Company Name: Document No: OP/QD/003

BIOTAN GROUP LIMITED Revision No: 0

Rev. Date: AUG 18,2022

Title: Complaints Handling Procedure
Page No. : 1 of 4

5.0 Definitions and Abbreviations

5.1 Definitions
For the purpose of this procedure the following terms and definitions will apply.
5.1.1 Complaint: any non-conformity or dissatisfaction reported by external and internal

customers.

5.1.2 Complaints originator: either an individual or an organization reporting complaint

5.1.3 Act: primary responsibility allocated to a person or group of persons to accomplish a specific

process/ activity, which results in a specific output.

5.1.4 Involved: contributory responsibility allocated to a person or group of persons to accomplish

specific process/ activity, which results in a specific output.

5.1 Abbreviations
ACT: Act
MD: Managing Director
FLW: Flowchart
HOD: Heads of Departments/Division
INF: Informed
INV: Involved
QC: Quality Controller
OP/QCD/003: OP=Operating Procedure , QCD= Quality Department, 003= document no. 003
OF= Operating Form
MDO = Managing Director’s Office
 Company Name: Document No: OP/QD/003
Revision No: 0
BIOTAN GROUP LIMITED

Rev. Date: AUG 18,2022

Title: Complaints Handling Procedure
Page No. : 2 of 4
6.0 Procedure
6.1 Process Flowchart
Responsibility Output
Input Process QC MD HOD/HB
O

Complaints Registered complaints

ACT INF
Registration Form: 1. Complaints registration Form: OF/QCD/001 and
OF/QCD/001 issued with a reference
no.

Service Request Forwarded complaints (

Form: 2A. Acknowledge Receipt of Complaints within 2 filled forms: OF/GMO/001
working days INF ACT INF
OF/MDO/001 & 2B.Forwarding complaints to the relevant HOD/
and OF/QCD/001)
OF/QCD/001 HOB for investigation and corrective action INF ACT INF

Filled Forms Corrective Action Report

OF/GMO/001 & 3. Corrective action if BIOTAN is responsible (filled form OF/QCD/002)
INF ACT
OF/QCD/001 &
OF/QCD/003 &
OF/QCD/002
4. Complaints
resolved?
Yes
No

Corrective Action
Report(filled form 5. Identifying the root causes of unresolved Recommended Corrective
ACT INF INV
OF/QCD/002) complaints & recommending corrective action Action

Recommended
Approved Corrective
Corrective action
6. Approval of recommended. INF ACT INF Action
Corrective action

Approved Corrective
Action Settled Complaints
7. Implementation of Corrective action INV INF ACT

Settled Complaints, Complaints Resolution

Filled form report
OF/QCD/002) ( Completed form
8. Reporting of Corrective actions
ACT INF OF/QCD/002)
 Company Name: Document No: OP/QD/003

BIOTAN GROUP LIMITED Revision No: 0

Rev. Date: AUG 18,2022
Title: Complaints Handling Policy and Procedure
Page No. : 3 of 4

6.2 Description of Process Steps

FLW Process Steps
1a. Biotan is empowered to provide an immediate response to any customer complaint and to provide the promise of further
investigation according to the company regulations.
1b. All complaints shall be directed to and registered by the Quality Controller using ‘’ Complaints Registration Form,,
2  The MD will acknowledge receipt of complaint within 2 working days to the complaints originator
 ‘’ Complaints Registration Form, shall be filled in two copies and QC shall file one copy and the other shall be forwarded
to the MD accompanied by ‘’ Service Request Form’. The MD will fill the ’ Service Request Form’ and forward it
accompanied by the copy of Complaints Registration Form to the relevant HD or HBO for investigation and action
 Complaints reported shall be and resolved as per ‘’ Corrective and Preventive Action Procedure’’
 Complaints reported against organizational plan and reputation, and policy issues shall be handled by the MD as per this
procedure.
3 Corrective actions shall be taken by the relevant HD, or MD as per‘’ Corrective and Preventive Action Procedure’’
Corrective actions taken shall be immediately reported to the QC filled in form’’ Complaints Resolution Report Form’’,
clearly indicating resolutions and agreements reached with the originator of the complaints and unresolved complaints, if
any.
Complaints difficult to resolve at HD level due to shortage of resources shall be reported to the QC for corrective action.
4 Description is not required for this process step.
5 Quality controller or any company representative shall:
 Discuss with originator of the complaints and the MD to find the root cause
of unresolved complaints’ reported either by the originator f the complaints or the relevant HD/
HBO or the GM, and propose corrective actions.
 Find the root causes of complaints reported against organizational plan and reputation, and
policy issues and proposes corrective actions.
6 Recommended corrective actions shall be approved to ensure that:
 They are relevant and adequate to the degree of non-conformity;
 They are implementable; and
 The necessary resources are available for effective implementation.
 Company Name: Document No: OP/QD/003

BIOTAN GROUP LIMITED Revision No: 0

Rev. Date: AUG 18,2022

Title: Complaints Handling Procedure
Page No. : 4 of 4

FLW Process Steps

7  The QC shall implement corrective actions for products’ complaints reported against organizational plan and
reputation, and policy issues
 The relevant MD shall implement the recommended corrective actions to settle the unresolved complaints
relevant to them.
 If yet the complaints are not resolved, MD may form a panel, as necessary, to identify the root causes of the
unresolved complaints and recommended appropriate corrective actions.
8
The QC shall:
 Produce a final report on corrective actions taken to settle the reported complaints, filled in Form ‘’
Complaints Resolution Report Form’’; and
 Initiate management review to be conducted as per ‘’ Management Review Procedure’’ to review the
corrective action.

