Deviations Management

Learn how to manage deviations within Masetra Quality Management System

đź“‹ What are Deviations?

A deviation is any departure from an approved procedure, specification, or standard. In pharmaceutical manufacturing, deviations must be properly documented, investigated, and resolved to maintain product quality and regulatory compliance.

🚀 Creating a Deviation

Step 1: Access Deviations Module

  1. Log into Masetra
  2. Click on “Deviations” in the main navigation
  3. Click “New Deviation” button

Step 2: Fill Deviation Details

  • Title: Brief, descriptive title
  • Description: Detailed description of the deviation
  • Category: Select from procedural, equipment, material, environmental
  • Classification: Critical, Major, or Minor
  • Department: Responsible department
  • Location: Where deviation occurred
  • Discovered Date: When deviation was identified

Step 3: Add Immediate Actions

Document any immediate corrective actions taken to prevent further impact.

Step 4: Submit for Review

Click “Save and Submit” to initiate the deviation workflow.

🔍 Investigation Process

Investigation Workflow

  1. Assignment: Quality manager assigns investigator
  2. Analysis: Use 5 Whys or Fishbone diagram
  3. Root Cause: Document primary cause
  4. Findings: Summarize investigation results
  5. Approval: Submit for management review

Investigation Tools

  • 5 Whys Analysis: Drill down to root cause
  • Fishbone Diagram: Categorize potential causes
  • Checklists: Standard investigation procedures

âś… Approval Workflow

Approval Steps

  1. Department Head Review
  2. Quality Assurance Review
  3. Management Approval
  4. Final Closure

Approval Actions

  • Approve: Proceed to next step
  • Reject: Return for corrections
  • Request Information: Ask for additional details

đź“Š Reporting and Analytics

Available Reports

  • Deviation Summary: Monthly deviation counts
  • Classification Report: Critical vs. Major vs. Minor
  • Department Performance: Deviation rates by department
  • Trend Analysis: Deviation patterns over time

Generating Reports

  1. Navigate to “Reports” section
  2. Select “Deviations” report type
  3. Choose date range and filters
  4. Click “Generate Report”
  5. Export as PDF or Excel

⚙️ Configuration Options

Deviation Categories

  • Procedural: Departure from standard operating procedures
  • Equipment: Equipment malfunction or failure
  • Material: Raw material or component issues
  • Environmental: Environmental condition problems

Classification Levels

  • Critical: Direct impact on product quality or patient safety
  • Major: Potential impact on product quality
  • Minor: No impact on product quality

đź”’ Compliance Features

Audit Trail

All deviation activities are logged with:

  • Timestamp
  • User identification
  • Action description
  • Before/after values

Regulatory Compliance

  • FDA 21 CFR Part 11 compliant
  • GMP guideline adherence
  • Electronic signature support

đź“ž Support

For questions about deviations management, contact info@masetra.com.

Last updated: July 30, 2025