Lack of Proper Drafting, Review, and Approval

Overview

Company:
RC Outsourcing LLC
Issued on:
23-Sep-22
Feinumber:
3011967886
Inspection Dates:
31 Aug 2022 to 23 Sep 2022
Location:
102 E Water St, Lowellville, OH 44436-1117
Investigators:
  • Ucheabuchi C Chudi-Nwankwor
  • Ucheabuchi Chud Nwankwor

Detailed Analysis

Key Observations

  • The absence of initiated change controls for the installation of new equipment indicates a gap in the firm's change control and documentation practices, which could impact product quality and regulatory compliance.

Possible Root Cause :

  • Lack of established protocols or procedures for initiating change controls in response to equipment installations.
  • Absence of a systematic approach to document and review changes in a timely manner within the organizational structure.
  • Inadequate training or oversight on the importance and process of documenting change controls among the staff.

Corrective Action:

  • Develop and implement a comprehensive change control procedure that mandates the initiation of change controls for equipment installations and significant procedural changes.
  • Conduct training sessions for staff across all relevant departments on the revised change control procedure.
  • Assign a change control coordinator or team responsible for overseeing the documentation, review, and approval of change controls to ensure compliance with established procedures.

Preventive Action

  • Establish an internal audit program to periodically assess the compliance with the change control procedure and identify areas for improvement.
  • Integrate change control management into the quality assurance system, making it a fundamental aspect of the organizational culture.
  • Use automated systems for change control documentation and management to streamline the process and improve traceability.
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