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National Quality Department

Business Excellence Program (BEX)


Business Process Management System
Training

Failure Mode & Effect Analysis


FMEA
April 2011
Rev 1.0

National Quality Department BPMS - FMEA Rev 1.0 1


About This Module…

An FMEA is a systematic method for identifying, analyzing,


prioritizing and documenting potential failure modes, their
effects on system, product, process performance and the
possible causes of failure.

National Quality Department BPMS - FMEA Rev 1.0 2


What We Will Learn…

1. As a Team, how to construct an FMEA and


associated Action Plan

2. How the FMEA process ties to process


mapping

3. The relationship between Failure Mode,


Cause and Effect

4. The different types of FMEAs

National Quality Department BPMS - FMEA Rev 1.0 3


Sample FMEA
p R
S O D R Actual r i Risk
Failure E C E P Resp. Schedule Compl. p p p p s X
Effects V Causes C Controls T N Action Recommended Person Date Action Taken Date S O D n k prpn
Must PM Schedule
redo Periodic created and
copy 6 Paper Jam 7 Maint. 7 294 Periodic preventive maintence Key Opr 3/1 implemented 2/15 6 3 7 126 3 378
Place sign over copier outlining
Must Existing standard size enlarge/reduce or
redo User notes on reliable mach to clearly indicate Place sign over
copy 6 misset size 6 copier 5 180 standard reduce/enlarge Key Opr 2/20 mach 2/15 6 3 2 36 1 36
Must User Existing
redo misset notes on Place sign to encourage user to Place sign over
copy 6 control 5 copier 4 120 utilize auto settings Key Opr 2/20 mach 2/15 6 2 2 24 1 24
Used
landscape
Must instead of
redo portrait or Tray Place note on ruler re tray
copy 6 vice versa 7 Selection 2 84 selection Key Opr 1/20 Placed Note 1/15 6 2 1 12 1 12

Must align Use Auto


redo marking Feeder / Enlarge marks for 8.5 " paper on
copy 6 not clear 4 align ruler 3 72 ruler Key Opr 1/15 Enlarged marks 1/14 6 2 1 12 1 12
Doc
Must moved Use Auto Place sign over copier re
redo when lid Feeder / "Ensure align prior to copying or
copy 6 closed 5 align ruler 2 60 use auto Feeder" Key Opr 1/15 Displayed Sign 1/14 6 1 1 6 1 6

Must User Auto Place sign over copier to


redo selected select encourage user to use auto tray Place sign over
copy 6 wrong tray 3function 3 54 select Key Opr 2/25 mach 2/20 6 2 3 36 1 36
Must Periodic
redo Cleaning Place cleaning material near Placed Cleaning
copy 6 Dirty Glass 6 SOP 1 36 copier Maint. 1/15 Matl 1/15 6 1 1 6 1 6

National Quality Department Datafile/CopyFMEA.xls


BPMS - FMEA Rev 1.0 4
Why Use FMEAs?

Identify
critical product characteristics and process variables

Prioritize
product and process deficiencies in support of downstream
improvement actions

Help focus
on prevention of product and process problems

National Quality Department BPMS - FMEA Rev 1.0 5


Benefits of FMEA’s

 Improves the quality, reliability and safety of processes.


 Helps increase customer satisfaction.
 Reduces process development timing and cost.
 Reduces the amount of rework, repair and waste.
 Documents and tracks actions taken.
 Prioritizes deficiencies to focus improvement efforts.

