PFD, PFMEA, and PCP TRAINING

Sanjoy Kumar, David Blanchard, Carlos Martinez Mendoza

With edits by Jason Ritacco and Nick Zurita

© 2022 Raytheon Technologies

All rights reserved.
Learning Objectives

PFD, PFMEA, and PCP Overview

• Provide and overview understanding of key PPAP elements, specifically:

– Process Flow Diagram (PFD)
– Process Failure Modes and Effects Analysis (PFMEA)
– Process Control Plan (PCP)
• Establish a basic understanding of these tools in their new format prior to
conducting working sessions, where users will:
– Apply these tools, PFD, PFMEA, & PCP to RTX production programs
 APQP BENEFITS FROM PROACTIVE APPROACH

• Reactive to proactive approach

• Improved product quality
PFMEA is a
critical APQP • Reduce failure costs through prevention
prevention • Increased customer satisfaction
activity
100
90 Prevention

80
70
Ins pe ction
60
50
Prevention
Failure internal
40
30
Ins pe ction
20 Failure external
10 Failure internal
Failure external
0
Be fore Afte r

Upfront costs are offset by reduction in failure and inspection cost

APQP FLOW DIAGRAM

Design Failure
Mode and
Effects Analysis

ADVANCED PRODUCT QUALITY PLANNING (APQP):

A set of activities required to develop new products and processes that will ensure customer quality, cost and delivery targets can be met.
RISK MITIGATION & MANAGEMENT
DISCRETE & CONTINUOUS ACTIONS

1) Discrete Actions
- Level 1 Mistake-Proofing
- Resequencing Operations
- Program Changes
- RCCA
- Six Sigma Projects 2) Continuous Actions
- Ongoing controls for operations
to manage & react to
CORE TOOLS
Examples pulled from various parts of the enterprise

Control Chart: Blade length

1.266
UPPER CONTROL LIMIT The

Measured Value of a Key

maximum value
1.262 UCL expected to be seen

Characteristic
1.258

1.254
CENTER LINE CL Th eexpected
average value
to be seen
1.250
1.246

1.242
The minimum value
1.238 LOWER CONTROL LIMIT LCL expected to be seen
1.234
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Time Order

► Design Engineering
► Manufacturing Engineering
CORE TOOLS INTRODUCTION

Process
Process Process
Failure Modes &
Flow Diagram Control Plan
Effects
(PFD) (PCP)
Analysis
(PFMEA
)

What am I supposed to do?

What could go wrong?
What does the process do? How am I supposed to do it?
Can we prevent or detect?
Where am I supposed to record it?
PFMEA TEAM ROLES
Champion /
Sponsor
Provides resources &
support Attends some
meetings Promotes team
efforts
Shares authority / power with
team Kicks off team
Implements recommendations
FMEA Core Team Facilitator
Team Leader 4 – 6 Cross-Functional Members “Watchdog“ of the
“Watchdog” of the process Keeps team
project Good Expertise in Product / Process on track FMEA Process
leadership skills PFMEA Requires 4 Roles (ME, QE, Ops, expertise
Respected & relaxed Design) Control Plan Requires 3 Roles– Encourages / develops team
Leads but doesn’t dominate (ME, QE, Ops) Honest Communication dynamics Communicates
Maintains full team Active participation assertively
participation Typically lead Respects other opinions Ensures everyone participates
engineer

Recorder
Keeps documentation of teams
efforts FMEA chart keeper
Coordinates meeting rooms/time
Distributes meeting rooms &
agendas
DEVELOPING THE PROCESS FLOW DIAGRAM
 PFD
What does the
process do?
PROCESS FLOW DIAGRAM
DEVELOPING THE PROCESS FROM BEGINNING TO END
Operation # Key Process
Outputs (KPO) Key Process Inputs (KPI)
& KC’s AKA Process
AKA Product
• Process Flow Diagram is the foundation Description Characteristics Characterstics

• The Process Flow Diagram provides a

logical (visual) depiction of the process that
is being analyzed.

• Identifies the process steps, process

descriptions, Key Process Inputs (KPI), Key
Process Outputs (KPO), what steps Key
Characteristics are manufactured/inspected

• The PFD is a direct input to the

PFMEA; recommend a vertical format

Flow
Diagram
A note on Formatting
Process Flow Diagram Inspection Key Changeover Key Part # WS-2021-rev b
P=Product Customer Part # WprSys-2024
Operation 30 A=Automatic
Product:

There are many templates available

T=Tooling

• M=Manual V=Visual

Organization: Q=Quality Audit

Wiper System
S=Softw are Rev Date:By
Prepared
Manufacturing Engineering Bill Haughey; Rhonda Brender;

to support creation of PFDs

Department: Wiper System - Quality L=Label Mike Bucala; Paul Baird, Ryan Winnicki; Ed
Operation Type
Myzienski; Mike Dow n; Carl Carlson;
Op- Process Special Lee Daw son; Mary
Operation Row zee; MaryBeth Soloy
Description Product Special

Process Function Priority

Seq Characteristics Process (Process Function) Characteristics Product

Packaging Interaction
Sources of Characteristic (Do This - To This - (Outputs) Characteristic

Administration (A)

Move / Transport
Minimum elements are proscribed

Lift / Get / Store

•

Scrap / Contain
Variation (Inputs) With This) (Purpose of

Traceability (T)

