CAPA
Corrective and preventive actions – from root cause analysis to effectiveness review.
The CAPA module takes corrective and preventive actions through successive stages: from the report with a problem description, through root cause and impact analysis, the action plan and its implementation with evidence, to the effectiveness review. A CAPA can be closed only after a positive review, and every stage stays in the history.
Why Your Team Needs This Module
The main benefits this module brings to your team’s day-to-day work.
CAPA register with deadlines
All CAPAs in one table: number, title, opening date, type, source, responsible person, planned deadline and status. An overdue deadline is marked in red. Filtering by every column.
Action plan and evidence of implementation
Each action has a responsible person, a deadline and a status: planned, in progress, completed or cancelled. The assigned person describes the implementation and uploads evidence, and a cancellation requires a justification.
Closure after the effectiveness review
A CAPA can be closed only after a positive effectiveness review. A negative review stays in the history and requires further actions to be planned. A closed CAPA can no longer be edited.
Root cause analysis with NexiMed AI
Based on the problem description and the CAPA source, NexiMed AI proposes possible causes and 5 Whys-style guiding questions. The responsible person picks, corrects or rejects the proposals and assesses whether the cause affects other products or processes.
Key Features of the Module
What exactly this module can do.
New CAPA
Number and opening date assigned automatically, type (corrective or preventive), source, problem description and a planned deadline picked from a calendar. The responsible person chosen from the employee list is notified of the assignment.
CAPA source
Complaint, internal audit, external audit (e.g. by a notified body), risk analysis, management review, production (e.g. a nonconforming product) or other – with a field to describe it.
Stages unlocked one by one
Information, root cause analysis, actions and effectiveness review. At every stage you can save a draft, and the next stage opens once the previous one is approved.
Action register
Actions with a name, type, description, responsible person and deadline. Clicking an action shows its details: implementation description, completion date and attached evidence. Each action is carried out independently.
Effectiveness review and history
Verification method and description, review date and an answer to whether the actions were effective. The history shows the course of the CAPA, including negative reviews, and the evidence of implementation is available for preview.
Cloud Security & EU Compliance
AWS architecture & GDPRHow this Module Connects with Other QMS Processes
NexiMed modules work together. Below are the processes related to this module.
Complaints
A CAPA with the “Complaint” source is linked to a specific complaint
Audits
A CAPA from an internal or external audit points to a specific audit
Product Realization
A CAPA from production, e.g. after a nonconforming product is found
Training
A training can serve as evidence of corrective actions
NexiMed AI
Proposes possible causes and 5 Whys-style guiding questions
Module Implementation FAQ
What happens when the effectiveness review is negative?
The CAPA cannot be closed. The process goes back to the action planning stage: the plan has to be changed, the evidence updated and the effectiveness reviewed again. The information about the negative review stays in the history.
Who fills in the implementation of actions and the effectiveness review?
The implementation of an action is filled in by the person assigned to it, and each action can be completed independently. The effectiveness review is carried out by the person responsible for the whole CAPA.
Can a closed CAPA be edited?
No. Editing is possible only while the CAPA is open. Before closing, the system asks for confirmation and reminds you that editing will not be possible once the status changes to “Closed”.
See CAPA in Action
Schedule an online demo with NexiMed specialists and see how this module can support the processes in your company.
Have questions?
Let's talk about your processes.
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