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Deviation Management

Deviation Management

Pre-Approval Phase

Deviations can be created in two ways:

  • Manually: A user identifies a non-conformity or unexpected event and registers a deviation directly in the system.
  • Automatically: A deviation is created after a complaint investigation is completed, if the outcome confirms that a deviation is necessary.

No matter how the deviation is created, the process for entering and reviewing the initial information is the same.

Once the deviation is created - either manually or automatically - the first step is to complete the required form. This is done by the employee who initiates the deviation and must be finished before the deviation can move to the approval workflow.

Below is a section-by-section guide to the information that must be entered.

1. General Information

  • Company - Select the legal entity where the deviation occurred (e.g., Ocean Stellar).
  • Department - Choose the department responsible for the area or process affected.
  • Name - Provide a short, clear title that identifies the deviation.
  • Code (readonly) - This code is generated automatically by the system and cannot be edited.

2. Occurrence Details

  • Occurred On - Enter the exact date and time when the deviation happened.
  • Reported By (readonly) - This is automatically filled in by the system with the name of the employee who registered the deviation.
  • Due date - Set the proposed deadline for resolving or closing the deviation.
    The due date can be changed manually only during the approval phase. Once the deviation is fully approved, and especially if it continues to investigation, the due date cannot be edited directly. Any change must go through a due date extension request, which is approved by the department manager, quality assurance, and the final approver (QP or Responsible Pharmacist). Only after all approvals are given, the new due date is applied.

3. Categorization

  • Deviation Type - Select:
    • Planned – the deviation was expected and authorized in advance.
    • Unplanned – the deviation occurred unexpectedly.
  • Repeat Occurrence - Indicate whether this deviation has occurred before: Yes, No, or N/A
  • Preliminary Categorization - Choose the initial classification based on severity: Minor, Major, or Critical

4. Deviation Description

  • Description - Provide a clear and detailed explanation of what happened and what the deviation involves.

5. Deviation Source

  • Affected Product - Specify the product involved, if applicable.
  • Batch (optional) - Select the batch number if the deviation is related to a specific production batch.
  • Equipment (optional) - Add the equipment involved in the deviation, if relevant.
  • Complaint (readonly) - If the deviation was created from a complaint, this field will be populated automatically.

6. Justification

  • Justification - Explain briefly why this deviation is being documented and what justifies its creation.

7. Immediate Actions

  • Immediate Action Taken - Select Yes or No depending on whether any actions were taken immediately after the deviation was identified.
  • Description of Action - If Yes, describe what action was taken and when.

Sections Visible But Not Completed at This Stage

There are two additional sections visible in the deviation form. These fields are not filled in by the creator of the deviation, but are completed later during the approval process by designated roles (e.g., Quality, QP, or Department Head):

8. Final Regulatory Decision

  • Final Categorization - The definitive classification of the deviation (e.g., Major), determined by Quality or a QP.
  • Final Approver Role - Indicates who is responsible for the final decision (e.g., Responsible Pharmacist).

9. Post Approval Actions

  • Requires Investigation - To be selected if an investigation is required. If selected, the Investigation Leader must be assigned.
  • Requires CAPA - To be selected if corrective or preventive actions will follow.
  • Requires Change Control - To be selected if a permanent change is needed.
  • Post Approval Notes - Used to capture comments or decisions made during the approval process.

Approval Workflow

Once the deviation form is completed and submitted, the system starts the approval workflow.

The approval process follows these steps:

  1. For Department Review
  2. For Quality Review
  3. For QP / Responsible Pharmacist Review
  4. Completed

Each approval step gives the reviewer the following options:

  • Approve → Move the deviation to the next step.
  • Send Back to Start → Return the deviation to the author with required comments.
  • Permanently Reject → End the process with no further actions.

Step 1: For Department Review

  • When the deviation is moved to “For Department Review”, the system sends an email notification to the Department Manager.
  • The department reviewer opens the deviation and reviews all provided information.
  • Available actions:
    • Approve → The deviation moves to “For Quality Review”.
    • Send Back to Start → The reviewer enters comments explaining what must be corrected. The system notifies the deviation author, who must revise and resubmit.
    • Permanently Reject → The deviation is closed and moved to the Permanent Rejection status.

Step 2: For Quality Review

After approval from the department, the deviation is routed to the Quality Assurance (QA) team.

QA reviewers must perform two key actions before approving:

A. Final Categorization and Final Approver Role

  • Final Categorization: Confirm or adjust the final severity level (Minor, Major, or Critical).
  • Final Approver Role: Select whether the final reviewer will be a:
    • Qualified Person (QP) or
    • Responsible Pharmacist (M.Pharm.)

This selection determines who the deviation is sent to for final approval.

