The audit schedule may need to extend over more days than would have been planned for an on-site audit. This is because there will likely be “down-time” to accommodate scheduling meetings between the auditors and the SMEs to cover specific processes or subjects. For example, if the on-site audit time was anticipated to be three days or 24 hours, these 24 hours of audit time may need to be scheduled and accomplished over a four or five-day period. Consideration should be given to audit participants that may be operating in different time zones.
Suggestions for How to Conduct Effective Remote Audits
10 tips written by QualityHub ex-FDA Experts
Conducting effective remote audits require a good deal of organization both before and during the audit to ensure adequate preparation of the audit team, effective communication, and ability to complete the audit scope. Effective use of audit plans and technology will facilitate remote audit logistics.
If you are experiencing audit-related time or resource constraints, or if you need a fresh perspective on your Quality Systems, processes or products, QualityHub can assist. We have experience performing remote audits on our clients’ behalf, or as independent auditors. We have proven audit methodologies and a team of highly skilled and experienced auditors. Ex-FDA personnel can be provided to assist on audits as needed.
A few suggestions on how to conduct remote audits are provided below.
How to Conduct Remote Audits
1. Build in Extra Time for your Audit Schedule
How to Conduct Remote Audits
2. Set up your Technology
Agree on technology to be used for document and record access and meetings. Prior to the audit, have the auditors and the audit team members test their access to file share programs to ensure appropriate permissions have been set up and that everyone understands how to access and use the selected file-share programs. It may also be helpful to hold a pre-opening meeting to enable everyone to test their ability to use the video-conference applications selected for the audit. Additionally, establish methodologies for remote viewing of video (for example, for product demonstrations, manufacturing equipment/processes).
3. Staff the Audit Accordingly
Audit Roles/Responsibilities are essentially no different for an audit conducted remotely. Ensure that the auditee provides an audit host and a note-taker. Just as with on-site audits, the host should attend all the interview sessions with SMEs and notes should always be taken. The site lead should assign a person to coordinate the collection and upload of documents and records, and be the “point person” for on-going document/record requests.
4. Provide Advanced Document Access
Advanced document sharing is one of the most important aspects of a successful remote audit. The audit plan should include a fairly extensive advance document request list to allow an upload of policies, standard operating procedures, plans, etc., to a secured file sharing site prior to starting the audit. Having early access to documents helps ensure the auditor can jump in and start reviewing documentation immediately, without having to wait for requests to be submitted remotely, receipt by the auditee, and then their upload to the shared file site.
5. Create Your Document Roadmap
As the audit progresses there will be a need for access to “records” as well as additional procedures not listed in the pre-audit document request. Managing the flow of these requests is important. The auditee needs to provide resources (personnel) for the audit who can help with identification, organization and the uploading of files and records. As with in-person audits, we need to organize information so that the auditor can locate and review the right documents and records, based on the Quality Management Process or subject being audited. One useful method is to set-up file folders for each of the processes included in the audit scope. Don’t upload everything into a single audit file folder. Often document file names and numbers are not intuitive (e.g. they are just the SOP # and revision level). It is important to provide a document roadmap and index to help the auditor locate the correct documents for review. As with in-person audits we should keep an on-going “living” document request/delivery list on the shared file site.
6. Determine Communication Strategy
Determine a method for the auditor to submit additional requests for record samples, additional procedures, etc. The methodology should consider who the requests should be submitted to and the method to be used for this communication. Often chat rooms provide real-time communications between site audit personnel and the backroom. Other methods to facilitate communications between team members include email, and/or MS Teams.
7. Keep a list of interviewees readily available for the Auditor
Because the auditor will not be able to collect business cards to help in referencing persons interviewed in the final audit report, the audit host should maintain an on-going spreadsheet to list the names all of the persons interviewed. This list should be maintained on the audit file sharing site. The list should include name, title, and subjects covered by the persons interviewed.
8. Organization is Key
The auditors have to be very organized when conducting their desk-top reviews. To ensure the efficiency of scheduled interviews, the auditor should have good notes linked to specific sections in the documents/records reviewed. Questions should be directed to the appropriate SME in scheduled interviews. As with in-person audits there may be a need to interview someone a second time as more data become available. Often the interviews and reviews will lead to additional audit requests (other records, data, or procedures). These requests should be submitted through the means specified by the audit plan and then additional follow up meetings can be scheduled after the additional documents have been provided to the auditor.
9. Use Visual Aids to Illustrate Processes
Quality Management Processes are often described in flow charts or similar work-flow diagrams. Visual aids have proven to be extremely useful in remote audits. Schematics and PowerPoints are excellent methods to convey information to the auditor. They are especially helpful when the auditor is reviewing complex processes. Audits are more successful when the auditor was provided an overview of the processes during the audit. Use of video conference calls and utilizing desk top sharing functionality can help greatly. Review of a manufacturing process can be especially challenged in a remote audit. It may be possible to use video to “tour” a manufacturing line, showing equipment used and the process, as it is being performed.
10. Don’t Close the File Share Until the Auditor has Completed their Work
As the audit concludes we should have a plan for closing down the audit file sharing site (e.g. SharePoint or Teams). Make sure that the site is not closed, or permissions restricted too early. We need to make sure the auditor has time to complete and finalize the audit report. Even though the audit has ended, the auditor may need access to data during preparation of their report.