Complaint Summary Report

This page displays the details of a complaint including contact information, events, products, andinvestigationevaluation information. A user having the QUM/GLR license can view all the details about a complaint and its associated objects from a complaint summary report.

Important: This app creates reports or generates content that contains personal data. Manage these in accordance with good personal data treatment practices.

You can print, save as PDF, send as email, and locally save the summary report. The commands for these actions are present in the upper-right corner of the report.

The summary report, which is saved in the pdf and html format is supported the hyperlinks and images. In the html format, all the html tags are supported. You need to follow the W3C standards while modifying the html tags. The report, which is in the pdf format is not supported for pdf formatting options.

The formatting options are not supported for the hyperlinks that are inserted in the pdf format of a summary report.

To access summary report follow the path as given below.

From the Complaints Power View page, go to the Properties tab toolbar, select Actions > Summary Report.

The details about the summary report are descried in the following tables:

This page discusses:

Basic Information
Complaint Event Details
Evaluations
Adverse Event Reports
Where Used

Basic Information


Field Name	Description
Owner	Name of the complaint owner
Originator	Name of the complaint originator
Modified	Date when the complaint was last modified
Orginated	Date when the complaint was originated
Status	State of the complaint. Possible states are Create, In Process, and Closed.

Additional Information


Field Name	Description
Date of Awareness	Date when the problem was identified
Description	Description of the problem
Distributor Awareness Date	Date when the problem was identified by the distributor
Source	Communication method through which the complaint was raised
Purchase Order	Purchase order number related to the product
Severity	Severity level of the complaint
Reassign Rationale	Reason provided when the complaint was reassigned
Change Justification	Reason provided when the complaint was converted from an equipment service request or inquiry
Reopen Rationale	Reason provided when the complaint was reopened
Customer Closure Date	Date when the complaint was closed by customer
Closed Date	Date when the complaint was closed
Reopen Count	Number of times the complaint was reopened

Contacts


Field Name	Description
Salutation	Formal salutation when addressing the contact
First Name	First name of the person
Last Name	Last name of the person
Title	Job title of the person
Business/Agency	Company where the person works
Contact Type	Contact types are: Company Representative Consumer Customer Distributor Manufacturer Reporter User Facility
Home Phone Number	Home number of the person
Work Phone Number	Work number of the person
Email Address	E-mail address of the person

Complaint Event Details


Column Name	Description
Experience Code	Experience code that is used to classify the problem
Model	Name of the model
Primary	Yes, if event is primary No, if event is not primary
Event Confirmed	Yes if event is confirmed No if event is not confirmed
Event Confirmed Date	Date on which event was confirmed
Date of Occurrence	Date on which the problem occurred
Receipt Date	Date on which the problem was reported
Issue Code	Issue code that is used to classify the issue
Complaint Date of Occurrence	Date on which the problem occurred
Complaint Event Timing	Process during which the problem was identified. This is FDA codes for timing. and the possible values are: Kit Inspection Other Unknown Upon Receipt
Complaint Event Detail	Description of the problem

Evaluations


Field Name	Description
Investigation Required	Yes, if investigation is required No, if investigation is not required
Severity	Severity of the investigation. Possible values are High, Low, Medium, and Urgent.
Rationale	Reason provided by the investigator to select the conclusion code
Methods	Investigation method code
Results Code	Investigation result code
Conclusion Code	Investigation conclusion code
Invalidator	Name of the investigator
Closed Date	Date when the investigation was completed
Analysis Required	Yes, if risk analysis is required No, if risk analysis is not required
Comments	Reason provided by the investigator about the risk analysis requirement
Malfunction	Yes if problem occurred due to reported item malfunction No if problem did not occur due to reported item malfunction
Use Error	Yes if problem occurred due to wrong usage No if problem did not occur due to wrong usage

Adverse Event Reports

Adverse Event Reports(AER) are accessible only to users having the GLR license.


Field Name	Description
Name	Name of the AER associated with the complaint
Type	Type of AER associated with the complaint. Possible values are MDR, CMDR, MDV, and PMDA.
Revision	Revision number of AER associated with the complaint
Final	True, if AER is final False, if AER is not final
Classification	AER classification based on type
Owner	Owner of the AER object
Reviewed Date	Date on which AER was reviewed
Submitted Date	Date on which AER was submitted

Tasks


Field Name	Description
Name	Name of the task
Title	Title of the task
Due Date	Scheduled completion date of the task
Assignee	Name of person to whom task is assigned
Instructions	Route instructions

Where Used


Field Name	Description
Name	Name of object related to the complaint
Type	Type of object related to the complaint
Status	State of object related to the complaint
Owner	Owner of object related to the complaint
Description	Description of the related object

CAPA


Field Name	Description
Name	Name of the CAPA/CAPA Request object associated to the complaint
Type	Type of the CAPA/CAPA Request object associated to the complaint
Status	State of the CAPA/CAPA Request object associated to the complaint
Owner	Owner of the CAPA/CAPA Request object associated to the complaint
Comments	Comments of the CAPA/CAPA Request object associated to the complaint

Related CAPA


Field Name	Description
Name	Name of the CAPA/CAPA Request object associated to the complaint
Type	Type of the CAPA/CAPA Request object associated to the complaint
State	State of the CAPA/CAPA Request object associated to the complaint
Owner	Owner of the CAPA/CAPA Request object associated to the complaint
Description	Description of the CAPA/CAPA Request object associated to the complaint

Returns


Field Name	Description
Name	Return name/Id
State	State of Return
Reported Against Item	Reported against item name
Product Returned	Yes, if product is returned No, if product is not returned
Quantity	Number of product
Unit of Measure	Unit of measure for product
Serial Number	Serial number for product
Shipping Carrier	Shipping Carriers are: FedEx UPS USPS other
Receiver Name	Name of person who received the product
Received Date	Date when the product is received

Fulfillments


Field Name	Description
Name	Fulfillment name or Id
Fulfillment Type	Fulfillment Types are: Coupon Product Sample cheque Credit Return box/Envelope Literature Tools Kit Medical Release Form
State	State of fulfillment
Reported Against Item	Reported against item name
Quantity	Number of product
Unit of Measure	Unit of measure for product
Amount	Amount for product (In dollars)
Shipped To Customer	Date when product is shipped to customer
Date Received By Customer	Date when product is received by customer
Date Shipped From Customer	Date when product is shipped from customer
Customer name	Name if the customer
Carrier	Shiping Carrier types are: FedEx UPS USPS other
Method	Method types are: 2nd day Next day by 10AM Overnight Standard

Summary Report as HTML

The summary report is saved in the html format can be accessed with below enhancements.

The summary report is supported with basic html tags and adds hyperlinks and images using the <href> and <img> tags respectively.
The hyperlink can be assigned either to the plain text or image.
By default, the summary report is not display in the programHTMLOutput.
When the summary report is downloaded in the html format, it is saved as SummaryReportHTML.zip file. The zip folder consists the html file and related images.