Process Flow, PFMEA, Control Plan

(How are they related ?)

These documents are inextricably linked.
The one logically follows the other (PF PFMEA PCP)
They represent the same process.
The PF document defines the process,
The PFMEA analyses the process for potential problems and,
The PCP protects the customer from the potential problems.
Process steps & step numbers must be the same on all these documents.
Process Flow
 Process Flow

Process Flow Diagram

The Process Flow Diagram shows the logical, step by step,
sequence of process operations and activities making up the
process.
It is the first step in designing a process.
It helps to initially identify where quality inspections and
controls should be placed and later, in the case of a problem, it
helps to pinpoint the Escape Point.
It helps to analyse the total process rather than individual
steps in the process.
Once the process has been finalised, each step must be
numbered. The process steps and activities must include
Goods In, Incoming, In-Process & Final Inspections, product
moves, storage, Packaging, Labelling, Despatch, Delivery
Basically, any activity where there is a potential for problems.
 Process Flow
Process Flow Diagram
4
1

Material Sample Check

2
7
Receive Material

Admin Check

5 Check 8 9 11 12
3 Store 6 Width and First off Cut Lengths 10 First off PressCut to Shape
Stretch a) Arm Pad
b) Main Panel

13 Manually move to upstairs in customer containers

24
14 Sew 17 Sew 20
16 19 23 Label for I.D.
darts in Arm 15 Arm Pad & 18 Top Stitch 21 22 and hand
Pad Main Panel
Patrol Check

Patrol Check

Patrol Check
Operator Limit Check
25

26 Store

27 Delivery Note

28 Despatch
 Process Flow

Process Flow Chart

The Process Flow Chart is a listing of process
operations and activities. It is derived directly from
the PFD (Process Flow Diagram) using exactly the
same process steps and step numbers.
It helps the team to focus on the process when
developing and/or reviewing the PFMEA and Control
Plan.
It helps to identify: multiple handling,
VA (Value Added) & NVA steps, optimum
cycle time.
 Process Flow

PROCESS FLOW CHART

Supplier: ______________________________________________________________________________________ Date:__________________________________

Part No : ______________________________________________________________________________________ Revision Number: __________________________

Part Desc: _____________________________________________________________________________________________________________________ Revision Date: ________________________________

Step Fab Insp Move Stor

Description Class Product Comments Process/Control Comments

1 Receive annealed spring steel (coils)

2 Inspect spring steel at receiving width, thickness, tensile, side curvature, Certificate of Analysis, BS1449,
surface condition, burrs Accept/Reject Card, Order
Chemistry, Hardness, Elongation GM Specification M1840
3 Move to store
4 Store Packaging, Rust
5 Move to Machine
6 Setup machine Shape with shadowgraph, length, height, 25 samples to inspector, 500 to Heat
hole position, hole size treatment
7 First off inspection shape, hole position, length, hardness, sample heat treat, dim. report,
load sign off report
8(a) Press parts: Side Crop&Hole Punch shape, hole position, length, burrs, height, Sign off each batch, First Off Inspection
rib height, flatness, load Job Record Card
8(b) Press parts: Form Ribs
8(c) Press parts: Crop & Form
9 Move to Heat treatment
10 Store in Heat Treatment Area
11 Heat treatment: Harden Hardness, oxidization, Conveyor speeds Temperature in 3 zones, atmosphere in
furnace Conveyor loading, quenching oil temperature
 Process Flow
PROCESS FLOW CHART
Supplier: ______________________________________________________________________________________ Date: __________________________________

Part No : ______________________________________________________________________________________ Revision Number: __________________________

Part Desc: _____________________________________________________________________________________________________________________ Revision Date: ________________________________

Step Fab Insp Move Stor Description Class Product Comments Process / Control Comments

