The purpose of this procedure is
- To identify the controls and related responsibilities and authorities for addressing non-conforming product
- To address detected non-conformities
- To take action to preclude its original intended use or delivery
- To authorize its use, release, or acceptance under concession by relevant authorities.
This procedure is applicable to all the following systems and standards
- ISO 29001: 2020/ API Spec Q1, 9th edition
- API Spec 6A
- API Spec 16A
- API Spec 5CT
- API Spec 5DP
- API Spec 7-1
- Management Representative
- QA/QC Engineer
- All concerned process owners
Final Product/output inspection
ALL MMEs, trained man power Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions
- The nonconforming Materials during receiving, in-process and final inspection are identified and corrective actions are taken as appropriate.
- The nonconforming Materials are dealt with and reviewed by QA/QC Engineer.
- The review includes the following.
- By taking action to eliminate the detected nonconformity.
- By authorizing its use, release or acceptance under concession by a relevant authority and where applicable, by customer.
- By taking action to preclude its original intended use or applicable.
- By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product/output is detected after delivery or use has started.
- Non-conforming product are identified, by means of attachment of a yellow sticker, documented and after evaluation are segregated, to ensure un-authorised use is not permitted prior to disposition action.
- Disposition of non-conforming material is made at inspection level, which ensures that where notification to functions affected is required and it can be achieved.
- When nonconforming product/output is corrected, that product/output is subjected to re-verification to demonstrate conformity to the requirements.
- Records of the nature of nonconformities and any subsequent actions taken including concessions obtained are maintained.
- The product/output that does not satisfy the original customer acceptance criteria satisfies that changes / new customer acceptance criteria.
- The details of nonconformity and repairs are recorded and maintained.
- The repaired or reworked product/output is re-inspected and records are maintained.
- All department managers and their staff are responsible to implement this procedure in order to attain its objective.
- It is the responsibility of QA/QC personnel to identify the non-conforming material immediately after inspection and notifying to the concerned personnel (production/or store).
- Production personnel are responsible for segregating or where segregation is not possible, clearly identified and stopped for further processing unless the procedure for disposition action being established. (Refer: Master List of Independent Inspection Personnel)
- Storekeeper is responsible for segregating, where possible and following with the concerned supplier/or procurement for disposition action.
- The QA/QC Engineer is the final authority of XXX to accept any non-conforming material based on the application and design/product acceptance criteria. The QA/QC Manager may contact the concerned authority (customer/design engineer) for acceptance of such, when required.
6.2 Non Conformance after product delivery:
The procedure for addressing non-conformance after delivery of product includes:
- Identification of customer complaints otherwise referred as field non-conformances. .
- The customers are notified in the event that product/output not conforming to customer acceptance criteria has been delivered and such notification records are maintained.
- The customer complaints are handled by Manager QA/QC and records are maintained. (Refer :Customer Complaint Record – XXX/QA/14)
- If the product is under the warranty period, based on the nature of complaint, the course of action towards the satisfactory completion of the complaint is initiated.
- The customer is informed in writing about the course of action and if required suitable person is deputed to the customer’s site to attend the complaint.
- The customer’s complaint and root cause of nonconformance is analyzed and corrective action is taken suitably to minimize recurrence of similar problems in future.
- All non-conforming materials are identified in accordance with this procedure and are recorded in the NCR.
- Non-conforming materials awaiting disposition action are identified by yellow sticker (“NON-CONFORMING”) or attached with a round yellow sticker on the material identification card.
- Non-conforming material, which cannot be rectified or utilised within the system is identified by red sticker (“REJECTED”) or attached with a round red sticker on the material identification card.
- All non-conformance materials are to have non-conformance report filled with disposition action and are followed accordingly.
6.4 REVIEW AND DISPOSITION OF NON-CONFORMING PRODUCT/OUTPUT
- The QA/QC Engineer is responsible for the review of non-conformity of the product/service or the quality system. On behalf of the Chairman, the QA/QC Engineer has the authority and organizational freedom for the disposition action.
- All non-conforming product are reviewed in accordance with this Procedure/Contract Technical requirement/or the product/output manufacturing specification (including API-specification and standards).
- Where the disposition action established is either repaired or re-work, acceptance with or without repair by concession, the product/output is regarded for alternative applications, or rejected/scrapped.
- The QA/ QC Engineer have to agree on disposition, concession or uplift of the non-conforming product/output or return of the non-conforming product/ output to the supplier or company stores. Details of the disposition action taken are recorded on the relevant inspection reports and/or NCR.
- Where required by the contract, the proposed use or repair of product/output which does not conform to specific requirement is reported for concession to the customer or customer’s representative. The description of non-conformity that has been accepted and of repair is recorded to denote the actual condition. All such records are maintained in accordance to Manual.
- Repair and/or reworked product are re-inspected in accordance with the quality plan and/or documented procedure.
XXX has maintained the records of non-conformities and any subsequent action taken, including concessions obtained in the Non-conformance Product Report.
Non conforming output records.
8.0 KEY PERFORMANCE INDICATOR
Zero non conforming product
9.0 ASSOCIATED DOCUMENTS & RECORDS
|Customer Complaint Record||XXX/QA/14||QA/QC Engineer|
|Non Conformity Product Report||XXX/MR/42||QA/QC Engineer|