What Is HARA? Hazard Analysis and Risk Assessment Explained for BRCGS Consumer Products

By Robert Low, Lead Management System Specialist and BRCGS Approved Trainer

HARA stands for hazard analysis and risk assessment, and it is about to become the most important acronym in consumer products manufacturing. The BRCGS Consumer Products Issue 5 draft places a structured HARA methodology at the heart of the standard, so if the term is new to your site, now is the time to get comfortable with it.

The Core Idea

HARA is a systematic way of answering four questions about your manufacturing operation. What could go wrong with the safety or legality of our product at each step? How likely is it and how bad would it be? What are we doing to prevent it? And how do we know those controls are actually working? If that sounds like common sense, it is. The value is in the discipline of doing it formally, step by step, for every process, rather than relying on experience and assumption.

The Methodology, Step by Step

Assemble a team. HARA is a multi-disciplinary exercise. Quality, production, engineering and product development all see different hazards, and the team needs a trained leader who understands risk assessment principles.

Establish your prerequisites. Prerequisite programmes are the baseline good practices that create an environment fit to manufacture in: cleaning, pest management, maintenance, training, supplier approval. Get these documented first, because your hazard analysis leans on them.

Describe the product and map the process. A full product description and a verified flow diagram of every manufacturing step, walked on the floor rather than drawn from memory, because the diagram in the office and the reality on the line are rarely identical.

Identify hazards and analyse them. At each step, list what could realistically contaminate, damage or compromise the product: physical, chemical, microbiological, and increasingly fraud and malicious threats. Assess likelihood and severity, taking your prerequisites into account.

Determine controls, set limits, monitor. For hazards that need dedicated control, define the control measure, validate that it works, set measurable limits, and monitor against them with records. Define in advance what happens when monitoring shows a limit has been breached, including what happens to product made while the process was out of control.

Verify and review. Internal audits, record reviews and complaint trends confirm the plan works in practice, and the whole plan gets reviewed at least annually and whenever anything significant changes.

If you work in food, you will recognise the shape of this immediately, and I have written a companion piece on HARA vs HACCP. For where HARA sits within the wider Issue 5 changes, see my full Issue 5 draft breakdown. And if your team is building a HARA for the first time, remote HARA development support is one of the services I offer, buttons below.