Standard Operating Procedure for Completing Non-Conformity Report

Purpose      To ensure correct method and sequence is followed in completing a Non-conformity   Report (F-09-02)

Scope       This procedure applies to the non-conformities identified in plant products, processes and services

 Responsibilities

E NCR Originator

E Concerned Department Heads

E Quality Management Representative / QA Incharge

Procedure  E Non-Conformity Report (F-09-02) can be raised as a result of

1)      Routine Inspection / Testing

2)      Customer Complaint

3)      Internal Audit

4)      GMP Audit

5)      Self inspection

6)      Corrective / Preventive Action

A) The Person raising NCR first discuss it with his department head then follow this procedure in processing the Report.

►    Enter date of Report

►    Mark appropriate box on line 1 & 2 based on nature of non-conformity.

►    Enter document number, which is used as standard to identify the non- conformance ( SOP-08--01 etc)

►    Identify person who raised the NCR (Write name of person or customer as applicable)

►    Enter department name, product, or process for which NCR is raised.

►    Non-conformance Write brief description of non conformity with:

a)      Objective evidence

b)      Applicable procedure Para or clause reference (Para 6.2 etc)

c)      Sign and date the non-conformance statement.

B) Root Cause and Result of Investigation:-

The Department Head (where non-conformance was identified) review the NCR and determine the course of action to be followed in consultation with area Incharge. Description of cause and investigation are entered, then corrective action and its implementation is enforced.

C) Corrective Action

The concerned department head is responsible to take corrective actions for identified non conformity & forward completed NCR with support documents; report etc to Quality Management Representative,/ QA Incharge who after review assigns it the sequential No.

D) Close Out

The NCR is closed out after corrective action follow up & review by Quality Assurance Manager / Quality Management Representative / Internal Auditor as applicable.

E) Quality Management Representative / QA Incharge maintains log of all NCRs & send copies of completed NCR to the concerned department. Quality Management Representative present status of non-conformance to management in Management Reviews as per Quality Management System.

F) Each department head should maintain documented record of non-conformances in their department.

Related Documents & Forms

Control of Non Conformity Corrective & Preventive Action            E   (QSP-09)

Product Recall                                                                                    E   (SOP-09-PRL)

Internal Quality Audits                                                                       E   (QSP-10)

Non-Conformity Report                                                                     E   (F-09-02)

Customer Complaint Log Marketing                                                  E   (F-09-01)

Log of NCRs (Product, Process Service)                                           E   (F-09-05)