Manufacturing Process

Excellence

Turning Process Excellence into a Competitive Advantage

Developed By: John Bero 1/07

Manufacturing Process Excellence

Training Scope
To teach the following Six Sigma methodologies using the
D.M.A.I.C process:

Characteristic Matrix

Process Map

Process FMEA
I
n
p
u
t
s

Ishikawa (Fishbone) Diagram

5 Whys

Control Plan
Manufacturing Instructions

Manufacturing Process Excellence

Training Objective
To implement Six Sigma methodologies to:
Reduce overall escapes to customers (DPPM)
Reduce Scrap and Rework.
Improve Internal Yield.
Reduce Final Inspection Rejects.
Encourage Relentless Root Cause Analysis & MistakeProofing.
Reduce variation in critical to quality features.
Proactively control cost of poor quality.
Turn actions into systemic process improvements.

Manufacturing Process Excellence

Output

EFINE SCOPE

Part/Product Family/Process, Critical

and Key Characteristics

EASURE

Process Map - Key process variables:

Inputs, Output Characteristics (C and K) .
Warranty Data.
Scrap.
DPPM/Sigma

NALYZE

Characteristic Matrix
Process FMEA
Ishikawa diagram
Process Capability Studies
5 Why's
MSA Studies

Input

Output

Input

Output

Output
Process Improvement Log

MPROVE

Input

Output

ONTROL

Process Control Plan:

(Characteristic Accountability).
Standardized Manufacturing Instructions:
Eliminate process variation by implementing
process control across a family of products.

Manufacturing Process Excellence

Key Outputs
The key outputs of the Manufacturing Process Excellence
project will include the following per product family or
Process:
Characteristic Matrix
Process Map
Process FMEA
Control Plan
Standardized Manufacturing Instructions.

Characteristic Matrix

The purpose of a characteristic matrix is to display the relationship

between the product characteristics, parameters and the manufacturing
operation

Key Inputs:
DFMEA, Process Map, Router

Product: Valve

K
K
K
K
K

2
2
2
2
2
2

Final Inspection

Valve
Overall Length (AOL)
Land Length
Distance Between Lands
Surface Finish
Pressure Relief
Relief spring length

Valve Testing

1
1.1
1.2
1.3
1.4
1.5
1.6

Valve Assembly

1 = Created
2 = Created/Inspected/Verified
3 = Sample Inspected/Verified
4 = 100% Inspected/Verified

Spring insertion

Characteristic

Receiving Inspection

Ref. No.

Rev: A
Supplier

123abc
Char. Class

C/M #:

3
3
3
3
3

3
3
3
4
3

Process Map

Purpose:
Used to get an overall understanding of the process flow and
interactions.
Is the basic tool used in the analysis of a process by looking at each
steps Key Process Output Variables and determining which Inputs can
be controlled and which ones we have to /choose to live with.

Minimum Requirements:
Software - Microsoft Visio (Basic Flow Chart Shapes).
Complete Process Flow.
Key process variables
Process Inputs.
Process Outputs.

Process Map
Most commonly used basic flow chart shapes, symbols and
connectors:

Processing function

Predefined Process

Decision

Manual Input

Document

Data

Manual Operation

Preparation

abcdefg

Terminator

Dynamic Connector

Annotation

Control Transfer

Process Maps
Example for a product family

INPUT:
material (casting)
Tooling

-C
Program - C

1) MILLING

OUTPUT:
Datum Aligned

(Mounting Pads)

per Print

Machine - C
Coolant - C

Input Definitions
C-Controllable- Those
inputs that we can changeSpeed, feeds, thickness,
machine,..

1) MILLING

OUTPUT:
Conforming Part

(Inspection)

N-Noise- Those inputs that

we cannot control or too
costly too. Humidity,
temperature,nonstandard
thickness,.

2) NEXT OPERATION

Process Maps

Example for a part number

CNC Lathe Operation
1
Previous
Operation
INPUT:
Operators - C/N
Training - C
4340 AMS 6410 Tooling -NC
Tooling Condition -C
Mai ntenance -C
Wor k Instruction - C
Measurement Error C
Program - C

INPUT:
XXXXXXX
XXXX
XXXXX
XX

2
CNC Lathe
Operation

3
Next Operation

OUTPUT:
.760/.758 Dia
Runout .005
.44 00/.4390 Dia
Runout .005

OUTPUT:
.XXX/.XXX AOL

10

Process Map

Top Level Process Example

CIRCUIT BOARD
TOP LEVEL PROCESS MAP
Output (Y)
Populated reflowed brd.
Input (X)
Traveler
Populated reflowed brd. with
active flux residue

WORK ORDER
ISSUED

Input (X)
Kit list

KITTING

Input (X)
Traveler
Correct Kit
Input (X)
Traveler
Stencil
Process set-up sheet
Blades
Paste

Input (X)
Traveler
Printed Board
Process Instructions

Output (Y)
Correct Material pulled
for Job.
Traveler

SMT KIT
PREP.

PRINTING
Output (Y)
Printed Board

4.1
WASH
4

POST PRINT
INSPECTION
Fail
Pass

Input (X)
Traveler
Correctly loaded kit
Process set-up sheet
Qualified printed board

SMT AUTO
PLACEMENT

Input (X)
(Traveler
IPC 610 (workmanship)
Populated Board
Process Instructions

6
POST PLACEMENT
INSPECTION
(Hand placement)

Input (X)
Traveler
Populated approved brd.
Process Instructions

Output (Y)
Correctly loaded kit
Machine set-up

Output (Y)
Qualified printed board

5
Output (Y)
Populated Board

Input (X)
Traveler
IPC 610 Certified Inspector
Fisrt Piece/Populated brds.
Input (X)
Traveler
TH Kit
Process Instructions
SMT Populated brd.

Input (X)
Traveler
Process Instructions
TH Populated brd.

Input (X)
Traveler
Process Instructions
IPC 610 compliant brd.

OVEN

Input (X)
Traveler
Process Instructions
Customer Compliant Board

Fail

9.1
TOUCH-UP

Output (Y)
IPC 610 SMT compliant
brd.

Pass

10
THROUGH-HOLE
INSERTION

Output (Y)
IPC 610 TH compliant
brd.

11
INSPECTION

Output (Y)
TH Populated brd.

12
WAVE SOLDER

Output (Y)
Soldered brd.

13

Input (X)
Traveler
Populated wave soldered brd.
with active flux residue
Input (X)
Traveler
Process Instructions
Soldered brd.

Output (Y)
Populated reflowed brd.
without active flux residue

INSPECTION

Input (X)
Traveler
TH populated brd
IPC 610

Input (X)
Traveler
Process Instructions
Completed brd.
Final sssembly kit

Output (Y)
Fully populated
approved board

WASH

Output (Y)
Populated wave soldered
brd. without active flux
residue

WASH
14

FINAL ASSEMBLY
Output (Y)
Completed brd.

15
FINAL
INSPECTION
15.1
TOUCH-UP

Output (Y)
IPC 610 compliant brd.
(TH, SMT)

Pass
Fail

16

FUNCTIONAL TEST
16.1
TOUCH-UP
REPAIR

Fail

Pass

17
SHIPPING

Output (Y)
Tested brd. compliant
to customer functional
test.
Output (Y)
Customer Compliant
Product

11

Process Failure Mode

and Effect Analysis
Process FMEA
PROCESS FAILURE MODE AND EFFECT ANALYSIS

Aerospace

Prototype
Product/Part Number/Area

Prepared by

Process Responsibility

Approval:

Plant:
Sensing and Controls 24 East Glenolden Avenue, Glenolden PA 19036-2107

Process Step /
Name

Potential Failure Potential Failure

Mode
Effects

Pre-Launch

Production

Core Team:

FMEA Number

Original Date:
Revision Date:
Revision:

Quality Assurance Manager

S
e
v

C
l
a
s
s

Potential Causes

O
c
c

Manufacturing Engineer Manager

Current Controls
Prevent (P) Detect (D)

D
e
t

R
P
N

Recommended
Actions

Person
Responsible
Target Date

Actions Taken

S
e
v

O
c
c

D
e
t

Creating a Process FMEA:

Use a cross functional Team; Typically Manufacturing, Manufacturing
Engineering, Quality Assurance and Design Engineering.
Follow the flow of the process map.
Include the entire process flow in the FMEA.
Do not overlook any characteristic. Remember a product is nonconforming if
it fails to meet any requirement.

12

R
P
N

Process FMEA

Purpose:
Track down and remove special causes of variation.
Verify that controls for key and critical product characteristics are
addressed in the process.
To identify the unacceptable process outputs that can be created at each
process step, the causes, the severity and the method of control to prevent
or detect the potential unacceptable process outputs.
To identify the possible ways in which non-conformities can occur in a
manufacturing process, and recommend actions to prevent the nonconformities and/or detect them before the non-conforming parts are
shipped to the customer.

Process FMEA Inputs:

DFMEA (If available)
Customer Returns, Complaints, Corrective Actions
Internal NR Data
Characteristic Matrix
Process Map
Final Inspection Reject Data
Process Capability Studies (Cpk)
MSA Studies

13

Process FMEA

Key Analysis Considerations

Characteristic Accountability
Self QC
Product Handling
Administrative Errors
Assembly Errors
Part Marking Errors
F.O.D.
Packing
Shipping Damage
Customer Perception

Brainstorming tools that will assist with developing a process FMEA:

Ishikawa Diagrams (Fish Bone)
Five Whys

14

Process FMEA
Ishikawa (Fish Bone) Diagram
Simple steps allow you to identify, analyze, and graphically depict with
increasing detail, all potential causes related to a problem or current
condition in order to discover its root causes.
F is h b o n e S u g g e s te d C a te g o r ie s
S e r v ic e In d u s t r ie s
(T h e 4 P s )

M a n u f a c t u r in g In d u s tr ie s
(T h e 6 M s )

P o lic ie s
P ro c e d u re s
P e o p le
P la n t/T e c h n o lo g y

Ma na ge m e nt

Ca use

M a c h in e s
M e th o d s
M a te r ia ls
M e a s u r e m e n ts
M o th e r N a tu r e ( E n v ir o n m e n t)
M a n p o w e r ( P e o p le )

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Ca use

Me a sure m e nt

Effe ct, Ca use ,

Fa ilure Mode
Proble m Sta te m e nt

Ca use

Ca use

Ca use

Me thod

Ma npow e r

Ca use

Ma chine

Ma te ria l

15

Process FMEA
How To Complete The 5 Whys:
1. Write down the specific problem. Writing the issue helps you formalize the
problem and describe it completely. It also helps a team focus on the same
problem.
2. Ask Why the problem happens and write the answer.
3. If the answer you just provided doesn't identify the root cause of the
problem that you wrote down in step 1, ask Why again and write that
answer down.
4. Loop back to step 3 until the team is in agreement that the problem's root
cause is identified. Again, this may take fewer or more times than five
Whys.

5 Why Example:
Problem Statement: You are on your way home from work and your car stops
in the middle of the road.
1.

Why did your car stop?

- Because it ran out of gas.

2.

Why did it run out of gas?

- Because I didn't buy any gas on my way to work.

3.

Why didn't you buy any gas this morning?

- Because I didn't have any money.

4.

Why didn't you have any money?

- Because I lost it all last night in a poker game.

5.

Why did you lose your money in last night's poker game?
- Because I'm not very good at "bluffing" when I don't have a good hand.

16

Process FMEA

How to complete an FMEA?

17

Process FMEA
Process Step/Name
What is the process Name /
Function?
Enter the specific process or workstation
name that is being evaluated, multiple
workstations should be reflected as
separate PFMEA line items.
Example:
TESTING (Air Decay)
ASSEMBLY (Press Fit)

P ro ce s s S te p /
Nam e

1) MILLING
(Mounting Pads)

NOTE: The numbering

sequence must match the
Process Map numbering for
each process.

Potential Failure Mode

How could this process/product fail to
meet it's intended function?
Over/Under sized
Rough
Eccentric
Deformed
Cracked
Open
Shorted
Leaking

P o te n tia l F a ilu re
M ode

Datum Skewed

NOTE: A Failure mode at one

operation can be an effect of
a failure mode in a previous
(upstream) operation.

18

Process FMEA
Potential Failure Effects
What are the effects / results of the
Failure Mode?

Potential Failure
Effects

Typical effects may include, but are not limited to:

Intermittent operation
Erratic operation
Inoperative
Unstable
Control impaired

Housing Alignment
or Distortion at
Install / Loss of
Position for
Secondary Ops

NOTE: Describe the effects in

terms of what the internal or
external customer would
experience.

Severity Number
How bad are the effects?
The severity number is estimated on a 1 to 10
scale that represents the severity of the effect.
The PFMEA Severity Matrix is used to
determine the severity ranking number in
correspondence with the effect listed.

S
e
v

19

Process FMEA
Severity Matrix
C R IT E R IA : S E V E R IT Y O F E F F E C T

EFFECT

CUSTOM ER EFFECT
V e ry h ig h s e v e rity ra n k in g w h e n a p o te n tia l
fa ilu re m o d e a ffe c ts s a fe ty a n d /o r in v o lv e s
n o n c o m p lia n c e w ith g o v e rn m e n ta l o r
c u s to m e r re g u la tio n w ith o u t w a rn in g .

V e ry h ig h s e v e rity ra n k in g w h e n a p o te n tia l
fa ilu re m o d e a ffe c ts s a fe ty a n d /o r in v o lv e s
n o n c o m p lia n c e w ith g o v e rn m e n ta l o r
c u s to m e r re g u la tio n w ith w a rn in g .

Ite m in o p e ra b le , lo s s o f p rim a ry fu n c tio n .

M a jo r d is ru p tio n to p ro d u c t lin e .

C u s to m e r v e ry d is s a tis fie d .

1 0 0 % o f p ro d u c t m a y h a v e to b e s c ra p e d o r
re p a ire d .

Ite m o p e ra b le , b u t a t re d u c e d le v e l o f
p e rfo rm a n c e .

