Draft standard CEI-MS-03: Determination of peptide content… — 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 does not state that a determination on one unit says nothing about the batch — arising from DRAFT-PEPTIDE-CONT/005. 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…
2. The limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-PEPTIDE-CONT/002. 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.
3. The search date is not on the face of the document — arising from DRAFT-PEPTIDE-CONT/003. 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.
4. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-PEPTIDE-CONT/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…
5. A determination does not record the version of the standard it was made under — arising from DRAFT-PEPTIDE-CONT/004. 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.
6. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-PEPTIDE-CONT/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…
7. The reporting threshold is not tied to a demonstrated limit of quantitation — arising from DRAFT-PEPTIDE-CONT/007. The reporting threshold is now conditional on demonstrating the required signal-to-noise at that threshold within the run, and a determination that cannot demonstrate it reports the achievable threshold instead of the nominal one.
8. The standard would be applied more consistently with a worked example — arising from DRAFT-PEPTIDE-CONT/008. 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.

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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