FAQs for "Quality Events"
1. How can I re-open a complaint that was accidentally closed?
A: Re-opening a Complaint is a task that can only be performed by an Admin.
If you are an Admin:
Navigate to the CAPA module on the left-hand side of the page.
Select the sub-module "Complaints".
Select the complaint you wish to re-open from the list view page.
Click the "Re-open Report" button in the bottom-left corner of the page.
2. Why can you create an NCR from an NCR?
A: If you notice a trend in some NCRs, you can use this button to link them together for easier tracking and analysis.
3. What is the "Control System Updates" section for in CAR?
A: This section contains a set of predefined actions that you can assign to a user.
If you want to customize actions, you can use the "Implementation Plan" section.
4. What does the "Process Function Requirements" and "Class" field refer to in PFMEA?
A:
Process Function Requirements describe the specific functions and performance requirements of a process step. It outlines what the process is intended to do, including measurable outputs, quality standards, and operational criteria.
Example: For a welding process, the requirements might include ensuring a secure bond between two metal components, with specified tensile strength and weld size.
Class is used to categorize the severity or criticality of a failure mode based on its impact on safety, regulations, or customer satisfaction.
Typical classifications include Critical (C), Significant (S), or High Priority (H) to highlight issues requiring close monitoring.
Example: A failure that compromises product safety might be classified as Critical (C), requiring immediate corrective action.
5. I tried editing the header fields with the little pencil in the CAPA modules, but it didn’t save. Is there a delay?
A: There should not be a delay when editing the header fields of a CAPA.
Make sure you click the Save button at the bottom of the screen before exiting the page to ensure changes are retained.
6. How do I export a log of Client Complaints?
A: In the "Complaints" module, you can download an export of your data. Click on the "Reports" box located on the right side of the page, and select the report that you would like to export. You can refine your report using the filters available.
7. Why is a Production level user is unable to save comments in their assigned action in a Deviation Report?
A: The description section for action items is intended to allow the assigner of the task to provide additional details about the task.
8. How do I re-open a closed event?
A: Admins can re-open a closed report by clicking the "Re-open Report" button at the bottom left of the page.