M in o r d is ru p tio n to p ro d u c t lin e .

P ro d u c t m a y h a v e to b e s o rte d a n d a p o rtio n
(le s s th a n 1 0 0 % ) m a y h a v e to b e s c ra p e d .

M in o r d is ru p tio n to p ro d u c t lin e .

A p o rtio n (le s s th a n 1 0 0 % ) m a y h a v e to b e
s c ra p e d (n o s o rtin g ).

Minor disruption to product line.

100% of product may have to be reworked.

Minor disruption to product line.

The product may have to be sorted and a

portion (less than 100%) reworked.

Minor disruption to product line.

A portion (less than 100%) of the product

may have to be reworked on-line but out-ofstation.

Very Minor disruption to product line.

A portion (less than 100%) of the product

may have to be reworked on-line but instation.

Slight inconvenience to operation or

operator, or no effect.

H a z a rd o u s w ith o u t
w a rn in g

H a z a rd o u s w ith w a rn in g

V e ry H ig h

H ig h

M o d e ra te

Low

Very Low

Minor

Very Minor

None

R A N K IN G

M A N U F A C T U R IN G / A S S E M B L Y E F F E C T

C u s to m e r d is s a tis fie d .

Ite m o p e ra b le , b u t s o m e
C o m fo rt/C o n v e n ie n c e ite m (s ) in o p e ra b le .

C u s to m e r e xp e rie n c e s d is c o m fo rt.

Item operable, but some

Comfort/Convenience item(s) operable at
reduced level of performance.

Customer experiences some dissatisfaction.

Fit & Finish/Squeak & Rattle item does not

conform.

Defect noticed by most customers (greater

than 75%).

Fit & Finish/Squeak & Rattle item does not

conform.

Defect noticed by 50% of customers.

Fit & Finish/Squeak & Rattle item does not

conform.

Defect noticed by discriminating customers

(less than 25%).

No discernible effect.

FLIGHT SAFETY RISK PRODUCT

M a y e n d a n g e r m a c h in e o r a s s e m b ly
o p e ra to r w ith o u t w a rn in g .

10

M a y e n d a n g e r m a c h in e o r a s s e m b ly
o p e ra to r w ith w a rn in g .

NON FLIGHT SAFETY RISK PRODUCT

20

Process FMEA

Characteristic Class
Critical (C) The letter C indicates a Critical characteristic.
A product or process characteristic for which reasonably
anticipated variation could significantly affect the products
safety or its compliance with governmental regulations.
Such as Hazardous without warning, flammability, occupant
or operator protection, loss of control etc.

S
e
v

C
l
a
s
s

NOTE: A Critical Characteristic (C) would be considered

a Flight Safety Risk and would be associated with
severity rankings of 8, 9 and 10.
Key (K) The letter K indicates a Key characteristic. A
product or process characteristic for which reasonably
anticipated variation is likely to significantly affect customer
satisfaction with a product (other than safety considerations)
such as its fit, partial function, mounting, or the ability to
process or build the product.
Standard ( ) Leaving the column blank/empty
indicates a standard characteristic. A product or process
characteristic for which reasonably anticipated variation
would not affect a products safety, fit/function or
compliance with governmental regulations. Would
include minor issues such as appearance, marking,
administrative errors.

21

Process FMEA

Potential Causes
What are the causes?
What conditions can bring about the failure
mode?
List, to the extent possible, every conceivable
failure cause assignable to each potential failure
mode.
Be specific
If a cause is exclusive to the failure mode, i.e., if
correcting the cause has a direct impact on the
failure mode, then this portion of the FMEA
thought process is completed.

P o t e n t ia l C a u s e s

Housing not
aligned during
milling

NOTE: Do not include

contributing causes:
Operator Error
Missed at final Inspection

Consider using Ishikawa (Fishbone) Diagrams

and the 5 Whys to help identify the real root
cause.

22

Process FMEA
Occurrence Number
How often does it happen?

O
c
c

Occurrence is how frequently the specific failure

cause/mechanism is projected to occur.

A number from 1 to 10 that represents the likelihood of each

cause listed.
The PFMEA Occurrence Matrix is used to determine the
likelihood that the cause list could occur.

Process Capability Study

A capability study is an excellent method for determining the rate of failure
and stability on measurable processes. (Reference the occurrence matrix)
The capability of the system refers to the ability of the system to perform in
comparison to its specification limits.
NOTE:
The Cpk tells how well a system can meet specification
limits while accounting for the location of the average.

