Draft standard CEI-MS-09: Assessment of appearance, cake… — 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 limitations section states what the method cannot do but not what a reader will wrongly conclude — arising from DRAFT-APPEARANCE-S/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.
2. A single method cannot support the conclusion the standard permits — arising from DRAFT-APPEARANCE-S/003. 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…
3. A field classified as critical is not one a reading turns on — arising from DRAFT-APPEARANCE-S/005. 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.
4. The standard specifies how to test a unit and not which units to test — arising from DRAFT-APPEARANCE-S/006. The selection method is now a required field on every report made under this standard, and the limitations section states that a determination on a selected unit supports no inference about the batch.
5. Nothing addresses the container the material was held in — arising from DRAFT-APPEARANCE-S/007. Container type and headspace atmosphere are now reported where known, and recorded as not held where they are not, rather than omitted.
6. A determination does not record the version of the standard it was made under — arising from DRAFT-APPEARANCE-S/008. 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.
7. The draft prescribes a procedure where it should state performance — arising from DRAFT-APPEARANCE-S/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…
8. The matrix interferes with the determination and no control is required — arising from DRAFT-APPEARANCE-S/011. 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.
9. A system suitability criterion is unachievable on instrumentation in general use — arising from DRAFT-APPEARANCE-S/012. 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…

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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