National Quality Department BPMS - FMEA Rev 1.0 6


Process and FMEA Hierarchies
Process - Level #1

Step #1 Step #2 Step #3


FMEA - Level #1

Process - Level #2

Step #1 Step #2 Step #3 FMEA - Level #2

Process - Level #3

Step #1 Step #2 Step #3 FMEA - Level #3

National Quality Department BPMS - FMEA Rev 1.0 7


Process FMEA Steps
 Steps Completed Prior to FMEA:
– Charter Team
– Develop and Characterize Process Map
 FMEA Steps:
1. Identify “Heavy Hitter” Process Step
1. Identify Associated y’s (Product Parameters)
1. Identify Failure Mode
1. Identify Failure Effects/Rate Severity
1. Identify Causes/Rate Occurrence
1. Identify Controls (if any)/Rate Detection
1. Calculate RPN
1. Prioritize by RPN Order
1. Determine Actions/Plan
1. Recalculate RPN Based on Plan
1. Take Action
National Quality Department BPMS - FMEA Rev 1.0 8
Header Accessible from

FMEA Form
View Header/Footer
in Excel

Workbook in Excel

\DataFile\FMEAForm.xls
National Quality Department BPMS - FMEA Rev 1.0 9
Cause -Failure Mode -Effect
Continuum
Effect (y’s)
Cause Failure
(x’s) Mode

National Quality Department BPMS - FMEA Rev 1.0 10


The Cause and Effect Diagram
Admin/Service Example
Example
Measurements Materials Manpower
First produced in 1950 by
Professor Kaoru Ishikawa -
Also called the:
 Ishikawa Diagram
 Fish Bone Diagram
Failure Mode
(Defect)
Developed to represent the
relationship between some
“effect and all possible
Failure “causes” influencing it.
Effect
Mother Methods Machines Create using Igrafx:
Nature

National Quality Department BPMS - FMEA Rev 1.0 11


The Cause and Effect
Diagram Example (cont.)
Measurement
Manpower Material
Reproducibility Repeatability
Inadequate Late
training Linearity
Wrong quantity
Stability
Lack of
experience Defective Calibration

Distractions

Defects
Too hot
Vague
Too humid
Not maintained Out of date

Too cold Inadequate capability Complex


Mother nature
Machines Methods

Datafile/Causeeffecte.igx
National Quality Department BPMS - FMEA Rev 1.0 12
Copy Machine Example
• Our process is copying documents
on a Xerox model XC1045 copy
machine.
• First we will construct a process
map
• Then we will construct a cause
and effect diagram
• Finally we will complete an FMEA

National Quality Department BPMS - FMEA Rev 1.0 13


Process: Making A Copy

Place Set Set Select


Enter size Press Retrieve
Document number of light/dark paper
required button copies
in Copier copies settings source

N Hinges C Copies C Size desired C Darkness C Size desired Cr Button


N Glass clean required Cr Size button desired x Paper
Cr Number
button
Make Copies

Document set Number of Size selected Darkness set Correct Copies Copies
correctly copies selected correctly directly paper tray Right number
Glass clean correctly selected Right contrast
Right
orientation
Right size
Right paper

Legend
C Controllable
Cr Critical
N Noise
P Procedure
x Input

National Quality Department BPMS - FMEA Rev 1.0 14


Step 1: Identify “Heavy Hitter” Process Step
 From the Process Map, identify the process step with the
most likelihood of having failure modes with significant
effects
 Use defect data and/or team knowledge about failure
modes when selecting process steps
 Significant impact to the business? (COPQ, cycle time,
fill rate, ...)
 Use a Cause and Effect Diagram to capture
brainstorming results.
 After completing FMEA Steps #2-7 for all failure modes
associated with this process step, return to this step and
select the next most likely “Heavy Hitter” process step
 Not all process steps will need to be analyzed by the
FMEA
National Quality Department BPMS - FMEA Rev 1.0 15
Step 2: Identify Associated y’s
 From the Process Map, identify the y’s that are associated with the
process step being investigated
 As the y’s are the indications of a successful completion of the
process step, they are crucial as a basis for determining failure
modes

National Quality Department BPMS - FMEA Rev 1.0 16


Step 3: Identify Failure Mode
• Brainstorm failure modes for the selected process step :
– Identify the ways in which the process could fail to generate
each of the expected “y’s”
• Eliminate “duplicates” from brainstorm list
• Are the failure modes from the same level of the process?
• Are the failure modes specific?
• Are the failure modes the most likely?
• Do the failure modes provide good coverage of the process
step?
• Have all y’s been considered?

