2.
FICCI CE
Categories of Quality Costs
Conformance Non-Conformance
Quality Costs
Appraisal
Prevention External failure
Internal failure
3.
FICCI CE
Cost of quality
Cost of quality = Cost of conformance + Cost of non-conformance
• Cost of conformance is the cost of providing products or services as
per the required standards. This can be termed as good amount
spent. (Prevention & Appraisal costs)
• Cost of non-conformance is the failure cost associated with a process
not being operated to the requirements. This can be termed as
unnecessary amount spent.( Internal & External failure costs)
4.
FICCI CE
Prevention Costs
Prevention costs are associated with Tool design & Simulation, Equipment
Maintenance, Mfg Process Monitoring, Process Validation, Die Care, and
planning prior to & during actual manufacturing process to avoid the
occurrence of defects.
The emphasis is on the prevention of defects so as to reduce the probability of
occurrence of defective products. Prevention activities lead to reduction of
appraisal costs and both type of failures (Internal and external).The motto is
“Prevention rather than appraisal”.
5.
FICCI CE
Activities associated with Prevention costs(APQP)
➢ 8.2.2 Quality Planning – Determine Manufacturing process and
inputs required, Decide check points – Quality Plan / Process Plan
➢ 8.2.3 Contract review- Customer Specific requirement
➢ 8.3 Mfg Process Design review
➢ 8.4 Supplier evaluation, selection, performance monitoring
➢ 8.4 Correct & Complete Purchasing specification of RM
➢ 8.5.1 Production Planning, Job Set up process, Correct Input
➢ 7.1.5 Calibration
➢ 8.6 Field trials if product designed by manufacturer
➢ Process capability review
➢ Design and manufacture of jigs and fixtures
➢ Preventive & Predictive maintenance Discipline
6.
FICCI CE
Should we try to reduce Prevention Costs
to
Bring down Cost of Quality ?
No
Why
Better take Preventive Actions to
reduce the Cost of Non-
Conformance
7.
FICCI CE
Should we try to Increase Prevention Costs
To Improve Quality & Reduce Non-Conformance
Yes/No
Right approach would be to optimize
Prevention Costs
By Focusing on:
a) Quality Planning (8.2.2) –Horizontal deployment of actions while preparing QUALITY PLAN /
PROCESS PLAN of similar successful products.
d) Jigs & Fixture(8.5.1/8.1) Commonising non critical components of Jigs & Fixtures,
toolings.
e) Reduce Inspection Waste:-Reduce Inspection & focus on Process Monitoring & Control
Video shoot to prepare activity chart. Review & eliminate waste operations.
f) Learn from Mistakes:- Dynamic FMEA review to address recurring internal NC or
customer returns.
g) Change Management Failures:- Improve change management implementation.
b) Supplier Evaluation, Performance(8.4)Upgrade, Educate & Standardize Supplier Base.
c) Calibration (7.1.5)- Usage based frequency, Replacement Strategy.
8.
FICCI CE
Appraisal costs
Appraisal costs are spent to detect defects to assure conformance to
quality standards. Appraisal cost activities sums up to the “cost of
checking if things are correct”. The appraisal costs are focused on the
discovery of defects rather than prevention of defects.
9.
FICCI CE
How to Reduce Appraisal Costs?
8.4.3- Vendor Surveillance-
- Standardize Product/ Grade specific Machining/Raw material vendors based
on their Quality & Delivery Performance.
- Motivate standardized product/ Grade specific vendors by giving regular &
sustained long term business.
8.4.3- Incoming Material Inspection-
- Introduce self certification policy for suppliers by intensive education
training & support to improve their processes. Take Experts Help.
- Price incentive & business guarantee for self certified suppliers.
-Motivate & reward self certified suppliers at regular intervals.
8.3 /8.6 Process Design & Product
Inspection-
-Design idiot proof process & controls. Validate all special processes e.g HT.
-Cover all critical processes by mistake proofing-Pokayoke
--Focus process monitoring & stabilization to eliminate/ reduce inspection
10.
FICCI CE
Activities associated with Appraisal costs
➢ 8.6 Proto type measurement & testing
➢ 8.4.3 Vendor surveillance
➢ 8.4.3 Incoming material inspection
➢ 8.3 Process Design /control
➢ 8.6 Product Inspection
➢ 7.1.5 Laboratory testing / measurement
➢ 9.2 Internal audits.
11.
FICCI CE
Internal failure costs
Internal failure costs occurs when results of work fail to reach designated
quality standards , and are detected before transfer to the customer takes
place.
ZERO
12.
FICCI CE
Activities associated with Internal failure costs
Design changes/ corrective action
Scrap due to tool / process design
changes
Excess inventory
Rectification / disposition of purchased
raw material
Rework/rejection in manufacturing
Downgrading of end product
Downtime of plant & machinery
Trouble-shooting & investigation of
defects
13.
FICCI CE
Is it possible to have zero internal failure cost??
