CONFIDENTIAL

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SOP-002 Complaint Handling Procedure

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

Table of Contents
Purpose 3

Scope 3

External References 3

Internal References 3

Key Terms 3

Roles and Responsibilities 5

Process Flow Chart 6

Procedure 7

Medical Device Reporting 9

Complaint Trending 10

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

1.0 Purpose

This procedure is intended to establish a compliant Complaint Handling Process.

2.0 Scope
This document applies to all company complaint handling practices and activities
associated with the complaint intake, processing, evaluations and closure.

3.0 External Associated references imply the most current version at the time of this document’s
References approval:
3.1 FDA CFR Title 21 Part 820 – Quality System Regulation
3.2 FDA CFR Title 21 Part 803 – Medical Device Reporting
3.3 FDA CFR Title 21 Part 11 – Electronic Records; Electronic Signatures
3.4 Draft Guidance for Industry and Food and Drug Administration Staff – Medical
Device Reporting for Manufacturers
3.5 ISO 13485, Medical devices – Quality Management Systems – Requirements
for regulatory purposes
3.6 MDD 93/42/EEC, European Medical Device Regulations concerning medical
devices
3.7 ISO 14971, Medical Devices- Application of Risk management to medical
devices
4.0 Internal
References 4.1 SOP-XXX, Document Controls
4.2 SOP-XXX, Risk Management Procedure
4.3 SOP-XXX, Corrective and Preventative Action Procedure
4.4 QS-XXX, Quality Systems Manual

5.0 Key Terms 5.1 Complaint - Any written, electronic or oral communication that alleges
deficiencies related to the identity, quality, durability, reliability, safety,
effectiveness, or performance of a device after it is released for distribution
5.2 Complainant - Person notifying the company of a complaint
5.3 Adverse Event - Any undesirable experience associated with the use of a
medical product in a patient
5.4 Awareness - When any employee of the company has acquired information
that reasonably suggests a reportable adverse event has occurred
5.5 Serious Injury - an injury or illness that:
5.5.1 Is Life-Threatening
5.5.2 Results in permanent impairment of a body function or permanent
damage to a body structure
5.5.3 Necessitates medical or surgical intervention to preclude permanent
impairment of a body function or permanent damage to a body
structure
5.6 Permanent - irreversible impairment or damage to a body structure or
function, excluding trivial impairment or damage

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

5.7 Medical Device Reportable Event - Events that manufacturers become

aware of that reasonably suggest that one of their marketed devices may
have caused or contributed to a death or serious injury or has malfunctioned
and the malfunction of the device or a similar device that the company
markets would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur.
5.8 Malfunction - A failure of a device to meet its performance specifications or
otherwise perform as intended. Performance specifications include all claims
made in the labeling for the device.
5.9 Master Complaint - When linking similar complaints, the first/original
complaint is considered the Master Complaint
5.10 30-Day report - Initial MDR report that must be submitted within 30 calendar
days after the day you become aware ofr a reportable device-related death or
serious injury, or a reportable malfunction.
5.11 5-Day report - A report that must be submitted to the FDA within 5 work days
after the day an employee with management or supervisory responsibilities
[over persons with regulatory, scientific, or technical responsibilities, or a
person whose duties relate to the collection and reporting of adverse events]
becomes aware of a reportable event:
5.11.1 that necessitates remedial action to prevent an unreasonable risk of
substantial harm to public health
5.11.2 For which the FDA has made a written request for the submission of
a 5-day report
5.12 Complaint Status Definitions:
5.12.1 OPEN - Initial status for complaint
5.12.2 COMPLAINT REVIEW - Once initial details are documented and
requires an evaluation to determine whether further investigation is
necessary and/or MDR requires submission
5.12.3 INVESTIGATION - Status denoting that the complaint is currently
being investigated
5.12.4 INVESTIGATION REVIEW - Status denoting that the investigation
requires review for completeness
5.12.5 FINAL REVIEW - Status denoting that the complaint requires a full
review and that it is ready for closure
5.12.6 CLOSED - Complaint is closed and data is locked
5.12.7 VOID - Complaint was opened in error or by accident and is no
longer a valid complaint