Inspect / Verify
Transformation
Comments

Fabrication /
Operation)

Changeover
Rework
by J1739. 30

30.05 Bar Code reader A/T X

Wiper System Installation

Get w iper linkage

H

L 1) Correct w iper Traceability

Bin Placard linkage

• The format below is available in

2) No damage
30.07 Placement of isolators X Get and manually install L Alignment of Dimensional
isolators isolators to w placement of
indshield molding isolators w ith

Stages
respect to w iper
linkage
30.10 Torque tool setting X Orient and secure w iper H 1) Alignment of Clearance to w Speed control, rotation control,
linkage to body structure w Linkage to w indshield torque control
ith battery torque tool indshield molding
2) Torque w ithin
design
specification
30.15 Bar Code reader T X Get w iper motor L 1) Correct w iper Traceability w ill be needed
motor
2) No damage
30.20 Locating feature in X Orient and secure w iper L 1) Correct Secured w ith Speed control, rotation control,
tray design motor to body and w iper alignment of motor correct torque torque control
Battery torque tool linkage w ith battery torque to vehicle
tool 2) Torque w ithin
design
specification
1) Operation layout to 1: KCC Orient and secure w iper 1) Error proof 1: CC Speed control, rotation control,
enable connector Degree of motor ground w ire to vehicle design to prevent Connector torque control
orientation connector rotation w ith battery torque tool connector rotation orientation 2: CC
30.30 X H
2) Torque tool setup 2: KCC 2) Torque Ground w ire
2) Torque tool Tool RPM fastener torque
calibration spec

11
 PFD
What does the
process do?
PROCESS FLOW DIAGRAM
DEVELOPING THE PROCESS FROM BEGINNING TO END

• The process must be defined step by step, including alternate

process steps and standard rework steps 1 2 3 5
Ground Blade Wire clamp Final
assembly assembly assembly assembly

• The PFD provides the structure to document what product Ground

4
Canister
assembly

characteristics and requirements (KPOs) are affected by a given pin 1

operation and how these characteristics and sources of variation Ground Ground
are controlled (KPIs) strap
assembly
• PFD is a graphical representation of every possible path a part Support
plate
can Press until pin
take through the anticipated manufacturing process Place ground strap
is fully set Press ground pin
thru ground strap
on to support
and support
plate
• Helps in developing equipment needs plate.

• PFD Key Questions Note pin

orientation
Note tab
– How will the process control non-conforming material? orientation

– How and when will inspections be performed

– What is required?
– How and when will parts be re-introduced into the process?
 PFD
What does the
process do?
PREPARING A PROCESS FLOW

Process Step / Process Function (description):

– Consecutive
– Consistent identification convention
– Consistent with other APQP documentation
– Appropriate level of detail

Too little detail will not expose the

problem, Too Much detail will hide
the problem
 PFD
What does the
process do?
PREPARING A PROCESS FLOW
REQUIREMENTS MANAGEMENT

Characteristics
List all types of KPOs produced at the process step
“what is this step in the process supposed to do or produce?”

List the most impactful KPIs used to control the KPOs for each
process step.

It is recommended that each requirement be identified by a unique

identification number (may come from a ballooned drawing)
 PFD
What does the
process do?
CHARACTERISTICS MATRIX
INPUT TO PFD & PFMEA

Shows relationship between process

steps and product requirements
created at a particular step

Shows where a specific feature is

inspected

Operations that can ‘affect’ a feature

created at an earlier operation are also
listed.

Examples of these types of processes

include Heat Treatment, Coating,
Welding, roughing operations,

Helps ensure all features are

analyzed

May not include all specification

requirements such as material
properties, damage, or surface finish
properties
 PFD
What does the
process do?
PROCESS INPUTS
VARIABLES WITH EFFECT ON OUTPUT

List any process input / process

parameter / input variable that
can potentially affect the
output (Physics of transformation)

Comparison
Process
Process Inputs
Output
NC Program
Insufficient detail
Surface Work Instructions to identify
Finish Operator process variables
& potential
Machine causes

Process
Process Inputs
Output
Spindle Speed (KPI)
Sufficient detail
This column is used to identify those sources of Surface Feed Rate (KPI) to identify
process variables
variation that can affect the process step. Finish Tool Condition (KPI) & potential
causes
Coolant Flow
 PFD
What does the
process do?
COMMON RED FLAGS
PROCESS FLOW DIAGRAM

• No KPIs or KPOs.
• No KCs (Product and Process).
• Flow Diagram formatted horizontal versus vertical.
• No material receipt or shipping and packaging operations.
• No evidence of in process inspection.
• KCs called out at inspection and not manufacturing operations.
• Lack of or inadequate receiving inspection.
• Process Flow does not link or correlate with job router
• Missing assembly steps
See supplement Process Flow Diagram: Essentials of Discrete Manufacturing in back-up charts for detail on Macro vs Micro PFDs
Process Failure Modes and Effects Analysis

18
“A PFMEA Should be Uncomfortable”
PFMEA must drive changes
 PFMEA WORKSHEET OVERVIEW
OVERVIEW & COLUMN INTERACTIONS
Y= f(x)

3. Causes of Failure
Modes, not Effects

7. Action Results
1. Failure 2. Customer 4. Occurrence: Cause rate,
Modes are Effects: not Failure Mode rate 6. Action Plan w/ Owners,
Process Flow Prevention Controls reduce
Failure to meet External & Dates & Predicted Risk
Requirements Internal Occurrence

