Lack of Written Calibration Procedures and Compliance


Cape Apothecary, Inc.
Issued on:
Inspection Dates:
21 Sep 2015 to 07 Oct 2015
1384 Cape Saint Claire Rd, Annapolis, MD 21401
  • Nebil A Oumer
  • Qin Xu

Detailed Analysis

Key Observations

  • The significant backlog of over 470 quality reports in an open status suggests systemic issues within the quality management system related to resource allocation, prioritization, and procedural adherence.

Possible Root Cause :

  • The quality management system might be inadequately designed or implemented, leading to ineffective tracking and closure of quality issues.
  • There may be a lack of clear responsibility and accountability for closing out reports, resulting in prolonged open status.
  • Potential understaffing or lack of adequately trained personnel to manage and address the volume of reports efficiently.
  • Inadequate prioritization of issues concerning their impact on product quality and patient safety, leading to delays in resolution.

Corrective Action:

  • Conduct a comprehensive review of all open reports to prioritize them based on their potential impact on product quality and patient health.
  • Identify and address any resource or training gaps within the teams responsible for investigating and closing these reports.
  • Implement a more robust project management approach for tracking progress and ensuring timely closure of all reports.
  • Revise the current quality management system procedures to incorporate clear accountability for report closure, stricter timelines, and escalation pathways for delayed reports.

Preventive Action

  • Develop and implement a risk-based approach to managing deviations, complaints, change controls, CAPAs, and quality protocols to prioritize efforts according to potential impact.
  • Introduce regular training and refreshers for staff on the importance and processes related to timely investigation and closure of quality-related reports.
  • Establish regular audits of the database system to ensure adherence to procedures and timelines.
  • Enhance the database system to automatically flag and escalate reports that are approaching or have exceeded their due dates.
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