F O R M 2

THE PATENT ACT, 1970

(39 of 1970)

&
The Patent Rules, 2003

COMPLETE SPECIFICATION

(See section 10: rule 13)

1. Title of the invention. – FMEA ASSESSMENT AND CORRECTION
METHOD AND KIT

2. Applicant(s)

(a) NAME : LARSEN &TOUBRO LIMITED

(b) NATIONALITY : An Indian Company

(c) ADDRESS : L & T House, Ballard Estate, Mumbai 400 001,
State of Maharashtra, India

3. PREAMBLE TO THE DESCRIPTION

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF THE INVENTION
The present invention relates to a method for assessing and correcting various potential failure modes and their causes and effects in failure mode and effect analysis and particularly relates to a process and a quality assurance kit for testing and ensuring reliability and quality in manufacturing processes and equipments.
BACKGROUND AND PRIOR ART
The increasing competition forces manufacturers, suppliers, inventory managers and virtually all entities in business to ensure that their products, processes, supply chain etc. are dynamic enough to quickly identify and evaluate product or process failures, review the same and immediately undertake remedial measures. In ensuring the smooth flow of activities, it is imperative to design systems that maintain certain minimum standards of quality. The marketability of a product directly depends as much upon their quality as upon the economic benefits accruing there from. It will be appreciated that although the same product from different parties may be available at the same cost, yet the marketability is severely dependent on the quality certifications like ISO, SEI - CMM etc. Thus, business entities need to continuously implement quality in every aspect of the manufacture and to adopt the best manufacturing practices. After implementation of the quality standards, they also need to monitor and evaluate the same using quality tools.
The most appreciated technique used in the art for preventing faults and errors in the design and manufacture is Failure Mode and Effect Analysis, commonly abbreviated as FMEA. It is a requirement mentioned in ISO / TS 16949:2002 and its procedure is mentioned in standards like MIL-STD 1629, SAE J1739, SAE ARP 5580 and I EC 60812. It is believed that Failure Mode Effect Analysis was invented by NASA early in the US Apollo space program to alleviate the stress between two conflicting mottos; "failure is not an option" and "perfect is the enemy of good". The first meant successfully completing the mission and returning the crew. The second meant that failure of at least some components was unavoidable, the job was to predict them, prevent them when possible, plan for them, and build in the ability to overcome failures. The currently used FMEA technique first identifies possible weakness areas in a product or a process, ranks them in a predetermined manner in accordance with a predetermined list, determines the overall risk factor associated with the stated product or process, directs the user to
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take a predetermined remedial action and documents the events for future feedback and retrieval. It is intended to be a preventive measure carried out before implementing or carrying out modifications therein, in a new product or process. Therefore, FMEA is conducted in the product design or process development stages, although conducting it on existing products and/or processes may also expectedly yield benefits.
The FMEA technique is divided into two major divisions, the Design FMEA (DFMEA), which is used by the design personnel and the Process FMEA (PFMEA), used by the manufacturing personnel. The primary purpose intended to be solved by FMEA is to analyze the design characteristics of the manufacturing process to ensure that the resultant product meets the customer expectations. The FMEA technique enables identifying potential failure modes and directs corrective actions to be taken, according to a predetermined manual, to eliminate or reduce the potential for occurrence. The technique further includes a critical analysis of potential failure modes of the product or the process, identifies possible causes and directs further corrective actions to be taken. The technique involves multiplying the occurrence and detection probabilities with the severity criteria of a potential failure mode to determine a risk priority number. The said technique is adapted to trigger predetermined corrective measures when the determined risk priority number reaches a predefined level. Although the FMEA analyses vary according to the end usage and the intended application thereof, the target of every analyses is to ensure reliability into the product or the process.
Therefore, FMEA used within this specification, may be defined as a process to recognize and evaluate the potential failure of a product or a process and to identify actions which could eliminate or reduce the probabilities of future occurrence of failures. The technique further includes documentation of the said process. A failure is any event that is contrary to the expectations. These tools are used to ensure that potential failure modes and their associated causes have been considered and addressed in the design or manufacturing process.
The DFMEA tool supports the design process in reducing risk of failures by ensuring that the probability of occurrence of potential failure modes and their effects on system and product operation are already considered in the design and development process. It provides an objective evaluation of design requirements and possible alternatives available to meet the stated requirements, by inter-alia, facilitating the design for
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manufacturing and assembly. The documentation step in the DFMEA tool provides additional information to aid in the planning of efficient design testing and product developments protocols and also provides future reference to aid in analyzing field concerns, evaluating design changes and developing advanced designs. It also provides a list of potential failure modes ranked according to their effect on the customer, thereby helping in establishing a priority system for design improvement and development testing. It also provides an open issues format for recommending and tracking risk-reducing actions.
The process FMEA (PFMEA) tool identifies potential product related failure modes, assesses the potential customer effects of the failures, develops a ranked list of potential failure modes thereby establishing a priority system for corrective action considerations. It also identifies the potential manufacturing or assembly process causes, identifies the process parameters and variables requiring a focused control for occurrence reduction or the detection of failure conditions. An essential integer of the PFMEA tool is the documentation of the results obtained by the manufacturing or the assembly process appraisal. The benefits achieved by PFMEA appraisal include enhancement of the design and manufacturing efficiencies, alleviating late changes crises, minimizing exposure to product failures and most importantly, adds to the customer satisfaction and the associated brand loyalty.
In the FMEA tools currently in vogue, the performance, reliability, safety and manufacturability of the product is analyzed by the failure possibilities such as severity (S), detectability (D) and occurrence (O).
S is an assessment of the seriousness of the effect of the potential failure mode, which is estimated on a 1 to 10 scale. The severity evaluation criterion is generally followed according to the following manual.
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Effect Criteria: SEVERITY of Effect Ranking
Hazardous-withoutwarning Very high severity ranking when a potential failure mode affects safe operation and/or involves noncompliance with regulations without warning. 10
Hazardous-with warning Very high severity ranking when a potential failure mode affects safe operation and/or involves noncompliance with regulations with warning. 9
Very high Product/item inoperable, with loss of primary function. 8
High Product/item operable, but at reduced level of performance. Customer dissatisfied. 7
Moderate Product/item operable, but may cause rework/repair and/or damage to equipment. 6
Low Product/item operable, but may cause slight inconvenience to related operations. 5
Very Low Product/item operable, but possesses some defects (aesthetic and otherwise) noticeable to most customers. 4
Minor Product/item operable, but may possess some defects noticeable by discriminating customers. 3
Very Minor Product/item operable, but is in noncompliance with company policy. 2
None No effect. 1
O is the assessment of the likelihood of the occurrence of a specific cause or mechanism, which is estimated on a 1 to 10 scale. The occurrence evaluation criterion is generally followed according to the following manual.
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Probability of Failure Possible Failure Rates Ranking
Very High: Failure is almost inevitable 1 in 2 10
1 in 3 9
High: Repeated Failures 1 in 8 8
1 in 20 7
Moderate: Occasional Failures 1 in 80 6
1 in 400 5
1 in 2,000 4
Low: Relatively Few Failures 1 in 15,000 3
1 in 150,000 2
Remote: Failure is Unlikely 1 in 1,500,000 1
D represents an assessment of the ability of a proposed design control to detect a subsequent failure mode before the manufactured component or system or a subsystem is released for production, which is again estimated on a 1 to 10 scale. The detectability evaluation criterion is generally followed according to the following manual.

