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Investigation Management

Investigation Management

Investigations are used to assess the root cause, impact, and risk of deviations or complaints that require deeper analysis. They help determine whether further action such as a deviation or a CAPA is needed.

Each investigation is led by an assigned Investigation Leader, who is responsible for:

  • Managing the investigation process
  • Collecting feedback from relevant departments
  • Summarizing the findings
  • Submitting the investigation for approval

An investigation can be created in two ways:

  • From a Complaint
  • From a Deviation

In both cases, the Investigation Leader is selected at the source level (complaint or deviation). When the investigation is created, the system automatically sends an email notification to the assigned leader.

Once the investigation is initiated, the leader fills in the required fields and then assigns feedback requests to departments. This is done by selecting the relevant departments and submitting requests within the investigation form. For each selected department, the system automatically creates three feedback tasks:

  • Impact Risk Analysis
  • Investigation Root Cause
  • Investigation Summary

These tasks are completed by the department manager (or a delegated assignee). Once all feedback is provided, the Investigation Leader writes a final recap in the investigation and then submits it for approval.

The approval matrix is the same as for deviations:

  1. Department Manager
  2. Quality Assurance
  3. Qualified Person or Responsible Pharmacist

After final approval, the system proceeds based on the post-investigation decision:

  • If a Deviation is required (for investigations from complaints), one will be created.
  • If a CAPA is required, the system will continue with the CAPA process.

This structured approach ensures that investigations are handled consistently, with input from all affected areas, and that proper action is taken based on the outcome.

Investigation Overview and Fields

Once an investigation is created, the Investigation Leader is responsible for completing and managing the following fields and sections. Many fields are prefilled from the originating complaint or deviation but can be updated if needed.

General Information

This section is filled in automatically by the system based on the originating complaint or deviation:

  • For Company – the legal entity the investigation belongs to
  • For Department – the responsible department
  • Deviation – linked deviation (if the source is a deviation)
  • Complaint – linked complaint (if the source is a complaint)

Investigation

Basic investigation details. Most fields are filled automatically but remain editable if necessary:

  • Name – the investigation name, copied from the complaint or deviation
  • Investigation Leader – auto-filled; can be changed after creation
  • Code – generated automatically by the system
  • Date – the creation date of the investigation

Description and Comments

  • Description – a short description, prefilled from the complaint or deviation; can be edited
  • Comments – a general-purpose comment field used during reviews, approvals, or internal notes

Investigation Connection

Details that link the investigation to related operational items:

  • Product – the affected product, if applicable
  • Batch – batch number related to the investigation
  • Equipment – the equipment involved in the issue

Production and Customer Notification

Information about production continuity and customer impact:

  • Continue Production – Yes, No, or N/A
  • Customer Notified – Yes, No, or N/A
  • Customer Notification Date – date when customer notification was sent (if applicable)

Risk Assessment

This section evaluates the level of risk using the Risk Priority Number (RPN) method:

  • Impact Severity – Low (1), Medium (2), or High (3)
  • Probability – Low (1), Medium (2), or High (3)
  • Detectability – Low (1), Medium (2), or High (3)
  • Risk Score – calculated automatically using the formula:
    Risk Score = Impact Severity × Probability × Detectability
    The result ranges from 1 to 27. Higher scores indicate greater risk and help prioritize the need for corrective actions.

Investigation Recap

This section is completed by the Investigation Leader once all department feedback is collected.

  • Supplier Qualification Impact – Yes, No, or N/A. Indicates whether the issue affects supplier qualification or compliance.
  • Final Approver Role – sets the final approval role (e.g., QP or Responsible Pharmacist). Normally carried over from the source deviation or complaint, but must be set by QA if not pre-filled.
  • Impact Risk Analysis – entered by the Investigation Leader once all departmental feedback is received.
  • Investigation Root Cause – summary of the identified root cause based on collected input.
  • Investigation Summary – overall investigation conclusion, based on all findings and feedback.