Cpk: .667

Cpk: 3.33

The higher the

Cpk, the more
stable the process
is.
Cpk:
1.33 Good
1.67 very Good
>2.00 Excellent

Is the preferred software for statistical analysis. Additional

training is available in Minitab and Eaton University

23

Process FMEA

PFMEA Occurrence Matrix

P r o b a b ility o f F a ilu r e

P o s s ib le F a ilu r e R a te s

Cpk

R a n k in g

= /> 5 1 %

< 0 .3 3

10

3 3 % to 5 0 %

= /> 0 .3 3

1 2 .5 % to 3 3 %

= /> 0 .5 1

5 % to 1 2 .5 %

= /> 0 .6 7

1 .2 5 % to 5 %

= /> 0 .8 3

.2 5 % to 1 .2 5 %

= /> 1 .0 0

.0 5 % to .2 5 %

= /> 1 .1 7

.0 1 % to .0 5 %

= /> 1 .3 3

.0 0 2 % to .0 1 %

= /> 1 .5 0

< .0 0 2 %

= /> 1 .6 7

V e ry H ig h : P e rs is te n t F a ilu re s

H ig h : F re q u e n t F a ilu re s

M o d e ra te : O c c a s io n a l F a ilu re s

L o w : R e la tiv e ly F e w F a ilu re s

R e m o te : F a ilu re is U n lik e ly

24

Process FMEA
Current Controls
How can the cause be prevented?
Description of prevention and detection
controls:
(D) SPC
(D) Gauging
(D) Automated inspection
(D) Visual Inspection
(P) Mistake-proofing
(D) Testing
(P) First Piece Inspection
(P) Calibration / Preventive
Maintenance
NOTE: Be specific, do not state: see
work instruction etc.

Current
Controls
Prevent
Current
Controls
Prevent
(P)
(P) Detect (D)
Detect (D)

(D) Visual check

Note - The assumption is that

all operators, assemblers,
technicians are properly
trained; therefore general
operator training should not be
listed as a control.

Think mistake proofing!

The methodology is used either to:
1.
Prevent the special causes that result in defects.
2.
To inexpensively inspect each characteristic (Self QC) as it is
produced to determine whether it is acceptable or defective. One
error occurs, not a batch.
Example:
Sometimes a worker will forget to put the spring under the button and a
defect occurs. A simple poka-yoke device to eliminate this problem was
developed. The worker counts out two springs from a bin and places them
in a small dish. After assembly is complete, if a spring remains in the dish,
an error has occurred.

25

Process FMEA
Detection Number
How good is this method of detecting?
A number from 1 to 10 that represents the effectiveness
of the current process controls to prevent or detect the
cause.
Detection values are associated with Current Controls.

D
e
t

The PFMEA Detection Matrix is used to determine the

detection number

Detection Matrix
Detection

Criteria

Inspection
Type
A

C - Manual
Inspection

Almost
impossible

Ranking

Absolute certainty of nondetection

Cannot detect or is not checked.

10

Control will probably not

detect

Control is achieved with indirect or random

checks only.

Remote

Controls have poor chance

of detection.

Control is achieved with visual inspection

only.

Very Low

Controls have poor chance

of detection.

Control is achieved with double visual

inspection only.

Control is achieved with charting methods,

such as SPC {Statistical Process Control}

Very Remote

Low

Controls may detect.

Moderate

Controls may detect.

Control is based on variable gauging after

parts have left the station, or Go/No Go
gauging performed on 100% of the parts after
the parts have left the station.

Moderately
High

Controls have a good

chance to detect.

Error detection in subsequent operations, OR

gauging performed on setup and first-piece
check (for set-up causes only).

High

Controls have a good

chance to detect.

Error detection in station, or error detection in

subsequent operations by multiple layers of
acceptance: supply, select, install, verify.
Cannot accept discrepant part.

Very High

Controls almost certain to

detect.

Error detection in-station (automatic gauging

with automatic stop feature). Cannot accept
discrepant part.

Certain

Controls certain to detect.

Discrepant parts cannot be made because

item has been error-proofed by
product/process design.

B - Gauging
A - Error-proofed

Detection Methods

26

Process FMEA

Risk Priority Number (RPN)

What is the risk?
The product of Occurrence X Severity X
Detection = RPN
The higher the RPN, the higher the calculated
risk is for producing undesirable process
outcomes.

R
P
N

280

For higher RPNs the team should undertake

efforts to reduce the calculated risk through
corrective actions.

Required Actions:
Any process step with an RPN of 125 or
greater, or a severity rating of 8 or higher will
require an MSA and process capability study (if
applicable/capable) for all key and critical
characteristics.

27

Process FMEA
Corrective Action
Recommended Actions:
Intent is to reduce Severity, Occurrence, and/or Detection Rankings.
If the effect could be a hazard to manufacturing personnel, cause must
be eliminated or controlled OR operator protection specified.
To reduce Occurrence ranking, process and/or design revisions are
required.
Only a design revision can reduce the Severity ranking.
Remember: If action is not taken to improve, the effectiveness of the
PFMEA is limited!

