Customer Experience Summary and Review
A customer experience only moves to the Summary and Review workflow state after all activities have been closed. If no activities exist, the customer experience moves to the Summary and Review state if it was deemed a valid complaint during the Evaluation state.
If you are assigned to the Customer Experience Reviewer role, use the following procedure to review the customer experience and confirm that it can be closed.
1. On your Home page, click the customer experience review task from the My Tasks table.
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Instead of navigating to the task page, you can right-click the task in the My Tasks table and select Enter Review Details.
The Subject column in the My Tasks table lists the customer experience identification information.
2. On the task page, click Enter Review Details.
3. In the Create Summary and Review window, under Summary and Review, enter the following information:
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To see information relevant to the customer experience, including its affected objects and previous workflows, click the Structure link in the upper right corner of the window.
Field
Description
Confirmed
Required. Select Yes or No to indicate if the customer experience was confirmed.
Verified
Required. Select Yes or No to indicate if the customer experience was verified.
Device Related
Required. Select Yes or No to indicate if the customer experience is related to a product or device.
Initiate CAPA
Required. Select Yes to indicate that a CAPA has been or needs to be initiated. This question itself does not create a new CAPA. If Windchill CAPA is installed, a CAPA Change Requests table appears on the lower part of the page. To create new CAPAs based on this customer experience, click the new CAPA request icon in the CAPA Change Requests table.
For more information on Windchill CAPA, see The Windchill CAPA Process.
Correction Indicated
Required. Select Yes or No to indicate if there is a correction for the customer experience. The FDA’s Code of Federal Regulations Title 21 Part 806 defines a correction as “the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.” For more information, see the FDA’s website for 21 CFR Part 806.
If you select No, enter information in the Correction Rationale field.
Correction Rationale
If you select No from the Correction Indicated list, describe the rationale in this field.
4. Under Failure Codes, if the failure code was confirmed, select the Confirm checkbox. If the failure code was not confirmed, clear the Confirm checkbox. The Confirm checkbox is the only field you can change in this table. For more information, see Failure Codes.
5. Optionally, under Conclusion, enter any notes related to your conclusion and the date you completed your review.
6. Optionally, under Final Codification, codify the customer experience with one or more categories by clicking the add icon and choosing a category from the code table.
7. Click Finish to complete your review. The customer experience moves to the Closed state.
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