Distinguish between QFD and FMECA
(p. 2)
Borth are carried out during the Design and Development Stage of a new product/service.
But the methodologies have different/complementary objectives:
QFD => supports the design of a new product/service, consistently with the Voice of the Customer (VoC)
FMECA => aims at ensuring the reliability of a new product/process/system.
Main Goal / Objective of FMECA
(p. 3)
developing a reliable entity (product, system, component, process…).
Definition Reliability
Reliability is the degree to which a generic entity performs specified functions, under specified conditions, for a specified period of time
Distinguish between Quality and Reliability
Quality => Satisfying needs
Reliability => Satisfying those needs over time
Describe (What is) FMECA
(p. 4)
Methodology to identify and analyze:
All potential failure modes of the various parts of a system
The effects these failures may have on the system,
How to avoid the failures, and/or mitigate the effects of the failures on the system.
Definition is FMECA
(p. 5)
Omdahl (1988) => FMECA is a technique used to identify, prioritize, and eliminate potential failures from the system, design or process before they reach customer
Sematech (1992) => FMECA is a technique to “resolve potential problems in a system before they occur
What does FMECA stands for
(p. 6)
Initially, the FMECA was called FMEA (today synonym)
FMEA => Failure Modes and Effects Analysis
The “C” remarks that failure modes are ranked based on their criticality
FMECA => Failure Modes Effects andcriticality Analysis
At which time of the product/system development FMCEA is used?
(p. 7, 12)
Should be initiated as early in the design process as possible
where we are able to have the greatest impact on the equipment reliability
A large part of the total costs are determined there
Lockin-costs are rouhgly 50% with the concept
From Pahse to Phase we have a *10 transmission of costs
Is usually performed during the conceptual and initial-design phases of the system
…in order to assure that all potential failure modes have been considered and the proper provisions have been made to eliminate these failures.
What are the purposes of FMECA
(p. 8, 9)
Assist in selecting design alternatives with high reliability and high safety potential during the early design phases.
Ensure that all conceivable failure modes and their effects on operational success of the system have been considered.
List potential failures and identify the severity of their effects.
Develop early criteria for test planning and requirements for test equipment.
Provide historical documentation for future reference to aid in analysis of field failures and consideration of design changes.
Provide a basis for maintenance planning.
Provide a basis for quantitative reliability and availability analyses.
What are the basic questions of FMECA
(p. 10)
How can each part conceivably fail?
What mechanisms (causes) might produce these modes of failure?
What could the effects be if the failures did occur?
Is the failure in the safe or unsafe direction?
How is the failure detected?
What inherent provisions are provided in the design to compensate for the failure?
Describe the FMECA-Team
(p. 11)
FMECA is carried out by a team of experts that includes individuals from different company functions and which collaborate from the beginning.
This aspect has a positive effect, since it encourages the internal collaboration between several divisions, within the same company.
What are possible Teammembers of FMECA
Project Manager
Design Engineer (hardware/software/systems)
Test Engineer
Reliability Engineer
Quality Engineer
Maintenance Engineer
Field Service Engineer
Manufacturing/Process Engineer
Safety Engineer
Name the two approaches for FMECA
(p. 15)
Bottom-up
Top-Down
Describe the following approaches for FMECA
It is used after the detailed-design phase.
Each component on the lowest level of the WBS/BOM is analysed individually.
The bottom–up approach is also called hardware approach.
The analysis is complete since all components are considered.
Top down
It is mainly used in an early-design phase, before the whole system structure is decided.
The analysis is usually function oriented. It starts with the main system functions – and how these may fail.
Functional failures with significant effects are usually prioritized.
The analysis will not necessarily be complete.
The top–down apprach may also be used on an existing system to focus on the most problematic parts.
According to the top-down approach
The analysis should be carried out on an as high level in the system hierarchy as possible.
If unacceptable consequences are discovered on this level of resolution, then the particular element (subsystem, sub-subsystem, or component) should be divided into further detail to identify failure modes and failure causes on a lower level.
What approach is better
(p. 16)
Starting from a low level (bottom-up approach) would provide a complete analysis, but at the same time be a waste of time and money!
Name the different FMECA Types
(p. 14)
Design FMECA
Process FMECA (P-FMECA)
System FMECA
Describe teh following FMECA Type
is carried out to eliminate failures during equipment design, taking into account all types of failures during the whole life-span of the equipment.
Process FMECA
(P-FMECA)
is focused on problems stemming from how the equipment is manufactured, maintained or operated.
looks for potential problems and bottlenecks in larger processes, such as entire production lines.
