Draft standard CEI-MS-19: Purity determination for peptides… — 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-POORLY-RETAI/011. 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. References should carry a persistent identifier for every cited source — arising from DRAFT-POORLY-RETAI/013. 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. The standard does not say what to do with a result outside the expected range — arising from DRAFT-POORLY-RETAI/012. 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.
4. The draft prescribes a procedure where it should state performance — arising from DRAFT-POORLY-RETAI/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…
5. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-POORLY-RETAI/007. 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…
6. The matrix interferes with the determination and no control is required — arising from DRAFT-POORLY-RETAI/008. 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.
7. The document is unreadable without specialist training — arising from DRAFT-POORLY-RETAI/010. 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.
8. Rounding conventions are not stated and change the reported result — arising from DRAFT-POORLY-RETAI/006. The standard now requires that no rounding be applied before the reporting step, states the reporting precision for each quantity, and states the rounding convention used at that step.
9. A determination does not record the version of the standard it was made under — arising from DRAFT-POORLY-RETAI/016. 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.
10. The search date is not on the face of the document — arising from DRAFT-POORLY-RETAI/015. 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.
11. Acceptance criteria are expressed in terms specific to one instrument family — arising from DRAFT-POORLY-RETAI/005. 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.
12. The same concept is given three different names in one document — arising from DRAFT-POORLY-RETAI/004. 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.

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.