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

6.0 Roles and

Responsibilities 6.1 Customer Service Representative
6.1.1 Responsible for entering initial details of the complaint
6.1.2 Responsible for assigning failure codes to a complaint
6.2 Quality or Service Or R&D Engineer
6.2.1 Responsible assessing complaints for investigation
6.2.2 Responsible for conducting investigations when needed
6.2.3 Responsible for reviewing investigation for completeness
6.2.4 Responsible for periodic trending of complaints
6.3 Regulatory and/or Quality Lead
6.3.1 Responsible for assessing complaints for medical device
reportability and for submitting MDR reports to governing bodies
6.3.2 Responsible for reviewing complaints for completeness
6.3.3 Responsible for closing complaints

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

7.0 Process Flow Chart

Customer notifies company of

alleged deficiencies

Customer Service Representative

intakes initial details of complaint.
Assign Failure Codes.

Complaint Status: Open

Regulatory and Quality Assurance

Regulatory and Quality Assurance
team assesses complaint for Medical Device Report (MDR)
team assesses whether complaint
Medical Device Reportability Submission
requires investigation
requirements

Complaint Status: Complaint Complaint Status: Complaint

Review Review

Quality Assurance, Service or

Regulatory/Quality Lead reviews
R&D team conducts investigation
entire complaint for completeness
to identify root cause

Complaint Status: Final Review Complaint Status: Investigation

Quality engineer reviews

investigation details for
completeness

Complaint Status: Closed

Complaint Status: Investigation
Review

Figure 1. Complaint Handling Process Flow

Figure 2. Complaint Phases

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

8.0 Procedure
8.1 Complaint Intake
8.1.1 Using the Complaint Intake Form (Note: You will need to create one)
8.1.2 Enter the following information:
8.1.2.1 Device
8.1.2.2 Serial Number
8.1.2.3 RMA Number
8.1.2.4 Service Number
8.1.2.5 Ship Date
8.1.2.6 Date Aware
8.1.2.7 Date of Event
8.1.2.8 Account Name, Address
8.1.2.9 Contact Name, Title, Phone Number, Email

8.1.3 Enter complaint description (note: be descriptive and only include details explicitly stated
by the complainant)

8.1.4 Select Failure Codes based on the complaint description (ie. Use Excel Spreadsheet)
8.1.5 Move Complaint Status to “Complaint Review”

8.2 Complaint Evaluations

8.2.1 Select complaint for review (identify complaints in “Complaint Review”)
8.2.2 Investigation Assessment
8.2.2.1 Make a decision about whether Investigation is needed for this
complaint. Note the following guidance:
8.2.2.1.1 Investigation is required if the complaint involves the
possible failure of the device, labeling, or packaging to
meet any of its specifications
8.2.2.1.2 Investigation may not be needed if one has already been
conducted for a similar complaint
8.2.2.1.3 If no investigation is needed, provide rationale for decision

8.2.3 Medical Device Reportability Assessment

8.2.3.1 Make a decision about whether this complaint is reportable. A Medical
Device Report (MDR) is required if the device:
8.2.3.1.1 May have caused or contributed to a death or serious
injury, or;
8.2.3.1.2 Has malfunctioned and the device (or similar device
marketed by your organization) would be likely to cause or

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

contribute to a death or serious injury if the malfunction

were to recur.
8.2.3.2 If a complaint has been decided to be reportable, follow the FDA
instructions here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Po
stmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93E
lectronicMedicalDeviceReporting/ucm2019327.htm
8.2.3.3 If remedial action is needed to prevent unreasonable risk of substantial
harm to public heatlh, notify management immediately.
8.2.3.4 Note: Medical Device Reportability assessments and submissions
must be completed within 30-days of any employee becoming aware of
information that may describe a reportable event (see Section 5.10). If
the event requires immediate remedial action to prevent unreasonable
risk of substantial harm to public health, submissions must be
completed within 5-days of an employee with management or
supervisory responsibilities becomes aware (see Section 5.11)