What are the main steps of FMCA
(p. 19)
Main Steps are
1) FMECA Prerequisites.
2) System Structure Analysis.
3) Failure Analysis and Preparation of FMECA Worksheets.
4) Team Review.
5) Corrective Actions
Steps 3, 4 & 5 are executed iterative
What ist the first step of FMCA
What ist the second step of FMCA
What ist the third step of FMCA
What ist the fourth step of FMCA
What ist the fivth step of FMCA
Describe the first step of FMECA
(1) FMECA Prerequisites
(p. 20, 21)
Define the system to be analyzed:
System boundaries (which parts should be included and which should not);
Main system missions and functions (including functional requirements);
Operational and environmental conditions to be considered
Note => Interfaces that cross the design boundary should be included in the analysis
Collect available information that describes the system to be analyzed
Collect information about previous and similar designs from internal and external sources
Which Informations should be collected the first step of FMECA
drawings
specifications
component lists,
functional descriptions
FRACAS (“Failure Reporting Analysis and Corrective Action System”, which is a methodology to keep track of all actual malfunctions of similar products/systems)
data
interviews with design personnel, operations and maintenance personnel, component suppliers
Describe the second step of FMECA
(2) System Structure Analysis.
(p. 22)
Divide the system into manageable units – tipically functional elements
To what level of detail we should break down the system will depend on the objective of the analysis
It is often desirable to illustrate the structure by a hierarchical tree diagram:
Describe the Worksheet of FMECA
(3) Failure Analysis and Preparation of FMECA Worksheets.
(p. 24)
A suitable FMECA worksheet for the analysis has to be decided
In many cases the client (customer) will have requirements to the worksheet format
for example to fit into his/her maintenance management system.
There is not a standard FMECA worksheet, but a sample covering the most relevant columns is given below:
Describe the thrid step of FMECA
The FMECA analysis starts with the decomposition of the product into subsystems.
Each subsystem is then decomposed into subcomponents.
For each element the analyst must consider all the functions of the elements in all its operational modes and ask if “any failure of the element may result in any unacceptable system effect”.
If the answer is NO => no further analysis of that element is necessary.
If the answer is YES => the element must be examined further.
Name the collumns of the simplified FMECA worksheet
(p. 25)
Unique Reference
Function
Operational Mode
Failure Mode
Effect
S
Faolure Causes
O
Detection System
D
RPN
Describe the first collumn of the simplified FMECA worksheet
(p. 26)
unique reference to an element (subsystem or component) is given
It may be a reference to an ID in a specific drawing, a so-called tag number, or the name of the element
Describe the 2. collumn of the simplified FMECA worksheet
(p. 27)
The functions of the element are listed.
It is important to list all functions
A checklist may be useful to secure that all functions are covered
Describe the 3. collumn of the simplified FMECA worksheet
(p. 28)
The various operational modes for the element are listed.
Example of operational modes are:
idle
standby
running
In applications where it is not relevant to distinguish between operational modes, this column may be omitted
Describe the 4. collumn of the simplified FMECA worksheet
(p. 29)
For each function and operational mode of an element the potential failure modes have to be identified and listed.
Note that a failure mode should be defined as a non-fulfillment of the functional requirements of the functions specified in column 2.
Describe the 5. collumn of the simplified FMECA worksheet
The effects each failure mode may have on other components in the same subsystem and on the subsystem as such (local effects) are listed
The effects each failure mode may have on the whole system (global effects) are listed. The resulting operational status of the system after the failure may also be recorded, that is, whether the system is functioning or not, or is switched over to another operational mode.
In some applications it may be beneficial to consider each category of effects separately, like: safety effects, environmental effects, production availability effects, economic effects, and so on.
Describe the 6. collumn of the simplified FMECA worksheet
The Severity (S) of a failure mode is the worst potential (but realistic) effect of the failure considered on the system level (the global effects)
The following severity classes for health and safety effects are sometimes adopted:
Describe the 7. collumn of the simplified FMECA worksheet
Failure causes
The failure modes identified in column 4 are studied one-by-one.
The failure mechanisms (e.g. corrosion, erosion, fatigue) that may produce or contribute to a failure mode are identified and listed.
Other possible causes of the failure mode should also be listed.
If may be beneficial to use a checklist to secure that all relevant causes are considered.
