Deviations

The Deviations page logs deviations from established procedures, with root cause investigation and immediate corrective actions, per ISO 17025 §7.10.

Toolbar

Record Actions

Clicking the icon on each row shows:

• Edit — Open the edit form
• Preview — View record as PDF
• Download PDF — Download the record as a PDF file
• Send Email — Send the record as a PDF attachment via email
• Delete — Delete the record (with confirmation)

Fields

High risk: the work hold (§7.10.1b)

The standard wants actions on nonconforming work — halting work, withholding reports — to follow the risk level the laboratory itself establishes. Here that is not advisory: an open deviation at High blocks approval of any analysis that uses the linked sample or the linked method — and with it the report snapshot and the email to the customer.

The hold lifts in only two ways: closing the deviation, or authorizing work resumption (below). There is a third route for one specific analysis: an override by the Lab Director, Quality Manager or Reviewer, with a written reason recorded in the audit trail.

Which results were affected (§7.10.1c)

From the row menu, Impacted Results scans the already released reports that fall inside the deviation's scope: the linked sample, the linked method, or the instrument and method of the linked quality control or proficiency-test round.

The action is offered on every row, not only where you expect findings: an empty list is itself the evidence an assessor asks for. The window that was scanned is shown at the top of the result.

When the cause is an out-of-tolerance calibration

A deviation born from an out-of-tolerance calibration shows its own block of affected results inside the dialog, along with the window examined: since the last successful calibration up to today. If there is no earlier successful calibration, that is said explicitly rather than passed over.

Notifying the customer (§7.10.1e)

Ticking Previously released results affected reveals the three fields the standard wants for the notification: Customer Notified On, Notified By and Notification Method.

Authorizing work resumption (§7.10.1f)

Authorize Work Resumption appears in the row menu only where it means something: a High-risk deviation, not closed, that has not already resumed. It asks for a written rationale and needs the same roles that close a deviation.

The point of it: the deviation stays open. What lifts is only the hold. The standard asks for the conditions of resumption to be defined — not for the issue to be closed so work can continue.

CAPA Audit Pack

The "nonconformity file" as one PDF, from the row menu and where you hold the permission:

Closing a Deviation

Close on a deviation's row (instead of Delete) opens a dialog that requires a mandatory reason. A deviation already in Closed status cannot be closed again. Only the Lab Director, Quality Manager or Reviewer can close a deviation (§8.7). In addition, a deviation cannot be closed without a linked Corrective Action (§8.7.1) — the Lab Director or Reviewer can override this check by recording a written override reason.

Connects to

Points at — this page does not stand without these:

• Control Samples
• Corrective Actions
• Lab Methods
• Proficiency Testing
• Samples
• Users

Used by — a change here shows up in these:

• Environmental Readings

Notes

• See also: Corrective Actions, Customer Complaints, Risk Assessments, Instruments.