PURPOSE

• This procedure outlines the process used in the company for managing of non-conformance, corrective actions and preventive actions.

SCOPE

This procedure is applicable for handling of both internal and external non-conformances, and the corrective action request arising from customer complaints and system non-conformance.

REFERENCE DOCUMENT

• ISO 9001

RESPONSIBILITIES

• The Management Representative (MR) is responsible to ensure compliance with this procedure.

PROCEDURE

External Non-conformance

• When any customer complaint is received, the management will verify the validity of the complaint, and if the complaint is valid, the management will inform the person responsible to take immediate action and rectify the situation.
• If the complaint is considered serious enough to affect the business, the MR or QA Manager will raise a CAR to document the complaint.
• The MR or QA Manager will then carry out investigation to determine the cause of the non-conformity and inform the responsible party to implement corrective action to avoid recurrence.
• The MR or QA Manager will carry out audit to verify the implementation corrective actions
• Information on complaints and the corrective actions taken will be shared with other employees and Client (if require).

Internal Non-conformance

• Con-conforming raw material or in-process product will be marked “REJECTED” with red paint by QC Inspector who detects the non-conformance. Items marked with the red “REJECTED” will be segregated as practicable and no production step will be applied to it. The CAR will be raised and reported to QA/QC Manager for his review and further actions.
• The non-conformance shall be handled and analyzed by concerned department or QA/QC department in conjunction with related department

• Once informed by QA/QC or any individual either by oral/email or CAR and get correction from concerned Dept manager or concerned Dept manager together with QA/QC Dept manager, responsible Dept should take positive action in soonest to eliminate the non-conformity.
• Once further action has been determined for the non-conforming item, QC Inspector will delete the red “REJECTED” mark and release the item from segregation. Otherwise the “REJECTED” mark and the segregation shall be maintained.
• In case the non-conformance cannot be repaired for intended quality/ using, degrading for other usage, concession for acceptance or discard shall be approved by authority.
• The QA Manager will take necessary action for investigation for the cause of non-conformity, determination of corrective actions, and communication to relevant departments/functions for their aware of the non-conformance, the CAR and the actions to be taken.
• QA Manager will carry out audit to verify the implementation of corrective actions and QC inspector shall verify for the results.
• CAR logbook shall be updated and maintained by QA/QC department, the logbook shall be included CAR No., non-conformity description, reason of non-conformity, date open/close, in-charge person.
• Statistic & analysis report should be submitted to MR for review every year.
• The CAR will be sent to client for information or reference (if require).

Records

• All CARs are maintained in accordance with the document control procedure.