[Company Name]

[Company Group, Division, Location]

Document Title: Customer Complaint Processing

Document Number: [Document Number]
Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY

STAMP HERE

OTHER
STAMP HERE

Revision Revision DCO/ECO Revision

Level Date Number Description of Revision Author
DRAFT DD/MM/Y YY-00000 Draft Author Name
Y
1.00 DD/MM/Y YY-00000 Initial Release Author Name
Y

COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Customer Complaint Processing
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table Of Contents

1.0 Purpose..........................................................................................................................................................2

2.0 Scope.............................................................................................................................................................2

3.0 Definition Of Terms......................................................................................................................................2

3.1 Assignee.............................................................................................................................................2
3.2 Attachments.......................................................................................................................................2
3.3 Complaint...........................................................................................................................................2
3.4 MDR (Medical Device Report)..........................................................................................................2
3.5 Medical Advisor (Applications Engineering)....................................................................................2
3.6 Return Authorization Number (RA#)................................................................................................2
3.7 Recipient.............................................................................................................................................2
3.8 CC Number........................................................................................................................................2

4.0 Types Of Complaints....................................................................................................................................2

5.0 References.....................................................................................................................................................3

6.0 Responsibilities and Requirements...............................................................................................................3

7.0 Procedure......................................................................................................................................................3
7.1 Recipient.............................................................................................................................................3
7.1.1 Returned Product.................................................................................................................3
7.2 Customer Service...............................................................................................................................3
7.3 Product Servicing Form.....................................................................................................................4
7.3.1 Product Service Request Form Completion........................................................................4
7.3.2 Generation of the Product Service Form.............................................................................4
7.3.3 Product Servicing Request Form Log.................................................................................4
7.3.4 Product Service Request Log Numbers...............................................................................4
7.3.5 Distribution of the Product Service Request Form..............................................................4
7.3.6 Completion of designated work...........................................................................................4
7.4 Field Service.......................................................................................................................................4
7.5 Quality Assurance..............................................................................................................................4
7.6 Quality Assurance Manager Review/Final Disposition.....................................................................4

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 1 of 4

[Company Name] Customer Complaint Processing
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

1.0 Purpose
To provide the procedure in which customer complaints will be received, processed and resolved.

2.0 Scope
This procedure applies to customer complaints regarding products and services provided by facilities of
(COMPANY NAME).

3.0 Definition Of Terms

3.1 Assignee
The individual or department responsible for the investigation of the complaint and suggesting
solutions to rectify the complaint.

3.2 Attachments
Copies of customer correspondence, written or electronic notes regarding verbal communication
with customers, service records, reports, records of investigations, or any completed forms.

3.3 Complaint
A Complaint is any written, electronic, or verbal communication indicating an alleged deficiency
in the identity, quality, durability, reliability, safety, effectiveness or performance of any product
or service manufactured or provided by (Company Name).

3.4 MDR (Medical Device Report)

A report submitted to the FDA by (Company Name) in the event a device may have caused or
contributed to a death, serious injury, or has malfunctioned and that the device or a similar device
marketed by (Company Name) would likely to cause or contribute to a death or serious injury if
the malfunction were to reoccur.

3.5 Medical Advisor (Applications Engineering)

"Medical Advisor" refers to individuals who:
(1) are licensed, registered, or certified by a State, territory, or other governing body, to
administer health care; (2) have a received a diploma or degree in a professional or scientific
discipline; (3) are employees responsible for receiving medical complaints or adverse reports; or
(4) are supervisors of such persons.

3.6 Return Authorization Number (RA#)

A unique number assigned to each return authorization, to be conspicuously placed on the
shipping package and documents, indicating the return has been authorized.

3.7 Recipient
Any (Company Name) employee, representative or agent of (Company Name), who receives a
complaint from a customer regarding product or service manufactured or provided by (Company
Name).

3.8 CC Number
A sequential number assigned to a complaint for easy identification and tracking purposes.

4.0 Types Of Complaints

[Insert the various types of complaints that are used at (company name) and provide a brief description
of each. Some examples of the types of complaints are: Product Performance, Product Safety, Product
Reliability, Product Appearance, Control Complaints, Serious/Adverse clinical event, service
complaints, etc.]

