It's easy to keep track of the causes of non-conformities and other issues with WebCAPA, making light work of improving your organisation's processes.
How is the information organised?
WebCAPA keeps track of four types of record:
- Issue - a non-conformance or finding that constitutes an error in how work has been performed, i.e. something that has already gone wrong.
- Problem - something that could lead to a non-conformance or finding in the future, if the organisation's processes are not corrected, i.e. something that might go wrong in the future, or area(s) for improvement.
- Corrective Action - is an action to address or correct an issue to prevent recurrence, i.e. to correct something that has already gone wrong.
- Preventive Action - is an action to address or correct a problem to prevent occurrence, i.e. to correct a faulty process which can lead to potential nonconformity in the future.
With these you can record the non-conformities, findings, etc. that have been uncovered together with the actions taken to rectify them.
Relations between issues, problems, corrective actions and preventive actions
Issues and Problems can both be identified directly as a result of external forces, i.e. an audit or inspection, questions from customers or from within the organisation itself. But further investigation of an issue (something that has gone wrong) can also lead to the identification of one or more problems (things that could go wrong in the future). Also one problem might be identified by more than one issue. WebCAPA lets you keep track of all this by allowing "many-to-many" relations between issues and problems, i.e. one issue can be related to one or more problems, and one problem can be related to one or more issues. When reading an issue or problem in WebCAPA you can easily follow a link (a single click) to related problems and issues.
In the same way an issue can be resolved by one or more corrective actions, and a problem can be resolved by one or more preventive actions. Conversely one corrective (or preventive) action could provide the solution to multiple issues (or problems) in the WebCAPA database. Therefore WebCAPA even supports "many-to-many" linkages between issues and corrective actions, and between problems and preventive actions.
WebCAPA supports two user roles
The QA Officer can add issues, problems, corrective actions, preventive actions and link them to each other.
The Responsible user can only see those corrective and preventive actions that have been assigned to them, as well as related issues and problems. The Responsible user can update the "Action", "Actual Date" and "Status" fields for their corrective actions and preventive actions. The Responsible user can also allocate an action to another user if they feel the action should be for them (the "Responsible" field).
Users with either of these two roles can also be granted administrator privileges, allowing the user to approve new users, change the user role, add or remove administrator privileges to users and to enable or disable users.
It is possible for one physical user to have the following roles and privileges in WebCAPA:
- QA Officer
- QA Officer + Administrator
- Responsible
- Responsible + Administrator
What does WebCAPA do for you?
The Responsible user can work with all actions they are responsible for. They can also see the issues/problems that those actions are linked to, in order to better understand what is required.
The QA Officer user can work with and extract reports for all items in the database.
WebCAPA sends e-mail reminders to Responsible users and QA officers as items become due and overdue.
WebCAPA keeps a full audit trail of all actions in the WebCAPA database.