NON-CONFORMANCE RESULTS

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: