How to Build-in Quality

Value Chain Competitiveness (VCC)

Version: 1
December 2019

This information is provided by Rolls-Royce in good faith based upon the latest information
© 2019 Rolls-Royce | Not Subject to Export available to it; no warranty or representation is given; no contractual or other binding
Control commitment is implied.
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How to Build-in Quality BACK Map NEXT

Scope Objectives & Principles

Prerequisites

Start 2. Identify and

Gate Gate 3. Error- Gate
1. Conduct control Key
Check Check Proofing / Check
PFMEA list
Process list list
Poka-Yoke
Variables

5.
Gate 6. Instruct Gate Gate 4. Compile
Measurement
Check control items Check Check the Control
list list
Systems list
and monitor Plan
Analysis

End

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Scope BACK Map NEXT

This ‘How To’ will enable you to:

• Understand the key principles behind the ‘Build-In Quality’ (BIQ) approach
• Join-up key activities to deploy a robust Quality Assurance System
• Familiarise yourself with typical ‘Build-In Quality’ tools and their use
• Focus on Prevention vs. Detection
• Design, implement and continuously improve the ‘Built-In’ Quality Assurance System

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Objective and Principles BACK Map NEXT

To ensure that process outputs meet or exceed Customer requirements

• ‘Zero Defects’
• ‘Right-First-Time’

A joined-up approach where the following are known and understood:

• Product or service related risk - Design Failure Mode & Effects Analysis (DFMEA)
• Process related risk - Failure Mode & Effects Analysis (PFMEA)
• Necessary controls for materials, equipment and process (Control Plan)
• Measurement System capability
• Effective instruction and deployment of the above (Work Instructions)

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Objectives and Principles – BIQ through BACK Map NEXT

effective process control

Process
variables
Input Checking
variables outputs only
Process

Process
X
Process
X
© 2019 Rolls-Royce
X Designing a process and checking its outputs will at best highlight
non-conformance and possibly help us to protect our customers.
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Objective and Principles – the essence BACK Map NEXT

of BIQ
X Designing a process, and checking the output of the product, will only permit rework and scrap.

Process
X variables

X Input
variables
Process
P Checking
outputs only

Designing a process that has all the controls built-in to assure quality of inputs and process variables will permit the supply of
P good product to the customer, right-first-time.
The priority in BIQ is to prevent non-conformance by error proofing. If not practical, then by detecting the causes of non-
conformance and stopping the process before a defect occurs. As a minimum, any non-conformance that may occur should
be detected early and near to the point of cause.

P
These controls must be developed at the earliest possible stage in process and product development to allow all the
equipment, tooling, fixturing and measurement devices to be specified such that they contain or effect these controls.

P Defined, understood and

controlled process variables

P Defined, understood and

controlled input variables
Process
P Results in greater process capability
and right first time

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Objective and Principles - the Need for BACK Map NEXT

BIQ
Current State Opportunity
Problem Solving Problem Prevention
Activity Activity

First In First In
Parts Service Parts Service
 Lack of a process for identifying and ✓ Build in Quality identifies the need for process
resolving potential and actual problems early control before parts are made
results in the need to develop the process ✓ Actively seeks out potential problems using
and hence product during full production PFMEA
 Effort is expended on returning to standard, ✓ Error-proofs the process
not in cost reduction or improvement
✓ Controls the process using measures
documented in a Control Plan
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Prerequisites BACK Map NEXT

Knowledge of:

• Existing or proposed manufacturing process (for current / new product)

• Key product features including control features specified by Design Engineering

• Any available DFMEA output studies to support process risk assessment (PFMEA)

• Current / other quality performance data / history

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1. Conduct PFMEA BACK Map NEXT

