Deficient Procedures for Complaint Management

Overview

Company:
iRhythm Technologies, Inc.
Issued on:
12-Aug-22
Feinumber:
3021769057
Inspection Dates:
25 Jul 2022 to 12 Aug 2022
Location:
6550 Katella Ave, Cypress, CA 90630-5102
Investigators:
  • Alexandria L Capuano
  • Janet Pulver

Detailed Analysis

Key Observations

  • The failure to categorize ZTickets documenting alleged deficiencies in the Zio AT Cardiac Monitoring System indicates a significant gap in the complaint handling process, potentially impacting patient safety and regulatory compliance.

Possible Root Cause :

  • The existing complaint handling procedures may be unclear, incomplete, or not effectively communicated to staff responsible for assessing and categorizing reported issues.
  • Lack of training or awareness among staff who receive and handle reported issues, resulting in inaccurate categorization or failure to recognize certain events as complaints.
  • Insufficient oversight or quality controls to ensure accurate and consistent application of complaint handling procedures.
  • Potential gaps in the SalesForce Customer Relationship Management system's setup or use, which could contribute to missed or miscategorized complaint records.

Corrective Action:

  • Review and update the complaint handling procedures to ensure they are comprehensive, clear, and effectively communicated across the organization.
  • Implement a training program or refresher courses focused on complaint handling protocols and the importance of accurately categorizing reported issues.
  • Establish regular audits of complaint records to ensure compliance with established procedures and to identify areas for further training or system improvement.
  • Evaluate the configuration and usage of the SalesForce Customer Relationship Management system to ensure it supports accurate complaint documentation and categorization.

Preventive Action

  • Develop regular competency assessments for staff involved in complaint handling to reinforce the importance of accurate issue categorization.
  • Incorporate checks or prompts within the SalesForce Customer Relationship Management system that guide users to correctly categorize reports as complaints.
  • Set up a cross-functional review team to periodically assess and validate the complaint handling process, ensuring continuous improvement.
  • Integrate feedback from complaint handling audits into procedural updates and staff training initiatives.
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