Manufacturing Process Changes Quiz

Compass Health SOP: Device Recall and Advisory Notices

• This procedure outlines instructions and a system for assigning responsibilities for recalling distributed Compass Health devices and issuing/implementing advisory notices.
• The scope covers all dispatched, shipped, and distributed Compass Health products, including investigational devices.
• The document specifies recall definitions and procedures for FDA QSR, Health Canada CMDR, and Australian regulations. Specific laws of each country must be followed.

Applicable Standards

• 21 CFR 7 (FDA Voluntary Device Recalls)
• 21 CFR 810 (FDA Mandatory Device Recalls)
• 21 CFR 806 (FDA Corrections and Removals)

Revision History

• Version 1.0, dated January 3, 2024, is the initial release.

Process Roles

• Management Representative of Recall Committee: responsible for maintaining internal records demonstrating efforts to contact all suitable consignees.
• Top Management: receives recall problem updates from Quality Assurance, including recall depth, notice type, and contact methods. They coordinate the recall plan with authorities.
• Recall Committee: responsible for initiating the recall, coordinating activities, and deciding if a recall is necessary. It's composed of minimum CTO, VP of Engineering, and QA/RA manager/director.
• Quality Assurance: responsible for maintaining the procedure and participating in recall initiatives.

Recall Process

• Top Management: ensures the procedure is understood and implemented.
• FDA Recall: refers to correcting or removing a marketed device violating FDA law.
• Health Canada Recall: refers to the manufacturer, importer or distributor's action to correct a faulty device or notify owners about its defectiveness.
• Types of Recalls: Class I (serious risk of death), Class II (temporary or medically reversible adverse health consequences), and Class III (no likely adverse health consequences).

Recall Classification

• Recall Classification (FDA): Class I, Class II, Class III determined by potential risk.
• Recall Classification (Australia/Canada): Follows similar (but not identical) classification structure focusing on potential health risk.

Recall Strategy

• The plan outlines courses of action for recalls to be conducted, addressing issues like depth of recall, public warnings, public notification, and effectiveness checks.

Recall Termination (FDA)

• FDA determines if a recall's termination is to occur, and any action by the sponsor is handled accordingly.

Recall Closure (FDA/Canada/Australia)

• Closure procedures, reporting requirements, disposition details, and required documentation (forms) are outlined.

Record Keeping

• Guidelines for maintaining records (advisory notices, minutes of meetings, correspondence) related to device recalls are provided.
• Records need to be kept for 2 years beyond the product lifecycle.
• Recall and advisory notice forms for FDA, Health Canada, and Australia's TGA are noted.

Contact Information

• Contact information for various individual and regional personnel are included (for the sponsor and FDA/Health Canada/TGA).

This quiz explores the key factors that define significant changes in the manufacturing processes of devices. Test your understanding of what constitutes a major alteration in manufacturing and how it impacts production and quality. Ideal for students and professionals in manufacturing and engineering fields.