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This SOP describes how feedback and customer complaints will be received, monitored, examined, documented, and resolved.
This SOP covers all products that have been released by the manufacturer but can include feedback that occurs during the development process. Feedback received can initiate other processes including the potential to impact change control, vigilance and reporting, corrective and preventive actions (CAPAs), risk management, and customer support.
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Feedback can be related to released products or products still under development. Feedback can originate from employees of the company, current or future customers or users, experts in the field, or other sources deemed relevant. Feedback includes information relating to whether customer requirements have been met and includes data captured through the customer support channel.
Feedback is captured at regular intervals through the post-market surveillance process (see SOP Post-Market Surveillance). However, feedback identified outside of the post-market surveillance process can also be deemed relevant if subjected to the feedback and complaint management system processes.
Feedback captured outside of the normal post-market surveillance procedures and the customer complaint system can come from the following sources, or others as determined to be relevant:
All feedback (including customer complaints) is classified into the following categories.
A serious deterioration of the state of health is defined as being at least one of the following:
Incident means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. (MDR, Article 2)
A member of the business team, quality team, or a dedicated feedback and complaint team member classifies the feedback according to the categories above.
Depending on classification, the feedback is either recorded in the Complaint Log or directed to the appropriate internal team for action.
Each type of feedback may result in a Change Request per SOP Change Management, if applicable. Additional information for processes associated with each type of feedback are described in more detail in the following sections.
A problem is defined as an actual or potential behavior of a software that a user or other interested person believes to be unsafe, inappropriate for the intended use or contrary to its specification. (IEC 62304:2006)
The complaint is logged in the complaint log by a business team member, quality team, or a dedicated feedback and complaint team member. Include the following information:
Action taken for each complaint will depend on the nature and description of the complaint. The following processes will be used for resolving complaints:
Customer complaints are reviewed annually as part of the SOP Post-Market Surveillance, including any potential trends.
The negative product even is logged in the complaint log by a business team member, quality team member, or a dedicated feedback and complaint team member that contains the following information:
The quality team shall be notified about any negative product events within 2 business days of determining that the feedback was a negative product event. Negative product events then undergo processes outlined in the SOP Vigilance for proper reporting and should undergo CAPA Qualification according to SOP Corrective and Preventive Action.
The business team, quality team, or a dedicated feedback and complaint team member proactively monitors the status of the complaint log that is updated in response to feedback in order to validate that required actions are executed.
Complaint closure is dependent on the type of feedback that the event is related to. Closure procedures for feedback resolution include the following:
If an investigation determines activities outside the organization contributed to the complaint, relevant information shall be exchanged between the organization and the external party involved as needed.