R ecom m ended
A c tio n s

Add Precision
Dedicated alignment
Fixture per P/N.
Add fixture to
calibration schedule

P e rs o n
R e s p o n s ib le
T a rg e t D a te

Joe Godoit

S
e
v

O
c
c

D
e
t

R
P
N

Precision
alignment Fixtures 5
created per P/N.

20

A c tio n s T a k e n

ASAP
Fixtures added to
calibration
schedule

Improvement actions must be taken for processes having capability indices

(Cpk), for critical and key characteristics, less than 1.67 Cpk and/or an RPN
greater then 175.
The intent of the recommended corrective action is to reduce any one or all
of the occurrence, severity, and/or detection rankings.

28

Process FMEA

Process FMEA Map

Operation
Impaired

What are the

5
causes?
What
conditionscan
bring aboutthe
failuremode?
Includeitems
the are the
actual root
cause, not
contributing
causes.

280 Add Precision

Dedicated alignment
Fixture per P/N.

1) (D) Visual check

How often does

ithappen?
6

Over or
Undersize
Diameters

Detect (D)

1)
2)
3)
4)
5)
6)

How good is 8
this method of
detecting?

(P) First piece inspection

(P) Dedicated Extension Tools
(D) 100% Visual inspection
(D) 100% bore gage of ID.
(D) SPC
(P) Cutting tool PM

Person
Responsible
Target Date Actions Taken
Joe Godoit
ASAP

Add fixture to
calibration schedule

Precision alignment
Fixtures created per
P/N.

RPN

Howbad
are the 4
effects?

What are the effects

/ results of the
FailureMode?
Typical effects may
3
include, butare
not limited to:
y Intermittent
operation
y Erratic operation
y Inoperativ e
y Unstable
y Control impaired

2
How could this
process/productfail
to meet it's intended
function?
y Ov er/Undersized
y Rough
y Eccentric
y Def ormed
y Cracked
y Open
y Shorted
y Leaking

Housing not
aligned during
milling

10

Recommended
Actions

DET

What is the 1
process Name /
Function?

Prevent (P)

OCC

QDM Leakage

Current Controls

SEV

Housing
Alignment or
Distortion at
Install / Loss of
Position for
Secondary Ops

6
5

Potential
Causes

DET

Datum Skewed

C
l
4 a
s
s

RPN

2) MILLING
(Port)

Potential
Potential
Failure Mode Failure Effects

OCC

1) MILLING
(Mounting Pads)

SEV

Process
Step/Name

20

Fixtures added to
calibration schedule

The product of 9
O X S X D = RPN

How can this be prevented?

Description ofprevention and

detection controls
y
y
y
y
y
y

(D) SPC
(D) Gauging
(D) Automated inspection
(D) Visual Inspection
(P)Mistake-proof ing
(D) Testing

y (P) First Piece Inspection

y (P) Calibration/ Prev entiv e
Maintenance on characteristic
creating tools machines etc.

Recommended Actions:

10

Intent is to reduce Sev erity , Occurrence, and/or Detection Rankings

If ef f ect could be a hazard to manuf acturing personnel, cause must

be eliminated or controlled OR operator protection specif ied

To reduce Occurrence ranking, process and/or design rev isions are

required

Only a design rev ision can cause reduction in Sev erity ranking

Remember: If action is not taken to improv e, the ef f ectiv eness of the

PFMEA is limited!

29

PROCESS CONTROL PLANS

PROCESS CONTROL PLAN

Aerospace

Key Cont act Name:

Dat e (Orig);

C o nt r o l P l an N umb er ;

Core Team:

Cust omer Engineering A pproval (If Req'd)

Dat e (If Req'd)

P ar t N umb er :

M anuf act uring Engineering M anager A pproval / Dat e:

Cust omer Qualit y A pproval (If Req'd)

Dat e (If Req'd)

P ar t N ame / D escr i p t i o n:

Qualit y A ssurance M anager Approval / Dat e:

Ot her A pproval (If Req'd)

Dat e (If req'd)

P l ant :

Ot her Approval Dat e (If Req'd):

Ot her A pproval (If Req'd)

Dat e (If req'd)

C o nt r o l P l an C at eg o r y

Prototype

Pre-Launch

Charact erist ics

Proc #

Process Name /
Operat ion descript ion

M achine, Device, Jig,

Tools For M f g.

No.

Dat e (Rev)

Revision:

Production

Product

Process

Special Char.
Class.

Product / Process
Specif icat ion /
Tolerance

M et hods
Evaluat ion /
Sample Sample
M easurement
Size
Freq.
Technique

Cont rol M et hod

React ion Plan

30

Process Control Plan

Purpose;
To aid in the manufacturing of products according to customer and design
requirements.
To focus resources on controlling special product and process characteristics.
Control plans are developed to create part number or product family specific
and systemic controls of product/process characteristics to aid in the
development of robust documentation.
The Control Plan describes the actions that are required at each phase of the
process to assure that all process outputs will be in a state of control.