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 2 of 4

[Company Name] Customer Complaint Processing
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

5.0 References
Product Servicing
Product Service Request Form Processing
Product Service Request Form
Corrective and Preventive Action
Correction or Removal of Marketed Product
Quality Records
MDR/MDVS Reports
Quality Investigation
Returned Product Authorization, Evaluation, and Disposition

6.0 Responsibilities and Requirements

[Insert the various responsibilities and requirements for the various positions associated with the
customer complaint process, the following positions are to serve as reference and may or may not be
applicable to every organization: Recipient, Customer Service, Customer Service Manager, Assignee,
Quality Assurance, Quality Assurance Manager, and Field Services].

7.0 Procedure

7.1 Recipient
[Insert company procedure for receiving customer complaints, include procedures for both verbal
and written complaints. Also include required details that must be present on all complaint
forms for example:
 Date complaint received, Recipient's name, department, phone number and extension.
 Type of Complaint (verbal, written or electronic).
 Customer Information and Patient Information
 If it is a product complaint, the Recipient must fill in the device name, model number, and
serial/lot number on the complaint form.
 The recipient must sign and date the customer complaint form along with any attachments to
Customer Service.
**This list is to be use for reference only, it will vary depending on each organization].

7.1.1 Returned Product

[Describe the procedure for receiving a returned product. Include the necessary
documentation that may need to accompany the return. Also explain the internal
process of handling a returned product].

7.2 Customer Service

[Insert the procedure that will be used for processing customer complaints. Include all aspects of
the customer service process, include the way (company name) handles Receipt of Customer
Complaint From Recipient, Insufficient Customer Complaint Information, Returned Product(s),
Registration and Assignment of Customer Complaint Number, Customer Complaint Database,
Processing, Follow-Up Reports, Customer Correspondence and the Closing of Customer
Complaint Files].

7.3 Product Servicing Form

7.3.1 Product Service Request Form Completion

[Insert criteria necessary for a Product Service Request Form, for example: A product
service request form shall be generated when a Customer Complaint Form is initiated if
deemed appropriate by the designated management personnel].

7.3.2 Generation of the Product Service Form

[The Generation of the Product Service Form shall be in accordance with Work
Instruction].

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 3 of 4

[Company Name] Customer Complaint Processing
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

7.3.3 Product Servicing Request Form Log

[Explain the relevant information that may be contained within the Product Service
Request Log].

7.3.4 Product Service Request Log Numbers

[Describe the numbers that will be assigned to the Product Service Request Form and
documented in a log. Explain the numbering scheme, for example: A two letter code AB
a six-digit number defining the month, date, and year, followed by a hyphen, and then a
sequential three-digit number. Example: AB-50199-001].

7.3.5 Distribution of the Product Service Request Form

[Explain the distribution of the Product Service Request Form].

7.3.6 Completion of designated work

[Describe where additional information will be recorded once the service has been
completed].

7.4 Field Service

[Explain the role and job function that an individual in this position would do in regards to the
customer complaint form, for example:
 The designated area (For example: Field Service) will respond with the type of maintenance
or service prescribed for the product. Product Servicing will be in accordance with Product
Service Request Form.
 At completion of the designated work Field Service shall return all appropriate
documentation to the designated individual. The individual shall sign off that the designated
work has been completed and that all appropriate documentation is in order.
 The individual will forward all appropriate documentation to Customer Service.
**This is to serve as an example and may/may not be applicable to each organization].

7.5 Quality Assurance

[Insert the tasks that must be performed by Quality Assurance. Make sure to include all steps
with in which their role is utilized].

7.6 Quality Assurance Manager Review/Final Disposition

[Describe the necessary responsibilities and actions to be taken by Quality Assurance
management, Include the steps that a manager should take if a Medical Device Report needs to
be submitted to the FDA. Also include any corrective action that may need to be taken.
(Describe the necessary information to be contained within the complaint in order for it to be
officially closed, example: signature and date), forwarding it to the appropriate party and file it
accordingly].

[Document Filename] COMPANY PROPRIETARY AND CONFIDENTIAL Page 4 of 4