Control and Reactions Plans

Control Plans
&
Reaction Plans
1
Course Deliverables
At the end of this training module, the participant
should be able to:
- Understand the importance of a robust Control/Reaction
plan
- Recognize/Communicate the requirements for robust

documentation linkages
- Be able to identify Control/Reaction Plan weaknesses

and coach the supplier to understand/implement the
necessary improvements
2
Why Do We Need To Focus on Control Plans?
Analysis of Quality Issues Shows:
Supplier
Design FMEA/ Control
25%
Plan
60%
40% Supplier Sub-Supplier
Internal Management
Supplier
Manufacturing
35% Process Control
Manage the (Cpk)
Change
Gage R & R
FMEA/Control Plan account for approximately

60% of the Supplier related issues 3
FMEA/ Control
The deficiencies include: Plan
1. Special Characteristics not included on the FMEA
2. Understating severity, detection, or occurrence on FMEAs
3. Failure mode not identified in FMEAs
4. Inadequate or no linkage between FMEAs & Control Plan
5. Ineffective control and/or gauging strategies
6. Process parameter controls not detailed in the control plan
7. Ineffective and/or inappropriate sampling plans
8. Inadequate or no Reaction Plan
9. Control Plan/Reaction Plan not followed

4
Legal implications
Control Plan, DFMEAs and PFMEAs are legal documents.

One common issue with these documents are severities
of 9 and 10 arbitrary assigned in the FMEAs..
When you sign-off on any of these documents, remember
that you are signing legal documents. You may want to
consider initialing every page in these documents just like
any other legal document.
Like any legal document, it must be correct. These
documents can and have been used in legal disputes.
5
AIAG Requirements for Control Plans
“The organization shall have a Control Plan that defines all

methods used for process control and complies with
customer-specified requirements (e.g., Advanced Product
Quality Planning and Control Plan reference manual).”
Note 1: Control Plans for “families” of parts are acceptable

if the new parts have been reviewed for commonality by
the organization.
Note 2: Control Plan approval may be required by certain

customers.
6
Ford Customer Specific Requirements
for Control Plans
“For all PPAP submission levels (1 through 5), Control

plan(s) for safety and regulatory ( ) component(s) require
Ford Product Development Engineering & STA approval.”
“The Control Plan shall include provisions for on-going

monitoring of process capability, stability and control.
Ford reserves the right to review and approve all
organization-developed Control Plan.”
7
What is a Control Plan?
Control Plans are written descriptions of the systems

used to control and minimize product and process
variation.
In addition, Control Plans specify the process monitoring

and control methods (i.e. Special Controls) used to
control Special Characteristics.
8
What is the purpose of a Control Plan?
The purpose of a Control Plan is to ensure that the customer requirements
are met by supporting the manufacture of quality products.
In addition to Special Characteristics, the Control Plan contains the Key

Process Input Variables (KPIVs) to be controlled, and the Key Process
Output Variables (KPOVs) to be monitored.
The Control Plan tells the operator what to monitor and how often to
monitor the Special Characteristic, KPIV, and/or KPOV.
The accompanying Reaction Plan tells the operator what to do when there
is an unexpected deviation involving the Special Characteristic, KPIV,
and/or KPOV being monitored.
Control Plans are really for the operator!!!

9
How often are Control Plans Updated?
Control Plans are living documents, which means as process

improvements are made & process knowledge increases,
Control Plans must be updated.
In accordance with the MSA requirements, FMEAs (and

related documents) must be reviewed annually and as
issues arise.
Control Plans are an integral part of any effective Quality

Operating System (QOS).
10
Who should participate in the Control
Plan review?
The Core Team, which should minimally include:
• Manufacturing Engineering
• Quality Engineering
• Production Operations
11
So why is a Control Plan necessary?
The primary intent of a Control Plan is to create a

structured approach for control of process and product
characteristics, while focusing the organization on the
characteristics that are important to the customer.
Control Plans should define the necessary systems that

need to be in place to control the process and minimize
the occurrence of the failure modes identified in the
FMEAs.
12
When are Control Plans used?
Control Plans
Control Plans aid in the manufacture of quality products

which meet customer expectations and requirements.
They provide a written description of the system and
mechanisms to minimize product and process variation.
Control Plans may apply to an individual part or product

or to a family of similar items produced using the same
process and equipment.
13
When are Control Plans used (Cont’d)?
During any manufacturing run, Control Plans provide the
process monitoring and control methods used to control part
characteristics and/or process outputs which should always
be in a state of control.
When gauge usage is required, the Control Plan shall identify

gauging methodology, tolerances, sample size and frequency.
The Control Plan feeds into the operator work instructions which
shall describe:
• What is to be monitored,
• How often the monitoring should occur,
• How to perform the monitoring and
• How to react when a deviation occurs.
14
When are Control Plans used (cont’d)?
During the product development cycle, Control Plans are
used to document and communicate the initial plan for
process control. There are three phases of Control Plans:
- prototype
- pre-production
- production
The Control Plan is a living document and is updated

as the design changes, the process changes (SREA)
or measurement systems and control methodologies
are improved.
15
Control Plan Scope
An effective Control Plan describes the actions that are used
at every step in the process including:
Incoming material
In-process (all processes) Manufacturing Finished
Receiving
Process Goods
Product being shipped to the customer
During the manufacturing process, Control Plans provide the

process monitoring and control methods that are used to
control the required process and part characteristics.
REMEMBER: Since some processes (typically SCs) are expected to be
continually improved, the Control Plan reflects a strategy
that is responsive to these changing process conditions.
16
Every Control Plan must contain the
following columns (per the AIAG template):
• Part/Process Number
• Process Name/Operation Description
• All machines, devices, templates, tools, jigs for manufacturing
• Characteristic to be controlled
• Product/Process specification/tolerance
• Evaluation/Measurement Technique including gauge number
(and the associated calibration program)
• The sampling plan including sample size and frequency
• The Control Method including chart type, Chart Champion,
Chart Location sampling plan including sample size and
frequency
• A reference to the Reaction Plan
17
Reaction Plans
Every controlled process or part characteristic requires a

defined Reaction Plan that is referenced in the Control Plan
and described in the Operator Work Instructions, including
step by step instructions for the:
Containment procedure
Customer notification
Method for disposition of suspect material
Issue Escalation procedure
18
So, how do we determine which process
characteristics need to be controlled?
The characteristics that must be controlled are CC, SC,

HIC (HI), OS, PTC characteristics as well Key Process
Input Variables (KPIVs).
The CC characteristics are found on the part drawing

and/or Engineering or Material Specification.
CC, SC, HIC and PTC must be listed in other documents

including the Supplement K or equivalent.
19
What is a Special Characteristic?
“Special Characteristics are those product or

process characteristics (CC, SC, HIC, and
PTC) that affect vehicle or process safety,
compliance with government regulations, or
customer satisfaction, and for which specific
actions are required to ensure products will
meet all engineering requirements as well as
requirements for operator safety.”
20
What is a Critical Characteristic (CC)?
“Critical characteristics are designated with the

inverted delta symbol ( ) and are those product
requirements (dimensions, performance, tests, etc.)
or process parameters (rates, temperatures,
pressures, etc.) that can affect compliance with
government regulations, or safe vehicle/product
function, and which require specific producer,
assembly, shipping or monitoring action and the
inclusion on the Control Plan.”
21
What is a Significant Characteristic (SC)?
“Significant Characteristics are those

product, process, and test requirements that
are important for customer satisfaction and
for which Quality Planning actions must be
addressed in a Control Plan.”
22
What is a High Impact Characteristic (HIC)?
“High Impact Characteristics are related to

parameters that severely affect the operation of
the process or subsequent operations if they are
outside the specification tolerance” and
has a FMEA severity < 9
23
What is a Pass-Through
Characteristic (PTC)?
Pass-Through Characteristics are defined as Product

