Understanding the Audit Process Presentation to KWWOA Department

Understanding the Audit Process Presentation to: KWWOA Department for Environmental Protection Environmental & Public Protection Cabinet To Protect and Enhance Kentucky’s Environment

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. 2

What is the process? • • Written audit announcement Audit exit meeting Audit report Laboratory Corrective Action Plan (CAP) DOW response to CAP (accept/reject) Issue Audit Certificate 3

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 4

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 5

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 6

Audit Report • DOW will compile audit findings and send an audit report to the laboratory within 2 weeks 7

Audit Report • Report elements – Cover letter – Deviation table – Recommendation Table 8

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 9

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 10

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 11

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 12

Audit Certificate • Once CAP is final DOW will issue an audit certificate with the laboratories current method -analyte pairing status 13

Questions? ? ? ? 14

Contact Information Franklin C. Hall, Jr. Lab Certification Coordinator (502)564 -3410 extension 4959 frank. hall@ky. gov DOWLab. Certification@ky. gov 15