and actions blank.	Write it.
`{n} signal(s): raise a CAPA or record why no action is needed`	Approve review with signals, no CAPA, and a short decision.	Raise a CAPA, or write the reason (20 characters or more).
`The approver must be someone other than the preparer`	The preparer tried to approve.	Ask the QA manager.

Next steps

Handle nonconformances and CAPAThe task these messages belong to.

Complaints and recalls refusalsComplaint and notice messages.

NCR and CAPA refusals

Nonconformance reportsCopy Anchor Link

Close NCRCopy Anchor Link

Concession (Use as is)Copy Anchor Link

CAPACopy Anchor Link

Stage stepsCopy Anchor Link

Editing a CAPACopy Anchor Link

Trend reviewsCopy Anchor Link