3. Control Plan
3
Page 3
Control Plans:
• Control the risks identified in the P-FMEA (High RPNs)
• A structured approach to control process and product characteristics
• Focusses on Customer Requirements
• Assure reaction plans are in place in case of out-of-control conditions
• Provide a central document for communication of control methods
• A Control Plan contains following key information:
Identification of the control factors
The specifications and tolerances
The measurement system
Sample size and frequency
The control method
The reaction plan
• Control Plans are living documents, just like FMEA’s
4. Control Plan, Objectives
Objectives of the training:
• To understand the use of a Control Plan
• To learn the steps to develop a Control Plan
• To learn how to link each step in the Control Plan
to the FMEA
4
Page 4
5. Control Plan, Summary
Control Plan, a systemic way to Control a process:
• Define Characteristics per process step:
• Machines, Devices, Jigs and Tools
• Product, Process and Special characteristics
• Define Methods per process step:
• Process and Product Specifications and Tolerances
• Measurement and Inspection techniques
• Sample size and frequency
• Actions that should be taken in case of
Non Conformities
5
Page 5
6. Control Plan, Summary
Control Plan, a systemic way to Control a process:
• Verify if defined steps are followed
• Audit the process by Control Plan on a regular
base
• Update the Control Plan consistently
6
Page 6
7. Benefits
7
Control Plan, Inputs
Page 7
Control Plan, inputs might include following tools:
• FMEA
• Flow Chart (process sequence)
• Lay-out Plan production line
• Sequence Of Events
• Part Number/ Tooling / Tool List
• Assembly Drawing
• Specifications/ Dimensions/ Tolerances
• CTQ List
• Process Map
• Historical OMS
8. A build B build Pilot
Drawing
Issue part approval form
Tool development
FMEA + control plan
1. Conditional approval
2. HVPT approval
3. Part approval
Quality and capacity confirmation
HVPT process approval
Fit / performance
Purchasing SQE QA
Source SQE approval
Issue HF PA
requirements
HF proto part
approval
HF full part
approval
(OT/OP)
MF and LF
part receipt
Inspection OK
– NOK send
CAR’s
VCB approval
SOP
Page 8
Control Plans, Planning
9. A B C D
Part /
Process
Number
Process Name /
Operation Description
Machine Device
Jig. Tools
for Manufacturing No.
Evaluation
Measurement
Technique
Product Process
Product/Process
Specification
tolerance
Special
Characteristics
Class
Size
Control
Method
Freq.
Reaction
Plan
Sample
Methods
Characteristics
Prototype Pre-launch Production
Control Plan Number Key Contact/Phone Date (Original)
Date (Revised)
Part Number/Latest Change Level
Part Number / Description
Plant / Supplier Supplier Code
Core Team
Plant / Supplier Approval Date Customer Eng.'s Approval / Date (if Required)
Customer Quality Approval / Date (if Required)
Other Approval / Date (if Required)
1 2 5 6 7 8 9 10 11 12
3 4
Advanced Product Quality Planning (APQP) Reference Manual, QS-9000
Page 9
Control Plans
Operation Characteristics Methods Reaction
Plan
10. 1. Part/Process Number:
• Usually referenced from the process flow chart, PFMEA or
Tool sheets
2. Process Name/Operation Description:
• Identify the process/operation that best describes the
activity being addressed (e.g. work elements)
• Use verb / noun format
3. Machine, Device, Jig, Tools for Manufacturing:
• Identify the processing equipment required. (e.g..
machine, device, jig power tools, assist arms, conveyors,
etc.)
What is being done?
A Operation
Page 10
Control Plans
LTVL010 8416010, FRAME, 1x 1
PART/
PROCESS
NUMBER
PROCESS NAME/
OPERATION
DESCRIPTION
MACHINE,
DEVICE
JIG, TOOLS
FOR MFG.
11. 4. Number:
• Identifies the cross reference number from the applicable
documentation.
7. Special Characteristic:
• key processes (e.g. Delta K, QS)
5. Product Characteristic:
• Distinguishing features and/or attributes
6. Process Characteristic:
• Characteristics of the process
What is Important?
B Characteristics
Page 11
Control Plans
1 1 Appearance Inspect the frame Y
CHARACTERISTICS
MACHINE,
DEVICE
JIG, TOOLS
FOR MFG.
NO. PRODUCT PROCESS
SPECIAL
CHAR.
CLASS
12. PRODUCT
CHARACTERISTIC
• physical properties of the part
• Identified important customer
characteristics (CTQs and
Delta-K)
Examples: length, width, tensile
strength, torque, weld integrity, color,
alignment, etc.
