CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
ABOUT THE TRAINING PROGRAM :-
Failure Mode and Effects Analysis or FMEA is a structured technique to analyze a process to determine shortcomings and opportunities for improvement. By assessing the severity of a potential failure, the likelihood that the failure will occur, and the chance of detecting the failure, dozens or even hundreds of potential issues can be prioritized for improvement.
DESIGNED FOR :-
Sr. Engineer, Engineer, Supervisor and Foreman engaged in maintenance, operation, Store, Supply chain, Quality, Safety and Engineering activities.
OBJECTIVE :-
Employees completing this training will be able to effectively participate on an FMEA team and can make immediate contributions to quality and productivity improvement efforts.
A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an organization, business unit, or cross-functional team to identify and evaluate the potential failures of a process. PFMEA helps to establish the impact of the failure, and identify and prioritize the action items with the goal of alleviating risk. It is a living document that should be initiated prior to process of production and maintained through the life cycle of the product.
PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following variables:
Severity — Assesses the impact of the failure mode (the error in the process), with 1 representing the least safety concern and 10 representing the most dangerous safety concern. In most cases, processes with severity scores exceeding 8 may require a fault tree analysis, which estimates the probability of the failure mode by breaking it down into further sub-elements.
Occurrence — Assesses the chance of a failure happening, with 1 representing the lowest occurrence and 10 representing the highest occurrence. For example, a score of 1 may be assigned to a failure that happens once in every 5 years, while a score of 10 may be assigned to a failure that occurs once per hour, once per minute, etc.
Detection — Assesses the chance of a failure being detected, with 1 representing the highest chance of detection and 10 representing the lowest chance of detection.
RPN — Risk priority number = severity X occurrence X detection. By rule of thumb, any RPN value exceeding 80 requires a corrective action. The corrective action ideally leads to a lower RPN number.
Failure mode and effects analysis (FMEA)—also "failure modes", plural, in many publications—was one of the first highly structured, systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. An FMEA is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. An FMEA can be a qualitative analysis.
Quality Maintenance is an "advanced" pillar of TPM and aims to assure zero defect conditions. Also known as Hinshitsu Hozen in Japanese, it does this by understanding and controlling the process interactions between the 4Ms - manpower, material, machines and methods that could enable defects to occur. The key is to prevent defects from being produced in the first place, rather than screening them out through inspection systems after they have been produced. Controlling quality through its causes is the essence of Quality Maintenance.
Developed by our JIPM-certified TPM Instructor, this presentation teaches the key concepts, principles and philosophy of Quality Maintenance, the 4M conditions that are essential for defect-free production, as well as the step-by-step process for Quality Maintenance.
LEARNING OBJECTIVES
1. Understand the key concepts, principles and philosophy of Quality Maintenance
2. Acquire knowledge on the 4M conditions and the prerequisites for promoting Quality Maintenance
3. Describe the 8-step process of Quality Maintenance and the key analytical tools and techniques
CONTENTS
1. Key Concepts & Philosophy of Quality Maintenance
2. 4M Conditions - The Determinants of Quality
3. The 8 Steps of Quality Maintenance
4. Key Tools & Techniques for Quality Maintenance
5. Towards Excellence in Quality Maintenance
To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations
Legal Aspects of FMEA, overview of Canadian Law,
Due Diligence vs Negligence, Criminal Negligenced and what everyone needs to know about duty of care
www.6sengineering.com
CAPA (Corrective and Preventive Action) Management : Tonex TrainingBryan Len
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course teaches you to develop an effective RCA investigation, and develop a corrective and preventive action plan suitable for the identified problems.
Learn About:
CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
CAPA data sources, Methods of data analysis
CAPA data flow charts, CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDA’s trending principals, ECI
Non-conformances or deviations
RCA tools and methods, Brainstorming methods
More...
