Friday, 13 September 2013

08-SOP FOR HANDLING OF MARKET COMPLAINTS

I. PURPOSE

To describe the procedure for Handling the Market complaints.

II. SCOPE

This SOP is applicable to the market complaint received from the customer through Marketing department regarding the material supplied from Unit - V.

III. RESPONSIBILITY

Marketing department

QA department

QC department

Production department

IV. ACCOUNTABILITY

Head -QA

V. PROCEDURE

1.0 Any communication, written or verbal, received directly from any customers or distributors, regarding the Quality, Quantity, Packing or any other such complaints are considered as Market Complaints.

2.0 All such complaints must be addressed to the QA department through marketing department.

3.0 On receipt of the complaint, QA allots a number and enters in the Market complaint log as per the Format No.: F01/SOPQA008-00.

4.0 The Marketing department acknowledges the customer within 24 hours, after receiving the complaint.

5.0 QA investigates the complaint with the help of Production, QC and Ware house departments and reports the investigation details as per the

Format No.: F02/SOPQA008-00.

6.0 If the complaint is regarding the product quality, then analyze the retention samples of the same batch.

7.0 If required, analyze the party’s sample.

8.0 If party’s method differs from our method, request the MOA from the party and analyze as per their Method of Analysis.

9.0 Extend the investigation to other batches, which may be affected by the reason of complaint.

10.0 Batch production and control record and related documents shall be checked thoroughly by QA for any deviations or abnormalities reported or recorded during the manufacturing of the subjected batch.

11.0 A written reply should be sent to the customer through the Marketing department regarding the findings and if required, take corrective actions. The investigation report must be sent within 15 days of receiving the complaint.

12.0 If required, perform joint analysis.

13.0 Record the corrective action and proposed preventive action in the Market complaint investigation report.

14.0 Retain all the documents related to the market complaint for at least one year after the expiry of the product or one year after the date of receipt of the complaint, whichever is longer.

15.0 Closing of Market Complaint

Market complaint should be closed as follows:

15.1 If response obtained from the customer against company written reply is satisfactory.

15.2 If the material is recalled.

15.3 If no response is obtained from the customer after 90 days from the date of company’s written reply.

16.0 Market complaint should be given numbering as follows

16.1