Quality System Procedure - Control of Nonconforming Work

Most recently edited by: Paul VanderWeele
Most recent edit date: Jan 26, 2021
Edits were authorized by: Paul VanderWeele

Purpose

To control any aspect of testing work or the results of this work that do not conform with its own procedures or the agreed requirements of the customer.

Scope

Nonconforming work or any part thereof.

Definitions and Acronyms

Nonconformity – nonfulfillment of a specified requirement.

Concession – written authorization to use or release a product which does not conform to the specified requirements.

Disposition of Nonconformity – action to be taken to deal with an existing nonconforming entity in order to resolve the nonconformity.

Repair – action taken on a nonconforming product so that it will fulfill the intended usage requirements although it may not conform to the originally specified requirements.

Rework – action taken on a nonconforming product so that it will fulfill the specified requirements.

Responsibilities

This procedure applies to all employees. Any employee can halt work when nonconformities are identified.

Technicians that are fully trained in trouble-shooting equipment problems are authorized to resume work that has been corrected before incorrect results have been reported to customers.

The Technical Manager or his/her deputies are responsible for authorizing the resumption of work after effective corrective action has been taken to prevent the release of unacceptable test results in the future. This requires the use of the corrective action procedure described in SOP# QSP-4-11-1 to find the root cause of the nonconformance and eliminate future occurrences.

Materials Required Corrective Action Request form Equipment logbook

Procedure

  1. Record the occurrence of a nonconforming event in the Corrective Action Request form / equipment maintenance logbook.

  2. Report the nonconforming event to the supervisor.

  3. Suspend further work and begin an investigation to correct the nonconformity.

  4. Evaluate the significance of nonconforming work.

  5. Notify the customer of all incorrectly reported results, if applicable.

  6. Correct nonconformity, if possible.

  7. Initiate corrective action to prevent recurrence of the nonconformity.

  8. Repeat the test or analysis, if possible.

Documentation

Nonconforming samples are recorded on accompanying submission forms. Equipment problems are recorded in the appropriate equipment maintenance log. All nonconformities are recorded in the Corrective Action Request form.

Root cause analysis and closed loop corrective actions taken to prevent recurrence of nonconformities are recorded as described in the Quality System Manual.

Required Record Custodian Signed Waiver or Deviation when required by customer agreement Responsible Manager Nonconformity Report (first section of CAR) Responsible Manager “Calibration Void – Do Not Use” label Responsible Manager “Out of Service – Do Not Use” label Responsible Manager