SOP Title: Control of Non-Conforming Products
- Objective:
This procedure deals with the disposal of products that do not conform to specification.
- Scope:
Applicable to non-conforming, set-up, on-line, off-line of Bulk, Semi-Finished and Finished products and general non-conforming.
- Responsibility:
Concerned Department: to fill no-conformance form, reporting and participate in investigation, initiating CAPA and implementation.
QA Head: to allocate non-conformance report number, investigation, CAPA, follow up and close out.
- Accountability:
Head QA/ Head Production
- Procedure:
- Definitions:
- Non-conformance: A non-conformance is, in essence or something that does not meet specifications.
- Procedure:
| 5.2.1 | If a product is found to be failing to meet its specification either during manufacturing or testing it shall be reported to the Head of Quality Assurance Department in “Non-Conformance Report”. | |
| 5.2.2 | Isolate the product-in-process that is likely to have been affected by the discrepancy noticed. | |
| 5.2.3 | The non-conforming part of the product or, the batch shall be quarantined and the production shall be temporarily suspended. | |
| 5.2.4 | Enter the details of non-conformity in the “Non –Conformance Log” and allocate number starting with the letters NCR, followed by a slash and a three digit serial number 001,002,003 etc. | |
| 5.2.5 | Investigate the non-conformity by reviewing the batch record. He/she shall also review the laboratory investigations related to the non-conforming test results. | |
| 5.2.6 | Assessment of significance of the non-conformity and suggest remedial measures which may include correcting the non-conformity, allowing the product to proceed or, rejecting the product.
The review of the non-conformity and the action to be taken shall be recorded as per SOP. |
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| 5.2.7 | The remedial action shall be taken and necessary batch records shall be filled. The required Batch Manufacturing Record (BMR) forms shall be obtained from QA after authorization. | |
| 5.2.8 | The products shall be reprocessed, only after authorization and permitted within the scope of Master formulation. | |
| 5.2.9 | If the corrective action of the non-conformity indicates the need for preventing recurrence the instruction given in the SOP “Corrective And Preventive Action”. | |
| 5.2.10 | Trending of non-conformities shall be done on yearly basis. If frequent non-conformity is observed on a particular product, then refer SOP (Corrective And Preventive Action) shall be followed to take necessary preventive action to avoid recurrence. | |
| 5.2.11 | For General Non-Conformance in plant shall be recorded in prescribe format. | |
| 5.2.12 | Record the details of general non-conformity in the “Non –Conformance Log” and allocate number starting with the letters GNCR, followed by a slash and a three digit serial number 001,002,003 etc. |
- Abbreviation:
| Abbreviation | Expansion |
| QAD | Quality Assurance Department |
| NCR | Non-Conforming Report |
| GNCR | General Non-Conforming Report |
| CAPA | Corrective And Preventive Action |
*Note – Ready to use SOP available in “DOWNLOAD” Section.