7. Records
The Quality Controller has the responsibility to maintain the following records:
 Master register of complaints
 Customer report of complaints
 Complaints resolution reports
8. Related Documents
Document Number Document Title
OF/QCD/001 Complaints Registration Form
OF/MDO/001 Service Request Form
OF/QCD/002 Complaints Resolution Report Form
OP/QCD/003 Corrective and Preventive Action Procedure
OP/MDO/002 Management Review Procedure
 Company Name: Document No: OF/QCD/001

BIOTAN GROUP LIMITED Revision No: 0

Rev. Date: AUG 18,2022
Title: Complaints Registration Form
Page No. : 1 of 1

PART A: TO BE COMPLETED BY COMPLAINTS RECEIVER/ ORIGINATOR

To: The Quality Controller

1. Date Reported:DD/MM/YY_______________________________________________________________________________
2. How the report received? _______ Tel. ______ Fax _________ Letter __________ Interface _________ Others.
3. Originator of the complaints: _____________________________________________________________________
4. Title of the complaints: __________________________________________________________________________
5. Description of the complaints: ___________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________Title and number of pages of
attached documents, if any: ______________________________________________
6. Did the complaints reported before? ___________ yes _____________ no.
If yes, what corrective actions were taken?

7. Address of the complaint originator (optional)

Name Organization P.O. Box Signature and Date
Tel:
E-mail

PART B: TO BE COMPLETED BY MANAGING DIRECTOR

Complaints Registration Number: Date Received:

Remarks by the Managing Director:

Name: Signature: Date:

Acknowledgement letter to Date: Ref. No. :
complainant
 Company Name: Document No:
OF/MDO/001
BIOTAN GROUP LIMITED
Revision No: 0
Rev. Date: AUG 18,2022
Title: Service Request Form
Page No. : 1 of 1

PART A: TO BE COMPLETED BY REQUESTING BODY

1. To:________________________________________________________________________________
2. Requested by:_______________________________________________________________________
3. Service requested:

4. Attached documents (Title and No. of pages):

5. Additional information (if any):

___________________________ ________________________ _______________________

Date of request (MM/DD/TIME) Requested by (ID/SIGN) Authorized by (ID/SIGN)
PART A: TOBE COMPLETED BY SERVICE GIVING BODY

SERVICE DELIVERY FOLLOW-UP

S/N Received by/Submitted to To be delivered/Service delivered Date/Time ID/Sign

NOTE: In the case of external customers, authorization of the request and ID No. of the applicant are not required.
 Company Name: Document No: OF/QCD/002

BIOTAN GROUP LIMITED Revision No: 0

Rev. Date: AUG 18,2022
Title: Complaints Resolution Report Form
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PART 1: TO BE COMPLETED BY HEADS OF DEPARTMENT/BRANCH OFFICE /DIVISION

1. Reporting Department/ Division /Branch Office/ or Office of General 2. Date reported

Manager

3. Originator of the complaints 4. Date the complaints received

5. Title and short descriptions of the complaints

6. Identified root causes of the complaints

7. Corrective actions taken

8. Are the complaints resolved? (Indicate by putting a cross)

a) Yes ______. If yes, indicate the agreement in point 9 below.

b) No ______. If no, describe the reasons of disagreement in point 10 below.

9. We agree that the reported complaints have been thoroughly resolved:

a) General Manager/Head of Department/ Division/Branch Office ____________________________

Name Signature & date

b) Feedback on Corrective Action to complainant _________________________ ____________________

Date Ref. No.

10. 10. If the complaints were not resolved describe the possible reasons of disagreements.
 Company Name: Document No: OF/QCD/002

BIOTAN GROUP LIMITED Revision No: 0

Rev. Date: AUG 18,2022
Title: Complaints Resolution Report Form
Page No. : 2 of 2

11. Recommendations to prevent reoccurrence of the potential problem.

12. Name 13. Signature & Date

PART 2: TO BE COMPLETED BY THE QUALITY CONTROLLER

14. We agree that the relevant Head of Department/Branch Office/Division or the General Manager satisfactorily
resolved the complaints.

Yes,
No. If no, describe the reasons of disagreement of the complaint originator.

15. Originator of the complaints: Name: ___________________ Sign & date ________________________

16. The unresolved complaint require the interference of TANICA Management and be handled thereto:

Yes.
No.

Date Name Signature & Date