The Nonconformity and Corrective Action Procedure AS9100 outlines the responsibilities and methods for identifying causes of nonconformities in the QMS, initialing corrective actions, and performing follow-up to ensure that those corrective actions have been effective in eliminating the nonconformity. The Nonconformity and Corrective Action Procedure AS9100 applies to all QMS nonconformities. (6 pages, 1477words)
When it is determined that corrective action is required, such action should begin with an AS1250-1 CORRECTIVE ACTION REQUEST (or CAR). Department management, the Quality Assurance Manager, or Top Management may initiate such a request. Every CAR should include a description of the problem, observation, or nonconformity and indicate when and where it was observed. The completed AS1250-1 should be submitted to the Quality Assurance Manager, who should assign a CAR number and enter the request in the AS1250-2 CORRECTIVE ACTION LOG.
Nonconformity and Corrective Action AS9100 Responsibilities:
The Quality Assurance Manager is responsible for ensuring that the corrective action procedures are accurate, understood, implemented effectively. and reported at Management Review Meetings.
All Employees are responsible for investigating and recording the cause(s) of nonconforming conditions when assigned and implementing the corrective actions determined by this procedure.
Nonconformity and Corrective Action AS9100 Definitions:
CAR – Corrective action request (or report).
Conform – Be in agreement; act according to prevailing standards or customs.
Correction – Action taken to rectify/repair a known nonconformity.
Corrective action – Act of eliminating the root cause of a known nonconformance, defect, or other undesirable situation to prevent its recurrence.
Nonconformity – output not conforming to a standard or specification; something that falls outside of defined critical limits; also known as “nonconformance” and includes complaints.
Root cause – Ultimate, or initiating, cause of an effect; usually identified through an exercise known as “root cause analysis”.