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
Document Retention

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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3.4 Draft Guidance for Industry and Food and Drug Administration Staff – Medical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

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

5.6 Permanent - irreversible impairment or damage to a body structure or

function, excluding trivial impairment or damage
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 6.1 Healthium Team

Responsibilities
6.1.1 All Healthium employees who come across any adverse event or product
complaint should be responsible for reporting complaints/Feedback related
to company products via Email '[email protected]'
6.2 Quality and Materiovigillance Team
6.2.1 Responsible for entering initial details of the complaint and checking
whether the required information is available.
6.2.2 Responsible for performing follows up with the Marketing team to
collect any missing information
6.2.3 Responsible for storing final report of complaint. Commented [VG1]: This responsibility needs to be finalized
6.3 Quality Team
6.3.1 Responsible for assessing complaints for investigation
6.3.2 Responsible for conducting investigations when needed
6.3.3 Responsible for reviewing investigation for completeness
6.3.4 Responsible for periodic trending of complaints
6.4 Materiovigillance Team
6.4.1 Responsible for assessing complaints for medical device
reportability and for submitting reports to governing bodies
6.4.2 Responsible for reviewing adverse events reports for completeness
6.4.3 Responsible for closing adverse events complaints
6.5 Regulatory Affairs and QA Team
6.5.1 Responsible for reviewing complaint trending

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

7.0 Process Flow Chart

Figure 1. Complaint Handling Process Flow

Figure 2. Complaint Phases

8.0 Procedure
8.1 Complaint Intake
8.1.1 The employee of Healthium should report any complaints with adverse events to
Materiovigillance department via Email slaes@healtiummedtech .com
/[email protected] as soon as possible or within 1 business Day
8.1.2 If complaint is received through message in mobile/ orally, then the person who received
the complaint should update the forms - Complaint Intimation Form/Adverse event form
depending on the type of complaint. Then the filled forms should be sent to
QA/Materiovigillance department via Email (slaes@healtiummedtech .com
/[email protected]) stating the primary source of complaint (Eg:
phone/oral)
8.1.3 The forms filled should have the following information to check reportability and to
conduct investigation:
8.1.3.1 Device Name, Lot and Batch number
8.1.3.2 Date of Awareness
8.1.3.3 Date of Event/ incident
8.1.3.4 Name and Address of the reporter (Contact Name, Title, Phone Number,
Email)
8.1.3.5 Patient Details (in AE form)
8.1.3.6 Is product available for investigation

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

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

8.2 Complaint Evaluations

8.2.1 The QA/Materiovigillance team reviews the complaint for completeness, reportability and
investigation and QA team assigns an unique complaint number which helps in tracking Commented [VG2]: This should be discussed with QA
complaint by both QA/ MV/ Complainant
8.2.2 The Complainant should be provided with the unique Complaint number which can be
used in future correspondence.
8.2.3 If the complaint received requires more information to decide the reportability and to
decide whether investigation is required or not, then team sends follow up to the
Complainant

8.2.4 Investigation Assessment Commented [VG3]: The QA SOP Number also needs to be
included here
8.2.4.1 QA Team Makes a decision about whether Investigation is needed for
this complaint or not based on the following guidance:
8.2.4.1.1 Investigation is required if the complaint involves the
possible failure of the device, labeling, or packaging to
meet any of its specifications
8.2.4.1.2 Investigation may not be needed if one has already been
conducted for a similar complaint
8.2.4.1.3 If no investigation is needed, provide rationale for decision

8.2.5 Medical Device Reportability Assessment

8.2.5.1 MV team Makes a decision about whether the complaint is reportable
or not based on the following guidance. A Medical Device complaint
will be Reportable if the device:
8.2.5.1.1 May have caused or contributed to a death or serious
injury, or;
8.2.5.1.2 Has malfunctioned and the device (or similar device
marketed by your organization) would be likely to cause or
contribute to a death or serious injury if the malfunction
were to recur.
8.2.5.1.3 Please check SOP for making Adverse Event Reporting
Decision for Medical Devices
8.2.5.2 If a complaint has been decided to be reportable, then the complaint
should be processed per SOP for case processing
8.2.5.3 If remedial action is needed to prevent unreasonable risk of substantial
harm to public health, notify management immediately.

8.3 Complaint Investigations

8.3.1 If a complaint required investigation, then the following information should be provided in
the investigation report
8.3.1.1 Provide dates and results of an investigation

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

8.3.1.2 Describe or reference any corrective action taken if applicable

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

8.5 Investigation Review

8.5.1 Quality team should review the investigation for completeness.
8.5.2 Once Investigation has been reviewed the investigation report should be sent to QA lead
for “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 Provide the investigation report to MV team to include in their case narrative
8.6.3 Once review has been completed, the complaint should be “Closed

9.0 Complaint Trending

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

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

10.0 Complaint Determination:

Events will be assessed against the following criteria to classify it as either non-complaints or
complaints.
10.1 Does the event allege a deficiency related to the identity, quality, durability, reliability,
safety, effectiveness, or performance of a product?
10.2 Does the event involve a product that was released for distribution?
10.3 Does the event involve a product manufactured, marketed and/ distributed by a
Healthium?

Events meeting all three above criteria are defined as complaints. If all three criteria cannot be
met, the event is defined as a non-complaint. For example, the following events are non-
complaints:

10.4 An event that does not allege a deficiency

10.5 An event that involves a product that has not been distributed, or
10.6 An event that involves a product not manufactured, marketed or distributed by a
Healthium

11.0 DOCUMENT RETENTION

11.1 Maintain all complaint files as electronic copies through the complaint management
system and retain the complaint files per the applicable document retention procedures.

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