Improving Field Sampling Quality Control Quality System Standards In Field Activities

1
Improving Field Sampling Quality Control Quality
System Standards In Field Activities
GCLN MEETING
David N. SpeisDirector, Corporate Quality
AssuranceAccutest Laboratories, Dayton, New
Jersey
October 20, 2004
2
Field Sample Quality The Knowns

• Sample Collection Is The Most Critical Step In
  Generating Data For Risk Determination.
• Sampling Activities Set The Stage For Subsequent
  Analytical Decision Making Processes
• Field Actions Cannot Be Reversed Or Modified Once
  They Have Occurred.
• Field Sampling Anomalies Have The Potential To
  Negatively Impact Data Usability,
  Representativeness And Comparability

3
Field Quality Issues High Error Rate

• Sample IDs/Times Not Matching Bottles CoCs,
• Unclear CoC Instructions - Clients Check Off
  8260VOC Without Defining Parameter Lists,
• TPH Requested As 8015-TPH On CoC Requires
  GRO/DRO Clarification (Soils). Method And TPH
  Type is Rarely Defined. (High Frequency!!),
• Insufficient Sample Volume For Requested Tests,
  Particularly For GRO VOC Combos. Screen Sample
  Sacrificed To Assure Sufficient Volume.

4
Field Quality Errors Process Impacts

• Increased Laboratory Expenses,
• Increased Field Expenses,
• Delays,
• Negative Potentially Fatal Data Quality
• Impacts.

5
Laboratory Field Quality Dichotomy

• Environmental Laboratories Comply to Defined
  Quality Standards, Providing The Basis For
  Accreditation By State Regulatory Agencies.
• Organizations Conducting Field Sampling
  Measurement Do Not Have Similar Standards.
• The Inconsistency Jeopardizes Data Usability,
  Compromising Data Generation Process Objectives.
• Development Of A Standard That Enables FSMOs To
  Take Steps Towards Improved Data Quality is
  essential to the Regulatory Objective.

6
Field Standard Design Implementation Issues

• National Standards for Laboratories are
  Comprehensive and Prescriptive.
• Adoption of a Similar Standard by FSMOs Poses
  Severe Implementation Difficulties.
• Development Of Less Prescriptive Requirements
  Facilitates Effective Implementation In Business
  Environments and Is Essential.
• This Effort is Key To Realizing An Improved
  Outcome Sound And Defensible Data Quality For
  Better Decisions.

7
Field Quality Standard Development Initiative

• Regulatory Agencies Recognize The Quality System
  Disparity Between FSMOs And Laboratories And Are
  Sensitive To The Negative Impact That The Absence
  Of FSMO Standards Has On Critical Data.
• Agencies Acknowledge That The Quality Of Samples
  And Field Data Sent To The Laboratory Is As
  Critical As The Quality Of Data Generated.
• Agencies Have Initiated Steps To Establish
  Quality System Requirements For Field Sampling
  And Measurement Organizations.

8
Field Quality Standard Key Developments

• July 1998, NELAC Constitution Amended Expanding
  Accreditation To Field Measurements Sampling.
• Dec 1999, NELAC Field Activities Committee
  Formed, Responsible For Developing Accreditation
  Standards for Field Activities
• May 2002, INELA Incorporated as a CSDO
• July 2003, USEPA Separates NELAC Standards
  Development Standards Adoption Functions
• NELAC Relies Exclusively on Accreditation
  Standards From CSDOs.

9
Field Quality Standard Elements Quality System

• The INELA Field Standard Employs Some Elements Of
  The NELAC Quality System Model.
• Field Accreditation Developed As A Stand Alone
  Standard Specifically For Organizations
  Performing Sampling And Field Measurements.
• Systems Approach To Quality Emphasized.
• Accreditation and Proficiency Elements Incomplete

10
Field Quality Standard Elements

• Quality System
• Organizational Definitions Quality System
• Document Control Contract review
• Subcontracting Purchasing
• Service to Clients Complaints
• Corrective Actions Preventative Actions
• Records Control Management Review
• Technical Requirements
• Personnel Environmental
• Sampling Measurement Data Control
• Equipment Supplies Calibration
• Documenting Reporting Field QC

11
Participation in Quality Standard Development

• Stakeholder Involvement In Standards Development
  is Essential,
• Institute for National Environmental Laboratory
  Accreditation Dawn Thomas, Chair Field
  Activities.
• Regulated Party Interest
• Regulatory Requirement
• Services Qualification