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Comprehensive Control Plan

Training

CCP 4/03 HK

Energy & Chassis Systems

Contents
Introduction
The

Comprehensive Control Plan


Elements of a Comprehensive Control
Plan

CCP 4/03 HK

Energy & Chassis Systems

Introduction
Quality

is designed into a product


through the Advanced Product Quality
Planning (APQP) process
APQP assures that customer requirements
are not lost in product and process design
APQP aims at minimizing variation through
better design and through process
controls

CCP 4/03 HK

Energy & Chassis Systems

Introduction
Customer Requirements:
Char. Verification Matrix (CVM)

Product Definition:

Characteristics: KPC's, QCI's,


DFMEA

Process Definition:
Process Flow Dia. (PFD), KCC's,

Failure Mode Analysis:


PFMEA,
Lineside Review Process

Control Strategy:

Comprehensive Control Plan,


Errorproofing

Manufacturing:

Process Monitoring,
Standard Cell, Layered Audit
CCP 4/03 HK

Energy & Chassis Systems

Introduction
PHASE

PRODUCT
ENGINEERING

MANUFACTURING
ENGINEERING

Define & Analyze Requirements

MANUFACTURING
OPERATIONS

PFD

QCI

QCI
KCC

Process Monitoring Plan

KCC

Service Life/
Durability
Customer Interface

C/O Checklist

KPC
QCI

Peformance

CVM

INPUTS

OUTPUTS

DFMEA

Testing Online
Preventive Maintenance
Gage Instruction
Errorproofing
Verification
Dept._________

KPC

QCI
Standard

PFMEA

First Time Quality

Drawings &
Specifications

CONTROL PLAN
KCC

KCC

QCI

QCC

SPC

SCC

Control
Strategy
Control
Strategy
Control
Strategy

VARIABLE

ATTRIBUTE
GO
NO-GO

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Energy & Chassis Systems

Introduction
Development

of a control plan is an
integral part of the Advanced
Product Quality Planning process
a control plan is one of the final outputs
of APQP

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Energy & Chassis Systems

Introduction

A comprehensive control plan is a written


summary of the methods and systems used
to control production parts and processes
addresses all product and process
characteristics and requirements for control.
monitors Process Stability
includes FTQ
aims at minimizing variation
Prevents defects from escaping the
manufacturing operation

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Energy & Chassis Systems

Introduction
Comprehensive Control Plan - Justification
- According to QS9000 Third Edition ( Pages 40 & 41)

Final Inspection & Testing 4.10.4


The Quality Plan ( Control Plan) and/or documented procedures
for final inspection and testing shall require that all specified
inspection and tests have been carried out and that the results
meet specified requirements.
Layout Inspection & Functional Testing 4.10.4.2
A layout inspection and a functional verification ( to applicable
customer engineering material and performance standards) shall be
performed for all products at a frequency established by the
customer (see Section II). Results shall be available for customer
review.

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Energy & Chassis Systems

Introduction
Comprehensive Control Plan Justification
(Continued)
Final Product Audit 4.10.4.2
The supplier shall conduct audits of packaged final
product to verify conformance to all specified requirements
( e.g. product, packaging, labeling) at an appropriate
frequency. Note: This activity, also known as a dock audit
is based upon sampling and is generally performed after final
inspection but prior to shipment.

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Energy & Chassis Systems

Introduction
APQP

calls for three (3) types of


control plans
prototype control plan
pre-launch control plan
production control plan

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10

Energy & Chassis Systems

(1) Prototype Control Plan

Introduction

Requirement:
dimensional measurements and functional tests on
prototype builds
process parameters that affect product
characteristics

Purpose:
to validate the prototype product
to validate the prototype process
a good way to find and fix real problems prior to
production tooling being made
Can provide input to Customer Verification Matrix
(CVM) Supplier Input Form
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11

Energy & Chassis Systems

Introduction

(2) Pre-Launch Control Plan

Comprehensive

Requirement:
includes dimensional measurements and
functional tests on early production parts
additional controls to be in place until the
process is validated

