Compass Health AI SOP: Analysis of Data PDF

Compass Health AI SOP: Analysis of Data 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...

Compass Health AI SOP: Analysis of Data 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-0025 Revision History Version Date Description 1.0 03-Jan-2024 Initial Release Document #: QMS-SOP-0025 1 Introduction This procedure provides a system and instructions for, and assigns responsibilities for collecting, analyzing and reporting data on the performance of, the Compass Health quality management system. 1.1 Scope This process governs recording, compilation, and analysis of: Customer Feedback Quality System Audits Conformity to product and process requirements Characteristics of processes and products Supplier quality performance 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Section 8.4 Analysis of Data 2.2 Reference Documents Document Title Document Number SOP: Management Review QMS-SOP-0004 SOP: Supplier Evaluation and Monitoring QMS-SOP-0016 SOP: Process Validation QMS-SOP-0017 Document #: QMS-SOP-0025  SOP: Feedback and Customer Satisfaction QMS-SOP-0022 SOP: Quality System Audits QMS-SOP-0023 SOP: Control of Nonconforming Product QMS-SOP-0024 SOP: Complaint Handling QMS-SOP-0026 SOP: Corrective and Preventive Actions QMS-SOP-0031 3 Acronyms and Definitions Table 1: Acronyms Term Meaning QMS Quality Manual System Table 1: Definitions Term Meaning Suitability Compass Health defines suitability as fit for use or adapted to a use or purpose consistent with organizational needs and objectives. Conformity to To meet or comply with specific requirements as a standard Product to measure against in accordance with regulatory Requirements guidelines. Effectiveness The degree a planned effect is achieved. Planned activities are realized. Equally, planned results are effective if these results are actually achieved. 4 Process Roles Role Description Document #: QMS-SOP-0025  Top Management Oversee all aspects of quality, performance trend analysis and to evaluate new and existing quality objectives. Note: Management reviews will be the major venue of such discussion however; continual communication with Quality Assurance will be maintained to update quality and performance trend data analysis. QA-RA Compile and analyze all applicable quality and operational performance trends with relevant departments and continually communicate such findings to Top Management. Monitor and measure the effectiveness of the quality system and search for opportunities for improvement in consultation with Top Management. Engineering Analyze quality and on-time delivery performance ratings Liaison with Quality Assurance to communicate all quality and performance trend discoveries Customer Success Review data collected through Mixpanel and Postgres to determine trends in the performance of the software. 5 Analysis of Data Process 5.1 General Data and information recorded in quality records are compiled and analyzed periodically to determine trends in the performance, suitability, adequacy and effectiveness of the quality system and to identify opportunities for improvement. These data shall also be analyzed to check for Conformity to Product Requirements (see definition). Document #: QMS-SOP-0025 5.2 Reporting and use of data Quality and operational performance data and trends shall be reported to Top Management for decision-making and planning. The information is communicated continually, by timely distribution of information, and periodically, by presentations and discussions conducted within the framework of management reviews of the quality system (refer to SOP: Management Review). Quality and operational performance data and trends are used to identify opportunities for improvement and for defining appropriate quality objectives. This process is defined in the SOP: Feedback and Customer Satisfaction, SOP Complaint Handling and SOP: Management Review. Data may be collected from various sources, including input from; Feedback Conformity to product requirements Characteristics and trends of processes and product Suppliers Audits 5.2.1 Software Reporting and Data Collection Compass Health may use multiple sources to track and collect data for software products. Tools and services chosen for data collection shall be geared towards providing advanced mobile & web analytics to help collect a wealth of data, including the type of device being used by the users; the location of the users; as well as all the features within the software that are being used. All data collection and analytic tools and services are subject to supplier evaluation (as per SOP: Supplier Evaluation and Monitoring) prior to use. Once data is collected, characteristics and trends of products shall be generated through business intelligence tools. Further, Compass Health shall use reliable and reputable software for monitoring website performance and availability. All data and trends collected shall be reviewed by the appropriate department to determine performance of the product, and to be used as input to enhance product features, as well as, implementation in design and development. Document #: QMS-SOP-0025 6 Methods of Analyzing The method of analyzing and determining trends can be performed through any means that are best fit to display the information. Irrespective of the method of analysis, all information shall be presented in a manner that is comprehensive and that effectively communicates the pertinent information that speaks to the performance and effectiveness of the quality system and to identify opportunities for improvement. 7 Analyzing Product conformance Product conformance may be assessed using sampling plans and documented in accordance with the appropriate Work Instruction (WI) and in the product Verification and Validation (V&V) plan. When conducting inspection for product conformance through sampling plans, the American National Standard: Sampling Procedures and Tables for Inspection by Attributes (ANSI/ASQ Z1.4-2003) shall be referenced for conductance of the sampling plan and procedure. At Compass Health Inc., sampling plans are applicable, but not limited to, inspection of the following: 1. End items 2. Components and raw materials 3. Operations 4. Materials in process 5. Supplies in storage 6. Data or records 8 Process Monitoring QA/RA personnel shall coordinate all data analysis activities, including compiling of all data and reporting conclusions and trends to the top management. Data shall be collected on a monthly basis for analysis. If the analysis of data shows that the QMS is not suitable, adequate or effective, the analysis will be used as input for improvement as per SOP: Corrective and Preventive Actions. This will also be incorporated within the framework of management reviews of the quality system, in accordance with SOP: Management Review. Document #: QMS-SOP-0025 9 Quality Records Record type Description Quality and Operational Results from the analysis of data and information performance data and recorded in quality records that were compiled trends Reported to Top Management Sampling Plan Records Results/ data extracted through performing sampling plans to analyze product conformance Document #: QMS-SOP-0025