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Method
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To be able to generate a control plan, the document type of the structure has to be PROCESS. |
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Select an existing control plan or create a new control plan by entering a name (this defaults to the name of the current process element). Then click on Finish. - Outcome: the control plan will open.
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Filtering and adjusting the Display of the Control Plan Editor
You can change the appearance of the control plan. From the right upper corner, you have to following
options:
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Note that there are options in the preferences menu regarding the Control Plan editor: showing and
hiding responsibilities and comments and adjusting the layout to fit the window width.
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SOX P-FMEA - Deriving a Control Plan From a P-FMEA
Introduction
To create a P-FMEA, follow the new FMEA Step-by-Step Guide.
To derive a control plan from P-FMEA, prepare the P-FMEA as follows:
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Product and process characteristics as well as tasks assigned to control method and reaction plan will appear in corresponding columns of the control plan. |
Example P-FMEA Structure
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To create tasks on containers Control method and Reaction plan, right click on either and select New > New Task (same as for prevention and detection actions on action groups).
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Choose Select existing or “New” to create a new control plan. - Outcome: product and Process characteristics as well as tasks assigned to control method and reaction plan appear in the corresponding columns.
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Adding Content to a Control Plan
To specify the Tolerance of a characteristic, a requirement of suitable type needs to be assigned to it providing the attributes needed for specification. How to customize requirement types is described in section SOX RM.
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To specify sample size and frequency, double-click in the relevant column and edit the values.
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To specify the tolerance of a characteristic in a control plan a new requirement type needs to be defined to customize the attributes of the characteristic as needed. In this example, the requirement type “Variable Characteristic” is defined.
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