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Quality system

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.

View as Markdown

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.

Training

For Training records and the training gate.

The training gate on a signed step

MessageWhenWhat to do
{name} is not current on {document status, ...}. Signed step blocked (ISO 13485 6.2).You signed a step while a Before task requirement for your job title is not Current. The message lists each document and its status.Ask the QA manager or HR to record your training.
{name} is not linked to a person, so signed steps and steps that need training are blocked. Ask an administrator to link your person in Settings › Users & invitations.Your login is not linked to a person.Ask an administrator.
{name} cannot take signed steps or steps that need training: {reason}. Ask an administrator to link an active employee in Settings › Users & invitations.Your login has no employee, the employee is missing, or the employee is Suspended.Ask an administrator.

Training records

MessageWhenWhat to do
Training records are recorded by the QA manager or HR (Org admin). You are signed in as {name} ({role}).Adding, editing or deleting a training record or requirement without that authority.Ask the QA manager or HR.
You cannot record or evaluate your own training, or that of the person you sign for. Ask the QA manager or HR.Deleting or attaching a file to your own training record.Ask the QA manager or HR.
You cannot record or evaluate your own training. Ask the QA manager or HR.The Employee on the record is you.Ask another manager.
You cannot record or evaluate the training of the person you sign for. Ask the QA manager or HR.The employee is the person you sign for as a delegate.Ask the QA manager.
Your login is not linked to an employee, so training cannot be recorded from it. Ask an administrator to link your employee in Settings › Users & invitations.The recorder's login has no employee.Ask an administrator.
Name the trainer who delivered or witnessed this training.Trainer is blank.Choose the trainer.
The trainer and the trainee must be different people.Trainer is the Employee.Choose another trainer.
The training date cannot be in the future.Trained on is after today.Enter today or an earlier date.
Record the evidence of the training (a sign-in sheet, test result or observation) before judging it Competent or Not yet competent.Effectiveness is judged with no Effectiveness evidence.Write the evidence.
No employee is named {name}. Choose an employee.The Employee is blank or unknown.Choose from the list.
Two employees are named {name}, so training cannot be filed under that name. Rename one in the employees register first.Two employees share the name.Rename one in the employees register.
{doc} has no revision {rev}. Its current revision is {current}; enter a revision the document has had.Rev trained is a revision the document never had.Enter a real revision.

Training requirements

MessageWhenWhat to do
{key} already requires {role} to be trained on {doc}.A second live requirement for the same role and document.Edit or retire the first one.
You cannot change the training required of your own job title ({role}). Ask the QA manager or HR.Editing or deleting the requirement of your own job title.Ask the QA manager or HR.

Policy acknowledgements

MessageWhenWhat to do
A policy acknowledgement is signed by the employee it is forSomeone else tried to sign your row.Ask the employee to sign it.
More than one employee is named {name}, so this acknowledgement cannot be tied to one person. Give them different names in Employees, then choose the employee again on this acknowledgementThe name on the row is shared.Rename one employee and choose again.

Gauges and calibration

For Gauges and calibration.

Gauge register

MessageWhenWhat to do
Calibration due and last calibrated change only through an approved calibration record. Use Record calibration.Editing Calibration due or Last calibrated by hand.Use Record calibration.
Your sign-in is not linked to an employee record. Ask an administrator to link it before {recording a calibration or editing a calibration record}.Your login has no employee.Ask an administrator.
STOP · {reason}An inspection uses a gauge that is overdue, out of tolerance, quarantined or retired. The result is not saved.Use a gauge in calibration.

Calibration records

MessageWhenWhat to do
Who recorded and who approved a calibration are set by the steps. They cannot be edited.Editing Recorded by or Approved by.Leave them.
Only the person who recorded this calibration can change its date, certificate, readings or findings. Ask them to correct it, or record a new calibration.Someone else edits a Draft.Ask the recorder.
Fill in first: {calibration date, calibrated by, certificate no., reference standard, as-found result, readings, as-left result}Approve calibration with those fields blank. The message lists the blank ones.Fill them in.
The calibration date {date} is in the future. Enter the day the gauge was calibrated.Calibrated on is after today.Correct the date.
This calibration has no recorder. Record it again with Record calibration.The record has no Recorded by.Start a new record.
The approver must be someone other than the person who recorded itThe recorder tried to approve.Ask the QA engineer.
Gauge {id} is not in the gauge register.The gauge was removed.Pick a gauge in the register.
Gauge {id} is retired. A retired gauge is not calibrated back into use.Approve calibration for a retired gauge.Register a new gauge.
The next due date {date} must fall between the calibration date and {latest} (the {n}-month interval of {gauge}).Next due is before the calibration or beyond the interval.Enter a date inside the range.
Write the impact assessment firstRaise NCR with Impact assessment blank.Write it.
{ncr} already linkedRaise NCR twice.Open the linked NCR.
Fill in first: {impact assessment, decision}Close · assessment complete with those blank.Fill them in.
Link the NCR (or use Raise NCR)Decision is NCR raised with no NCR linked.Choose Raise NCR, or link one.

Gauge R&R

MessageWhenWhat to do
A study needs at least 5 parts, 2 operators and 2 trialsCalculate · submit with fewer.Run a bigger study.
Enter EV, AV, PV and the toleranceOne of those is blank or zero (AV may be 0).Enter all four.
{gauge} is not capable for {characteristic}. Reject the study and quarantine the gauge.Approve study on an Unacceptable result.Choose Reject · gauge not capable.
Conditional result: enter the justification for continued useApprove study on a Conditional result with no Justification (conditional).Write the justification.

Next steps

Training records and the training gateThe training task.

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