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Last updated on 2024年11月14日

What are the differences between FMEA and Hazard Analysis and Critical Control Points (HACCP)?

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If you are involved in quality management, you may have encountered two methods for identifying and preventing potential failures or hazards in a process or product: FMEA and HACCP. But what are the differences between these two approaches, and how can you choose the best one for your situation? In this article, you will learn about the main features, benefits, and limitations of FMEA and HACCP, as well as some examples of how they are applied in different industries.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality…
Jahirul Haque

Senior Executive - QA, at Hohenstein Laboratories Bangladesh Limited
Abubakar Ibrahim Garba

Consultant |FSSC 22000 | ISO standards | SAP Trainer | Data Analyst (SPSS, JMP, MiniTab)| Food Scientist | Nutrition…

1 What is FMEA?

FMEA stands for Failure Mode and Effects Analysis. It is a systematic technique for analyzing the possible ways that a process or product can fail, and the effects of those failures on the performance, safety, or quality of the output. FMEA also helps to prioritize the risks and determine the actions needed to reduce or eliminate them. FMEA can be applied at different stages of the design, development, or operation of a process or product, and it can be classified into three types: Design FMEA, Process FMEA, and System FMEA.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality Management Voice I Top Team Management Voice I Lead Trainer I Validation Project Management
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FMEA is the tools of Quality Risk Management. It is mainly used to analyze the risk of process, facilities, system. According to update regulatory guideline, FMEA is the popular and effective method of Quality Risk analysis. It is applicable for Proactive analysis of Process/facilities/system failure, taking control measures and mitigation plan the failure through RCA and CAPA managment.

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2 What is HACCP?

HACCP stands for Hazard Analysis and Critical Control Points. It is a preventive approach for ensuring the safety and quality of food products by identifying and controlling the biological, chemical, or physical hazards that can cause harm to consumers. HACCP involves seven principles: conducting a hazard analysis, identifying the critical control points, establishing the critical limits, monitoring the critical control points, taking corrective actions, verifying the effectiveness of the system, and keeping records. HACCP is widely used in the food industry, as well as in other sectors such as pharmaceuticals, cosmetics, and water treatment.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality Management Voice I Top Team Management Voice I Lead Trainer I Validation Project Management
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HACCP is a systematic, proactive and preventive tools. It is mainly used for assessment of product quality. It is a structural approach. Few steps of HACCP are mentioned below : 1. Determination of Hazard analysis and CAPA 2. Determination of Critical Control Point 3. Set up critical specification 4. Set up system to monitor CCP 5. Mitigation of control points 6. Verification 7. Recording keeping system

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3 How are FMEA and HACCP different?

FMEA and HACCP share similarities in being proactive, systematic, and team-based methods for identifying and managing risks. However, they also have some key differences. FMEA focuses on all possible failures and their effects, while HACCP is tailored to specific hazards and their prevention. Moreover, FMEA uses a numerical scale to rank the severity, occurrence, and detection of failures, while HACCP employs a qualitative approach to determine the criticality of hazards. Additionally, FMEA can be applied to any process or product, whereas HACCP is mainly used for food safety and quality. Furthermore, FMEA is more flexible and adaptable compared to HACCP which is more standardized and regulated.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality Management Voice I Top Team Management Voice I Lead Trainer I Validation Project Management
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Determination of difference between FMEA and HACCP can be done on the basis of few points: FMEA : 1. FMEA is used for Risk analysis of Potential Failure of Process performance 2. It is the powerful tools to detect the important mode of failures, causing of failure and effect of failures HACCP 1. HACCP is used for determination of Hazard analysis 2. Systematic application of Risk of Quality parameters 3. Determination of critical control points. Basically FMEA can detect failure mode, cause and effect and HACCP can detect Hazard and critical control point of product performance

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4 How to choose between FMEA and HACCP?

