Which status should a blank specification field carry?
A blank specification field should carry the status that describes why it is blank: not provided when relevant information has not been supplied; not applicable when the field does not fit the system or scope; and not assessed when the issuer, assessor or record confirms that the property has not been evaluated. These statuses describe the record’s evidence state. None assigns a performance score or says that a system passed or failed. [1] [3]
- Use not provided when a relevant value or supporting document has not been supplied; it may be added later. [2] [3]
- Use not applicable only when the field does not fit the defined system or scope, and record the reason. [3]
- Use not assessed when the issuer, assessor or record confirms that the property has not been evaluated. NSAI agrees assessment scope and sets criteria case by case for MMC, so an unassessed property is not a failed one. [1]
- Check the field definition, record scope and available documents, then ask the responsible issuer or designer if the evidence state remains unclear. [1] [3]
What does each status say?
Not provided means the field is relevant, but the record does not include its value or supporting document. The information may exist and may be added later. The BioSamples database at the European Bioinformatics Institute (EMBL-EBI) recommends this term for information that may have been collected but was not included in a submission. In a supplier record, an example might be a fire test report that has not been supplied. The record should state which document is missing and, if known, who is expected to provide it. [2]
Not applicable means the field does not apply to the defined system or scope. The International Nucleotide Sequence Database Collaboration (INSDC) defines the term for information that is inappropriate to report in its sample metadata vocabulary. For example, a field for factory unit weight could be marked not applicable if the system is supplied as loose components rather than as factory-made units. That is a hypothetical illustration, not a finding about a particular supplier. State the reason beside the status so readers can check that the decision follows from the system scope. Vocabularies differ: BioSamples lists not applicable among values to be removed from submissions, while INSDC includes it as a defined term. [2] [3]
Not assessed means the issuer, assessor or record confirms that the property or criterion has not been evaluated. Unlike the other two terms, not assessed is this index’s recording convention, not a term defined by NSAI, INSDC or BioSamples. It does not mean the property is absent, unacceptable or non-compliant. NSAI’s Guide to Agrément Certification for MMC, dated 08.12.2021, says assessment work may include laboratory test result checks, site evaluations and factory inspections, depending on the product or system. If the responsible assessor or designer confirms that no evaluation was made, mark it not assessed; if a result may exist but was not supplied, mark it not provided. [1] [2]
How should you choose the status?
First check whether the field applies to the system and the scope being recorded. If it does not, use not applicable and give the reason. If it does apply, check the dated documents and source list. When no value or evidence has been supplied, use not provided. Use not assessed only when the record confirms that the criterion has not been evaluated. If the evidence does not establish which condition is true, leave the status unresolved and ask the responsible issuer or designer. [1] [3]
For example, imagine a record with a blank transport-dimension field. If the supplier has not sent the dimensions, the status is not provided. If the recorded system is not transported as a single unit and the field is defined specifically for single-unit dimensions, the status may be not applicable, with that scope stated. If a transport assessment is expected but has not been carried out, as confirmed by the supplier or assessor, the status is not assessed. These are hypothetical cases; the field definition and responsible party’s records determine the correct entry. [1] [3]
What should accompany the status?
Keep the status next to the field, then add a short note that makes it verifiable: the applicable scope, missing document, or uncompleted assessment. Record the source and its date when evidence exists. NSAI’s Guide to Agrément Certification for MMC describes an application in which the manufacturer states the proposed use and scope, NSAI agrees the assessment scope with the manufacturer, and a Technical Assessment Specification sets the assessment criteria case by case. A missing result therefore should not be read as a negative finding or as proof that the criterion was outside scope. [1]
Before closing a supplier record, compare each status with the field definition and supporting documents. Ask the supplier, issuer or responsible designer to confirm any claim that a field does not apply or has not been assessed. Keep the status unchanged until that evidence is recorded. [1] [3]