Compass Health SOP: Data Analysis Procedures

Compass Health SOP: Analysis of Data

• This document outlines the procedures for data analysis within Compass Health's quality management system.
• Version 1.0, initial release, dated January 3, 2024.
• Approvals: Tenzin Yangzom (Head of QA/RA, Author, January 2, 2024) and James Baskin (COO, Approver, January 2, 2024).
• Document number: QMS-SOP-0025

Scope

• This process covers recording, compiling, and analyzing:
  • Customer feedback
  • Quality system audits
  • Conformity to product and process requirements
  • Characteristics of processes and products
  • Supplier quality performance

Applicable Standards

• ISO 13485:2016 Section 8.4 Analysis of Data

Reference Documents

• SOP: Management Review (QMS-SOP-0004)
• SOP: Supplier Evaluation and Monitoring (QMS-SOP-0016)
• SOP: Process Validation (QMS-SOP-0017)
• 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)

Acronyms and Definitions

• QMS: Quality Manual System
• Suitability: Defined as "fit for use or adapted to a use or purpose consistent with organizational needs and objectives".
• Conformity to Product Requirements: Meeting or complying with specific requirements as a standard to measure against.
• Effectiveness: The degree a planned effect is achieved.

Process Roles

• Top Management: Oversees quality, performance, and new/existing quality objectives; communication to QA is maintained.
• QA/RA: Compiles and analyzes quality and operational trends, communicating findings to Top Management and monitoring quality system effectiveness. This includes analyzing delivery performance and communicating trends.
• Engineering: Analyses quality and on-time delivery ratings, liaises with QA regarding trends.
• Customer Success: Reviews data to determine software performance trends.

Data Analysis Process

• General: Data analysis is performed periodically to review system suitability and identify improvement opportunities. This includes checking product requirements.
• Reporting and Use of Data: Reporting quality and operational performance trends to Top Management for decision-making via continual communication. Uses data to identify improvement and quality objectives including feedback, conformity to requirements, process characteristics, suppliers and audits.
• Methods of Analyzing Data: Data analysis can be done via any suitable method, being comprehensive and communicating performance/effectiveness.
• Product Conformance Analysis: This is performed through sampling plans and documented. Data analysis is conducted in line with the appropriate work instructions. ANSII/ASQ Z1.4-2003 should be followed for sampling plans, if necessary. Inspections of end products, raw materials, in-process materials, supplies and data are included.
• Process Monitoring: QA/RA coordinates data analysis activities, compiling and reporting findings. If the QMS is unsuitable, it is reported via Corrective and Preventative Actions (SOP) and incorporated into management reviews.

Quality Records

• Quality and Operational Performance Data and Trends: Reporting results to Top Management.
• Sampling Plan Records: Extracted data through sampling methods for examining product conformity.

This document provides a comprehensive overview of the procedures for data analysis within Compass Health's quality management system. It covers various aspects such as customer feedback, quality audits, and supplier performance in accordance with ISO 13485:2016. Approval details and applicable standards are also included.