Post Approval Process

This section defines the next steps after the investigation is completed and approved:

  • Deviation Required – Yes / No. Used only when the investigation originates from a complaint, to determine if a deviation should be created.
  • CAPA Required – Yes / No. Indicates whether the investigation should trigger a Corrective and Preventive Action.
  • CAPA Justification – explanation of why a CAPA is needed.
  • CAPA Responsible – person who will be assigned to the CAPA.
  • CAPA Must Close with Deviation – Yes, No, or N/A. Indicates whether the deviation and CAPA should be closed together.

Departmental Feedback Requests

As part of the investigation process, the Investigation Leader is required to involve other departments by requesting their input. This is done through the “Departmental Feedback” tab in the investigation screen.

Important: The investigation cannot be moved to the “In Progress” step unless at least one departmental feedback request has been created. This ensures that every investigation includes cross-departmental input from the beginning.

These requests are used to gather structured reports from departments regarding:

  • Impact Analysis
  • Root Cause Investigation
  • Investigation Summary

Creating a Departmental Feedback Request

To create a feedback request, the Investigation Leader navigates to the “Departmental Feedback” tab and clicks “Add”. The following fields must be completed:

  • Department – Select the department from which feedback is required. The list includes all departments in the organization.
  • Deadline – Set the date by which the department must complete the request. This deadline will automatically be applied to all related tasks.
  • Request – Enter a short title for the request. This will appear in the name of the tasks created.
  • Description – Provide more details about what is needed from the department. This will be included in the task descriptions.

After clicking Add, the system automatically creates three tasks linked to this request:

  1. Investigation Summary
  2. Root Cause Investigation
  3. Impact Analysis

Each task is assigned to the Department Manager of the selected department. They immediately receive an email notification with a direct link to the assigned tasks.

How Department Feedback is Submitted

The assigned Department Manager can:

  • Complete the task personally, or
  • Reassign the task to a team member within their department.

The person responsible for each task must enter their findings in the “Execution Report” field and then move the task to status “Completed”. These tasks ensure structured and consistent reporting from each department involved in the investigation.

Completion Requirement

The investigation cannot be submitted for approval until all departmental feedback tasks are completed. The Investigation Leader can submit the investigation for approval only after all assigned departments have completed their tasks.

Investigation Approval Process

Before an investigation can move forward, all departmental feedback tasks must be completed. The Investigation Leader can only submit the investigation for approval after all requested departments have finished their input.

The approval process follows the same structure as deviation approvals, using a clearly defined approval matrix.

1. Department Review

Once the investigation is ready, the Investigation Leader submits it for Department Approval. The system automatically sends an email notification to the Department Manager of the department where the original complaint or deviation occurred.

The manager reviews the investigation and chooses one of the following actions:

  • Approve – The investigation moves to the next step: For QA Review.
  • Send Back to Start:
    • The manager enters comments explaining what needs to be corrected.
    • The Investigation Leader is notified and must update the investigation before submitting it again.

2. Quality Assurance Review

After the department approves, the investigation is sent to the Quality Assurance (QA) team.

QA reviewers can:

  • Approve – The investigation moves to the Final Approval step.
  • Send Back to Start – Comments must be added. The Investigation Leader is notified and must revise and resubmit.

3. Final Approval – QP or Responsible Pharmacist

The final approver is determined based on the field Final Approver Role, selected during the investigation setup (or inherited from the related deviation or complaint). This can be either the Qualified Person (QP) or the Responsible Pharmacist (M.Pharm.).

They review the completed investigation and then:

  • Approve – The investigation is marked Completed.
  • Send Back to Start – Comments are required. The investigation must be revised and resubmitted.

What Happens After Final Approval?

Once the investigation is fully approved, the system checks the Post Approval Process settings to determine the next steps:

  • If no follow-up is selected: The investigation is complete, and the process ends.
  • If “Deviation Required” is selected (only for investigations created from complaints): A Deviation is automatically created and linked to the investigation.
  • If “CAPA Required” is selected: A CAPA is automatically created and the process continues in the CAPA module.

This ensures the investigation leads to appropriate follow-up actions, based on risk and findings.