Gather the required information & understand risk rankings

Aerospace Industry
Required for an effective PFMEA activity:
see PFMEA standard
• Agreed scope for activity AS13004 from SAE website
• Cross-functional team (knowledge / experience as appropriate)
• Completed process map or SIPOC diagram
• Team Go-Look-See observation opportunity
• Associated Work Instructions
• Component / assembly drawings and / or other related specifications
• PFMEA template and risk ranking guidelines (1~10)

Risk rankings scored between 1 (no / least risk) and 10 (highest risk):
Failure Mode Effect SEVERITY Failure Cause OCCURRENCE Probability Control Method DETECTION Effectiveness
• Relate the criteria to downstream • Relate scores to the likelihood of the failure • Relates to the probability of either
customers, internal and external cause happening based on past experience preventing the cause from happening, or
• Relate to impact on product / service or prediction the probability of detecting the failure
quality, function, delivery / cost • ranking is related to the probability of mode before it escapes and causes the
• Effects on safety, regulatory or legal occurrence of the failure cause; lower effect.
requirements will produce high severity frequency = lower score
ranking scores
The Risk Priority Number (RPN) = Severity x Occurrence x Detection
Note. RPN is used for analysis to guide/ influence action priority
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1. Conduct PFMEA BACK Map NEXT

Identify Failure Modes, Effects and Causes Time order of events

The first step of the Process FMEA is to identify how something Cause 1
can go wrong (potential failure mode), the consequences of this Cause 2
Effect A
happening (effect) and how this could be triggered (cause)
Cause 3
The process flow of the PFMEA activity steps is counter- Failure mode 1 Effect B
intuitive, as it doesn’t follow the time order of events, i.e. cause,
failure mode then effect Process Step

Failure mode 2 Effect X

The order for the PFMEA activity is usually (unless otherwise
decided by the IPT: Cause 4
• Go-Look-See / walk the process Cause 5 Effect Y
• potential failure mode brainstorm Cause 6
• determine potential effects / impacts on the customer Cause 7
(internal / external) Effect Z

• propose potential causes of the failure mode and implement Note: The above example shows 7 different causes
countermeasures on a priority basis based on the criticality, for 2 different process failure modes having 5
different effects, all of which may have different
or Risk Priority Number (RPN) levels of impact on the process customer…
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1. Conduct PFMEA BACK Map NEXT

Identify Failure Modes, Effects and Causes PFMEA ‘Thinking-way’ order

• Map the process out and break down into elemental
steps, describing each step in the template under Effect A
“Process Details” Failure mode 1
Cause 1

Cause 2
• Take each process step as defined in the SIPOC Process Step Cause 3
diagram / detailed process map in turn, and Effect B
brainstorm all the possible ways that they could fail
to produce the desired outcome; these are the Effect X
Failure mode 2
potential Failure Modes Cause 4

Cause 5
• For each potential Failure Mode identify all of their
potential effects, i.e. the things that could happen. Cause 6
Note: there are often multiple effects from each Effect Y
Cause 7
potential failure mode
Effect Z

• Identify the events that switch the failure modes on; Note: The above example shows 7 different causes for 2
the potential causes different process failure modes having 5 different effects,
all of which may have different levels of impact on the
process customer…
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1. Conduct PFMEA BACK Map NEXT

Effect: Binding with

• Example 1a. mating component
leading to possible
seizure during operation
Cause: Component
removed from bath
Failure Mode: Coating too soon
not completely
removed from surface Bath chemical
composition incorrect

Op 650 Chemical Etch Process to Preparation prior to Preventive /

Corrosion in service immersion in bath not countermeasure
remove sacrificial coating carried out correctly / improvement
actions required
Component scrap
Component damaged Packaging providing Use RPN to
insufficient protection guide action
prioritisation
Components stored in
gangway on FLT route

Rework required Difficult to load

component in bath
Delivery to
following
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1. Conduct PFMEA BACK Map NEXT

