Six Sigma Consultants, 1996

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: Responsible: Prepared by: Page ____ of ____

FMEA Date (Orig) ______________ (Rev) _____________ 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 What is the new process capability? D E T Are the detection limits improved? R P N Recomkpute RPN after actions are complete. 0 0 0 0 0 0 0 0 0 0 0 0

Process Function

Potential Failure Mode

Potential Effects of Failure

S E V How Severe is the effect to the cusotmer?

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

Current Process Controls 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 How well can you detect cause or FM?

R P N SEV x OCC x DET

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?

The highest value process steps from the C&E matrix.

How often does the cause or failure mode occur?

0 0 0 0 0 0 0 0 0 0 0 0

What is the new severity?

In what ways might the process potentially fail to What is the effect of each failure meet the process requirements and/or design intent? mode on the outputs and/or customer requirements? The customer could be the next operation, subsequent operations, another division or the end user.

Process / Product FMEA Master Failure Modes and Effects Analysis (FMEA)
Process or Product Name: Responsible: Prepared by: Page ____ of ____

FMEA Date (Orig) ______________ (Rev) _____________ 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 What is the new severity? O C C What is the new process capability? D E T Are the detection limits improved? R P N Recomkpute RPN after actions are complete. 0 0 0 0 0 0 0 0 0 0 0 0

Process Function

Potential Failure Mode

Potential Effects of Failure 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.

S E V How Severe is the effect to the cusotmer?

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

Current Process Controls 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 How well can you detect cause or FM?

R P N SEV x OCC x DET

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?

How often does the cause or failure mode occur?

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?

0 0 0 0 0 0 0 0 0 0 0 0

Page 3

Severity of Effect Rating May endanger machine or operator. 10 Hazardous without warning May endanger machine or operator. 9 Hazardous with warning Major disruption to production line. 8 Loss of primary function, 100% scrap Reduced primary function performance. 7 Product requires sorting, some scrapping Minor disruption of production. Some Scrap. 6 Loss of secondary function performance Minor disruption to produciton. 100% Rework. 5 Reduced secondary function performance. Minor defect noticed by most customers 4 Product requires sorting and some reworked. Fit& Finish/Squeak & Rattle item. Minor defect 3 noticed by some customers. Defects may be reworked on-line. 2 Minor defect noticed by observant customers. No effect 1

None

Low

Moderate

High

Extreme

Likelihood of Occurrence

Failure Rate 1 in 2

Very High

Failure is almost inevitable 1 in 3 Process is not in statistical control. Similar processes have experienced problems. 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. Process is in statistical control. Only isolated failures associated with almost identical processes. Failure is unlikely. No known failures associated with almost identical processes. 1 in 15k 1 in 150k 1 in 1.5M

Re- Ver Low mote y

Moderate

High

Capability (Cpk) Rating < .33 > .33 > .51 > .67 > .83 > 1.00 > 1.17 > 1.33 > 1.50 > 1.67 10 9 8 7 6 5 4 3 2 1

Likelihood that control will detect failure

DPPM 100,000 50,000

Ver y Low

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

Controls have a remote chance of detecting the failure. 20,000 10,000 Controls may detect the existence of a failure 5,000 2,000 Controls have a good chance of detecting the existance of a failure 1,000 500 200 100

High Very High

Moderate

The process automatically detects failure. Controls will almost certainly detect the existence of a failure.

Probability Rating 1 in 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 10 9 8 7 6 5 4 3 2 1

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

Cpk

Sample Size

Date

Actions

Date: Product: Process: What's Controlled? Input or Output?

Revision:

Process Step

Spec. Limits / Requirements

Measurement Method

Sample Size

Frequency

Who/What Measures

Where Recorded

Decision Rule/ Corrective Action

Approved by:

Approved by: Approved by:

SOP's