When deciding between FMEA and HACCP, several factors should be taken into account. The nature and scope of the process or product is essential; if it is complex or innovative, FMEA may be more suitable, while if it is food-related and has specific hazards and regulatory requirements, HACCP may be more appropriate. Additionally, the purpose and objectives of the analysis should be considered; if you want to improve the reliability, performance, or quality of your process or product, FMEA may be more helpful. Lastly, the resources and expertise available should be assessed; if you have enough time, money, and skills to conduct a comprehensive and quantitative analysis, FMEA may be more feasible. Ultimately, the choice between FMEA and HACCP depends on a variety of factors.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality Management Voice I Top Team Management Voice I Lead Trainer I Validation Project Management
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FMEA is applicable for Process failure. So it shall be used before proactive risk analysis on the basis of failure mode. HACCP is applicable for product performance and effect on outcome.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality Management Voice I Top Team Management Voice I Lead Trainer I Validation Project Management
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FMEA is robust tools to find out multiple risk factors. It helps to reduce process error. With cross- functional team, much more risk may reduce for high definition factor process. Through process mapping, hazard may identify. From Hazard analysis, risk can analyze, assessed and finally risk recommendations for mitigation and risk reviews plan shall be set up according to risk criteria.

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5 Examples of FMEA and HACCP

To illustrate the differences between FMEA and HACCP, here are some examples of how they are applied in different industries. FMEA is used in the automotive industry to identify and prevent the failures that can affect vehicle performance, safety, or customer satisfaction. For instance, a Design FMEA can analyze potential engine design failures, such as overheating, noise, or vibration, and their effects on fuel efficiency, emissions, or durability. Additionally, a Process FMEA can analyze potential manufacturing process failures, such as defects, errors, or delays, and their effects on quality, cost, or delivery. On the other hand, HACCP is used in the food industry to identify and control hazards that can affect food safety and quality. For example, a HACCP plan can analyze potential hazards of a meat processing plant, such as bacteria, toxins, or foreign objects. It can also establish critical limits, monitoring procedures, corrective actions, verification methods, and record-keeping practices for the plant.

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Md Mainul Hoque

Manager Validation @ Opsonin Pharma Ltd | Master of Science, Microbiology I Six Sigma Black Belt I LinkedIn Top Quality Management Voice I Top Team Management Voice I Lead Trainer I Validation Project Management
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FMEA examples : 1. Product processing eg. Granulation, compression and coating stage failure mode analysis 2. Sterilization process failure, cause and effect 3. HVAC system failure mode analysis, 4. Aseptic processing failure mode, cause and contamination control 5. Cleanroom qualification failure mode HACCP : 1. Hazard of Product performance 2. Critical control points of critical equipment 3. Determination of Critical Process parameters and CAPA 4. Determination of hot spot of Thermal Mapping of warehouse 5. Determination of Cold spot of Sterilization

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Jahirul Haque

Senior Executive - QA, at Hohenstein Laboratories Bangladesh Limited
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Failure Mode and Effect Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP) are both systematic methodologies used in different industries to manage and mitigate risks, but they have distinct differences. FMEA is a proactive approach primarily employed in engineering and product development. FMEA aims to prevent failures or defects by addressing potential issues before they occur. While both FMEA and HACCP are risk management tools, FMEA is more widely applicable across industries and addresses various types of failures, whereas HACCP is specifically tailored for the food industry, concentrating on the prevention of hazards related to food safety.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Abubakar Ibrahim Garba

Consultant |FSSC 22000 | ISO standards | SAP Trainer | Data Analyst (SPSS, JMP, MiniTab)| Food Scientist | Nutrition Expert | SDGs Champion | Quality Assurance Specialist | Project Manager | Research Enthusiast
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HACCP is more proactive as such give quality control officer more rapid control of hazard as all critical points were already identified and documented together with their critical points. Some HACCP systems are proactive that is they are made in the way that control systems are made available that can detect and address the problem at hand FME in a large system can not work effectively

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What are the differences between FMEA and Hazard Analysis and Critical Control Points (HACCP)?

1

2

3

4

5

6

1 What is FMEA?

2 What is HACCP?

3 How are FMEA and HACCP different?

4 How to choose between FMEA and HACCP?

5 Examples of FMEA and HACCP

6 Here’s what else to consider

Quality Management

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What are the differences between FMEA and Hazard Analysis and Critical Control Points (HACCP)?

1

2

3

4

5

6

1 What is FMEA?

2 What is HACCP?

3 How are FMEA and HACCP different?

4 How to choose between FMEA and HACCP?

5 Examples of FMEA and HACCP

6 Here’s what else to consider

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