A

Seminar Report
on
Review on PFMEA

Submitted By
Srushti Rajkumar Kajale

Under the guidance of

Prof. S. H. Patil

Department of Mechanical Engineering

Government College of Engineering, Karad
2022-2023
 Acknowledgment

I would like to express my deep and sincere gratitude to my Guide Prof S.H. Patil , Department of
Mechanical Engineering, for guiding me to accomplish this Seminar.
I express my deep gratitude to Dr. R K Shrivastava Head of Mechanical Engineering Department,
for his valuable guidance and constant encouragement. I am very much thankful to Dr. A.T.Pise,
Principal, Government college of Engineering, Karad.
 GOVERNMENT COLLEGE OF ENGINEERING, KARAD

DEPARTMENT OF MECHANICAL ENGINEERING

This is to certify that, Srushti Rajkumar Kajale has satisfactorily completed the Seminar on
“Review on PFMEA " This report is being submitted in partial fulfilment for the award of degree
of Bachelor of Engineering in Mechanical- (Mechanical Engineering) to Shivaji University,
Kolhapur, under my guidance.

Prof. S.H.Patil Dr. R.K. Shrivastava

Guide Professor & HOD
Dept. of Mechanical Engineering Dept. of Mechanical Engineering
Govt. College of Engineering, Karad Govt. College of Engineering, Karad

Dr. A.T. Pise

Principal
Govt. College of Engineering, Karad
 CONTENT

➢ INTRODUCTION

➢ LITERATURE SURVEY

➢ ABSTRACT

➢ PFMEA

➢ CASE STUDY

➢ CONCLUSION

➢ REFERENCES
 INTODUCTION
ASQ defines Failure Mode and Effects Analysis (FMEA) as a process analysis tool that takes a
“step-by-step approach for identifying all possible failures in a design, a manufacturing or
assembly process, or a product or service.”

The goal of FMEA is to ensure organizations consistently release high-quality products to

market. Initially developed by the U.S. Armed Forces during the 1940s, FMEA allowed troop
leaders to identify failures impacting mission safety.

PFMEA is a subtype of FMEA with a focus on process improvement. PFMEA is one of three
types of FMEA; the other types of analyses are:

➢ Process FMEA: 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. FMEA 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 lifecycle of the product.
➢ System FMEA: System FMEA identifies and assesses failure modes that impact
systems and subsystems. Also known as functional FMEA, it’s based on the
assumption that a system failure is rarely an isolated event. It can occur between
multiple assets and processes.
➢ Design FMEA: This type of FMEA focuses on the design of deliverables. Managers
use it to assess failure modes that can result in product malfunctions, impacting
quality standardization, consumer/worker safety, and regulatory compliance.
Essentially, design FMEA ensures that customers receive reliable products a nd
services.

Basically, FMEA takes a broader look at failure modes, while PFMEA restricts itself to
failure modes related to operational processes.
 LITERATURE SURVEY

Liviu Dorin Pop and Nagy Elod, implemented SPC as an ISO/TS 16949 standard for
improving product quality and presented it in 8th International Conference
Interdisciplinary in Engineering in 2014. In this work the authors mentioned that the
implementation of ISO/TS 16949 standards for any organization is necessary to become
direct vendor of majorautomotive manufacturer [2].

Nadia B., Abdel-Rahim Al Ali, Nanci K. presented the importance of the Control Plan in
the product development and staging, this being one of the tools on which PPAP
methodology isbased [3].

Folta Martin and Bradac Jose studied Production Part Approval Process (PPAP) for
metallurgical products states that input to flow chart, PMEA and control plan are taken
from customer engineering approved drawings, engineering changes documents andother
requirements of customer [4]

Josef Gawlik, Jan Rewilak and Tomasz Tokaj studied Production Part Approval Process
(PPAP) carried out by American Industry and mentioned the PFD, PMEA and Control plan
as key elements in approval process [5]

Mr. Vitthal R.Jumbad, Mr. Samir Telang, Mr. Anant W. Nemade, Dr. Arvind L.Chel,carried
out case study which states Process Flow diagram determines inputs to the PFMEA,
PFMEA outputs are taken in control plan.[6]
 ABSTRACT

