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

2 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.

3 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

4 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

5 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

6 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

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

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

9 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

10 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

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) extension