Creating a Control Plan:

Use a cross functional team.
Key Inputs: Design FMEA, Characteristic Matrix, Process Map, Process
FMEA.
Control Plans are a living document; the control plan must reflect the current
process documentation.

31

PROCESS CONTROL PLANS

How to complete a
control plan

32

Process Control Plan

Process Number and Name

What is the process number?
The sequence of the process should line
up with the process map and PFMEA
What is the process name?

P ro c #

Pro ces s Name /

Op erat io n d es crip t io n

MILLING
(Mounting Pads)

The process name should line up with

the process map and PFMEA

Machine, Device, Jig, Tools for Mfg.

What significant machines or tools are
used?
List the processing equipment, e.g.,
machine, device, jig, or other tools for
manufacturing, as appropriate

M a c h in e , D e v ic e , J ig ,
T o o ls F o r M f g .
CNC Alignment Fixture
per Part Number

33

Process Control Plan

Characteristics
NOTE:
Characteristics
No.

3.5

Product

Process

Special Char.
Class.

Datum

Product and process

characteristics should be
separate line items.
They will often have a
different characteristic
class, specification and
control methods.

No.
What is the Characteristic Number (No.) ?
A reference number for the characteristic on the corresponding matrix or
print (if available).
Product.
What is the Product Characteristic?
A product characteristic is a feature such as dimension, size etc.
Process
What is the Process Characteristic?
Process characteristics are the process variables such as machine
pressure, flow, speed etc.
Special Characteristic Class
What is the Special Characteristic Classification?
Assign the appropriate characteristic classification to the identified product
or process characteristic.
Critical (C) The letter C indicates a Critical characteristic.
Key (K) The letter K indicates a Key characteristic.
Standard ( ) Leaving the column blank/empty indicates a standard
characteristic.
34

Process Control Plan

Methods
Product / Process
Specification /
Tolerance

Per print by
part number

Methods
Evaluation /
Sample Sample
Measurement
Size
Freq.
Technique

Visual,
Alignment
Fixture per
P/N

Control Method

100% 100% Precision

Alignment
Fixture per P/N

Product / Process Specification / Tolerance

What are the characteristic requirements ?
List the specifications that are required for the characteristic to be in
compliance. 2.+/- .005, Ra 16, finish acceptance per per print xyz etc.
Evaluation / Measurement Technique
What methods are used to measure the characteristic ?
List the measurement system being used. It could be gages, fixtures,
tools, visual/special inspection techniques, and/or test equipment.
Sample Size and Frequency
How many pieces are checked to verify the characteristic meets
spec and how often ?
Sample Size: List the percentage, quantity or AQL level.
Sample Frequency: List the percentage or sample rate (1/shift, 1/10 lots
etc.)
Control Method
How is the characteristic controlled?
SPC, inspection, attribute data, automated, sampling plans, mistake
proof process etc.
35

Process Control Plan

Reaction plan

Reaction Plan

Contact Cell Leader.

Repeat Set-up.
Scrap per NCM Process.

What does the operator do if the characteristic does not meet

specifications ?
Example: reject, scrap, repair process/print number referenced, rework,
readjust device/machine, reevaluate process, segregate, tag
nonconforming product and notify leader for disposition.

36

Process Control Plan

Process Control Plan Map

PRO CESS CO NTRO L PLAN
C o n tr o l P la n N u m b e r :

1234

P ro t o t y p e

P art N um ber:

P a r t N a m e / D e s c r ip tio n :

P ro d u c t io n

P re L a u n c h

H o u s in g

K e y C o n ta c t:

J o h n S m ith

C ore Team :

T o o m a n y P e o p le

E a to n A e r o s p a c e , G le n o ld e n P A

V endor:
P a rt /
P ro c e s s
N um ber

P ro c e s s N a m e /
O p e ra tio n d e s c rip tio n

M a c h in e , D e v ic e , J ig ,
T o o ls F o r M fg .

P la n t:

C h a r a c te r is tic s
No.

P ro d u c t

P ro c e s s

S p e c ia l
C h a r.
C la s s .