12 Degrease Oil Free Automatic Timer

13 Store in Heat Treatment Area
14 Inspection by operator (Sample) Hardness Destruction test for brittleness (Snap Test)
15 Heat treatment: Temper Hardness Temp / Time graph, Decarburisation Test
16 Store in Heat Treatment Area
17 Inspection (Samples) check load & Record
18 Group parts into loading groups loading groups
19 Move from Heat Treatment Area to
polish area
20 Polish and load tuning surface finish, load, Load / Time chart
21 Spin Dry
22 Drying in heated Gritocob in Vibrator Dry / rust Time in drier
23 Move to final Inspection
24 Final Inspection Hole position, hardness, load, general Job Record Card
condition, visual shape,
25 Pack 10,000 per carton in non rust
paper
26 Move to store
27 Store
28 Despatch
 Process Flow
PROCESS FLOW CHART CHECKLIST

Customer or Internal Part Number:____________________________

Question Yes No Comments / Action Required Resp. Due

1 Does the Flow Chart illustrate the sequence
of production and Inspection stations ?

2
3 Is the Flow Chart keyed to product & process
checks in the Control Plan ?

4 Does the Flow Chart describe how the

product will move, e.g. forklift, roller conveyor,
manual ?

5 Has the Pull System/Optimisation been

considered for this process ?

6 Have the provisions been made to identify and

inspect reworked products before being used ?

7 Have potential quality problems due to handling

and outside processing been identified and
corrected ?
 Process Flow
EXERCISE 1

a) Choose a process.
This process will be the subject of our training throughout the
course.

b) Represent the process flow on a Process Flow Diagram.

c) Test your process against the Process Flow Checklist.

d) Number each Process Step.

e) Using the blank Process Flow Chart form, fill in all the Header information.

f) List each Process Step number and Description.

g) Record caution reminders and special customer requirements in the

Product / Process / Control Comments.

h) Complete the process psychometric chart.

 Process Flow
Floor Plan Layout
The Floor Plan Layout should be developed &
reviewed to determine acceptability of:
inspection points, control chart location,
applicability of visual aids, interim repair stations,
defective material storage.
Is there enough space to accommodate the above?
Material flow should be keyed to the Flow Chart and
Control Plans.
It helps to identify multiple handling, VA (Value
Added) and NVA steps, kanban opportunities,
optimum cycle time improvements, ergonomics,
material shortest travel distance.
 Process Flow
1 Goods
Floor Plan Layout
2 4
3
In
Admin 6 Material
Check Sample 5
28 Despatch Check
GI Store
7 8 10
Temp Check 9
Hold Area Width & Cut
Stretch Lengths 27 Delivery Note

26 Store
Stores
Office
11 First off

12 PressCut to Shape

13

Manually move
Quality

25
Mezzanine Floor
24 23 20 19 17 Sew 16 14 Sew
Label for I.D. and Top Stitch Arm Pad & darts in Arm
hand 21 Main Panel Pad
22 18 15
 Process Flow

FLOOR PLAN CHECKLIST

Customer or Internal Part Number:____________________________
Question Yes No Comment / Action Required Resp. Due
1 Does the Flow Plan identify all required process
and inspection points ?
2 Have demarcated areas for materials, tools and
equipment at each operation been considered ?
3 Has sufficient space been allocated for all
equipment?
4 Are process and inspection areas adequate ?
5 Are process and inspection areas adequately
lighted ?
6 Do inspection areas contain necessary equipment and files ?
7 Are there adequate
8 Impound areas ?
9 Are inspection points so located as to prevent
shipment of non conforming products ?
10 Have controls been established to prevent
contamination with non conforming items ?
11 Is material protected from overhead or air
handling systems contamination ?
12 Have final audit facilities been provided ?
13 Have incoming materials audit facilities been
provided and to isolate non conforming
material ?
 PFMEA

PFMEA
PROCESS FAILURE MODE AND EFFECTS ANALYSIS
 PFMEA
PFMEA
(PROCESS FAILURE MODE AND EFFECTS ANALYSIS)