Assess each failure mode for action

• RPN numbers are generated from ordinal
scales (1, 2, 3…10) so when we multiply them to
obtain the RPN, the result is not a true
variable scale
• An RPN of 400 may not be twice the risk of
RPN 200
• Severity 8 x Occurrence 6
x Detection 5 = RPN 240
but
Severity 4 x Occurrence 6
x Detection 10 = RPN 240
• The action taken from the first example would be different from that for the second
• Do not assume that the three failure mode indices (S, O & D) are all equally important
• Initial focus should always be on SEVERITY, followed by SEVERITY x OCCURRENCE as a general rule
• Focus on preventing the defect from being made in the first place, this puts the emphasis on minimising
the probability of occurrence rather than improving the ability to capture the defect after the event
• Remember, detection is not a solution, it is the ‘last chance saloon’…
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Gate checklist 1: Conduct PFMEA BACK Map NEXT

 The reason for completing the PFMEA is understood

 The process has been broken down into process steps

 All relevant documentation and quality / service history is available

 The scoring for Occurrence, Severity and Detection are defined and agreed

 Preventive and reactive controls have been evaluated and understood

 The initial phase of the PFMEA has been completed using ‘go-look-see’, and scores determined for
the severity, occurrence and detection rankings

 High RPN scores have been identified for action

 High scores in ‘Severity’ and ‘Severity x Occurrence’ are focal points for action

 Actions have been verified and recorded and visual controls updated

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2. Identify and control Key Process BACK Map NEXT
Variables
• Identify the input and process variables, which determine whether the outputs conform
Key Process
Variables (KPV) High output variation due
to poor control of input &
process variables

Process
Key Process Input Key Process Output
Variables (KPIV) Variables (KPOV)

Inputs Process Outputs

• Reduce the input variation by • Define the Key Process • By standardising and
Variables, parameters,
defining the required set of inspection, record and recording KPIV data the
inputs and how to operate the confirmation methods in occurrence of KPOV going
process in a standardised way Control Plans out of control should reduce,
but more importantly the
• Define required escalation for • Record the process KPV data
and react in accordance with ability to trace the problem
non conformance
escalation plans i.e. stop the back to point of cause and
• Monitor to ensure compliance process and contain then root cause will increase

© 2019 Rolls-Royce • Monitor to ensure compliance

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2. Identify and control Key Process BACK Map NEXT
Variables
• On an Ishikawa diagram, each process input variable can be categorised as:
• discrete – managed with error-proofing using Poka-Yoke
• or continuous – managed using set-points, tolerancing & SPC confirmed using experiments
(mistake-proofing may also be required)
Operator Material/Consumables Method (Process)
Concentrate Pick over
Particle ppm & size
Depth of cut
Offsets entered Temperature
Mix %
correctly? Pressure
Feed rate
Correctly located Coolant
in fixture? Nose radius Spindle Speed
Right part in right fixture? Rake angle
Cutter size
Cutting angle
Feed rate override Machining strategy
Cutting insert
Surface Finish

External vibration Correct program loaded?

Ambient temperature Coolant mist on when called for?

Correct tools in carousel?

Rigidity of the machine

Backlash in drives

Machine alignment

Guideway straightness

Environment Machine
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2. Identify and control Key Process BACK Map NEXT
Variables
Document the KPVs on the Control Plan

CONTROL PLAN
Plant: Project: Who ME Team Ldr. MEM Who Operator Cap. Owner Plant Ldr.
Process: ManEng Operations

Quality Control System

Process Control Characteristics
Inspection System Record System

Escalation
Procedure
Process Known
Key Process CCF Confirmation
Work Generic/Part Set point & Inspection Capability Responsibilit Check Work
Op. No. Name Variable reference Frequency level &
Element Specific Tolerance +/- Method (Red/Amb y (Who) Sheet # Instruct #
(KPV) (if any) Frequency
(PG/PS) er/Green)