National Quality Department BPMS - FMEA Rev 1.0 17


Step 4: Identify Failure Effects/Rate Severity
 Pick the most likely failure mode and brainstorm the most
important Effects:

– FAILURE EFFECTS are the outcome of the occurrence of the


failure mode on the process. The impact on the customer ---
What does the customer experience as a result of the Failure
Mode?
 Identify each effect as being “Attribute” or “Variable”
 Severity doesn’t change unless the design changes.

National Quality Department BPMS - FMEA Rev 1.0 18


Step 5: Identify Causes/Rate Occurrence
 Identify the most likely causes for each failure mode using a
Cause and Effect Diagram:

– CAUSES are the conditions that bring about the Failure Mode
 Transfer the resulting information to the FMEA form
 Assign an occurrence value (1-10) to the likelihood that each
particular cause will happen and result in the failure mode
 The occurrence score for each cause should be related to the
likelihood of that cause resulting in the failure mode and producing
the specific associated effect

National Quality Department BPMS - FMEA Rev 1.0 19


Organize Brainstorming Ideas
Materials Manpower
Measurement
Wrong Size Selected wrong
Wrong Paper orientation
Selected Size

Copy Misaligned
Too Humid Document Moved
When Lid was Alignment Marking
Closed Unclear

Mother Method
Nature Machine

What would you add?

National Quality Department BPMS - FMEA Rev 1.0 20


Step 6: Identify Controls (if any)/Rate
Detection
 Identify the current mechanisms in place which prevent the cause
from occurring, or detect it before the product reaches the
customer. Some examples of controls are SPC, training,
maintenance, inspection/review, SOP etc.
 Assign a detection value (1-10) based on an assessment of the
likelihood that the current control mechanisms will detect the cause
of the failure mode before it reaches the customer.
 Don’t agonize over detectability.

National Quality Department BPMS - FMEA Rev 1.0 21


Step 7: Calculate Risk Priority Number (RPN)

The product of the estimates of severity

occurrence and

detection.

The RPN provides a relative priority for taking action


the bigger the RPN, the more important to address.

RPN = SEVERITY x OCCURRENCE x DETECTION

National Quality Department BPMS - FMEA Rev 1.0 22


Steps 8 and 9

8: Prioritize by RPN Order


Use the “Sort” command in Excel to order the spreadsheet in
descending order of Risk Priority Number (RPN).

9: Determine Actions/Plan
Based on the causes found, determine actions that will
minimize the effect of each cause, in priority order.

National Quality Department BPMS - FMEA Rev 1.0 23


Steps 10 and 11
10: Recalculate RPN Based on Plan
 Assuming the actions are carried out successfully, reassign
severity, occurrence and detectability.
 Place these new ratings in the “predicted” columns (ps, po & pd).
 Assign a rating from 1 to 5 for each action that will show the “risk”
associated with each action (5 being the greatest risk). Place the
rating in the “risk” column.

11: Take Action


 Based on the risk mitigation column (Risk * prpn), take the actions
indicated or reassign actions. Then….
 Complete the actions indicated by the times stated!

National Quality Department BPMS - FMEA Rev 1.0 24


Step 2
ID y’s
Steps 1-11
Step 1 Step 6 Step 9
ID Process Steps Step 4
Step 11 R
p
S
Failure E
O
C
D R
E P
FMEA Resp. Schedule
Actual
Compl. p p p
r
p
i Risk
s X
Effects V Causes C Controls T N Action Recommended Person Date Action Taken Date S O D n k prpn
Must PM Schedule
redo Periodic created and
copy 6 Paper Jam 7 Maint. 7 294Periodic preventive maintence Key Opr 3/1 implemented 2/15 6 3 7 126 3 378
Place sign over copier outlining
Must Existing standard size enlarge/reduce or
redo User notes on reliable mach to clearly indicate Place sign over
copy 6 misset size 6 copier 5 180 standard reduce/enlarge Key Opr 2/20 mach 2/15 6 3 2 36 1 36
Must User Existing
redo misset notes on Place sign to encourage user to Place sign over
copy 6 control 5 copier 4 120 utilize auto settings Key Opr 2/20 mach 2/15 6 2 2 24 1 24
Used
landscape
Must instead of
redo portrait or Tray Place note on ruler re tray
copy 6 vice versa 7 Selection 2 84 selection Key Opr 1/20 Placed Note 1/15 6 2 1 12 1 12