NO
Strive to consistently reduce till it is minimized
to best industry practices
Design Changes/ Corrective Actions (8.3.4 & 8.3.4.2 & 8.3.6)
1) Conduct design simulations to validate die design, Validate HT process
for all new parts at development stage.
TO AVOID
a) Scrap cost due to design changes , b) Rework cost, c) set up cost
d) Inspection & re-inspection cost, e) HT rework & Retesting cost,
f) Opportunity Cost etc. etc.
But How?
2) Improve designs & HT processes upfront from lessons learnt & wrongs
done in designing, manufacturing & heat treatment of similar products &
similar material grade in past.
14.
FICCI CE
External failure costs
External failure costs occur when the product or service from a
process fails to reach designated quality standards , and is not
detected/ recognized until informed by the customer.
15.
FICCI CE
Activities associated with External failure costs
Processing / investigation of customer complaint
Repair/replacement of sold goods
Warranty claims
Premium Freights due to delays associated with quality problems
Loss of customer goodwill & sales.
16.
FICCI CE
Is it possible to have zero external failure cost??
NO
Strive to consistently reduce till it is minimized & close to best
industry norms.
Processing/ Investigation of customer complaints (8.7 & 10.2)
1.Avoid knee jerk reaction to arrive at Gut feel Root Cause. Practice honest root cause analysis
fearlessly using simple yet most effective QC tools- 3-legged 5 why-why analysis, Fish Bone
Diagram & Pareto Analysis.
But How?
3. Arrive at achievable corrective & preventive actions
4. Ensure implementation of CAPA.
5. Conduct Surprise Audits to assess effectiveness of CAPA implementation.
6. Modify QMS documents with pictorials as necessary to standardize CAPA.
7. Train operating level persons on QMS changes.
2. Review Process FMEA and Revise as necessary
8. Share & display results at work stations.
9 Reward achievers to motivate them & fellow employees.
17.
FICCI CE
This Will have Direct Impact on
a. Repair/ Replacement of sold goods.
b. Warranty Claims.
↓
↓
c. Premium Freights. ↓
d. Customer Goodwill, Share of Business
& New Business
18.
FICCI CE
Size of four categories of quality costs.
Organizations which do not follow TQM practices explained above, give less
emphasis on prevention and continue focus on appraisal/ detection with not
much control on process monitoring suffer with high quality cost.
Studies have shown that quality cost in manufacturing companies world over
range from 20 % to 30 % of turnover and in the case of service companies it
can go up to 40 % as illustrated in graph on the next slide.
19.
FICCI CE
Size of various quality cost elements
Preventive
1%
Appraisal
4-6%
Internal
Failure
10-12%
External
Failure
10-15%
The total quality
costs 25-35 %
of turnover.
Quality
costs
in
%
of
sales
20.
FICCI CE
Impact of Investment on Prevention & not
Detection(TQM).
TQM aims to improve the Product Quality, process stability, higher
customer satisfaction and better working environment for the employees.
Most dramatic impact of TQM is on reduction of quality costs
directly reflecting in company bottomline showing profitability in
balance sheets.
Results of TQM implementation illustrated in next slide will better explain
the benefits.
21.
FICCI CE
Impact of TQM on costs.
prevention
Appraisal
Internal
Failure
Prevention
Internal
Failure
0
5
10
15
20
25
30
35
%
of
sales
Graphical Illustration.
Before TQM After TQM
Appraisal
22.
FICCI CE
1-10-100 Pyramid
1
10
100
Rs
Rs
Rs
Rs
Rs
Prevention
Correction
Failure
Stages
Higher the investment on Prevention lower the correction & failure costs.
23.
FICCI CE
cost of quality
Traditionally recorded quality cost generally account for only 4 to
5 percent of sales which mainly comprise of cost of scrap, re-work
and warranty.
BUT IS IT ACTUALLY SO???
24.
FICCI CE
Hidden costs of quality
There are additional costs of quality which are hidden and do not appear in
the account books of the company, as they are intangible and difficult to
measure. These additional costs could be as high as 20-25% of sales and
comprise of low conversion efficiency of materials, cost of resolving
customer problems, inadequate resource utilization, high inventory, long
cycle times, more set-up times, penalties due to late delivery and lost
customer loyalty and goodwill.
25.
FICCI CE
•Scrap
•Rework
•Warranty costs
Hidden Costs
Visible costs
• Failure in following Process discipline
• High inventory
• Inadequate resource utilization
• Cost of Tool Correction & re-inspection
• Cost of attending customer complaints
• Lost customers / Goodwill
Visible and hidden costs
• Low Material Yield
26.
FICCI CE
10 Steps to reduce hidden costs.
➢ Identify Hidden Costs
➢ Measure Hidden Costs
➢ Appraise Impact of Hidden costs to CFT
➢ Explore solutions to reduce Hidden costs
➢ Get sanctions for investments if any
➢ Implement &Evaluate effectiveness of solutions
➢ Share the Impact with CFT
➢ Appraise tangible benefits to Top Management
➢ Identify new opportunities.
➢ Repeat the cycle
27.
FICCI CE
Slide- 27
Cost of Poor Quality in Rupees.
