Be “audit” you can be

By Kelly Huckabone

April 2019

Although most companies try to be “audit or inspection ready”, there are always some things you can do to help prepare for internal, external, or customer audits. Here is a quick guideline that may help you make the most out of your audit experience and help you pass with flying colors:

  1. Know your audience — understand the purpose of the audit and obtain an agenda well in advance.
  2. Use the agenda as a basis for your planning.
    • Identify SME (Subject Matter Experts) that can present information to the auditor. Many companies only allow their Quality Team members to interact with auditors but that is not a true reflection of operations. Get people involved and it will help grow your quality culture.
    • Understand the scope of the audit (regulation, contractual requirements, etc.)
    • Plan enough time for the respective functional areas or processes to be reviewed.
  3. Ensure you have the logistics locked down.
    • Book a room
    • Determine security requirements
    • Obtain the visitor Wi-Fi login credentials
    • Ensure a working lunch is available (auditors typically don’t like to leave the building during an audit)
  4. Document Preparation – Have readily available all relevant documentation which can include, but is not limited to, Standard Operating Procedures, work instructions, training records, operational records, metrics/KPIs, list of continual improvement initiatives, quality records.
  5. Prepare a capabilities presentation – Request time on the agenda to present an overview of your company highlighting growth, wins, and expand on your quality culture.
  6. Have management and leadership presence during the opening and closing meeting.
  7. Review all key documents to ensure they are in good standing order prior to the audit
  8. Conduct a preparation meeting for affected departments and be sure to include a summary of audit etiquette.
  9. Request a verbal debrief at the end of the audit so there are no surprises when the audit report is received.
  10. Last step, take a deep breath and proceed. Many successful companies outsource services for different reasons. Sometimes they do not have the required expertise or certification for all capabilities offered within their portfolio and sometimes it is to drive savings. Whatever the reason, it is important to have a strong and robust supplier/subcontractor onboarding process.

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About the Author

Kelly Huckabone is the North American Audit Program Manager who oversees the Unity Lab Services internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with the American Society for Quality (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.