TONEX RCA and CAPA Management Training Format:
The course is fun and dynamic
The training is a combination of theory and practice
The theoretical section is delivered in the form of interactive presentation
The practical section includes exercising with real-world examples, individual/group activities, and hands-on workshops
Audience:
CAPA Management is a 4-day course designed for:
CRAs
Project Managers/CRA Managers
Principal Investigators
Site Research Directors/Managers
Clinical Research Coordinators
QA/QC staff
GMP personnel
All individuals who are involved in investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment.
Training Objectives:
CAPA Management training course, the attendees are able to:
Describe what RCA and CAPA are
Identify the non-compliance, Define the investigator
Discuss performance management concepts
Know the purpose of Corrective and Preventive Action
Improve their RCA and CAPA executive skills for effective site risk management
Understand the requirements in 21 CFR 820 Quality
System Regulation
Foster prevention actions
More...
Course Outline:
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
TONEX RCA and CAPA Hands-On Workshop Sample
Learn more. Request more information. Visit Tonex training website link below. Ask for anything related to CAPA (Corrective and Preventive Action) Management Training.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
We all want to support the accomplishment of safe and trouble-free products and processes. Failure Mode and Effects Analysis has the potential to be a powerful reliability tool to reduce product design and manufacturing risk in a cost effective manner. With shorter product development times, tighter budgets and intense global competition, Design for Reliability tools such as FMEA must be applied correctly. Yet in practice, FMEA does not always achieve the expected results. Why is it that some companies have outstanding success in their FMEA application and others do not? What is the difference between well done and poorly done FMEAs? What are the essential elements of an effective FMEA process? These questions and more are answered in these three new short courses on FMEA.
This presentation will help you identify waste in your environment. Reducing these wastes from your life will give you more time and freedom for more important things which matter to you in your life.
A Process Failure Mode Effects Analysis (PFMEA) is a structured analytical tool used by an organization, business unit, or cross-functional team to identify and evaluate the potential failures of a process. PFMEA helps to establish the impact of the failure, and identify and prioritize the action items with the goal of alleviating risk. It is a living document that should be initiated prior to process of production and maintained through the life cycle of the product.
PFMEA evaluates each process step and assigns a score on a scale of 1 to 10 for the following variables:
Severity — Assesses the impact of the failure mode (the error in the process), with 1 representing the least safety concern and 10 representing the most dangerous safety concern. In most cases, processes with severity scores exceeding 8 may require a fault tree analysis, which estimates the probability of the failure mode by breaking it down into further sub-elements.
Occurrence — Assesses the chance of a failure happening, with 1 representing the lowest occurrence and 10 representing the highest occurrence. For example, a score of 1 may be assigned to a failure that happens once in every 5 years, while a score of 10 may be assigned to a failure that occurs once per hour, once per minute, etc.
Detection — Assesses the chance of a failure being detected, with 1 representing the highest chance of detection and 10 representing the lowest chance of detection.
RPN — Risk priority number = severity X occurrence X detection. By rule of thumb, any RPN value exceeding 80 requires a corrective action. The corrective action ideally leads to a lower RPN number.
Failure mode and effects analysis (FMEA)—also "failure modes", plural, in many publications—was one of the first highly structured, systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. An FMEA is often the first step of a system reliability study. It involves reviewing as many components, assemblies, and subsystems as possible to identify failure modes, and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. An FMEA can be a qualitative analysis.
Quality Maintenance is an "advanced" pillar of TPM and aims to assure zero defect conditions. Also known as Hinshitsu Hozen in Japanese, it does this by understanding and controlling the process interactions between the 4Ms - manpower, material, machines and methods that could enable defects to occur. The key is to prevent defects from being produced in the first place, rather than screening them out through inspection systems after they have been produced. Controlling quality through its causes is the essence of Quality Maintenance.
Developed by our JIPM-certified TPM Instructor, this presentation teaches the key concepts, principles and philosophy of Quality Maintenance, the 4M conditions that are essential for defect-free production, as well as the step-by-step process for Quality Maintenance.
LEARNING OBJECTIVES
1. Understand the key concepts, principles and philosophy of Quality Maintenance
2. Acquire knowledge on the 4M conditions and the prerequisites for promoting Quality Maintenance
3. Describe the 8-step process of Quality Maintenance and the key analytical tools and techniques
CONTENTS
1. Key Concepts & Philosophy of Quality Maintenance
2. 4M Conditions - The Determinants of Quality
3. The 8 Steps of Quality Maintenance
4. Key Tools & Techniques for Quality Maintenance
5. Towards Excellence in Quality Maintenance
To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations
Legal Aspects of FMEA, overview of Canadian Law,
Due Diligence vs Negligence, Criminal Negligenced and what everyone needs to know about duty of care
www.6sengineering.com
CAPA (Corrective and Preventive Action) Management : Tonex TrainingBryan Len
CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course teaches you to develop an effective RCA investigation, and develop a corrective and preventive action plan suitable for the identified problems.
Learn About:
CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
CAPA data sources, Methods of data analysis
CAPA data flow charts, CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDA’s trending principals, ECI
Non-conformances or deviations
RCA tools and methods, Brainstorming methods
More...
TONEX RCA and CAPA Management Training Format:
The course is fun and dynamic
The training is a combination of theory and practice
The theoretical section is delivered in the form of interactive presentation
The practical section includes exercising with real-world examples, individual/group activities, and hands-on workshops
Audience:
CAPA Management is a 4-day course designed for:
CRAs
Project Managers/CRA Managers
Principal Investigators
Site Research Directors/Managers
Clinical Research Coordinators
QA/QC staff
GMP personnel
All individuals who are involved in investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment.
Training Objectives:
CAPA Management training course, the attendees are able to:
Describe what RCA and CAPA are
Identify the non-compliance, Define the investigator
Discuss performance management concepts
Know the purpose of Corrective and Preventive Action
Improve their RCA and CAPA executive skills for effective site risk management
Understand the requirements in 21 CFR 820 Quality
System Regulation
Foster prevention actions
More...
Course Outline:
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
TONEX RCA and CAPA Hands-On Workshop Sample
Learn more. Request more information. Visit Tonex training website link below. Ask for anything related to CAPA (Corrective and Preventive Action) Management Training.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
We all want to support the accomplishment of safe and trouble-free products and processes. Failure Mode and Effects Analysis has the potential to be a powerful reliability tool to reduce product design and manufacturing risk in a cost effective manner. With shorter product development times, tighter budgets and intense global competition, Design for Reliability tools such as FMEA must be applied correctly. Yet in practice, FMEA does not always achieve the expected results. Why is it that some companies have outstanding success in their FMEA application and others do not? What is the difference between well done and poorly done FMEAs? What are the essential elements of an effective FMEA process? These questions and more are answered in these three new short courses on FMEA.
This presentation will help you identify waste in your environment. Reducing these wastes from your life will give you more time and freedom for more important things which matter to you in your life.
Value" is any action or process that a customer would be willing to pay for. Lean manufacturing is a management philosophy focused on the reduction of the "seven wastes in" order to improve overall customer value.
Persuading, influencing and negotiating skillsMohammed Gamal
These skills are important in many jobs, especially areas such as marketing, sales, advertising and buying, but are also valuable in everyday life. You will often find competency-based questions on these skills on application forms and at interview, where you will be required to give evidence that you have developed these skills.
If you want to take your influencing skills to the next level, email me:
alanbarker830@btinternet.com
This set of slides summarizes my approach to influencing skills as a trainer and coach. Sources of the main ideas are given.
CADmantra Technologies Pvt. Ltd. is one of the best Cad training company in northern zone in India . which are provided many types of courses in cad field i.e AUTOCAD,SOLIDWORK,CATIA,CRE-O,Uniraphics-NX, CNC, REVIT, STAAD.Pro. And many courses
Contact: www.cadmantra.com
www.cadmantra.blogspot.com
www.cadmantra.wix.com
Failure mode and effects analysis is the process of reviewing as many components, assemblies, and subsystems as possible to identify potential failure modes in a system and their causes and effects
1. Process Failure Mode & Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
2. Process Failure Mode & Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
3. Process Failure Mode & Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
4. Process Failure Mode & Effect Analysis (PFMEA)
“Our product or process is established, it doesn’t have any failure modes.”
Every product or process has modes of failure, which can arise even
though your product or process is established and you are producing or
performing it for years.
Uniparts India Limited By: Pankaj Nalwa
5. Process Failure Mode & Effect Analysis (PFMEA)
“FMEA takes lot of time and resources, also it does not provide any benefit. It
can be done by one person instead.”
FMEA do take time and people resources as it is a team based activity.
Effective FMEAs cannot be done by one person sitting alone and filling
out FMEA forms.
FMEA do not require complicated statistics, still it can yield significant
savings for organization by reducing cost liabilities due to process or
product that does not performed as required.
Uniparts India Limited By: Pankaj Nalwa
6. Process Failure Mode & Effect Analysis (PFMEA)
Current Paradigm
FMEA
-Taken lightly
… “Selective” products / processes chosen.
… Based on opinion.
… All “magically” below the RPN cut-off.
-Too late
… Error / Mistake proofing window long gone.
… Rarely validated with field results.
“Paper exercise done when pushed”
Uniparts India Limited By: Pankaj Nalwa
7. Process Failure Mode & Effect Analysis (PFMEA)
New Paradigm
FMEA
Error / Mistake Process Control Maintenance
Proofing Plans Plans
-Taken Seriously
… All critical and new products / processes.
… Data driven.
… Roll-up RPN values.
-Early
… Completed while design is still fluid.
… “Living” document.
“Ensures our products and processes are
robust”
Uniparts India Limited By: Pankaj Nalwa
8. Process Failure Mode & Effect Analysis (PFMEA)
The objective of a FMEA is to look for all of the ways a process or
product can fail.
A product failure occurs when the product does not function as it
should or when it malfunctions in some way.
Failures are not limited to problems with the product. Because
failures also can occur when the user makes a mistake, those types
of failures should also be included in the FMEA.
Anything that can be done to ensure the product works correctly,
regardless of how the user operates it, will move the product closer
to 100% total customer satisfaction.
Uniparts India Limited By: Pankaj Nalwa
9. Process Failure Mode & Effect Analysis (PFMEA)
Process FMEA is an effort to prevent failures (due to process)
before they happen, to assess the risk associated with those failure
modes, to rank the issues in terms of importance and to identify and
carry out corrective actions to address the serious concerns.
Process FMEAs uncover process problems related to the manufacture of
the product.
It is helpful when conducting a process FMEA to think in terms of the five
elements of a process: People, Materials, Equipment, Methods and
Environment. With these five elements in mind, ask: How can process
failure affect the product, processing efficiency or safety?
Uniparts India Limited By: Pankaj Nalwa
10. Process Failure Mode & Effect Analysis (PFMEA)
FMEA Core Team
It is helpful to have people in team who have different levels of familiarity
with the product or process.
Those who are most familiar with it will have valuable insights, but may
overlook some of the most obvious potential problems. Those who are less
familiar with the process or product will bring unbiased, objective ideas into
the FMEA process.
A point is often debated with FMEAs is what role the process expert plays
on the FMEA team. A person with expertise in the process can bring
tremendous insight to the team and can help speed the process.
Uniparts India Limited By: Pankaj Nalwa
11. Process Failure Mode & Effect Analysis (PFMEA)
Ten Steps for an Process FMEA
1) Review the process.
2) Brainstorm potential failure modes.
3) List potential effects of each failure mode.
4) Assign a Severity ranking for each effect.
5) Assign an Occurrence ranking for each failure mode.
6) Assign a Detection ranking for each failure mode and /or effect.
7) Calculate the Risk Priority Number for each effect.