Characteristics that are not tested or controlled by
subsequent processing by the tier 1 supplier.
A PTC is a characteristic that could have a significant

impact on customer satisfaction and/or warranty (and
has not been identified as a SC, or CC).
Remember that PTCs are a subset of HICs.
24
Why should we be concerned about PTCs?
Many Stop Ships/Field Actions are caused by

sub-suppliers
Usually, the offending characteristic is not monitored

by the tier 1.
25
Where should the controls be
implemented in the production process?
The controls should be implemented as close as possible to the

step in the process where the part characteristic being
controlled is generated.
In fact, the controls should be implemented at the KPIV (Key

Process Input Variables) level as much as possible.
26
FMEA/Control Plan Linkage
DFMEA PFMEA Control Reaction

Plan Plan
• Engineering Documents
• Quality Data
• Process Knowledge
27
Process
DFMEA PFMEA DVP&R
Flow
Prototype Build parts using on the prototype

process, utilizing the prototype Control
Control Plan Plan
Based on Based on
Update Based on Update lessons learned Update
Process
DFMEA design changes PFMEA from prototype Process Flow
changes
process
Work
Instructions
This requires process
knowledge y = f(x) Launch Update DFMEA, Production
PFMEA, Process
Control Plan Flow Control Plan
Remember that Control Plans, just like DFMEAs & PFMEAs are living
documents, because all documents must be updated whenever
changes are made. For inverted Delta new signatures from STA &
PD are required. 28
Engineering Documentation includes
• Part drawings
• Engineering Specifications
• Engineering Material Specifications
• Critical manufacturing process parameters (if applicable)

- Heat Treat
- Casting
- Welding
• Government Regulations
• Design Requirements
These are all very important inputs to Control Plans
29
Quality Documentation includes
• Warranty
• Field Actions
• Stop Ships
• QRs
• TGWs / Customer Concerns
• Employee & Customer Safety
• Capability
• Productivity
• FTT
• Scrap
30
Process Knowledge includes
• Lessons Learned
• Installation Drawings
• Process Sheets
31
Information Flow into Control Plan
1) The Critical to Satisfaction (CTS)
CTS
characteristics must be understood. This
means that we must understand what is
important to the customer.
2) Then we need to understand how the CTS is
related to the Key Process Output Variables KPOV
(KPOVs).
3) Then we need to understand how the KPOV is
related to the Key Process Input Variables (KPIVs).
4) If the appropriate KPIVs are controlled, the
KPOVs are predictable. This is typically the way KPIV
excellent suppliers control their processes.
32
Control of Process Parameters
The control of KPIVs means controlling the process

parameters that affect the characteristics that are
important to the customer.
The KPIVs are placed in the process specification

column in the Control Plan. (This column is usually
unused or inappropriately used on many Control
Plans).
When KPIVs are controlled, the KPOVs will be conforming.
33
So, what does this mean?
y = f(x) This means that the output of the For the ideal y, f(x) must
process (y) is a function of the be optimized to be as
inputs to the process (x). close to ideal as possible
KPOV = f(KPIV) This means that the KPOVs are Now, we must minimize
a function of the KPIVs failure modes
Monitoring is done Monitoring can be done at the This is driven down from
at the KPOV level KPOV level but this is reactive. DFMEA to
(after the product is produced). PFMEA to
In-process controls detect Control Plan
unacceptable levels of
variation before non-compliant
parts are produced.
Control is best when

implemented at the KPIV level
34
Guidelines for Implementing Controls
1. Determine which part characteristics need to be

controlled.
2. Determine where the controls should be

implemented in the production process.
3. Select the appropriate type of control chart for the

application.
4. A reaction plan must be associated with each

control chart to provide operator instructions for
dealing with out of control conditions.
35
Control Plans should be based on controlling the
inputs (only the KPIVs) so that the outputs (the
KPOVs) are predictable
KPIVs f (x) KPOVs
This transfer function is based on the physics

of the process.
36
Design FMEA
“In accordance with AIAG, Ford Product Development

Engineering must provide a DFMEA for every part or family
of similar parts or materials (e.g., Paint, Adhesives, etc.)
used in similar applications and/or environments.”
“Ford Product Development Engineering must approve

Design FMEA(s) for safety and regulatory component(s).
For example, if the part is an inverted delta ( ) part, a Ford
Product Development Engineer must signoff on the
DFMEA.”
37
There are 2 basic strategies for preventing
non-conforming product from reaching the
customer.
• Prevention Strategy (Preferred)
• Detection Strategy
38
Prevention Strategy
A prevention strategy prevents the production

of non-conforming product.
The process is monitored and adjusted as

required in order to ensure that non-conforming
product is not manufactured.
An effective prevention strategy requires up-front

planning and investment.
However, a good prevention strategy is very cost

effective. It will save money by reducing scrap,
rework, and warranty costs.
39
Prevention Strategy
Understand how the product or process is
suppose to work {define Y = f(x)}
Maximize the Y performance to the customer

requirements.
Ensure that the process is stable and in-control.
Apply SPC charts when appropriate to control

the process.
Apply Poke-Yokes to detect special causes

identified in the PFMEA.
40
Detection Strategy
A detection strategy attempts to weed out

defective product before it reaches the
customer.
This is typically done through 100% sorting.
Often, the rejected, sorted material is

reworked or repaired. However, the
rework/repair process itself can create
additional defects.
41
Let’s discuss linkage…
The DFMEA links to the potential PFMEA classification.
The DFMEA will have one of 3 classifications:

- YC
- YS
- Blank
A YC has a severity of either 9 or 10.
A YS has both a severity of 5 to 8 & an occurrence of 4 to10.
These are the only possible classifications on a DFMEA

42
And this is a slide from the Ford FMEA handbook
43
DFMEA Severity Rating Table
44
DFMEA Occurrence Rating Table
45
DFMEA Detection Rating Table
46
PFMEA Severity Rating Criteria
47
PFMEA Occurrence Rating Table
48
PFMEA Detection Rating Tables
49
PFMEA Classification Table
This table shows the linkage special controls in the

Control Plan. 50
This is the classification hierarchy
51
So what does this mean?
YC = Potentially Critical
This means that based on the process, this could become
classified in the PFMEA as an inverted delta item which
mean that it will be denoted with the inverted delta symbol.
This will be identified as a CC in the supplement K.
YS = Potentially Significant
This means that based on the process, this could become a
SC in the PFMEA and designed in the PFMEA with the SC
designation. This will be identified as an SC in the
supplement K.
Note: If the DFMEA severity is a 9 or 10, the part drawing must have
the inverted delta symbol on it (Ford Procedure PTP07-101).
52
This means that…..
If a YC becomes a CC, it must be included in the

