******** Published in August 2, 2017 ********
With this course, you will be able to perform, at any level of detail and complexity, a complete Failure Mode and Effect Analysis, Criticality Analysis and Matrix, mastering indexes like Risk, Risk Priority Number, Failure Mode Failure Rate, etc.
Risk Management is an extremely fascinating field, since it helps in foresee and manage hazards and probabilities thereof.
Nowadays, this disciplines is widely used in many fields, and sometimes also required by the legislation. The most common use of risk management are:
- risk evaluation in product design, e.g. during medical devices and machinery design
- financial risk evaluation
- safety on workplace risk assessment
- design and processes in automotive and aerospace
- risk evaluation during potentially hazardous processes, like food production, and so on
- risk evaluation in project management
- process control techniques, e.g. six sigma
We may resort to many different techniques for risk evaluation, however, the most widely used and accepted, is FMEA/FMECA, i.e. Failure Modes, Effects and Criticality Analysis.
This methodology follows a bottom-up approach, and starting from the failure of a component (or a phase if we are talking about a process), estimates the final effect and evaluates it consequences. Even if it seems easy to understand at a first sight because of its intuitive concept, actually, performing it thoroughly is not an easy matter, especially if you consider that, the FMEA/FMECA documentation often has a legal value, since you may be asked by the court in case of accidents to show it, in order to prove your design or process was performed with the user safety in mind.
+++++ Have a look at the course curriculum and at the intro lesson +++++
In this course we will study both FMEA and the Criticality Analysis, starting from the basic qualitative analysis to the more complex quantitative criticality analysis (and its representation with the criticality matrix) using modal failure rates, and effect conditional probability.
There are many version of FMEA/FMECA, and in order to provide the most useful and valuable learning experience to you, we will use as a reference the International Standards IEC 60812, "Analysis techniques for reliability - Procedure for failure mode and effects analysis (FMEA)" .
However, this standard cover very effectively only FMEA and the qualitative and semi-quantitative FMECA, not providing much details on quantitative criticality analysis. Therefore, for the latter methodology, I will refer to the methodology borrowed from the US military Standard MIL-STD-1629, which provide a very accurate numerical methodology for the criticality calculation.
Which are also the approaches I use in my professional activity.
In the course, we will also talk about of Process FMEA, PFMEA, with a simplified example on a cooking process, and of Design FMEA, DFMEA. We will provide various example, on electric toys, cooking process and various components. However you will get the most from the course if you work in the design field, in particular product design or electronic design, and you will find many examples in it.
HAVE A LOOK AT THE LESSONS AVAILABLE FOR FREE IN THE COURSE CURRICULUM !!!
As we said, FMEA/FMECA are very versatile tools, therefore, once learned its concepts, it will be easy to transfer it to other fields, therefore even if you are not exactly in the product development or electronics field, you will earn valuable information and concepts from this course.
At the end of the course, you will be able to perform, at any level of detail and complexity, a complete Failure Mode and Effect Analysis, and a Criticality Analysis.
In this lesson we will talk about the functional approach to FMEA/FMECA.
In this lesson we will talk about the hardware functional approach to FMEA/FMECA, an alternative to the functional approach, but often used together in projects.
In this lesson we will explain the bottom-up approach, how to proceed during the analysis, and how, a same event, may be seen as a Failure Cause, Failure Mode or Failure Effect, depending on the indenture level and on the level of system analysis.
In this lesson we will start to talk about the FMEA worksheet, introducing the header and identification column.
In this lesson we will see the Failure Mode worksheet column, and how to identify failure modes.
In this lesson we will see the Failure Causes worksheet column and what to write in it.
In this lesson we will see the Failure Effect worksheet column and what to write in it, both local and final effects.
In this lesson we will see the Failure Compensating Measures worksheet column and what to write in it, both hardware and procedural measures.
In this lesson we will see the Detection Method worksheet column and what to write in it.
In this lesson we will see the Severity worksheet column and what to write in it. We will see the definition of severity and we will introduce a scale from I to IV.
In this lesson we will see the Probability of Occurrence worksheet column and what to write in it. We will introduce a scale from A to E.
In this lesson we will see the Remark worksheet column and what to write in it.
In this lesson we will see a flowchart on the complete FMEA procedure as an iteration process for each item and each failure mode.
In this lesson we will provide a FMEA example on an electronic toy, using the FMEA worksheet.
In this lesson we will provide a FMEA example on a power wheelchair, using the FMEA worksheet.
In this lesson we will provide a Process FMEA (PFMEA) example on a cooking process, using the FMEA worksheet.
In this lesson we will introduce FMECA.
In this lesson we will explain the qualitative approach and the probability classification.
In this lesson we will introduce the criticality matrix, and how it is made.
In this lesson we will explain how to read and use the criticality matrix as a tool for decision making.
In this lesson we will introduce the concept of Risk and Risk Priority Number, together with its function of prioritizing remedial and preventive action.
In this lesson we will provide an example of ranking scales from the automotive sector.
In this lesson we will talk of how to use the RPN for risk evaluation and remedial/preventive actions prioritization.
In this lesson we will use the previous example on Power Wheelchair FMEA, and we will enrich the analysis and the worksheet with the RPN.
In this lesson we will discuss the weaknesses of this semi-quantitative approach using the RPN.
In this lesson we will introduce the Failure Mode Ratio and its importance.
In this lesson we will see how to obtain the failure rate for a failure mode, starting from an item failure rate and its failure mode ratios.
In this lesson we will see the sources of the alpha values, in order to gather these information during the analysis.
In this lesson we will talk about the Failure Effect Probability and its meaning.
In this lesson we will see how to obtain, from the previous parameters, the criticality number both for a failure mode and for an item.
In this lesson we will see the criticality matrix obtained with reliability data (quantitative), and how to display information on it.
In this lesson we will see an example which displays the failure modes criticalities on the criticality matrix.
In this lesson we will see an example which displays the failure modes effects criticalities on the criticality matrix.
In this lesson we will see what the contents of a final FMEA/FMECA report should be.
In this lesson we will highlight the overall benefits of a FMEA/FMECA analisys.
In this lesson we will highlight the overall limitations and deficiencies of a FMEA/FMECA analisys.
Marco Catanossi lives and works in Italy. He has a MSc in electronics engineering and he is an expert in product safety and certifications, helping many companies from different countries to successfully put their product on the market. The Author has also experience as assessors on product safety on behalf of the Court of Justice and he is member of the European Union engineering panel for innovation projects evaluation. Since 2008, Marco has built a consulting business helping manufacturers from different fields (from medical devices to toys and garments) to meet regulatory and technical requirements worldwide. He is a dedicated professional with a high specialization in products safety (including electrical/electronics), a deep insight in product liability and a strong practical approach to product engineering and design.