Remote Audit: Medical Device Supplier Quality Audit Checklist
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Remote Audit: Medical Device Supplier Quality Audit Checklist
Streamline your remote audits of medical device suppliers using our thorough audit checklist, promoting quality and compliance.
1
Select a suitable supplier for audit
2
Prepare a detailed audit plan
3
Send audit agenda and plan to the supplier
4
Set up communication tools for remote audit
5
Collect and review pre-audit documents for supplier
6
Prepare questions for key personnel
7
Approval: Prepared Audit Questions
8
Conduct interview sessions with supplier's key personnel
9
Collect and review post-audit documents
10
Analyze data and documentation obtained from the audit
11
Identify non-compliances, if any
12
Prepare a draft of audit report
13
Approval: Audit Report Draft
14
Discuss draft report with supplier for clarifications if needed
15
Finalize audit report after incorporating comments from supplier
16
Submit final report to supplier
17
Follow up with the supplier for development of corrective action plan
18
Review supplier's corrective action plan
19
Approval: Corrective Action Plan
20
Monitor the implementation of corrective actions
21
Close the audit after successful implementation of corrective actions
Select a suitable supplier for audit
This task is crucial in ensuring that a reliable and competent supplier is chosen for the audit. The audit outcome greatly depends on this decision. Consider factors such as supplier's track record, quality management system, and compliance with regulatory standards. Have you thoroughly assessed the supplier's capabilities and quality standards?
1
United States
2
China
3
Germany
4
India
5
Australia
Prepare a detailed audit plan
A well-structured audit plan is essential for efficient and effective execution of the audit. It should outline the objectives, scope, and methodology of the audit. Additionally, consider the availability of resources, timeline, and potential risks. What key elements should be included in the audit plan?
Send audit agenda and plan to the supplier
To ensure smooth coordination with the supplier, it's important to provide them with the audit agenda and plan. This will help them understand the purpose of the audit, its timeline, and their role in the process. Have you included all relevant details in the communication to the supplier?
Audit Agenda and Plan
Set up communication tools for remote audit
In order to conduct a successful remote audit, it is important to set up appropriate communication tools to facilitate seamless interaction with the supplier. Consider using video conferencing, file sharing platforms, and instant messaging applications. Which communication tools will be used for this remote audit?
1
Zoom
2
Microsoft Teams
3
Google Meet
4
Slack
5
Skype
Collect and review pre-audit documents for supplier
To ensure a thorough audit, it is necessary to collect and review relevant pre-audit documents provided by the supplier. These documents can include quality manuals, procedures, certifications, and previous audit reports. What specific documents are required for this audit?
1
Quality Manual
2
Procedures
3
Certifications
4
Audit Reports
5
Supplier Contracts
Prepare questions for key personnel
Engaging with the supplier's key personnel is essential to gain deeper insights into their quality management system and overall performance. Prepare a set of well-thought-out questions to address various aspects of their operations. What key questions should be included in the questionnaire?
Approval: Prepared Audit Questions
Will be submitted for approval:
Prepare questions for key personnel
Will be submitted
Conduct interview sessions with supplier's key personnel
The interview sessions with the supplier's key personnel provide an opportunity to gather valuable information directly from the source. This allows for a better understanding of their processes and any potential areas of improvement. Are the interview sessions scheduled and ready to be conducted?
Collect and review post-audit documents
Following the audit, it is important to collect and review post-audit documents from the supplier. These documents can include corrective action plans, implementation reports, and any other relevant documentation. Have you received and reviewed the necessary post-audit documents?
1
Corrective Action Plan
2
Implementation Report
3
Verification Records
4
Training Records
5
Supplier Feedback
Analyze data and documentation obtained from the audit
Effective analysis of the data and documentation collected during the audit is crucial to identify any potential non-compliances or areas of improvement. This analysis forms the basis for the audit report and helps in providing meaningful recommendations. How will you analyze the audit data and documentation?
Identify non-compliances, if any
During the audit analysis, it is important to identify any non-compliances observed in the supplier's quality management system or processes. This helps in addressing these issues and ensuring the supplier's compliance with regulatory requirements. Have you identified any non-compliances so far?
1
Deviation from Quality Standards
2
Lack of Documented Procedures
3
Inadequate Training
4
Non-conformities in Products
5
Safety Hazards
Prepare a draft of audit report
The audit report summarizes the findings, observations, and recommendations resulting from the audit. It provides a comprehensive overview of the supplier's performance and compliance. Have you prepared a detailed draft of the audit report?
Approval: Audit Report Draft
Will be submitted for approval:
Prepare a draft of audit report
Will be submitted
Discuss draft report with supplier for clarifications if needed
Engage in a collaborative discussion with the supplier to clarify any aspects of the draft audit report. Address any concerns, questions, or misunderstandings raised by the supplier to ensure a mutual understanding of the findings and recommendations. This discussion will contribute to the accuracy and clarity of the final audit report. Have you discussed the draft report with the supplier for clarifications?
Finalize audit report after incorporating comments from supplier
Incorporate the comments and feedback received from the supplier during the discussion phase into the draft audit report. Make necessary revisions and ensure the report accurately reflects the audit findings and the supplier's perspective. A collaborative and transparent approach will lead to a final audit report that both parties agree upon. Have you finalized the audit report after incorporating the supplier's comments?
Submit final report to supplier
Share the final audit report with the supplier to provide them with a comprehensive overview of the audit findings, non-compliances, and recommendations for improvement. The report should be clear, concise, and easy to understand, enabling the supplier to take appropriate actions based on the audit results. Have you submitted the final audit report to the supplier?
Final Audit Report
Follow up with the supplier for development of corrective action plan
Initiate a follow-up communication with the supplier to discuss and develop a corrective action plan that addresses the identified non-compliances and recommendations. Collaborate with the supplier to define specific actions, responsibilities, timelines, and success criteria for each corrective action. Effective communication and mutual agreement will ensure the successful implementation of the corrective action plan. Have you followed up with the supplier for the development of the corrective action plan?
Review supplier's corrective action plan
Review the corrective action plan proposed by the supplier to ensure it adequately addresses the identified non-compliances and incorporates the recommended improvements. Assess the feasibility, effectiveness, and clarity of the proposed actions and provide feedback or suggestions for refinement if necessary. This review will set the foundation for monitoring the implementation of the corrective actions. Have you reviewed the supplier's corrective action plan?
Approval: Corrective Action Plan
Will be submitted for approval:
Follow up with the supplier for development of corrective action plan
Will be submitted
Monitor the implementation of corrective actions
Continuously monitor and track the supplier's progress in implementing the agreed-upon corrective actions. Maintain open lines of communication with the supplier, providing support, guidance, and feedback throughout the implementation process. Regularly assess the effectiveness of the corrective actions and adjust the monitoring approach as needed. Have you started monitoring the implementation of the corrective actions?
Close the audit after successful implementation of corrective actions
Once the supplier has successfully implemented the corrective actions and demonstrated sustained compliance with the quality standards and regulatory requirements, close the audit. Celebrate the supplier's achievements and formally acknowledge their commitment to quality improvement. Closing the audit signifies the completion of the remote audit process. Has the supplier successfully implemented the corrective actions and is ready to close the audit?