Control Plan.
If a YS becomes a SC, it must be included in the

Control Plan.
In addition, any of HI, PTC, OS, or KPIVs must also

be included in the Control Plan.
53
Here is a DFMEA to PFMEA Linkage Example
POTENTIAL
System FMEA Number: FM0001
FAILURE MODE AND EFFECTS ANALYSIS
Subsystem Fuel Tube Assembly (DESIGN FMEA) Prepared by: Beth Rowen
Component; Design Responsibility BI Automotive FMEA Date (Orig.) 6/9/2004
Model Year(s)/Program(s) 2009 VN127 Key Date 2-Jun-08 FMEA Date (Rev.) 1/30/2008
Core Team: Bill Smart, Kurt Ramirez
mirez, Kay Jones
Item / Action Results
Classification
Current Current
Occurrence
Responsibility
Detection
Function
Severity
O ccurrence
Potential Potential Potential
Detection
Design Design Recommended & Target
S everity
RPN
Failure Effect(s) Causes(s) Actions Taken
RPN
Controls Controls Action Completion
Mode of Failure of Failure & Effective Date
Prevention Detection Date
Requirements
Tube Assemly- Fluid Leak: System: Erratic Operation 10 YS Improper armoring 3 GD&T, Package Customer 2 60 Durability review Ford/BI; Ford
Transmit fuel Cracked/fractured/Corr (s=7) Other Systems: length/location soecified. Layout Study, Vehicle Heat Mgmt. Study Engineering
(liquid) and oded tube Degradation of surrounding Improper armor attachment Design Durability CETP
vapor to components (s=5), Vehicle: Review,Design R310 (Ford
engine. Degradation of performance Guide, Pass Car), APG
Contain fuel (s=7), End User: Dis Packakge layout 215 (Ford Light
(liquid) and satisfied (s=7), Gov't: Non study, Design Truck)
vapor. compliance with Gov't aid investigation
regulations (s=7)
So what, if anything, is wrong with this DFMEA?
54
PFMEA Classification Table
In the previous slide, the severity rating was 10, but the
characteristic was incorrectly classified as a YS. 55
Here is the correct classification…
POTENTIAL
System FMEA Number: FM0001
Subsystem Fuel Tube Assembly (DESIGN FMEA) Prepared by: Beth Rowen
Component; Design Responsibility BI Automotive FMEA Date (Orig.) 6/9/2004
Model Year(s)/Program(s) 2009 VN127 Key Date 2-Jun-08 FMEA Date (Rev.) 1/30/2008
Core Team: Bill Smart, Kurt Ramirez
mirez, Kay Jones
Item / Action Results
Classification
Current Current
Occurrence
Responsibility
Detection
Function
Severity
Occurrence
Potential Potential Potential
Detection
Design Design Recommended & Target
RPN
Severity
RPN
Requirements
Tube Assemly- Fluid Leak: System: Erratic Operation 10 YC Improper armoring 3 GD&T, Package Customer 2 60 Durability review Ford/BI; Ford
Transmit fuel Cracked/fractured/Corr (s=7) Other Systems: length/location soecified. Layout Study, Vehicle Heat Mgmt. Study Engineering
(liquid) and oded tube Degradation of surrounding Improper armor attachment Design Durability CETP
vapor to components (s=5), Vehicle: Review,Design R310 (Ford
engine. Degradation of performance Guide, Pass Car), APG
Contain fuel (s=7), End User: Dis Packakge layout 215 (Ford Light
(liquid) and satisfied (s=7), Gov't: Non study, Design Truck)
vapor. compliance with Gov't aid investigation
regulations (s=7)
Since the severity was rated as a 10, the

classification must be a YC.
56
And this the linkage to the PFMEA…
POTENTIAL
FMEA Number: PF392
(PROCESS FMEA) Prepared by: Sherrie Walker
Item: 9C24-772L291-PG Process Responsibility BI Automotive FMEA Date (Orig.) 6/25/2008
Model Year(s)/Program(s) 2009 VN127 Key Date 7/25/2008 FMEA Date (Rev.) 7/1/2008
Core Team: Roger Lanthan, Ellis Horton, Gary Evans
Process Step Action Results
Classification
Current Current
Occurrence
Responsibility
Detection
/ Function
Occurrence
Potential Potential Severity Potential
Detection
Process Process
Severity
Recommended & Target
RPN
RPN
Requirements
7. CNC Bend Splits and Crack -No build condition- 10 -Incorrect Set Up - 1 -Daily PM Check - -First/Last pc off.- 7 70 None
Leak Machine Malfunction - Set Up Instruction Five pieces per
Worn or Broken Tooling hour audit sheet -
Visual 100%
The YC flows to the PFMEA and the classification is now

inverted delta.
57
And the linkage to the Control Plan
CONTROL PLAN
Control Plan Number CP392 Key Contact/Phone Joe Western Date (Orig.) Date (Rev.)
313-555-1212 6/25/2008
Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
9C24-772L291-PG Roger Lanthan, Ellis Horton, Gary Evans
Part Name/Description Organization/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)
Tub Asy Fuel & Brk
Organization/Plant Organization Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
BI Automotive LL899B
MACHINE, CHARACTERISTICS METHODS
PART/ PROCESS NAME/ SPECIAL
DEVICE REACTION
PROCESS OPERATION CHAR. PRODUCT/PROCESS EVALUATION/ SAMPLE
JIG, TOOLS CONTROL PLAN
NUMBER DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
FOR MFG. SIZE FREQ. METHOD
TOLERANCE TECHNIQUE
7 Bend Bender 4 Leak No Leak Leak Test 100% 100% First/Last pc off See MD 612
Procedure.In Process
audit Sheets
What, if anything, is wrong with this Control Plan?
58
And that same characteristic is also on the PFMEA as a CC
( )
And that same characteristic is also on the Control Plan as

an Inverted Delta ( )
59
Remember, you can’t get all this information
(i.e., requirements, linkages, etc.) from one
document!!!
However, Supplement K pulls this information from the various
documents and clearly demonstrates linkage from the:
- DFMEA (YC) -"Potential Critical Characteristic" to:
- PFMEA (CC) - Confirmed Critical Characteristic to:
- Control Plan (CC) - Confirmed Critical Characteristic and

Special Control Required.
Note: Inverted delta symbol ( ) classification columns on the

PFMEA/Control Plan documents denotes CC
characteristic.
60
Three types of Control Plans
Select the appropriate type of control plan. It will either be a:

• Prototype The control plan should contain:
Product/process characteristics
• Pre- Launch Process controls
Measurement systems
• Production Testing
61
Now, let’s talk about the header portion of the Control
Plan Form
Ensure that the correct format of the form is being used!!!

