Handling of Customer Complaint

1.0         Purpose    :     To provide instruction for handling of customer complaint.

2.0         Objective  :    To provide a documented procedure for handling of customer complaint.

3.0           Scope     :      This procedure is applicable for handling of customer complaint.

4.0         Responsibility  :

·        Primary: Officer – QA

·        Secondary: Officer-QA

5.0       Procedure:

·        Followings are the Source of Complaint.

Ø     From within the company

Ø     From some point within the distribution chain

Ø     From customer or user

·        Flow of complaint analysis

	Registration of Complaint				Review of Complaint

·        Procedure handling of Customer Complaint.

Ø     Receipt of Complaint.

o       Any complaint received by the marketing department or by Corporate office shall be handed over to Corporate QA.

o       Corporate QA shall review the complaint. If corporate QA feels that the immediate action is necessary, QA shall forward the complaint to respective site QA.

o       On receipt of complaint from Corporate QA, Site QA shall start the investigation.

Ø     Registration of complaint

o       On receipt of a product complaint from corporate QA, Site QA shall enter the entry in complaint register and assigning a registration number as under.

o       The customer complaint registration number shall be given as follow.

                     XXXX/YYY (e.g. 2008/001)

                             Where, XXXX represents the year, e.g. Year 2008

             YYY represents the serial number, 001, 002, etc.

Ø     Review of complaint

o       Site QA shall review the complaint and decide whether any additional data is required for evaluation of complaint.

o       If additional data is required than QA shall coordinate with other department for collecting the data.

o       If any test / analysis need to be carry out to review the complaint, QA shall direct the instruction to concern department.

Ø     Guideline for Immediate action

o       An actual or potential hazard to life, health or well being of a user or consumer.

o       A defect which, while not necessary hazardous, could adversely affect the standing or repudiation of company.

o       Product difficult or inconvenient to use.

o       Immediate action shall be,

o        “Freezing” off all relevant stock available in the company.

o       Reviewing distribution records and requesting all points in distribution chain to “freeze” all relevant stocks, and not to use them or distribute them further.

o       Initiation of recall

Ø     Action on complaints

o       If QA feel immediate action is necessary, he/she shall consult to corporate QA before taking any immediate action.

o       After confirmation from corporate QA, Site QA shall initiate the immediate action.

o       If the decision is made to recall the products then product shall be recalled as        per standard operating procedure.

o       If decision is made that it is necessary to freeze only existing stock in the company, pending further investigation, inform to stores immediately orally first and than confirm in writing as soon as possible.

o       The information should be included following:

ü      Name of product(s)

ü      Batch Number(s)

ü      Nature of Complaint / Defects

ü      Precise action to be taken

o       If complaint is not considered to be sufficient serious as to warrant recall, freeze or any other emergency action, a letter of acknowledgement shall be sent in response to complaint.

Ø     Preventive action and Review of preventive action

o       In any case detailed investigation shall be carried out and accordingly preventive actions shall be suggested by QA.

o       QA shall also indicate who will be monitoring preventive action and time frame.

o       After specified time frame, QA shall review the effectiveness of preventive actions.

o       Product Complaint Form

o       Fill the product complaint form and attach with all related data collected for complaint review and analysis.

NOTE:

If the complaint is serious and immediate action is required, it is necessary to inform to statutory authority of the concern country or to the concern buyer, before taking the immediate action.

6.0      Reference Document:

v     Complaint logbook

                           LOG BOOK FOR COMPLAINT RECORDING

           

Complaint no.

Date of received

Product Name

Batch No.

Mfg. Date

Exp. Date

Received From

Nature of rejection

Action taken

Remarks

7.0      Abbreviations:

·        QA   = Quality Assurance department

·        SOP = Standard Operating Procedure

·        GMP = Good Manufacturing Practices

8.0      Copies to Distribution Sites.

·        QA

·        QC

·        Stores

9.0   Review History:

Sr. No.	Previous Revision No.	New Rev. No.	Review Date	Reason For Review	Change Control No.	Approved By