8) Prioritize the failure modes for action.
9) Take action to eliminate or reduce the high-risk failure modes.
10) Calculate the resulting RPN as the failure modes are reduced or
eliminated.
Uniparts India Limited By: Pankaj Nalwa
12. Process Failure Mode & Effect Analysis (PFMEA)
Ways in which a product or process can fail are called FAILURE
MODES.
Each failure modes has a potential effect, and some effects are more
likely to occur than others. In addition, each potential effect has a
relative risk associated with it.
The FMEA process is a way to identify the failures, effects, and risks
within a process or product, and then eliminating or reduce them.
Uniparts India Limited By: Pankaj Nalwa
13. Process Failure Mode & Effect Analysis (PFMEA)
Evaluating the Risk of Failure
The relative risk of a failure and its effects is determined by three
factors:
Severity – The consequence of the failure should it occur.
Occurrence – The probability or frequency of the failure occurring.
Detection – The probability of the failure being detected before the
impact of the effect is realized.
Uniparts India Limited By: Pankaj Nalwa
14. Process Failure Mode & Effect Analysis (PFMEA)
Using the data and knowledge of the process or product, each potential
failure mode and effect is rated in each of these three factors on a scale
ranging from 1 to 10, low to high.
By multiplying the ranking for the three factors (Severity x Occurrence x
Detection), a risk priority number (RPN) will be determined for each potential
failure mode and effect.
The risk priority number (which will range from 1 to 1,000 for each failure
mode) is used to rank the need for corrective actions to eliminate or reduce
the potential failure modes.
Once corrective action has been taken, a new RPN for the failure is
determined by reevaluating the Severity, Occurrence and Detection
rankings. This new RPN is called “Resulting RPN”.
Improvement and corrective action must continue until the resulting RPN is
at acceptable level for all potential failure modes.
Uniparts India Limited By: Pankaj Nalwa
15. Process Failure Mode & Effect Analysis (PFMEA)
For High Severity 9/10
Uniparts India Limited By: Pankaj Nalwa
16. Process Failure Mode & Effect Analysis (PFMEA)
Current or
Customer Process
Expected Process Implementation
Design Flow
quality Changes and verification
Requirements Diagram
performance
Recommended
Corrective actions
Process FMEA document i.e.
Error proofing
Process Continuous Improvement Efforts
Control And RPN reduction loop
Plan
Operator Communication of standard
Job
of work to operators
Instructions
Uniparts India Limited By: Pankaj Nalwa
17. Process Failure Mode & Effect Analysis (PFMEA)
Criteria: Severity of Effect
These rankings results when a potential failure mode results in a final
customer and/or a manufacturing/assembly plant defect.
Effect The final customer should always be considered first. Ranking Remarks
If both occur, use the higher of two severities.
Customer Effect Manufacturing / Assembly Effect
Hazardous without
warning
Very high severity ranking when a
potential failure mode affects safe
Or may endanger operator
(Machine or assembly) without
10 Critical
characteristic
vehicle operation and/or involves warning.
noncompliance with government
regulation without warning.
Hazardous with
warning
Very high severity ranking when a
potential failure mode affects safe
Or may
(Machine
endanger
or
operator
assembly) with
9 Critical
characteristic
vehicle operation and/or involves warning.
noncompliance with government
regulation with warning.
Very High Vehicle / item inoperable (loss of
primary function)
Or 100% of product may have to be
scrapped, or vehicle / item repaired
8 Major
characteristic
in repair shop with repair time
greater than one hour.
High Vehicle / item operable but at a
reduced level of performance.
Or product may have to be sorted
and a portion (less than 100%)
7
Customer very dissatisfied. scrapped, or vehicle / item repaired
in repair department with a repair
time between ½ hr and an hour.
Moderate Vehicle/item operable but comfort /
convenience item(s) inoperable.
Or a portion (less than 100%) of the
product may have to be scrapped
6
Customer dissatisfied. with no sorting, or vehicle / item
repaired in repair shop with a repair
time of less than ½ hr.