Cost Of Poor Quality= [{Cost of Internal Rejection + Cost of External Rejections + QAAppraisal
Cost(wages of QA persons) + Expenses incurred on account of Travel to attend quality complaint + Cost of
prevention (cost incurred on calibration of instruments/equipments + cost of new instruments+ cost of repair
of instruments) + Opportunity cost.(cost of opportunity lost for making good forgings due to rejections
produced) + Rework/salvage cost + Transportation cost incurred for incoming rejection and replacement}÷
Total sales ] X 100
Month 1st
Month 2nd
Month 3rd
Month 4th
Month
Target for Internal Rejection <1.50% <1.50% <1.50% <1.50%
Actual Internal rejection 1.21% 1.22% 1.24% 1.20
Costs not included to
compute COPQ
Calibration Cost+ Opportunity
cost+ cost of RW at prod.
unit+Salvage cost by
machining or Grinding.
Opportunity cost+ Salvage
cost by Machining /
grinding+ Cost of RW at
hammer.
Opportunity cost+
Salvage cost by
machining or grinding.
Opportunity cost
Cost of Internal Rejection 4.84 Lacs 6.3 Lacs 7.75 Lacs 9.0 Lacs
Cost of Poor Quality
12.80 Lacs
(Air Freight-0.69 Lacs)
11 Lacs
(Air Freight-0.12 Lacs)
10.8 Lacs.
(Air Freight-0.12 Lacs)
10.5 Lacs
(Air Freight-0.10 Lacs)
Difference(∂) between
COPQ and cost of Internal
rejection
7.96 Lacs 5.3 Lacs 3.05 Lacs 1.5 Lacs
28.
FICCI CE
Slide- 28
Structure of Cost of Poor Quality(COPQ) Calculation Sheet
Red Box-Few Focus Area to reduce COPQ
Sr. No. Cost Heads 1st Month 2nd Month 3rd Month 4th Month 5th Month 6th Month
1 Cost of Appraisal
a QA & QC salary 281534 285000 286500 283450
b
Cost of Calibration of measuring Equipments(
Dimensions+ Metallurgy)
247950 140230 98405 56490 0 0
A=a+b TOTAL SALE VALUE 529484 425230 384905.00 339940.00 #REF! #REF!
% =(A/G)100 % of A W.R.T. SALE VALUE 0.75% 0.60% 0.52% 0.43% #REF! #REF!
2 Internal Cost
c Sale Value of internal Scrap 484245 630243 775200 906500
b Recovery from scrap
d Cost of In-house Re-work Forge 0 41900 34900
e
Opportunity cost (cost of opportunity lost by
producing rejected parts i.e cost of lost shifts
to recover scrap parts
f
Cost incurred for salvaging by Machining /
grinding
0 0 0 24510 0 0
B=c+d+e+f TOTAL SALE VALUE 484245 630243 817100 965910 0 0
% of B W.R.T. SALE VALUE 0.68% 0.88% 1.11% 1.21% #DIV/0! #DIV/0!
3 External cost
f
Sale price of rejections received in plant &
Scrapped
154050 149900 150690 132740 0 0
g Sale price of parts scrapped at cust end 0 0 0 0 0 0
h
Cost incurred to travel to attend customer
complaint
5060 3600 2900 2500 0 0
i Cost Incurred for rework at customer end 35090 21860 22750 12450 0 0
j Debit Note Values( export + domestic) 285096 104906 37068 21654 0 0
C=f+g+h+i TOTAL SALE VALUE 479296 280266 213408 169344 0 0
% of C W.R.T. SALE VALUE 0.68% 0.39% 0.29% 0.21% #DIV/0! #DIV/0!
D= A+B+C SUB TOTAL 1493025 1335739 1415413 1475194 #REF! #REF!
E Recovery from scrap 212450 235650 334950 425090
F= D--E Final Cost for calculating COPQ 1280575 1100089 1080463 1050104
G SALE VALUE 70978000 71250000 73690000 79980000
5=F÷Gx100 COST OF POOR QUALITY(COPQ) 1.80% 1.87% 1.92% 1.84% #REF! #REF!
29.
FICCI CE
Conclusion.
➢Cost Reduction with Systemic approach is simple
➢ Use Quality Management Tools to your advantage
➢OK is no longer OK
➢Race against time and strive to be the best
➢Be your own critic
➢Do not keep systems bound in manuals for audits
➢ Success Guaranteed
ONLY IF
30.
FICCI CE
Tools for Cost Reduction through Rejection Control
• Advance Product Quality Planning APQP
• Definition:-Structured method of defining and establishing the steps necessary to assure that a
product satisfies the customer with lowest rejection
Objectives of APQP
• Team Involvement for best product quality and process discipline
• Optimise mfg.process with available resources
• Apprehend Quality issues to decide proactive mitigation actions in process or tool design
• Minimal product launch quality risks
Benefits
• Resources are directed towards customer satisfaction
• Proactive approach for changes necessary to achieve objectives
• On time Quality product at the lowest rejection cost.
Methodology
• Prepare Timing chart to decide inputs such as customer Inputs, business plans etc to get output such as
Bill of Material, Process flow Chart, List of Special Characteristics, Quality Plan
Product Design and Development- (Out of scope of discussion)
Process Design and Development
• Process Sequencing & Flow Chart
• Preliminary Process Capabilities Study Plan
• Packaging Standards
• Tool Design
• Process Monitoring, controls & Validation
• Production Trial Run
31.
FICCI CE
Process Failure Modes & Effects Analysis(PFMEA)
Definition:-Process Failure Mode and Effect Analysis is a systemetic study to ensure that potential process
failures throughout the manufacturing process are identified and addressed at development process stage
and documented.
PFMEA Objective
• Process FMEA is a dynamic document prepared honestly at feasibility study in the right spirit
• PFMEA apprehends potential failures in all manufacturing processes & evolves actions to mitigate and control
• PFMEA to be developed by people with adequate process knowledge
• Risk Priority Numbers (RPN) high or low alone does not guarantee process quality or stability. It is the
authenticity of real data used to allot risk numbers and time bound action plan to reduce risks & improve
controls.
Benefits
• Proactive process risks identification, addresal and mitigation to reduce rejections
• Inculcate cultural change of forward thinking in organization before start of manufacturing
• Helps confidence building in process monitoring and establish control mechanism
• Dynamic review discipline helps reduce risks likely to occur due to variety of changes
Methodology
Review and revise whenever:-
• Change of process for any reason in house or at vendors end
• Change of Input RM section or spec or steel supplier or any other input likely to impact process
• Change in Mfg Location or Mfg Equipment
• Abnormal rejection or customer returns or field failures
• Change of Key operatives, Customer issued Engineering Change that impact the process
• Minimum once a year if none of the above applicable to comply to standard requirement
32.
FICCI CE
Measurement System Analysis
• Definition: Measurement system is a process to study the possibility of variance likely to come in the product or
process tangible measurements which may make the measurements unreliable for decision making process.
Objective:-
To study the impact of variance caused by Man (appraiser) Machine( Equipment) Method & Material in a given environment
while measuring a product or process.
Benefits:-
• Comparative study of various measuring instruments helps to choose the appropriate equipment to reduce rejections
• Identify suspect gauges, instruments likely to give erratic measurement results leading to rejections.
• To evaluate the efficacy & quality of repairs of measuring equipment
• Helps to validate quality of new measuring equipment
• Helps to assess gauge or instrument wear and tear likely to result in rejections.
• Helps to prevent a good part declared bad or vice versa
Methodology:-
Conduct studies for:-
Bias:- Difference between observed average of measurements and a reference valve (Accuracy)
Linearity:-The difference in Bias errors over the operating range of measurement system
Stability:-The total variation in measurement system’s Bias over time on a given part or master part.
Repeatability:-The variation in measurement obtained while measuring Same Characteristics repeatedly on the same part
with same measuring instrument by one appraiser.
Reproducibility:-Variation in the averages of the measurements made by different appraiser using same measurement
instrument while measuring the identical characteristics on the same part.
33.
FICCI CE
Production Part Approval Process (PPAP)
Definition:-Disciplined approach to establish the manufacturing process to produce consistently good quality
products as per customer engineering standards at quoted production rate on pre-decided set of equipment installed
at a particular location.
Objective:-
Manufacturing process establishment to ensure defect free supplies consistently from a defined location & equipment under
given set of variables.
Benefits:-
Control on internal & customer rejections
Stability in productivity and quality
No risk of field failures
Reliable Quality records from PPAP file for end user
Helps confidence building with customer approved part submission warrant
Methodology:-
Conduct PPAP study whenever:-
• Change of process for any reason in house or at vendors end
• Change of Input RM section or spec or steel supplier or any other input likely to impact process
• Change in Mfg Location or Mfg Equipment
• Abnormal rejection or customer returns or field failures
• Change of Key operatives
• Customer issued Engineering Change
34.
FICCI CE
PFMEA – Process Failure Mode Effect Analysis
35.
FICCI CE
2 Reasons why we should do an FMEA
Assessment of Unacceptable risk and the determination of
actions to mitigate that risk
Significant savings in Engineering time due to reduction in
changes immediately before and after Job
36.
FICCI CE
An FMEA can be described as a systemized group of activities intended to :
(a) Recognize and evaluate the potential failure of a product /process and its effects
(b ) Identify actions which could eliminate or reduce the chance of the potential failure
occurring , and
(c) Document the process, It is complementary to the process of defining what a
design or process must do to satisfy the customer
By its self, an FMEA is NOT a problem solver.
It is used in combination with other problem solving tools. ‘The FMEA presents
the opportunity but does not solve the problem’
37.
FICCI CE
Important factors for successful implementation of an FMEA is
Timeliness, BEFORE –THE EVENT action and not AFTER THE
FACT exercise
T
o Achieve the greatest value , the FMEA must be done before
the product or process failure mode has been incorporated into
product or process
An FMEA can reduce or eliminate the chance of implementing a
preventive /Corrective change
38.
