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Virtual audits are our current situation; yes, it’s a bit out of our collective comfort zone, but it beats not performing audits at all during this time of uncertainty. Quality System compliance can still be assessed no matter the environment, with a few key changes in the way we performed audits a month or two ago. Maybe this experience will change the way we handle auditing in the future.

 

  • Ensure your Quality System can be accessed remotely. Not just your Quality System documents, but all of the records that provide objective evidence that the Quality System is working. 
  • Download key documentation on a file sharing service before the audit. Folders, subfolders, and files need to be clearly named for the auditor. Make sure personnel are available in the virtual backroom to download other requests as they are received.
  • Have your IT person standing by in case of access issues.
  • Check your communication method, and figure out a back-up – all BEFORE the audit! How many times have you had issues with WebEx, Zoom, MS Teams, or Skype for an hour-long meeting? Imagine relying on the same for a full-day audit? Check the connection and give the auditor your cell number (and charge your phone!) the day before the audit.
  • Be flexible. It’s okay to break the audit up into smaller timeframes to allow the auditor time to review documents, records, and other objective evidence. As the auditee, you need to be on stand-by, but a break from the remote connection is acceptable. Provide subject matter experts timelines for when they are necessary, but apply a degree of flexibility when developing the audit plan because the schedule may change. Update all involved as the audit progresses to keep the audit team informed on the status of the audit timeline.
  • Be patient. There’s no question that being physically present at an audit keeps the process moving. When an auditor has difficulty finding a particular piece of objective evidence, you, as the auditee can point to its location. In a virtual audit, the auditor is both blind and unfamiliar with your materials, so you may have to provide some “tour guide” experience as you direct the auditor to the location within the shared files or the document/record itself. Make sure the audit plan takes extra measures for time management.
  • There are simply some Quality System topics you cannot audit. It may be that some records cannot be obtained in a virtual audit. Maybe it’s a training system that is located on a separate server or production process that cannot be assessed because Manufacturing is closed due to social distancing. Work with your auditor to make an audit plan that is both manageable, doable, and creates value for your compliance assurance.