5. Detection for
Cause -or- Failure Mode
PFMEA TEAM ROLES

Process Map ME ME ME Ops Manufacturing Engineering (ME)

CIPT QE Quality (QE)
Design (CIPT)
Operations (Ops)
Team Leader & Facilitator

THIS DOCUMENT DOES NOT CONTAIN TECHNICAL DATA SUBJECT TO THE EAR OR ITAR
 FMEA STRUCTURE
ITEM / Failure Recommended
Requirement Effects Cause Control
Function Mode Actions

Recommended
Control
Actions

Recommended
Why PFMEAs get large Cause Control
Actions

A process step may have more than

one “Requirement” Control

A “Requirement” may have more than one

Failure Recommended
“Failure Mode” Mode
Effects Cause Control
Actions

A “Failure Mode” may have more than one

“Cause of Failure” Control
Recommended
Actions

A “Cause of Failure” may have more than one

“Process Control” Cause Control

Control

Failure Recommended
Requirement Effects Cause Control
Mode Actions

ETC...
PW PROPRIETARY / THIS SLIDE CONTAINS NO EXPORT REGULATED TECHNICAL DATA
 PFMEA
What could go wrong?

REQUIREMENTS / FAILURE MODES Could we prevent it?

Could we detect it?
AIAG EXAMPLE

Process Function Requirement Failure Mode

Four screws Less than four screws

Wrong screw used (larger dia)
Specified screws
Wrong screw used (smaller dia)
Operation 20:
Assembly sequence:
Starting screw placed in any other
Attach seat First screw in right
hole
cushion to track front hole
using a torque gun Screws fully seated Screw not fully seated
Screws torqued to Screw torqued too high
dynamic torque
specification Screw torqued too low

Failure Mode as failure to meet

requirement
 PFMEA
What could go wrong?

SEVERITY OF EFFECT Could we prevent it?

Could we detect it?

Severity is the rank associated with the most serious

effect of the failure mode on the external (Product) and
internal (Process) customer:

– Assess the severity of each effect by team consensus using

the ranking table, in the Effects column.
– Consider Customer Effect (External) and
Manufacturing/Assembly Effects (Internal)

Enter a severity for each effect; place highest rating in the

Severity column
PFMEA SEVERITY CRITERIA
GRAPHICAL REPRESENTATION
 PFMEA
What could go wrong?

POTENTIAL CAUSES OF FAILURE MODES Could we prevent it?

Could we detect it?
EXAMPLES

Determined by the FMEA team using subject matter knowledge and experiences.

Excessive Torque Applied Inaccurate Measurement/Gage

Weld temperature too low Worn Locator

Worn Tool Missing Locator

Wrong Tool Wrong Material Used

Inadequate Venting Lubrication Fatigue

No Preventive Maintenance Inadequate Lighting

Programming does not handle interactions Set-up offset too high

Not “Operator Error”

Not “Work instructions not

followed”
INPUTS are CAUSES, look at your Inputs from the PFD
PFMEA OCCURRENCE CRITERIA
GRAPHICAL REPRESENTATION
PFMEA DETECTION CRITERIA
GRAPHICAL REPRESENTATION
PFMEA Example

17.0 Special Characteristic Classification

16.0 Severity
9.0 Doc. 12.0 Process Function/ 14.0 Potential 15.0 Potential
10.0 Operation # 11.0 Process Step 13.0 Requirements
(Line) # Description Failure Mode Effect(s) of Failure

20.0 Occurrence

22.0 Detection

23.0 RPN

25.0 SO
24.0 SD
18.0 PotentialOP80/ 19.0 Prevention 27.0 Recommended
21.0 Detection Controls 26.0not
Parts are Comments
adhesive will not Action
Cause(s)
1 of Failure
Assembly Controls Step 1 Clean part Parts are clean 4
clean work properly

OP80/ assembly will not

Adhesive was not
2 Assembly Step 2 Bonding operation Apply adhesive properly maintain 7
parts missed clear work instructions applied properly
2 visual inspection 7 56 28 8 relationships None
cleaning stage established
Team to design system to
improper adhesive clear work instructions
3 visual inspection 7 147 49 21 apply adhesive
use established
consistently
 PFMEA WORKSHEET OVERVIEW
SUMMARY OF KEY COLUMNS & INTERACTIONS
Y= f(x)

3. Causes of Failure
Modes, not Effects

7. Action Results
1. Failure 2. Customer 4. Occurrence: Cause rate,
Modes are Effects: not Failure Mode rate 6. Action Plan w/ Owners,
Process Flow Prevention Controls reduce
Failure to meet External & Dates & Predicted Risk
Requirements Internal Occurrence

5. Detection for
Cause -or- Failure Mode
Process Control Plan
Implementing the current controls and improvement actions from the
PFMEA

31
 INTENT OF CONTROL PLANS
THE KNOBS AND SWITCHES OF THE PROCESS

Mfg. Eng.
Take actions on …and monitor
inputs… product outputs.

Control Plan Control & Capability on Product

CHARACTERISTICS METHOD
Sample
Special Characteristic Classification

Machine,
Process Function/ Product or Process
Operation # Process Step Device, Jig, Doc. Product Process Evaluation / Measurement Reaction Plan
Description Specification/ Control Method
Tools For Mfg. (Line) # (KPOs) (KPIs) Tolerance
Technique
Size Freq.

