|
Column
|
Details
|
|
Process
Step
|
From the
Process Map, FMEA, C & E
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|
High risk
, critical steps only
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What's controlled?
|
Name of
input or output
|
|
Input or
output? -Specify
|
Initially
, the plan may have more controls n outputs than inputs
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|
Goals is
for input control, not output monitoring
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|
Spec.
Limits/ Requirements
|
List the
targets and tolerances for each critical input or output
|
|
Meas.
Method.
|
What
process or machine makes the measurement?
|
|
Control
method
|
What method
is used for control? SPC? Automation? Error proofing?
|
|
Sample
Size
|
Select
sample size on measurement system and process capabilities
|
|
Sample
Freq.
|
Select frequency
based on measurement system and process capabilities and operation
requirement
|
|
Who/what
Measures?
|
Who or
what is responsible to ensure the data is taken?
|
|
Where
Recorded
|
Where
does the data reside? Databases, charts, both?
|
|
Decision/Rule/Corrective
action
|
What
happens when the process is out of control? Who takes the action?
|
|
SOP's
|
What
documentation governs this control process?
|
