Hazard Identification & Risk Assessment (HIRA)

Overview

Hazard Identification & Risk Assessment (HIRA) is a systematic approach used to identify hazards, evaluate associated risks, and determine appropriate controls before incidents occur.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports pharmaceutical, biopharmaceutical, API, medical-device, laboratory, warehouse, engineering, and other industrial organizations with HIRA studies covering routine operations, non-routine activities, equipment, utilities, chemicals, maintenance, projects, and workplace conditions.

Our approach focuses on hazard recognition, likelihood and severity assessment, existing control evaluation, risk prioritization, and practical risk-reduction measures.

Our HIRA Services

Workplace Hazard Identification

Systematic review of work areas and activities to identify physical, chemical, biological, ergonomic, mechanical, electrical, and operational hazards.

Task-Based Risk Assessment

Assessment of specific tasks and activities to identify hazards associated with each work step.

Process Risk Assessment

Review of manufacturing and utility operations to identify risks associated with process conditions, equipment, materials, and operational failures.

Chemical Risk Assessment

Evaluation of risks related to chemical handling, storage, transfer, exposure, compatibility, and spill potential.

Equipment & Machinery Risk Assessment

Assessment of mechanical hazards, moving parts, guarding, interlocks, energy sources, and maintenance activities.

Non-Routine Activity Assessment

Risk assessment for activities such as shutdowns, maintenance, equipment opening, cleaning, modifications, or special project work.

Project & Construction HIRA

Assessment of hazards associated with installation, construction, commissioning, expansion, and modification activities.

Control Effectiveness Review

Assessment of whether existing engineering, procedural, administrative, and PPE controls adequately reduce risk.

Risk Register Development

Preparation of structured risk registers showing hazards, causes, consequences, existing controls, risk ratings, and recommended actions.

Hazards We May Assess

Depending on scope, MGS may evaluate:

• Chemical exposure
• Flammable materials
• Toxic materials
• Corrosive materials
• Dust
• Vapors and fumes
• Biological hazards
• Moving machinery
• Rotating equipment
• Pressure systems
• Steam
• Hot surfaces
• Electrical hazards
• Work at height
• Confined spaces
• Manual handling
• Ergonomic risks
• Noise
• Heat
• Slips, trips, and falls
• Material movement
• Vehicle movement
• Fire and explosion
• Utility failures
• Maintenance activities
• Contractor activities
• Environmental releases

HIRA Methodology

A typical HIRA may consider:

• Hazard

What can cause harm?

• Cause

What event or condition could lead to the hazard?

• Consequence

What could happen if the hazard is not adequately controlled?

• Existing Controls

What controls are already in place?

• Likelihood

How probable is the event?

• Severity

How serious could the consequence be?

• Risk Rating

What is the level of risk based on defined criteria?

• Additional Controls

What further actions are required to reduce risk to an acceptable level?

Hierarchy of Controls

Recommended risk controls are prioritized using the hierarchy of controls:

1. Elimination – Remove the hazard where practicable.
2. Substitution – Replace it with a less hazardous alternative.
3. Engineering Controls – Isolate or physically control the hazard.
4. Administrative Controls – Use procedures, training, permits, supervision, or work restrictions.
5. PPE – Provide appropriate personal protective equipment as an additional layer of protection.

Our Approach

• Define the Scope

Identify the area, activity, process, equipment, workforce, and assessment boundaries.

• Identify Hazards

Review each activity and determine potential sources of injury, illness, damage, or environmental impact.

• Evaluate Existing Controls

Assess whether current safeguards are adequate and consistently implemented.

• Assess Risk

Rate likelihood and severity using the agreed risk matrix.

• Recommend Additional Controls

Define practical measures to eliminate, reduce, or manage unacceptable risks.

• Track & Review

Support action closure, residual-risk assessment, and periodic HIRA review.

Typical Deliverables

Depending on scope, MGS can provide:

• HIRA procedure
• Activity-wise HIRA
• Process HIRA
• Chemical risk assessment
• Equipment risk assessment
• Project HIRA
• Risk matrix
• Hazard register
• Risk register
• Control recommendations
• Residual-risk assessment
• Corrective-action tracker
• HIRA review schedule
• Follow-up assessment

Why Choose MGS

Practical Site-Based Assessment

MGS evaluates actual operations, activities, equipment, and workplace conditions.

Structured Risk Prioritization

Risks are ranked systematically to help organizations focus on the most significant hazards first.

Engineering & EHS Integration

Our approach considers both technical safeguards and operational safety controls.

Prevention-Focused

HIRA helps identify risks before they result in incidents, injuries, or process disruption.

Action-Oriented Outputs

Assessment results are translated into clear and practical risk-reduction actions.

Who We Support

MGS can provide HIRA support for:

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical facilities
• Medical-device organizations
• Laboratories
• Warehouses
• Utility areas
• Engineering projects
• Construction activities
• Greenfield facilities
• Brownfield modifications
• Organizations strengthening their EHS risk-management systems