A Process FMEA is a risk assessment and continuous improvement tool used to identify
potential process/manufacturing issues and mitigate them before the product (or service) is
released to the customer. Importance of the Control Plan in the product development using
the results from Failure Mode and Effects Analysis (FMEA) to evaluate a process or product
for strengths and weaknesses and to prevent problems before they occur. The importance of
interlinking of the PFD, PFMEA and Control plan is studied.
 PFMEA
Process Failure Modes and Effects Analysis (PFMEA) is a systematic, proactive method of
evaluating a process. A PFMEA identifies the opportunities for failure, or “failure modes,” in
each step of the process. “Failure modes” refers to the ways, or modes, in which something
might fail. Failures are any errors or defects, especially ones that affect the customer or the
products being built, and they can be potential or actual. Each failure mode gets a numeric
score that quantifies:

➢ the likelihood that the failure will occur (the occurrence of the potential failure)
➢ the likelihood that the failure will not be detected (the detection of the potential
failure) and
➢ the amount of harm or damage the failure mode may cause to a person or to
equipment (the severity of the potential failure).

The product of these three scores is the Risk Priority Number (RPN) for that failure mode.
The sum of all the RPNs for the failure modes is the overall RPN for the process. As an
organization works to improve a process, it can anticipate and compare the effects of
proposed changes by calculating hypothetical RPNs for different scenarios. Just remember
that the RPN is a measure for comparisons within one process only; it is not a measure for
comparing risk between processes or organizations.

When to use PFMEA

➢ When a new process is being put into place

➢ When an existing process or product is being applied in a new way
➢ Before developing control plans for a new or modified process
➢ When improvement goals are planned for an existing process, product or service
➢ When analysing failures of an existing process, product or service
➢ Periodically throughout the life of the process, product or service

Advantages of PFMEA
Manufacturers across many industries can benefit from this analytical tool.

1. Its preventive nature; instead of reacting to failures after the fact, such as by
inspection or (more seriously) customer complaints, a cross-functional team can
proactively address the system factors that lead to defects. Team members with close
knowledge of the process can follow this tool to devise unexpected ways to error-
 proof the process and even make certain defects impossible. This results in reduced
scrap rates, better safety, and a wider understanding and control of process variables.
2. PFMEA is a risk-based process. The RPN displays semi-quantitatively which failure
mode needs to be addressed first.
3. PFMEA identifies the safety concerns of machine operators, highlights the customer
impact of failure modes, and provides data to the design team on changes that may be
needed in the design.

Quality Objectives of Process FMEA:

1. Process improvements: The FMEA drives process improvements as the primary

objective with an emphasis on error/mistake-proofing solutions.
2. High-risk failure modes: The FMEA addresses all high-risk failure modes, as
identified by the FMEA team, with executable action plans all other failure modes are
considered.
3. Control plans: The pre-launch and production control plans consider the failure
modes from the process FMEA
4. Integration: The FMEA is integrated and consistent with the process flow diagram
and process control plan, the Process FMEA considers the Design FMEA, if available
as part of its Analysis
5. Lessons learned: The FMEA considers all major “lessons learned” (such as high
warranty, campaigns, non-conforming, product, customer complaints, etc.) as input to
failure mode identification.
6. Special or key characteristics: The FMEA Identifies appropriate key characteristic
parameters as an input to the key characteristic selection process, if applicable.
7. Timing: The FMEA is completed during the “window of opportunity” where it could
most efficiently impact the design of a product or process.
8. Team: The right people participate as a part of the FMEA team throughout the
analysis and are adequately trained in FMEA methods. As appropriate, a facilitator
should be used.
9. Documentation: The FMEA document is filled out “by the book” including “actions
taken” and new RPN values
10. Time usage: Effective and efficient time spent by the FMEA team with a value-based
result. This assumes recommended actions are identified as required and actions are
Implemented.
Industries that use PFMEA