Mill top Surface Controlled

010 Mill Speed PG 200 +/-10 Green Every part N/A N/A N/A
surface Finish in process

Mill top Surface Controlled

010 Mill Feed Rate PG 60 +0, -2 Green Every part N/A N/A N/A
surface Finish in process

• The Control Plan shows how, when and by whom each KPV is measured, and if it goes out of
tolerance, what happens (e.g. stop the process and escalate)
• In this example the KPVs are managed within the CNC program and the “Feed rate override” KPV
has been eliminated by disabling the control on the machine

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Gate checklist 2: Identify and control Key BACK Map NEXT
Process Variables
 Key variables identified

• Key Process Output Variables (KPOVs)

• Key Process Variables (KPVs)

• Key Process Input Variables (KPIVs)

 Set points and tolerances determined for each KPIV & KPV

 Variable controls documented in the Control Plan and Poka-Yoke / error-proofing methods
identified

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3. Error-Proofing / Poka-Yoke BACK Map NEXT

Different controls have different effects on human behaviour. The level the device
operates at must be determined A Guarantee has 'absolute' power; prevention is ‘built-in’
Type of device Power Level • guarding interlock / 3-pin plug / USB connector
• the process can only be followed with compliance
Guarantee Absolute
Ensures • process stops when non-compliance detected
adherence
and A Control device limits decision-making opportunities; non-

Increasing Power
compliance
Control Significant compliance options are limited
• car parking barriers
• scheduling boards (provides direction, quantity, size, so
Signal Some Suggests an the risk of non-compliance is ‘obvious’)
appropriate
behaviour A Signal device draws attention to a condition to prompt a
decision, but compliance again remains ‘optional’
Indicator None
• traffic lights / Andon lights / shadow boards
The control device capability should match the severity of • tells me what I should do
the failure mode cause being prevented
An Indicator device shows what could happen, but
An error-proofing (poka-yoke) device prevents failure compliance is voluntary
mode occurrence. Their aim is to ensure only one method
of operation – the correct one • road signs / road markings
• tells me what, where, how many…
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3. Error-Proofing / Poka-Yoke BACK Map NEXT

Basic error-proofing device examples

• Guide rods or pins
• Limit switches
• Counters
• Sequence enforcers
• Proximity sensors
• Optical/photoelectric sensors
• Symmetry/asymmetry
• Visual indicators
• Sorting devices
Determined from PFMEA, operation and
control requirements

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Gate checklist 3: Error-Proofing / Poka- BACK Map NEXT
Yoke
 Levels of Error-Proofing / Poka-yoke understood

 Opportunities for implementing error-proofing devices have been determined from the PFMEA
and process variable control requirements

 Error-Proofing / Poka-yoke devices implemented

 BIQ documents updated (eg. work instructions, control plan) and control confirmed as effective

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4. Compile the Control Plan BACK Map NEXT

BI 211 Bloggs Inc. PROCESS CONTROL PLAN

Document No. Part No.(s) Issue number Issue date Approval (stamp/sign) Aerospace Industry
XWB 442 LK 69234~8 3 12/03/4567
Document Category (circle / delete)

Pre-Prod. Prod.
Part Classification

SENSIT IVE
Billy-Bob Johnson (method owner)
see Control Plan
PROCESS
MACHINE, FIXTURE,
CHARACTERISTICS
SPECIAL /
METHODS
standard AS13004 REACTION PLAN /

from SAE website

EC/MEC TOOLS FOR MFG / KEY CHAR. EVALUATION /
PROCESS NAME / PRODUCT / PROCESS SAMPLE SAMPLE CONTROL REFERENCE
(RRES OP. NUMBER MEASUREMENT NO. PRODUCT PROCESS CLASS MEASUREMENT RESP.
OPERATION DESCRIPTION SPEC. / TOLERANCE SIZE FREQ. METHOD
90000) TECHNIQUE

Between Max / Min in glass Update daily

n/a 001 Machine checks DS&G Autolathe Oil level
window
Visual Daily Operator
check-sheet
LLP001

