What are the best ways to ensure medical device design control activities are properly audited?

1 Know the audit scope and criteria

Before the audit, you should have a clear understanding of the audit scope and criteria. This means knowing what type of audit it is (e.g., internal, external, supplier, or regulatory), what design control activities and documents are involved, and what standards and regulations are applicable (e.g., ISO 13485, FDA 21 CFR Part 820, or EU MDR). You should also review the audit plan and agenda, and communicate with the auditor about any questions or concerns. Knowing the audit scope and criteria will help you focus on the relevant areas and avoid unnecessary surprises.

2 Organize and maintain your design history file

Your design history file (DHF) is the main source of evidence for your design control activities. It should contain all the documentation that demonstrates how you have met the design input requirements, performed the design output, verification, validation, and transfer activities, and addressed any design changes or problems. Your DHF should be organized, complete, accurate, and up-to-date. You should also have a system for tracking and controlling your DHF documents, such as a document management software or a paper-based index. Organizing and maintaining your DHF will make it easier for you to retrieve and present the information during the audit.

3 Train and involve your team members

Your team members are the key stakeholders and contributors to your design control activities. They should be trained and familiar with the design control processes, procedures, and tools that you use. They should also be aware of their roles and responsibilities in the audit, and be prepared to answer any questions or demonstrate any tasks that the auditor may ask. You should also involve your team members in the audit preparation, such as reviewing the DHF documents, performing self-assessments, or conducting mock audits. Training and involving your team members will enhance their confidence and competence in the audit.

4 Follow the audit protocol and best practices

During the audit, you should follow the audit protocol and best practices that ensure a smooth and professional audit process. This means being courteous and respectful to the auditor, providing honest and factual answers, avoiding arguments or defensiveness, and admitting any mistakes or nonconformities. You should also provide the auditor with the requested documents or evidence in a timely and organized manner, and avoid providing unsolicited or irrelevant information. You should also document any observations, findings, or corrective actions that the auditor may raise, and follow up with them after the audit. Following the audit protocol and best practices will help you establish a positive and cooperative relationship with the auditor.

5 Learn and improve from the audit feedback

After the audit, you should learn and improve from the audit feedback that the auditor provides. This means reviewing and analyzing the audit report, findings, and recommendations, and identifying any gaps or weaknesses in your design control activities. You should also implement and verify any corrective actions or preventive actions that you have agreed with the auditor, and monitor their effectiveness and sustainability. You should also share the audit feedback and lessons learned with your team members and other stakeholders, and update your design control processes, procedures, or tools accordingly. Learning and improving from the audit feedback will help you enhance your design control performance and quality.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?