The PROCESS FAILURE MODE AND EFFECTS ANALYSIS is

a disciplined, prevention oriented, analytical technique
that assesses the probability and effect of failure
for the purpose of reducing the risk associated with it.
It is a living document and should always reflect the latest design level &
relevant actions including those occurring after SOP (start of production) for
example actions as a result of a PRP (Problem Resolution Process).
It should be initiated:
Before or at the feasability stage.
Prior to tooling for production.
Take into account all manufacturing operations, from individual components
to assemblies.
The PFMEA follows the definition of the process (Process Flow Diagram,
Process Flow Chart, Process Flow Floor Plan).
The better the definition of the process, the better the chance to identify all
the potential failure modes.
 PFMEA
PFMEA
(PROCESS FAILURE MODE AND EFFECTS ANALYSIS)

The PROCESS FAILURE MODE AND EFFECTS ANALYSIS

Identifies the process functions and requirements.

Identifies product and process related failures.

Assesses the effects of the potential failures on the customer.

Identifies the potential manufacturing or assembly process causes and

identifies process variables on which to focus controls for occurrence
reduction or detection of the failure conditions.

Identifies process variables on which to focus process controls.

Develops a ranked list of potential failure modes thus establishing a priority

system for preventive /corrective action considerations.

Documents the results of the manufacturing or assembly process.

 PFMEA

THE FORM
POTENTIAL Page: of ________________ ________________

FAILURE MODE and EFFECTS ANALYSIS

(PROCESS FMEA)

Part/sub-assy/assy: _______________________________________________________________ Number: ___________________________________________________________________ FMEA Number: ________________________________________________

Model Year(s): ____________________________________________________________________________________________________ Key Date: ______________________________________________

Design Responsible: ____________________________________________________________________ Orig. FMEA Date: ______________________________ Rev. FMEA Date: ________________________________

Core Team: _____________________________________________________________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________________ Prepared by: _ _______________

Step / Potential Potential S Potential O Current Process D R Recommended Resp/ S O D R Actions

Descr. Failure Effects of E Causes C Controls E P Action Plans Target E C E P Taken
ModeFailure V of Failure C Prevent Detect T N Prev. Det. Date V C T N
 PFMEA

THE FORM
POTENTIAL Page: of ________________ ________________

FAILURE MODE and EFFETCS ANALYSIS

(PROCESS FMEA)
Part/sub-assy/assy: 2 Number: 2
_______________________________________________________________ FMEA Number:
___________________________________________________________________
1
________________________________________________

Model Year(s): 5
____________________________________________________________________________________________________ Key Date: ______________________________________________
6
Design Responsible: 3
____________________________________________________________________ Orig. FMEA Date: ______________________________ Rev.
7 FMEA Date: ________________________________
7
Core Team: 8 Prepared by:
_____________________________________________________________________________________________________________________________________________________________________________________________ _ _______________
4
Step / Potential Potential S Potential O Current Process D R Recommended Resp/ S O D R Actions
Descr. Failure Effects of E Causes C Controls E P Action Plans Target E C E P Taken
Mode Failure V of Failure C Prevent Detect T N Prev. Det. Date V C T N

9 10 11 12 13 14 15 16 17 18 19 20 21

Process step What controls How can we reduce

and What are What are the are in place to the RPN?
description the effects causes of the prevent the How can we improve
of the failure? cause and/or the controls?
failure? detect the
failure?

What can
What are the
go wrong? What is the How frequent is
chances that the
severity of the failure due
control will prevent
the effect? to the cause?
the cause and/or
detect the failure?
 PFMEA