A description of the state of the
component or vehicle after the
particular operation is completed
PROCESS
CHARACTERISTIC
• identify characteristics, which
when controlled, reduce
variation in product
characteristics
Examples: pressure, temperature,
force, feed rate, RPM (torque), etc.
Related to product characteristics
Characteristics: Identify Product and Process
characteristics for each Control Plan step
Page 12
Control Plans
13. 8. Product/Process Specification:
• Specifications/tolerance for a part or process. (eg. may be
obtained from various engineering documents)
9. Evaluation/Measurement Technique:
• Identifies the measurement system being used to measure
product/process characteristics. (eg. gages, fixtures, test
equipment, blocks, go/no go, etc)
10 / 11. Sample Size/Frequency:
• List sample size and frequency to perform evaluation. (eg. size: 4
pieces / frequency: fifth time per shift)
What is the Means for Controlling?
Methods
Control Plans
Page 13
C
PRODUCT/PROCESS EVALUATION/ SAMPLE
SPECIFICATION/ MEASUREMENT
TOLERANCE TECHNIQUE
No damage Visual Inspection 1 1/Works
hop
OMS Inform Trainer
FREQ.
CONTROL
METHOD
METHODS
REACTION
PLAN
SIZE
14. Benefits
1
4
Control Plan,
Sample size and frequency
Page 14
Station:
1-nov-08
2-nov-08
3-nov-08
4-nov-08
5-nov-08
6-nov-08
7-nov-08
8-nov-08
9-nov-08
10-nov-08
Install O-ring Mee-1247 1
C/R into C/C Mee-1248
S/R assy Mee-1250
S/R height Mee-1251
V-coupling assy Mee-1253
Act assy Mee-1255 1
Lever welding Mee-1288 1 2 3 1
Lever welding Mee-1289
Act measurement Mee-1291 2 2 1 3
Engraving Mee-1256 1
Rev & K-ring check Mee-1257
Weld-assy-act Mee-1258
C/C angle check Mee-1259 1 4
V-coupl-lever-act Mee-1260 2
Total NOK 3 2 1247 0 0 7 1 2 0 4
OK 220 450 300 350 455 275 400 430
• Until a process is Capable (Cpk 1.33), 100% Inspection is required
• If process is Capable, define Sample Size and Frequency reflecting acceptable risk
• Use Six Sigma tools and techniques to control the Process
6
5
4
3
2
1
50
45
40
35
30
Sample
Sample
Mean
_
_
X=39.42
UCL=51.01
LCL=27.82
6
5
4
3
2
1
20
1 5
1 0
5
0
Sample
Sample
Range
_
R=6.17
UCL=20.15
LCL=0
Xbar-R Chart of x
Counting Defects
C-Graph of Defects
SPC Chart
Capability Graph
15. PRODUCT/PROCESS EVALUATION/ SAMPLE
SPECIFICATION/ MEASUREMENT
TOLERANCE TECHNIQUE
No damage Visual Inspection 1 1/Works
hop
OMS Inform Trainer
FREQ.
CONTROL
METHOD
METHODS
REACTION
PLAN
SIZE
12. Control Method:
• Brief description of how the operation will be controlled
• When selecting the method of control, focus on:
• process control rather than product control
• prevention rather than detection
• targeting nominal rather than specification limits
Examples:
- Check sheets (weld, quality, tool,
material, etc)
- Preventative tooling maintenance
- Variation control charts
- Error/mistake proofing
- SPC charts
Methods
Control Plans, Control Method
C
Page 15
16. 13. Reaction Plan:
• Specifies who to inform to make a decision or what to do when a
process goes out of control
• Written for people closest to the process (e.g. replace a drill)
• Review systemic root cause and update the FMEA
Examples:
- Call supervisor
- 100% Inspection until the process is back in control
- Calibrate equipment
D Reaction Plan
Control Plans, Reaction Plan
Page 16
PRODUCT/PROCESS EVALUATION/ SAMPLE
SPECIFICATION/ MEASUREMENT
TOLERANCE TECHNIQUE
No damage Visual Inspection 1 1/Works
hop
OMS Inform Trainer
FREQ.
CONTROL
METHOD
METHODS
REACTION
PLAN
SIZE
17. Control Plans, Plug Example
Page 17
Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.) 1
1 Wytse Zijlstra
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
PL30 Wytse Zijlstra, Stephen McLaughlin N/A
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)
Plug assembly 15/10/2016 N/A
Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
Hyster-Yale Group N/A
PRODUCT/PROCESS EVALUATION/ SAMPLE
SPECIFICATION/ MEASUREMENT
TOLERANCE TECHNIQUE
PL-10 1010; 1 Plug face Code: PA320,
White Bar Grip
Rew ireable 13A
Resilient Plug Top
Select 1 plug face w ith
inside facing operator
Visual Inspection 100% OMS Inform Trainer
PL-10 1345; 1 Cable Grip.
