Example of Procedure for Control Of Non Conforming Products

Uncategorized 4 Minutes

1.0 PURPOSE

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.

2.0 SCOPE

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

3.0 RESPONSIBILITY

  • Management Representative
  • QA/QC Engineer
  • All concerned process owners

4.0 INPUTS

Final Product/output inspection

5.0 RESOURCES

ALL MMEs, trained man power Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions

PROCEDURE

  1. The nonconforming Materials during receiving, in-process and final inspection are identified and corrective actions are taken as appropriate.
  2. The nonconforming Materials are dealt with and reviewed by QA/QC Engineer.
  3. 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.
  4. 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.
  5. 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.
  6. When nonconforming product/output is corrected, that product/output is subjected to re-verification to demonstrate conformity to the requirements.
  7. Records of the nature of nonconformities and any subsequent actions taken including concessions obtained are maintained.
  8. The product/output that does not satisfy the original customer acceptance criteria satisfies that changes / new customer acceptance criteria.
  9. The details of nonconformity and repairs are recorded and maintained.
  10. The repaired or reworked product/output is re-inspected and records are maintained.

6.1 Responsibility

  1. All department managers and their staff are responsible to implement this procedure in order to attain its objective.
  2. 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).
  3. 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)
  4. Storekeeper is responsible for segregating, where possible and following with the concerned supplier/or procurement for disposition action.
  5. 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:

  1. Identification of customer complaints otherwise referred as field non-conformances.  .
  2. 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.
  3. The customer complaints are handled by Manager QA/QC and records are maintained. (Refer :Customer Complaint Record – XXX/QA/14)
  4. 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.
  5. 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.
  6. 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.

6.3 IDENTIFICATION

  1. All non-conforming materials are identified in accordance with this procedure and are recorded in the NCR.
  2. 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.
  3. 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.
  4. 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

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. Repair and/or reworked product are re-inspected in accordance with the quality plan and/or documented procedure.

6.5 Records

XXX has maintained the records of non-conformities and any subsequent action taken, including concessions obtained in the Non-conformance Product Report.

7.0 OUTPUTS

Non conforming output records.

8.0 KEY PERFORMANCE INDICATOR

Zero non conforming product

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
Customer Complaint RecordXXX/QA/14QA/QC Engineer
Non Conformity Product ReportXXX/MR/42QA/QC Engineer

Published by Pretesh Biswas

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