HEADERS
1) FMEA Number
Allocate a number that is used to track FMEA’s.
2) Part, Sub-assembly, Assembly Number and Description
Enter the identification details of the product / process / project.
3) Process Responsibility
Name of the person / group / organisation responsible for the PFMEA.
4) Prepared by
Name of the person responsible for preparing PFMEA, Tel. No. and company name.
5) Model Year
Model year(s) and vehicle line(s) that will be affected by this part / product.
6) Key Date
The initial PFMEA due date which should not exceed the start of production date.
7) FMEA Date
Date on which the PFMEA was originally complied and the latest Revision date.
8) Core Team
Names of all members of the team. Append a separate sheet listing the names of all
the team members, Positions (relative to the Process FMEA), Departments and,
Telephone numbers.
 PFMEA
DEVELOPING the PFMEA
For a good PFMEA you must have a good Process Flow Document which clearly
shows the step by step progression of the part.
Step 1: From the Process Flow Chart, transfer Process Step numbers and Process Descriptions to
the PFMEA document.
Compartmentalize each step (draw a line across all columns).
Step 2: For each Process Step, ask WHAT CAN GO WRONG?. List all the failure modes.
Step 3: For each Failure Mode (from black line to black line), list all the effects.
Step 4: For each Effect allocate a Severity number (refer to FMEA 3 rd Edition. Severity guidance chart)
Step 5: For each Failure Mode, record the highest Severity number in the SEV column.
Step 6: For each Failure Mode, list all possible causes of failure mode.
Compartmentalize each cause (draw a line from the Possible Causes column to the right).
Step 7: For each Cause (from purple line to purple line), allocate the probability of the failure mode
occurring due to the cause (refer to the FMEA 3 rd Edition Occurrence guidance chart). Record
each OCC number in the OCC column next to each Cause.
Step 8: For each Cause, list all Controls that are intended to, Detect the Failure Mode or Prevent
the Cause (use relevant Prevent/Detect columns).
Step 9: For each Control, allocate the DET number (the probability of the control to Detect the
Failure Mode or to Prevent the Cause).
Step 10: For each cause, list the lowest DET number in the DET column.
Step 11: Calculate RPN’s. For each cause, multiply the SEV number in the column to its left, by its OCC
number, by the DET number in the DET column.
 PFMEA
PROCESS FAILURE MODE & EFFECTS ANALYSIS
Step 1: Transfer Process Step Step 2: For each Process Step,
Numbers and Descriptions from list all that can go wrong.
the Process Flow Chart.

PROCESS Process Step FAILURE EFFECTS of S CAUSES O CONTROLS D R

STEP DESCRIPTION MODES Failure E of Failure C E R
Number Mode V Mode C PREVENTIVE DETECTIVE T N

8 Milling of
Mounting Surface
Surface Flatness
out of Spec.
Clamping effect
on piston.

Chain tensioner
failure.

Engine Noise
(chain rattle).

Part thickness too

thin.

Unmachined areas on
mounting surface

9 Brush de-burring
 PFMEA
PROCESS FAILURE MODE & EFFECTS ANALYSIS
Step 3: For each Failure
Mode, list all the Effects.
Step 4: For each Effect, allocate Step 5: For each Failure Mode, record
a Severity number. the highest Severity number.
PROCESS Process Step FAILURE EFFECTS of S CAUSES O CONTROLS D R
STEP DESCRIPTION MODES Failure E of Failure C E R
Number Mode V Mode C PREVENTIVE DETECTIVE T N

8 Milling of
Mounting Surface
Surface Flatness
out of Spec.
Clamping effect
on piston.
(7)

Chain tensioner
failure.
(8) 8

Engine Noise (6)

(chain rattle).

Part thickness too

thin.

Unmachined areas on
mounting surface

9 Brush de-burring
 PFMEA
PROCESS FAILURE MODE & EFFECTS ANALYSIS
Step 6: For each Failure Mode, Step 7: For each Cause, allocate
list all possible causes. the probability of the failure mode
occurring due to the cause.

PROCESS Process Step FAILURE EFFECTS of S CAUSES O CONTROLS D R

STEP DESCRIPTION MODES Failure E of Failure C E R
Number Mode V Mode C PREVENTIVE DETECTIVE T N

8 Milling of
Mounting Surface
Surface Flatness
out of Spec.
Clamping effect
on piston.
(7) Part moves in clamp 7
during machining.

