Closing of Corrective Action Requests (CARs)

SQA Advisory Number 8

Original date: July 30, 2004
Revision date: July 30, 2004
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Introduction:

Whenever an SQA auditor identifies and verifies the existence of a nonconformance to an applicable requirement he/she will issue a Corrective Action Request (CAR). CARs may be issued against the following source requirements: a) the applicable standard; b) the organizations self-generated requirements, e.g., policies, procedures, work instructions, other; c) customer specific requirements; d) the SQA Description of, and Agreement for Services; e) applicable legal requirements.

Discussion:

The fact that a CAR is issued means that there was a breakdown in one or more portions of the management system. Such breakdowns could be of a minor or major significance. Regardless of degree, all breakdowns require action be taken to identify the root cause and implement positive, effective, and irreversible corrective action. In the past, if the degree of nonconformance was classified as minor, SQA permitted organizations to implement corrective action during a current assessment, provided that the auditor could witness all activities related to the aforementioned actions. (In the case of ISO/TS 16949 audits, this action had the additional requirement that time be added to the planned audit-days.) A review of CAR responses has created concern that this practice did not provide the organization with sufficient time to execute effective root cause analysis, implement corrective action and check for its effectiveness in precluding recurrence and/or not creating new problems.

SQA Position:

Effective September 1, 2004, SQA will no longer permit the closure of CARs during an assessment. Should a CAR be issued, it will need to be responded in accordance with the directions as indicated on the CAR. Typically this means a written response within 30 days and closure within a total 60 or 90 days depending upon the standard. Closure will be accomplished via review of objective evidence by an SQA auditor. This review may be executed on- or off-site; the decision is up to the issuing SQA auditor, with the exception that CARs classified as “major” require on-site review of objective evidence. For all CARs, regardless if they were closed on- or off-site, the effectiveness of the corrective action will be assessed at the next scheduled assessment. Should there be evidence that the corrective action was ineffective, a new CAR will be issued.

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