Phoenix Ambulatory Blood Pressure Monitor Project
Sub-project: Quality System

Plan

Project Description

The goal of this project is to design quality system (QS) regulation processes for the manufacture, packaging, labeling, device evaluation, distribution, complaint handling, record retention, training, auditing, and preparing for governmental inspections.

• Quality System Regulation

Contents:

• Standard Operating Procedures
  • Design Processes
  • Manufacturing Processes
    • Records
    • Changes in Process
  • Device Evaluation Methods
  • Chain of Custody Forms, Procedures, & Records
    • Links = CFR 21 § 820.60 and § 820.65
  • Packaging Processes
    • Link = CFR 21 § 820.130
  • Labeling Requirements and Methods
    • Link = CFR 21 § 820.120
  • Auditing
    • Links = CRF 21 § 820.20, § 820.22, and § 820.25
  • Distribution of Devices
    • Link = CFR 21 § 820.160
  • Complaint Procedure Forms, Reporting Requirements, & Records
    • Link = CFR 21 § 820.100
  • Record Retention Procedures
    • Link = CRF 21 § 820.180, § 820.181, § 820.184, § 820.186, and § 820.198
  • Training of Employees and Record Retention
  • Calibration of Equipment & Record Retention
  • Maintenance of Equipment, Logs, & Record Retention
  • Miscellaneous
    • SOP on Writing SOPs
• Facility Inspections - Manufacturing
• Equipment Inspections
• Documentation of Quality Systems
  • Forms for Inspections
  • Deviations and Corrections
• Outline Standards for a Non-Conforming Product (device evaluation)
  • Links = CFR 21 § 820.90, § 820.80, and § 820.86
• Adverse Events
  • Handling
  • Forms, Records, and Retention
  • Reporting to Relevant Agencies
  • Response
  • Follow-up Measures
  • Metrics Evaluating Success of Response

 

 

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