Part machined twice. 6

Chain tensioner
failure.
(8) 8
3
Incorrect machine setup.
Engine Noise (6)
(chain rattle).

Part thickness too

thin.

Unmachined areas on
mounting surface

9 Brush de-burring
 PFMEA
PROCESS FAILURE MODE & EFFECTS ANALYSIS
Step 8: For each Cause, list all Controls Step 9: For each Control, the probability
that are intended to, Detect the Failure of the control to Detect the Failure Mode
Mode or Prevent the Cause. or to Prevent the Cause).

PROCESS Process Step FAILURE EFFECTS of S CAUSES O CONTROLS D R

STEP DESCRIPTION MODES Failure E of Failure C E R
Number Mode V Mode C PREVENTIVE DETECTIVE T N

8 Milling of Surface Flatness Clamping effect (7) Part moves in clamp 7 Air pressure (5)
Mounting Surface out of Spec. on piston. during machining. sensor under part.
Constant Hydr.
Clamp pressure 5
Chain tensioner
failure.
(8) 8 sensor. (7)

SPC (8)
Engine Noise (6)
(chain rattle). Part machined twice. 6

3
Incorrect machine setup.

Part thickness too Step 10: For each cause, list

thin.
the lowest DET number in the
Unmachined areas on DET column.
mounting surface

9 Brush de-burring
 PFMEA
PROCESS FAILURE MODE & EFFECTS ANALYSIS

Step 11: For each cause,

calculate the RPN

PROCESS Process Step FAILURE EFFECTS of S CAUSES O CONTROLS D R

STEP DESCRIPTION MODES Failure E of Failure C E R
Number Mode V Mode C PREVENTIVE DETECTIVE T N

8 Milling of Surface Flatness Clamping effect (7) Part moves in clamp 7 Air pressure (5)
Mounting Surface out of Spec. on piston. during machining. sensor under part.
Constant Hydr.
Clamp pressure 5 280
Chain tensioner
failure.
(8) 8 sensor. (7)

SPC (8)
Engine Noise (6)
(chain rattle). Part machined twice. 6 Lack of material
sensor. (3)
3 144

SPC (8)
Incorrect machine setup. 3 First off
(4)
certification.
4 96
SPC (8)

Part thickness too

thin.

Unmachined areas on
mounting surface

9 Brush de-burring
 PFMEA

Materials Equipment

Metallurgy Machine

Chemistry Material Holding

Dimensions Fixture

Tooling

Customer Teamwork Continual Improvement Customer

Requirements Satisfaction

Team work Humidity Set-up

Communications Lighting Instructions

Training/knowledge Ambient Temp Measurement Systems

Operation Variation Cleanliness Preventive Maintenance

Ergonomics

People Environment Methods/Systems

Continual Improvement Loop


13) Classification
Use this column to classify any
special product characteristics such
as:- critical, key, major, significant if
additional process controls are
required.
Consider:-
Safety,
Environmental,
Legal
Fit, Form, Function, Durability,
Performance,
An appropriate note should be
placed in the Recommended
Actions column and there should be
special process controls identified
in the Process FMEA.
Potential
Effect(s)
of Failure
No n Co nfo rming pa rt
Re duce d or b lo cke d pa s s a g e 8
Le a ks whe n ho s e is a p p lie d
No n Co nfo rming pa rt
No n Co nfo rming pa rt
No n Co nfo rming pa rt
We a k (b rittle ) p a rts (8)
We a k (b rittle ) p a rts (8)
We a k mo uld ings
P a rt o ut o f to le ra nce
P a rts d is colora tio n (Ae s the tics )8
We a k mo uld ings
Ae s the tics
PFMEA
P o te ntia l
S e v Cla s s . Ca us e (s ) Occ Curre nt
Me cha nis m(s ) P roce s s
of Fa ilure Contro ls
8 Incorre ct ma chine s e tting 3 SPC
Wo rn o ut p in o r bro ke n o ff 3 Vis ua l or fe e le r pin co ntro ls
8 Worn o ut ins e rts 3 Vis ua l che ck
8 Incorre ct ma chine s e tting 3 Ma nufa cturing da ta s he e t
8 P re s s He a te r s ys te m d a ma g e d 2 Continuo us Indica to rs
8 P re s s He a te r s ys te m da ma g e d2 Continuo us Indica to rs
8 Me lt te mp e ra ture to o hig h 3 Ma nufa cturing da ta s he e t
8 High % of ma s te r b a tch 2 Ins p e ction a t Re ce iving
8 2 Ce rt of Ana lys is
8 inco rre ct mix s e tting 2 Auto ma tic mix fe e d
8 2 Vis ua l che ck
5 Ma chine s e tting s 2 Ma nufa cturing da ta s he e t
Drie r te mpe ra ture to o hig h 2 Ma nufa cturing da ta s he e t
8 2 Control p la n (ro utine ins p .)
8 Drie r s e tup / fa ilure 2 Mo is ture % che ck
8 2 Control p la n (ro utine ins p .)
8 2 Ma nufa cturing da ta s he e t
 PFMEA