This is a minimum requirement and nothing can be deleted
from the template 62
Prototype Control Plans
Prototype Control Plan must be available for use by GPDS

FDJ milestone.
Element 9. Prototype Build Control Plan

Deliverable Number 19
Expectation Number - 76
Completion Milestone - FDJ
Demonstrate that inspection plans exist for all material and
engineering specifications, and values will be recorded for form, fit,
and function characteristics for specified number of prototype parts as
required by the Vehicle Team. Include all subcomponent parts with
emphasis on those areas that have been identified as Significant
Characteristics (SCs) and Critical Characteristics (CCs) from the
Process FMEA and included in the Prototype Build Control Plan.
63
Pre-Launch control plan
• Element 19 of schedule A
• Pre-Launch control plans are a description of the dimensional
measurements & material & functional tests that will occur after
prototype & before full production. The pre-launch control plan should
include additional product/process controls to be implemented until the
production process is validated. The purpose of the pre-launch control
plan is to contain potential nonconformances during or prior to initial
production runs.
• Examples:
– More frequent inspection
– More in-process & final check points
– Robust statistical evaluations
– Enhanced audits
– Identification of error-proofing devices
64
Production Control Plans
Element 23 Production Control Plan
Deliverable Number 37
Expectation Number – 168, 169, 170
Completion Milestone – TTMRD
Develop the Production Control Plan using the AIAG Advanced Product
Quality Planning and Control Plan manual. Ensure that the control plan
defines the process step(s) and the control method for each product and
process characteristic.
Review all product and process characteristics, including those identified from
Lessons Learned during previous builds, and ensure that updates are captured in
the Production Control Plan.
Demonstrate that datums, measurement procedures, gauging methods and
ongoing capability requirements are defined.
Ensure that Reaction Plans specify the preventive, corrective and containment
actions necessary to avoid operating out-of-control or producing non-conforming
products. Demonstrate reaction plans are implemented "in a timely manner" or
"immediately following" the identification of any non-conforming specification or
statistical special-cause condition.
65
Check the dates…
Always ensure that the dates make sense!

The original date must be before the organizational
approval date.
If there is a revision, the revision date must be prior to the

organization approval date because every time there is a
revision, the organization must re-approve the Control
Plan.
If the part is an part, both Ford PD Engineering and

STA must re-approve the Control Plan.
66
Common Control Plan Mistakes
Box 2. Every Control Plan document must have a tracking number. For
multiple page documents, enter page number (page ____ of _____). The
revision level must also be included.
Box 3. The part number is the number of the part being manufactured in this
process. It must match the part number and suffix level of the latest
engineering release. This must be verified. The revision level must also
match both the DFMEA and the PFMEA.
Box 4. The part name must match the part name on the drawing. Remember
that if the part is an part, the symbol must be included in the part
number.
Boxes 12 & 13. If the part is an inverted delta part, Customer Engineering
and STA Approval is required. When Customer Engineering Approval is
required, the engineer should do the following:
1) Print their name
2) Sign their name
3) Print the date
4) CDSID.
67
Now, let get to the control
portion of the Control Plan
68
Part/Process Number
Enter the CONTROL PLAN
operation Control Plan Number

FILE.XLS
Key Contact/Phone
555-555-5555
Date (Orig.)
1/1/1996
Date (Rev.)
1/1/1996
number of the NUMBER
Part Name/Description
ECL
Supplier/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)
process step. NAME

Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
SUPPLIER CODE
This is on the PART/
PROCESS NAME/
MACHINE, CHARACTERISTICS SPECIAL METHODS
PROCES DEVICE REACTION
process flow S
NUMBER
OPERATION
DESCRIPTION
JIG, TOOLS
FOR MFG.
NO. PRODUCT
CHAR. PRODUCT/PROCESS EVALUATION/
PROCESS CLASS SPECIFICATION/ MEASUREMENT
TOLERANCE TECHNIQUE
SAMPLE
SIZE FREQ.
CONTROL
METHOD
PLAN
diagram. 15
69
Process Name/Operation Description
Every step in a CONTROL PLAN
manufacturing Control Plan Number

FILE.XLS
Key Contact/Phone
555-555-5555
Date (Orig.)
1/1/1996
Date (Rev.)
1/1/1996
process have NUMBER
ECL
a process or NAME
SUPPLIER CODE
operation PART/
PROCESS NAME/
MACHINE, CHARACTERISTICS SPECIAL METHODS
name. S
NUMBER
OPERATION
DESCRIPTION
JIG, TOOLS
FOR MFG.
NO. PRODUCT
TOLERANCE TECHNIQUE
SAMPLE
SIZE FREQ.
CONTROL
METHOD
PLAN
This is on the 16
process flow
diagram.
70
Machine, Device, Jig, Tools for
Manufacturing
CONTROL PLAN
For the Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
operation Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
NUMBER ECL
described in the Part Name/Description
NAME
previous Supplier/Plant
SUPPLIER
Supplier Code
CODE
Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
column, identify PART/

PROCES
S
PROCESS NAME/
OPERATION
MACHINE,
DEVICE
JIG, TOOLS
CHARACTERISTICS SPECIAL METHODS
CHAR. PRODUCT/PROCESS EVALUATION/ SAMPLE
CONTROL
REACTION
PLAN
DESCRIPTION NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
the equipment NUMBER FOR MFG. TOLERANCE TECHNIQUE
SIZE FREQ. METHOD
used in this 17
step of the
process.
71
Characteristic Number
CONTROL PLAN
This is a cross- Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
reference Part Number/Latest Change Level
NUMBER ECL
Core Team Customer Engineering Approval/Date (If Req'd.)
number from Part Name/Description

NAME
one of the Supplier/Plant

SUPPLIER
Supplier Code
CODE
Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
PART/ MACHINE, CHARACTERISTICS METHODS

following: PROCES
S
PROCESS NAME/
OPERATION
DEVICE
JIG, TOOLS
SPECIAL
CONTROL
REACTION
PLAN
-Ballooned print NUMBER FOR MFG. TOLERANCE TECHNIQUE
SIZE FREQ. METHOD
-FMEAs 18
-Supplement K
72
Product Characteristics
CONTROL PLAN
This is the
Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
name of the FILE.XLS
Part Number/Latest Change Level Core Team
555-555-5555 1/1/1996 1/1/1996
Customer Engineering Approval/Date (If Req'd.)
part NUMBER
ECL
characteristic NAME
SUPPLIER CODE
that is being PART/
PROCES
PROCESS NAME/
MACHINE,
DEVICE
REACTION
OPERATION CHAR. PRODUCT/PROCESS EVALUATION/ SAMPLE
monitored. S
NUMBER
DESCRIPTION
JIG, TOOLS
FOR MFG.
NO. PRODUCT PROCESS CLASS SPECIFICATION/ MEASUREMENT
TOLERANCE TECHNIQUE
SIZE FREQ.
CONTROL
METHOD
PLAN
19
This is a part
feature or
characteristic
that is
identified on
the part
drawing or in
the
engineering
specification.
73
Process Characteristics
Process
characteristics are CONTROL PLAN
Key Process Input Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
Variables (KPIVs) Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
that directly NUMBER

ECL
impact the Key NAME
Process Output SUPPLIER CODE
Variables PROCES
PROCESS NAME/
OPERATION
DEVICE
SPECIAL
REACTION
S JIG, TOOLS CONTROL PLAN
(KPOVs). NUMBER
DESCRIPTION
FOR MFG.
TOLERANCE TECHNIQUE
SIZE FREQ. METHOD
Process 20
characteristics are
parameters like
temperature,
pressure, cure
time, etc.
When the KPIVs
are controlled, the
KPOVs are
conforming. This
is based on the
physics of the
process.
74
Special Characteristic Classification
CONTROL PLAN
And you
should know FILE.XLS
Part Number/Latest Change Level Core Team
555-555-5555 1/1/1996 1/1/1996
Customer Engineering Approval/Date (If Req'd.)
all about this NUMBER

