NCQM — National Committee for Quality Management

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Practice tool

Product Applicability Record

Version 1.0 · Tool & checklist

Record the product, jurisdictional triggers, applicable requirements and reasons for exclusions.

Before the review

Define one product configuration and market activity for each record. Use a separate row for requirements that have different applicability conditions. This worksheet is an NCQM practice tool; it is not a government application or a determination that the product may be marketed.

Working record

Review field Information to record Decision or evidence
Product identity Model, revision, materials, accessories and software Controlled configuration reference
Intended use Functions, claims, users and operating environment Approved use and claim description
Market activity Manufacture, import, install, operate or transport Responsible legal and operational roles
Jurisdiction trigger Characteristic connecting the product to an agency Relevant definition or scope provision
Candidate requirement Citation and source type Official source and checked date
Applicability conclusion Applies, excluded or unresolved Reason tied to the product and rule
Technical baseline Standard designation and adopted edition Adopting provision or contract
Evidence needed Test, certificate, analysis or record Owner and acceptance criterion
Open question Missing fact or interpretation Responsible reviewer and decision point
Approval Review authority and conclusion Dated decision and conditions
Review trigger Product, source, use or rule change Linked change record

Use the record

Enter the controlling provision and the product fact that makes it relevant. Distinguish a confirmed exclusion from an unanswered question. If several agencies apply, retain separate conclusions rather than combining them into a general statement of U.S. compliance.

Complete the decision

Assign unresolved matters and identify which must be resolved before release. Record the technical and regulatory competence needed for the decision. A completed form without supporting evidence is an index of assertions, not a demonstrated acceptance basis.

Maintain the baseline

Review the record when intended use, design, materials, supplier, software, claim or source requirements change. Keep earlier versions with the deliveries they governed. Read Finding the Requirements for a Product.

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