Must align Use Auto


redo marking Feeder / Enlarge marks for 8.5 " paper on
copy 6 not clear 4 align ruler 3 72 ruler Key Opr 1/15 Enlarged marks 1/14 6 2 1 12 1 12
Doc
Must moved Use Auto Place sign over copier re Step 10
redo Stepwhen
3 lid Feeder / "Ensure align prior to copying or
Step 5 Step
use auto7Feeder"
&8
ID Failure Modes 5
copy 6 closed align ruler 2 60 Key Opr 1/15 Displayed Sign 1/14 6 1 1 6 1 6
National Quality Department BPMS - FMEA Rev 1.0 25
Types of FMEAProcess FMEA
• Helps analyze manufacturing and assembly processes to reduce the
occurrence and improve detection of defects.
• Assists in the development of process control plans.
• Establishes a priority for improvement activities.
• Documents the rationale behind process changes and helps guide
future process improvement plans.
• IS PROACTIVE! Should be started when new processes are
designed or when old processes are changed.

National Quality Department BPMS - FMEA Rev 1.0 26


Process FMEA Scoring Definition

Score SEVERITY CRITERIA OCCURRENCE DETECTION


10 Hazardous Without Warning 1 in 2 Very High Absolute Uncertainty
9 Hazardous With Warning 1 in 3 Very High Very Remote
8 Very High 1 in 8 High Remote
7 High 1 in 20 High Very Low
6 Moderate 1 in 80 Moderate Low
5 Low 1
1 in
in 400 Moderate Moderate
4 Very Low 2,000
1 in Moderate Moderately High
3 Minor 15,000
1 in Low High
2 Very Minor 150,000
£1 in Low Very High
1 None 1,500,00 Remote Almost Certain

Note: When completing a Process FMEA, first assume the material is good and
the process is bad. Then assume that the process is good and the material is
bad. Lastly, review the process for safety considerations.

National Quality Department BPMS - FMEA Rev 1.0 27


Design FMEA
• Helps to identify potential process failure modes early
in the process development cycle.
• Increases the likelihood that all potential failure modes
and their effects on assemblies will be considered.
• Assists in evaluating process design requirements and
test methods.
• Establishes a priority for design improvement.
• Documents the rationale behind design changes and
helps guide future development projects.
• IS PROACTIVE! Should be done when new processes
are designed or existing processes are changed.

National Quality Department BPMS - FMEA Rev 1.0 28


Defect FMEA
• Helps identify the root causes of defects.
• Establishes a priority for improvement activities.
• Documents plan of action.
• Provides methodology to battle initial ground swell
of defects.
• Focuses effort on defects with highest $ impact.
• IS NOT PROACTIVE!

National Quality Department BPMS - FMEA Rev 1.0 29


Scoring Criteria Use actual
defect quantities

Score SEVERITY CRITERIA OCCURRENCE DETECTION


10 Hazardous Without Warning Very High Absolute Uncertainty
9 Hazardous With Warning Very High Very Remote
8 Very High High Remote
7 High High Very Low
6 Moderate Moderate Low

5 Low Moderate Moderate

4 Very Low Moderate Moderately High


3 Minor Low High
2 Very Minor Low Very High
1 None Remote Almost Certain

Note: To change header information, click on "View" then "Header".


RISK: Optional field used to reflect the probability of completing actions.

National Quality Department BPMS - FMEA Rev 1.0 30


The Catapult
Analyze the Catapult process using the FMEA tool.
(Remember we want to get the “most bang for the buck”.)

