Fmea & Cp Forms

7/28/2019 Fmea & Cp Forms

1/16

Six Sigma Consultants, 1996

PFMEA Number:

Process Name:

Process Responsibility:

Prepared By:

Affected Product(s):

PFMEA Key Date:

PFMEA Origination Date:

PFMEA Revision Date:

Core Team Members:

Potential Failure Modes andEffects Analysis (Information

Sheet)

PFMEA Information Sheet


2/16

Process or Product Name:

Responsible:

The highest value process steps from the C&E matrix. In what ways might the process potentially fail to

meet the process requirements and/or design intent?

What is the effect of each fail

mode on the outputs and/or

customer requirements?

The customer could be the ne

operation, subsequent operat

another division or the end us

Process Function Potential Failure ModePotential Effects

of Failure


3/16

FMEA Master

Process or

Product Name:Prepared by:

Responsible: FMEA Date (Orig) ________

The highest value

process steps from

the C&E matrix.

In what ways might the

process potentially fail to meet

the process requirements

and/or design intent?

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.

HowSevereistheeffect

tothecusotmer?

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.

owoten

oeste

causeorfailuremode

occur?

What are the existing controls an

procedures (inspection and test)

either prevent failure mode from

occurring or detect the failure sh

occur? Should include an SOP

number.

Current

Process

Controls

Process

FunctionPotential Failure Mode

Potential Effects

of Failure

S

E

V

Potential Cause(s)/

Mechanism(s) of Failure

O

C

C

Process / ProductFailure Modes and Effects Analysis

(FMEA)

Page 3


4/16

Severity of Effect Rating

May endanger machine or operator.

Hazardous without warning10

May endanger machine or operator.Hazardous with warning

9

Major disruption to production line.

Loss of primary function, 100% scrap8

Reduced primary function performance.

Product requires sorting, some scrapping7

Minor disruption of production. Some Scrap.

Loss of secondary function performance6

Minor disruption to produciton. 100% Rework.Reduced secondary function performance.

5

Minor defect noticed by most customers

Product requires sorting and some reworked.4

Fit& Finish/Squeak & Rattle item. Minor defect

noticed by some customers.3

Defects may be reworked on-line.

Minor defect noticed by observant customers.2

None

No effect 1

Extreme

High

Moderate

Low


5/16

Likelihood of Occurrence

Failure

Rate

1 in 2

1 in 3

1 in 8

1 in 20

1 in 80

1 in 400

1 in 2000

Low

Process is in statistical control. 1 in 15k

Ver y

Process is in statistical control. Only isolated

failures associated with almost identical processes.1 in 150k

Re-

mo

te Failure is unlikely. No known failures associatedwith almost identical processes. 1 in 1.5M

Failure is almost inevitable

Process is not in statistical control.

Similar processes have experienced problems.

Process is in statistical control but with isolated failures.

Previous processes have experienced occasionalfailures or out-of-control conditions.

Very

High

High

Moderate


6/16

Capability

(Cpk) Rating

< .33 10

> .33 9

> .51 8

> .67 7

> .83 6

> 1.00 5

> 1.17 4

> 1.33 3

> 1.50 2

> 1.67 1


7/16

Likelihood that control will detect failure DPPM

Ver y No known control(s) available to detect failure mode. 100,000

50,000

20,000

10,000

5,000

2,000

1,000

500

200

100

The process automatically detects failure.

Controls will almost certainly detect the existence of a

failure.

Controls have a good chance of detecting the existance of

a failure

Low

Moderate

High

Very

High

Controls have a remote chance of detecting the failure.

Controls may detect the existence of a failure


8/16

Probability Rating

1 in 10 10

1 in 20 9

1 in 50 8

1 in 100 7

1 in 200 6

1 in 500 5

1 in 1,000 4

1 in 2,000 3

1 in 5,000 2

1 in 10,000 1


9/16

Customer Requirement(Output Variable) MeasurementTechnique %R&R or P/TRatio

Upper

SpecLimit

Target

Lower

SpecLimit

Cp

Key Process Output VariableCapability Status Sheet


10/16

Cpk SampleSize Date Actions


11/16

Date: Revision:

Product:

Process:

Process StepWhat's

Controlled?

Input or

Output?

Spec. Limits /

Requirements

Measurement

Method


12/16


13/16

Sample Size FrequencyWho/What

Measures

Where

Recorded

Decision Rule/

Corrective Action

Approved by:


14/16

Approved by:

Approved by:


15/16

SOP's


16/16

Documents

Fmea & Cp Forms