Performing Virtual Internal Audits
  • CODE : NELL-0003
  • Duration : 60 Minutes
  • Level : Advance
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Nellie Bushman's expertise and experience in the medical device industry, along with her dedication to supporting small startups in implementing Quality Management Systems (QMS).

Nellie's background spans over two decades in the industry, providing her with a wealth of knowledge and practical insights. Her degree in business management and Leader Auditor Certificate from ASQ since 2003 showcase her commitment to continuous learning and professional development.

Nellie's passion for helping small medical device startups succeed is evident in her creation of the BushmanQC VQMS. By offering simple procedures and resources, she aims to make QMS implementation accessible and affordable, addressing a common challenge faced by startups.

Through her specialized Virtual Quality Management System, Nellie provides startups with a flexible and efficient solution, leveraging technology to streamline processes and ensure compliance with regulatory standards.

Nellie brings her expertise and hands-on experience to guide startups through the complexities of QMS implementation. Her goal is to empower entrepreneurs with the knowledge and tools they need to navigate regulatory requirements and uphold product quality standards, ultimately contributing to the success and growth of their businesses.

In summary, Nellie Bushman's blend of industry experience, educational background, and passion for teaching makes her a valuable resource for startups seeking guidance in implementing Quality Management Systems for their medical device innovations.

Conducting a virtual internal audit has become increasingly common in today's digital age, especially with the widespread adoption of remote work and technological advancements. While traditional audits involve physical presence and face-to-face interactions, virtual audits leverage digital tools and platforms to achieve similar objectives efficiently. Whether due to pandemic-related restrictions or the need for cost-effectiveness and flexibility, virtual internal audits offer numerous benefits if executed correctly. This article explores the key steps and best practices for conducting a successful virtual internal audit.

  • Preparation Phase:
     - Define Objectives and Scope: Clearly outline the purpose, objectives, and scope of the audit. Determine what areas or processes will be assessed, ensuring alignment with organizational goals and regulatory requirements.
     - Select Technology Tools: Identify and select appropriate technology tools and platforms for conducting the audit. This may include video  conferencing software, document sharing platforms, collaboration tools, and virtual whiteboards.
     - Establish Communication Channels: Set up communication channels for seamless interaction between auditors and auditees. Ensure all stakeholders are familiar with the chosen platforms and understand how to use them effectively.
     - Schedule Meetings and Interviews: Coordinate schedules with relevant stakeholders to arrange virtual meetings, interviews, and discussions. Allocate sufficient time for each session and ensure participants have access to necessary documentation and information.
  • Execution Phase:
     - Conduct Entrance Meeting: Begin the audit with an entrance meeting to introduce the audit team, clarify objectives, and outline the audit process. Discuss expectations, roles, responsibilities, and confidentiality agreements to establish a collaborative and transparent environment.
    - Set Up Tracking System: Implement a tracking system to monitor audit requests, including documentation, evidence, and responses. Utilize project management tools or audit management software to track the status of requests, showing completion and pending items.
    - Gather Evidence: Collect evidence remotely through document reviews, electronic records, virtual tours, and interviews. Ensure all documentation and evidence are securely shared and stored in a per the companies data protection procedures.
    - Perform Risk Assessment: Assess risks associated with the audited processes or systems. Identify potential areas of non-compliance, inefficiencies, weaknesses, or vulnerabilities that may impact organizational performance or integrity.
    - Document Findings: Document audit findings, observations, and evidence systematically using digital tools. Maintain accurate records of discussions, interviews, and supporting documentation to facilitate analysis and reporting. Update the tracking system to reflect the status of completed tasks and pending items.
    - Conduct Interviews and Discussions: Engage with auditees through virtual interviews, discussions, and workshops. Encourage open communication and active participation to gain insights into processes, controls, and potential improvement opportunities. Log interview notes and action items in the tracking system for follow-up.
    - Review Controls and Procedures: Evaluate the effectiveness of internal controls, policies, and procedures in mitigating risks and achieving organizational objectives. Identify gaps, deviations, or areas for improvement and provide actionable recommendations. Track the implementation status of recommendations and corrective actions.
  • Reporting Phase:
     - Prepare Draft Audit Report: Compile audit findings, conclusions, and recommendations into a comprehensive audit report. Clearly communicate key observations, risks, and opportunities for improvement in a structured format. Include a section in the report that outlines the status of audit requests and completion of action items.
     - Review and Validate Findings: Review the draft audit report internally to validate findings and ensure accuracy and completeness. Address any discrepancies or unresolved issues before finalizing the report. Verify the status of pending items and update the tracking system accordingly.
     - Finalize Audit Report: Incorporate feedback and revisions to produce the final audit report. Ensure the report is concise, objective, and actionable, providing management with valuable insights and recommendations for decision-making. Include a summary of completed tasks and outstanding actions in the report.
    - Present Findings: Schedule a closing meeting with relevant stakeholders to present audit findings and recommendations. Discuss implications, action plans, and timelines for addressing identified issues and implementing improvements. Review the tracking system to demonstrate progress and follow-up actions.
     - Follow-Up and Monitoring: Monitor the implementation of corrective actions and recommendations following the audit. Conduct follow-up reviews to assess progress, address any outstanding issues, and ensure sustained compliance and effectiveness. Update the tracking system regularly to reflect the current status of audit requests and action items.

Areas Covered    

Conducting a virtual internal audit:

  • Preparation
      - Select Technology Tools
      - Establish Communication Channels
      - Schedule Meetings and Interviews
  • Execution
     - Conduct Entrance Meeting
     - Set Up Tracking System
     - Gather Evidence
     - Perform Risk Assessment
     - Document Findings
    - Conduct Interviews and Discussions
    - Review Controls and Procedures
  • Reporting
    - Prepare Draft Audit Report
    - Review and Validate Findings
    - Finalize Audit Report
    - Present Findings
    - Follow-Up and Monitoring

Who Should Attend    

  • Quality Managers
  • Quality Engineers

Why Should You Attend

Virtual audits offer unparalleled flexibility by enabling auditors to remotely assess documentation, conduct interviews, and scrutinize facilities without geographical constraints. This approach minimizes disruptions to manufacturing operations and reduces the need for on-site visits, consequently optimizing resource allocation and streamlining audit timelines.

Moreover, virtual audits empower medical device companies to maintain compliance with evolving regulatory requirements while navigating global supply chain complexities. Auditors can leverage secure communication channels and advanced data analytics to effectively evaluate risk management practices, supplier relationships, and product lifecycle management strategies.

In summary, virtual audits represent a transformative paradigm in the medical device industry, offering unparalleled agility, efficiency, and transparency in regulatory compliance and quality management. By embracing digital innovations and fostering collaborative partnerships, medical device companies can uphold the highest standards of patient safety and product efficacy in an increasingly interconnected world.

Topic Background    

In the dynamic landscape of the medical device industry, the adoption of virtual audits has emerged as a crucial strategy to ensure regulatory compliance, quality assurance, and operational integrity. With advancements in digital technologies, remote auditing has become an indispensable tool for scrutinizing manufacturing processes, product safety, and adherence to stringent industry standards.

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