Quality Policy Not Understood or Implemented Organization-Wide


Philips Respironics, Inc.
Issued on:
Inspection Dates:
26 Aug 2021 to 09 Nov 2021
1001 Murry Ridge Ln, Murrysville, PA 15668-8517
  • Katelyn A Staub-Zamperini

Detailed Analysis

Key Observations

  • The organization's management, including those with executive responsibility, was aware of significant product safety issues well in advance of taking corrective actions, highlighting systemic failures in the quality management system.

Possible Root Cause :

  • Lack of effective oversight and action by management with executive responsibility despite knowledge of foam degradation issues.
  • Inadequate risk management processes to identify and mitigate risks related to product safety timely.
  • Insufficient corrective and preventive action processes to address identified product quality issues.
  • Poor communication and enforcement of quality policies across all levels of the organization.

Corrective Action:

  • Conduct a comprehensive review of the management review and CAPA processes to identify gaps and implement improvements.
  • Increase training and awareness campaigns across the company to ensure understanding and implementation of the quality policy at all levels.
  • Develop and implement a more robust risk management process that includes timely identification, evaluation, and mitigation of product safety risks.
  • Re-evaluate current product designs and materials to prevent similar issues from occurring in the future.

Preventive Action

  • Establish a regular schedule for management review meetings with mandatory attendance for management with executive responsibility, to ensure ongoing oversight of the quality management system.
  • Introduce routine audits of the CAPA and risk management processes to ensure they are effectively identifying and addressing product quality and safety issues.
  • Enhance training programs focused on quality policy, risk management, and CAPA processes for employees at all levels of the organization.
  • Improve communication channels within the organization to ensure timely dissemination of information related to product safety and quality.
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