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A useful finding identifies the
requirement,

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the specific design evidence and the gap.

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For example: drawing revision B contains a
cleaning pocket

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that has no reviewed rationale against the
cleaning concept.

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Assign an owner and define what evidence
would support closure.

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Avoid replacing the finding with a vague
status such as vendor to confirm.

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A due date helps manage work, but it does

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not establish that the design is suitable.

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Our teaching review uses three distinct
outcomes:

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design evidence adequate, an open design
finding,

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or a proposed requirement change.

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These are course labels, not mandatory
regulatory terminology.

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If the vendor cannot meet a requirement,

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assess options with the appropriate
process and quality expertise.

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Do not close the gap by deleting the
requirement without impact review.

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A proposed change remains a proposal until

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the applicable approval process accepts
it.

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Conditional progression concerns a
particular next

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qualification activity, not unrestricted
production.

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In the fictional case, a missing product-
contact

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gasket basis prevents a final materials
conclusion.

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For example, a proposed transition to IQ
may be limited to equipment

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identification checks unaffected by the
gasket gap.

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This requires a documented assessment of
no

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significant impact on that next activity

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and authorization by responsible
personnel.

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Gasket-dependent checks remain on hold.

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Preparing documents alone is

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not progression to a qualification stage,

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and neither activity authorizes
manufacturing.

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The responsible personnel need a
documented impact assessment

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and an authorized decision for the
proposed stage.

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Do not assume that the training author,

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supplier or learner can grant a site’s
approval.

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When a gasket specification changes,
retain the earlier baseline

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and record why the new design was
selected.

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Revisit contact compatibility, cleaning
assumptions

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and verification plans as appropriate.

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Update affected conclusions through the
quality system.

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The record should allow another reviewer
to reconstruct the decision

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without relying on memory.

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Your activity is to write an action
closure

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that references the revised evidence

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and preserves any outstanding later tests.