Hazard Analysis vs Risk Analysis vs Failure Mode and Effect Analysis

I’d like to get clearer picture of the difference between Hazard Analysis, Risk Analysis, and Failure Mode and Effect Analysis. In the planning stage, ISO 22000 requires hazard analysis to be conducted on all hazards likely to occur in the food product. So my question - When to do the Risk Analysis - When to do FMEA?

In food safety, do you recommend using all these terms? If so, I can see the benefits of differentiating the terms. Otherwise the terms Hazard Analysis, Risk Analysis and FMEA are used interchangeably.

I cannot explain the precise differences simply and quickly, however...

HACCP evolved from FMEA for the specific requirements of controlling food safety hazards. HACCP risk assessment it is a means of analyzing hazards in a structured manner so as to identify the significant and then implement adequate preventative control measures.

Stick to HACCP most others do.

It would be good if any member could explain the precise differences quickly and simply.

Regards,
Simon

All of these systems, HACCP, Hazard Analysis and FMEA are in essence tools to use to identify and quantify risk and to design and implement controls to minimise these risks.

There are similarities and difference between them and individuals have their favourites techniques and can get quite protective about them.

I don't have much practical experience with FMEA but there is one part which I do find complicated and inconsistantly applied, and that is the concept of detectability.

It is included with the likelihood and severity assessment, normally using a score based system to determine the level of risk.

ie L x S x D = Risk.


I have seen detectability assigned a figure as if there were no control in place and also after a control has been designed and implemented. I find the logic confusing. To me, the detectability is the same as operation of the control itself.

I have often seen it applied such that you have a hazard which is highly likely to occur, very dangerous if it does occur, but easy to detect and the conclusion is that it is low risk. I just can't get my brain around this at all.

Any clarification would be appreciated.

As Simon said, HACCP evolved from FMEA and no-one really talks about FMEA in terms of food safety as HACCP has evolved away from it. It is a useful comment to say to engineers though (who use FMEA) as it can demystify what HACCP is to them.

To me, Hazard and Risk have distinct and specific meanings, probably from my (limited) health and safety knowledge.

A hazard is a source of something dangerous, be this a food safety danger or a health and safety danger. For example, a hazard could be a 16 tonne weight balanced on a small ledge or the presence of Listeria in a sandwich.

A risk is the likelihood that something bad would happen, that a person will be made ill or injured by the hazard. So, in my example above, the 16 tonne weight could present no risk if that was in the middle of an unpopulated field but if in a factory, obviously there is the danger of it falling and crushing someone (or possibly resulting in the falling of a piano but maybe I've been watching too many cartoons.) With the sandwich, the risk changes depending on who ate it. If a healthy adult ate it, the risk is small. If a pregnant woman or a baby ate it (yes, my 10 month old baby eats sandwiches) then the risk of illness would be very high.

So IMO you should be very specific about how you use the terms 'Hazard' and 'Risk' and ignore the term FMEA completely.

Dear MOM,

So my question - When to do the Risk Analysis - When to do FMEA?

Your question is i think addressed within the context of ISO 22000.

Hazard analysis is in this case assumed to be as per the Codex system.

So the simple answer to yr question is - you don't.

Rgds / Charles.C

Dear MOM,


Your question is i think addressed within the context of ISO 22000.

Hazard analysis is in this case assumed to be as per the Codex system.

So the simple answer to yr question is - you don't.

Rgds / Charles.C

You are right Charles C. That's for ISO 22000.

A HACCP Plan is incomplete and the subsequent HACCP System is flawed if the hazard analysis is not supported by risk analysis. The basic fundamentals of risk assessment and risk categorization is thus ignored. In short, you can combine the term and call it "Hazard Risk Analysis" and I hope this answers your question.

Dear Charles Chew,

I hope this answers your question.

I agree yr logic, not so sure about the new terminology and have even more doubts as to the above.

Another suggestion (though hardly a solution).Staying within the ISO 22000 context - Codex defines hazard analysis as -

The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.

Implementing the process stated above necessitates some form of "risk analysis". And the latter is where the real problems start. Sadly, IMHO, the crucial steps to carry out the hazard analysis, especially preceding the determination of CCPs are only rudimentarily addressed by Codex. And without a single example. And similarly ISO 22000. And all for the fear of plagiarism.

Rgds / Charles.C

Dear Charles Chew,



I agree yr logic, not so sure about the new terminology and have even more doubts as to the above.

Another suggestion (though hardly a solution).Staying within the ISO 22000 context - Codex defines hazard analysis as -



Implementing the process stated above necessitates some form of "risk analysis". And the latter is where the real problems start. Sadly, IMHO, the crucial steps to carry out the hazard analysis, especially preceding the determination of CCPs are only rudimentarily addressed by Codex. And without a single example. And similarly ISO 22000. And all for the fear of plagiarism.

Rgds / Charles.C

Can we say that staphylococcus aureus, Escherichia coli, Salmonella etc are hazards which can result in foodborne disease, food poisoning etc (risk)?

hazard = cause
risk = affect.

The risk bit is both the likely effect in terms of the severity of the effect and the likelihood which may vary with your consumer group. So the risk with Salmonella could be infection leading to illness or even death depending on the age and the immune status of the consumer (think baby milk for example) and the likelihood will probably be dose dependent and dependent on whether instructions have been followed.

Dear MOM,

Some more Codex -

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Risk – A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

cx0 - codex 2003 hygiene document .pdf   74KB   127 downloads

cx1 - Session_2_-_Risk_Analysis_in_Codex.ppt.pdf   211.96KB   197 downloads

And a rather more heavyweight version -

cx2 - Overview of Codex Risk Analysis - SP01.pdf   6.35MB   194 downloads

Rgds / Charles.C

added -

Can we say that staphylococcus aureus, Escherichia coli, Salmonella etc are hazards which can result in foodborne disease, food poisoning etc (risk)?

hazard = cause
risk = affect.

Yes, Stap.aureus, etc are certainly (specific) hazards

As per the above and previous post, the (Codex) meaning of "risk" is a little more complicated in that it usually involves probability / multiple variables. A variety of formulae for quantifying risk can be found in the literature in addition to various qualitative (high, low etc) methods so that it can sometimes get quite confusing unless one is using a common reference base.

Dear MOM,

Some more Codex -

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Risk – A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Thanks, that was what I was trying to say put much better.