RGA6234 WRITTEN ASSIGNMENT#1

Topic: Medical Devices Risk Management, Quality, and Supply Chain Compliance Case Scenario:

A manufacturer who markets Hydrophilic Wire Guides is dealing with a post-market scenario. The Hydrophilic Wire Guides were notified and subject to potential contamination with glass particles. The manufacturer followed up with a voluntary U.S. and Global Recall and notified its customers for the following actions: 1) Examine inventory immediately to determine if they have received any affected products and to quarantine the affected products; 2) Return affected products to the manufacturers third-party service center.; 3) Even if the customer has not received any contaminated or affected products inventory, they must report and acknowledge via the receipt form and fax to the manufacturer; 4) The customer report any adverse events to the manufacturer via phone/fax or by email during their business hours.

The manufacturer has decided to recall all global markets’ inventory of this device. The reason behind this decision was the discovery of potential coating contamination with glass particles. The quality team has made a proposal to complete a though investigation to determine the root case. To proceed the manufacturer has to notify the FDA and initiate a CAPA. Based upon the probable route for identification of the root cause the company will need to make a determination if this device issue requires preventative or corrective action, or both types.

Assignment:

Write a mock CAPA form explaining the reason for opening this action and the determination routes (preventative or corrective) that would be required. Take into consideration the QSR, Risk Analysis and Compliance Management as covered in the course modules.

As the company has initiated a recall, it is critical to understand what issues could have triggered this type of action. Conduct a general web research on the Hydrophilic Wire Guides device and its probable failure modes based upon their intended use.

Attempt this assignment as a quality and risk assessment exercise. Include the following in your analysis summary for the mock CAPA form.

• What are Hydrophilic Wire Guides and the type of risk which could be associated with such devices.
• Define the risk index, taking into consideration the level of risk (1 -5).
• Assess the probability of severity versus occurrence.
• Describe the probable root cause(s) which caused this issue leading to recall.
• Include in your analysis and CAPA write-up, the following:
  • Identify the issue
  • Analyze
  • Cause Analysis

• Proposed strategy for resolution
  • Proposed Root Cause Analysis.
  • Proposal for continuous improvement.
  • Other action plan topics as applicable

Assignment Instructions:

• To write this analysis and mock CAPA use the Appendix C only, given in the CAPA SOP (or create your own summary using information from Attachment C). The CAPA SOP is a reference document.

• This is an individual contribution and graded assignment. Refer to course syllabus for grade point distribution.

• Review the course rubric on CANVAS.

Page Limit: 4 Pages (primarily use this attachment C to write your analysis). The title page and references can be added additional to the page count.

Review Materials:

1. Course Module Materials
2. CAPA SOP – Example
3. General Information on CAPA – Refer to FDA

-End of Document-

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