Call maintenance to verify

Renishaw OMP- DRO is correct. If correct,
999, Artifact Tool, Visually Inspect Coolant Chiller Per maintenance to fix chiller
20 Stock Prep Rough Out Stock Calibration
7, 15, 17 Coolant Temperature KPI 23 deg. C +/- 2 deg.
DRO
1
Cycle
Run Chart (Prolink)
and run coolant for 15
Subroutine minutes before starting
cycle.

Call maintenance to verify

Renishaw OMP- DRO is correct. If correct,
999, Artifact Tool, Visually Inspect Coolant Chiller Per maintenance to fix chiller
20 Stock Prep Rough Out Stock Calibration
7, 15, 17 Coolant Temperature KPI 23 deg. C +/- 2 deg.
DRO
1
Cycle
Run Chart (Prolink)
and run coolant for 15
Subroutine minutes before starting
cycle.

Have Tool Services inspect

Renishaw OMP- fixture or torque wrench to
999, Artifact Tool, Per see why it cannot torque
20 Stock Prep Rough Out Stock Calibration
7, 15, 17 Clamping Force KPI 55 PSI +/- 2 PSI Preset torque wrench 1
Cycle
Visual
to spec. Tool Services to
Subroutine fix or replace wrench or
fixture as required.

If Out of Control:
Recalibrate part and tool
probes and run another
ME Dim: 10.000 +/- cycle
20 Stock Prep Rough Out Stock Haas VFXXX 11 OD KPCM
.015
In-Process Part Probing 2 100% I-MR Chart (Prolink)
If Out of Spec:
QR parts & Inititate RCCA
Process

If gage will not read in

"High" Pressure zone and
Per Part Visual Process
40 Finish Mill Finish Mill Blade Micron 500 23,24,28 Clamping Pressure KPI High Pressure Setting Pressure Gage 1 high pressure is
Loaded Check & Checklist sleected, call
maintenance to fix
clamping pressure.

Controller Locks
Out Feedrate in
Program- No
120 IPM @ 100% +/- Override Option for
40 Finish Mill Finish Mill Blade Micron 500 21,22,23 Feed Rate KPI Controller 1 100% Operator N/A
0%

Level 1 Mistake
Proof
IMPORTING KC’S FROM PFMEA
Key Characteristics
Identified by:
(KC's) Design Eng. Mfg. Eng.

KPC-1 KPC-M
Product KPC-2 KPC-A
KC (Outputs KPC-D (IDS KC)
Category ) K (Critical)
M
(Major)
Process
KPI
(Inputs)
SYSTEM DIAGRAM

Identify
Product
C h a r ac te r istic s
7.2 Co n t ra c t
Review
OP10
Customer
R e qu irem en ts Associate PCs
(ex: specifications, with Operational
design Id e n tify
Steps
performance OP 20 P ro ce ss P ro ce ss Root
specification, Identify Cause
Flow Process
FMEA
p ro t o t y p e
requirements) C h a r ac te r istic s
(s o u rc e s /c a u s es
OP 30 of variat ion) 8- D

Implement
Process Ac t i o n P l a n
Improvements

Im p le m e n t
Control
St ra t e g y AS9100
Pr oce du res
C o n tro l
Plan
O p e ra t i o n s
Ins tru ction s
WHAT IS A CONTROL PLAN?

• Written description of systems for controlling product and process variation

in manufacturing and assembly processes
• Contract between the supplier and the customer

• Summarizes entire control strategy for a system, subsystem or component

• Basis for development of process work instructions— not a substitute for

them!
• Identifies statutory, regulatory, customer, supplier, Key and Critical characteristics
CONTROL PLAN

• The PFMEA (current process controls) describes the methods which will be used
to control the process from Receiving to Shipping.
• The Control Plan provides the details of those controls.

• Control Plan must be maintained and used throughout the product life cycle.

• A Control Plan may apply to a group or family of products produced by the

same process.
 PRODUCTION CONTROL PLAN: INPUTS
THE DATA OR INPUTS THAT WILL BE USED TO DEVELOP THE CONTROL PLAN MAY INCLUDE SOME OR ALL OF
THE FOLLOWING. THIS DATA WILL BE REVIEWED BY THE MULTIDISCIPLINARY TEAM DURING THEIR
MEETING.
Primary Source • Work Instructions for similar parts or processes
• Process FMEA • List of Key/Critical Characteristics
• Pre-launch Control Plan • List of Machines, Tools, Jigs or Fixtures
• Production Trial Run • List of Gauging or Equipment for each measurement,
test or inspection
Supporting Information • Performance Testing Requirements
• Aerospace APQP and AS9103 • Design Reviews
• Customer Prints & IDS • Optimization Data
• In-Process Prints • Process Flow Diagram
• Customer and Internal Specifications • System and/or Design FMEA or IDS
• Inspection Plans and Sampling Frequency
PROCESS CONTROL PLAN FORM

All Control Plan elements must be communicated to the operators of the process in the working
documents employed, such as operator and process instructions, manufacturing sheets, assembly
sheets, shop documents, Inspection Plans, etc.
 SPECIFICATIONS

• What the characteristic will be controlled to; information can be found in:
– Drawings / Prints
– Specifications / Tolerances
– Standards
– CAD Data
– Manufacturing / Assembly Standards