Purpose
to protect the customer from potential
quality issues during early production
to check the process prior to and during
start of production
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Energy & Chassis Systems

Introduction
(3) Production Control Plan (Comprehensive)
Requirement:

systems for controlling parts and processes


includes receiving inspection, manufacturing
processes, assembly, packaging, labeling, etc. as
applicable ( Dock to Dock)

Purpose

to provide a product to the customer that meets


or exceeds quality requirements

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Energy & Chassis Systems

The Control Plan Process

Identify a core team and appoint a leader


Manufacturing Engineering owns control plan prior to
Start of Production ( SOP).Quality owns updating
it after SOP
need representatives from groups involved in
product design, process/tool engineering, industrial
engineering, gauging, quality, supplier quality,
manufacturing personnel, etc.
train team if necessary

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14

Energy & Chassis Systems

The Control Plan Process

Understand the product requirements


Characteristics Verification Matrix
where KPCs and QCIs first identified
Supplier Input Form

System and/or Design FMEA


information from design reviews
lessons learned, warranty info, customer
complaint information from similar products
information on how the customer is going to test,
measure and use the product
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15

Energy & Chassis Systems

The Control Plan Process

Understand the manufacturing process


Characteristics Verification Matrix
where KCCs and QCCs first identified

Process Flow Diagram


learn about steps that involve rework or scrap
learn about incoming component quality

Process FMEA
information from similar processes, such
as,Design of Experiments ( DOE), capability, first
time quality, etc.

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16

Energy & Chassis Systems

The Control Plan Process


Define

characteristics to be controlled
and methods for controlling them
if CVM available, characteristics to be controlled
are defined here
consider all process steps as listed in Process Flow
Diagram for input and output information
paretoize RPNs on the PFMEA to help understand
high risk processess
include all KPCs, QCIs and standard product
characteristics designated by the customer or
internally(Prints, Specifications, Math Data)

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17

Energy & Chassis Systems

The Control Plan Process

- Each part drawing characteristic or

requirement must be numbered and have its


corresponding number identified in the
Control Plan. If the total number of drawing
requirements is greater than 20, it is
acceptable to group drawing numbers that will
be checked at the same defined frequency
into a single entry on the control plan.

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Energy & Chassis Systems

The Control Plan Process


- Drawing characteristics include physical
requirements ( KPC, weight, volume,
appearance) , structural requirements
(porosity,cracks,voids,hardness),
performance requirements ( dielectric
integrity, leak, adhesion), and packaging &
labeling requirements.
- Sample size & frequency must be based on
variation exhibited ( e.g. part to part, operator
to operator, lot to lot, set-up to set-up)
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Energy & Chassis Systems

The Control Plan Process


-

The minimum standard for assuring


compliance of special characteristics is a first
and last piece inspection/test of the special
characteristics
- All control methods must be traceable to
control activity to maintain stable & capable
output. (e.g. die held dimension requires
defined die P.M. or tool requires defined level
of tool change based on wear.
- Control activity monitored through FTQ
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Energy & Chassis Systems

CONTROL PLAN

Control Plan Category

Key Contact Name

Prototype

Pre-Launch Production

Control Plan Number

Key Contact Phone

123456789

248 813-3000

Part Number

Date (Orig)

ECL

Date (Rev)

3/2/2003

John Doe

Page
3/31/03

Customer Engineering Approval (If Req'd)

Date (If Req'd)

Supplier / Plant Approval / Date

Customer Quality Approval (If Req'd)

Date (If Req'd)

Other supplier approval by (If Req'd)

Other Approval (If Req'd)

Date (If req'd)

12

123456789
Part Name / Description

Measurement Assy.
Supplier / Plant

Supplier Code

ACME / Plant 1

Other Approval Date (If Req'd)

00908090

Core teamM embers

Control Plan Example with Grouping of some Product Characteristics on Control Plan
Characteristics
Part /
Proc
#
12

20

Process
Name /
Operation
description
End of Run
Inspection

Annual Layout

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Machine,
Device,
Jig, Tools
For Mfg.

