Compass Health SOP: Quality Systems Audit

Compass Health SOP: Quality Systems Audit

• Purpose: Internal audits are crucial for assessing the functionality and effectiveness of Quality Management Systems. They identify system weaknesses, pinpoint problems, and drive improvements.
• Scope: This procedure outlines the process for conducting and reporting internal audits for Compass Health's Quality Management System on a yearly basis. Internal audits check actual practices against SOPs.
• Applicable Standards: The procedure adheres to FDA QSR § 820.22, ISO 13485:2016 Section 8.2.4, and TG(MD)R Sch3 P1 1.4(5)(b)(iii).
• Reference Documents: Various documents are referenced for specific procedures, including SOPs for Control of Records, Corrective and Preventative Action, Internal Audit Checklists, and CAPA forms.

Process Roles

• QA/RA: Organizes internal audits, ensuring corrective actions are closed out within deadlines. The QA/RA also reports audit results.
• Auditor/Team: Arranges audit schedules, develops audit checklists based on SOPs, completes audits, and ensures objectivity.
• Department Representative: Supports the audit process by cooperating with the internal auditor to provide necessary information.
• Management: Solves issues if corrective actions can’t be agreed upon between the auditor and auditee.
• CAPA Administrator: Tracks and monitors corrective actions (CAPAs), ensures CAPAs are completed, and verifies closure. Monitors CAPA progression, and closes out CAPA's.

Quality System Audit Process

• Systematic Process Audits: Audits are conducted based on status and importance rather than an annual cycle.
• Procedure: The process involves determining audit schedule, preparation, conducting audits, reporting findings, determining if CAPA is required. If required, follow-up on CAPA results, and closure if satisfactory.

Responsibility for Audits

• Regulatory Affairs Lead: Top management designates the lead for scheduling, conducting, reporting, and managing internal audits.
• Scheduling Audits: QA-RA develops an annual audit timetable for internal audits.
• Lead Auditor Selection: QA-RA chooses the lead auditor who meets criteria like experience in medical device regulations, sufficient training, and 3+ years of experience in the field.

Conducting Audits

• Evaluation: Audits determine if processes are defined, responsibilities assigned, procedures implemented and maintained, and if processes are effective to achieve desired results.
• Audit Plan: Includes documentation, checklist, and sample questions for each item to be audited.
• Process: Includes an entrance briefing to address purpose, requirements, contacts, and other concerns and follow up on previous audits. Findings are recorded on an audit checklist.
• Discussion: After the audit, auditors discuss findings with representatives and ensure mutual agreement.
• Documentation: Documentation of audit findings, dates, non-conformances, follow-up on corrective actions, observations, conclusions, and the number of non-conformances raised and processes audited are included in the audit record.

Corrective Action

• CAPA Requests: The QA-RA issues Corrective/Preventative Action (CAPA) Requests for non-conformances identified during audits.
• Follow-up: The audit report includes CAPA details and is circulated for evaluation and action within one month.
• Completion: CAPAs are closed after completion (and appropriate action). If not complete, new dates are agreed upon. The CAPA Administrator assesses the action effectiveness.
• Categorization: Non-conformances are categorized as critical, major, or minor based on their potential impact on the product and quality system.

Process Monitoring & Quality Records

• Monitoring: QA periodically reviews audit reports and CAPAs to ensure timely and successful action to correct non-conformances.
• Reporting: Results of the review are made available to management.
• Quality Records: Records include internal audit checklists and audit reports (which detail findings, follow-up on corrective actions and other observations).
• Records Keeping: Required documentation includes specific forms and logs (per SOP's). Also includes the conclusion.

This quiz covers the internal audit process for Compass Health's Quality Management Systems as outlined in the SOP. Participants will learn about the purpose, scope, applicable standards, and process roles involved in conducting quality audits. It is essential for understanding compliance with FDA and ISO standards.