Understanding the Audit Process

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Understanding the Audit Process

• Presentation to
• KWWOA
• Department for Environmental ProtectionEnvironmen
  tal Public Protection Cabinet

To Protect and Enhance Kentuckys Environment
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Why an Audit?

• An audit establishes a baseline of where a
  laboratory is in regards to meeting the standards
  established within the method and the state or
  federal regulations.
• It further establishes where the laboratory
  deviates from those standards and creates a path
  for the laboratory to come back into compliance.

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What is the process?

• Written audit announcement
• Audit
• Audit exit meeting
• Audit report
• Laboratory Corrective Action Plan (CAP)
• DOW response to CAP (accept/reject)
• Issue Audit Certificate

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Written Audit Announcement

• Approximately 2 weeks prior to audit the
  laboratory will receive an audit notice
• Will give date time
• Who is auditing
• Scope of the audit
• Request data/information

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The Audit

• Pre meeting
• Tour
• Audit of facilities/general requirements
• Utilize standardized checklists against the state
  federal requirements
• Safety will be looked at and noted but not within
  the scope of the actual audit
• Audit of individual methods
• Utilize crosswalks of the methods
• Interviews with analyst
• Review of records
• Review of reagents

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Audit Exit Meeting

• Review of all major audit findings
• Laboratory has opportunity to provide any
  additional information relevant to the findings
• Auditors answers any question concerning the
  findings.
• Auditors can provide citations for requirements
  at this time
• Explain the future time frames for reports

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Audit Report

• DOW will compile audit findings and send an audit
  report to the laboratory within 2 weeks

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Audit Report

• Report elements
• Cover letter
• Deviation table
• Recommendation Table

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Audit Report

• Deviation vs. Recommendations
• Deviations the laboratory must address
• DOW will list a citation for the deviation
• DOW will provide a suggested corrective action
• Recommendations are just that, recommended
  changes
• DOW will list a citation for the deviation
• DOW will provide a suggested corrective action

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Laboratory CAP

• The laboratory must submit a CAP response back to
  DOW within 30 days of receipt of the audit report
• Laboratory must adequately address all deviations
• Laboratory should address all recommendations

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Elements of a Laboratory CAP

• What is the laboratory doing to correct the
  deviation
• Provide time frames for implementation of
  corrective actions
• Provide documentation of implementaions

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DOW Response to CAP

• DOW then will respond back to the CAP within 5
  business days
• Accept
• May accept but require additional documentation
• Reject
• Laboratory then has 5 business days to revise the
  CAP and resubmit to DOW
• Then DOW responds back within 5 business days
• This exchange continues until DOW accepts the CAP

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Audit Certificate

• Once CAP is final DOW will issue an audit
  certificate with the laboratories current
  method-analyte pairing status

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Questions?

• ???

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Contact Information

• Franklin C. Hall, Jr.
• Lab Certification Coordinator
• [phone] extension 4959
• frank.hall_at_ky.gov
• DOWLabCertification_at_ky.gov