ECL
from the NAME

SUPPLIER CODE
linkage and PART/
PROCES
PROCESS NAME/
MACHINE,
DEVICE
REACTION
classification S
NUMBER
DESCRIPTION
JIG, TOOLS
FOR MFG.
TOLERANCE TECHNIQUE
SIZE FREQ.
CONTROL
METHOD
PLAN
discussion. 21
75
Product/Process Specification Tolerance
This column CONTROL PLAN

contains the Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
specification for the FILE.XLS 555-555-5555 1/1/1996 1/1/1996

product or process NUMBER ECL
Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)
characteristic that is NAME
being controlled. Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
SUPPLIER CODE
PROCESS NAME/ SPECIAL
Specifications for S
OPERATION
DESCRIPTION
JIG, TOOLS
NO. PRODUCT
SAMPLE
CONTROL PLAN
NUMBER FOR MFG. SIZE FREQ. METHOD
product characteristics TOLERANCE TECHNIQUE
are obtained from:

- Drawings 22
- Specifications
- Material Standards
Specifications for
process characteristics
are obtained from:
- Designed experiments
- Assembly requirement
- Lessons Learned Data
base
- Generic FMEA which
comprehends all past
issues.
76
Evaluation/Measurement Technique
This column
identifies the CONTROL PLAN
measurement Control Plan Number Key Contact/Phone Date (Orig.) Date (Rev.)
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
system being Part Number/Latest Change Level Core Team Customer Engineering Approval/Date (If Req'd.)
NUMBER ECL
used to evaluate Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)
the product or NAME

process SUPPLIER CODE

characteristic. PROCES
S
PROCESS NAME/
OPERATION
DEVICE
JIG, TOOLS
SPECIAL
CONTROL
REACTION
PLAN
TOLERANCE TECHNIQUE
This includes all
gages, templates, 23
fixtures, tools,
and test
equipment
required to
perform the
measurements.
Remember:
All gages and
templates must
have acceptable
gage R&Rs.
77
Let’s discuss sample size & frequencies
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
SUPPLIER CODE
TOLERANCE TECHNIQUE
24
Let’s discuss sampling strategies…….

78
Rational Sampling
A rational sample is a collection of process output

measurements with only common cause variation
affecting the samples.
Therefore, a rational sample is where the “within”
sample variation is less than the “between” sample
variation.
Special cause variation effects are confined to time
periods between sample collection.
To satisfy SPC sampling requirements, all samples must

be rational. This allows the differentiation between
common cause and special cause variation.
79
Rational Sampling continued
To obtain rational samples, collect subgroups of

production parts. Each subgroup of parts must be
produced consecutively under the same process
conditions.
Remember to avoid selecting consecutive samples that

were interrupted by a tool change, an operator change, a
material change or some other change (or production
interruption) that may introduce special cause variation.
80
So, what is the ultimate goal of
rational sampling?
Minimize “within” subgroup variation by collecting parts that are as much

alike as possible. Parts made in a row are as much alike as possible.
“Within” subgroup variation should consist of only common cause

variation:
• Less than 3 parts collected in a row means that there are
not enough samples to assess “within” subgroup variation
• More than 7 parts collected in a row may allow special

cause variation to creep into the sample.
• The optimal number of parts collected in a row is 5.
This strategy will allow the “between” variation to be assessed.

81
Consider the following data…
Using day as a subgroup:
- Poor choice because
the different conditions
are combined
- The conditions
includes shifts,
operators, setups, etc
- There may be special

cause variation
introduced into the day
!
sub-group.
"
82
Now let at the data by shift…
"
# $ # $ # $
Looking at shift-to-shift data, we observe that there is

likely special cause variation between shifts.
83
Analysis Of Output By Shift:
!
"
# $% &
$ $ $ $ $ $ $ $ $ $ $ $
# # # # # # # # # # # #
% &
Each shift provides a rational sub-grouped sample

84
Comments On Rational Sub-groups
• If you have data that supports rational sub-groups
and you do not sample and code accordingly, you
will:
– Lose the ability to accurately assess the sources of
variation
– Lack sufficient knowledge of where to focus your efforts
(Prior example indicated the 3 shifts were all targeting
differently)
• Some projects have one machine, or shift, or location

that is completely successful and if the correct rational
sub-group is chosen, both special causes and the
project solution
become apparent
85
It is not a good practice to select arbitrary “chunks of
data” that have low variation after the fact and call
them sub-groups.
We define sub-groups before we collect the data in

such a way that we DO collect short term common
cause variation and DO NOT collect long term special
cause (shift and drift) variation.
86
Sub-grouping And Sampling Guidelines
• Sub-group/Sample Size
– Variable data: 5 if possible (more is better if cost is
minimal)
– Attribute data: 50 or more depending on defect rates
• Sampling Frequency
– Not too many (costly) but not too few (unreliable
information)
– Generally, the more frequent, the better
– Guideline to create initial baseline is 25 to 30 sub-
groups
87
When creating Sampling Plans
• When creating or evaluating a sampling plan, these

four questions should be considered:
– What is captured within a sub-group?
– What is not captured within a sub-group?
– What is captured between sub-groups?
– What is not captured between sub-groups?
88
Why is rational sampling important?
Rational Sampling helps to assess:
• “Within” subgroup (common cause) variation
• “Between” subgroup (special cause) variation
89
Things to remember……
Variable data is more powerful than attribute data
• Fewer samples are required when using

variable data (see AIAG SPC manual for more details)
• Variable data provides a lot more information
about the process
• It is much easier to see process shifts
Always take data as close as possible to the point

in the process where the characteristic of interest
is created.
Always analyze the data immediately.

90
Some important sample size facts
• A sample size of one is only acceptable if the process is

homogenous.
• Typically 3 to 7 consecutive samples are collected. The

optimal number of consecutive samples is 5.
• When the sample size is less than 3, the within variation

can not be assessed.
• When the sample size is greater than 7, special cause

variation can creep in.
91
Before implementing sampling
frequencies…
The process must:

• produce the expected distribution.
• be stable.
• be in control.
• And have at least short term capability.
Now, let’s discuss how to determine

appropriate sampling frequencies. 92
When establishing sampling frequencies,
always considering the following….
• How long does the process (or similar processes)

typically stay in control?
• How often is the process interrupted?

- Line stoppages
- Tool Changes
• How often do the incoming material lots change?
93
Guidelines for sampling frequency…
•Sampling should occur when:
• When expected out of control conditions occur
• Tool Changes occur
• After Set-up changes
• Planned operator changes (depending on the

operator’s impact on the process)
• Material lot changes – depending on the type of process

used to manufacture the material and the
appropriateness as well as the effectiveness of the
process controls.
94
Sample Size base assumptions
The process must have an acceptable measurement
system for the characteristic being evaluated. If it is not
acceptable, fix the system before proceeding.
The process must:
• Be stable
• Be in-control, except for explainable causes (mean shifts)
• Produce the expected distribution
• And….. be capable
If the base assumptions are not met, the sampling

frequency should be 100%
95
Control Methods
CONTROL PLAN
FILE.XLS 555-555-5555 1/1/1996 1/1/1996
NUMBER ECL
NAME
SUPPLIER CODE
TOLERANCE TECHNIQUE
25
Continued on next slide….

