Incident Investigation, Nonconformity, Corrective and Preventive Action Procedure

Purpose

To establish, implement and maintain a procedure for dealing with Incident Investigation, non-conforming product, actual and potential nonconformities, corrective actions.

Responsibility and Authority

The QEH&S Management Representative shall have the responsibility and authority to ensure conformance to the activities described in this procedure.

Procedure - Incident Investigation – Health and Safety

1. Required incident reports will be determined by the QE&HS Management Representative. Any employee, contractor or vendor may recommend one be written.

2. Health and Safety Incidents must be recorded on the Incident Report Form and tracked on the Incident Report Log.

3. All health and safety incidents must be investigated and analyzed to determine and underlying QEH&S deficiencies and other underlying factors that may have contributed to the incidents.

4. Investigation of Health and Safety incidents shall be handled in a timely manner and results communicated to appropriate personnel

5. Health and Safety Incidents shall be analyzed to identify opportunities for preventive action and continual improvement.

6. Health and Safety Incident Investigation requiring corrective and preventive action will be handled according to the instructions below.

Procedure - Incident Investigation – Spill or Release

1. Spill or Release Incidents must be recorded on the Incident Report Form and tracked on the Spill or Release Report and tracked on the Incident Report Log.

7. All Spill or Release Incidents must be investigated and analyzed to determine and underlying QEH&S deficiencies and other underlying factors that may have contributed to the incidents.

8. Investigation of Spill or Release Incidents shall be handled in a timely manner and results communicated to appropriate personnel

9. Spill or Release Incidents shall be analyzed to identify opportunities for preventive action and continual improvement.

10. Spill or Release Incident Investigation requiring corrective and preventive action will be handled according to the instructions below.

Procedure - Incident Investigation - Data Breach

2. Data Breach Incidents must be recorded on the Incident Report Form and tracked on the Incident Report Log.

3. All Data Breach incidents must be investigated and analyzed to determine and underlying security deficiencies and other underlying factors that may have contributed to the incidents. Evidence shall be collected from the time that the security breach is initially detected, retained and presented in conformity with the rules of evidence in the relevant jurisdiction(s), if the data breach incident involves legal action (civil or criminal).

4. Investigation of Data Breach incidents shall be handled in a timely manner and results communicated to relevant authorities, affected supplier(s), and other interested parties as required by law.

5. Data Breach Incidents shall be analyzed to identify opportunities for preventive action and continual improvement.

6. Data Breach Incident Investigation requiring corrective and preventive action will be handled according to the instructions below.

Procedure - Non-Conforming Product

1. Routine product verification and monitoring at all stages in the work process should be aimed at identifying any non-conforming or defective products or services. All personnel must report non-conforming products.

2. Non-conforming product can be found in the following processes:

1. Receiving – Not Accepted Material

2. Sorting – Not Accepted Material, Incorrectly Sorted Material

3. Reuse and Refurbishment – Returned Materials

4. Quality Control – failed functionality QC testing

5. Quality Control – failed data destruction validation

3. Non-conforming product in each process area above are handled according to the appropriate departmental procedure.

4. The appropriate departmental procedure describes how non-conforming product is clearly identified and segregated, where possible in a designated quarantine area.

5. Non-conforming product returned from the customer shall be recorded on the RMA Log. Any pricing concessions shall be recorded in emails between the Company and the Customer.

6. All non-conforming products or services must be dealt with promptly to prevent the deficiency becoming worse or affecting the Customer.

Procedure - Corrective Actions

1. Nonconformities may be identified by, but not limited to, any of the following

   1. Customer complaints,

   2. External Provider complaints,

   3. Employees,

   4. Monthly facility inspections or other inspection activities,

   5. Internal audits, and

   6. External audits.

2. Nonconformities identified both internally and externally shall be addressed using the CAPA Report. All employees have the authority to generate a CAPA Report.

3. The QEH&S Management Representative shall designate the person responsible (assignee) for completion of the correction and corrective action plan and will track the completion of the corrective action using the CAPA Log.

4. The QEH&S Management Representative shall be responsible for approving all corrections and corrective action plans before those plans are implemented.

5. The QEH&S Management Representative shall be responsible for ensuring that any necessary changes are made to environmental, health and safety management system documentation resulting from the correction and corrective action.

6. The QEH&S Management Representative shall have the authority and responsibility to evaluate the effectiveness of the correction and corrective action.

Procedure - Preventive Actions

1. Preventive Actions may be identified by employees, inspections, internal audits and external audits.

2. Preventive actions identified both internally and externally shall be addressed using the CAPA Report. All employees have the authority to generate a CAPA Report.

3. The QEH&S Management Representative shall designate the person responsible (assignee) for completion of the preventive action plan and will track the completion of the preventive actions using the CAPA Log.

4. The QEH&S Management Representative shall be responsible for approving all preventive action plans before those plans are implemented.

5. The QEH&S Management Representative shall be responsible for ensuring that any necessary changes are made to environmental, health and safety management system documentation resulting from the preventive action.

6. The QEH&S Management Representative shall have the authority and responsibility to evaluate the effectiveness of the preventive action.

Related and Supporting Documents

8.1.1.7-F Incident Report Form

8.1.1.8-F Incident Report Log

8.1.4.3-F RMA Log

10.2.2-F CAPA Report

10.2.3-F CAPA Log

10.2.4-F Spill or Release Report

Document Revision History

Rev. Description of Change Date By

0 New 01-07-22 C.Vo

10.2.1-P Incident Investigation, Nonconformity, Corrective and Preventive Action Procedure - Rev.0

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