• Break into the Catapult teams


• We have already constructed a process map
• First, we will construct a cause and effect diagram
• Then we will complete at least two failure modes for the
most critical step(s) of our process
• Appoint a spokesman for your team to debrief the class on
your progress, questions, etc.
• Complete the FMEA (FMEAform.xls) for the Catapult
process before the third session (We will use this 25 minutes!
information for our DOE competition)

National Quality Department BPMS - FMEA Rev 1.0 31


Catapult Process Map
Assemble Select Catapult Set Catapult
Start Secure to table
Catapult Settings Pins

Pins (2) Clamp Plan or Positions


Arm Tape Measure Prediction Designated
Rubber Band Tape equation
Ball Computer

Arm Aligned Feasible Correct


moves with tape settings settings
smoothly ± 3 inches

Pull Arm to Measure Record


Shoot Stop
Proper Angle distance distance

Operator Tape Measure


Consistency Operator Recorder
Lateral Observers Computer
No Parallax positioned
movement
properly

Correct
angle Ball flys Accurate Correct
straight measurement distance
± 2 inches recorded

National Quality Department BPMS - FMEA Rev 1.0 32


FMEA
Complete the Diagram Below
Exercise
Men
Method Material
Rubber Band Release consistency
Calculation procedure Angle measurement
Ball

Distance

Air Conditioner Arm moves freely Repeatability

Reproducibility
Mother nature
Machine Measure

Datafile/CatapultC&E.IGX

National Quality Department BPMS - FMEA Rev 1.0 33


When To Update an FMEA?
FMEA Summary

An FMEA should be updated whenever a change is being considered


to a process’s:
 design
 application
 environment
 material
 operation

National Quality Department BPMS - FMEA Rev 1.0 34


Summary of Product/Process FMEA’s
 What is the tool?  When do you apply this tool?
– Spreadsheet – When evaluating product for
robustness (functionality,
produceability, reliability)
 What will the tool
identify/show? – During early stages of defect reduction
efforts to identify causes
– All product/process failure
– When identifying key process/product
modes, related effects,
causes, & methods of parameters and evaluating methods
controlling them for controlling them
– Risk Priority Number (RPN)
for action based on failure  What results can you expect?
severity, probability of – Learn to identify critical product/
occurrence and detection process parameters
capability – Achieve consensus on solutions and
– Actions/plans to reduce methods of implementation
elements of RPN – Detailed product/process
understanding

National Quality Department BPMS - FMEA Rev 1.0 35


Keys to Success
 Identify purpose...BE SPECIFIC!

 Understand effects...INVOLVE CUSTOMERS & SUPPLIERS!

 Link to the process map.

 Use to prioritize efforts, allocate resources.

 Use as a risk assessment/prioritization tool based on predicted impact.

 Use to build consensus on prioritization.

 Encourage creativity...TEAMWORK!

 PLAN!

 ASK QUESTIONS!
National Quality Department BPMS - FMEA Rev 1.0 36
Process FMEA Steps
 Steps Completed Prior to FMEA:
– Charter Team
– Develop and Characterize Process Map
 FMEA Steps:
1. Identify “Heavy Hitter” Process Step
1. Identify Associated y’s (Product Parameters)
1. Identify Failure Mode
1. Identify Failure Effects/Rate Severity
1. Identify Causes/Rate Occurrence
1. Identify Controls (if any)/Rate Detection
1. Calculate RPN
1. Prioritize by RPN Order
1. Determine Actions/Plan
1. Recalculate RPN Based on Plan
1. Take Action
National Quality Department BPMS - FMEA Rev 1.0 37
What We Have Learned

1. As a Team, how to construct an FMEA and associated


Action Plan

2. How the FMEA process ties to process mapping

3. The relationship between Failure Mode, Cause and Effect

4. The different types of FMEAs

National Quality Department BPMS - FMEA Rev 1.0 38


FMEA Appendix
FMEA Scoring Criteria, Terminology and
Spreadsheet

National Quality Department BPMS - FMEA Rev 1.0 39


FMEA Appendix
Key Definitions for FMEA
Severity is an assessment of how serious the effect of the potential failure mode is on the customer.
The customer in this case could be the next operation, subsequent operations, or the end user.