96
Typical Types of Control Methods
1. Poke-Yoking the KPIVs to ensure compliant KPOVs

(prevention)
2. Mistake proofing at the KPOV level (detection)
3. SPC
4. Inspection
This list is in order of preference

97
Control Methods
“If elaborate control procedures are used, the plan will
typically reference the procedure document by a
specific identification name and/or number.”*
For example: Operator Work Instructions
Gauge Instructions
Job set-up instruction
Poke-Yoke Challenge Instructions
“The method of control should be continually evaluated

for effectiveness of process control. For example,
significant changes in the process or process capability
should lead to an evaluation of the control method.”*
* Please refer to page 53 of AIAG APQP second edition
98
Control Chart Data Management
Control Plan data should happen real time! Remember, the
control plan dictates the number of samples, the sampling
frequency and the type of control chart to be used.
Samples should be collected, analyzed and charted real time.
Data should not stored in a drawer and analyzed once a

month.
If the data is not analyzed real time, by the time an out-of-control
condition is finally identified, the parts are already shipped (and
probably on vehicles) and….
You won’t be able to identify the special cause which resulted in
the out-of-control condition (so it will probably happen again, and
again, and again….)
99
Roadmap for Control Chart Selection
Start
No Is the rational
Attribute
Data?
subgroup size Xbar-S chart
less than 8? No
Yes
Yes
No Constant Defectives Defects or

P-chart Sample size Defectives? Is the rational Yes
subgroup size Xbar–R Chart
Yes greater than 2?
Defects
np-chart
No
No Are lot size &

Subgroup
U-chart sample size
size = 1 and Yes
always constant? I-MR Chart
Homogenous
process.
No (subgroup size = 2) or
(subgroup size = 1 &
Yes process not homogenous)
C-Chart See your MBB

100
Control Principles
When using a control chart, follow the ROADMAP to
ensure appropriate control chart selection
Correctly calculate the control limits when control charts

are used
Remember, when using control charts that

specification limits are not control limits
Monitor the process where the characteristic of

interest was created
Use the data collected in real-time
101
Control Principles (cont’d)
Properly control the process
Use variable data where available (as opposed to

attribute data) for the specific characteristic
Use I-MR charts only for homogenous processes,

or where part to part variation is not meaningful
React immediately to out-of-control conditions

102
The most commonly used Variable Data Control
Charts in the automotive industry are:
• XbarR
Used for non-homogenous processes
• XbarS
• I-MR Used only for homogenous processes
103
What is a homogenous process?
A homogenous process is a process where there is

no variation expected between the measurement of
consecutive samples except for gauge error.
For example:
A vat of molten aluminum
A well mixed batch of paint
104
The most commonly used Attribute Data Control
Charts in the automotive industry are:
These two chart types are for defectives.
• p-charts - used with varying sample sizes
• np-charts - used with constant sample sizes
These two chart types are for defects.

• u-charts - used with varying sample sizes
• c-charts - used with constant sample sizes
105
What is a defect?
A defect is a nonconformity. A nonconformity is the
failure to meet one of the customer requirements.
However, a nonconforming product is not necessarily unfit for a

different use.
For example:
• After-market tires (may not meet OE specifications but are
still suitable for use).
• Roller Bearings are graded based on dimensional tolerances.
There are premium grade bearings, which are more expensive
than extra precision bearings. Extra precision bearings command
a higher price than industrial grade bearings, and so on.
106
What is a defective?
A defective is a unit containing one or

more defects.
A defective is unusable in it current state. This

means that we either scrap the part or repair the
part.
But remember - repair processes can create

other defects!
107
SPC is used to:
• Improve quality and customer satisfaction by
promoting a prevention strategy.
• Monitor and control processes to prevent
unnecessary process adjustments.
• Provide process capability information.
• Evaluate and stimulate continuous improvements.
• Support problem solving methods.
The goal of SPC is to notify the operator that an out of
control condition has occurred so that the operator
can react (per the reaction plan), thus protecting the
customer.
108
Risks when using SPC
(vs. 100% Measurement)
• SPC is based on a sampling strategy (as defined in the
control plan). As the process begins to shift, it will be
evident with the charting. The effectiveness of SPC is
directly impacted by the sampling plan.
• The risk when measuring all parts depends on the
type of measurement system being utilized. If you
have an attribute measurement system, there will be
no way to know if the process is drifting.
• If every part is measured, we know (with certainty)
that non conforming product will never be shipped
but if the measurement system is attribute, there will
be no evidence of process drift.
109
Control Methods (see Appendix A)
Control Charts require parts to be sampled at a

specific quantity and frequency (as specified in
the Control Plan)
The type of Control Chart that is appropriate to use

depends on the type of data being charted
(Variable data or Attribute data)
110
Remember…
Control charting should happen real time!
Samples should be collected, analyzed and

charted real time.
Data should not stored in a drawer and analyzed once a
month.
If the data is not analyzed real time, by the time an out-

of-control condition is finally identified, the parts are
already shipped (and probably on vehicles) and….
You won’t be able to identify the special cause which

resulted in the out-of-control condition (so it will
probably happen again, and again, and again….)
111
In theory, here’s what needs to happen….
First we must describe:

Y = f(X)
This means that you have a clear understanding of
how the process is suppose to work, at a fundamental
level of predictability
KPOV = f (KPIV)
Which means that :
For the Ideal Y, we must Optimize the KPIVs and

control the rest of the inputs
112
This means……….
Optimize the process to be as close to ideal
as possible
This will minimize the number of failure modes
The FMEA should reflect the remaining

failures modes
And we must employ countermeasures against

these failure modes until we understand better
how to control them.
113
So, what now?
What often happens is that we monitor at
the KPIV level.
• The KPIV is frequently checked to ensure that

it is within specification limits
But, the better way to do this is to control the

KPIV level.
• The KPIV is poke-yoked to ensure that it stays

within the specification limits
114
But Remember, Shift Happens
No process will stay in control forever
When a process does go out of control, we need to make

sure that we know how to react in order to:
Understand what caused the process to go out of
control
Adjust the process to correct the issue and
regain process control
Contain all non-compliant product produced by the
out of control process
To accomplish this, you need to have a robust Reaction Plan

115
Reaction Plans
Reaction CONTROL PLAN
Plans: Control Plan Number

FILE.XLS
Key Contact/Phone
555-555-5555
Date (Orig.)
1/1/1996
Date (Rev.)
1/1/1996
-Must describe NUMBER
ECL
containment NAME
actions to be SUPPLIER
PART/
PROCESS NAME/
MACHINE,
CODE
taken. S
NUMBER
OPERATION
DESCRIPTION
JIG, TOOLS
FOR MFG.
NO. PRODUCT
TOLERANCE TECHNIQUE
SAMPLE
SIZE FREQ.
CONTROL
METHOD
PLAN
-Describe in
26
detail what the
operator
should do
immediately.
-Problem
Solving
activities.
116
AIAG APQP & Control Plan 2nd Edition says
“The reaction plan specifies the corrective actions necessary

to avoid producing nonconforming products or operating out
of control. The actions should normally be the responsibility
of the people closest to the process, the operator, job-setter,
or supervisor, and be clearly designated in the plan.
Provisions should be made for documenting actions taken.”
“In all cases, suspect and nonconforming products must be

clearly identified and quarantined, and disposition made by
the responsible person designated in the reaction plan. This
column may also refer to a specific reaction plan number and
identify the person responsible for the reaction plan.”
117
So, what is the goal of a reaction plan?
The primary goal of a reaction plan is to protect the customer.
1. Isolate suspect product in-house.

