Hazard analysis

Hazard analysis is a systematic process of identifying potential hazards associated with a product, process, or system and evaluating their significance to determine appropriate controls (NACMCF 1998, p.10)^[1]. Every recalled food product, every industrial accident, every contamination scandal represents a failure of hazard analysis—or a failure to implement what the analysis revealed. The technique originated in the space program but has spread throughout food manufacturing, pharmaceuticals, chemicals, and beyond. When done well, hazard analysis prevents disasters. When done poorly or ignored, people get hurt.

The method is both science and art. Identifying what could go wrong requires deep process knowledge. Evaluating which hazards matter most demands risk assessment skills. Deciding on controls involves balancing safety against practicality and cost. Hazard analysis sits at the intersection of engineering, biology, chemistry, and management.

Origins and development

Hazard analysis emerged from an unlikely source:

NASA origins. In the early 1960s, NASA contracted with the Pillsbury Company to develop safe food for space missions. Traditional end-product testing couldn't guarantee safety—astronauts couldn't risk food poisoning in orbit. Howard Bauman and his team at Pillsbury pioneered the preventive approach that became HACCP (Hazard Analysis and Critical Control Points)^[2].

Early adoption. The FDA began applying HACCP concepts to low-acid canned foods following botulism outbreaks in the early 1970s. The Pillsbury Company presented the HACCP concept publicly in 1971 at the National Conference on Food Protection.

International spread. Codex Alimentarius, the joint FAO/WHO food standards body, adopted HACCP principles in 1993. European regulations followed. By the 2000s, hazard analysis had become mandatory for food producers in most developed nations.

Beyond food. Pharmaceutical companies, medical device manufacturers, and chemical processors adapted hazard analysis methodologies. Each industry developed its own frameworks while retaining core principles.

The hazard analysis process

Effective hazard analysis follows structured steps:

Hazard identification

The first step catalogues everything that could cause harm:

Biological hazards. Microorganisms capable of causing illness—bacteria (Salmonella, Listeria, E. coli O157:H7), viruses (Hepatitis A, norovirus), parasites (Cryptosporidium, Trichinella), and fungi. These dominate food safety concerns^[3].

Chemical hazards. Toxins, allergens, pesticide residues, cleaning agents, heavy metals. Undeclared allergens cause more recalls than any other food safety issue. Lead contamination periodically surfaces in spices and supplements.

Physical hazards. Foreign objects that can injure consumers—glass, metal fragments, stones, plastic pieces, bone. X-ray and metal detection systems address many, but not all, physical hazards.

Radiological hazards. Less common but relevant for certain products. Nuclear facility proximity, naturally occurring radioactive materials in some soils and waters.

Hazard evaluation

Not all hazards merit equal attention:

Severity assessment. How serious would the harm be if the hazard occurred? Death? Hospitalization? Temporary discomfort? Clostridium botulinum toxin kills; many pathogens cause self-limiting illness.

Likelihood assessment. What's the probability of occurrence given current practices? Some hazards are theoretically possible but practically improbable. Others occur regularly without controls^[4].

Risk matrices. Combining severity and likelihood yields risk priority. High severity, high likelihood hazards demand immediate attention. Low severity, low likelihood hazards may need only monitoring.

Population considerations. Vulnerable populations—infants, elderly, immunocompromised individuals, pregnant women—face greater risk from many hazards. Products targeting these groups require stricter controls.

HACCP framework

The most widespread application combines hazard analysis with control point management:

Seven HACCP principles

Principle 1: Conduct hazard analysis. Identify hazards and assess their significance. This provides the foundation for everything that follows.

Principle 2: Determine critical control points (CCPs). Identify steps in the process where control can be applied to prevent, eliminate, or reduce hazards to acceptable levels. Not every step is critical; identifying the truly essential ones focuses resources effectively^[5].

Principle 3: Establish critical limits. Define measurable criteria that separate acceptability from unacceptability at each CCP. Cooking temperature, pH level, water activity, time at temperature—specific numbers enable objective verification.

Principle 4: Establish monitoring procedures. Define how and when critical limits will be checked. Continuous monitoring (like temperature recording) beats periodic sampling when feasible.

Principle 5: Establish corrective actions. Specify what happens when monitoring reveals a critical limit has been exceeded. Products must be segregated, the problem must be fixed, and documentation must be completed.

Principle 6: Establish verification procedures. Confirm that the HACCP system works. Review records, conduct testing, audit procedures. Verification differs from monitoring—it checks the system itself.

Principle 7: Establish documentation and record keeping. Maintain evidence that the system operates correctly. Records demonstrate due diligence and enable investigations when problems occur.