SEVERITY RANKINGS
Criteria: Severity of Effect Criteria: Severity of Effect
This ranking results when a potential failure mode results in a This ranking results when a potential failure mode
final customer and/or a manufacturing/assembly plant defect. results in a final customer and/or a
The final customer should always be considered first. If both manufacturing/assembly plant defect. The final
occur, use the higher of the two severities. customer should always be considered first. If both
Effect (Customer Effect) occur, use the higher of the two severities. Ranking
(Manufacturing/Assembly Effect)
Hazardous Very high severity ranking when a potential failure mode affects Or may endanger operator (machine or assembly) 10
without warning safe vehicle operation and/or involves noncompliance with without warning.
government regulation without warning.
Hazardous Very high severity ranking when a potential failure mode affects Or may endanger operator (machine or assembly) with 9
with warning safe vehicle operation and/or involves noncompliance with warning.
government regulation with warning.
Very High Vehicle/item inoperable (loss of primary function). Or 100% of product may have to be scrapped, or 8
vehicle/item repaired in repair department with a
repair time greater than one hour.
High Vehicle/item operable but at a reduced level of performance. Or product may have to be sorted and a portion (less 7
Customer very dissatisfied. than 100%) scrapped, or vehicle/item repaired in
repair department with a repair time between a half-
hour and an hour.
Moderate Vehicle/item operable but Comfort/Convenience item(s) Or a portion (less than 100%) of the product may have 6
inoperable. Customer Dissatisfied. to be scrapped with no sorting, or a vehicle/item
repaired in repair department with a repair time less
than a half-hour.
Low Vehicle/Item operable but Comfort/Convenience item(s) operable Or 100% of product may have to be reworked, or 5
but at a reduced level of performance. vehicle/item repaired off-line but does not go to repair
department.
Very Low Fit and Finish/Squeak and Rattle item does not conform. Defect Or the product may have to be sorted, with no scrap, 4
noticed by most customers (greater than 75%). and a portion (less than 100%) reworked.
Minor Fit and Finish/Squeak and Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have 3
noticed by 50% of customers. to be reworked, with no scrap, on-line but out-of-
station.
Very Minor Fit and Finish/Squeak and Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have 2
noticed by discriminating customers (less than 25%. to be reworked with no scrap, on-line but in-station.
None No discernible effect. Or slight inconvenience to operation or operator, or no 1
effect.

