Missing Quality Audits

Overview

Company:
Theranos, Inc.
Issued on:
16-Sep-15
Feinumber:
3006231732
Inspection Dates:
25 Aug 2015 to 16 Sep 2015
Location:
7333 Gateway Blvd., Newark, CA 94560
Investigators:
  • Mary R Hole
  • Yung W Chan
  • Stayce E Beck

Detailed Analysis

Key Observations

  • The lack of performed quality audits signifies a major oversight in monitoring and maintaining the integrity of the Quality Management System. Without regular audits, unnoticed discrepancies, and non-compliances can proliferate, potentially impacting product quality and regulatory compliance.

Possible Root Cause :

  • Lack of established internal audit schedule
  • Inadequate adherence to established Quality Management System procedures
  • Possible understaffing or lack of trained personnel to conduct internal audits
  • Potential oversight or lack of prioritization of audit activities within the quality management framework

Corrective Action:

  • Develop and implement a documented internal audit schedule as part of the Quality Management System
  • Conduct immediate quality audits to assess and identify gaps within the current Quality Management System
  • Train additional personnel or assign dedicated resources to ensure regular and systematic internal audit execution
  • Revise existing SOP to reinforce the importance and mandatory nature of internal audits within the quality management framework

Preventive Action

  • Regular training sessions for staff on the importance and methodology of internal audits
  • Establish a reminder system or automated schedule to ensure timely execution of audits
  • Implement a corrective action and preventive action (CAPA) system to address findings from internal audits promptly
  • Regularly review and update the internal audit schedule and procedures to adapt to changes within the manufacturing and quality control environment
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