B. Post Approval Actions

  • QA determines whether further action is required:
    • Requires Investigation: If selected, an investigation will be created automatically after approval. The Investigation Leader must be assigned.
    • Requires CAPA: If selected, a CAPA will be created after approval.
    • Post Approval Notes: QA can enter comments for traceability.

Once these fields are completed, QA can:

  • Approve → The deviation moves to the selected final approver.
  • Send Back to Start → With comments that the author must address.
  • Permanently Reject → The deviation is closed and not processed further.

Step 3: QP / Responsible Pharmacist Review

Based on the selection made by QA, the deviation is sent to the Qualified Person (QP) or the Responsible Pharmacist for final review.

At this step, the final reviewer has full access to the following fields and can review and make changes if needed:

  • Final Categorization
  • Final Approver Role
  • Post Approval Actions, specifically:
    • Requires Investigation
    • Requires CAPA

The reviewer then chooses one of the following:

  • Approve → The deviation moves to the final stage, Completed, or continues to the investigation/CAPA process.
  • Send Back to Start → With comments to the author for correction.
  • Permanently Reject → Ends the process.

What Happens After Final Approval?

Once the deviation is fully approved by the final approver, the system checks the selected Post Approval Actions and proceeds accordingly:

  • If no further actions are selected:
    • The deviation is marked Completed and the process ends.
  • If Investigation is required:
    • An investigation is created automatically.
    • The deviation moves to status “Investigation in Progress”.
    • When the investigation is completed, the system will automatically update the deviation to status Completed.
  • If CAPA is required:
    • A CAPA is created automatically.
    • The deviation enters status Completed, and the process continues in the CAPA module.

Note: Only one follow-up action can be selected — either Investigation or CAPA, but not both.
The system does not allow selecting both at the same time. The appropriate path must be chosen based on the nature and risk of the deviation.

Due Date Extension Process

Once a deviation is approved, the due date can no longer be changed manually. If additional time is needed after approval, the user must request a Due Date Extension through a formal process.

This ensures that all changes to deadlines are fully traceable and approved by the responsible roles.

In the deviation screen, users will see two buttons on the left side:

  • View due date extensions
  • Request due date extension

Viewing Due Date Extension Requests

Clicking View due date extensions opens a table showing all extension requests made for the current deviation.

Each request is listed with the following details:

  • ID – a clickable button that opens the specific request
  • Status – current stage or final outcome of the request
  • Previous Due Date – the original deadline before the request
  • New Due Date – the proposed updated deadline
  • Justification – the reason provided by the requestor

From this table:

  • Approvers can open and review requests
  • The requestor or QA can access and cancel a request if needed
  • If the request is still in progress, approval actions can be taken directly from here

This view helps all involved users and approvers monitor the full history and current state of due date extensions for the deviation.

Request Due Date Extension

Clicking Request due date extension opens a pop-up window with two fields:

  • Justification for extension – explain why more time is needed.
  • New due date – enter the new proposed deadline.

Once both fields are filled in, click OK to submit the request. This starts the official approval process.

Approval Flow for Due Date Extension

The approval matrix follows the same order as the main deviation approval process:

  1. The request is first sent to the Department Manager.
    They can either:
    • Approve → moves the request to For Quality Review, or
    • Reject → moves the request to Rejected (must enter a comment).
  2. Then the Quality Assurance (QA) reviewer can:
    • Approve → moves the request to For Final Approval, or
    • Reject → request is marked as Rejected (comment required).
  3. The final approver is the same role selected in the original deviation - Either the Qualified Person (QP) or the Responsible Pharmacist.
    They can:
    • Approve → the new due date is applied to the deviation, and the request is marked Completed.
    • Reject → the request is marked as Rejected, and the author is notified.

Important:

  • For each approval step, approvers can optionally add a comment when approving.
  • If they reject, a comment is mandatory to explain the reason.
  • The author is automatically notified if the request is rejected and can submit a new one if needed.

Canceling a Request

In specific cases, a due date extension request can be cancelled. This can be done by:

  • The author of the deviation
  • Мember of the Quality Assurance team

Rules and System Limitations

To ensure proper tracking and avoid misuse, the system applies the following rules:

  1. Only one active request at a time:
    You cannot submit a new request if there is already one that is not yet closed (approved or rejected)
  2. Each combination of dates must be unique:
    • You cannot submit a request with the same new due date as a previous one.
    • You cannot submit a request with the same previous due date twice.
  3. The new due date must be later than the current one:
    The system will reject the request if the new date is not after the current due date.

This controlled extension process ensures full traceability, proper escalation, and a consistent way to manage deviations requiring more time. It protects the integrity of deadlines while still allowing flexibility through a structured workflow.