Occurrence is an assessment of the likelihood that a particular cause will happen and result in the
failure mode.
Detectionis an assessment of the likelihood that the current controls (design and process) will detect
the cause of the failure mode, should it occur, thus preventing it from reaching your customer.
The customer in this case could be the next operation, subsequent operations, or the end user.

Current Controls (for both design and process) are the mechanisms which prevent the cause of the
failure mode from occurring, or detect the failure mode, should it occur, before the product
reaches your “customer.” For example, current controls include SPC, inspections, written
procedures, training, preventive maintenance and all other activities that ensure a smooth
running process.
Critical Characteristics are those items which affect customer safety and/or could result in non-
compliance to regulations and thus require controls to ensure 100% compliance. These are
usually process“settings” such as temperature, time, speed, etc.

Significant Characteristics are those items which require SPC and quality planning to ensure
acceptable levels of capability.
National Quality Department BPMS - FMEA Rev 1.0 40
FMEA
Appendix
A.
Terminology
Process or Product Name – Description of Process or Product being analyzed.
B. Responsible – Name of Process Owner.
C. Prepared By - Name of Agent coordinating FMEA study.
D. FMEA Date – Dates of Initial and subsequent FMEA Revisions.
E. Process Step/Part Number – Description of individual item being analyzed.
F. Potential Failure Mode – Description of how the process could potentially fail to meet the
process requirements and/or design intent, i.e. a description of a non-conformance at that
G. Potential Failure Effects – Description of the effects of the Failure Mode upon the customer,
i.e. what the next user of the process or product would experience or notice.
H. SEV (Severity) – An assessment of the seriousness of the effect of the potential failure mode
I. Potential Causes – Description of how the failure could occur, described in terms of something
J. OCC (Occurrence) – Description of how frequently the specific failure cause is expected to
K. Current Controls – Description of process controls that either prevent, to the extent possible,
L. DET (Detection) – An assessment of the probability that the current controls will detect the
potential cause, or the subsequent failure mode.
M. RPN (Risk Priority Number) – The product of the Severity, Occurrence, and Detection
Rankings i.e., RPN = SEV * OCC * DET.
N. Actions Recommended – Actions to reduce any or all of the Occurrence, Severity or Detection
rankings.
O. Responsibility – Person or group responsible for the Recommended Action.
P. Actions Taken – Brief description of actual action and effective date.
Q. New SEVERITY Rating after corrective action.
R. New OCCURENCE Rating after corrective action.
S. New DETECTION Rating after corrective action.
T. Resulting new RPN after corrective action.
National Quality Department BPMS - FMEA Rev 1.0 41
FMEA
Appendix
Suggested PFMEA Severity Evaluation Criteria
Criteria : Severity of Effect Criteria : Severity of Effect
This ranking results when a potential failure This ranking results when a potential failure mode
mode results in a final customer and/or a results in a final customer and/or a
manufacturing/assembly plant defect. The final manufacturing/assembly plant defect. The final
customer should always be considered first. If customer should always be considered first. If
both occur, use the higher of the two both occur, use the higher of the two severities.
Effect severities. (Manufacturing / Assembly Effect)
(Customer Effect) Ranking

Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 10
Without failure mode affects safe vehicle operation assembly) without warning
warning and/or involves noncompliance with
government regulation without warning

Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 9
With failure mode affects safe vehicle operation assembly) without warning
warning and/or involves noncompliance with
government regulation with warning

Very High Vehicle/item inoperable (loss of primary Or 100% of product may have to be scrapped, 8
function) or vehicle/item repaired in repair department
with a repair time greater than one hour.

