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. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-WATER-KARL-F/010. 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…
2. References should carry a persistent identifier for every cited source — arising from DRAFT-WATER-KARL-F/016. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
3. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-WATER-KARL-F/001. 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…
4. A determination does not record the version of the standard it was made under — arising from DRAFT-WATER-KARL-F/011. Every determination reported under this standard now carries the standard identifier and version on its face, and a claim of conformance that does not identify the version is recorded by the Institute as not conformant.
5. The document is unreadable without specialist training — arising from DRAFT-WATER-KARL-F/007. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
6. Results are reported without an estimate of measurement uncertainty — arising from DRAFT-WATER-KARL-F/004. 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.
7. The same concept is given three different names in one document — arising from DRAFT-WATER-KARL-F/014. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
8. The standard assumes a reference standard of known assigned content — arising from DRAFT-WATER-KARL-F/005. 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…
9. The standard does not say what to do with a result outside the expected range — arising from DRAFT-WATER-KARL-F/006. 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. A single determination is permitted where duplicates would be inexpensive — arising from DRAFT-WATER-KARL-F/002. The standard now requires duplicate preparation and injection with a stated maximum difference between the two, and requires that a difference exceeding it be investigated before any figure is reported.
11. The search date is not on the face of the document — arising from DRAFT-WATER-KARL-F/012. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
12. The matrix interferes with the determination and no control is required — arising from DRAFT-WATER-KARL-F/009. An inhibition and enhancement control is now required for every determination under this standard, with stated recovery limits, and a determination reported without it is recorded as not conformant rather than as a low result.
13. The standard would be applied more consistently with a worked example — arising from DRAFT-WATER-KARL-F/015. 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.
14. A field classified as critical is not one a reading turns on — arising from DRAFT-WATER-KARL-F/003. The classification test is now stated in the standard: a field is critical where its absence changes the meaning of a reported figure or prevents attribution to a batch. One field has been reclassified under that test and the reasoning recorded.
15. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-WATER-KARL-F/013. The limitations section now lists the specific conclusions a conformant determination does not support, each stated as a sentence a reader could otherwise have written, and the list is placed before the references rather than in an annex.
16. A conformance claim is not defined and will be made loosely — arising from DRAFT-WATER-KARL-F/008. 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…

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

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.