FICCI CE
IMPROVES THE QUALITY
, RELIABILITY AND
SAFETY OF THE EVALUATED PRODUCTS
REDUCESPRODUCT RE DEVELOPMENT TIMING AND COST
DOCUMENT AND TRACKS ACTIONS TAKEN TO REDUCE RISK
AIDS IN THE DEVELOPMENT OF ROBUST CONTROL PLANS
AIDS IN THE DEVELOPMENT OF DESIGN VERIFICATION PLANS
HELPS ENGINEERS PRIORITSE AND FOCUS ON ELIMINATING PRODUCT
AND PROCESS CONCERNS AND/OR
HELPS PREVENT PROBLEMS FROM OCCURRING
IMPROVES CUSTOMER/CONSUMER SATISFACTION
39.
FICCI CE
•FMECA
•Failure Mode Effects and Criticality Analysis
•1950’s Origin - Aerospace & US Military
•T
o categorize and rank for focus
•T
argeted prevention as a critical issue
•Addressed safety issues
•FMEA
•Failure Mode and Effects Analysis - 1960’s and 70’s
•First noticed & used by reliability engineers
•System of various group activities provided through documentation of potential
failure modes of products and/or processes and its effect on product performance.
•The evaluation and documentation of potential failure modes of a product or
process. Actions are then identified which could eliminate or reduce the potential
failure
Origins
40.
FICCI CE
•The team developing the FMEAturns out to be one individual.
•The FMEAis created to satisfy a customer or third party requirement, NOT to
improve the process.
•The FMEAis developed too late in the process and does not improve the
product/process development cycle.
•The FMEAis not reviewed and revised during the life of the product. It is not
treated as a dynamic tool.
•The FMEAis perceived either as too complicated or as taking too much time.
Common Mistakes in Preparing FMEA leading to Failures
41.
FICCI CE
1. IDENTIFY THE TEAM
2. IDENTIFY PROCESS FOR FMEA STUDY –
REFER PROCESS FLOW CHART
1. DEFINE THE PROCESS FUNCTION AND REQUIREMETNS.
2. INPUTS FROM DESIGN FMEA
3. INPUTS FROM SIMMILAR PROCESS.
4. REJECTION , WARANTY CLAIMS , COMPLAINTS FOR
SIMMILAR PARTS.
Steps to Prepare FMEA
42.
FICCI CE
The FMEAProcess
Identify Functions ,Requirements &
Specifications
Identify Failure Modes
Identify Effects of the Failure Mode
Determine Severity
Apply Procedure for
Potential Consequences
Identify Potential Causes
Determine Occurrence
Calculate Criticality
Identify Root Cause
Identify Special Characteristics
RPN & Final Risk Assessment
Determine Detection
Determine Design & Process Controls
Take actions to reduce Risk
44.
FICCI CE
Procee
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cl
as
sif
ic
ati
on
Potential
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
ENTER THE SIMPLE DESCRIPTION OF THE PROCESS OR OPERATION ANALYSED
(EXAMPLE : TURNING, DRILLING, FORGING, TAPPING, WELDING, ASSEMBLING)
REVIEW APPLICABLE PERFORMANCE, MATERIAL, ENVIRONMENT
, PROCESSAND
SAFETY STANDARDS
NOTE PROCESS FUNCTION –REQUIREMENTS INCLUDES PRODUCT AND PROCESS
CHARACTERISTICS
45.
FICCI CE
process
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cl
as
sif
ic
ati
on
Potential
Cause
(s) of
Failure
Current
process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
Is defined as the manner in which a PROCESS could potentially fail to meet the process
requirements and/or design Requirement .It is a description of the NC at that specific operation
No Function
• Partial / Over Function
• Degraded over time
• Intermittent Fn
• Unintended Fn
46.
FICCI CE
Process
Step/Function
Requirement Potential Failure Mode Effects of Failure
Finisher
Forging
Four Blows Fewer than four Blows
or more than four blows
Thickness Oversize or
Undersize
Blow
scale
from both
dies after
3rd blow
Operator fails to blow scale Pit marks
Part to be gently
picked by contract
labour from behind the
hammer
Crew short of one person Parts thrown resulting in dent
marks or parts left untrimmed
Lubricant
ratio to be
1:10
Lubrication ratio not
monitored
Sticking or oil shuts
47.
FICCI CE
Process
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cl
as
sif
ic
ati
on
Potential
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
Potential Effects of failure are defined as the effects of the failure mode on the function,
as perceived by the customer
CUSTOMER IN THIS CASE IS THE NEXT OPERATION END USER, VEHICLE OWNER
Typical failure Effects could be but not limited to :
NOISE ROUGH
ERRACTIC OPERATION IN OPERATIVE
POOR APPERANCE UNPLEASANT ODOUR
UNSTABLE OPERATION IMPAIRED
INTERMITTENT OPERATION THERMAL EVENT
LEAKS REGULATORY NON COMPLAINCE
IF THE CUSTOMER IS THE NEXT OPERATION OR SUB SEQUENT OPERATION THE EFFECTS
MUST BE STATED
CANNOT FASTEN DOES NOT FIT
CANNOT BORE /TAP DOESNOT CONNECT
CANNOT MOUNT DOESNOT MATCH
CANNOT FACE DAMEGES THE EQUIPMENT
ENDAGERS THE OPERATOR EXCESSIVE TOOL WEAR
48.