High Vehicle/item operable but at a reduced level of Or product may have to be sorted and a 7
performance. Customer very dissatisfied. portion (less than 100%) scrapped, or
vehicle/item repaired in repair department with
repair time between a half – hour and an hour.

Moderate Vehicle/item operable but comfort/convenience Or a portion (less than 100%) of the product 6
item(s) inoperable. Customer dissatisfied may have to scrapped with no sorting, or
vehicle/item repaired in repair department with
a repair time less than a half-hour

National Quality Department BPMS - FMEA Rev 1.0 42


FMEA
Appendix
Suggested PFMEA Severity Evaluation Criteria
Low Vehicle/item operable but Or 100% of product may have 5
comfort/convenience item(s) to be reworked, or vehicle/item
operable at a reduced level of repaired offline but does not go
performance. to repair department.
Very Low Fit and finish/squeak and rattle Or the product may have to be 4
item does not confirm. Defect sorted, with no scrap, and a
noticed by most customers portion (less than 100%)
(greater than 75%) reworked.
Minor Fit and finish/squeak and rattle Or a portion (less than 100%) of 3
item does not confirm. Defect the product may have to be
noticed by 50% of customers reworked, with no scrap, on-
line but out-of-station
Very Fit and finish/squeak and rattle Or a portion (less than 100%) of 2
Minor item does not confirm. Defect the product may have to be
noticed by discriminating reworked, with no scrap, on-line
customers (less than 25%) but in-station.
None No discernible effect Or slight inconvenience to 1
operation or operator, or no
effect
National Quality Department BPMS - FMEA Rev 1.0 43
FMEA
Appendix

Suggested PFMEA Occurrence Evaluation Criteria


Probability Likely Failure Rates * Ranking
Very High : Persistent ≥ 100 per thousand pieces 10
Failure
50 per thousand pieces 9
High : Frequent Failures 20 per thousand pieces 8
10 per thousand pieces 7
Moderate : Occasional 5 per thousand pieces 6
Failures
2 per thousand pieces 5
1 per thousand pieces 4
Low : Relatively Few 0.5 per thousand pieces 3
Failures
0.1 per thousand pieces 2
Remote: Failure is Unlikely ≤ 0.01 per thousand pieces 1
National Quality Department BPMS - FMEA Rev 1.0 44
FMEA
Appendix

Suggested PFMEA Detection Evaluation Criteria


Detection Criteria Inspection Types Suggested Range of Ranking
Detection Methods
A B C

Almost Absolute certainty of non-     X Cannot detect or is not 10


Impossible detection checked

Very Controls will probably not     X Control is achieved with 9


Remote detect indirect or random checks
only
Remote Controls have poor chance     X Control is achieved with 8
of detection visual inspection only
Very Low Controls have poor chance     X Control is achieved with 7
of detection double visual inspection only

Low Controls may detect   X X Control is achieved with 6


charting methods, such as
SPC {Statistical Process
Moderate Controls may detect   X   Control}
Control is based on variable 5
gauging after parts have left
the station, or Go/No Go
gauging performed on 100%
of the parts after parts have
Moderately Controls have good chance X X   Error detection
left the station in subsequent 4
High to detect operations, OR gauging
performed on setup and first-
piece check(for set – up
National Quality Department BPMS - FMEA Rev 1.0 causes only) 45
FMEA
Appendix

Suggested PFMEA Detection Evaluation Criteria


High Controls have good X X   Error detection in- 3
chance to detect station, or error
detection in subsequent
operations by multiple
layers of acceptance:
supply, select, install,
verify. Cannot accept
discrepant part.
Very High Controls almost X X   Error detection in- 2
certain to detect station, (automatic
gauging with automatic
stop feature). Cannot
accept discrepant part.

Very High Controls certain to X     Discrepant parts cannot 1


detect be made because item
has been error-proofed
by process/product
design.

Inspection Types:
A: Error-proofed
National QualityB:Department
Gauging BPMS - FMEA Rev 1.0 46
C: Manual Inspection
Questions ?

National Quality Department BPMS - FMEA Rev 1.0 47