QA Officers are the most active role in WebCAPA. QA Officers are responsible for adding issues, problems, corrective actions and preventive actions to the system as well as actively working with and following up on those items.
When a QA Officer logs on to the system they will be shown the QA Officer menu.
Issues
The QA Officer can add new issues, list all open issues, list all closed issues or list all issues (open and closed).
Problems
The QA Officer can add new problems, list all open problems, list all closed problems or list all problems (open and closed).
Issues and Problems have the following fields:
- ID - an unique id in WebCAPA. Note that issues, problems, corrective actions and preventive actions all have their own ID number series, so it is possible for all four to have the same number but that they need not be related. "Issue #1" is not the same as "Problem #1".
- Version - the item version is an integer, and is updated by WebCAPA whenever a change is made to the item.
- Origin -The origin of the item, i.e. where it arose from
- Originator's ID - WebCAPA will assign a unique id to the item, but this is to record the id that the reporter of the item used. Note that sometimes one originator's id can be connected to multiple issues and/or problems in WebCAPA, so this is not necessarily a unique identifier in this system, only in the original report.
- Slogan - a one line title or description of the item.
- Description - a more detailed description defining the item.
- Recommendation - if the reporter has provided any recommendations about how the item can be addressed these should be recorded here.
- Cause Analysis - an analysis of how and why the item has arisen at Viedoc.
- Severity - the severity assigned to the item by the reporter. Viedoc uses the EMA standard values for the severity are used (critical, major, minor, comment) and other values used by reporters should be translated into one of these four values.
- State - one of "New", "Open" and "Closed". The state is set to "New" when the item is first added, and then changed by the QA Officer as work progresses. A "New" item is classed as an open item in relation to the reports created by WebCAPA.
- Type - one of a number of fixed types of issue/problem allowing metrics to be kept.
- Area - the area the issue/problem is associated with, that is the QMS, ISMS, Data Privacy, Training or a local department procedure.
Corrective Actions (CAs)
The QA Officer can add new CAs, list all open CAs, list all completed CAs, list all closed CAs or list all CAs.
Preventive Actions (PAs)
The QA Officer can add new PAs, list all open PAs, list all completed PAs, list all closed PAs or list all PAs.
Corrective and Preventive actions have the following fields:
- ID - an unique id in WebCAPA. Note that issues, problems, corrective actions and preventive actions all have their own ID number series, so it is possible for all four to have the same number but that they need not be related. "Issue #1" is not the same as "Problem #1".
- Slogan - a one line title or description of the preventive action.
- Responsible - The id of the user responsible for implementing this preventive action.
- Version - the item version is an integer, and is updated by WebCAPA whenever a change is made to the item.
- Action - the actions to be taken/taken to implement this preventive action.
- QA Review - comments from the QA department when reviewing the actions taken (only visible to QA Officers).
- Planned Date - the date by which the preventive action shall have been implemented.
- Date Completed - the data the preventive action was implemented, if already known.
- State - one of "New", "Accepted", "Rejected, "Completed" and "Closed". The state is set to "New" when the item is first added, and then changed by the user responsible for the action as work progresses. "New" and "Accepted" items are classed as open items in relation to the reports created by WebCAPA, while "Rejected" and "Closed" items are classed as "Closed". The user responsible for the action cannot close the action, they set it in status "Completed" when they are finished with all actions. A QA Officer will then review the actions taken and close the action.
Linking Items
Issues can be linked to Problems or Corrective Actions, and Problems can be linked to Preventive Actions or Issues. Corrective Actions can be linked to Issues, and Preventive Actions can be linked to Problems. Adding links is done from the detailed view of an issue or a problem.