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The NELAC Institute (TNI) Laboratory Standards for Quality Systems in Environmental Testing Laboratories. Robert P. Di Rienzo Quality Assurance Manager ALS Laboratory Group. Environmental Measurement Symposium NEMC 2009. What is Consensus?.

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The NELAC Institute (TNI) Laboratory Standards for Quality Systems in Environmental Testing Laboratories

Robert P. Di Rienzo

Quality Assurance Manager

ALS Laboratory Group

Environmental Measurement SymposiumNEMC 2009


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What is Consensus? Systems in Environmental Testing Laboratories


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Consensus Systems in Environmental Testing Laboratoriesis a decision-making process that not only seeks the agreement of most participants, but also to resolve or mitigate the objections of the minority to achieve the most agreeable decision.


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What is a Standard? Systems in Environmental Testing Laboratories


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A Systems in Environmental Testing Laboratoriesstandard is an established norm or requirement. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes and practices.


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TNI Quality Systems Expert Committee Systems in Environmental Testing Laboratories

Accreditation Bodies:

Aaren Alger, State of Pennsylvania

Laurie Carhart, State of New York

Michelle Potter, State of New Jersey

Accredited Laboratories:

Robin Cook, City of Daytona Beach

Robert Di Rienzo, DataChem Laboratories

Wilson Hershey, Lancaster Laboratories

Paul Junio, Test America

Other:

Silky Labie, State of Florida

Fred McLean, DoD

Randy Querry, A2LA


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How does a laboratory know what to do? Systems in Environmental Testing Laboratories


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Will the laboratory every get it right? Systems in Environmental Testing Laboratories


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The TNI Standards are based on the Systems in Environmental Testing Laboratories

concept of sectors, volumes, and modules.

Environmental Laboratory Sector

Volume 1 – Management and Technical Requirements for Laboratories Performing Environmental Analysis

Module 1 – Proficiency TestingModule 2 – Quality Systems General Requirements Module 3 – Quality Systems for Asbestos Testing Module 4 – Quality Systems for Chemical Testing Module 5 – Quality Systems for Microbiological TestingModule 6 – Quality Systems for Radiochemical TestingModule 7 – Quality Systems for Toxicity Testing


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The TNI Standards are based on the Systems in Environmental Testing Laboratories

concept of sectors, volumes, and modules.

Environmental Laboratory Sector

Volume 1 – Management and Technical Requirements for Laboratories Performing Environmental Analysis

Module 1 – Proficiency Testing PT Testing Requirements for Laboratories

Module 2 – Quality Systems: General Requirements Module 3 – Asbestos Testing Module 4 – Chemical Testing Module 5 – Microbiological TestingModule 6 – Radiochemical TestingModule 7 – Toxicity Testing


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The TNI Standards are based on the Systems in Environmental Testing Laboratories

concept of sectors, volumes, and modules.

Environmental Laboratory Sector

Volume 1 – Management and Technical Requirements for Laboratories Performing Environmental Analysis

Module 2 – Quality Systems General Requirements

A Quality System for all laboratories


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Volume 1 Systems in Environmental Testing Laboratories

Environmental Laboratory Sector

Laboratories Requirements

Module 2 - Quality Systems General Requirements

  • Format consistent with ISO 17025:2005

  • Additional NELAC 2003 requirements follow applicable ISO sections

  • Specific technical requirements in Modules 3 to 7


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Module 2 - Quality Systems General Requirements Systems in Environmental Testing Laboratories

1.0 INTRODUCTION, SCOPE AND APPLICABILITY

Introduction and Scope

2.0 NORMATIVE REFERENCES

3.0 TERMS AND DEFINITIONS

Additional Terms and Definitions, Definition Sources, and Exclusions and Exceptions


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Module 2 - Quality Systems General Requirements Systems in Environmental Testing Laboratories