M IL L IN G
( M o u n tin g P a d s )

CNC
A lig n m e n t fix tu r e p e r P /N

D a tu m

P e r P rin t b y P /N

M IL L IN G
( P o rt)

CNC

P o r t ID

P e r P rin t b y P /N

W h a t is th e
p ro c e s s
nam e?
T h e p ro c e s s
n a m e s h o u ld
lin e u p w ith
th e p ro c e s s
m ap and
PFMEA

W h a t a r e th e c h a r a c t e r is t ic s a n d c la s s ?
P ro d u c t a n d p ro c e s s c h a ra c te ris tic s s h o u ld b e
s e p a ra te lin e ite m s b e c a u s e th e y w ill o fte n
h a v e a d iffe re n t c h a ra c te ris tic c la s s ,
s p e c ific a tio n a n d c o n tro l m e th o d s .
N o .: A re fe re n c e n u m b e r fo r th e c h a ra c te ris tic
o n th e c o rre s p o n d in g m a trix o r p rin t.
P r o d u c t: A p r o d u c t c h a ra c te ris tic is a fe a tu re
s u c h a s d im e n s io n , s iz e e tc .
P r o c e s s : P ro c e s s c h a ra c te ris tic s a re th e
p ro c e s s v a ria b le s s u c h a s m a c h in e p re s s u r e ,
flo w , s p e e d e tc .
S p e c ia l C h a r a c t e r is t ic C la s s ific a tio n :
A s s ig n th e a p p ro p ria te c h a r a c te r is tic
c la s s ific a tio n to th e id e n tifie d p ro d u c t o r
p ro c e s s c h a ra c te ris tic . re fe re n c e th is
p ro c e d u re fo r th e c la s s ific a tio n s .

V endor N u m ber:

R ev. #:

W h a t a r e th e
c h a r a c te r is tic
r e q u ir e m e n t s ?
L is t th e
s p e c ific a tio n s
th a t a r e re q u ir e d
fo r th e
c h a ra c te ris tic to
b e in
c o m p lia n c e . 2 .+ /.0 0 5 , R a 1 6 ,
fin is h a c c e p ta n c e
p e r p e r p rin t x y z
e tc .

E v a lu a tio n /
M e a s u re m e n t
T e c h n iq u e
V is u a l
A lig n m e n t F ix tu r e
V is u a l, b o re g a g e

W h a t m e th o d s
a r e u s e d to
m e a s u r e th e
c h a r a c te r is tic ?
L is t th e
m e a s u re m e n t
s y s te m b e in g
u s e d . It c o u ld b e
g a g e s , fix tu re s ,
to o ls , v is u a l/
s p e c ia l
in s p e c tio n
te c h n iq u e s , a n d /
o r te s t
e q u ip m e n t.

N /A

M e th o d s

2)

W hat
s ig n ific a n t
m a c h in e s o r
to o ls a r e
used?
L is t th e
p r o c e s s in g
e q u ip m e n t, e .g .,
m a c h in e ,
d e v ic e , jig , o r
o th e r to o ls fo r
m a n u fa c tu rin g ,
a s a p p ro p ria te

1 1 /1 /2 0 0 6

R e v . D a te :

P ro d u c t / P ro c e s s
S p e c ific a t io n / T o le ra n c e

1)

W h a t is th e
p ro c e s s
n u m b e r?
The
sequence of
th e p r o c e s s
s h o u ld lin e u p
w ith th e
p ro c e s s m a p
and P F M E A

O r ig . D a te :
G le n o ld e n , P A

S a m p le
F re q .

100%

100%

Each
ru n

P re c is io n d e d ic a te d
a lig n m e n t fix tu re b y
P /N .
F ir s t P ie c e s e t- u p
In s p e c tio n

S c ra p p e r N C M p r o c e d u r e

100%

100%

SPC

A d ju s t m a c h in e s e ttin g s .
S c ra p p e r N C M p r o c e d u r e

How m any
p ie c e s a r e
c h e c k e d to
v e r ify th e
c h a r a c te r is tic
m e e ts s p e c
and how
o f te n ?

C o n tro l M e t h o d

R e a c t io n P la n

S a m p le
S iz e

H o w is t h e
c h a r a c te r is t ic
c o n t r o lle d ?
SPC,
in s p e c tio n ,
a ttrib u te d a ta ,
a u to m a te d ,
s a m p lin g
p la n s e tc .

C o n ta c t c e ll le a d e r
R e p e a t s e tu p p ro c e s s
S c ra p p e r N C M p r o c e d u r e

W h a t d o e s th e
o p e r a to r d o if th e
c h a r a c te r is t ic
do es not m eet
s p e c ific a tio n s ?
E x a m p le : re je c t,
s c r a p , re p a ir
p ro c e s s /p rin t
n u m b e r re fe r e n c e d ,
re w o r k , re a d ju s t
d e v ic e /m a c h in e ,
re e v a lu a te p ro c e s s ,
s e g r e g a te , ta g
n o n c o n fo rm in g
p ro d u c t a n d n o tify
le a d e r fo r
d is p o s itio n .

37

Manufacturing Instructions
Purpose:
To define the requirements for developing comprehensive and
supplemental Manufacturing Instructions (MI) for product, process, or
activity to be produced which is to be applied at each operation or
workstation.

Staking Process

38