Internal Corrective Action Requestpage 1

Internal Corrective Action Requestpage 1

Internal Corrective Action RequestPage 1

1.Purpose

1.1.Defines the method used to document and investigate the cause of discrepancies discovered during audits.

2.Scope

2.1.Applies to Management System Audits (See NPP-99036), Product Audits or Process Audits (See NPP-99037) performed by Quality Assurance or other designated personnel at Corporation facilities.

2.2.Applies to the Quality Manual () section 4.14 “Corrective and Preventive Action”.

3.DEFINITIONS(optional)

Responsible Person

The person accepting the responsibility to investigate a discrepancy, initiates the action to correct the problem, and takes action to prevent it’s recurrence.

Corrective Action

Action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.

Preventive Action

Action taken to eliminate the causes of a potential nonconformity, defect or other undesirable situation in order to prevent occurrence.

4.POLICY

4.1.The Internal Corrective Action Request (ICAR) form (See Exhibit) is initiated by the Systems Assessment function or other designated personnel to describe a discrepancy found during an audit.

5.PROCEDURE(optional)

5.1.Each report will be identified by the Report Number entered in one of the appropriate fields under “Audit Type/Report Number”. The report number is arbitrary, but must be unique. It typically consists of the quality system audit number or model number being audited, followed by a sequential number starting with one. The ICAR field “Description of Requirement” is used to quote/state the reference condition that was not met.

5.2.The person having the responsibility for taking corrective/preventive action, usually the area manager, will be given a copy of the form. When appropriate action has been implemented, the form will be returned to the Systems Assessment function with a dated signature by the “Responsible Person”, a description of the actual cause of the discrepancy, a description of the corrective action taken, and a description of the preventive action taken.

5.3.If an ICAR is open over 30 days, the responsible person is required to provide a plan to close the ICAR, with an estimated date of completion.

5.4.If an ICAR is open over 60 days with no plan on file, or the plan elapses, an escalation ICAR may be generated per NPP-99036.

5.5.Each ICAR, after it has been completed by the “Responsible Person”, will be followed up by a internal quality system auditor per NPP-99036 and NPP-99037. These follow up audits will determine if the corrective and preventive action is completed, implemented, and effectively remedies the original nonconformity.

5.6.ICARs will be tracked and filed by the Systems Assessment Department. This may be done by hard copy or electronically. There are three ICAR statuses. Open, Closed, and Closed and Audited. There will typically be a hard copy maintained for Closed and Audited ICARs.

5.7.Open ICAR forms for Quality System Audits, that have not been completed after thirty days from the request date, will be reviewed with the “Responsible Person” and the Systems Assessment function to get a commitment of a completion date, and if necessary a corrective action plan. An electronic reminder may also be sent to the responsible person.

5.8.The responsible person presents status to the Quality Council for each ICAR open more than 30-days. The Quality Council will pursue corrective and disciplinary actions necessary to correct nonconformities without delay.

5.9.Nonconformities issued by an accredited institution will be converted to ICAR(s) for the purpose of tracking and ensuring closure of corrective and preventive actions.

6.EXHIBITS

6.1.See Internal Corrective Action Request form on the following page.(optional)

INTERNAL CORRECTIVE ACTION REQUEST

NOTE: Timely action maintains ISO 9000 registration. Complete within 30 days, inform QA. If it takes more than 30 days, submit a detailed plan to QA.

Responsible Person / Auditee / Audit Type/Report Number
Quality Sys. / Product / Process
QA Expects Response by: / Auditor: / Reference Info:
Description of Requirement:
Description of Condition:
Actual Cause:
Describe what action was taken to CORRECT this condition:
Describe what action was taken to PREVENT this condition:
Signature / Title / Date

Return Completed Form To QA

Results of Follow Up Audit:
Follow Up Auditor / Title / Date