FICCI CE
Requirement Potential Failure Mode Effect
Four screws Fewer than four screws End User: loose seat cushion and noise.
Manufacturing and Assembly: stop shipment and additional sort
and rework due to affected portion
Specified screws Wrong screw used (larger dia) Manufacturing and Assembly: unable to install screw in station
Assembly sequence: first
screw in right front hole
Screw placed in any other hole Manufacturing and Assembly: difficult to install remaining screws
in station.
Screws fully seated Screw not fully seated End User: loose seat cushion and noise. Manufacturing and
Assembly: sort and rework due to affected portion
Screws torqued to dynamic
torque specification
Screw torqued too high End User: loose seat due to subsequent fracture of screw and
noise.
Manufacturing and Assembly: sort and rework due to affected
portion
Screw torque too low End User: loose seat due to gradual loosening of screw and
noise.
Manufacturing and Assembly: sort and rework due to affected
portion
49.
FICCI CE
Process
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cl
as
sif
ic
ati
on
Potential
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
Severity is an assessment of how serious the Effect of the
potential Failure Mode is on the Customer
Severity is the rank associated with the most serious effect for a given
failure mode
A reduction in the severity mode can be effected only through a
design change
NOTE : IT IS RECOMMENDED TO MODIFY THE CRITERIA RANKING VALUES
9 AND 10 .
FAILURE MODES WITH A RANK OF SEVERITY 1 SHOULD NOT BE
ANALYSED FURTHER
Classify any special product /process characteristics ( Critical, Key, major, significant)
For components, sub system, system
Class may also be used to highlight high priority failure modes for engg assessment
This slide is more relevant for Design FMEA.
We can ignore as we consider severity 8 or 9 while preparing forging process FMEA as explained in next slide
50.
FICCI CE
Effect Criteria: Severity of Effect on Product (customer Effect) Rank Effect Criteria: Severity of Effect on Process
(Manufacturing/Assembly Effect)
Failure to
Meet Safety
and/or
Regulatory
Requirements
Potential failure mode affects safe vehicle operation
and/or involves noncompliance with government
regulation without warning.
10 Failure to
Meet Safety
and/or
Regulatory
Requirement
May endanger operator (machine or assembly)
without warning.
Potential failure mode affects safe vehicle operation
and/or involves noncompliance with government
regulation with warning.
9 May endanger operator (machine or assembly)
with warning.
Loss or
Degradation
of Primary
Function
Loss of primary function (vehicle inoperable, does
not effect safe vehicle operation ).
8 Major
Disruption
100% of product may have to be scrapped.
Line shutdown or stop ship.
Degradation of primary function (vehicle operable,
but at reduced level of performance).
7 Significant
Disruption
A portion of the production run may have to be
scrapped. Deviation from primary process
including decreased line speed or added
manpower.
Loss or
Degradation
of Secondary
Function
Loss of secondary function (vehicle operable, but
comfort/convenience function inoperable).
6 Moderate
Disruption
100% of production run may have to be
reworked off line and accepted.
Degradation of secondary function (vehicle operable,
but comfort/convenience function at reduced level of
performance).
5 A portion of production run may have to be
reworked off line and accepted.
Annoyance Appearance or Audible Noise, vehicle operable, item
does not conform and noticed by most customers
(>75%).
4 Moderate
Disruption
100% of production run may have to be
reworked in station before it is processed.
Appearance or Audible Noise, vehicle operable, item
does not conform and noticed by many customers
(50%).
3 A portion of production run may have to be
reworked in station before it is processed.
Appearance or Audible Noise, vehicle operable, item
does not conform and noticed by discriminating
customers (25%).
2 Minor
Disruption
Slight inconvenience to Process, Operation, or
Operator.
No effect No discernible effect. 1 No effect No discernible effect.
51.
FICCI CE
Requirement Failure Mode cause Prevention Action Detection Control
Screws
torqued until
fully seated
Screw not fully
seated
Nut runner not held
perpendicular to work
surface by operator
Operator training Angle sensor included in nut runner to
detect cross-threading not allowing part
to be removed from fixture until value is
satisfied
Screws
torqued to
dynamic
torque
specification
Screws torqued
too high
Torque setting set
too high by non-set –
up personnel
Password protected
control panel (only set-
up personnel have
access)
Torque validation box included in set-up
procedure to validate setting prior to
running
Torque setting set
too high by set –up
personnel
Training of set-up
personnel
Torque validation box included in set-up
procedure to validate setting prior to
running
Settings added to set-up
instructions
Screws torqued
too low
Torque setting set
too low by non-set –
up personnel
Password protected
control panel (only set-
up personnel have
access)
Torque validation box included in set-up
procedure to validate setting prior to
running
Torque setting set
too low by set –up
personnel
Training of set-up
personnel
Torque validation box included in set-up
procedure to validate setting prior to
running
Settings added to set-up
instructions
52.