• For Part or Process Family documents, refer to the spec. sheet or drawing, as appropriate
Control Plan
Guide for Improved reaction plans as part of the process

40
 PROCESS CONTROL METHODS

The Reaction Plan, the last column on a Process Control Plan (PCP) is commonly misunderstood
Often, the assumption is a nonconforming part is generated driving the user to create an operator
Reaction Plan that requires the operator to utilize the local MRB procedure
PCP reaction plans should correlate to the process control employed
If the process control indicates something is going astray or isn’t right, the reaction plan instructs the
Operator on what to do
It is suggested to have this table present when conducting a PFMEA Validation Event or evaluating a
Process Control Plan

The best process control methods avoid the error state of making mistakes and subsequent defective
parts; Reaction plans should respond to the control method signal
 COMMON CONTROL METHODS
More
Effective 1.Error/ Mistake Proofing
a. Level 1 (Best)- Method eliminates the mistake and the defect from occurring at
the source
b.Level 2 (Better)- Method detects the mistake while alerting operator to take
appropriate
action resulting in zero defects
c. Level 3 (Good)- Method detects defect resulting from a mistake and prevents
further processing
2. Control Charts for Variable Data (I-MR, X-Bar & R, etc.)
3.Run Charts with Non-Statistical Limits
4.Pre-Control Charts
5.Life/ Usage Control
6.Attribute Control Charts
7.Visual Process Check & Checklist
Less 8.First Piece Check
Effective 9.Test Piece Evaluation
PROCESS CONTROL METHODS
CONTROL
NO. APPLICATION EXAMPLE PCP REACTION PLAN
METHOD
To avoid defects caused by inadvertent errors. ●One-way fit of a die insert to prevent mis- ●Level I M/P device prevents the possibility
The most robust and preferred method. orientation during loading. of entering an error state so no reaction plan
is required.

Error / Mistake ●Level II devices such as alarms and buzzers

1 require the operator to stop and investigate the
Proofing Mistake Proofing devices build quality into a
●Use of a physical device to prevent installation error cause. This reaction may lead to following a
process in order to prevent and/or detect
of an oil-fill tube into the wrong port. precribed recovery plan that eliminates the error
errors prior to defects being made.
condition or at least to contact their M.E. and/or
supervisor for the next steps to take.

●Dimensional product features are plotted on

control charts at the point of process and Variable Control Charts will send signals to the
monitored by the operator. The operator takes operator in the way of unusual/non-random
action to investigate and remedy issues when patterns displayed by the data. These are known
To monitor a process input or process outputs special causes are detected. as the Western Electric Rules. Operators using
Variable Control that is continuous in nature for the purpose of control charts should have a laminated copy of
2 these rules at their workstation, stop the job if any
Charts establishing and maintaining a state of
statistical control (statistical stability). ●The pressure drop in a vaccum furnace is of these patterns are displayed on the control
monitored on a control chart to warn of developing chart, take the appropriate action to bring the
issues. The operator responds to special causes process back into statistical control. The operator
by performing equipment diagnostic checks. may also decide to seek help from their M.E.
and/or supervisior.

To monitor process inputs that require ●The viscosity of the slurry used in an investment
adjustment within acceptable operating limits in casting process is monitored. When a limit is
response to natural drift.Likely to be used when reached, the operator adds water to the mixture to
statistical limits offer little practical benefit or correct for evaporation over time. Run Charts may have "warning limits" applied that
lead to false signals of special cause. may have been determined by taking 50% or
●A highly capable genral toleranced characteristic 75% of the engineering tolerance. While these
on a machined part where tool wear is expected limits may not be statistically determined, the
Run Charts with and can be tolerated to a point to maximise its reaction plan is similar to the ones used for
To control conditions that follow a specific
3 Non-Statistical effective use. The operator changes the tool at a Variable & Attribute Control Charts. The signal
'profile' during the operation of the process.
Limits predetermined dimension before the dimension isn't so much an unusual pattern but
becomes nonconforming. approaching the warning limits that trigger the
●Furnace run charts tracking thermocouple operator to stop and investigate what action to
temperature levels throughout a cycle for heat treat take. The operator may also decide to seek help
and brazing processes. Each point in the cycle from their M.E. and/or supervisior.
will have a normal 'operating window' beyond
which investigation occurs. Most likely to use an
IT system linked to the equipment.
PROCESS CONTROL METHODS
CONTROL
NO. APPLICATION EXAMPLE PCP REACTION PLAN
METHOD
To keep a capable process on target when the ●Qualification that set-up of a fuel control valve
Pre-Control Charts have "warning limits" based on
process either have a tendency to move from grinding process is done by running the process
establishing an Upper PreControl and Lower
the nominal value. The process is not sensitive and making adjustment until process is centred.
PreControl Limit that represent 50% of the
to small changes and statistical stability offers Once centred the process is monitored and only
engineering tolerance. While these limits may not
little benefit. adjusted when pre-control rules are broken.
be statistically determined, the reaction plan is
similar to the ones used for Run Charts with Non-
4 PreControl Charts Statistical Limits. The signal isn't so much an
●Monitoring of the outside diameter of an air unusual pattern but approaching the PreControl
cycle machine shaft where the operator controls limits that trigger the operator to stop and
When simple operating rules are beneficial
adjustments by use of a machine offset in investigate what action to take. The operator may
response to signals on the pre-control chart. also decide to seek help from their M.E. and/or
supervisior.

