Digital Solution for OpenText and SAP infrastructure.
What is CAPA?
Corrective Actions Preventive Actions is what defines CAPA and Corrective Preventive Action stands for CPA.Then there is Root Cause Analysis or recommended corrective action. Which is preferred in industry? We have heard them all and CAPA is generally accepted as the process term. Anyone can suggest a corrective preventive action to mitigate the cause or reduce the harmful effects of an undesirable situation.
All regulated industries should have a documented process for CAPA, a typical process follows:
Incident or Non-Conformity is reported
Incident is triaged (given a priority)
Based on incident type and priority; Work Order is created to correct problem
Corrective action is taken, all action taken is documented
Based on severity of incident, Root Case Analysis (Root Cause Analysis) may be required
Based on Root Cause Analysis, a Preventative Procedure may be created
Any Lessons Learned are documented and made available
What is the Sextant Digital Solution?
Another definition of Corrective Action Preventative Action within a Risk Management view is as follows:
An accident or incident is reported
Safety(security, etc) managers are notified
Preliminary investigation and risk assessment is performed
Targeted closure date set to communicate to all personnel urgency to close the issue
Responsible manager either accepts recommended corrective preventive actions, or comes up with his own
Responsible manager assigns corrective preventive actions to personnel within his control with a deadline
Personnel assigned to the corrective preventive action completes task and notifies responsible manager
Responsible manager either accepts or rejects performance of the corrective action preventive action
If accepted, and this is the last corrective preventive action to be finished, safety manager is notified
If rejected, assigned personnel is notified that performance has been rejected
An automated or digital Corrective Action Preventative Action (CAPA) process allows managers to monitor corrective preventive actions’ progress and identify road blocks that prevent issues from meeting their targeted closure date deadlines.
It is critical for managers to easily review and manage corrective actions in one simple view.
Although most regulated companies have some Corrective Action Preventative Action automation, very few automate all process steps
Tracking of Corrective Action is usually manual
Any documentation created during the corrective action is difficult to track & retrieve later
Status of ongoing Corrective Action Preventative Action processes are difficult to obtain
Inability to retrieve Corrective Action documentation reduces ability to create a Preventative Action
A Corrective Action may introduce investigations or fines from regulatory bodies
Corrective Action is a reactive process thus more expensive to complete
Root Cause Analysis is time consuming and expensive
Status of Root Cause Analysis is difficult to obtain
Lessons Learned from Root Cause Analysis are not easy to find and reuse
Preventative Action process is manual
Any documentation is difficult to track and retrieve
Difficulty in retrieving available Corrective Action documentation or Lessons Learned reduces ability to create Preventative Action
A Preventative Action is a proactive and less expensive process
Preventative Action’s do not require Root Cause Analysis
Sextant Digital Corrective Action Preventative Action Process Solution
Work Order is used to drive Corrective Action (Corrective Action) workflow
Process can be Mobile enabled
All supporting documentation (reports, photos, video, etc.) for Corrective Action can be attached to Work Order
Once Work Order is complete and approved all supporting documentation is easily retrievable
Corrective Action Process is fully auditable
Escalation is available
Corrective Action Process Dashboard provides status
If Root Cause Analysis is required, workflow can drive process
Process can be Mobile enabled
All supporting documentation (reports, photos, video, etc.) for Root Cause Analysis can be attached
All Root Cause Analysis documentation can be associated with work order
Documentation can also be associated with Lessons Learned
Preventative Action (Procedure creation can be Workflow driven
Preventative Action Work Order process can leverage Corrective Action process
Escalation is available
Preventative Action Process Dashboard provides status
Sextant Digital CAPA Process Value
Both CA and PA Processes leverage workflow control
Mobile enablement provides maximum flexibility and control
Escalation and Dashboards enhance transparency
Early recognition of pending issues
Drives events(triggers)
Drives urgency and timely completion of CA or PA to avoid regulatory audits or fines
Supporting documentation for both CA and PA processes are easily retrievable
This same documentation is available to Lessons Learned
Sextant Digital CAPA Process facilitates the ability for an organization to perform more less expensive PA processes than the more expensive CA
Regulatory Fine
Regulatory Investigation
RCI is expensive ($120k+ each)
Enhancement of the PA through use of structured process that allows for minimize CA and increase the PAs. Enhanced by controlling the work that was done, easily searchable.
Drive the process of creating the PA
Cause a review and through a workflow cause (supporting materials) to a PA being created
Why Sextant Digital – we know how to:
Automate the manual aspects of:
the CAPA process
Correction action process – repair non-conformity, document and supporting documentation of that repair (e.g. images, reports)
Corrective action process– RCI – capture all reports, recommendations, and supporting documentation, gathered and associated with the RCI
RCI – capture the recommendations and procedure (auditable, regulated document) made to create the published Preventative Action.
Capture Lessons Learned – use a workflow to create the documents and reports with the actual Lessons Learned content and Published. System stores and retains – who did Lessons Learned, where are the Lessons Learned, available to support the Preventative Action Procedure. Readily available in system with easily retrievable search parameters.
