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A system boundary is a practical agreement
about what is included in the assessment.

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Our vessel receives product materials and
a heating or cooling service,

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and transfers bulk solution downstream.

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The simplified diagram shows these
interfaces.

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It does not assert that the utility is
qualified by qualifying the vessel.

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Each interface needs an owner and a clear
connection to the evidence for

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the supplying or receiving system.

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A component does not need to touch product
to affect quality.

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A temperature sensor sends information to
a controller,

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which can influence the jacket service and
therefore the product.

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Conversely, physical proximity alone does
not make every room object

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equally important.

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Describe the mechanism by which a
component failure could affect the

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process.

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Use that explanation to support scope
decisions rather than relying only

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on a label such as critical.

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Engineering understands the design and
installation.

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Operations understands how people use and
clean the equipment.

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Quality oversight connects decisions to
the pharmaceutical quality system.

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Additional expertise may be needed from
development, microbiology,

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metrology or information technology.

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This is a suggested team for the fictional
project,

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not a universal organizational chart.

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Identify who prepares evidence, who
reviews it and who has authority to

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approve each decision.

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Review this handover: the vessel report is
ready,

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but the transfer hose has no approved
cleaning procedure and the utility

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connection is not identified.

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Calling the vessel ready for routine use
would hide unresolved interfaces.

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Record the gaps and assess their impact.

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For the activity, draw a boundary and
assign an owner to each interface.

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A boundary is useful only when work
outside it has somewhere explicit to go.