Potential Failure Modes and

Effects Analysis (Information

Sheet)

PFMEA Number:
Process Name:
Process Responsibility:
Prepared By:
Affected Product(s):
PFMEA Key Date:
PFMEA Origination Date:
PFMEA Revision Date:
Core Team Members:

Process / Product
Failure Modes and Effects Analysis
(FMEA)
Process or Product
Name:

Prepared by:

Responsible:

FMEA Date (Orig) ______________ (Rev) _____________

Communication No direct
from Cust Service communication
to Supporting
Dept
Representative

Outdated employee
information in current
profile

Delayed transfer of
customer case

No incentive for
Manager to comply
completely with
requirement

No formal liaison
9

HR checklist for tasks to

be completed upon
change in employee
status

R
P
N

Recommended
Action(s)

126

ID Dept liaison for all

Slim Pickins
supporting Departments 8/3/00
8

288

Action Results
S
O
Actions Taken E
C
V
C

What are the actions for

Who is responsible List the completed
reducing the occurrence, or for the recommended actions that are
improving detection, or for action?
included in the
identifying the root cause if
recalculated RPN.
it is unknown? Should
Include the
have actions only on high
implementation date
RPN's or easy fixes.
for any changes.

Issue delinquency report C.C. Largelist

5/1/00

Customer complaints
4

Responsibility
and Completion
Date

D
E
T

R
P
N

Procedure changed
to include
delinquency report
7/15/00

30

Procedure
changed, Dept
liaisons identified
8/31/00

72

Are the detection limits

improved?
Recomkpute RPN after
actions are complete.

What are the existing

controls and procedures
(inspection and test) that
either prevent or detect
occurrence?

D
E
T

SEV x OCC x DET

How can the failure

occur?
Describe in terms of
something that can be
corrected or controlled.
Be specific.

Current
Process
Controls

What is the new process

capability?

Not filled out

correctly

Potential Cause(s)/ O
Mechanism(s) of
C
Failure
C

What is the new severity?

Manager
completion of
change form

What is the effect of

each failure mode on
the outputs and/or
customer requirements?

S
E
V

How well can you detect

cause or FM?

The highest value In what ways might

process steps from the process
the C&E matrix. potentially fail to
meet the process
requirements and/or
design intent?

Potential Effects
of Failure

How often does the cause

or failure mode occur?

Potential Failure
Mode

How Severe is the effect to

the cusotmer?

Process
Function

Page ____ of ____

FMEA Master

Process / Product
Failure Modes and Effects Analysis
(FMEA)
Process or
Product Name:

Prepared by:

Responsible:

FMEA Date (Orig) ______________ (Rev) _____________

Page 3

Recommended
Action(s)
What are the actions for
reducing the occurrence, or
improving detection, or for
identifying the root cause if it is
unknown? Should have
actions only on high RPN's or
easy fixes.

Responsibility
and
Completion
Date
Who is
responsible for
the
recommended
action?

Action Results
Actions Taken
List the completed actions
that are included in the
recalculated RPN.
Include the implementation
date for any changes.

S
E
V

O
C
C

D
E
T

R
P
N
Recomkpute RPN after
actions are complete.

R
P
N

Are the detection limits

improved?

What are the existing controls and

procedures (inspection and test) that
either prevent failure mode from
occurring or detect the failure should it
occur? Should include an SOP
number.

D
E
T

What is the new process

capability?

Current
Process
Controls

What is the new severity?

How can the failure occur?

Describe in terms of something
that can be corrected or controlled.
Be specific. Try identify the causes
that directly impacts the failure
mode, i.e., root causes.

O
C
C

SEV x OCC x DET

What is the effect of each failure

mode on the outputs and/or
customer requirements?
The customer could be the next
operation, subsequent operations,
another division or the end user.

Potential Cause(s)/
Mechanism(s) of Failure

How well can you detect

cause or FM?

The highest value In what ways might the

process steps from process potentially fail to meet
the C&E matrix. the process requirements
and/or design intent?

S
E
V

How often does the cause

or failure mode occur?

Potential Failure Mode

Potential Effects
of Failure

How Severe is the effect

to the cusotmer?

Process
Function

Page ____ of ____

Extreme
High
Moderate
Low
None

Severity of Effect

Rating

Loss of major key customers.

10

May result in illegal activity or regulatory

compliance failure.

Render product, process, or service unfit for use.

Cause extreme customer dissatisfaction; will

generate complaints.

Result in partial malfunction of product, process,

or service.

Cause a loss of performance which is likely to

result in complaint.

Cause minor performance loss.

Cause a minor nuisance which can be overcome

with minor performance loss.

Be unnoticed and only have minor affect on

performance; drives rework.

Be unnoticed and have no affect on performanced.

Likelihood of Occurrence

Very
High

Process is not in statistical control.

Similar processes have experienced problems.

Moderate

High

1 in 2
Failure is almost inevitable

Re- Very
Low
mote Low

Failure
Rate

1 in 3
1 in 8
1 in 20
1 in 80
Process is in statistical control but with isolated failures.
Previous processes have experienced occasional
failures or out-of-control conditions.

1 in 400
1 in 2000

Process is in statistical control.

1 in 15k

Process is in statistical control. Only isolated

failures associated with almost identical processes.

1 in 150k

Failure is unlikely. No known failures associated

with almost identical processes.

1 in 1.5M

Rating
10
9
8
7
6
5
4
3
2
1

Very
Low

DPPM

No known control(s) available to detect failure mode.

100,000
50,000

Controls have a remote chance of detecting the failure.

20,000

Moderate

Controls may detect the existence of a failure

High

10,000

Controls have a good chance of detecting the existance of a

failure

Very
High

Low

Likelihood that control will detect failure

The process automatically detects failure.

Controls will almost certainly detect the existence of a
failure.

5,000
2,000
1,000
500
200
100

Probability Rating
1 in 10

10

1 in 20

1 in 50

1 in 100

1 in 200

1 in 500

1 in 1,000

1 in 2,000

1 in 5,000

1 in 10,000

Key Process Output Variable

Capability Status Sheet
Customer Requirement
(Output Variable)

Measurement
Technique

%R&R or P/T
Ratio

Upper
Spec
Limit

Target

Lower
Spec
Limit

Variable
Sheet
Cp

Cpk

Sample
Size

Date

Actions

Date:

Revision:

Product:
Process:

Process Step

Employee
Status
Change Form

What's
Controlled?
Status
Change
indicator

Input or Spec. Limits /

Output? Requirements

Measurement
Method
Mgr Review
HR Inspection

List Select

New Dept

List Select

New Grade

List Select

New Salary

Grade Guidelines

Mgr Review

New Mgr

Org Chart

Mgr Review

Change Effect
Date

None

Mgr Review
HR Inspection
Mgr Review
HR Inspection

Mgr Review
HR Inspection

Sample Size

Frequency

Who/What
Measures

Where
Recorded

Decision Rule/
Corrective Action

100%

As Needed

Mgr, HR
Clerk

HR Checklist

Return to Mgr for Correction

100%

As Needed

HR Checklist

Return to Mgr for Correction

100%

As Needed

HR Checklist

Return to Mgr for Correction

100%

As Needed

Mgr

100%

As Needed

Mgr

100%

As Needed

Mgr, HR
Clerk

HR Checklist

Return to Mgr for Correction

Mgr, HR
Clerk
Mgr, HR
Clerk

Approved by:
Approved by:
Approved by:

SOP's
9.3012
9.3012
9.3012
9.3012
9.3012
9.3012