2. Notify the customer if the customer has or will receive suspect
product.
3. Select the appropriate containment and certification method and
verify the effectiveness of the selected method.
4. Certify that compliant material is being produced and supplied to
the customer.
5. Integrate in to FMEAs and Control Plan as appropriate.
6. Cascade Lessons Learned to other Ford production lines, as
appropriate.
118
Let’s review page 1 of the following Control Plan
Control Plan
Date (Orig): 07-23-07 Date (Rev): 07/23/2007 (A)

____ Prototype __ Pre-Launch __X__ Production Supplier/Plant:
Control Plan number: All Auto-Bent Formed Parts - Flow PFMEA CP Rev A 07-23-2007.xls Supplier Code: Internal
Part #/Latest Chg. Level: Various Key Contact/Phone:

Part Name/Description: All Auto-Bent Formed Parts Core Team:
File Name:
Characteristics Methods
C
OP Process Name Machine, Material, l Product Evaluation Sample Control Reaction
# Operation Jig, Tools Product Process a Process Measure. Method Plan
Description For Mfg. s Spec./Tolerance Technique Size Freq.
s
Move tubing required for

Receive Internally Extruded Visual Inspection, Per FIFO Procedure and Notify Lead Operator, Reject
10 Hand Cart / Fork lift Extruded Tube production per Glycol Form 100% Continuous
Tubing Review W IP Labeling Job Instructions Nonconforming Product
Schedule.
Per Job Instruction Load Sort to last known good,

Load per Job
20 Load Automated Bender Load Bender Sensor Detects Load Automated Sensors Sensors 100% Continuous Sensor with alarm Display Reject nonconforming
Instructions
- Auto Shut Down material.
Temperature/
Temprature and Notify Lead Operator,
Per Control Panel
Proximity Sensors W ith Sort Suspect Material,
Automated Bender Cell Final Cure & Form Settings, All settings have Automated Heat Sensors 100% Continuous
Alarm Displays - Auto Reject Non-conforming
standared +/-10 Degrees
Shut Down Material
tolerance.

Automated Sensors. For
30 Auto Bend Forming Automated Bender Extruded Tube Final Cure & Form Tube Kink, Tube Length Length and Kinking (cool 100% Continuous
down sensor)
Shut Down Material

Time/ Proximity Sensors W ith Sort Suspect Material,
Automated Bender Extruded Tube Final Cure & Form Automated Time Sensor 100% Continuous
per index for Bender Alarm Displays - Auto Reject Non-conforming
Shut Down Material
Gauging / Visual Inspection ( Temprature and

Per hour and at Notify Lead Operator, Sort
If Finished Goods) per Job Instructions - Final Proximity Sensors W ith
Part Gage Formed Tube Visual Inspection / Gauge 5 the Beginning of Suspect Product, Reject
otherwise Final Assembly Gage
Shift
Alarm Displays - Auto Nonconforming Product.
Gage. Shut Down
40 Bend Contour
Temprature and
Notify Lead Operator, Sort
Ink Mark Parts Proximity Sensors W ith
Ink Stamper Stamp or Paint Pen Mark Per print Per Gage 100% Continuous Suspect Product, Reject
(If Applicable) Alarm Displays - Auto Nonconforming Product.
Shut Down

Automated Bender or Per Packaging Matrix or Job
Final Formed Tube Packaging Visual 100% Continuous Per job instruction Suspect Product, Reject
Operator Instruction
Nonconforming Product.
Pack parts (if Finished

50
Goods)

Per Packaging Matrix or Job
Operator Final Formed Tube Labeling Viusal 100% Continuous Per job instruction Suspect Product, Reject
Instruction
See Final Assembly Control

Plan (if applicable)
Customer Approval: See Final Assembly Sign Off (If Applicable) Date:
Engineering Approval: Date:
Quality Approval: Date:
Production Approval: Date:
119
This reaction plan does….
Verify containment back to the last known conforming product
This reaction plan does not….

Describe when to notify the customer
Describe problem resolution
Describe how to resolve the quality concern
120
Common Reaction Plan Mistakes
Roles and responsibilities are not clearly defined
Containment procedure not clearly defined
Customer notification procedure not defined
Method for disposition of suspect material not defined
Problem solving methodology not defined
121
Now, let’s discuss the issues with this Reaction Plan
Control Plan
Date (Orig): 07-23-07 Date (Rev): 07/23/2007 (A)

____ Prototype __ Pre-Launch __X__ Production Supplier/Plant:
Control Plan number: All Auto-Bent Formed Parts - Flow PFMEA CP Rev A 07-23-2007.xls Supplier Code: Internal
Part #/Latest Chg. Level: Various Key Contact/Phone:

Part Name/Description: All Auto-Bent Formed Parts Core Team:
File Name:
Characteristics Methods
C
OP Process Name Machine, Material, l Product Evaluation Sample Control Reaction
# Operation Jig, Tools Product Process a Process Measure. Method Plan
Description For Mfg. s Spec./Tolerance Technique Size Freq.
s
Move tubing required for

Receive Internally Extruded Visual Inspection, Per FIFO Procedure and Notify Lead Operator, Reject
10 Hand Cart / Fork lift Extruded Tube production per Glycol Form 100% Continuous
Tubing Review W IP Labeling Job Instructions Nonconforming Product
Schedule.
Per Job Instruction Load Sort to last known good,

Load per Job
20 Load Automated Bender Load Bender Sensor Detects Load Automated Sensors Sensors 100% Continuous Sensor with alarm Display Reject nonconforming
Instructions
- Auto Shut Down material.
Temperature/
Per Control Panel
Automated Bender Cell Final Cure & Form Settings, All settings have Automated Heat Sensors 100% Continuous
standared +/-10 Degrees
Shut Down Material
tolerance.

Automated Sensors. For
30 Auto Bend Forming Automated Bender Extruded Tube Final Cure & Form Tube Kink, Tube Length Length and Kinking (cool 100% Continuous
down sensor)
Shut Down Material

Time/ Proximity Sensors W ith Sort Suspect Material,
Automated Bender Extruded Tube Final Cure & Form Automated Time Sensor 100% Continuous
per index for Bender Alarm Displays - Auto Reject Non-conforming
Shut Down Material
Gauging / Visual Inspection ( Temprature and

Per hour and at Notify Lead Operator, Sort
If Finished Goods) per Job Instructions - Final Proximity Sensors W ith
Part Gage Formed Tube Visual Inspection / Gauge 5 the Beginning of Suspect Product, Reject
otherwise Final Assembly Gage
Shift
Alarm Displays - Auto Nonconforming Product.
Gage. Shut Down
40 Bend Contour
Temprature and
Ink Mark Parts Proximity Sensors W ith
Ink Stamper Stamp or Paint Pen Mark Per print Per Gage 100% Continuous Suspect Product, Reject
(If Applicable) Alarm Displays - Auto Nonconforming Product.
Shut Down

Automated Bender or Per Packaging Matrix or Job
Final Formed Tube Packaging Visual 100% Continuous Per job instruction Suspect Product, Reject
Operator Instruction
Pack parts (if Finished

50
Goods)

Per Packaging Matrix or Job
Operator Final Formed Tube Labeling Viusal 100% Continuous Per job instruction Suspect Product, Reject
Instruction
See Final Assembly Control

Plan (if applicable)
Customer Approval: See Final Assembly Sign Off (If Applicable) Date:
Engineering Approval: Date:
Quality Approval: Date:
Production Approval: Date:
There is no description of:: Roles and responsibilities not defined

