Improving the Lab Audit Process with Integrated Electronic NELAC-Style Software

1. Improving the Lab Audit Process with Integrated Electronic NELAC-Style Software Richard M. Amano, Principal Chemist Laboratory Data Consultants, Inc. 7750 El Camino Real, Ste 2L Carlsbad, CA 92009

2. Introduction • Laboratory audits are routinely conducted by the regulatory community and commercial entities to assure data of known quality can be generated using acceptable procedures and adequate QA systems • Three common issues: • High effort/cost of doing on-site audits • Inconsistent audits and documentation of findings • Inadequate tracking of past audits, PTs, correspondence, and corrective action

3. Development Process • Identified the need to improve the audit process • Reviewed current issues with the auditing process • Determined what processes handled manually now could be effectively integrated with some automation • Used the NELAC documents and checklists as a starting point • Focused on audit consistency, electronic retrieval of technical audit references, and improve assessor efficiency

4. Product Details • Built on a Microsoft ACCESS platform • Developed for QA oversight personnel and regulatory authorities • Uses checklist to track certification processes, NELAC or Non-NELAC • Ability to reference and retrieve documents such as past internal and external audits, PT results, certification details, and hyperlinks to technical references and other pertinent documents • Generates correspondence templates, Certification documents and final audit report • Centralizes storage of certification data, PT performance history and audit records.

5. Primary Components • Laboratory Certification Module • PT Tracking and Assessment Module • Audit Module • On-site Audit • Document Review

6. Certification Module Features • Complete tracking of accreditation process, from initial application to approval and renewal • Uses checklist to standardize process and track progress of each lab step-by-step • Different requirements for different categories: • NELAC Primary • NELAC Secondary (Reciprocal Certification) • Non-NELAC • Checklist captures key dates • Automatic notification of pending renewals, etc.

7. Certification Module Features • Maintains record of all certifications and status of each certification for each laboratory in the database • Generates report listing all FOTs for each laboratory certificate with real-time status of each FOT • Automatic generation of form letters for communication with lab (MS Word) • Certification granted/denied/suspended/revoked • Certification Renewal/Audit Due • Corrective Action Requests • Add/withdraw FOTs

8. PT Module Features • Direct upload of electronic results from PT Provider • Uses format specified by USEPA National Standards for Water Proficiency Testing Studies Criteria Document, December 30, 1998 • XML format will be supported in future versions • PT data is checked for errors, formatting and usability before appending to main database • Form letters for communications with labs (MS Word format)

9. PT Module Features • Retrieval of PT results by lab, study type, date range, evaluation result status • Automatic assessment of PT results by FOT (User may also set manually) • Classifies status of each FOT as Good, Warning, Suspended, Revoked or Withdrawn • Studies are classified as either Mandatory or Supplemental • Data can be filtered by evaluation result or FOT status to generate reports for each lab

10. Automatic Notification • Monthly Summary Report automatically generated and e-mailed to each user summarizing important deadlines • Upcoming audit due dates • Labs due for renewal • Labs due for Routine and Supplemental PT • List of outstanding communications, e.g. labs with pending or overdue CA responses, etc. • Summary of FOTs by lab in Warning, Suspended or Revoked status

11. Audit Module Features • Standardization of audit process and audit reporting through automation • Uses NELAP and other agency or project-specific checklists and requirements to guide the user through the audit • Centralized storage of audit records for review by audit team • Allows for improved tracking of past deficiencies, PT resultsand corrective action • Real time retrieval of audit reference documents by hyperlinks • Generation of clear, concise and technically sound reportsfor the laboratory and data users • Field Sampling Audit and Quality Systems audit versions available • Document Review Module in development

12. Audit Process Overview Central Database (Network Server) Print Briefcase Module (Laptop/Tablet) HardcopyChecklist Contract Lab List Lab Personnel (POC) Analytical Methods NELAC/DoD Standards Lab & Project SOPs Reference Documents Historical Audits/Findings RR/PT Results Laboratory Contract Client Project List Standard Checklist Report Templates Audit Timetable (tickler) Auditor Time log Transcribe Lab-Specific Info Specific Methods to Audit Applicable Standards (hyperlinked) Tagged Reference Documents Lab-Specific Past Performance Lab-Specific Client Projects Audit-specific checklist Opening & Closing Mtg. Notes Assessment Report Tabular Summary Of CA/R (auto) Audit Timetable Auditor Time log Communications History Audit- export Specific Template Upload ScannedDocuments (Run logs, raw data) To Lab (debrief) Completed import Audit Package Findings & Suggested CorrectiveActions (.xls file) LabResponse

13. Central Database • Master List of labs • Audit/Lab Personnel • Analytical methods • NELAC and other applicable standards • QAPPs/Lab SOPs • Reference documents (i.e., DOD QSM, AFCEE QAPP, SW-846, etc) • Historical audits/findings • Historical PT results • Report templates • Audit schedule (timeline) • Auditor time log

14. Briefcase Module • Specific methods for audit with appropriate checklists • Hyperlink to reference documents • Applicable historical PT results • Project specific questions • Audit specific checklist (can be appended by user) • Opening/closing meeting notes • Audit report • Automated tabular summary of findings (Excel format) • Audit schedule (timetable) • Auditor time log • Communication history • Audit specific e-documents, pictures, audit exhibits

15. AAS Software Bundle

16. PT/Certification Opening Screen

17. Certification Main Screen

18. Certification Information

19. Certification Checklists

20. Application Evaluation

21. Laboratory Information Screen

22. Certification Listing

23. PT Module – Import Results

24. PT Query

25. PT Query

26. PT Query

27. PT Query

28. PT Query

29. View PT Results Screen

30. Audit Central Module

31. Create Audit Template

32. Create Audit Template

33. Select Lab

34. Audit Timeline

35. Select Methods

36. Select Audit Documents

37. Briefcase Module

38. Audit Checklist

39. Multiple Auditors

40. Specific PDF Hyperlink

41. Additional Audit Questions

42. Audit Report Template

43. Audit Findings

44. Audit Closure Letter Template

45. Contacts • Laboratory Data Consultants, Inc. • Richard Amano: ramano@lab-data.com, 760-634-0437 • Tim Fitzpatrick: tfitzpatrick@lab-data.com, 928-759-3404