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 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

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

Print

Findings&

SuggestedCorrective

Actions(.xls file)

LabResponse

Completed

import

AuditPackage

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: ramano@lab-data.com, 760-634-0437

Tim Fitzpatrick: tfitzpatrick@lab-data.com, 928-759-3404