Containment Procedure not defined
Method for material disposition not defined
Customer notification procedure not defined
Problem resolution methodology not defined 122
Reaction Plans must…
Protect the customer by isolating and containing the

suspect product throughout the supply chain.
Contain back to the last verified conforming product or

beyond. (Depending on the failure rate, the sample size
and frequency, the last verified check may not be
enough).
Describe the escalation procedure within the

supplier manufacturing facility.
Describe the customer notification procedure,

if/when appropriate.
123
And this is what a good example should look like
This should refer to a separate

procedure because there is not
enough space to adequately
provide the required information.
Procedure B106 contains the following:

Defined Roles and Responsibilities
Defined Containment Procedure
See procedure B106 Defined Method for material disposition
Defined Customer Notification Procedure
Defined Problem Resolution Procedure
124
Procedure B106
Operator:
1) Adjust the process to correct the out of control condition, verify control
and document actions taken.
2) Contain any suspect material that is in station.
3) If control can not be verified then immediately notifies respective
supervisor for assistance.
Supervisor:
4) Authorizes line stoppage
5) Authorizes the team to quarantines all suspect stock away from
production line and clearly identify all suspect material
6) Contacts MP&L to authorize dock hold if necessary
7) Contacts quality office to initiate quality investigation
Quality Engineer:
8) Review issue to validate quality concern.
9) If appropriate (Quality Engineer or Quality Manager) notify the customer
of the potential issue and the ramifications of this failure mode.
10) If necessary develop plan to quarantine all suspect stock in transit or at
the customer for future disposition.
125
Procedure B106
12) Initiate 8D process.
Note: Disposition of the material once it is determined to be non-compliant
must be clearly identified. Destruction is the preferred method after it has
been clearly identified as non-useable.
Once the root cause is identified (5 why's, 8D, etc….), the systemic failures
need to be addressed and appropriate documentation (DFMEA, PFMEA,
Control Plan, Work Instructions, etc….) updated.
Permanent corrective actions need to validated with data (gage R&R,
Capability, etc.)
Notify customer of the permanent corrective action implementation.
126
Customer notification
• Notify customer of possible issue. Ford VOP-QUN-008

will allow the SIM not to be impacted if the supplier
notifies us of the issue.
• Notify all possibly affected Ford Assembly and/or

Manufacturing Plants.
127
Perform Root Cause Analysis
• Perform a root cause analysis
• Once root cause analysis has been

completed, update FMEAs, Control Plan’s,
Work Instructions, Supplement K’s, etc…
128
Procedure B106
Operator:
1) Adjust the process to correct the out of control condition, verify control
and document actions taken.
2) Contain any suspect material that is in station.
3) If control can not be verified then immediately notifies respective
supervisor for assistance.
Supervisor:
4) Authorizes line stoppage
5) Authorizes the team to quarantines all suspect stock away from
production line and clearly identify all suspect material
6) Contacts MP&L to authorize dock hold if necessary
7) Contacts quality office to initiate quality investigation
Quality Engineer:
8) Review issue to validate quality concern.
9) If appropriate (Quality Engineer or Quality Manager) notify the customer
of the potential issue and the ramifications of this failure mode.
10) If necessary develop plan to quarantine all suspect stock in transit or at
the customer for future disposition.
129
Procedure B106
12) Initiate 8D process.
Note: Disposition of the material once it is determined to be non-compliant
must be clearly identified. Destruction is the preferred method after it has
been clearly identified as non-useable.
Once the root cause is identified (5 why's, 8D, etc….), the systemic failures
need to be addressed and appropriate documentation (DFMEA, PFMEA,
Control Plan, Work Instructions, etc….) updated.
Permanent corrective actions need to validated with data (gage R&R,
Capability, etc.)
Notify customer of the permanent corrective action implementation.
130
When should the DFMEA/PFMEA/Control
Plan be revisited?
When there are:
• Engineering Changes
• Part Quality Changes
• Process / Process Knowledge Changes
• Annual review (per Q1 MSA)
131
Examples of Engineering Changes
• Specification changes
• Drawing Changes
• Material Changes
• Updates to the DFMEA based on new design

related failure modes discoveries
132
Examples of Part Quality Changes
• Major quality issues (QR’s)
• Warranty Issues
• When new PTCs are identified
• Gauging changes or improvements
• Optional Material changes that meet the existing design specification
• SREAs
• Stop Ships
• Field Actions
• Internal quality issues

133
Examples of Process Changes
• New knowledge, such as additional process linkages
• The process sequence is physically changed
• New equipment is utilized in the manufacturing process
• Performance results either improve or deteriorate
134

Control and Reactions Plans

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Control and Reactions Plans

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Control Plans

- Recognize/Communicate the requirements for robust

- Be able to identify Control/Reaction Plan weaknesses

Analysis of Quality Issues Shows:

FMEA/Control Plan account for approximately

The deficiencies include: Plan

1. Special Characteristics not included on the FMEA

2. Understating severity, detection, or occurrence on FMEAs

3. Failure mode not identified in FMEAs

4. Inadequate or no linkage between FMEAs & Control Plan

5. Ineffective control and/or gauging strategies

6. Process parameter controls not detailed in the control plan

7. Ineffective and/or inappropriate sampling plans

8. Inadequate or no Reaction Plan

9. Control Plan/Reaction Plan not followed

Control Plan, DFMEAs and PFMEAs are legal documents.

“The organization shall have a Control Plan that defines all

Note 1: Control Plans for “families” of parts are acceptable

Note 2: Control Plan approval may be required by certain

“For all PPAP submission levels (1 through 5), Control

“The Control Plan shall include provisions for on-going

Control Plans are written descriptions of the systems

In addition, Control Plans specify the process monitoring

In addition to Special Characteristics, the Control Plan contains the Key

Control Plans are really for the operator!!!

Control Plans are living documents, which means as process

In accordance with the MSA requirements, FMEAs (and

Control Plans are an integral part of any effective Quality

The primary intent of a Control Plan is to create a

Control Plans should define the necessary systems that

Control Plans aid in the manufacture of quality products

Control Plans may apply to an individual part or product

When gauge usage is required, the Control Plan shall identify

The Control Plan is a living document and is updated

During the manufacturing process, Control Plans provide the

Every controlled process or part characteristic requires a

Method for disposition of suspect material

Issue Escalation procedure

The characteristics that must be controlled are CC, SC,

The CC characteristics are found on the part drawing

CC, SC, HIC and PTC must be listed in other documents

“Special Characteristics are those product or

“Critical characteristics are designated with the

“Significant Characteristics are those

“High Impact Characteristics are related to

Pass-Through Characteristics are defined as Product

A PTC is a characteristic that could have a significant

Remember that PTCs are a subset of HICs.

Many Stop Ships/Field Actions are caused by

Usually, the offending characteristic is not monitored

The controls should be implemented as close as possible to the

In fact, the controls should be implemented at the KPIV (Key

DFMEA PFMEA Control Reaction

Prototype Build parts using on the prototype

• Engineering Material Specifications

• Critical manufacturing process parameters (if applicable)

The control of KPIVs means controlling the process

The KPIVs are placed in the process specification

When KPIVs are controlled, the KPOVs will be conforming.

Control is best when

1. Determine which part characteristics need to be

2. Determine where the controls should be

3. Select the appropriate type of control chart for the