➢ Automotive: PFMEA has helped automotive manufacturers to avoid high-risk

failures resulting in mass recalls. For example, proximity parking sensors now help
prevent crashes and unnecessary expenses on repairs. Other safety features that have
been improved through PFMEA include airbag deployment and the inability to
remove ignition keys while in Park mode.
➢ Manufacturing: Manufacturers rely on the methodology to deal with potential
process failures before costly repairs down the line. As manufacturers routinely lose
millions of dollars in revenue because of unplanned downtime. In addition, mistake-
mitigating methodology safeguards quality controls and deliverables.
➢ Healthcare: Accident prevention hasn’t historically played a significant role in
medical practices. For whatever reason, many hospital systems weren’t designed to
safeguard doctors, nurses, and administrative workers from making tragic errors. But
that began to change when the industry adopted healthcare PFMEA to reduce the
likelihood of facility power failures, MRI machinery malfunctions, and numerous
other risks.
➢ Software Development: Software FMEA focuses on eliminating engineering
deficiencies that lead to wonky software programs, unreliable user experiences, and
costly mistakes that developers must later correct. The methodology guides engineers
through a sequential process for identifying missing program requirements, analyzing
software system responses to external requests, uncovering hardware malfunctions,
and preventing single-point failures from becoming catastrophic failures.
➢ Transport and Logistics: The transportation and logistics industry has come a long
way since coining the term “supply chain” During the 1980s. During this time,
increased global planning, loading, and turning over goods motivated industry leaders
to seek new process improvement systems. Today logistics players use PFMEA to
evaluate logistics bottlenecks, optimize routes, and improve customer service
delivery.
➢ Agriculture: Lastly, the agricultural industry has been known to use PFMEA.
Farmers assess environmental, equipment, and production risks that could impact
product quality. Not only are such systems essential for productivity, but they also
provide a layer of protection against ethical, legal, and environmental ramifications.
 STEPS TO PROCESS FMEA
Process Failure Mode and Effects Analysis must be done in a step-wise fashion since each
step builds on the previous one. Here’s an overview of the 10 steps to a Process FMEA.

STEP 1: Review the process

➢ Use a process flowchart to identify each process component.

➢ List each process component in the FMEA table.
➢ If it starts feeling like the scope is too big, it probably is. This is a good time to break
the Process Failure Mode and Effects Analysis into more manageable chunks.

STEP 2: Brainstorm potential failure modes

➢ Review existing documentation and data for clues about all of the ways each
component can failure.
➢ The list should be exhaustive – it can be paired down and items can be combined after
this initial list is generated.
➢ There will likely be several potential failures for each component.

STEP 3: List potential effects of each failure

➢ The effect is the impact the failure has on the end product or on subsequent steps in
the process.
➢ There will likely be more than one effect for each failure.

STEP 4: Assign Severity rankings

➢ Based on the severity of the consequences of failure.

STEP 5: Assign Occurrence rankings

➢ Rate the severity of each effect using customized ranking scales as a guide.
STEP 6: Assign Detection rankings

➢ What are the chances the failure will be detected prior to it occurring.
STEP 7: Calculate the RPN

➢ Severity X Occurrence X Detection

STEP 8: Develop the action plan

➢ Decide which failures will be worked on based on the Risk Priority Numbers. Focus
on the highest RPNs.
➢ Define who will do what by when.

STEP 9: Take action

➢ Implement the improvements identified by your Process Failure Mode and Effects
Analysis team.

STEP 10: Calculate the resulting RPN

➢ Re-evaluate each of the potential failures once improvements have been made and
determine the impact of the improvements.

THE PROCESS FMEA STEPS

 CASE STUDY
This case study is conducted in a small-scale sheet metal industry by targeting sheet metal
press part quality. In first stage all operation flow in press part production was arranged in
sequence by symbolic representation and Process Flow Diagram is prepared. Before going
for production all possible operations involved in press parts production are addressed with
their possible failure modes. Then all possible failure modes and their controls are addressed
with Risk Priority Number (RPN) and data entered in a standard format. The control plan is
prepared by taking outputs from PFMEA and arranged in a systematic manner.

PROCESS FLOW DIAGRAM: The process flow diagram represents the sequence of
operation with standard symbols. This sequence is maintained in Process FMEA and Control
plan. Process flow diagram helps to take overview of process flow on line or station.

PROCESS FAILURE MODE AND EFFECT ANALYSIS:

All the operations mentioned in the PFD were addressed as a function in PFMEA and all
possible failure modes in press parts quality were recorded. The effects of failure mode
addressed along with the severity ranking. The prevention and detection control were
analysed and Risk Priority Number (RPN) for each failure mode were calculated.