Decision trees

Identifying CCPs requires systematic analysis:

The Codex decision tree. A series of questions guides determination of whether a step is a CCP:

1. Is control at this step necessary for safety?
2. Does this step eliminate or reduce the hazard to acceptable levels?
3. Could contamination occur or increase to unacceptable levels?
4. Will a subsequent step eliminate or reduce the hazard?

Different answers lead to different conclusions. The logic prevents both over-identification (treating every step as critical) and under-identification (missing genuine control points)^[6].

Hazard analysis methods

Several structured techniques support hazard identification:

HAZOP (Hazard and Operability Study). Originally developed for chemical processes, HAZOP systematically examines deviations from design intent. Guide words (no, more, less, reverse, etc.) prompt consideration of what could go wrong.

FMEA (Failure Mode and Effects Analysis). Identifies potential failure modes and their consequences. Common in manufacturing and engineering contexts. Risk Priority Numbers (RPNs) quantify severity, occurrence, and detectability.

Fault Tree Analysis. Works backward from an undesired event to identify contributing causes. Visual diagrams show how combinations of failures lead to problems.

What-If Analysis. Less structured brainstorming using "what if" questions. Useful for simpler processes or initial screening before more rigorous methods.

Industry applications

Hazard analysis adapts to different sectors:

Food manufacturing

Mandatory HACCP implementation spans most food categories in developed countries. Cooking temperatures for meat products, pasteurization parameters for dairy, acidification for canned goods—all derive from hazard analysis^[7].

Pharmaceuticals

ICH Q9 guidelines establish risk management frameworks for pharmaceutical manufacturing. Hazard analysis identifies contamination risks, potency variations, and other quality threats. Clean room classifications, water system controls, and component testing all trace to hazard analysis conclusions.

Medical devices

ISO 14971 requires risk analysis throughout medical device design and manufacture. Hazard analysis identifies how devices might fail, harm patients, or compromise therapy effectiveness.

Chemical processing

Process Safety Management regulations require hazard analysis for covered facilities. Chemical release scenarios, explosion risks, and environmental hazards demand systematic evaluation.

Common failures

Hazard analysis programs fail in predictable ways:

Paper compliance. Creating documentation without genuine hazard thinking. Plans that satisfy auditors but don't reflect actual risks.

Outdated analysis. Initial hazard analysis becomes obsolete as processes change, ingredients shift, and new hazards emerge. Regular review is essential but often neglected.

Missing expertise. Effective hazard analysis requires understanding of both the science of hazards and the specific process. Teams lacking either produce inadequate results^[8].

Over-complication. Identifying too many CCPs dilutes attention from genuinely critical steps. Everything becomes "critical," meaning nothing is truly prioritized.

Under-resourcing. Hazard analysis requires time, expertise, and management commitment. Organizations treating it as a box-checking exercise underinvest in quality.

Regulatory requirements

Governmental mandates drive implementation:

United States. The FDA Food Safety Modernization Act (FSMA) requires preventive controls including hazard analysis for most food facilities. USDA HACCP regulations cover meat and poultry.

European Union. EC Regulation 852/2004 mandates HACCP-based procedures for food businesses.

International standards. ISO 22000 provides an international framework integrating hazard analysis with quality management systems.

Hazard analysis — recommended articles

Risk assessment — Quality control — Food safety — Process management

References

• NACMCF (1998), Hazard Analysis and Critical Control Point Principles and Application Guidelines, National Advisory Committee on Microbiological Criteria for Foods.
• Mortimore S., Wallace C. (2013), HACCP: A Practical Approach, 3rd Edition, Springer.
• FDA (2023), HACCP Guidance, U.S. Food and Drug Administration.
• Codex Alimentarius (2020), General Principles of Food Hygiene, FAO/WHO.

Footnotes

1. ↑ NACMCF (1998), HACCP Principles, p.10
2. ↑ Mortimore S., Wallace C. (2013), HACCP: A Practical Approach, pp.1-23
3. ↑ FDA (2023), HACCP Guidance, Biological Hazards Section
4. ↑ NACMCF (1998), HACCP Principles, pp.15-23
5. ↑ Codex Alimentarius (2020), General Principles, Annex
6. ↑ Mortimore S., Wallace C. (2013), HACCP: A Practical Approach, pp.89-112
7. ↑ FDA (2023), HACCP Guidance, Industry-Specific Sections
8. ↑ Mortimore S., Wallace C. (2013), HACCP: A Practical Approach, pp.234-256

Author: Sławomir Wawak