Steps to Implement Incident Module in Calem

Incident Module is added in Calem in the coming release of R2024d (August 2024). This blog presents the steps to implement Incident Module in Calem.

1. What is an Incident?

An incident (IR) is any event that disrupts normal operations, poses a risk, or could potentially cause harm, or results in damage or injury. Incident investigation and record keeping may be mandatory for regulatory compliance for an organization. 

 2. Incident Roles and Investigation

The first step of implementation is to set up the roles and investigation plans for incidents.

• Incident roles: Organization | ACL Profiles | Incident Setting
  • They include a) Principal Investigator; b) Review Board; and c) Others.
  • They are assigned to sites.
  • A principal investigator may be designated as default by site.
  • Investigators who are assigned to incident actions.
  • Users or teams can be assigned to roles by site (screenshot below).
• Investigation Plans: Organization | ACL Profiles | Incident Setting
  • Priorities of incidents include a) Accident; b) Near-Miss; or c) Incident.
  • Plans are PM Plans with steps defined for investigation.
  • Plans are assigned by priority and site.
  • Different plans may be defined for different priorities.
  • Leave site empty to assign Plans by priorities (screenshot below).
• Incident Planners and Monitors:
  
  • Menu: Organization | ACL Profiles | Monitor User
  • Create teams or users with roles of a) Incident Planner; and b) Incident Monitor
  • Incident planners can assign principal investigators to IRs by site.
  • Incident monitors can receive workflow notifications when incidents are changed.

 3. Assign Roles to Incidents

There are two types of resources to assign to an incident:

• The investigators to work on incident actions. They include users assigned to a site.
• The reviewers to evaluate the incident investigation reports.
• The resources are assigned to an IR by a PI.
• These users along with the requester and Incident Planners can modify an IR. 

4. Create an Incident

An incident is created by a user with access to the incident module.

• An Asset or Location is required to create an IR.
• Files may be attached when creating an IR.
• After an IR is created, a PI (Principal Investigator) needs to be assigned by an IR planner for a site.
• An IR Planner assigns PI for an incident.
• The PI builds a team by assigning users for IR Action and Evaluation (screenshot above).
• A home screen is available for IR including IR stats, menu, and data lists for quick actions.
  • New IR: new IRs not processed
  • Open IR: IRs in process, not completed or accepted.
  • Completed: Completed IRs ready for evaluation.
  • My IR (PI): Incidents with login user being a principal investigator.
  • My Assignment: Open IRs with login user as an investigator.
  • My Evaluation: Open IRS with login user as reviewer.
  • All IR: All incidents accessible to the login user.

 5. IR Integration with CAPA | MOC | Work Permit

An IR investigation may drive the creation of a CAPA, MOC and/or work permits.

• IR form | More | Create CAPA, Create MOC, Create Work Permit.
• An investigator or reviewer may create CAPA, MOC, work permits out of the investigation of an IR.

 6. IR Lifecycles

Only Principal Investigators (PI for an IR) can modify IR statuses.

• Additional PIs can be added to an IR as evaluation member with the PI role.
• An IR action can be completed by the user assigned to it or a PI.
• An IR step can be completed by users assigned to actions.
• An IR evaluation can be completed by the user assigned to it or a PI.
• An IR cannot be completed if there are unfinished actions.
• An IR cannot be accepted if there are unfinished evaluation tasks.

7. IR Investigation Plans

IR plans include investigation steps. You may set up plans for different priorities. For instance, one plan for accident investigation, one for near-miss, and one for incidents. Upload templates are provided for setting up plans in excel and upload to Calem.

• Excel file to upload PM Plans for investigation: cm_pm_plan.IR-Incident.xls
• Excel file to upload investigation steps for a PM Plan: cm_pm_step.IR-Incident.xls
• You may modify the excel files to create your own investigation plans and steps for your organization. Then, upload to your service.

 Additional Resources

• Steps to Implement CAPA in Calem
• Why Implementing Change Management (MOC) in Calem
• Work Permits in Calem
• Work Order Module Training
• Service Request Module Training
• User Guide and Admin Guide (customer account required)
• Calem Enterprise Training Site
  
• Calem Enterprise Blogs
  
• Calem Enterprise demo