Compass Health AI Feedback SOP PDF

Compass Health AI SOP: Feedback Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Bask...

Compass Health AI SOP: Feedback Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document QMS-SOP-0022 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document QMS-SOP-0022 1 Introduction 1.1 Purpose The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for gathering and analyzing post-production feedback and for determining customer satisfaction. As well as providing early warning of quality problems and input into the corrective and preventive action processes. 1.2 Scope This procedure applies to products, delivery, servicing, and other activities bearing on customer satisfaction. 2 Applicable Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 8.2.1 Feedback TG(MD)R Sch1 P1 2, Sch3 P1 1.4(3), 1.4(5)(b)(iii) &1.4(5)(f) 2.1 Reference Documents Document Title Document # SOP: Management Review QMS-SOP-0004 SOP: Control of Non-Conforming Product QMS-SOP-0024 Document QMS-SOP-0022  SOP: Analysis of Data QMS-SOP-0025 SOP: Complaint Handling QMS-SOP-0026 SOP: Corrective & Preventative Action QMS-SOP-0031 3 Acronyms and Definitions Term Meaning Customer complaints, product nonconformity reports, clinical Customer feedback evaluation reports, and other such records referenced in this and records associated procedures. Customer Customer complaints and other such records referenced in this satisfaction records and associated procedures. A product requirement as collected and refined in collaboration Epic with industry practitioners, potential customers and internal analysis of the market and technical capabilities Product feedback/design suggestions received from internal and Idea external users Document QMS-SOP-0022 4 Process Roles Role Description of Responsibilities Responsible for reporting on any significant feedback on products or customer satisfaction Use information gathered via feedback process as input into Product risk management for monitoring and maintaining product requirements and well as product realization and improvement processes. Customer Review and report on feedback and customer satisfaction Success pertaining to complaints and/or returns Coordinate collection of feedback and customer satisfaction results for management review. QA-RA Report on non-conforming product trends, and Complaints (with Operations) 5 Customer Feedback Procedure The feedback system is for collecting and analyzing information about post-production performance of our products. The purpose is to provide early warning of quality problems and for input into the corrective and preventive action processes. Feedback information is collected from the following sources: Customer and user complaints: Complaints are collected, classified and analyzed by Customer Success in accordance with SOP: Complaint Handling. Document QMS-SOP-0022  Complaints related to product quality are forwarded to Quality Assurance for evaluation and investigation of root causes. Product Feedback Sessions: Product team engages in customer calls to gather feedback on post-production performance of our product on a regular and ongoing basis. Defective or otherwise nonconforming product returned by customers: Returned products alleged to be defective or nonconforming are inspected and evaluated to determine the problem, in accordance with SOP: Control of Nonconforming Product. These inspection reports are evaluated by QA-RA to determine whether a corrective or preventive action should be initiated. Clinical evaluations: Results of any clinical evaluations or studies, whether undertook by our company or by other organizations are closely reviewed to determine whether any corrective or preventive actions might be warranted to improve the product or address its weaknesses. Reviews and articles in trade and professional publications: Management is responsible for monitoring trade and professional publications, trade shows, and other such media and venues to identify opinions and reviews concerning our products. Any such feedback that could relate to product design or quality is communicated to Engineering and QA-RA for further evaluation and, where appropriate, follow-up with corrective or preventive actions. Unsolicited Customer feedback: Direct customer feedback, spontaneous expressions of satisfaction, and other unsolicited customer feedback are collected and processed by Customer Success. Complaints are classified into various categories to help with statistical processing of the data for determining customer satisfaction. These activities are defined in SOP: Complaint Handling. The resulting data is periodically compiled and analyzed by Customer Success, and is presented and discussed at Management Review meetings. Product returns: Customer Success handles product return authorization requests. The reason for each return request or claim is recorded. Reasons for product returns are classified into the same categories that are used for customer complaints. This is to assure compatibility with other customer satisfaction data acquired from other sources. Product return records are periodically compiled and analyzed by customer success, and are presented and discussed at management review meetings. All feedback collected/provided by users shall be recorded and inputted as an "idea" into the Product Team's IDEAS board. Product Team reviews and prioritizes tickets based on Document QMS-SOP-0022 customer urgency and demand and schedules the tickets into their product planning roadmap. Once a ticket is included into the product backlog, an Epic will be linked. 6 Process Monitoring 6.1 Analysis and presentation of customer Feedback Results Cross-functional teams, including but not limited to Customer Success and Product teams, assemble, integrate and analyze all customer satisfaction data collected from various sources and pertaining to different aspects of the company's products and services. Results of the analysis are presented to executive management at Management Review meetings (refer to SOP: Management Review). Attained customer satisfaction levels in all aspects are compared with results from previous years and to projections for the current year. Managers participating in the meeting discuss the reasons for successes or failures in reaching customer satisfaction objectives, and provide input for setting new objectives for the coming year, as part of product realization or improvement processes. Information gathered in the feedback process shall also serve as potential input into risk management for monitoring and maintaining the product requirements. 7 Quality Records Record type Description An electronic log format that all customer complaints are Complaint Logs documented on. Supporting documentation of such complaints is filed and correlated with the complaint number The details (including the reason for each return request) are Product Returns recorded in this report. Reasons for product returns are classified into the same categories that are used for customer complaints. Document QMS-SOP-0022