CONFIDENTIAL

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SOP-002 Complaint Handling Procedure

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1.0 Purpose

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

2.0 Scope
This document was designed for O2O Holdings complaint handling practices and activities
associated with the complaint intake, processing, evaluations and closure.

3.0 Key Terms 3.1 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
3.2 Complainant - Person notifying the company of a complaint
3.3 Awareness - When any employee of the company has acquired information
that reasonably suggests a reportable adverse event has occurred
3.4 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.
3.5 30-Day report - Initial MDR report that must be submitted within 30 calendar
days after the day you become aware for a reportable device-related death or
serious injury, or a reportable malfunction.
3.6 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
3.7 Complaint Status Definitions:
3.7.1 OPEN - Initial status for complaint
3.7.2 COMPLAINT REVIEW - Once initial details are documented and
requires an evaluation to determine whether further investigation is
necessary and requires submission
3.7.3 INVESTIGATION - Status denoting that the complaint is currently
being investigated
3.7.4 FINAL REVIEW - Status denoting that the complaint requires a full
review and that it is ready for closure
3.7.5 CLOSED - Complaint is closed and data is locked
3.7.6 VOID - Complaint was opened in error or by accident and is no
longer a valid complaint

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4.0 Roles and
Responsibiliti
es 4.1 Customer Service Representative
4.1.1 Responsible for entering initial details of the complaint
4.1.2 Responsible for assigning failure codes to a complaint
4.2 Quality or Service Representative
4.2.1 Responsible assessing complaints for investigation
4.2.2 Responsible for conducting investigations when needed
4.2.3 Responsible for reviewing investigation for completeness
4.2.4 Responsible for periodic trending of complaints
4.3 Regulatory and/or Quality Lead
4.3.1 Responsible for assessing complaints for device
4.3.2 Responsible for reviewing complaints for completeness
4.3.3 Responsible for closing complaints

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5.0 Process Flow Chart

Customer notifies O2O Holdings Service

representative about the device defects

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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6.0 Procedure
6.1 Complaint Intake
6.1.1 Using the Complaint Intake Form (Note: You will need to create one)
6.1.2 Enter the following information:
6.1.2.1 Device
6.1.2.2 Serial Number
6.1.2.3 RMA Number
6.1.2.4 Service Number
6.1.2.5 Ship Date
6.1.2.6 Date Aware
6.1.2.7 Date of Event
6.1.2.8 Account Name, Address
6.1.2.9 Contact Name, Title, Phone Number, Email

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

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

6.2 Complaint Evaluations

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

6.2.3 Medical Device Reportability Assessment

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

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 contribute to a death or serious injury if the malfunction
were to recur.
6.2.3.2 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
6.2.3.3 If remedial action is needed to prevent unreasonable risk of substantial
harm to public heatlh, notify management immediately.
6.2.3.4 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)

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

6.3 Complaint Investigations

6.3.1 If a complaint requires investigation, provide the following information in the investigation
6.3.1.1 Provide dates and results of an investigation
6.3.1.2 Describe or reference any corrective action taken
6.3.1.3 Include any replies to the complainant
6.3.1.4 For a reportable event include additional info:
6.3.1.4.1 State whether the device failed to meet specifications
6.3.1.4.2 State whether the device was being used for treatment or
diagnosis
6.3.1.4.3 Describe the relationship, if any, of the device to the
reported event

6.4 File Attachments

6.4.1 Attach relevant files to the complaint, such as (but not limited to):
6.4.1.1 Email correspondences
6.4.1.2 Photos of customer device
6.4.1.3 Technical information
6.4.1.4 Investigation test results

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

6.6 Final Review

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

6.7 Voiding Complaints

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

7.0 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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 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

8.0 Complaint Trending

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

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