No.

Product

Process

Methods
Special
Char.
Class.

Product /
Evaluation /
Process
Sampl Sample
Measurement
Specification
e Size Freq.
Technique
/ Tolerance

Inside
Diameter

QCI-3

13.01 +/0.06

Outside Dia.

QCI-4

16.0+/-0.1

Gage 2563m02 1 pc Once


Measure &
per
per
Record
cavity shift

Control Method

Reaction
Plan

P12-01

P13-01

Process sheet

Contain
Material/ Fix
process

1 pc Once
per
per
cavity shift

1 thru See Annual


5
Layout Sheet

CMM
Fixture xyz
Measure &
Record
separately
Low, Avg, Hi
See Annual See Annual
Layout Sheet Layout Sheet

1 pc Once
Annual Layout
per
per year Sheet
cavity

P20-01

8 thru See Annual


30
Layout Sheet

See Annual See Annual


Layout Sheet Layout Sheet

1 pc Once
Annual Layout
per
per year Sheet
cavity

P20-01

21

Energy & Chassis Systems

CONTROL PLAN

Control Plan Category

Key Contact Name

Prototype

Pre-Launch

Control Plan Number

Key Contact Phone

123456789

248 813-3000

Part Number

Date (Orig)

John Doe

Production

ECL

Date (Rev)

3/2/2003

Page
3/31/03

Customer Engineering Approval (If Req'd)

Date (If Req'd)

Supplier / Plant Approval / Date

Customer Quality Approval (If Req'd)

Date (If Req'd)

Other supplier approval by (If Req'd)

Other Approval (If Req'd)

Date (If req'd)

12

123456789
Part Name / Description

Measurement Assy.
Supplier / Plant

Supplier Code

ACME / Plant 1

Other Approval Date (If Req'd)

00908090

Core team M embers

Control Plan Example with All Numbered Product Characteristics listed on Control Plan
Characteristics
Process
Part /
Name /
Proc
Operation
#
description
12
End of Run
Inspection

20

Annual Layout

CCP 4/03 HK

Machine,
Device,
Jig, Tools
For Mfg.

No.

Product

Process

Methods
Special
Char.
Class.

Product /
Evaluation /
Process
Measurement
Specification
Technique
/ Tolerance
13.01 +/Gage 2563m02
0.06
Measure &
Record

Inside
Diameter

QCI-3

Outside Dia.

QCI-4

Length

85.0 =/-0.8

Champher

0.5 x 45 Dg.

CMM
Fixture xyz

Flange Width

30.0 +/-0.8

Calipers

Flange
Thickness

10.0 +/- 0.8

Calipers

16.0+/-0.1

22

CMM
Fixture xyz
Measure &
Record
separately
Low, Avg, Hi
Caliper

Sampl Sample
e Size Freq.

Control Method

Reaction
Plan

1 pc
Once
per
per
cavity shift

P12-01

P13-01

1 pc
Once
per
per
cavity shift

Process sheet

Contain
Material/ Fix
process

1 pc
per
cavity
1 pc
per
cavity
1 pc
per
cavity
1 pc
per
cavity

Once
Annual Layout
per year Sheet

P20-01

Once
Annual Layout
per year Sheet

P20-01

Once
Annual Layout
per year Sheet

P20-01

Once
Annual Layout
per year Sheet

P20-01

Energy & Chassis Systems

Elements of a Control Plan

4 Main Sections

Header Information
1

Product/
Product/
Process
Process
Description Characteristics

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Control
Methods

Reaction
Plan

Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

-- Product/Process Description --

This

section identifies all parts/components and


associated process steps that are in need of
control.

