by Steve Ford, OMEDtech
The medical device industry is a highly-regulated and constantly-evolving landscape, and, as a result of global and national regulations, there is an increased focus on auditing. It is critical to be prepared for third-party audits, as they are responsible for confirming your quality management system (QMS) compliance. Preventative auditing (internal practice audits) is the best way to ensure your company is well-equipped for a quality audit.
Without adequate preparation, quality audits can be an overwhelming source of stress and pain for any company. Not only do quality audits expose systems (and all their flaws), but they can be an incredibly time-consuming process that can lead to potential violations for nonconformance. Audits serve as an important health meter for QMS performance, and can give insight into how your processes actually work as opposed to how they may appear on paper.
Audit planning and preparation
External audits can happen at any time, and if your medical device has a CE marking, you are guaranteed to be presented with an unexpected audit at least once every five years. Avoid day-of panic and mediate the risk of nonconformance by maintaining a compliant quality management system. Internal audits can expose areas that need attention that might otherwise impact your ‘official’ audit report.
How to prepare for a quality audit:
- Create a checklist of your quality commitments–define the specific operational obligations required by your QMS (it’s a lot of work, but well worth the effort)
- Review the checklist with staff who operate the various components of your QMS to identify any requirements that may have been overlooked
- Create a plan to catch up on activities that are behind schedule (such as required periodic reports) and monitor progress
- Review any nonconformance from your notified body to confirm that all have been addressed
- Prepare copies of:
- Quality Manual and QMS Procedures
- All logs (example: change control, nonconformance, CAPA log, PO log, complaint log, etc.)
- Latest management review and internal audit reports performed in the last 12 months
- Quality policy and objectives
- Organization chart
Expert tip: Reduce the headache during the audit by preparing and organizing all relevant files and supporting documentation in files, folders, binders, etc., either physically or electronically
The Audit: execution, reporting, and follow-up
The auditor knocks on your door, now what?
If you followed the steps above, you’re already halfway there. Demonstrating to the auditor that you are well prepared provides a lot of value in getting through a successful quality audit and makes a great first impression for your company. Begin your audit by sharing important “housekeeping” information with the auditor— where to find the restrooms, photography policy, pandemic requirements, etc. To avoid delays throughout the audit, ensure your staff is readily available to answer questions and to offer explanations on processes and documentation is immediately accessible.
Based on the auditor’s feedback, you can ask questions, answer concerns, and most importantly, take note of the areas that need immediate attention. A successful audit is when there are only minor areas that require amending, and the results didn’t produce a nonconformance violation. Once you have the auditor’s feedback, make the corrective actions necessary as soon as possible, and definitely in time for the follow-up audit. The audit only truly ends when the report is issued and any follow-up items have been addressed.
More than a burden
Auditing is much more than checking a box for a regulatory requirement or just a rigid review of processes, but rather it is your basic tool for finding areas needing improvement. Successful audits ensure consistent processes, improved product quality, regulatory compliance, reduced cost (both personnel and product), improved bottom-line, and satisfied customers. They are also the tool required by the standard and regulation to help executive managers to understand the day-to-day functions of their QMS and hold their staff members accountable, in addition to bringing their quality management systems into sharper focus.
What compliance means today can change drastically tomorrow. it is not always easy to track and understand the regulatory changes that come into effect. Ensuring you have partners that understand the regulatory landscape and set you up for success is critical.
To learn more strategies and best practices for enhancing compliance to quality processes watch our recent webinar Pathways for Successful Medical Device Quality Audits.
OMEDtech was founded in 2002 with the primary mission of consulting with companies to successfully meet their quality and regulatory challenges. Over the years, OMEDtech has stayed current on changing regulations and requirements such as: identification of regulatory pathways, regulatory submissions, quality management systems, internal and supplier auditing, and new regulatory and quality requirements. OMEDtech works with you to meet the challenges of new product approvals, identifying and correcting regulatory deficiencies, improving operational systems and filling the gap when resources are limited and schedules are unrelenting.