Draft standard CEI-MS-10: Identification and quantification… — 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. The standard would be applied more consistently with a worked example — arising from DRAFT-COUNTER-ION-/001. A worked example is added showing the same primary data treated two ways, with both resulting figures stated and the difference between them quantified, so that the consequence of the misapplication is visible rather than described.
2. The standard does not state that a determination on one unit says nothing about the batch — arising from DRAFT-COUNTER-ION-/002. Every determination made under this standard now carries a sampling statement recording how many units were sampled, from what population and by what plan, and the standard states that a determination on a single unit supports no inference about any other…
3. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-COUNTER-ION-/003. 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.
4. A conformance claim is not defined and will be made loosely — arising from DRAFT-COUNTER-ION-/004. Conformance is now defined as meeting every requirement classified as critical together with the stated system suitability criteria, partial conformance must be described by naming the requirements not met, and a claim of conformance made without the sampling…
5. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-COUNTER-ION-/005. 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…
6. The scope does not say which materials the standard excludes — arising from DRAFT-COUNTER-ION-/006. The scope now states both what the standard applies to and what it does not, with the excluded classes named and, where another standard covers them, cross-referenced.
7. The standard assumes a reference standard of known assigned content — arising from DRAFT-COUNTER-ION-/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…
8. Nothing states how long a prepared standard solution remains usable — arising from DRAFT-COUNTER-ION-/009. 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. The standard does not say what to do with a result outside the expected range — arising from DRAFT-COUNTER-ION-/010. The standard now requires that every determination performed on a sample be reported, that a repeat be permitted only where an assignable cause is documented, and that the assignable cause be stated on the face of the report.
10. Nothing requires a laboratory to demonstrate ongoing performance — arising from DRAFT-COUNTER-ION-/011. 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.
11. The preparation solvent is not specified and changes what is measured — arising from DRAFT-COUNTER-ION-/012. 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.
12. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-COUNTER-ION-/013. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
13. A single method cannot support the conclusion the standard permits — arising from DRAFT-COUNTER-ION-/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…

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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