●A forging die is running for a predetermined ●The operator will be provided a signal by a
number of cycles (or number of predetermined part and/or machine cycle counter. The reaction
pieces monitored by a counter) before being is to inform 1st line supervision that the die will
removed for refurbishment/disposal. The life and need to be inspected and/or replaced per the
Processes that degrade over time where the die change is managed to coincide with batch line procedure.
Life / Useage useful life/usage is known. Limits to operation changes.
5
Control (Time or number of cycles) will be set ●Cutting tools with known wear characteristics ●Cutting tool wear may be accounted by tracking
conservatively to avoid non-conformance. are run for a specific cutting time. The life is a predetermined number of pieces using a
monitored by recording operation to a Baluff chip counter, Run Chart w/o statistical limits, control
and the life control is set up in the CNC program to chart or PreControl Chart. Once achieved, the
prevent overuse. reaction plan will be to replace the subject tool

For the monitoring of quality levels of

Variable Control Charts will send signals to the
product/process attributes where the output is ●Inspectors counting solder defects on a printed
operator in the way of unusual/non-random
based on counts (typically defects) or circuit board (PCB) use a system that monitors the
patterns displayed by the data. These are known
classification (typically defectives). average number of defects per PCB. If a special
as the Western Electric Rules. Operators using
cause is detected the soldering process owner is
Attribute Control control charts should have a laminated copy of
6 informed and investigates the cause of the issue.
Charts these rules at their workstation, stop the job if any
The charts are reviewed by the operations
Used for recognising changes in quality level management to identify opportunties for of these patterns are displayed on the control
due to special causes of variation chart, take the appropriate action to bring the
improvement and results of improvement
process back into statistical control. The operator
initiatives.
may also decide to seek help from their M.E.
and/or supervisior.
PROCESS CONTROL METHODS

NO. CONTROL APPLICATION EXAMPLE PCP REACTION PLAN

METHOD
●A forging die is periodically examnined by an
operator for evidence of damage, wear or scoring. Reaction Plan for the operator when a visual
The operator uses a checklist to record that the process check and/or set-up checklist illustrates a
Visual Process Checking a process attribute against a known check has been conducted, and the result of the issue to a known standard, and/or checklist
standard and recording it as conforming check. requirement, will be to correct, if possible, the
7 Check and
(before allowing a process to run, or during a ●An operator of a process with a lengthy setup nonconformance prior to running the job.
Checklist operation uses a checklist to confirm each step of
process run). Otherwise, the operator shall inform 1st line
an operation is completed before running the supervision and/or M.E. to aid in a
machine. The checklist may also include safety corrective action.
items.

If the first piece check inspection reveals a

●A CMM check of the first part in a batch of parts
nonconformance, the inpsector shall inform the first
off a press is performed following change of press
To validate the set-up and quality of a process line supervisor, M.E., and producing operator.
8 First Piece Check tooling. If the part meets the requirements the
prior to the full production run. Following will be an investigation of the set-up
process is controlled using other control methods
in the process. and set-up procedure used to identify the cause
of the first piece rejection.
For a test specimen that does not meet
Commonly used along with process parameter ●A piece of test material processed along with a
specifications upon the test conducted, the
control to provide validation of product quality. batch of carburized gears in a heat treatment cycle
reaction plan will instruct the test operator to
Typically a destructive examination. is tested in a laboratory.
Test Piece contact the appropriate engineer (e.g., Materials,
9
NOTE: A destructive examination processed Quality or Manufacturing Engineer) who will
●Tensile strength destructive examination of a test
evaluation with a batch of material is more inspection than investigate the process parameter inputs, furnace
speciman used in a heat exchanger vacuum braze
control; so needs to be used along with run schedule, etc. as for clues to why the test
process.
effective process input control. specimen failed to meet the test.
 PFMEA
What could go wrong?

EXAMPLES OF MISTAKE PROOFING

Could we prevent it?
Could we detect it?

1. Sensors
2. Limit switches
3. Stop gates
Mistake-Proofing covered in-
4. Defect delivery chute depth in the Process Control
5. Odd-part-out isolation Methods section of this training

6. Counters
7. Templates
8. Guides/reference point/interference pins
9. Sequence restriction
10. Critical condition indicator
11. Standardize and solve
12. Mistake-proof the mistake-proof device
Mistake proofing devices should be planned in the product and or process design
stage, rather than implementing these after a problem occurs.
The PFMEA should identify areas where Mistake Proofing (and Error
Proofing) could/must be applied.
 EVALUATION/ MEASUREMENT TECHNIQUE

• If you change or update control strategy during PCP, PFMEA must be updated accordingly
o Ex: if you didn’t have measurement technique to transfer to PCP, but you identified one during
the PCP
CONTROL METHOD DETAILS

• Determining the sample size and frequency:

– The “how many” and “how often”

• Sample Plan must be consistent with ASQR-20.1

• Depends on:
– The importance / impact level (severity) of the failure mode
– The control factors – the dominant source(s) of variation
– The capability and performance of the process
– Statistical validity of sampling plan (see ASQR-20.1)

Control Method must be consistent with PFMEA “Current

Controls”
EXAMPLE 4 – HEAT TREAT, VISUAL PROCESS CHECK & CHECKLIST
READ THE STORY FROM LEFT TO RIGHT AS IF YOU’RE THE ME AND THIS IS YOUR PLAN.
Back-up

50
Nick Zurita
Optimization Lead
Industrial Systems Engineering

Process Flow Diagram

Essentials of Discrete Manufacturing
Bottom-Line Up-Front
• The process flow diagram (PFD) is an integral part of the Advanced Product
Quality Planning (APQP) methodology.
• It requires the appropriate level of operational granularity to ensure a process
can be measurable in order to derive actionable data.
• Currently there is no standard method that ensures PFDs are appropriately
measurable.
• Consequently, data originating from our operational routers tends to provide
inconsistent levels of actionable data.
• Therefore, requiring support staff to continuously organize investigational
projects to gather actionable data.