Detection Criteria: Likelihood of DETECTION by Design Control Ranking
Absolute Uncertainty Design Control will not and/or can not detect a potential cause/mechanism and subsequent failure mode; or there is no Design Control. 10
Very Remote Very remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 9
Remote Remote chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 8
Very Low Very low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 7
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Low Low chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 6
Moderate Moderate chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 5
Moderately High Moderately high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 4
High High chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 3
Very High Very high chance the Design Control will detect a potential cause/mechanism and subsequent failure mode. 2
Almost Certain Design Control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 1
Subsequent to the evaluation of S, 0 and D, a risk priority number (RPN) is determined by multiplying the severity (S), occurrence (O) and detectability (D) rankings. The determined RPN is therefore a measure of design risk and is estimated on a scale of 1 to 1000. e.g. A severity ranking of 2, occurrence ranking of 3 and detectability of 4 results in RPN 24. The subsequent step in the FMEA consists of arranging all the possible failure modes in order of increasing or decreasing risk priority numbers. The risk priority numbers so arranged facilitates directing the corrective action to the highest ranked failures and other critical items revealed during the evaluation. The intent of any recommended action is to reduce any or all of the severity, occurrence and detection rankings.
However, there are many problems, which severely prejudice the benefits accruing from implementation of such quality tools.
The risk priority number scale ranges from 1 to 1000, but it is not continuous as there are several holes in the scale. These holes result from its inherent limitation that some numbers can never actually occur on the scale e.g. all prime numbers greater than 10. Another possible limitation is that even if one of the S, O or D ranks is an even number, the resulting risk priority number can never be an odd number. In such a case, half of the
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scale is rendered virtually useless. John B Bowles, An assessment of RPN Prioritization on a Failure Mode Effects and Criticality Analysis, 2003 Proceedings Annual Reliability and Maintainability Symposium, 2003 IEEE teaches that 88 percent of the currently used RPN scale is empty and the remaining values are duplicated and dumped in a smaller range, which ultimately leads to confusion. The following table illustrates the difficulties faced in using the currently available risk priority number systems.

Severity Occurrence Detectability RPN
10 10 1 100
1 10 10 100
10 1 10 100
2 10 5 100
2 5 10 100
5 10 2 100
5 2 10 100
5 5 4 100
4 5 5 100
5 4 5 100
As is evident from the above table, some scale values are repeated with greater frequency. For example, RPN 120 and 72 may repeat 24 times with various combination of numerals. Similarly, 24, 36, 40, 48, 60, 80 and 90 occur 21 times with SOD combinations. John B Bowles, An assessment of RPN Prioritization on a Failure Mode Effects and Criticality Analysis, 2003 Proceedings Annual Reliability and Maintainability Symposium, 2003 IEEE acknowledges that scale values repeated more than 20 times in the current RPN scale is very undesirable. A further dilemma with such a scaling system is that the interchange of the values between severity, occurrence and detectability does not affect the RPN value. In the first three rows in the table illustrated above, interchange of values 1 and 10 between the various failure modes has no impact on the RPN value. The scale therefore does not reflect the practical situation where some of the failure modes may be more critical than the others. More importantly, the final RPN value does not reflect whether actually the process is implemented or the design of the process has been modified and so on. A further problem associated with the use of RPN system as described above is that after the actual implementation of a corrective measure in response to a particular failure mode, it is practically impossible to predict the S, O and D values based on a given RPN value for possible future reference. While the stated limitation may creep in due to improper documentation procedures in practice, the limitation almost always also results due to multiple duplication of the scale. To ascertain
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the accurate cause that triggered the particular response, it will be imperative to repeat the entire process to locate the exact cause of the trigger, which is invariably a time consuming process adversely affecting the quality management procedure.
The FMEA technique herein described is basically based on three particular failure modes, which are the severity of the failure (S), the number of occurrences of the failure (O) and the probability of detection of the failure (D). These failure modes are inherently different from each other and their individual contribution to a particular trigger may not be equivalent. A possible scenario is that a particular withdrawal of a product may be entirely due to the severity of the failure (which may be 10), but the occurrence and detectability parameters may be 1, which leads to a RPN value of 10 only, which may not trigger a response. The herein described RPN methodology does not give priority to either of severity, occurrence and detectability, but simply multiplies the rank values to determine the risk priority number treating them all similarly. It will be appreciated that these three failure modes are inherently different, each contributing differently to a given failure. Therefore, it is imperative that a proper failure risk model should be based on a specified priority. A person skilled in the art will appreciate that in fatigue and creep problems where failures occur suddenly, the detectability of failure is less while the severity is more. It is therefore imperative in such a situation to assign a higher priority to the severity than the detectability, which is not possible using the conventional RPN methodology.
US 6909994, which is incorporated herein by reference in its entirety, teaches a method for performing failure mode and effect analysis throughout the product life cycle. The method comprises receiving incident data from a requestor, said incident data including a requestor product and a requestor failure mode. A shared FMEA database is accessed triggered by the request and searched for an existing entry that includes the incident data, the contents thereof are transmitted to the requestor in response.
US 5586252, which is incorporated herein by reference, in its entirety, teaches and claims a combination of group-ware, data bases, bridge programs and report generators to configure RAM in a network of workstations in a meeting room to manage prompting members, recording responses, reaching consensus and documenting results. The method and system taught herein again suffers from the aforesaid disadvantages of using the conventional risk priority numbers.
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Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that facilitates in the shortening of product development time and thereby confers the first mover advantage upon the party using the process.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that ensures successful development of new products.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that increases quality consciousness or problem consciousness among the employees of a company.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that provides an improved information feedback relating to a particular product or a process.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that is simple to implement and does not require any employee training programs.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that casts a favorable impact on product and manufacturing schedules.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that reduces the sudden financial impact required to upgrade design, manufacturing and process equipments and tools.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that implements a String risk priority number (String RPN) value scale, which is devoid of any holes.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that implements a String risk priority number (String RPN) value scale which avoids duplication of values in the
11

scale, as well as avoids dumping the risk failure values in a smaller range thereby avoiding confusion in implementing the quality programs in a company.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that implements a String risk priority number (RPN) value scale where the risk failure value is automatically altered by altering the criticality of severity, occurrence and detectability and therefore closely reflects the practical situation.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that implements a String risk priority number (String RPN) value scale that facilitates the possibility to predict the values of severity, occurrence and detectability of a particular failure mode based on a given risk failure value after the actual implementation of the corrective measure in response to the said failure mode.
Yet another object of the present invention is to provide a process for analyzing faults and failures in the design of an industrial process or a product that implements a String risk priority number (String RPN) value scale that is based on a predetermined priority among the severity, occurrence and detectability of a particular failure mode.
Yet another object of the present invention is to provide a process and a quality assessment kit for analyzing and correcting faults and failures in the design of an industrial process or a product that implements a String risk priority number (String RPN) value scale which avoids interchangeability of values in the scale and sensitivity of values in the said scale thereby avoiding confusion in implementing the quality programs in a company.
SUMMARY OF THE INVENTION
According to an aspect, the present invention provides a process for analyzing faults and failures in the design of an industrial process or product comprising:
(a) identifying the scope and function of the product or the process to be analyzed ;
(b) creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) identifying all possible modes of failure of the said identified product or process;
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(d) determining the likely effect of each failure identified;
(e) developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure; and
(f) determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability: as a string in a predetermined priority sequence.
According to an aspect, the present invention provides a method for analyzing faults and failures in the design of an industrial process or product comprising:
(a) a computer implemented means and/or module for identifying the scope and function of the product or the process to be analyzed ;
(b) a computer implemented means and/or module for creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) a computer implemented means and/or module for identifying all possible modes of failure of the said identified product or process;
(d) a computer implemented means and/or module for determining the likely effect of each failure said identified;
(e) a computer implemented means and/or module for developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure; and
(f) a computer implemented means and/or module for determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence.
In another aspect, the present invention relates to a quality assessment kit comprising:
(a) a list including information identifying the scope and function of the product or the process to be analyzed;
(b) a multi-column spreadsheet, said columns labeled according to predetermined criteria;
(c) a list identifying all possible modes of failure of said identified product or process;
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(d) a list including the relative values for assumed frequency of occurrence, the severity of failure and the likelihood of identifying said failure; and
(e) a list including the risk failure values, said risk failure values being determined by placing the said values, developed for the severity, occurrence and detectability of said identified mode of failure, as a string in a predetermined priority sequence.
According to an aspect, the present invention provides a process for analyzing and correcting faults and failures in the design of an industrial process or product comprising:
(a) identifying the scope and function of the product or the process to be analyzed ;
(b) creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) identifying all possible modes of failure of the said identified product or process;
(d) determining the likely effect of each failure identified;
(e) developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure;
(f) determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence;
(g) identifying remedies for the identified failure modes;
(h) prioritizing the identified remedial actions in a predetermined sequence based on
the said determined risk factor values;
(h) documenting and validating each remedial action taken; and
(j) verifying that the performed remedial action is continuing at a predetermined
time.
According to an aspect, the present invention provides a method for analyzing and correcting faults and failures in the design of an industrial process or product comprising:
(a) a computer implemented means and/or module for identifying the scope and function of the product or the process to be analyzed ;
(b) a computer implemented means and/or module for creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) a computer implemented means and/or module for identifying all possible modes of failure of the said identified product or process;
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(d) a computer implemented means and/or module for determining the likely effect of each failure identified;
(e) a computer implemented means and/or module for developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure;
(f) a computer implemented means and/or module for determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence;
(g) a computer implemented means and/or module for identifying remedies for the identified failure modes;
(h) a computer implemented means and/or module for prioritizing the identified
remedial actions in a predetermined sequence based on the said determined risk
factor values;
(i) a computer implemented means and/or module for documenting and validating
each remedial action taken; and
(j) a computer implemented means and/or module for verifying that the performed
remedial action is continuing at a predetermined time.
In another aspect, the present invention relates to a quality assessment kit comprising:
(a) a list identifying the scope and function of the product or the process to be analyzed;
(b) a multi-column spreadsheet, said columns labeled according to predetermined criteria;
(c) a list identifying all possible modes of failure of said identified product or process;
(d) a list identifying each said identified failure mode;
(e) a list including the relative values for assumed frequency of occurrence, the severity of failure and the likelihood of identifying said failure;
(f) a list including the risk failure values, said risk failure values being determined by placing the said values, developed for the severity, occurrence and detectability of said identified mode of failure, as a string in a predetermined priority sequence; and
(g) a list identifying the remedies for the identified failure modes; and
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(h) a list including the remedial actions arranged in a predetermined sequence
based on the said determined risk failure values;
(i) a list including the documentation and validation of each of the remedial actions
taken; and
(j) a list including information relating to the verification of the performed remedial
action, said information further including information relating to the continuance
of the remedial action taken at a predetermined time.
DETAILED DESCRIPTION OF THE INVENTION
Unless otherwise stated, the term "failure mode" shall include a manner in which a component, system, sub-system or a process could fail to meet the desired intent or perform its desired function. The failure modes should be described in physical or technical terms. The preliminary step in such analysis is selection of the team members and formation of FMEA team responsible for implementing FMEA tools. The FMEA team trying to identify the possible failure may begin by posing questions as to how the process or the component may fail to meet the desired specifications or what defects would a customer consider objectionable. Representative examples of some typical keywords suggesting possible failure modes are short circuit, open circuit, crack, damage, loosened, bent, improper set up, fractured, oxidized, burned, leaking, deformed, worn and dirty. A particularly useful strategy would be compare the contemplated product or process with similar products and/or processes or a customer review may be conducted. It should always be born in mind that more than one or a multiple number of possible failure mode can result for a given product or a process. It may further happen that some failures may be gradual and/or partial, while others may occur completely and/or suddenly. A potential failure mode may also, for example, be the cause of a potential failure mode in a higher level sub-system, with the effects of the preceding failure mode either magnified or diminished in the subsequent failure mode. Identification of the potential failure modes may also be made with an assumption that the failure could occur but may not occur. Therefore, even potential failure modes, whose chances of occurring are very remote, should also be identified, e.g. a corroded battery case.
The first step in the process for analyzing and/or correcting faults and failures in the design of an industrial product or a process is identification of the scope and function of the process or product to be analyzed.
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The use of flow charts for analyzing process designs may be useful. A flowchart clearly identifying the various steps of a process or the various components of a product may be created. The process steps or the product design components may then be compiled into a list. In an embodiment of the invention, the said list may be generated using a computer implemented means and/or module in accordance with the methods and means described and taught in US 5586252 and US 6909994.
After the scope and the function of the product or the process to be analyzed has been identified, all potential failure modes need to be identified. In one aspect of the invention, there is provided a list comprising all potential failure modes identified for the product or the process identified in the previous step. The potential failure modes may include without being limited to
a) corrosion,
b) hydrogen embrittlement,
c) electrical short or open,
d) torque fatigue,
e) deformation,
f) cracking,
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g) yielding, and
h) buckling.



In another aspect, said list including the potential failure modes and identification thereof may be generated by a computer implemented means and/or module, which may be accomplished using the means and/or module generally known in the art or that taught in either of US 5586252 or US 6909994.
There are many statistical tools available in the art for the identification of potential failure modes, any one or more of which may be employed for an identified product or a process. Some of the statistical tools which may be employed are Pareto diagrams, cause- and-effect diagrams, histograms, control charts, graphs and checksheets.
(a) Pareto Diagrams help to classify various kinds of failure modes according to their causes. The potential failures are diagrammed according to their priority in a bar graph format, wherein 100% indicates total amounts of failures.
(b) Cause and Effect Diagrams are also known as "fishbone diagrams" in the art. These diagrams are used to analyze the characteristics of a product or a process and the factors that contribute to the potential failures, which may creep in. Any indication of a design weakness, the consequence of which may be a potential failure mode should be identified. The typical causes and/or mechanisms for the failure mode may be
i) Incorrect material specification.
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j) Inadequate design life assumption.
k) Inadequate maintenance instructions.
I) Yield stress.
m) Fatigue.
n) Material instability.
o) Wear.
p) Corrosion.
q) Improper torque applied.
r) Improper operating conditions.
s) Contamination.
t) Erroneous process steps.
u) Improper alignment.
v) Excessive loading.
w) Excessive voltage.
x) Improper tooling and fixtures.
y) Selection of wrong parts.
(c) Histograms represent the frequency data obtained from various measurements. They are usually observed to display a peak around certain values, which may be used to determine potential failures by checking the dispersion shape, center value and the nature of the dispersement.
(d) Control Charts are used to detect abnormal variations. Representative sample data defining potential failures are plotted to evaluate situations and trends in the identified product or the process. Thereafter, comparisons are made against the required control parameters to obtain information regarding the potential failure modes.
(e) Scatter Diagrams are used to plot a dependent variable against an independent variable to determine the correlation between the data and their possible consequences on the potential failure modes. The potential failure modes can thereby be identified and analyzed.
Apart from the statistical tools as described herein above, possibilities exist for situations wherein the required information regarding the product or process variables are not available, for example for a new product yet to be launched or in the development of a new process for manufacturing a known product. In situations like these, corresponding data from similar projects may be employed to predict and correct potential failure modes. In a project like these, generally experts from different technical fields sit together and chalk out the potential failure mode, generally by asking questions relating to the product or the process. Where the
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FMEA technique is being used in analyzing a product, the possible questions that may be set forth are:
1. Is there any waste in the material?
2. Is the quality standard adequate for the contemplated product?
3. Is the handling adequate?
4. Is the inventory level adequate?
5. Are there impurities mixed in?
6. Are there any mistakes in grade?
7. Are there any mistakes in volume?
Where the technique is employed to analyze a process, the possible questions that may be set forth are:
1. Are the work standards adequate?
2. Is the process a safe one?
3. Is it sufficient to ensure a good product?
4. Is it an efficient product?
5. Are the temperature, humidity and other conditions adequate?
6. Is the lighting adequate?
7. Is there adequate contact with the previous and the next processes?
Where the technique is employed to analyze a machine, the possible that may be set forth are:
1. Does it meet production requirements?
2. Does it meet process capabilities?
3. Does it meet precision requirements?
4. Is the layout adequate?
5. Are there enough machines/facilities?
6. Is everything in good working order?
7. Is the operation stopped often due to mechanical problems?
The questions posed above may be selected and identified by a team of experts selected for the implementation of the FMEA tools in a company. Accordingly, the process and the method of the present invention may additionally comprise a step of identifying team members from the resource pool available within an industry for implementing the required FMEA tool. Such a step would normally be the first step in the process and the method of the present invention, and are encompassed to lie within the scope of the present invention even when such a step is not explicitly stated so.
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All possible failure modes for a product or a process being analyzed that can introduce non-conformance in the identified product or process must be identified as a potential failure mode. A potential failure mode can be a cause associated in a downstream operation, or may be an effect in a previous upstream operation.
According to the present invention, identification of potential failure modes includes identification of the potential effects of the failure modes as well, which include the effects of the failure mode as perceived by the customer. In this context, the customer may include the next or subsequent operations or the end user or any intermediate user and/or operations.
After the potential failure modes have been identified and/or listed and/or generated using computer implemented means and/or module, the likely effect of each of the potential failure modes is determined.
A representative list of the likely effects of a hypothetical failure mode may be represented as follows:
(a) injury to the user,
(b) inoperability of the product or the process,
(c) improper appearance of the product or the process,
(d) odors,
(e) degraded performance,
(f) noise, and
(g) vibration.
In another aspect, the invention also provides a list comprising the likely effects of the potential failure modes said identified. In yet another aspect, the invention also provides a computer implemented means and/or module for determining the likely effect of each of the failure modes identified. Such a list may be generated using a means and/or module generally known in the art or according to that described in US 5586252 or US 6909994, which are incorporated herein in their entirety.
Thereafter, a consensus list of the relative values for the assumed frequency of occurrence, the severity of failure and the likelihood of detecting the failure is developed. Unless otherwise stated, the term "severity" used within this specification shall include an assessment of the seriousness of the effect of the potential failure mode. The term "severity" shall be understood to apply to effect only. A person skilled in the art is aware
21

that a reduction in the severity may only be effected by effecting a change in the design of the product or the process. According to the present invention, severity is estimated on a "0" to "9" scale. The estimation of severity of a particular failure mode according to the present invention may be made as hereunder.

Severity Effect Effect Rank
Very high severity ranking when a potential Hazardous without 9
failure mode affects safe product operation warning
and/or involves noncompliance with government
regulations without warming
Very high severity ranking when a potential Hazardous with warning 8
failure mode affects safe product operation
and/or involves noncompliance with government
regulations with warming
Product / item inoperable, with loss of primary Very High 7
function
Product / item operable, but at reduced level of High 6
performance. Customer dissatisfied
Product / item operable, but comfort / Moderate 5
convenience item(s) inoperable. Customer
experiences discomfort.
Product / item operable, but comfort / Low 4
convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
specifications. Defect noticed by discriminating
customers.
No effect None 0
The information classifying severity of a failure mode is intended to be used to identify any special process or product characteristics for components, their systems, subsystems, processes into particularly critical, key, major or significant categories that may require additional or focused controls to ensure the consistency of quality thereof, e.g. if a classification is identified in the process FMEA, the design personnel responsible there for is intimated since the identified failure may affect or prejudice the document
22

containing the control item identification. The potential causes or the mechanisms by which the identified failure mode may occur is also identified and listed and/or generated. The potential cause of the failure mode may include information identifying how the identified failure modes may occur, which could be described as being dependent on some parameter of the process or the product that may be controlled. It is important here to list to the maximum possible extent, every conceivable cause that is assignable to each identified failure mode. Typical failure causes may include, but are not limited to, inaccurate gauging, improper heat treating relating to the time or temperature, any component missing or dislocated.
Unless otherwise stated otherwise, the term "occurrence" used within this specification shall include the likelihood that a specific cause or mechanism of failure mode is expected to occur. According to the present invention, occurrence is measured on a scale of from 0 to 9. Therefore, correcting or controlling one or mode of the possible causes or mechanisms of the potential failure modes through a change in the design of the product or the process is a possible way to reduce the occurrence ranking of a particular failure mode. The estimation of occurrence of a particular failure mode according to the present invention may be made as hereunder.

Probability of failure Rate of occurrence Rank
Extremely high, bound to occur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur occasionally 1/100 5
1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
Unless otherwise stated, the term 'detectability' used within the specification shall include an assessment of the ability of the proposed process or product design controls to design a potential cause or mechanism of a failure mode or to detect a subsequent possible failure mode before the component, system, sub-system or process is released and/or approved for production. The detectability ranking, according to the present invention, is based on a scale of 0 to 9 depending upon the actual detection level. The

estimation of detectability of a particular failure mode according to the present invention may be made as hereunder.

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8
Remote Remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 7
Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
The term "process" used within the specification shall be construed to include any possible combination of (a) methods, (b) materials, (c) machine, (d) manpower, (e) environment, and (f) measurement to complete a predetermined task, such as producing a product or performing a service. A process has measurable input parameters and correspondingly measurable output.
In another aspect, the present invention provides a list including the relative values for the assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure. In yet another aspect, the present invention provides a computer implemented means and/or module for generating such a list, which may be generated

by means and/or methods generally known in the art or using the means and/or module such as the ones described in US 5586252 or US 6909994, which are incorporated herein in their entirety.
Thereafter, the failure risk value is determined from the said identified severity, occurrence and detectability values identified. The values developed for the severity, detectability and occurrence are placed as a string in a predetermined priority sequence to determine the failure risk value. There are no numerical operations to be performed on the S, 0 and D scales. The risk values according to the present invention continuously vary from 000 to 999. Hence the scale values according to the present invention are evenly distributed, continuous, easy to follow and linear as shown in the following table.
Assuming that the S, O and D values are S = 2, O = 3 and D = 4, the following table may be prepared depending upon the predetermined priority sequence of the scales.

S No. Priority sequence String risk priority number (String RPN) value according to the present invention
1 SOD 123
2 SDO 132
3 OSD 213
4 ODS 231
5 DOS 321
6 DSO 312
The priority sequence may be predetermined in a manner that best suits the process oi the product being analyzed. In another aspect of the invention, there is provided a list including the failure risk values determined from the severity, occurrence and deteactability values as in the above given table. In another aspect, the determination o the failure risk values may be performed by a computer implemented means and/o module, which is programmed to determine the failure risk values from the giver severity, occurrence and detectability values in a predetermined sequence.
In a preferred aspect of the invention, the severity of a particular failure mode is giver the first priority, followed by the occurrence, which is followed by the detectability value However, depending upon the possible failure mode, the priority sequence as aforesaid may be interchanged in any desired sequence.
25

In another aspect, the invention provides flexibility such that the String risk priority number (String RPN) value may not be sorted in an ascending or descending order, since the S, 0, and D values can be easily visualized. A glimpse of the string risk priority number (String RPN) can individually identify the corresponding severity, occurrence and detectability values.
In a further aspect of the invention, sorting, if required, may optionally be preformed individually for S, O and D through computer-implemented means. For example, the present invention may be adapted to sort only the string risk priority number (String RPN) values wherein the severity values are greater than a predetermined number, e.g. the string risk priority number values may be sorted wherein the severity value is greater than 5. In another aspect, the aforesaid sorting may be performed using the severity and/or occurrence and/or detectability values in isolation or in various possible combinations thereof.
Such variations in the priority sequence between the severity, detectability and occurrence of a particular failure mode are readily apparent skilled in the art and are therefore encompassed with the ambit and scope of the present invention.
An advantage of the present invention is that whereas the interchange of the values between the severity, occurrence and detectability does not affect the risk priority number values conventionally used within the art, such variations are adequately and apparently reflected in the string risk priority number (String RPN) value according to the present invention. For example, interchange of the values of 10 and 1 between various failure mode has no effect on the existing scale, whereas the risk failure value according to the present invention adequately reflects the variation.

26

Therefore, the risk failure number obtained by the existing scale is misleading in the sense that a particular failure cannot be traced back to underlying severity, occurrence or detectability of the failure, which is more important as the role of these possible failure modes in a failure is different. It is therefore desirable to distinguish role of the possible failure modes underlying a potential failure.
Another advantage of the present invention is that the String risk priority number (String RPN) value according to the present invention is less sensitive than the risk value number of the existing state of the art, which makes the process of the present system more reliable. Sensitivity refers to the response of the system for the small input changes. To compare the sensitivity of the risk priority numbers as conventionally used within the art vis-a-vis the String risk priority number (String RPN) value according to the present invention, the occurrence and detectability values are kept constant at the initial, middle and final stage of the scale to analyze the response of the system by varying the severity value.

Case Severity Occurrence Detectability Risk priority number calculated according to the existing method String risk priority number (String RPN) value according to the present invention
1 1 1 1 1 000
2 1 1 2 100
II 1 5 5 25 044
2 5 5 50 144
1 10 10 100 099
III 2 10 10 200 199
Case I
The occurrence (O) and detectability (D) values are kept constant at 1 and the severity (S) is increased from 1 to 2. Consequently, it is seen that the risk priority number is doubled.
27

Case II
The occurrence (O) and detectability (D) values are kept constant at 5 and the severity (S) is increased from 1 to 2. Consequently, it is seen that the risk priority number is doubled.
Case III
The occurrence (O) and detectability (D) values are kept constant at 10 and the severity (S) is increased from 1 to 2. Consequently, it is seen that the risk priority number is doubled.
In all of the above cases, the risk priority number, as conventionally used, are doubled wherein the corresponding risk failure value according to the present invention depends and varies with the level of the scale, which is desirable. The failure risk value according to the present invention is capable of assigning a predetermined priority to each of severity (S), occurrence (O) and detectability (D), which is not possible conventionally. Further, the conventional risk priority number sensitivity is as low as 1 at the initial stages and as high as 100 at the final stages. In the case II, the conventional risk priority numbers from 26 to 49 cannot be eliminated with different combinations of S, O and D values, thereby demonstrating that the conventional risk priority numbers are too sensitive. A process and a method that implements a less sensitive scale is certainly desirable.
In other aspect, the present invention also provides a process for analyzing and correcting faults and failures in the design of an industrial product or process. In this aspect, for each of the potential failure modes identified, certain remedies are identified. The remedial actions will vary from one failure mode to the other, and will be independently decided for each failure mode. In another aspect, the present invention provides a list including the corrective actions to be taken in response to a particular failure mode identified.
A representative list including, but not limiting to, the possible remedial actions for a potential failure mode is provided below.
(a) Specific inspection.
(b) Testing or quality procedures.
(c) Limiting environmental stresses or operating range.
28

(d) Redesign of the item to avoid the failure mode.
(e) Performing preventative maintenance.
In another aspect, the invention provides a computer implemented means and/or module for generating such a list, which may be generated by means and/or methods generally known in the art or as described in US 5586252 or US 6909994, which are incorporated herein in their entirety.
Thereafter, the identified remedial actions may be prioritized based on increasing failure risk values, such that failure modes having higher failure risk values will receive prioritized remedial action. In another aspect, the invention provides a list comprising the failure risk values arranged in a predetermined sequence, which facilitates identification of higher-ranking failure risk values. The failure risk as aforesaid may be arranged in either increasing or decreasing order, whereby the higher-ranking failure risk values may be determined and remedial actions corresponding to the same may be identified and taken. In another aspect, such predetermined arrangement of the failure risk values may be performed by a computer-implemented means and/or module, which may sort the inputted failure risk values in a predetermined sequence. The said means and/or module may further be adapted to display appropriate remedial actions to be taken for failure risk values having more than a threshold numerical value. Such means/or modules are generally known in the art or may be used in accordance with the disclosure of US 5586252 or US 6909994, which are incorporated herein in their entirety.
After the remedial actions have been taken, the documentation procedure follows. The documentation step is required to identify the process or product analyzed and corrected including the potential failure modes identified, determined S, O, and D values and the risk values, determining the remedial actions identified and taken. The documentation procedure keeps a record of all the happenings and persons and systems associated with the same, so that a potential failure mode in future, which has already been identified before may be easily identified and easily corrected. The documentation procedure confers the following advantages:
(a) Helps to understand the existing products and processes and evaluate their chances of success and failures.
(b) Helps to visualize how the existing products may be improved.
29

(c) Facilitates benchmarking of the existing product or process with the best manufacturing practices in the art.
The information which may be typically documented relating to a product or a process are:
(a) Information identifying the process, product or a system, component or a subsystem being analyzed.
(b) Information identifying the manufacturer or supplier responsible for the product/process design.
(c) Information identifying the personnel carrying out the documentation.
(d) Information identifying the customer or the person who is the recipient of the analysis of the faults and failures.
(e) Information identifying the target date when the analysis and correction was due completion.
(f) Information identifying the date of completion of the analysis and the next probable dates of re-analysis.
(g) Information identifying the core team responsible for carrying out the analysis and correction.
(h) Information identifying the FMEA number, which may be used for tracking and product and/or process identification that is being analyzed.
(i) Information identifying the design controls, which may include the prevention, validation, verification and other activities that assure design accuracy for the failure mode under analysis. The said information must include the features that prevent the failure mode from occurring and that decrease the probability of their occurrence, the cause and the mechanism of such failures, which indicate possible corrective actions, and detection of the failure mode being analyzed.
(j) Information identifying the recommended actions for an identified failure mode.
(k) The severity, occurrence and detectability values corresponding to an identified failure mode and the determined risk failure values.
The said documentation may include appropriately filling out the required information in a pre-printed request list. Accordingly, the present invention provides a list including said information relating to the documentation and validation of a failure mode and the corrective actions taken. In another aspect, the said documentation may be performed by a computer-implemented means and/or module programmed to be fed said
30

information and arranging the same in the predetermined format, which is adapted to be retrieved when required.
Thereafter, the product or the process said analyzed and corrected is monitored to ensure and verify that the performed remedial action is in continuation at predetermined intervals of time. Personnel may be made responsible for assuring that all the recommended remedial actions have been implemented and adequately addressed. In another aspect of the invention, such verification may be effected by means of a computer-implemented module, which is programmed to verify the remedial action at predetermined intervals of time. In another aspect, such verification may be carried out by personnel in accordance with pre-printed checklist.
DESCRIPTION OF THE DRAWINGS
Figure 1 demonstrates the frequencies of risk priority numbers for the scale conventionally used in the art. It demonstrates the problems with the existing risk priority number method, wherein the scale values are repeated/ duplicated for the various combinations of S, 0 and D values. The X - axis represents the risk priority number scale values conventionally used in the current state of the art and the Y - axis represents the frequency of the corresponding scale values. For example, the scale value 72 and 120 are repeated 24 times and the values 24, 36, 40, 48, 60, 80 and 90 occur 21 times.
The String risk priority number (String RPN) value analysis according to the present invention is capable applied directly in industries. More particularly, it can be implemented in any industry that relies upon the failure mode and effect analysis such as product, process and systems in automobile, aerospace, industrial products, packing industries and domestic appliances.
Figure 2 demonstrates the frequency of the String risk priority number (String RPN) value according to the present invention. It clearly demonstrates that the frequency of the String risk priority number (String RPN) value according to the present invention is clearly one i.e. the scale values from 000 to 999 occurs only once in the entire scale range. The present invention therefore clearly avoids duplication of scale values and holes therein.
31

Figure 3 demonstrates non-linearity of the scale conventionally used in the art.
The scale values of the conventional risk priority numbers are plotted on both the X and the Y - axis, whereby the curve obtained is not a linear one showing that the scale conventionally used in the art is non-linear.
Figure 4 demonstrates the linearity of the String risk priority number (String RPN) values according to the present invention. The scale values of the String risk priority number (String RPN) values according to the present invention are plotted on both the X and Y - axis whereby the curve obtained is exactly linear.
Fig 5 demonstrates a typical flowchart depicting the process steps for the FMEA analysis according to the present invention.
Table 1 illustrates a sample failure mode and effect analysis spreadsheet, which may be adjusted with minor modifications, for use in various industries.
Table 2 illustrates a sample failure mode and effect analysis spreadsheet for an air-conditioner that illustrates use of the String risk priority number (String RPN) values according to the present invention.
Table 3 illustrates a sample failure mode and effect analysis spreadsheet for an air-conditioner that illustrates use of the conventional risk priority number scale used within the state of the art.
32

WE CLAIM
1. A process for analyzing faults and failures in the design of an industrial process or product, said process comprising:
(a) identifying the scope and function of the product or the process to be analyzed ;
(b) creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) identifying all possible modes of failure of the said identified product or process;
(d) determining the likely effect of each failure identified;
(e) developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure; and
(f) determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence.
2. A process as claimed in claim 1, wherein said value for severity is determined according to the following table:

Severity Effect Effect Rank
Very high severity ranking when a potential Hazardous without 9
failure mode affects safe product operation warning
and/or involves noncompliance with government
regulations without warming
Very high severity ranking when a potential Hazardous with warning 8
failure mode affects safe product operation
and/or involves noncompliance with government
regulations with warming
Product / item inoperable, with loss of primary Very High 7
function
Product / item operable, but at reduced level of High 6
performance. Customer dissatisfied
Product / item operable, but comfort / Moderate 5
convenience item(s) inoperable. Customer
experiences discomfort.
33

Product / item operable, but comfort / Low 4
convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
specifications. Defect noticed by discriminating
customers.
No effect None 0
3. A process as claimed in claim 1 - 2, wherein said value of occurrence is determined according to the following table:

Probability of failure Rate of occurrence Rank
Extremely high, bound to occur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur occasionally 1/100 5
1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
4. A process as claimed in any preceding claim, wherein said value for detectability is determined according to the following table:

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8
Remote Remote chance the design control will 7

detect a potential cause/mechanism and subsequent failure mode
Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
5. A process as claimed in any preceding claim, wherein said developed values for severity, occurrence and detectability are placed as a string in a priority sequence such that the severity of a particular failure mode is given the first priority, followed by occurrence which is followed by detectability.
6. A process as claimed in any preceding claim, wherein the said identified remedial actions are prioritized based on increasing risk failure values such that identified failure modes having higher failure risk value receive prioritized remedial actions.
7. A method for analyzing faults and failures in the design of an industrial process or
product comprising:
(a) a computer implemented means and/or module for identifying the scope and function of the product or the process to be analyzed ;
(b) a computer implemented means and/or module for creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) a computer implemented means and/or module for identifying all possible modes of failure of the said identified product or process;
35

(d) a computer implemented means and/or module for determining the likely effect of each failure said identified;
(e) a computer implemented means and/or module for developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure; and
(f) a computer implemented means and/or module for determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence.
8. A method as claimed in claim 7, wherein the said value for severity is determined

Severity Effect Effect Rank
Very high severity ranking when a potential Hazardous without 9
failure mode affects safe product operation warning
and/or involves noncompliance with government
regulations without warming
Very high severity ranking when a potential Hazardous with warning 8
failure mode affects safe product operation
and/or involves noncompliance with government
regulations with warming
Product / item inoperable, with loss of primary Very High 7
function
Product / item operable, but at reduced level of High 6
performance. Customer dissatisfied
Product / item operable, but comfort / Moderate 5
convenience item(s) inoperable. Customer
experiences discomfort.
Product / item operable, but comfort / Low 4
convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
36

specifications. Defect noticed by discriminating customers.
No effect None 0
9. A method as claimed in any of the claims 7-8, wherein said value for occurrence is determined according to the following table:

Probability of failure Rate of occurrence Rank
Extremely high, bound to occur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur 1/100 5
occasionally 1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
10. A method as claimed in any preceding claim 7-9, wherein said value for detectability is determined according to the following .table:

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8
Remote Remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 7
Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent 2
37

failure mode
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
11. A method as claimed in any preceding claim 7-10, comprising placing said developed values for severity, occurrence and detectability are placed as a string in a priority sequence such that the severity of a particular failure mode is given the first priority, followed by occurrence which is followed by detectability.
12. A method as claimed in any preceding claims 7-11, wherein the said identified remedial actions are prioritized based on increasing risk failure values such that identified failure modes having higher failure risk value receive prioritized remedial actions.
13. A quality assessment kit comprising:
a. a list including information identifying the scope and function of the
product or the process to be analyzed;
b. a multi-column spreadsheet, said columns labeled according to
predetermined criteria;
c. a list identifying all possible modes of failure of said identified product or
process;
d. a list including the relative values for assumed frequency of occurrence,
the severity of failure and the likelihood of identifying said failure; and
e. a list including the risk failure values, said risk failure values being
determined by placing the said values, developed for the severity,
occurrence and detectability of said identified mode of failure, as a string
in a predetermined priority sequence.
14. A kit as claimed in claim 13, wherein said list for determining the severity value
includes the following table:

Severity Effect Effect Rank
Very high severity ranking when a potential failure mode affects safe product operation Hazardous warning without 9

and/or involves noncompliance with government regulations without warming
Very high severity ranking when a potential failure mode affects safe product operation and/or involves noncompliance with government regulations with warming Hazardous with warning 8
Product / item inoperable, with loss of primary function Very High 7
Product / item operable, but at reduced level of performance. Customer dissatisfied High 6
Product / item operable, but comfort / convenience item(s) inoperable. Customer experiences discomfort. Moderate 5
Product / item operable, but comfort / convenience item(s) operable at reduced level of performance. Customer experiences some dissatisfaction. Low 4
Cosmetic defect in finish, fit finish / squeak or rattle item that does not conform to specifications. Defect noticed by most customers. Very low 3
Cosmetic defect in finish, fit finish / squeak or rattle item that does not conform to specifications. Defect noticed by average customers. Minor 2
Cosmetic defect in finish, fit finish / squeak or rattle item that does not conform to specifications. Defect noticed by discriminating customers. Very minor 1
No effect None 0
15. A kit as claimed in any of claims 13-14, wherein said list for determining the occurrence value includes the following table:

Probability of failure Rate of occurrence Rank
Extremely high, bound to occur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur occasionally 1/100 5
1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
39

16. A kit as claimed in any of claims 13-15, wherein said list for determining the detectability value includes the following table:

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8
Remote Remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 7 ,
Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
7. A kit as claimed in any preceding claims 13-16, wherein said list including the failure risk values includes the severity value for each potential failure mode followed by the occurrence, which is followed by detectability of said potential failure mode.

19. A process for analyzing and correcting faults and failures in the design of an
industrial process or product comprising:
a. identifying the scope and function of the product or the process to be analyzed;
b. creating a multi-column spreadsheet, said columns being labeled according to
predetermined criteria;
c. identifying all possible modes of failure of the said identified product or process;
d. determining the likely effect of each failure identified;
e. developing a consensus list of relative values for assumed frequency of
occurrence, the severity of the failure and the likelihood of detecting the failure;
f. determining the risk failure value from the said values developed for the severity,
occurrence and detectability of said identified mode of failure by placing the said
developed values for severity, occurrence and detectability as a string in a
predetermined priority sequence;
g. identifying remedies for the identified failure modes;
h. prioritizing the identified remedial actions in a predetermined sequence based on
the said determined risk factor values;
i. documenting and validating each remedial action taken; and
j. verifying that the performed remedial action is continuing at a predetermined
time.
20. A process as claimed in claim 19, wherein said value for severity is determined
according to the following table:

Severity Effect Effect Rank
Very high severity ranking when a potential failure mode affects safe product operation and/or involves noncompliance with government regulations without warming Hazardous without warning 9
Very high severity ranking when a potential failure mode affects safe product operation and/or involves noncompliance with government regulations with warming Hazardous with warning 8
Product / item inoperable, with loss of primary function Very High 7
Product / item operable, but at reduced level of performance. Customer dissatisfied High 6
Product / item operable, but comfort / convenience item(s) inoperable. Customer Moderate 5
41

experiences discomfort.
Product / item operable, but comfort / Low 4
convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
specifications. Defect noticed by discriminating
customers.
No effect None 0
21. A process as claimed in any of the claims 19-20, wherein said value for occurrence is determined according to the following table:

Probability of failure Rate of occurrence Rank
Extremely high, bound to occur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur 1/100 5
occasionally 1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
22. A process as claimed in any of claims 19 - 21, wherein said values for detectability are determined according to the following table:

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8
Remote Remote chance the design control will detect a potential cause/mechanism and 7

subsequent failure mode
Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
23. A process as claimed in any of the claims 19-22, wherein said developed values for severity, occurrence and detectability are placed as a string in a priority sequence such that the severity of a particular failure mode is given the first priority, followed by occurrence which is followed by detectability.
24. A process as claimed in any preceding claims 19 - 23, wherein the said identified remedial actions are prioritized based on increasing risk failure values such that identified failure modes having higher failure risk value receive prioritized remedial actions.
25. A method for analyzing and correcting faults and failures in the design of an industrial process or product comprising:

(a) a computer implemented means and/or module for identifying the scope and function of the product or the process to be analyzed ;
(b) a computer implemented means and/or module for creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria;
(c) a computer implemented means and/or module for identifying all possible modes of failure of the said identified product or process;
43

(d) a computer implemented means and/or module for determining the likely effect of each failure identified;
(e) a computer implemented means and/or module for developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure;
(f) a computer implemented means and/or module for determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence;
(g) a computer implemented means and/or module for identifying remedies for the identified failure modes;
(h) a computer implemented means and/or module for prioritizing the
identified remedial actions in a predetermined sequence based on the
said determined risk factor values;
(i) a computer implemented means and/or module for documenting and
validating each remedial action taken; and
(j) a computer implemented means and/or module for verifying that the
performed remedial action is continuing at a predetermined time.
26. A method as claimed in claim 25, wherein the said value for severity is determined according to the following table:

Severity Effect Effect Rank
Very high severity ranking when a potential failure mode affects safe product operation and/or involves noncompliance with government regulations without warming Hazardous without warning 9
Very high severity ranking when a potential failure mode affects safe product operation and/or involves noncompliance with government regulations with warming Hazardous with warning 8
Product / item inoperable, with loss of primary function Very High 7
Product / item operable, but at reduced level of performance. Customer dissatisfied High 6
Product / item operable, but comfort / convenience item(s) inoperable. Customer experiences discomfort. Moderate 5
Product / item operable, but comfort / Low 4
44

convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
specifications. Defect noticed by discriminating
customers.
No effect None 0
27. A method as claimed in any of the claims 25 - 26, wherein said value for occurrence is determined according to the following table:

Probability of failure Rate of occurrence Rank
Extremely high, bound to onrur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur 1/100 5
occasionally 1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
28. A method as claimed in any preceding claim 25 - 27, wherein said value for detectability is determined according to the following table:

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8

Remote Remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 7
Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
29. A method as claimed in any preceding claim 25 - 28, comprising placing said developed values for severity, occurrence and detectability are placed as a string in a priority sequence such that the severity of a particular failure mode is given the first priority, followed by occurrence which is followed by detectability.
30. A method as claimed in any preceding claims 25 - 29, wherein the said identified remedial actions are prioritized based on increasing risk failure values such that identified failure modes having higher failure risk value receive prioritized remedial actions.
31. A quality assessment kit comprising:

(a) a list identifying the scope and function of the product or the process to be analyzed;
(b) a multi-column spreadsheet, said columns labeled according to predetermined criteria;
(c) a list identifying all possible modes of failure of said identified product or process;
46

(d) a list identifying each said identified failure mode;
(e) a list including the relative values for assumed frequency of occurrence, the severity of failure and the likelihood of identifying said failure;
(f) a list including the risk failure values, said risk failure values being determined by placing the said values, developed for the severity, occurrence and detectability of said identified mode of failure, as a string in a predetermined priority sequence; and
(g) a list identifying the remedies for the identified failure modes; and
(h) a list including the remedial actions arranged in a predetermined sequence based on the said determined risk failure values;
(i) a list including the documentation and validation of each of the remedial actions taken; and
(j) a list including information relating to the verification of the performed remedial action, said information further including information relating to the continuance of the remedial action taken at a predetermined time.
32. A kit as claimed in claim 31, wherein said list for determining the severity value includes the following table:

Severity Effect Effect Rank
Very high severity ranking when a potential Hazardous without 9
failure mode affects safe product operation warning
and/or involves noncompliance with government
regulations without warming
Very high severity ranking when a potential Hazardous with warning 8
failure mode affects safe product operation
and/or involves noncompliance with government
regulations with warming
Product / item inoperable, with loss of primary Very High 7
function
Product / item operable, but at reduced level of High 6
performance. Customer dissatisfied
Product / item operable, but comfort / Moderate 5
convenience item(s) inoperable. Customer
experiences discomfort.
Product / item operable, but comfort / Low 4
convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
47

customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
specifications. Defect noticed by discriminating
customers.
No effect None 0
33. A kit as claimed in any of claims 31 - 32, wherein said list for determining the occurrence value includes the following table:

Probability of failure Rate of occurrence Rank
Extremely high, bound to occur >=1/2 9
1/3 8
High, will occur frequently 1/10 7
1/20 6
Intermediate, will occur occasionally 1/100 5
1/500 4
1/2000 3
Low, will occur rarely 1/10000 2
1/100000 1
Zero, will never occur 1/1000000 0
34. A kit as claimed in any of claims 31-33, wherein said list for determining the detectability value includes the following table:

Detection Criteria Rank
Absolute uncertainty Design control will not and/or cannot detect a potential cause/mechanism and subsequent failure mode, or there is no design control 9
Very remote Very remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 8
Remote Remote chance the design control will detect a potential cause/mechanism and subsequent failure mode 7
48

Very low Very low chance the design control will detect a potential cause/mechanism and subsequent failure mode 6
Low Low chance the design control will detect a potential cause/mechanism and subsequent failure mode 5
Moderate Moderate chance the design control will detect a potential cause/mechanism and subsequent failure mode 4
Moderate high Moderate high chance the design control will detect a potential cause/mechanism and subsequent failure mode 3
High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequent failure mode. 0
35. A kit as claimed in any preceding claims 31 - 34, wherein said list including the failure risk values includes the severity value for each potential failure mode followed by the occurrence, which is followed by detectability of said potential failure mode.
36. A kit as claimed in any preceding claim 31 - 35, wherein said list comprising the failure risk values is arranged in a predetermined manner which facilitates identification of higher ranking failure risk values.
37. A kit as claimed in claim 36, wherein said list comprising the failure risk values is arranged in increasing order.
38. A kit as claimed in any preceding claims 31 - 37, wherein said list including the remedial actions identifies appropriate remedial action to be taken for failure risk values having more than a predetermined threshold numerical value.
39. A spreadsheet comprising a plurality of columns, each said column identifying information displayed thereon, at least one said column identifying the item to be corrected and/or analyzed, at least one further column identifying all the possible potential failure modes for said identified item, at least one further column
49

identifying the potential effects of said identified potential failure modes, at least one further column identifying the severity value for the said identified potential failure mode, at least one further column identifying potential causes of failure for the said identified potential failure mode, at least one further column identifying the occurrence value for each said identified potential failure mode, at least one further column identifying process control and detection information, at least one further column identifying the detectability value for each identified potential failure mode, at least one further column identifying the String risk priority number (String RPN) value for each said identified potential failure mode, at least one further column identifying the recommended action to be taken for each said identified potential failure mode having said identified String risk priority number (String RPN) value more than a predetermined threshold numerical value
Characterized in that the said identified String risk priority number (String RPN) value is determined by placing the said values, developed for the severity, occurrence and detectability of said identified mode of failure, as a string in a predetermined priority sequence.
40. A spreadsheet as claimed in claim 39, wherein said developed values for severity, occurrence and detectability are placed as a string in a manner such that the severity of the potential failure mode gets the highest priority, followed by the occurrence which is followed by the detectability of the potential failure mode.
41. A spreadsheet as claimed in any preceding claim 39 - 40, further comprising a column identifying the responsible person for identifying and optionally correcting the identified potential failure mode and the target date by which said identification and correction of the potential failure mode is to be completed.
42. A spreadsheet as claimed in any preceding claims 39-41, further comprising a plurality of columns such that at least one said column identifies the corrective action taken for each said identified potential failure mode; at least one further column identifying the severity value for each said identified potential failure mode, said severity value being determined after the identified corrective action has been taken; at least one further column identifying the occurrence value for each said identified potential failure mode, said occurrence value being
50

43.

determined after the identified corrective action has been taken, at least one further column identifying the detectability value for each said identified potential failure mode, said detectability value being determined after the identified corrective action has been taken; and at least one further column identifying the String risk priority number (String RPN) value, said String risk priority number (String RPN) value being determined by placing the said values, developed for the severity, occurrence and detectability of said identified mode of failure after the identified corrective action has been taken, as a string in a predetermined priority sequence.
A spreadsheet as claimed in any preceding claim 39 - 42, wherein said severity value for an identified potential failure mode is determined according to the

Severity Effect Effect Rank
Very high severity ranking when a potential Hazardous without 9
failure mode affects safe product operation warning
and/or involves noncompliance with government
regulations without warming
Very high severity ranking when a potential Hazardous with warning 8
failure mode affects safe product operation
and/or involves noncompliance with government
regulations with warming
Product / item inoperable, with loss of primary Very High 7
function
Product / item operable, but at reduced level of High 6
performance. Customer dissatisfied
Product / item operable, but comfort / Moderate 5
convenience item(s) inoperable: Customer
experiences discomfort.
Product / item operable, but comfort / Low 4
convenience item(s) operable at reduced level of
performance. Customer experiences some
dissatisfaction.
Cosmetic defect in finish, fit finish / squeak or Very low 3
rattle item that does not conform to
specifications. Defect noticed by most
customers.
Cosmetic defect in finish, fit finish / squeak or Minor 2
rattle item that does not conform to
specifications. Defect noticed by average
customers.
Cosmetic defect in finish, fit finish / squeak or Very minor 1
rattle item that does not conform to
specifications. Defect noticed by discriminating
51

customers.
No effect None 0
44. A spreadsheet as claimed in any preceding claim 39 - 43, wherein said occurrence value for an identified potential failure mode is determined according to the following table:

Zero, will never occur 1/1000000 0
45. A spreadsheet as claimed in any preceding claim 39 - 44, wherein said detectability value for an identified potential failure mode is determined according to the following table:

52

High High chance the design control will detect a potential cause/mechanism and subsequent failure mode 2
Very high Very high chance the design control will detect a potential cause/mechanism and subsequent failure mode 1
Almost certain Design control will almost certainly detect a potential cause/mechanism and subsequentfailure mode 0
46. A process for analyzing and correcting faults and failures in the design of an industrial process or product substantially as described herein with reference to the accompanying drawings and tables.
47. A method for analyzing faults and failures in the design of an industrial process or product substantially as described herein with reference to the accompanying drawings and tables.
48. A quality assessment kit substantially as described herein with reference to the accompanying drawings and tables.
49. A spreadsheet substantially as described herein with reference to the
Accompanying drawing tables
Dated this 30th day of November 2005

ABSTRACT
Title : FMEA ASSESSMENT AND CORRECTION METHOD AND KIT
A process for analyzing and correcting faults and failures in the design of an industrial process or product comprising identifying the scope and function of the product or the process to be analyzed; creating a multi-column spreadsheet, said columns being labeled according to predetermined criteria; identifying all possible modes of failure of the said identified product or process; determining the likely effect of each failure identified; developing a consensus list of relative values for assumed frequency of occurrence, the severity of the failure and the likelihood of detecting the failure; determining the risk failure value from the said values developed for the severity, occurrence and detectability of said identified mode of failure by placing the said developed values for severity, occurrence and detectability as a string in a predetermined priority sequence; identifying remedies for the identified failure modes; prioritizing the identified remedial actions in a predetermined sequence based on the said determined risk factor values; documenting and validating each remedial action taken; and verifying that the performed remedial action is continuing at a predetermined time. Also described is a kit, a method and a spreadsheet according to the present invention.
54