8.2.4 Once both Investigation and MDR decisions have been made, move
complaint to next status.

8.3 Complaint Investigations

8.3.1 If a complaint requires investigation, provide the following information in the investigation
8.3.1.1 Provide dates and results of an investigation
8.3.1.2 Describe or reference any corrective action taken
8.3.1.3 Include any replies to the complainant
8.3.1.4 For a reportable event include additional info:
8.3.1.4.1 State whether the device failed to meet specifications
8.3.1.4.2 State whether the device was being used for treatment or
diagnosis
8.3.1.4.3 Describe the relationship, if any, of the device to the
reported event

8.4 File Attachments

8.4.1 Attach relevant files to the complaint, such as (but not limited to):
8.4.1.1 Email correspondences
8.4.1.2 Photos of customer device
8.4.1.3 Technical information
8.4.1.4 Investigation test results

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

8.5 Investigation Review

8.5.1 Quality and Regulatory teams should review the investigation for completeness.
8.5.2 Once Investigation has been reviewed, move complaint to the next status. Select “Final
Review”

8.6 Final Review

8.6.1 When complaint is under “Final Review”, RAQA lead shall review complaint for
completeness.
8.6.2 Once review has been completed, move complaint to “Closed”

8.7 Voiding Complaints

8.7.1 If a complaint was opened by accident or in error, a complaint may be voided.

9.0 Medical Device Reporting

a. A separate and labelled MDR location may be used to collect information about the
potential reportable event.
b. All complaints shall be assessed for reportability requirements per CFR Title 21 Part 803.
c. Investigation of a reportable event shall be documented and include, at a minimum:
i. Name of the device
ii. Date the complaint was received
iii. Any unique device identifier (UDI) or universal product code (UPC), and any
other device identification(s) and control number(s) used
iv. Name, address, phone number of the complainant
v. Nature and details of the complaint
vi. Dates and results of the investigation
vii. Any corrective action taken
viii. Any reply to the complainant
ix. Whether the device failed to meet specifications
x. Whether the device was being used for treatment of diagnosis
xi. The relationship, if any, of the device to the reported incident or adverse event

d. Information that is required to make an assessment must be obtained from the customer
in a timely manner. If information cannot be accessed, evidence showing “good faith
effort” to obtain the information must be made available.
e. If an event has been assessed to require reporting, all submissions shall be made using
the FDA electronic MDR submission formats: eSubmitter
(http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm) or HL7 ICSR
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirem
ents/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/uc
m127948.htm)
f. MDRs shall be submitted in a timely and effective manner, adhering to all required
deadlines (see Section 5. Definitions for 30-day and 5-day report requirements)

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 STANDARD OPERATING PROCEDURE
Procedure Name: Complaint Handling Procedure Revision Level: A
Document Number: SOP-002

g. MDR Files shall be maintained for two years from the date of the event or a period
equivalent to the expected life of the device, whichever is greater.
h. Supplemental Reports
i. Supplemental or “follow-up” reports must be submitted whenever the company
obtains information not known or available at the time of the initial 30-day or 5-
day report submission.
ii. Supplemental reports must be made 30 calendar days following the receipt of
additional information

10.0 Complaint Trending

10.1 Complaints shall be periodically reviewed to identify adverse trends in product quality,
complaint process timeliness and customer satisfaction.
10.2 Complaints shall be reviewed as needed
10.3 Complaints shall be reviewed with statistical techniques where applicable and with
reasonable resources.
10.4 Complaint trends that have been determined to exhibit an adverse trend shall be
reviewed for Corrective and Preventative Action (CAPA).

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