(AIAG PFMEA Third Edition)

 PFMEA

OCCURRENCE RANKING
Probability Likely Failure Rates PpK Ranking
Very High: Persistent Failures > 100 per Thousand Pieces < 0.55 10
50 per Thousand Pieces > 0.55 9
High: Frequent Failures 20 per Thousand Pieces > 0.78 8
10 per Thousand Pieces > 0.86 7
Moderate: Occasional Failures 5 per Thousand Pieces > 0.94 6
2 per Thousand Pieces > 1.00 5
1 per Thousand Pieces > 1.10 4
Low: Relatively Few Failures 0.5 per Thousand Pieces > 1.20 3
0.1 per Thousand Pieces > 1.30 2
Remote: Failure is Unlikely < 0.01 per Thousand Pieces > 1.67 1
(AIAG PFMEA Third Edition)
 PFMEA

16) Current Process Controls

Current Process Controls are descriptions of the controls that either prevent the failure mode
or cause/mechanism of failure from occurring or, detect the failure mode or cause/mechanism
should the failure occur. These controls can be process controls such as error/mistake
proofing, statistical process control (SPC) or can be post process evaluation. The evaluation
may occur at the subject operation or at subsequent operations.

Consider two types of controls:

1) Prevent the cause/mechanism or failure mode from occurring, or reduce their

rate of occurrence,
2) Detect the cause/mechanism of failure or the failure mode, and lead to corrective
action.
The initial occurrence rankings will be affected by the prevention controls provided they are
integrated as part of the process intent. The initial detection rankings will depend on process
controls that either detect the cause/mechanism of failure or detect the failure mode.
 PFMEA

18) RPN (Risk Priority Number)

Risk Priority Number (RPN) = Severity X Occurrence X Detection

The RPN is a measure of the design risk. This value will be between 1 and 1,000 and is used to
rank the order of concerns, i.e. for higher RPN’s effort must be put into reducing the risk
through corrective action.

Further, regardless of the RPN value, special attention should be given when the Severity
ranking is high.
 PFMEA
DETECTION RANKINGS

Inspection
Proofed
Gauged
Manual
R ating

Detection Criteria Suggested range of detection methods

Error
Almost Absolute certainty of
10 Cannot detect or is not checked.
Impossible non-detection. X
Very Controls will
9 Control achieved with Indirect or random checks only.
Remote probably not detect. X
Controls have poor
8 Remote Control is achieved with visual inspection only.
chance of detection. X
Controls have poor
7 Very Low Control is achieved with double visual inspection only.
chance of detection. X
6 Low Controls may detect. X X Control is achieved with charting methods, such as SPC.
Control is based on variable gauging after parts have left
5 Moderate Controls may detect. the station, or go/no-go gauging performed on 100% of the
X parts after parts have left the station.
Controls have a Error detection in subsequent operations, OR gauging
Moderately
4 good chance to performed on set-up and first piece check (for set-up
High
detect. X X causes only).
Controls have a Error detection in station, OR error detection in subsequent
3 High good chance to operations by multiple layers of acceptance: Supply,
detect. X X select, install, verify. Cannot accept discrepant part.
Controls almost Error detection in-station (automatic gauging with
2 Very High
certain to detect. X automatic stop feature). Cannot pass discrepant part.
Controls certain to Discrepant parts cannot be made because item has been
1 Certain
detect. X error proofed by process/product design.
(AIAG PFMEA Third Edition)
 PFMEA

19) Recommended Actions

Firstly, special must attention must be given to Failure modes with severity ratings of 9 and 10.
Then, the team should consider the other failure modes with the intent of reducing the severity,
then occurrence, then detection.
The ratings of each of severity, occurrence and detection can be rank ordered and
corrective action should first be directed to the higher ratings, concerns and critical items. The
aim of recommended action is to reduce any or all of the Severity, occurrence and Detection
rankings.
To reduce the probability of occurrence, process and or design revisions are required.
Only a design or process revision can bring about a reduction in the severity rating.
The preferred method to accomplish a reduction in the detection rating is the use of err/mistake
proofing. Increasing the frequency of inspection is not an effective preventive/corrective action
and should only be used as a temporary measure until permanent action is installed. Changes
to the current control system maybe implemented to increase the probability.
Emphasis must be placed on preventing defects (reducing the occurrence rather than detecting
them.