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Energy & Chassis Systems

Elements of a Control Plan


1

Part/Process

-- Product/Process Description --

Number

reference number to the Process Flow Diagram


e.g. process step 10 on PFD must link with PFMEA
and Control Plan
Process Flow Diagram is the foundation for process
numbering
there should be no ambiguity

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Energy & Chassis Systems

Elements of a Control Plan


1

Process

-- Product/Process Description --

Name/Operation Description

describe the operation or process step


concisely
the description should match the
description in the Process Flow Diagram
recommended that you use the format
verb+object
e.g. load hopper; move parts to assembly area
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Energy & Chassis Systems

Elements of a Control Plan


1

-- Product/Process Description --

Machine,

Device, Jig, Tools for


Manufacturing
identify the machine used in the process
step
be specific: if only certain machines out
of many are used for this part, identify
the specific machines in the control plan
e.g. mold machines #15,16,17

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Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

Section 2
Contains a detailed description of the specific characteristics
that must be controlled in order to assure quality.
Must identify product and process characteristics separately
-not on the same line
Each component and/or process step listed in the previous
section, Product/Process Description, might have several
characteristics that need to be controlled.
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Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Number

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

cross-reference number to a product or


process characteristic on a drawing,
sketch, process flow diagram, FMEA, or
other applicable document
adds more detail to the part/process number
applicable drawings and flow diagrams should
be easily tracked from the control plan
there should be no ambiguity
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Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

Product Characteristics
features, attributes, or properties of a part,
component, or assembly
examples:

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dimensions, weights, geometrical attributes


appearance items such as gloss
material-related characteristics such as hardness
etc.
30

Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

Process Characteristics

process variables and parameters that have a


cause and effect relationship with product
characteristics
can only be measured at the moment it occurs
examples:
mold temperature
cycle time

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31

Energy & Chassis Systems

Elements of a Control Plan

Fishbone diagrams are a useful tool to help


identify process parameters that have an effect
on product characteristics
man

machine
process char

process char

Product
Characteristic
process char

method
CCP 4/03 HK

material
32

Energy & Chassis Systems

Elements of a Control Plan


There

is often a complex relationship


between product and process
characteristics
one product characteristic affected by
more than one process characteristic
several product characteristics affected
by one process characteristic

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Energy & Chassis Systems

Elements of a Control Plan

-- Product/Process Characteristics -

Special Characteristics
(KPCs and KCCs, QCIs and QCCs) must be
included and designated by the appropriate
symbol or text in the control plan Special
Characteristics Classification column

Format on Control Plan


Each product or process characteristic must be
listed on a separate line in order to maintain
continuity with the rest of the information
listed on the plan

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Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

Header Information
1

Product/
Product/
Process
Process
Description Characteristics

The

Control
Methods

Reaction
Plan

Control Methods section includes the:

product/process specification and tolerance


evaluation/measurement technique
sample size/frequency
control method

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Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

Product/Process

Specifications/Tolerances
identified for the characteristics that are to
be controlled in Section 2
obtained from engineering drawings, process
specifications, material standards, assembly
requirements, etc.

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Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

Evaluation/Measurement Technique
Many different types
. dimensional Measurement
. functional Gaging

variable or attribute gaging


on-line or off-line testing
visual inspection
error proofing
use of Test/Gage Set-up Masters must be listed in
Control Plan

Short description or reference number:


measurement gages, fixtures, etc.
measurement procedures

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Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

Error Proofing

Two types of Error Proofing


Error Prevention
Error Detection

Error Prevention
Error cannot occur by design or process

Error Detection
Detection at the source
Detection downstream
visual inspection
on-line testing/gaging
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Energy & Chassis Systems

Elements of a Control Plan


--Control Methods-

Evaluation/Measurement Techniques

Measurement System Analysis must be performed


on any measurement system used for controlling
product quality
Measure whatever characteristic (product or
process) that will be used for control
Linearity, repeatability, reproducibility,stability &
accuracy maybe required to qualify measuring
equipment
For attribute measurement methods, repeatability
and reproducibility must also be assessed

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39

Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

Sample

Size and Frequency

used for Lot Control of Special


Characteristics
examples

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1st and last piece


5 pcs every hour
1st piece after setup/change over
100% ongoing
First piece after preventive maintenance
40

Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

Things to consider when determining sample size and


frequency:

What is the process capability?


