Describe your process for conducting internal audits and how you address findings.

Auditee: Conducting internal audits is a critical aspect of maintaining a robust quality management system and ensuring compliance with FDA regulations. Here’s a description of our process for conducting internal audits and addressing findings:

Step 1: Audit Planning

Audit Schedule: An annual audit schedule is developed, outlining the areas, processes, and functions that will be audited throughout the year.
Audit Criteria: Audit criteria are established based on FDA regulations, industry standards, and our internal policies and procedures.
Audit Team: A team of trained internal auditors is selected to conduct the audits. Auditors are independent from the areas being audited.

Step 2: Audit Execution

Preparation: Auditors review

relevant documentation, procedures, and previous audit reports to familiarize themselves with the area being audited.

Audit Plan: An audit plan is developed, outlining the scope, objectives, and methods of the audit.

On-Site Audit: Auditors visit the audited area, conduct interviews with personnel, review records, and observe processes to assess compliance and identify potential gaps.

Step 3: Finding Identification

Evidence Collection: Auditors collect objective evidence to support findings, such as non-compliance with procedures, incomplete records, or deviations from standards.
Finding Classification: Findings are classified based on their severity and potential impact on product quality, patient safety, or regulatory compliance.

Step 4: Audit Report and Findings

Audit Report: A comprehensive audit report is prepared, detailing the audit scope, methodology, findings, evidence, and observations.
Finding Documentation: Each finding is clearly documented, including the specific non-compliance, relevant regulations, and recommended corrective actions.

Step 5: Corrective and Preventive Actions (CAPA)

Root Cause Analysis: For each finding, a thorough root cause analysis is conducted to determine the underlying reason for the non-compliance.
Corrective Actions: Corrective actions are defined and implemented to address the identified issues, prevent recurrence, and bring the processes into compliance.
Preventive Actions: In addition to addressing immediate issues, preventive actions are developed to mitigate potential risks and improve overall processes.

Step 6: Follow-Up and Verification

Implementation Verification: Auditors verify that corrective and preventive actions have been implemented effectively and are addressing the identified issues.
Effectiveness Evaluation: The effectiveness of corrective and preventive actions is assessed to ensure sustained compliance and process improvement.

Through this systematic process, we conduct internal audits to identify areas for improvement, ensure compliance with FDA regulations, and continuously enhance our quality management system. The focus on addressing findings through corrective and preventive actions helps us maintain product quality, regulatory compliance, and patient safety.