ENVIRONMENTAL LABORATORY SECTOR VOLUME 1 …

1 ENVIRONMENTAL LABORATORY SECTOR VOLUME 1 MANAGEMENT AND technical requirements FOR laboratories performing ENVIRONMENTAL ANALYSIS Module 4: Quality Systems for Chemical Testing Working Draft Standard July 2011 Box 2439 Weatherford, TX 76086 817-598-1624 2009 The NELAC InstituteEL-V1M4-2009 TNI Voting Draft Standard July 2011 EL-V1M4-2009: Chemical Testing page i This page intentionally left Voting Draft Standard July 2011 EL-V1M4-2009 page ii PREFACE This Standard is the result of many hours of effort by those volunteers on The NELAC Institute (TNI) Quality Systems Committee.

2 The TNI Board of Directors wishes to thank these committee members for their efforts in preparing this Standard as well as those TNI members who offered comments during the voting process. This Standard supplements Module 2, Quality Systems General requirements , and may be used by any organization that wishes to implement a program for the accreditation of ENVIRONMENTAL laboratories . TNI Voting Draft Standard July 2011 EL-V1M4-2009: Chemical Testing page iii This page intentionally left Voting Draft Standard July 2011 EL-V1M4-2009 page iv VOLUME 1, MODULE 4 Quality Systems for Chemical Testing Table of Contents CHEMICAL TESTING.

3 1 Introduction .. 1 Scope .. 1 Terms and Definitions .. 1 Additional Terms and Definitions .. 1 Exclusions and Exceptions .. 1 Method Selection .. 1 Method Validation .. 2 Validation of Methods .. 2 Limit of Detection and Limit of Quantitation (However Named) .. 2 Limit of Detection (LOD) .. 2 Limit of Quantitation (LOQ).

4 3 Evaluation of Precision and Bias .. 3 Evaluation of Selectivity .. 4 Demonstration of Capability (DOC) .. 4 General .. 4 Initial DOC .. 4 Ongoing DOC .. 6 technical requirements .. 6 Initial Calibration.

5 6 Instrument Calibration .. 6 Continuing Calibration .. 8 Quality Control .. 9 Negative Control Method Performance: Method Blank .. 9 Positive Control Method Performance: LABORATORY Control Sample .. 9 Sample Specific Controls .. 10 Matrix Spike; Matrix Spike Duplicates.

6 10 Matrix Duplicates .. 11 Surrogate Spikes .. 11 Data Reduction .. 11 Reagent Quality, Water Quality and Checks .. 11 Selectivity .. 12 Data Acceptance/Rejection Criteria.

7 12 Negative Control Method Performance: Method Blank .. 12 Positive Control Method Performance: LABORATORY Control Sample .. 12 Sample Specific Controls .. 13 Sample Handling .. 14 TNI Voting Draft Standard July 2011 EL-V1M4-2009: Chemical Testing page v This page intentionally left Voting Draft Standard July 2011 EL-V1M4-2009 page 1 VOLUME 1, MODULE 4 1 2 Quality Systems for Chemical Testing 3 4 5 CHEMICAL TESTING 6 7 Introduction 8 9 This document contains detailed quality control requirements for ENVIRONMENTAL testing activities 10 involving chemical measurements.

8 The evaluation of laboratories for this discipline is in conjunction 11 with a quality system as specified in the general requirements module. Adherence to quality 12 systems requirements will ensure that all quality control procedures specified in this module are 13 being followed. 14 15 Scope 16 17 The essential quality control procedures applicable to chemistry measurements are included in this 18 module. Additional quality control requirements that are either specified by method, regulation or 19 project shall be met by laboratories . 20 21 Terms and Definitions 22 23 The relevant definitions from TNI, VOLUME 1, Module 2, Section are the preferred references.

9 24 Definitions related to this document, which are used differently or do not exist in the above 25 references are defined below. 26 27 Additional Terms and Definitions 28 29 Physical Parameter: a measurement of a physical characteristic or property of a sample as 30 distinguished from the concentrations of chemical or biological components. 31 Reserved 32 33 Exclusions and Exceptions 34 35 Reserved 36 37 Method Selection 38 39 Refer to VOLUME 1 Module 2 Sections , and 40 A reference method is a method issued by an organization generally recognized as competent to do so.

10 41 (When ISO refers to a standard method, that term is equivalent to reference method). When a 42 LABORATORY is required to analyze a parameter by a specified method due to a regulatory 43 requirement, the parameter/method combination is recognized as a reference method. 44 45 If there is not a regulatory requirement for the parameter/method combination, the parameter/ 46 method combination need not be validated under ) as a non-reference method if it can be 47 analyzed by another similar reference method of the same matrix and technology. The inclusion of 48 the parameteranalyte in the method shall meet all required calibration requirements and the quality 49 control requirements of the method to which the parameteranalyte is being added.