Improving the Lab Audit Process with Integrated Electronic
NELAC-Style Software
Richard M. Amano, Principal ChemistLaboratory Data Consultants, Inc.
7750 El Camino Real, Ste 2LCarlsbad, CA 92009
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
Introduction
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
Development Process
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.
Primary Components
Laboratory Certification Module PT Tracking and Assessment Module Audit Module
On-site Audit Document Review
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.
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
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)
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
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
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 results
and corrective action Real time retrieval of audit reference documents by hyperlinks Generation of clear, concise and technically sound reports
for the laboratory and data users Field Sampling Audit and Quality Systems audit versions
available Document Review Module in development
Briefcase Module(Laptop/Tablet)
Central Database(Network Server)
Contract Lab ListLab Personnel (POC)Analytical Methods
NELAC/DoD StandardsLab & Project SOPs
Reference DocumentsHistorical Audits/Findings
RR/PT ResultsLaboratory ContractClient Project ListStandard ChecklistReport Templates
Audit Timetable (tickler)Auditor Time log
To Lab
(debrief)
Lab-Specific InfoSpecific Methods to Audit
Applicable Standards (hyperlinked)Tagged Reference DocumentsLab-Specific Past Performance
Lab-Specific Client ProjectsAudit-specific checklist
Opening & Closing Mtg. NotesAssessment Report
Tabular Summary Of CA/R (auto)Audit TimetableAuditor Time log
Communications History
Audit-export
SpecificTemplate
Findings&
SuggestedCorrective
Actions(.xls file)
LabResponse
Completed
importAudit
Package
HardcopyChecklist
Transcribe
ScannedDocuments(Run logs, raw data)
Upload
Audit Process Overview
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
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
AAS Software Bundle
PT/Certification Opening Screen
Certification Main Screen
Certification Information
Certification Checklists
Application Evaluation
Laboratory Information Screen
Certification Listing
PT Module – Import Results
PT Query
PT Query
PT Query
PT Query
PT Query
View PT Results Screen
Audit Central Module
Create Audit Template
Create Audit Template
Select Lab
Audit Timeline
Select Methods
Select Audit Documents
Briefcase Module
Audit Checklist
Multiple Auditors
Specific PDF Hyperlink
Additional Audit Questions
Audit Report Template
Audit Findings
Audit Closure Letter Template
Contacts
• Laboratory Data Consultants, Inc.Richard Amano: [email protected], 760-634-0437
Tim Fitzpatrick: [email protected], 928-759-3404
