Compass Health SOP: Quality Systems Audit

Study Notes

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.

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.

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.

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.

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.

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.

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.