Unresolved Batch Failures Lacking Conclusions


SSM Health Care St. Louis DBA SSM St. Clare Health Center
Issued on:
Inspection Dates:
16 Sep 2021 to 28 Sep 2021
1015 Bowles Ave, Fenton, MO 63026-2394
  • Wayne D Mcgrath

Detailed Analysis

Key Observations

  • The recurring theme of incomplete documentation in investigations into batch failures indicates a systemic issue within the Quality Control Unit's processes, necessitating comprehensive corrective and preventative measures to address the root causes.

Possible Root Cause :

  • Lack of a robust quality management system that ensures complete documentation and follow-up on identified issues.
  • Insufficient training or oversight on the part of the Quality Control Unit (QCU) in conducting and documenting investigations.
  • Ineffective communication and documentation practices leading to incomplete records of investigations.
  • Failure to establish clear and stringent standard operating procedures (SOPs) for the documentation of investigations.
  • Negligence in adhering to established SOPs for investigations, particularly in documenting the conclusions and follow-up actions.

Corrective Action:

  • Review and revise SOPs related to batch failure investigations to ensure they include requirements for complete documentation, including conclusions and follow-up actions.
  • Conduct a comprehensive training program for all QCU personnel on the importance of complete documentation for investigations.
  • Implement a quality management software tool that prompts and tracks completion of all required investigation documentation steps, including conclusions and follow-up actions.
  • Perform regular audits on investigation reports to ensure compliance with revised SOPs and documentation requirements.
  • Establish a cross-functional team to review all investigation documentation before closing any investigation to ensure completeness and adequacy.

Preventive Action

  • Develop and implement continuous training programs emphasizing the importance of documentation completeness in investigations.
  • Introduce periodic reviews of investigation SOPs to ensure they remain up-to-date and comprehensive.
  • Leverage technology to automate and monitor the investigation documentation process, prompting users for missing information.
  • Enhance the oversight role of the Quality Assurance department to ensure compliance with documentation practices.
  • Foster a culture of quality and transparency that values thorough investigation and documentation.
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