Quality and safety, can it be?

By Kelly Huckabone

February 2020

2020 is off to an interesting start. For the last two years we have been focusing on quality process audits. We conduct most of our quality audits using a remote virtual approach. We have some depots and warehouses that require an onsite audit. For depots/buildings, a walkabout is the best way to kick-start the audit process.

This year we will be combining quality with some safety audits. Many companies keep them separate but if you think about it, an EHS inspection or quality audit follow a parallel path.

  • You use a checklist and make notes
  • You observe the work and request to see procedures/policies
  • You verify training records
  • You check for calibration of critical equipment/you check PPE
  • You review KPIs and/or metrics
  • You follow up on past issues (quality or safety)
  • You log findings and expect the owner to act
  • You identify best practices and opportunities

We are planning to pilot this approach and I think the question for me is, should there be one combined report or two separate ones? I would be curious as to what your thoughts are on this and would welcome your feedback.

Thank you.

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About the Author

Kelly Huckabone is the North American Audit Program Manager who oversees Unity Lab Service‚Äôs internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with ASQ, and has been conducting audits for over 25 years for different quality systems, including ISO 9001, 13485, and 17025, as well as Health Canada and the FDA.

Contact me at kelly.huckabone@thermofisher.com if you have any questions.