4.0 MANAGEMENT REQUIREMENTS

Organization, Management, Document Control, Review

of Request, Tenders and Contracts, Subcontracting,

Purchasing Services and Supplies, Service to the Client,

Complaints, Control of Nonconforming Work,

Improvement, Corrective Action, Preventive Action,

Control of Records, Internal Audits, Management

Review, and Data Integrity Surveillance


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Module 2 - Quality Systems General Requirements Systems in Environmental Testing Laboratories

5.0 TECHNICAL REQUIREMENTS

General, Personnel, Accommodation and

Environmental Conditions, Environmental

Test Methods and Method Validation,

Calibration Requirements, Measurement

Traceability, Collection of Samples, Handling

Samples and Test Items, Quality Assurance

for Environmental Testing, and

Reporting the Results


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Module 2 - Quality Systems General Requirements Systems in Environmental Testing Laboratories

Example Section from Module 2 – Non ISO version

4.14 Internal Audits (ISO/IEC 17025:2005(E), Clause 4.14)ISO text 4.14.1 to 4.14.4 here

4.14.5 Additional Items

a) The laboratory shall have a policy that specifies the time frame for notifying a client of events that cast doubt on the validity of the results.

b) The laboratory management shall ensure that

these actions are discharged within the agreed time frame.

c) The internal audit schedule shall be completed annually.


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

  • ISO 17025:2005 Changes

    • Addition of section on Improvement (4.10)

    • Management System = Quality System

    • Summary of ISO Changes is available.


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

  • NELAC 2003 Reorganization

    • All Technical Requirements moved to Technical Modules

    • Elements of Quality Manual in section 4.2.8

    • Calibration Requirements


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

4.2.8 Additional Management System Requirements

4.2.8.3 The quality manual shall contain:

a) document title;

b) laboratory's full name and address;

c) name, address of individual(s) responsible for the laboratory;


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

d) identification of all major organizational units and the effective date of the version;

e) identification of the laboratory's approved signatories;

f) the signed and dated concurrence of all responsible parties;


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

g) the objectives of the quality system and contain or reference the laboratory’s policies and procedures;

h) the laboratory’s official quality policy statement and management’s commitment to ethical laboratory practices and to upholding the requirements of this Standard; and

i) a table of contents, and applicable lists ofreferences, glossaries and appendices.


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

4.2.8.4 The quality manual shall contain or reference:

a) all maintenance, calibration and verification procedures;

b) major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests;

c) verification practices, use of reference materials and internal quality control schemes;


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

d) procedures for reporting analytical results;

e) the organization and management structure

f) procedures to ensure that all records are retained and procedures for control and maintenance of documentation;


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

g) job descriptions;

h) procedures for traceability;

i) a list of all test methods;

j) procedures for reviews all new work;

k) procedures for handling samples;


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

l) procedures for corrective action when discrepancies are detected, or departures from documented policies and procedures occur;

m) policy for permitting departures from documented policies and procedures;

n) procedures for dealing with complaints;


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

The Quality Manual

o) procedures for protecting confidentiality;

p) procedures for audits and data review;

q) procedures for personnel experience and needed training; and

r) policy addressing the use of unique electronic signatures.


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

Calibration Requirements

5.5.13 Additional Requirements and Clarifications

Calibration requirements for analytical support equipment are included in this Section while requirements for instrument (testing) calibration are included in technical modules (i.e., Asbestos, Chemistry, Microbiology, Radiochemistry and Toxicology).


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

  • Additional Requirements

    • NONE

  • Significant Changes in Requirements

    • No Arbitrary Expiration Dates

    • Removes NELAC 2003 language and replaces with ISO 17025:2005 language, where applicable


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The TNI Standards are based on the Systems in Environmental Testing Laboratories

concept of sectors, volumes, and modules.

