CREATIVITY and FLEXIBILITY are two crucial skills needed to function during the 2020 pandemic environment, and maintaining a certified ISO-based quality system is no exception. With quarantine requirements instituted between some state-to-state travels, changing pandemic alert levels from county-to-county, and new policies in place for all business-to-business and person-to-person interaction, it became clear that the safest option would be to conduct a remote audit for our ISO 13485:2016 re-certification
Fortunately, Kent Elastomer Products had experience hosting remote customer audits, and Eagle Registrations, our registrar, was well equipped and experienced with conducting remote certification audits.
As our audit neared, early planning sessions with the auditors ensured we could start the audit without a glitch. Bev Kiglics, Sr. Director QA, and Clarissa Fashbaugh, QA Supervisor, held a “dry-run” check in advance with the auditors to make sure all technologies and environments were conducive.
We are most proud of the team’s creativity and flexibility while conducting our first remote ISO audit. Everyone really jumped in and did whatever was asked.
During the Audit
Facilitators used video calls on personal cell phones to walk the auditors through each operating plant. Keep in mind, we are all amateur video chatters, not professional videographers. Facilitators handled it like pros, giving a thorough tour while making sure everything was displayed adequately/steadily on the cell phone screen. Facilitators for the tours were:
- KENT: John Danes, VP of Operations
- MOGADORE: Bev Kiglics, Sr. Director QA
- WINESBURG: Clarissa Fashbaugh, QA Supervisor
The audit was also conducted on office computers using video conferencing. This format was incredibly flexible, enabling one-on-one interviews, screen sharing, and hosting for large group meetings. One auditee seamlessly completed his portion of the audit while working from home.
Our auditors were equally as flexible. For example, they understood that factory noise levels might be a factor in some areas, and they provided some up-front solutions to work around this.
We loved the challenge of hosting this audit. Even though both auditors were physically hundreds of miles away & in different states, it was as if they were on-site; it was a robust and very thorough audit. It went so smoothly that we are interested in proposing remote auditing options for the future!
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