Every deviation handled the same way
On the night shift a deviation goes in a notebook, and the next morning one just like it is handled differently. In VisualQMS each deviation is a record that follows the same steps, linked to the corrective action it leads to.
- The same steps every time
- Linked to the corrective action
- Found by customer or product
From the first report to the corrective action
Each deviation follows the workflow you have agreed. The steps, and the people in them, can be set up to match how you work.
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Register it
Record what happened, with the details the workflow asks for.
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The person responsible acts
The workflow sends the task to the designated people, with reminders, and escalates it if it runs late.
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Find the cause
Look into the cause, and link a CAPA if the fix needs one.
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Linked to what it concerns
The deviation stays cross-referenced to its CAPA and to the documents it concerns.
What happened and what was done, kept together
Out of the notebook
Every deviation is a record in VisualQMS, whichever shift found it.
Linked to the corrective action
When the fix needs a CAPA, the deviation and the CAPA refer to each other.
Find them by customer or product
Filter and sort the records by their fields, such as customer, product or vendor.
When a deviation points to something deeper
A CAPA can reference the deviation that started it. Non conformances have a module of their own, and so do recorded issues and customer complaints.
The process maps show the process a deviation departs from, with each activity linked to its approved documents. Customers, products and vendors can come from your ERP or CRM, so they are kept in one place.
Questions about Deviation Management
What makes this different from a spreadsheet log?
A spreadsheet records that a deviation happened. In VisualQMS each deviation is a record with its own workflow, the workflow can require certain information before the record moves on, and the record is cross-referenced to the CAPA and documents it concerns.
Is Deviation Management a core module or an add-on?
It is an add-on module. Non conformances have one of their own, with workflow states such as Registration, Investigation, Closure, Review and Approval.
How does a deviation connect to a CAPA?
Both are add-on modules, fully cross-referenced to the other modules, so a CAPA can reference the deviation that started it.
How does follow-up stay on time?
The quality activity modules use standardised workflows with scheduling, reminders and notifications. Workflows route tasks to the designated people, and overdue tasks are escalated.
Can we use customer and product data from our ERP?
Yes. VisualQMS can fetch customers, products, manufacturers or vendors from your ERP or CRM through APIs, direct ODBC connections and other methods, so the information is used in quality work without being created or maintained again in VisualQMS.
Do we have to file deviations in the right folder to find them later?
No. VisualQMS is metadata-driven, so records are found through views that filter and sort by their fields instead of by folder location.
Where a deviation can lead next
Internal Audit Management
Know where every audit stands, with reminders for the people involved and observations tied to CAPA.
See Internal Audit ManagementIssue Management
Record an issue or a customer complaint, decide how each kind is handled, and keep it tied to the CAPA it leads to.
See Issue ManagementCAPA Management
Corrective and preventive actions with a person responsible and a deadline, linked to the finding that started them.
See CAPA ManagementTraining Management
See who has read the new procedure. Assign training by role, department or any other employee detail, and the manager hears when it is overdue.
See Training ManagementChange Management
Change requests that say what changes and why, approved before a controlled document is edited.
See Change ManagementNon Conformance Management
Non conformances recorded in their own module, taken from registration to review and approval, and linked to the CAPAs that fix them.
See Non Conformance ManagementRisk Management
Risk assessments that follow your own method and stay linked to the CAPAs, changes and documents they concern.
See Risk Management