52
Process Flow Diagram Essentials
• The process flow diagram (PFD) is a Macro-level PFD (J1739, Fig 32.)

representation of the sequential Op 5

Shipping and
Op 10
Wiper arm Route Wire
Op 20 Op 30
Wiper System
Op 40
Washer System
Op 50
Final Audit and

steps of the process which includes Receiving subassembly Harness Installation Installation Test

all operations from receipt of the

material through to storage, Micro-level PFD (J1739, Fig 33.)
packaging, and shipment (J1739- Process Flow Diagram Inspection Key Changeover Key Part # WS-2021-rev b

2021, 6.2.1, Pg. 59).

P=Product Customer Part # WprSys-2024
Operation 30 A=Automatic
T=Tooling Product:
M=Manual V=Visual Wiper System
Organization: Q=Quality Audit S=Softw are Rev Date:By
Prepared
Manufacturing Engineering Bill Haughey; Rhonda Brender;

• A PFD is divided into 2 two levels, Department: Wiper System - Quality L=Label Mike Bucala; Paul Baird, Ryan Winnicki; Ed
Operation Type
Myzienski; Mike Dow n; Carl Carlson;
Op- Process Special Lee Daw son; Mary
Operation Row zee; MaryBeth Soloy
Description Product Special

Process Function Priority

Seq Characteristics Process (Process Function) Characteristics Product

Packaging Interaction
consisting of a macro and a micro Sources of Characteristic (Do This - To This - (Outputs) Characteristic

Administration (A)

Move / Transport

Lift / Get / Store

Scrap / Contain
Variation (Inputs) With This) (Purpose of

Traceability (T)

Inspect / Verify
Transformation
Comments

Fabrication /
Operation)

Changeover
set of diagrams (see right).

Rework
30 Wiper System Installation H

30.05 Bar Code reader A/T X Get w iper linkage L 1) Correct w iper Traceability
Bin Placard linkage
2) No damage
30.07 Placement of isolators X Get and manually install L Alignment of Dimensional
isolators isolators to w placement of
indshield molding isolators w ith
respect to w iper
linkage
30.10 Torque tool setting X Orient and secure w iper H 1) Alignment of Clearance to w Speed control, rotation control,
linkage to body structure w Linkage to w indshield torque control
ith battery torque tool indshield molding
2) Torque w ithin
design
specification
30.15 Bar Code reader T X Get w iper motor L 1) Correct w iper Traceability w ill be needed
motor
2) No damage
30.20 Locating feature in X Orient and secure w iper L 1) Correct Secured w ith Speed control, rotation control,
tray design motor to body and w iper alignment of motor correct torque torque control
Battery torque tool linkage w ith battery torque to vehicle
tool 2) Torque w ithin
design
specification
1) Operation layout to 1: KCC Orient and secure w iper 1) Error proof 1: CC Speed control, rotation control,
enable connector Degree of motor ground w ire to vehicle design to prevent Connector torque control
orientation connector rotation w ith battery torque tool connector rotation orientation 2: CC
30.30 X H
2) Torque tool setup 2: KCC 2) Torque Ground w ire
2) Torque tool Tool RPM fastener torque
calibration spec

53
Macro-Level PFD Essentials
• The macro-level PFD is intended to provide an overview that outlines all
operations where value is added, normally through the integration or
modification of configuration-managed material.
• An appropriately detailed macro-level PFD is part of the continuous
improvement process and should enable line-balancing efforts and time-
variance statistical analysis.
• A macro-level PDF is not intended to highlight “hidden factory” operations, and
are therefore managed at the micro-PFD level (J1739-2021, 6.2.1, Pg. 59).
• The example below highlights current product is/should-be conditions.
Op 70 Op 80
Current assembly TPAR-ASSY- TPAR-ASSY-
Macro-level PFD detail MECH04 MECH05

Op 110 Op 120 Op 130 Op 140 Op 150 Op 160 Op 170

Compliant assembly Install Dewar Install Dewar &
Install Cooler Install Analog Install Digital
Install Cable
Install Heatsink Drive Cable Detector Detector
Macro-level PFD detail Guide Plate
Assembly Interface Interface
Retainers

54
Macro-Level PFD Essentials
• What is an operation?
• An operation occurs when an object:
– Is intentionally changed in any of its physical or chemical characteristics.
– Is assembled or disassembled from another object.
– Is arranged or prepared for another operation, transportation, inspection, or
storage
• An operation also occurs when:
– Information is given or received.
– Planning or calculating takes place.