What is the production rate/hour?
How many cavities or dies are there?
What is the standard pack quantity?
At what frequency are parts going to be shipped?
What is the buffer size?
How long does the inspection or test take?
Does the sampling plan make sense? Does it address the primary
family of variation? (e.g. within part, part to part, setup to setup,
shift to shift, material lot to material lot, time to time, etc.)

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Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

AIM IS TO:

ASSURE TIMELY PROCESS


FEEDBACK TO PREVENT POOR
QUALITY WHILE
MINIMIZING ANY
POTENTIAL RISK TO THE
CUSTOMER
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Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

Control

Method

this column contains a description of how


the operation will be controlled, including
procedure numbers where it applys
the control method utilized should include
the documentation form that is used to
record the results of the characteristic
being evaluated or measured

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43

Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods -Examples of control method documentation


include:

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Process Monitoring Check Sheets


Statistical Process Control forms
Off-line test records
Receiving Inspection records
Error Proofing Verification documentation
Preventive Maintenance records
Calibration records
44

Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

The control method should be continually


evaluated for effectiveness by performing:
Line Side Review
Prior to PPAP to verify no documentation gaps
in process flow/ control plan/ pfmea/ work
instructions. Include all characteristics of part
or material.
Observe from plant floor ( See Line Side
Review Training).

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45

Energy & Chassis Systems

Elements of a Control Plan

-- Control Methods --

The control method should be continually


evaluated for effectiveness by monitoring:

process capability
control charts
process monitoring data sheets
first time quality data
continuous improvement efforts document on
gate chart
process stability monitoring alarm limits &
reaction plan
audit data

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Energy & Chassis Systems

Elements of a Control Plan


Header Information
1

Product/
Product/
Process
Process
Description Characteristics

Control
Methods

Reaction
Plan

Reaction Plan
corrective action to be performed to prevent
nonconformances from reaching the customer
prefer actions that keep the process in control
be sure to mark and quarantine nonconforming
product (according to procedures)
document what corrective action was taken on
appropriate form

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Energy & Chassis Systems

The Control Plan Process


Update

the control plan as the


product or process changes, or as new
issues emerge
the control plan is a living document
throughout the product life cycle

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Energy & Chassis Systems

Control Plan Example


Form 818-1 (Rev 12Apr02)

Prototype

Pre-Launch

CONTROL PLAN

Production

Part Number/Latest Change Level

Key Contact/Phone

Control Plan No:


Date (Orig.)

Customer Part Number


ACME XYZAA
Part Name/Description
End-Cap (Machined State)
Supplier/Plant
Supplier Code

Core Team

Customer Engineering Approval/Date (If Req'd.)

Supplier/Plant Approval/Date

Customer Quality Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Other Approval/Date (If Req'd.)

Characteristics
Process Name/
Op-Seq
Operation
No.
Description

Machine,
Device, Jig,
Tool for Mfg.

10-6

Turn End-cap

10-6

Turn End-cap

CNC Lathe

10-6

Turn End-cap

10-6

30-5

No.

Product

Methods

Process

End-cap

Special
Char.
Class

Product/Process
Specification/
Tolerance

Evaluation
Measurement
Technique

QCI 4 Diameter
18 +/- 0.05 mm

Calipers

Turning speed

QCC 4 500 +/- 10 RPM

Speed Sensor

CNC Lathe

Turning speed
setpoint
verification

QCC 4 500 RPM

Visual

Turn End-cap

CNC Lathe

Cutter Life

Drill Hole

CNC

CPTraining.ktm.ppt

Key-chain hole

Date (Rev.)

