5.1 Following this practice should result in precision-and-bias statements that can be achieved by any laboratory properly using the test method studied. These precision-and-bias statements provide the basis for generic limits for use in the Quality Control section of the test method. Optionally, the detection and quantitation values provide estimates of the level at which most laboratories should be able to achieve confident detection and meet the minimum precision (expressed as relative standard deviation) expected.

5.2 The method specifies the matrices for which the test method is appropriate. The collaborative test corroborates the write-up within the limitations of the test design. An extensive test can only use representative matrices so that universal applicability cannot be implied from the results.

5.3 The fundamental assumption of the collaborative study is that the matrices tested, the concentrations tested, and the participating laboratories are a representative and fair evaluation of the scope and applicability of the test method as written.

1.1 This practice establishes uniform standards for estimating and expressing the precision and bias of applicable test methods for Committee D19 on Water. Statements of precision and bias in test methods are required by the Form and Style for ASTM Standards, Section A21. Precision and Bias (Mandatory). In principle, all test methods are covered by this practice.

1.2 Except as specified in 1.4 , 1.5 , and 1.6 , this practice requires the task group proposing a new test method to carry out a collaborative study from which statements for precision (overall and single-operator standard-deviation estimates) and bias can be developed. This practice provides general guidance to task groups in planning and conducting such determinations of precision and bias.

1.3 This practice also provides guidance to task groups for conducting limited-scale collaborative studies (known as comparability studies) for test methods that have been revised, when such revision includes substantive modifications. Examples of substantive modifications may include, but are not limited to, changes in mandatory or allowable instrumentation, reagents, reaction times, etc.

1.4 If a full-scale collaborative study is not technically feasible, due to the nature of the test method or instability of samples, the largest feasible scaled-down collaborative study shall be conducted to provide the best possible limited basis for estimating the overall and single-operator standard deviations.

1.5 A collaborative study that satisfied the requirements of the version of this practice in force when the study was conducted will continue to be considered an adequate basis for the precision-and-bias statement required in each test method. If the study does not satisfy the current minimum requirements for a collaborative study, a statement listing the study's deficiencies and a reference to this paragraph shall be included in the precision-and-bias statement as the basis for an exemption from the current requirements.

1.6 This paragraph relates to special exemptions not clearly acceptable under 1.4 or 1.5 . With the approval of Committee D19 on the recommendation of the Results Advisor and the Technical Operations Section of the Executive Subcommittee of Committee D19, a statement giving a compelling reason why compliance with all or specific points of this practice cannot be achieved will meet both ASTM requirements ( 1 ) ² and the related requirements of this practice. In addition, Committee D19, through a Main Committee ballot, may approve publication of a Preliminary Standard Method for a period not to exceed 5 years. Preliminary Standards must contain a minimum of a single-operator precision-and-bias statement and a Quality Control section based on the single operator data. Publication of a Preliminary Standard is conditional on the approval of a full D2777 collaborative study design for the standard. Precision-and-bias statements authorized by this paragraph shall include the date of approval by Committee D19.

1.7 Per Section A21.2.3 of the ASTM Form and Style Manual the committee may delay an interlaboratory study for a new method and include a temporary statement in the Precision and Bias Section that addresses only single operator precision (repeatability). This statement is valid for five years from the initial publication date. In this case, a single laboratory study shall be conducted in accordance with Section 7.6.

1.8 In Section 12 this practice shows exemplary precision-and-bias-statement formats for: ( 1 ) test methods yielding a numerical measure, ( 2 ) test methods yielding a non-numerical report of success or failure based on criteria specified in the procedure, and ( 3 ) test methods specifying that procedures in another ASTM test method are to be used with only insignificant modifications.

1.9 All studies, even those exempt from some requirements under Sections 1.4 through 1.8, shall receive approval from the Results Advisor before being conducted (see Section 8 ) and after completion (see Section 13 ).

1.10 This practice satisfies the QC requirements of Practice D5847 .

1.11 It is the intent of this practice that task groups make every effort to retain all the data from their round-robin studies. Values should not be eliminated unless solid evidence exists for their exclusion. The Results Advisor should work closely with the task groups to effect this goal.