Complete Pharma Solution
NON-CONFORMANCE RESULTS
OBJECTIVE: To lay down the procedure for define the necessary action against the non-conformance of a product.
SCOPE: This procedure is applicable for information, investigation and control for any kind of non- conformance noticed or confirmed in Production, Stores on in others area for its proper investigation
RESPONSIBILITY:
Officer – IPQA shall be responsible for the implementation and compliance of the Standard Operating Procedure.
Officer/Executive-QA shall be responsible for the implementation and compliance of the Standard Operating Procedure.
ACCOUNTABILITY:
Head- Quality Assurance shall be accountable for the implementation and compliance of the Standard Operating Procedure.
Head – Production shall be accountable for the implementation and compliance of the Standard
Operating Procedure.
ATTACHMENTS:
Non-Conformance Report – Attachment-I
PROCEDURE:
Whenever any non-conformance of procedure, result, activity observed with respect to the standards shall immediately bring to the notice of the concerned department Head and Head-Quality Assurance.
Non-conformance report shall be filled by the concerned Department officer with all details as per format.
After checking all the details filled in the form, Department – Head shall forward the same to Quality Assurance.
On receipt of the non-conformance intimation slip, Head- Quality Assurance shall take an early step to the non-conformance and will advise for the future course of action.
Head-Quality Assurance shall discuss and investigate the non-conformance observed in detail and ideal solution to the non-conformance shall be worked out and the same shall be written on the non-conformance report.
The corrective action and solution in detail to be filled by the Head-Quality Assurance and shall send to concerned Department for implementation.
Head-Quality Assurance or his nominee shall ensure that the action suggested is implemented correctly.
Concerned department shall write the details of the action taken on the non-conformance report and return the non-conformance report to Head-QA.
Head-Quality Assurance shall check that action suggested has been complied with and if satisfactory, the Quarantine status shall be lifted.
ABBREVIATIONS:
SOP : Standard Operating Procedure
QA : Quality Assurance
DISTRIBUTION LIST:
Quality Assurance Department
Quality Control Department
Production (Formulation) Department
Production (Packing) Department
Engineering & Utility Department
Warehouse Department
9.0 HISTORY OF REVISION:
| Revision No. | Date of Revision | Reason for Revision |
| 00 | – | New SOP |