FICCI CE
Item
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cl
as
sif
ic
ati
on
Potential
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
LIST , TO THE EXTENT POSSIBLE , EVERY POSSIBLE CAUSEAND/OR FAILURE
MECHANISM FOR EACH FAILURE MODE
IF A CAUSE IS EXCLUSIVE TO THE FAILURE MODE I.e., IF CORRECTING THE CAUSE
HAS A DIRECT IMPACT ON THE FAILURE MODE , THEN THIS PORTION OF FMEA
IS COMPLETE
TYPICAL FAILURE CAUSES INCLUDES , BUT NOT LIMITED TO
•IMPROPER TORQUE OVER/UNDER INADEQUATE GATING AND VENTING
•IMPROPER WELD –CURRENT
,TIME,PRESSURE
•INACCURATE GUAGING IMPROPER HEAT TREAT TIME,TEMPERATURE
•INADEQUATE OR NO LUBRICATION
•PART MISSING OR MIS LOCATED WORN LOCATOR, WORN TOOL
• IMPROPER MACHINE SETUP IMPROPER PROGRAMMING
53.
FICCI CE
Item
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cla
ssifi
cati
on
Potenti
al
Cause
(s) of
Failure
Current
process
Control
Prevention
O
cc
ur
re
nc
e
Current
process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
CURRENT PROCESS CONTROLS ARE DESCRIPTION OF THE CONTROLS THAT EITHER
PREVENT TO THE EXTENT POSSSIBLE THE FAILURE MODE/CAUSE FROM OCCURING
OR DETECT THE FAILURE MODE OR CAUSE SHOULD IT OCCUR
THERE ARE 2 TYPES OF PROCESS CONTROL
1. TYPE 1 PREVENTION : PREVENT THE CAUSE OR FAILURE MODE
EFFECT FROM OCCURRING OR REDUCE THE RATE OF
OCCURRENCE
2. TYPE 2 DETECTION: DETECT THE CAUSE
/MECHANISM AND LEAD TO CORRECTIVE
ACTIONS
54.
FICCI CE
Item
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cla
ssifi
cati
on
Potenti
al
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
Detection : Visual Check, T
esting, On line testing, Life testing
Prevention : Mistake proofing, preventive actions, Mistake Proofing
Occurrence is the likelihood that a specific cause/mechanism will occur during the design life
Estimate the likelihood of occurrence of potential failure cause /or mechanism on a scale of 1 to 10
Use the rating table
For causes listed, assign one occurrence that this cause will occur over the design life of the item
Use a 10 if the occurrence cannot be estimated at this time or the team cannot agree to the occurrence
55.
FICCI CE
Requirement Failure Mode cause Prevention Action Detection Control
Four
Blows in
Finisher
Thickness
Oversize
or
Undersize
, Parts
remains
underfill.
Less Blows or
More Blows
than four
Thickness
oversize or
undersize
notlikely
because die to
die kissing
validated in last
stroke.
Variance in
number of
blows linked to
production rate
per hour being
monitored
Automatic Go/NO GO gauge
for 100% thickness check
installed at exit of trim press
and camera scanner installed
for 100% visual inspection of
underfill. Alarm will activate if
variance in no of parts per
hour recorded on more than
three instances in a shift.
56.
FICCI CE
Likelihood of Failure Criteria; Occurrence of Cause-PFMEA (incident per items/vehicles) Rank
Very High ≥100 per thousand
≥1 in 10
10
High 50 per thousand
1 in 20
9
20 per thousand
1 in 50
8
10 per thousand
1 in 100
7
Moderate 2 per thousand
1 in 500
6
.5 per thousand
1 in 2,000
5
.1 per thousand
1 in 10,000
4
Low .01 per thousand
1 in 100,000
3
≤.001 per thousand
1 in 1,000,000
2
Very Low Failure is eliminated through preventive control 1
57.
FICCI CE
Opportunity for
Detection
Criteria: Likelihood of Detection by Process Control Rank Likelihood of
Detection
No detection
opportunity
No current process control; Cannot detect or analyzed. 10 Almost
Impossible
Not likely to detect at
any stage
Failure Mode and/or Error (cause) is not easily detected (e.g., random audits). 9 Very Remote
Problem Detection
Post Processing
Failure Mode detection post-processing by operator through visual/tactile/audible means. 8 Remote
Problem Detection at
Source
Failure Mode detection in-station by operator through visual/tactile/audible means or post-
processing through use of attribute gauging (go/no-go, manual torque check/clicker wrench,
etc.).
7 Very Low
Problem Detection
Post Processing
Failure Mode detection post-processing by operator through use of variable gauging or in-
station by operator through use of attribute gauging (go/no-go, manual torque check/clicker
wrench, etc.).
