SOP FOR HANDLING OF NON-CONFORMANCE OBSERVATION

SOP for HANDLING OF NON-CONFORMANCE OBSERVATION

1.0 OBJECTIVE

The purpose of this SOP is to establish a systematic procedure for identification, reporting, investigation, classification, control, and closure of non-conformances observed during product processing, and to prevent their recurrence in future manufacturing processes or product delivery.

2.0 SCOPE

This procedure is applicable to all types of non-conformances observed during:

• Incoming material inspection

• In-process manufacturing activities

• Packing operations

• Final product inspection

• Routine shop floor audits

• IPQA activities

• Regulatory or in-house Quality Management System observations

This SOP covers investigation, corrective action, preventive action, documentation, and closure of Non-Conformance Reports (NCR).

3.0 RESPONSIBILITY

3.1 Officer/Executive – Production

• Identify and report non-conformances during processing and packing.

• Ensure segregation and prevention of further use of non-conforming materials/products.

3.2 Officer/Executive – Quality Assurance (QA)

• Record and issue NCR.

• Conduct investigation and root cause analysis.

• Review corrective and preventive actions.

• Monitor implementation and close NCR.

3.3 Head of Department (HOD) – Concerned Department

• Implement immediate correction and corrective action.

• Propose preventive actions.

• Ensure compliance within the department.

• Provide required training to personnel.

4.0 ACCOUNTABILITY

4.1 Head – Quality Assurance / Designee shall be accountable for overall implementation, review, and closure of NCRs under this SOP.

5.0 DEFINITION & ABBREVIATIONS

5.1 Definitions

Not Applicable.

5.2 Abbreviations

6.0 PRECAUTIONS, SAFETY & EHS

Not Applicable.
(Refer to relevant Safety and EHS SOPs where required.)

7.0 MATERIALS & EQUIPMENT REQUIRED

7.1 Materials: Not Applicable
7.2 Equipment: Not Applicable

8.0 PROCEDURE

8.1 Detection of Non-Conformance

8.1.1 Any abnormal finding observed during routine shop floor audit, IPQA activity, regulatory inspection, Drugs & Cosmetics compliance review, or internal Quality Management System shall be considered as Non-Conformance.

8.1.2 non-conforming material/product may be detected at any stage, including:

• Incoming inspection

• In-process inspection

• Final inspection

8.1.3 All non-conforming materials/products shall be clearly identified and segregated to prevent mix-up with conforming materials/products.

8.1.4 Incoming materials found non-conforming shall be:

• Clearly labeled

• Segregated

• Stored in the designated Incoming Rejection Area

8.1.5 In-process non-conforming materials shall be:

• Placed in Red Bins or tagged with Red Labels

• Stored at a designated rejection location

• Prevented from further processing or delivery

8.1.6 Finished goods found non-conforming shall be clearly identified using rejection tags and segregated to prevent mix-up with conforming products.

8.1.7 Any process-related observation that deviates from approved procedures shall also be treated as non-conformance.

8.2 Investigation of Observation

8.2.1 A complete investigation shall be conducted for every non-conformance.

8.2.2 Root cause analysis shall be performed to identify the underlying reason for non-conformity.

8.2.3 All non-conformances shall be classified into the following categories:

8.2.3.1 Critical

Non-conformances that may result in:

• Product failure or recall

• Adverse drug reaction

• Regulatory action

• Significant impact on product quality or stability

8.2.3.2 Major

Non-conformances that may result in:

• Equipment/system breakdown

• Yield discrepancy

• Material damage during transportation

• Potential impact on product quality

8.2.3.3 Minor

Non-conformances that:

• Can be corrected within a scheduled program

• Do not pose risk of market complaint

• Do not cause equipment breakdown

• Have no direct impact on product quality

8.3 Control of Non-Conformance

8.3.1 All non-conformances shall be documented in the prescribed format:
Non-Conformance Observation & Investigation Report 

8.3.2 QA personnel shall:

• Initiate the NCR

• Document immediate action taken

• Hand over the NCR to the concerned HOD

8.3.3 QA Officer, along with the concerned HOD, shall:

• Investigate root cause

• Assess impact of non-conformance

• Define corrective action

• Assign responsibility

• Specify target completion date

8.3.4 Preventive action shall be proposed by the concerned HOD in consultation with QA to prevent recurrence.

8.3.5 The concerned department shall implement corrective action within the defined timeline and update progress in the NCR.

8.3.6 QA shall review the implementation and effectiveness of corrective action.

8.3.7 If corrective action requires modification or additional improvement, QA shall:

• Notify the concerned department

• Assign a revised target completion date

8.3.8 NCR shall be finally reviewed and closed by Head – Quality Assurance after satisfactory implementation of corrective and preventive actions.

8.3.9 QA department shall maintain all copies of closed NCRs for record retention.

8.3.10 Department Head, in coordination with QA, shall conduct need-based training related to the non-conformance.

8.4 Documentation and Log Maintenance

8.4.1 All NCRs shall be recorded in the Non-Conformance Observation Log (Annexure-II).

8.4.2 The log shall include:

• NCR number

• Date of observation

• Department

• Category (Critical/Major/Minor)

• Status (Open/Closed)

• Closure date

9.0 ENCLOSURES

• Annexure-I: Non-Conformance Observation & Investigation Report

• Annexure-II: Non-Conformance Observation Log