Uniparts India Limited By: Pankaj Nalwa
18. Process Failure Mode & Effect Analysis (PFMEA)
Criteria: Severity of Effect
These rankings results when a potential failure mode results in a final
customer and/or a manufacturing/assembly plant defect.
Effect The final customer should always be considered first. Ranking Remarks
If both occur, use the higher of two severities.
Customer Effect Manufacturing / Assembly Effect
Low Vehicle / item operable but comfort /
convenience item(s) operable at a
Or 100% of product may have to be
reworked, or vehicle / item repaired
5
reduced level of performance. off-line but does not go to repair
department.
Very Low Fit and Finish / Squeak and Rattle
item does not conform. Defect
Or the product may have to be
sorted, with no scrap, and a portion
4
noticed by most customers (greater (less than 100%) reworked.
than 75%).
Minor Fit and Finish / Squeak and Rattle
item does not conform. Defect
Or a portion (less than 100%) of the
product may have to be reworked,
3
noticed by 50% of customer. with no scrap, on-line but out-of-
station.
Very Minor Fit and Finish / Squeak and Rattle
item does not conform. Defect
Or a portion (less than 100%) of the
product may have to be reworked,
2
noticed by discriminating customers with no scrap, on-line but in-station.
(less than 25%).
None No discernible effect. Or slight inconvenience to operation
or operator, or no effect.
1
Uniparts India Limited By: Pankaj Nalwa
19. Process Failure Mode & Effect Analysis (PFMEA)
Suggested P.F.M.E.A Occurrence Evaluation Criteria.
Probability Likely Failure Rates Ranking Remarks
Very High: Persistent Failures ≥ 100 per thousand pieces 10
50 per thousand pieces 9
High: Frequent Failures 20 per thousand pieces 8
10 per thousand pieces 7
Moderate: Occasional
Failures
05 per thousand pieces 6
02 per thousand pieces 5
01 per thousand pieces 4
Low: Relatively Few Failures 0.5 per thousand pieces 3
0.1 per thousand pieces 2
Remote: Failure is unlikely ≤ 0.01 per thousand pieces 1
Uniparts India Limited By: Pankaj Nalwa
20. Process Failure Mode & Effect Analysis (PFMEA)
Inspectio
Detection Criteria n Types Suggested Range of Detection Methods Ranking
A B C
Almost Absolute certainty of non- Cannot detect or is not checked.
Impossible detection 10
Very Control will probably not detect Control is achieved with indirect or random checks only.
Remote 9
Remote Controls have poor chance of Control is achieve with visual inspection only.
detection 8
Very Low Control have poor chance of Control is achieve with double inspection only.
detection 7
Low Controls may detect Controls is achieved by charting methods, such as Statistical
Process Control. 6
Moderate Controls may detect Control is based on variable gauging after parts have left the
station, or GO/NO-GO gauging performed on 100% of the parts 5
after parts have left the station.
Moderately Controls have a good chance to Error detection in subsequent operations, Or gauging
High detect performed on set up and first-piece check (for set up causes 4
only).
High Controls have a good chance to Error detection in-station, Or error detection in subsequent
detect operations by multiple layers of acceptance: supply, select, 3
install, verify. Cannot accept discrepant part.
Very High Controls almost certain to detect Error detection in-station (automatic gauging with automatic
stop feature). Cannot pass discrepant part. 2
Certain Controls certain to detect Discrepant parts cannot be made because item has been error-
proofed by process/product design. 1
Uniparts India Limited By: Pankaj Nalwa
21. Process Failure Mode & Effect Analysis (PFMEA)
10
Confirmed Critical Characteristic
9
S 8
e 7 Confirmed Significant
v
Characteristic; Action Required
e 6
r 5
i
4 Annoyance
t
y 3 Zone
2
1
1 2 3 4 5 6 7 8 9 10
Occurrence
Uniparts India Limited By: Pankaj Nalwa