20) Responsibility (for the recommended action)

The Organisation, Responsible person and Target Completion Date should be entered.
21) Actions Taken
A brief description of the action taken and effective date should be recorded.
21) Resulting RPN
After correction action, all the rankings and RPN should be recalculated.
 Process Control Plan

Pre-Launch Control Plan

A Control Plan is a written description of the systems for
controlling parts and processes.

The purpose of the Pre-Launch Control Plan is to contain

potential non conformances during or prior to initial
production runs.

Increased Inspection Frequency

PFMEA Increased in-process and final check points
Statistical evaluations
PROCESS Additional Product/process controls
DIAGRAM Increased audits
Material and performance tests
 Process Control Plan

Production Control Plan

is a written description of the systems for controlling parts and processes. It
is a living document and should be updated to reflect the addition/deletion
of controls based on experience gained by producing parts. It is a logical
extension of the pre-launch control plan.
Mass production provides the producer the opportunity to evaluate output,
review the control plan, and make appropriate changes.

Pre-launch
Control
Plan
Increased Inspection Frequency
Increased in-process and
final check points
Statistical evaluations
Additional Prod./proc. controls
Increased audits
Material and performance tests
Production
Control
Plan
Product/process
characteristics are monitored
and verified using
production gauging at specified
inspection frequency
 Process Control Plan

CONTROL PLAN
Proc. Process Machine, Characteristics Spec Methods
No. Description Device, Jig, Char Prod/Proc Evaluation Sample Control Method Reaction
Tool No. Product Process Class Specification Measurement Size Frequency Plan
& Tolerance Technique Prevent 13
12 Detect 14
1 2 3 4 5 6 7 10 11
8 9
Same as Same as Make, Product Process refer to examples examples: What to
do
Process Process Model, Dimens. Parameters drawing, Micrometer, per hour, when in
Flow Flow Capacity material specs. Caliper, per box failure
mode.
Chart Chart Year Specs. Special instr., per shift, Reference
to
Serial No gauge, start/end specific
analysis, of shift, procedures
refer to mark test, is permitted.
marked KPC, master sample,
drawing KCC,
and Instructions
Dimens. examples results record
Report 50 grams state the
5 items, document
reference
number
 Process Control Plan

1. Process Step No.

Directly from the Process Flow Chart.

2. Process Step Description

Directly from the Process Flow Chart.

3. Machine, Device, Tool, Jig

State as unique references as possible.
Consider: Make, Model, Serial No., Year Purchased, Designe Capacity,
Asset No., Production Machine No.,
General Internal Description (Sondronic Welder).

4. Characteristic No.
The characterisitic number allocated on the drawing when
marked up.
 Process Control Plan

5. Product Characteristic
What type of characteristic is it?
e.g. diameter, length, width, depth, thickness, hardness,

6. Process Characteristic
What type of characteristic is it?
e.g. Speed, temperature, pressure, current, flow rate, waiting time,

7. Special Characteristic Class

A signal to indicate if the characteristic is Special,
Significant or Key. (refer to customer requirements).
The customer specifies these and the supplier can self impose them.
Applicable to both Product or Process Characteristics.
 Process Control Plan

8. Product or Process Spec. & Tol.

Examples: Ø23.4 ±0.01
40 – 50 Kpa
400 - 500 ºC
The customer specifies these. The supplier can self impose stricter
tolerances.

9. Evaluation Measurement Technique

How do you measure the characteristic?
(instrument, method, medium, standard, chart)

10. Sample Size

The number of parts to be checked at any one time.

11. Sample Frequency

How frequent are the above samples checked?
(every hour, every shift, daily, every batch, every restart)
 Process Control Plan

12. Control Method (Preventive)

Preventive controls in place to prevent the cause/problem.
Examples:
• automatic detection of missing part – assembly will not continue
• error proofing device to ensure m/c plunger goes down to a preset level)

13. Control Method (Reactive)

Reactive controls in place to detect the defective part.
• automatic detection of out of spec part .
• height detector on conveyor belt.

14. Reaction Plan

Operator/inspector instructions on what to do when a defective part /
process is detected/discovered/suspected.