Environmental Laboratory Sector

Volume 1 – Management and Technical Requirements for Laboratories Performing Environmental Analysis

Module 1 – Proficiency TestingModule 2 – Quality Systems: General RequirementsModule 3 – Quality Systems for Asbestos Testing Module 4 – Quality Systems for Chemical Testing Module 5 – Quality Systems for Microbiological TestingModule 6 – Quality Systems for Radiochemical TestingModule 7 – Quality Systems for Toxicity Testing


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Volume 1 Systems in Environmental Testing Laboratories

Environmental Laboratory Sector

Laboratories Requirements

Modules 3 to 7 – Quality Systems for Asbestos, Chemical, Microbiological, Radiochemical, and Toxicological Testing

  • Specific to Testing Activity

  • Consistent Format and Structure in all Technical Modules


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

  • NELAC 2003 Reorganization

    • Combination of Requirements from NELAC 2003, Chapter 5 and Appendix C and D

    • Format Consistent in all Technical Modules

    • All Testing Requirement Related to Technology

    • Support Equipment Requirements in Module 2


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

  • Major Items

    • Initial Demonstration of Capability and Ongoing Demonstration of Capability

    • Technical Requirements include:

      • Calibration

      • Quality Control

      • Data Reduction

      • Acceptance/Rejection Criteria

      • Sample Handling


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Modules 3 to 7 – Quality Systems for Testing Systems in Environmental Testing Laboratories

_____________TESTING

1.1 Introduction

1.2 Scope

1.3 Terms and Definitions


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Modules 3 to 7 – Quality Systems for Testing Systems in Environmental Testing Laboratories

_____________TESTING

1.4 Method Selection

1.5 Method Validation

Validation of Methods, Limit of Detection

and Limit of Quantitation, Evaluation of

Precisions and Bias, and Evaluation of

Selectivity


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Modules 3 to 7 – Quality Systems for Testing Systems in Environmental Testing Laboratories

_____________TESTING

1.6 Demonstration of Capability (DOC)

General, Initial DOC, and Ongoing DOC

1.7 Technical Requirements

Initial Calibration, Continuing Calibration,

Quality Control for Chemistry, Data Reduction,

Reagent Quality, Water Quality and Checks,

Data Acceptance/Rejection Criteria, and

Sample Handling


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Modules 3 to 7 - Example Section Systems in Environmental Testing Laboratories

1.6 Demonstration of Capability (DOC)

1.6.1 General

Prior to acceptance and institution of any method for which data will be reported, a satisfactory initial DOC is required (see Section 1.6.2).

Thereafter, ongoing DOC (Section 1.6.3), as per the quality control requirements in Section 1.7.3 (such as laboratory control samples) is required.

In cases where a laboratory analyzes samples using a method that has been in use by the laboratory for at least one year prior to applying for accreditation, and there have been no significant changes in instrument type, personnel or method, the ongoing DOC shall be acceptable.


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Modules 3 to 7 - Example Section Systems in Environmental Testing Laboratories

1.6 Demonstration of Capability (DOC)

1.6.1 General (Continued)

The laboratory shall have records on file to demonstrate that a DOC is not required.

For the initial DOC, appropriate records as discussed in Section 1.6.2 shall be completed.

An initial DOC shall be completed each time there is a change in instrument type, personnel, or method.

All demonstrations shall be documented.

All data applicable to the demonstration shall be retained and readily available at the laboratory.


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

Demonstration of Capability

1.6.2 Initial DOC

An initial DOC shall be conducted prior to using any test method, and at any time there is a change in instrument type, personnel or test method or any time that a method has not been performed by the laboratory or analyst in a twelve-month period.


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Major Changes from NELAC 2003 Systems in Environmental Testing Laboratories

Demonstration of Capability

1.6.3 Ongoing DOC

1.6.3.1 The laboratory shall have a documented procedure describing ongoing DOC. The analyst(s) shall demonstrate on-going capability by meeting the quality control requirements of the method, laboratory SOP, client specifications, and/or this Standard. It is the responsibility of the laboratory to document that other approaches to ongoing DOC are adequate.


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Questions? Systems in Environmental Testing Laboratories

Robert P. Di Rienzo

Quality Assurance Manager

ALS Laboratory Group, Environmental Division (Salt Lake City, UT)

[email protected]

(801) 266-7700


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