Describe the 8. collumn of the simplified FMECA worksheet
The Occurence (O)
Refers to the frequency a combination of failure mode & failure cause (more in general, «item») is likely to be
It is a natural number from 1 to 10 and it has negative connotation.
Describe the 9. collumn of the simplified FMECA worksheet
The various possibilities for detection of the identified failure modes (due to specific failure causes) are listed.
Some failure modes are evident, other are hidden.
The failure mode «fail to start» of a pump with operational mode «standby» is an example of a hidden failure.
Describe the 10. collumn of the simplified FMECA worksheet
(un)detectability (D)
indicator which ranks the likehood that a combination of failure cause & failure mode will be detected before the system reaches the end-user / customer.
It is a natural number from 1 to 10 and it has negative connotation
Distinglish between Failure mode, effect and causes
(p. 35, 36)
Failure mode => The way in which a system fails, or the way in which an equipment/machine failure occurs.
it focuses on the present
Each failure mode has one or more relevant causes.
It is better to avoid failures than to repair them.
Simpler designs are more effective in this respect than complex ones
Failure cause => describes why a failure happened
it focuses on the past
Failure effect => All about the consequences of the failure
it focuses on the future
Describe the fourth step of FMECA
(4) Team Review.
(p. 54)
The review team studies the FMECA worksheets, the risk matrices and the RPN.
The main objectives are:
To decide whether or not the system is acceptable
To identify feasible improvements of the system to reduce the risk.
If improvements are decided, FMECA worksheets have to be revised and the RPN should be updated.
Problem solving tools like brainstorming, flow charts, Pareto charts and nominal group technique may be useful during the review process.
How feasible improvements of the system to reduce the risk can be indentified
reducing the likelihood of occurrence of the failure (O)
reducing the effects of the failure (S)
increasing the likelihood that the failure is detected before the system reaches the end-user (D)
How can th risk related to the various failure modes be presented?
(p. 43)
The risk related to the various failure modes is often presented by a
Risk Priority Number (RPN)
Risk / Cirticality Matrix
The two tools are complementary
Describe the Risk Priority Number (RPN)
(p. 44, 45)
The RPN synthetically depicts the overall criticality of a generic combination of failure mode and failure cause.
The RPN has no clear meaning since:
How the ranks O, S, and D are defined depend on the application and the FMECA standard that is used
The O, S, D, and the RPN can have different meanings for each FMECA
Sharing numbers between companies and groups is very difficult
Formula Risk Priority Number (RPN)
(p. 44)
RPN= SOD
S = the rank of the severity of the failure mode,
O = the rank of the occurrence of the cause related to the failure mode,
D = the rank of the likehood the failure (when due to a specific cause) will be (un)detected before the system reaches the end-user/customer.
How can failure causes and failure modes can be prioritized
(p. 46)
based on the construction of the Pareto Chart. Here is an example:
Describe the Risk Matrix
(p. 47)
The risk associated to failure mode is a function of the frequency of the failure mode and the potential end effects (severity) of the failure mode.
The risk may be illustrated in a so-called Risk Matrix
Describe the fifth step of FMECA
(5) Corrective actions
(p. 55, 58)
Possible actions to correct the failure and restore the function or prevent serious consequences may also be listed in the worksheet.
Actions that are likely to reduce the frequency of the failure modes should also be recorded
An additional column in the worksheet could possibly be dedicated for recording pertinent information not included in the other columns.
The risk reduction related to a corrective action may be comparing the RPN for the initial and revised concept, respectively.
How can the risk reduced through Corrective actions
(p. 56)
Design changes to reduce the propensity to occur of failures (O)
Engineered safety features (S)
Safety devices (S)
Warning devices (D)
Procedures / Training.
Name application areas of the FMECA
(p. 57)
Design engineering (trough Desgin-FMECA)
The FMECA worksheets are used to identify and correct potential design related problems.
Manufacturing (trhough Porcess FMECA)
The FMECA worksheets may be used as input to optimize production, acceptance testing, etc.
Maintenance planning
The FMECA worksheets are used as an important input to maintenance planning – for example, as part of reliability centered maintenance (RCM). Maintenance related problems may be identified and corrected.
Name pros of using FMCA
(p. 62)
FMECA is a very structured and reliable method for evaluating hardware and systems.
The concept and application are easy to learn, even by a novice.
The approach makes evaluating even complex systems easy to do.
Name cons of using FMCA
The FMECA process may be tedious, time-consuming (and expensive)
The approach is not suitable for multiple failures
Possible omission of failure modes/causes in the analysis (human errors).
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