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:

PFMEA Information Sheet

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

Prepared by:

Responsible:

FMEA Date (Orig) ______________ (Rev) _____________

Pnuemonia
patient recieves
1st medication

Delay in receiving
medicine

Survival rate
lessened - increased
recovery period or
death

10

How can the failure

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

Lab results delayed lab not open at night

Medication not
available from hospital
10 pharmacy-2 hour
delay for supply from
affiliate hospital
Medical office
completes
reimbursement
form

Box 15 not properly

filled out - missing
or incorrect
information.

Reimbursement sent
to rework. Customer
contacted; customer
payment delayed 730 days.

Office personnel not

familiar with medical
codes.

What are the existing

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

Lab technicians on call;

notified after triage approximately 45 minute
delay

Alert from Pharmicomp

when < 3 patient supply
on hand

Codebook distributed to
all client medical offices.
No inspection prior to
recipt at payer.

D
E
T

R
P
N

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

D
E
T

R
P
N

Who is responsible
for the
recommended
action?

List the completed

actions that are
included in the
recalculated RPN.
Include the
implementation
date for any
changes.

Cross-train ER
personnel to run lab
350 tests - 15 minute delay

Joan Sensori (ER

Director)

3 night shift
techncians trained
& certified May 15

108

Increase alert to < 5 on

hand

Arnold Cejka
(Pharmacy Clerk)

Pharmacomp alert
changed to 5
patient supply

10

120

40

240

Mistake proof the screen Chris Disk (IT)

entry to capture errors
9

Action Results
S
O
Actions Taken E
C
V
C

405

Program changed
& distributed - Jan
23

Are the detection limits

improved?
Recomkpute RPN after
actions are complete.

What is the effect of

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

Current
Process
Controls

What is the new

severity?
What is the new process
capability?

In what ways might

the process
potentially fail to
meet the process
requirements
and/or design
intent?

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

SEV x OCC x DET

The highest value

process steps
from the C&E
matrix.

S
E
V

How well can you detect

cause or FM?

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
May endanger machine or operator.
Hazardous without warning

Rating
10

May endanger machine or operator.

Hazardous with warning

Major disruption to production line.

Loss of primary function, 100% scrap

Reduced primary function performance.

Product requires sorting, some scrapping

Minor disruption of production. Some Scrap.

Loss of secondary function performance

Minor disruption to produciton. 100% Rework.

Reduced secondary function performance.

Minor defect noticed by most customers

Product requires sorting and some reworked.

Fit& Finish/Squeak & Rattle item. Minor defect

noticed by some customers.

Defects may be reworked on-line.

Minor defect noticed by observant customers.

No effect

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

Capability
(Cpk)
Rating
< .33

10

> .33

> .51

> .67

> .83

> 1.00

> 1.17

> 1.33

> 1.50

> 1.67

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

Cp

ble

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