Draft standard CEI-MS-04: Determination of water content in… — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. Nothing in the standard addresses transfer of the method between laboratories — arising from DRAFT-WATER-KARL-F/001. The standard now states the maximum difference between laboratories analysing the same sample at which results are treated as agreeing, and requires that a comparison across laboratories state whether that criterion was met.
2. Nothing prevents a chromatogram being reprocessed until it passes — arising from DRAFT-WATER-KARL-F/002. The standard now requires the processing method and its version to be recorded with every result and the primary data to be retained. A full audit trail is recommended and not required, since it depends on software many laboratories in scope do not run.
3. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-WATER-KARL-F/005. The standard now requires that system suitability results be trended across runs and that a determination report whether the trend was within the laboratory's stated limits, which places the demonstration inside the document the Institute can read.
4. Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-WATER-KARL-F/007. The acceptance criteria are now expressed in instrument-independent quantities, with the conversion from the common manufacturer-specific reporting units given in a note so that a laboratory can check conformance without recalculating by hand.
5. The standard assumes a reference standard of known assigned content — arising from DRAFT-WATER-KARL-F/008. The standard now states which determinations remain available without a reference standard of assigned content, requires that such determinations be labelled as relative rather than absolute, and requires the assumption used in place of an assigned content to…
6. The draft prescribes a procedure where it should state performance — arising from DRAFT-WATER-KARL-F/009. The prescriptive clauses are converted to performance requirements, the specific conditions are retained as a worked example clearly labelled as one, and a laboratory using a different validated procedure that meets the stated performance reports a conformant…
7. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-WATER-KARL-F/010. The suitability criterion is now stated at two levels, a general level achievable on instrumentation in common use and a stricter level required only where the standard is applied to the discrimination named in the scope, with the reason for the difference…
8. Nothing states how long a prepared standard solution remains usable — arising from DRAFT-WATER-KARL-F/011. The procedure now requires solution stability to be demonstrated over the period of intended use, and the demonstration to be recorded with the result.
9. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-WATER-KARL-F/012. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
10. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-WATER-KARL-F/013. Every determination now reports the repeatability observed in the run, the reporting precision, and a statement that two results differing by less than the stated repeatability are not distinguishable by this method.
11. A single method cannot support the conclusion the standard permits — arising from DRAFT-WATER-KARL-F/015. The standard now distinguishes a determination of the measured quantity, which stands alone, from a conclusion about the material, which requires a named orthogonal determination, and states that the second claim made on the strength of the first alone is not…
12. The preparation solvent is not specified and changes what is measured — arising from DRAFT-WATER-KARL-F/016. The preparation solvent is now a required reporting field and the procedure names an acceptable range. Specifying one solvent for every material in scope would exclude compounds the standard is intended to cover.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute

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