Must be replaced every Machine Counter


4000 pieces max
QCI 1 3.0 +/- 0.1 mm

49

Plug gages
(attribute check)

Sample
Size
5

100%

Freq.

Control
Method

Reaction
Plan

Every two hours

X-R chart

Perform
troubleshooting
procedure,
contain parts
since last check
if required

Continuous

CNC Controller

Run diagnostics
and perform
maintenance
Correct setting
and contain
previous parts
for
measurement

Start of shift,
Process
changeovers,
Monitoring
maintenance (end Worksheet
of shift if less than
3-shift operation)

Maximum of 4000 Process


pieces
Monitoring
Worksheet

Change tool

Every two hours

Perform
troubleshooting
procedure,
contain parts
since last check
if required

Process
Monitoring
Worksheet

Energy & Chassis Systems

C
o
n
t
r
o
l

CONTROL PLAN

Control Plan Category

Key Contact Name

Prototype

Pre-Launch

Production

Control Plan Number

John Doe
Key Contact Phone

123456789
ECL

Part Name / Description


Supplier Code

ACME / Plant 1

Supplier / Plant Approval / Date

Customer Quality Approval (If Req'd)

Date (If Req'd)

Other supplier approval by (If Req'd)

Other Approval (If Req'd)

Date (If req'd)

Measurement Assy.
Supplier / Plant

Page
3/31/03

Date (If Req'd)

12

123456789

Date (Rev)

3/2/2003

Customer Engineering Approval (If Req'd)

248 813-3000

Part Number

Date (Orig)

Other Approval Date (If Req'd)

00908090

Core team Members

2 Examples of showing FTQ monitoring at a station level. This FTQ would be an indication of the process stability.
Characteristics
Part /
Process Name /
Machine, Device, Jig,
Proc # Operation description
Tools For Mfg.

10

Torque assembly Assy. Ststion


to body
111

No.

Product

Process

Leak Rate

QCI

Leak Tester
FTQ

OR
FTQ

CCP 4/03 HK

Special Char.
Class.

P
l
a
50n

QCC

Product / Process
Specification /
Tolerance

Methods
Evaluation /
Sample Sample
Measurement
Control Method
Size
Freq.
Technique

Reaction Plan

200 SCCM Max. LEAK TESTER 100% Conti


nuou
s
Pass/ Fail
2
Shift Process sheet
Masters
Alarm Limits
Visual count
1
Hr
Tally Sheet
8max. /2min. per
hour

Place rejects into FTQ


reject cart

Refer to FTQ
010 for limits

FTQ Reaction Plan


FTQ 010

Visual count

Hr

Tally Sheet

Contain Material/ Fix


process
FTQ reaction plan
FTQ-010

Energy & Chassis Systems

Comprehensive
Control Plan

C&R

CONTROL OR
MONITOR
INSPECT/CHECK
TEST
AUDIT
OK/NOT OK STD

CONTAIN & REACT

All Product and Process checks


are verified prior to lot release
RECEIVE
OK
C&R

MANUFACTURE
Y

PRODUCT
PACK
LABEL

OK
C&R

OK Y

C&R

PRODUCT
FIT
FORM
FUNCTION
PERFORMANCE
PROCESS
TOOL
EQUIPMENT
MEASUREMENT
SETTINGS
OPERATOR
Y

MACHINE

C&R

LOT
OK

PACK

SHIP

OK Y

Y
C&R

OK
C&R

QUANTITY

PRODUCT
PACK
FIT
LABEL
FORM
FUNCTION
MAINTENNANCE
PERFORMANCE
TOOL
PROCESS
TOOL
EQUIP
EQUIPMENT
MEASUREMENT
MEASURE
SETTINGS
OPERATOR

QUANTITY
PACK
LABEL

OK
C&R

SYSTEM VERIFICATION/AUDIT
POLICIES
PROCEDURES
INSTRUCTIONS

OK

METHOD

CCP 4/03 HK

C&R

MAN

MATERIAL

LOT ASSURANCE

51

Energy & Chassis Systems