Responsibilities and Procedures Not Documented or Followed


Empower Clinic Services, LLC
Issued on:
Inspection Dates:
12 Feb 2020 to 06 Mar 2020
5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041-5251
  • Camerson E Moore

Detailed Analysis

Key Observations

  • The observation highlights significant deficiencies in the establishment and adherence to written procedures by the quality control unit, specifically in the areas of change control management and the handling of non-conformances. This indicates a broader issue of inadequate quality oversight and process documentation within the firm.

Possible Root Cause :

  • Lack of a comprehensive and efficiently documented quality control system.
  • Inadequate change control procedures and documentation practices, leading to unauthorized or unrecorded changes to protocols and processes.
  • Inadequate training or adherence to existing procedures by staff, resulting in deviations from established protocols without proper authorization or documentation.
  • Insufficient oversight by the quality control unit to ensure that all procedures and responsibilities are well-documented, communicated, and followed across different processes.

Corrective Action:

  • Conduct a comprehensive review of all quality control and change management procedures to ensure they are in line with regulatory requirements and best practices.
  • Update or establish written procedures for the quality control unit that clearly outlines its responsibilities, including change control and investigation of non-conformances. Ensure these procedures are detailed and cover all necessary aspects to prevent ambiguity or oversight.
  • Implement a training program for all relevant staff on the updated procedures to ensure understanding and compliance. Include a refresher training schedule to maintain awareness and adherence over time.
  • Establish a robust documentation system that accurately records all changes, deviations, and actions related to protocol modifications. This system should include a mandatory approval process involving the quality control unit and relevant management before any changes are implemented.
  • Increase oversight and routine audits by the quality control unit to monitor adherence to procedures and identify areas for improvement.

Preventive Action

  • Develop an ongoing audit and review program for the quality control unit to periodically assess the effectiveness of procedures and adherence by staff.
  • Implement a culture of quality and continuous improvement within the organization, encouraging staff to proactively identify and report potential quality issues.
  • Enhance the change control process to include a more comprehensive impact assessment that considers the implications of changes on all aspects of production and quality.
  • Establish clear consequences and corrective measures for non-adherence to documented procedures to deter future deviations.
  • Leverage technology to automate documentation and process control where possible, reducing the risk of human error.
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