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Complaint Handling SOP
Complaint Handling SOP
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REVISIONS REVISIONS
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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
Procedure 7
Complaint Trending 10
1.0 Purpose
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3.4 Draft Guidance for Industry and Food and Drug Administration Staff – Medical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
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”
8.2.4 Once both Investigation and MDR decisions have been made, move
complaint to next status.
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)
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