Compass Health SOP: Complaint Handling

Compass Health SOP: Complaint Handling

• This document outlines the standard operating procedure (SOP) for handling complaints at Compass Health.
• The document version 1.0 was released on January 3, 2024.
• Tenzin Yangzom, Head of QA/RA, and James Baskin, COO, approved the SOP.

Introduction

• The procedure provides instructions and a system for handling customer complaints and feedback related to the quality of Compass Health products.
• Complaints provide valuable feedback on organizational effectiveness and help improve products.
• The SOP aims to offer an open and responsive complaints-handling process for customers.

Scope

• The procedure applies to all internal and external customer complaints about Compass Health Inc. products, including investigational devices.

Applicable Documents

• This SOP adheres to ISO 13485:2016 Section 8.2.2 on complaint handling.
• It follows the Canadian Medical Device Regulation (CMDR-(SOR/98-282), specifically sections 57 & 58.
• It adheres to FDA QSR § 820.198 and § 803 for medical device reporting.

Reference Documents

• The procedure cites and refers to other Compass Health internal documents regarding record control, management reviews, control of non-conforming products, device recalls, medical device reporting, and corrective/preventive action.
• It also references TG(MD)R Sch1 P12 for device design, Sch3 P1 1.4(3)- Post market requirements, 1.4(5)(b)(iii) &1.4(5)(f) which is about documenting post-market experience.

Definitions and Acronyms

• The document includes a table defining terms like "Corrective Action", "Incident", "Manufacturer", "Device Complaint", "Intended Purpose", "User Error", "General Complaint", "MDR Reportable Complaint", "Complainant", "Malfunction", "Mandatory Problem Reporting (MPR)", etc.
• It provides acronyms for different terms.

Process Roles

• Engineering: Assists in complaint processing.
• RA (Regulatory Affairs): Maintains records, informs senior management.
• Product: Identifies and resolves complaint fixes.
• Customer Success: Receives, classifies, and logs complaints.
• All Employees: Report complaints to Customer Success.

Receiving and Recording Complaints

• Complaints originate from internal and external sources (partners, users).
• Customer Success handles recording and verification of all complaints.

Complaint Classification

• Complaints are categorized as "General" or "Device" complaints.
• General complaints include issues with product quantity, delivery, communication, business practices, etc.
• Device complaints include labeling issues, quality issues, safety, and regulatory non-conformity.

Customer Complaint Logs

• Complaints are stored electronically (Complaint Handling Software).
• The records include reference IDs, originator details, device information (if applicable), complaint description, determination of reportable complaints, risk assessment, and response to the complaint.

Device Complaint Processing

• Customer Success assesses device complaints using the severity classification table.

MDR/MPR/Device Recall Assessment

• If a complaint involves a reportable event (FDA 21 CFR Part 803), the Regulatory Affairs (RA) team investigates it.
• Recalls are investigated when necessary.

Reportable Complaints

• These complaints trigger more detailed investigation processes per FDA and Canadian regulatory guidelines.
• These complaints need to meet specific criteria regarding product failure or safety issues.

General Complaints Processing

• Customer Success handles general complaint reviews and follow-ups.
• Complaints are logged, and personnel are informed.

Complaint Closure

• General complaints are closed by assigned personnel.
• Device complaints are closed per particular procedures (e.g. defect handling, non-conforming product, corrective action).
• If not answered within 10 business days, Customer Success closes them accordingly.

Complaint Trending

• Complaints are reviewed for patterns or trends.

Quality Records

• The document defines the different types of quality records and electronic logs used, including customer complaint logs, and when reportable complaints are filed separately.

This SOP document outlines the procedure for managing customer complaints at Compass Health. It emphasizes the importance of feedback in improving product quality and ensures compliance with relevant regulations. The process aims to be open and responsive to both internal and external complaints.