Incident Management Procedure Using Salesforce Cases for Quality Management System
Objective: To establish a clear and efficient procedure for managing incidents within the Quality Management System (QMS) using Salesforce cases. This procedure ensures that all incidents are reported, investigated, resolved, and analyzed to prevent recurrence.
Roles:
Quality Manager is Jan Tenenberg
1. Scope
This procedure applies to all incidents related to quality issues, non-conformance, customer complaints, or other quality-related events that could impact the organization's products, services, or processes.
2. Definitions
Incident: An event that leads to, or has the potential to lead to, non-conformance or a quality issue within the organization.
Salesforce Case: A record in Salesforce used to document, track, and resolve incidents.
Case Owner: The person responsible for investigating and resolving the incident.
Case Status: The current stage of the incident within the Salesforce system (e.g., New, In Progress, Resolved, Closed).
3. Responsibilities
Employees: Report incidents by logging a case in Salesforce.
Quality Manager: Assigns cases, monitors progress, reviews incident analysis, and ensures timely resolution.
Case Owner: Investigates the incident, determines root cause, implements corrective actions, and closes the case.
4. Procedure
4.1 Incident Reporting
Step 1: When an incident occurs, employees must log into Salesforce and create a new case.
Navigate to the "Cases" tab in Salesforce.
Click on "New Case."
Complete the required fields, including:
Case Origin (e.g., Internal Audit, Customer Complaint)
Description of the Incident
Date and Time of the Incident
Product/Process Involved
Severity Level (e.g., Minor, Major, Critical)
Attach any relevant documents (photos, reports, emails, etc.).
Submit the case.
4.2 Case Assignment
Step 2: The Quality Manager receives a notification of the new case.
Reviews the details of the incident.
Assigns the case to an appropriate Case Owner based on expertise and availability.
Updates the case status to "Assigned."
4.3 Investigation and Root Cause Analysis
Step 3: The Case Owner begins the investigation.
Gathers relevant information and evidence.
Interviews relevant personnel if needed.
Performs root cause analysis (e.g., using Fishbone Diagram, 5 Whys).
Updates the case with findings and analysis results in the “Case Notes” section of Salesforce.
Changes the case status to "In Progress."
4.4 Corrective and Preventive Actions (CAPA)
Step 4: The Case Owner determines and implements corrective and preventive actions.
Document corrective actions in the Salesforce case (e.g., process changes, retraining, equipment updates).
Assign tasks to team members if needed (e.g., corrective action implementation).
Set deadlines for each corrective action.
Update case status to "Pending CAPA Review."
4.5 Review and Closure
Step 5: The Quality Manager reviews the completed corrective actions.
Verifies the effectiveness of the actions taken.
Ensures no recurrence of the incident.
Changes the case status to "Resolved."
If further actions are needed, the status is changed back to "In Progress" and the Case Owner continues with additional CAPAs.
4.6 Closure and Reporting
Step 6: The Quality Manager reviews the case for completeness and final approval.
Updates the case status to "Closed."
Generates reports from Salesforce on incident trends, root causes, and CAPA effectiveness.
Distributes the incident report to relevant stakeholders for further learning and improvement.
5. Case Statuses
New: The incident has been reported and is awaiting assignment.
Assigned: The case has been assigned to a Case Owner and is ready for investigation.
In Progress: The incident is being investigated, and actions are being determined.
Pending CAPA Review: Corrective actions have been implemented, and the case is awaiting review.
Resolved: The incident has been resolved but not yet closed.
Closed: The case has been fully resolved and is archived.
6. Monitoring and Reporting
The Quality Manager will review all open cases on a weekly basis to ensure timely progress.
Monthly incident reports will be generated from Salesforce to track trends, identify recurring issues, and ensure continuous improvement.
High-priority or recurring incidents will be escalated for management review.
7. Training and Awareness
All employees will be trained on how to log and manage cases within Salesforce.
Refresher training will be provided on a semi-annual basis to ensure the procedure remains effective.
8. Continuous Improvement
Feedback from case owners and team members will be regularly collected to improve the incident management procedure.
Lessons learned from resolved cases will be integrated into training programs and process improvements.
This procedure ensures incidents are effectively captured, investigated, and resolved, promoting continuous quality improvement across the organization.