1060; 2 cable screw s
1 Assembly Fit 1x Cable Grip using 2
cable screw s. Screw hand
tight
Y Ensure Cable Grip
screw s go through
back of cable grip
Hand tight 100% OMS Adjust/ re-check
PL-10 Deliver batch of plugs to station 2 Box OMS Inform Trainer
PL-20 6789; 1 Fuse holder 2 Assembly Fit fuse holder Y Check correct location
of the fuse holder
Visual Inspection 100% OMS Adjust/ re-check
PL-20 1011; 1 Live pin 3 Assembly Fit 1 Live pin Y Pin has fuse clamp on
top
Visual Inspection 100% OMS Adjust/ re-check
PL-20 1213; 1 Neutral pin w ith black band on
pin
4 Assembly Fit 1 Neutral pin Y Check if black band on
pin
Visual Inspection 100% OMS Adjust/ re-check
PL-20 1415; 1 Earth pin Assembly Fit 1 Earth pin Check if pins are in
correct position
Visual Inspection 100% OMS Adjust/ re-check
PL-20 1617; 1 fuse 13 Amp
1616; 1 fuse 5 Amp
5 Assembly Fit 1 fuse Y 13 Amp fuse
5 Amp for Euro
Visual Inspection 100% OMS Adjust/ re-check
PL-20 Deliver batch of plugs to station 3 Box Deliver batch of plugs to
station 3
OMS Inform Trainer
PL-30 2022; 3 screw s to connect w ires Screw driver 6 Assembly Fit 1 screw to Neutral pin,
Earth pin and Live pin and
tighten hand tight w ith
screw driver
Y Ensure all screw s are
nipped tight and unable
to undo by hand
Hand tight 100% OMS Adjust/ re-check
PL-30 Deliver batch of of plugs to station 4 OMS Inform Trainer
PL-40 1819; Plug Front 7 Assembly Fit Plug Front Y Ensure all screw s are
tight
Hand tight 100% OMS Adjust/ re-check
PL-40 2013; Wiring diagram 8 Assembly Fit w iring diagram Y Ensure text is readable Visual Inspection 100% OMS Adjust/ re-check
PL-40 Deliver batch of plugs to QA Box OMS Inform Trainer
PART/
PROCESS
NUMBER
PROCESS NAME/
OPERATION
DESCRIPTION FREQ.
CONTROL
METHOD
CHARACTERISTICS METHODS
H-Y
REACTION
PLAN
05/10/2016
MACHINE,
DEVICE
JIG, TOOLS
FOR MFG.
NO. PRODUCT PROCESS
SPECIAL
CHAR.
CLASS SIZE
18. Control Plans, Next Steps
Page 18
Next Steps to H-Y Suppliers:
1. Know your customers’ expectations - CTQ’s (Critical to Quality
Characteristics)
2. Have a defined and documented production process (SOE)
3. Follow 5S Principles
4. Employ a formal training system
5. Involve the people on the shop floor
6. Audit the production process constantly
7. Manage supplied parts and control supplier performance
8. Measure/monitor key quality performance indicators
9. Use an effective Corrective & Preventative Action Process
FMEA and Control Plans are mandatory for PPAP
submission level 3.
20. Quality Focus Day Workshop
Page 20
List of acronyms:
CTQ: Critical To Quality, a characteristic judged to be important to the fit and function of a component or assembly as well
as customer satisfaction
FMEA: Failure Mode and Effect Analysis
ICAM: Interactive Corrective Action Management
OMS: Operational Method Sheet
Off Tool: (Production Tooling) - When a part is said to be “Off Tool” it is required that the part be manufactured using the
exact tooling which will be used for long-term production. This does NOT mean the parts were manufactured from tooling
that is “like” or “similar” to the intended production tooling.
Off Process:(Production Process) – When a part is said to be “Off Process” it is required that the part be manufactured and
tested using the exact process that will be used for long-term production. This does NOT mean the parts were
manufactured using a “like” or “similar” or less than 100% completed process.
P.A.: Part Approval process to determine if part characteristics and specifications are understood and met by the supplier.
PCR: Process Change Request
PFD: Process Flow Diagram
SQM: Supplier Quality Manual
QFD: Quality Function Deployment
QS-9000, PPAP: Product Part Approval Process
QS-9000, APQP: Advanced Project Quality Plan