Amid the ongoing pandemic, groups like the European Commission (EC) and the International Accreditation Forum (IAF) have announced notified bodies (NBs) can conduct remote audits for key certifications.
While having auditors work with your facility remotely offers benefits such as efficiency and reduced costs, they’re also uncharted territory for many manufacturers.
With that in mind, let’s look at what authorities have said about remote audits, how to prepare, and how a digital quality management system (QMS) can streamline the process.
Remote Audits: A Growing Trend
Multiple regulatory authorities and standards organizations have announced or expanded the use of remote audits, at least temporarily, during the pandemic. Remote audits are possible for compliance with:
- ISO standards: ISO 19011:2018 guidelines for auditing management systems allow for remote QMS audits, although they weren’t widely used before the pandemic. ISO and IAF guidance provides an overview of the process and what manufacturers and auditors need to consider.
- EU Medical Device Regulation (MDR): The European Commission’s Medical Device Coordination Group (MDCG) clarified in recent guidance that remote EU MDR audits may be conducted in certain situations. The EC also stated that there would be no unannounced audits for the duration of the pandemic.
- Medical Device Single Audit Program (MDSAP): A December 2020 transmittal from MDSAP assessment program managers (APMs) details the expanded alternatives for in-person audits under MDSAP.
- Pharmaceuticals and Medical Devices Agency (PMDA): Japan’s PMDA released in November its procedure for remote inspections, which it is using in certain situations.
The U.S. Food and Drug Administration (FDA) has also issued temporary guidance for industry, recognizing the impact of COVID-19 on drug development, manufacturing and agency inspections. While inspections were suspended in 2020, they have resumed pre-approval and surveillance inspections on a case-by-case basis, all of which are pre-announced.
Understanding Who’s Eligible
While the details vary among the various released guidance documents from the above organizations, there are several common themes.
First, registrars and NBs will have to carefully assess whether a remote audit is feasible for auditors and auditees, who must be competent in the technology required to execute the audit. Confidentiality, security, and data protection (CSDP) are key considerations, given that companies will need to share sensitive information.
Decisions on whether to audit remotely may need to be made on a case-by-case basis, requiring a risk analysis based in part on the manufacturer’s compliance history.
Not all situations are appropriate for a remote audit, such as when corrective actions must be verified in person. In many cases, there is flexibility in how to incorporate remote auditing, such as combining a remote stage 1 audit with an onsite location stage 2 audit.
Preparing for Remote Audits
Planning is key for remote audits and includes working with your registrar or NB to determine how you will share various information types.
For example, how will you provide documentation to a remote team, and how will you provide visual evidence of the manufacturing process? Will you need to provide video access to the manufacturing area? Talk to your registrar or NB about how they run remote audits, what you can expect at each step, and what technology will be used. You should also review the reference materials linked above to understand expectations ahead of time.
Other steps to take include:
- Review technology capabilities to ensure security and confidentiality of sensitive data.
- Train team members who will be part of the audit to use remote platforms used during the audit, such as Zoom, Skype, or Microsoft Teams.
- Load and test any mobile apps or devices to show auditors the manufacturing floor (and verify those devices have connectivity in those locations).
- Plan your route for sharing live video access, considering which areas auditors will want to focus on.
- Choose a site guide familiar with the manufacturing floor as well as your chosen video-sharing tool.
- Test device connectivity along the planned route where you’ll share live video footage.
- Conduct practice runs of web meetings and live-video sharing before the day of the audit.
- Pre-submit documentation where possible to accelerate the audit.
The length of your audit depends on the content of the audit and its complexity. If you’ve never done a remote audit before, it could take longer. For example, you may experience file transfer delays. If you’ve had a history of compliance issues, the registrar or NB may also require an onsite visit.
Leveraging EQMS Automation for Remote Audits
A digital enterprise quality management system (EQMS) gives companies a distinct advantage when executing remote audits smoothly. Specifically, an EQMS will streamline prep work, pre-submission work, and responding to information requests during the audit itself.
For example, companies without a digital QMS will have to take photos of documents and scan them to provide them to their auditor. Compare this with an automated system that allows users to pull up records immediately and grant limited access to auditors on various mobile platforms and devices.
Key EQMS capabilities manufacturers should be sure to leverage during the process include:
- Document control for submitting records ahead of time and providing them during audits
- Reporting and analytics for providing evidence of performance as well as monitoring, measurement, and continuous improvement opportunities
- Corrective actions for identifying issues that need attention before the audit, reviewing closed items, and verifying effectiveness.
- Complaint management to review all post-market product quality issues and reporting incidents to regulatory authorities as necessary.
Remote auditing is quickly becoming standard practice across the globe. Success all boils down to preparation—and your ability to leverage digital tools and platforms. With careful planning, you may even be surprised at how smoothly your audit goes.
- Medtech Dive, MDR IVDR Remote Audits OK’d Amid Pandemic Pressures
- Quality Magazine, Remote Quality Management System Audits: An ISO 9001 Auditor’s Perspective and Lessons Learned
- ISO, ISO 9001 Auditing Practices Group Guidance on Remote Audits
- European Commission, MDCG 2020-4
- MDSAP, Transmittal Number AO 2020-10
- PMDA, Procedure for Remote Inspections
- Kestrel Tellevate, Virtual Audits: Best Practices to Make Them Work