6 Low
Problem Detection at
Source
Failure Mode or Error (cause) detection in-station by operator through use of variable gauging
or by automated controls in-station that will detect discrepant part and notify operator (light,
buzzer, etc.) gauging performed on setup and first-piece check (for set-up causes only).
5 Moderate
Problem Detection
Post Processing
Failure mode detection post-processing by automated controls that will detect discrepant part
and lock part in station to prevent further processing.
4 Moderate
High
Problem Detection at
Source
Failure Mode detection in-station by automated controls that will detect discrepant part and
lock part in station to prevent further processing.
3 High
Error Detection and/or
Problem Prevention
Error (cause) detection in-station by automated controls that will detect error and prevent
discrepant part from being made.
2 Very High
Detection not
applicable; Error
Prevention
Error (cause) prevention as a result of fixture design, machine design or part design.
Discrepant parts cannot be process/product design.
1 Almost
certain
58.
FICCI CE
Item
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cla
ssifi
cati
on
Potenti
al
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
The risk priority number is the product of the S O D
With in the scope of the individual FMEA THIS VALUE
Can lie between 1 to 1000
ENGINEERING ASSESSMENT SHOULD DIRECT THE ACTION ON HIGH SEVERITY
OR HIGH RPN VALUE
REVISED TEST PLAN
REVISE DESIGN SPECIFICATION
REVISE MATERIAL SPECIFICATION
59.
FICCI CE
Item
/
Function
Req
uire
me
nt
Potential
Failure
Mode
Potenti
al
Effect
(s) of
Failure
S
E
V
Cla
ssifi
cati
on
Potenti
al
Cause
(s) of
Failure
Current
Process
Control
Prevention
O
cc
ur
re
nc
e
Current
Process
Control
Detectio
n
D
e
t
e
c
t
R
P
N
Recomme
nded
Action
Responsibility
& Target
Completion
Date
Action Results
–
Action Taken
& Completion
date
S
E
V
O
C
C
D
E
T
R
P
N
THE PURPOSE OF AN ACTION IS TO ELIMINATE POTENTIAL FAILURE MODES
THE ACTION SHOULD PRIORITISE ACTIONS BASED ON THOSE FAILURE MODES
• WITH EFFECTS THAT HAVE THE HIGHEST SEVERITY RANKINGS
• WITH CAUSES THAT HAVE THE HIGHEST SEVERITY TIMES OCCIRRENCE
RATINGS
• WITH THE HIGHEST RPN’S
REVISED PROCESS PARAMETERS ,CONTROLS
NOTE
1. SEVERITY CAN BE BY DESIGN CHANGE
2. OCCURRENCE RANKING CAN BE EFFECTED ONLY BY REMOVING OR
CONTROLLING ONE OR MORE CAUSE
60.
FICCI CE
OUTPUTS OF PROCESS FMEA
PRELAUNCH CONTROL PLAN
OPERATOR WORK INSTRUCTIONS
OPERTAOR TRAINING NEEDS
MISTAKE PROFFING
62.
FICCI CE
THE PROCESS FMEA IS ALSO A LIVING DOCUMENT AND SHOULD BE INITIATED :
BEFORE OR AT THE FEASIBILITY STAGE
PRIOR TO TOOLING FOR PRODUCTION
AND TAKE INTO ACCOUNT ALL MANUFACTURING OPERATIONS , FOR INDIVIDUAL
COMPONENTS TO ASSEMBLIES
63.
FICCI CE
A PROCESS FMEA IS CONSIDERED “COMPLETE” WHENALL OPERATIONS
HAVE BEEN CONSIDERED ,WHEN ALL SPECIAL CHARACTERISTICS HAVE BEEN
ADDRESSED, AND WHEN THE CONTROL PLAN HAS BEEN COMPLETED
64.
FICCI CE
Process FMEA Benefits
•Identifies potential product related process failure modes.
•Assesses the potential customer effects of the failures.
•Identifies the potential manufacturing or assembly process causes and identifies
process variables on which to focus controls for occurrence reduction or detection
of the failure conditions.
•Develops a ranked list of potential failure modes, thus establishing a priority
system for corrective action considerations.
•Documents the results of the manufacturing or assembly process.
•Identifies process deficiencies to enable engineers to focus on controls for
reducing the occurrence of producing unacceptable products, or on methods to
increase the detection of unacceptable products.
•Identifies confirmed Critical Characteristics and/or Significant Characteristics and
aids in development of thorough Manufacturing or Assembly Control Plans.
•Identifies operator safety concerns.
•Feeds information on design changes required and manufacturing feasibility back
to the design community
65.
FICCI CE
•Process FMEA Outputs
•A list of potential process failure modes.
•A list of confirmed Critical Characteristics and/or Significant
Characteristics.
•A list of Operator Safety and High Impact Characteristics.
•A list of recommended Special Controls for designated product
Special Characteristics to be entered on a Control Plan.
•A list of processes or process actions to reduce Severity,
eliminate the causes of product failure modes, or reduce their rate
of Occurrence, and to improve product defect detection if process
capability cannot be improved.
•Changes to process sheets and assembly aid drawings
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