As defined by ASME Y15.3 (Process Charts)

55
Macro-Level PFD Essentials
• The macro-level PFD operations should be granular enough to enable the
ability to monitor and control statistically independent processes.
• Manufacturing processes are said to be independent if the event occurrence of
one does not affect the probability of event occurrence of the other.
– For example, defect events associated with applying a label, do not affect the probability of defect
events associated with installing a cable subassembly.
• The example from the product below highlights the issue:

• A failure at the “operation” TPAT-TEST-UT01 requires support staff to spend

additional time delving into defect data to understand whether a particular
failure was found in one of the 2 alignments, 3 tests, 2 setup/breakdowns, 1
verification, or 2 torque operations.
56
Micro-Level PFD Essentials
• The micro-level PFD is a Process Flow Diagram
Operation 30 A=Automatic
Inspection Key Changeover Key
P=Product
T=Tooling
Part # WS-2021-rev b
Customer Part # WprSys-2024
Product:

continuation of the macro-PFD,

M=Manual V=Visual Wiper System
Organization: Q=Quality Audit S=Softw are Rev Date:By
Prepared
Manufacturing Engineering Bill Haughey; Rhonda Brender;
Department: Wiper System - Quality L=Label Mike Bucala; Paul Baird, Ryan Winnicki; Ed
Operation Type

and is intended to provide a

Myzienski; Mike Dow n; Carl Carlson;
Op- Process Special Lee Daw son; Mary
Operation Row zee; MaryBeth Soloy
Description Product Special

Process Function Priority

Seq Characteristics Process (Process Function) Characteristics Product

Packaging Interaction
Sources of Characteristic (Do This - To This - (Outputs) Characteristic

Administration (A)

Move / Transport
detailed view of all suboperations

Lift / Get / Store

Scrap / Contain
Variation (Inputs) With This) (Purpose of

Traceability (T)

Inspect / Verify
Transformation
Comments

Fabrication /
Operation)

Changeover
Rework
that comprise an operation in the 30

30.05 Bar Code reader A/T X

Wiper System Installation

Get w iper linkage

H

L 1) Correct w iper Traceability

macro-PFD, and should also

Bin Placard linkage
2) No damage
30.07 Placement of isolators X Get and manually install L Alignment of Dimensional
isolators isolators to w placement of
indshield molding isolators w ith

highlight “hidden factory”

respect to w iper
linkage
30.10 Torque tool setting X Orient and secure w iper H 1) Alignment of Clearance to w Speed control, rotation control,
linkage to body structure w Linkage to w indshield torque control

operations (J1739-2021, 6.2.1, Pg.

ith battery torque tool indshield molding
2) Torque w ithin
design
specification
30.15 Bar Code reader T X Get w iper motor L 1) Correct w iper Traceability w ill be needed

59).
motor
2) No damage
30.20 Locating feature in X Orient and secure w iper L 1) Correct Secured w ith Speed control, rotation control,
tray design motor to body and w iper alignment of motor correct torque torque control
Battery torque tool linkage w ith battery torque to vehicle

The micro-level PFD is part of the

tool 2) Torque w ithin

• 1) Operation layout to 1: KCC Orient and secure w iper

design
specification
1) Error proof 1: CC Speed control, rotation control,
enable connector Degree of motor ground w ire to vehicle design to prevent Connector torque control

continuous improvement process

orientation connector rotation w ith battery torque tool connector rotation orientation 2: CC
30.30 X H
2) Torque tool setup 2: KCC 2) Torque Ground w ire
2) Torque tool Tool RPM fastener torque
calibration spec

and should enable the identification

of sources of variation, the creation
of work instructions, and the Process
Failure Mode &
Process
Control Plan
Bill of
Resources
Work
Instructions
Time
Standards
utilization of time standards. Effect Analysis

57
Process Flow Diagram vs Value Stream Map
The PFD: The VSM:
• Has a product-limited • Has a comprehensive Product

scope value-stream scope

Requirements

Product Product Material Factory

Preservation
Design Method (PPM) Master Calendar

• Shows links between • Shows links between Design Failure

Mode & Effect
Analysis
(DFMEA)
Bill of
Material
(BOM)
Material
Requirements
Planning (MRP)
Master
Production
Schedule (MPS)

operations and information and material Process Flow

Diagram
(PFD)
Work
Instruction
Time
Standards
Capacity
Assessment
Value Stream
Map (VSM)
Continuous
Improvement
Plan

manufacturing processes flows Process Failure

Mode & Effect
Analysis
Bill of
Resources
(BOR)
Facilities
Layout
Plan For
Every Part
(PFEP)
(PFMEA)

• Selectively highlights • Comprehensively Product

Requirements
Control
Plan
Measurement
System Analysis
(MSA)
Process
Capability
Study
Statistical
Process
Control (SPC)

waste highlights waste First Article

Inspection
Total
Productive
Maintenance
(TPM)

• Neglects time • Considers time for Product Product

Preservation
Material Factory
Design Master Calendar
considerations interactions
Method (PPM)

• Is integral to tracking • Is integral to tracking Design Failure

Mode & Effect
Bill of Material Master
Material Requirements Production
product-process value-stream continuous Analysis
(DFMEA) (BOM) Planning (MRP) Schedule (MPS)

continuous improvement improvement

Process Flow Conti
Work Time Capacity Value Stream
Diagram Impro
(PFD) Instruction Standards Assessment Map (VSM) P

Process Failure Bill of Plan For

Mode
Note: & Effectrequirements in red
APQP Facilities
Resources Every Part
Analysis
(PFMEA) (BOR) Layout (PFEP) 58
59
Thank you.

60