SEVERITY RANKING: Severity is the seriousness of the effect of failure mode in particular
operation. Severity ranking is given on the basis of degree of seriousness of the effect of
failure mode. It is ranges from 1-10. Higher the number more is the severity.
 Table No. 1: Severity Ranking

OPERATION NO FAILURE MODE EFFECT SEVERTY

1 Wrong material Not suitable for
thickness operation 7
2 Dent, damage and Rejection
rusty 7
3 Incomplete piercing Rejection 7

4 Burr in piercing Fitment problem 8

5 Blanking burr Fitment problem 8

OCCURRENCE RANKING: Occurrence denotes the ability of a particular issue to be

occurred frequently. Occurrence ranking is given on the basis of frequency of failure mode to
be occurred. It is given in the range of 1-10. More is the number more is the frequency of
occurrence

Table No. 2: Occurrence Ranking

Operation No Potential cause Occurrence rating

1 Bad control on process 4

parameters from supplier

2 Bad storage facility 4

3 Less entry of punch in die 4

4 Punch clearance not ok 8

5 Die Clearance not ok 8

DETECTION RANKING: Detection is the easiness with which a particular issue is

identified. Detection ranking is given on the basis of ability of process control to detect
problem. A particular quality issue will be having higher detection ranking if the problem is
very difficult to detect. It is given in the range of 1-10. More is the detection ranking less is
the chance of detecting the problem.
 Table No. 3: Detection Ranking

Operation No. Process control (Detection) Detection ranking

1 Dispatch report 4

2 Visual inspection 4

3 Visual inspection 2

4 Visual inspection 6

5 Visual inspection 6

RISK PRIORITY NUMBER (RPN): It is the rating to the quality issue to determine priority
of action on the specific issue. RPN is product of Severity (1-10), occurrence (1-10) and
detection (1-10) and hence maximum value of RPN goes to 1000. The quality issue with
highest RPN will be on top most priority. RPN=Severity X Occurrence X Detection

Table No.4 Risk Priority Number calculation

Operation No. Calculation of RPN

severity(S*O*D)

1 7*4*4 112

2 7*4*4 112
3 7*4*2 56

4 8*8*6 384
5 8*8*6 384

Process Number 4 and 5 is at priority for taking action as RPN is more

CONTROL PLAN: Control plan is the summary of all operations with product and process
characteristics and their control measures in a standard table format. All outputs from FMEA
are to be considered during preparation of control plan. All preventive and detective

measures were addressed in control plan. Control plan generally preferred during process
audit and all control measures for the process failures are verified. Control plan contains all
details of process characteristics evaluation and measurements. The control methods of
process characteristics are also mentioned in control plan. Thus, control plan gives us brief
introduction about process function, process characteristics, process measurement and control
methods to control quality of part under study. To verify the process control and capability of
the given operation control plan is generally preferred. Statistical process control if used is
mentioned in the control plan.

CONTROL PLAN
INTERLINKING OF PFD, PFMEA AND CONTROL PLAN:
 CONCLUSION
Failure mode and effects analysis (FMEA) is a tool to identify risks in your process, it can be
used in multiple places in process improvement and it is helps to determine where problems
are, identify cause/ effect relationship and highlight risks in solutions and actions to take. It is
easier to identify risks to define categories like: (1) severity of impact (2) probability of
occurrence and (3) ability to detect the occurrence. PFD, PMEA and Control plan are the
effective ways of process mapping to prevent and control quality related issues on
production line. Process Flow diagram determines inputs tothe PFMEA, PFMEA outputs are
taken in control plan.
 REFERENCES

[1] Liviu Dorin Pop, Nagy Elod, “Improving product quality by implementing ISO/TS
16949”, Procedia Technology 19 (2015) 1004-1011.

[2] Nadia Belu, Abdel-Rahim, AL Ali, Nancy Khassawneh, “Application of Control Plan-
PPAP Tool in Automotive Industry Production”. Quality access to success, Vol.14, No.
136/October 2013.

[3] Folta Martin and Bradac Jose, “Production Part Approval Process in Metallurgical Sector
for Automotive Industry”. 24th Intenational Conference on Metallurgical Sector for
Automotive Indusrty, Jun 3rd-5th 2015, Brno, Czech Republic, EU.

[4] Potential Failure Mode and Effect Analysis (FMEA), Reference Manual, 4th Edition,
AIAG.

[5] Josef Gawlik, Jan Rewilak and Tomasz Tokaj studied Production Part Approval
Process (PPAP) carried out by American Industry and mentioned the PFD, PMEA and
Control plan as key elements in approval process

[6] International Journal of Engineering Technology Science and Research IJETSR

www.ijetsr.com ISSN 2394 – 3386 Volume 5, Issue 3 March 2018