Start of shift / Update daily

n/a 001 Coolant check DS&G Autolathe Water / coolant mix ratio 5~8% Karl Zeiss Prism graticule
1 per 4 hrs
Operator
check-sheet
LLP001

Instructed by TI /
100% before
n/a 005 Tooling insert check Sandvic SS3 tip Cutting tool tip radius r 0.9mm Radius gauge All
use
Operator router signed when LLP006
changed

• The Control Plan captures all the key actions and controls required to
Instructed by TI /
100% before
n/a 005 Tooling insert check Sandvic SS3 tip Tip condition Free of damage / wear Visual All
use
Operator router signed when LLP001
changed
Instructed by TI /
Upon 100% before
n/a 008 Cutting tool location DS&G C-405 holder Tight to datum location Zero gap to datum location Visual / feeler gauge
installation use
Operator router signed when LLP001
changed

n/a

n/a
050

055
assure the quality of our products and services
Partial turn outside ø 60mm

Enter off-set
DS&G Autolathe

DS&G Autolathe
03

03
Location diameter

Location diameter
Calculation of cutting-tool
off-set for finish cut

KPV: 90~95% feed-rate

MAX
MCF

MCF
(measured dia. - 60) / 2

off-set calculated as above

50~75mm micrometer

50~75mm micrometer
All

All
100%

100%
Operator

Operator
SPC chart visual
at process

SPC chart visual

at process
LLP125

LLP125

KPV: 90~95% feed-rate + 0.000 SPC chart visual

EC 060 Turn outside ø 60mm DS&G Autolathe 03 Location diameter CCF / KCF 50~75mm micrometer All 100% Operator LLP125

• Important characteristics of the products, processes and services are

MAX - 0.003 at process

KPV: 90~95% feed-rate Ra <100 nm SPC chart visual

EC 060 Turn outside ø 60mm DS&G Autolathe 03 Location diameter
MAX
CCF / KCF
Rq <140 nm
Taylor Hobson Talysurf All 100% Operator
at process
LLP126

Cration of new sub-datum SPC chart visual

included in the Control Plan

EC 080
shoulder surface for Op 150
DS&G Autolathe 05 Sub-datum length 50mm +/- 0.002 Vernier depth gauge All 100% Operator
at process
LLP125
`

Remove, turn around and re-

n/a 090
insert component into chuck
DS&G Autolathe Chuck jaw condition Free from damage and swarf Visual All 100% Operator LLP001

Remove, turn around and re- Component tight to chuck

n/a 090
insert component into chuck
DS&G Autolathe
jaw as 'X' machine datum
Zero gap to datum location Visual / feeler gauge All 100% Operator LLP001

n/a

MEC
• 110

130
Confirmation of tooling and equipment status are integral to the quality
Create measurement check
length

Enter off-set
DS&G Autolathe

DS&G Autolathe
08

08
Pre finish-cut length check

Abutment length CCF / KCF

51.0mm - measured length

50mm +/- 0.002

Length micrometer All

All
100%

100%
Operator

Operator
LLP125

LLP001

MEC 150
assurance activity
Finish turn length, clearance
dia., disc width & diameter

Finish turn length, clearance

DS&G Autolathe 08 Abutment length CCF / KCF 50mm +/- 0.002 Length micrometer All 100% Operator
SPC chart visual
at process

SPC chart visual

LLP125

EC 150
dia., disc width & diameter
DS&G Autolathe 10 Disc thickness CCF / KCF 10mm +/- 0.002 0~25mm Micrometer All 100% Operator
at process
LLP125

Remove component and clean- After completing

n/a 160
down
DS&G Autolathe Chuck jaw area All swarf removed Visual
op. sequence
Operator LLP001

Remove component and clean- After completing

n/a 160
down
DS&G Autolathe Chuck jaw area Confirmed free from damage Visual
op. sequence
Operator LLP001

Remove component and clean- Every hour

n/a 160
down
DS&G Autolathe Swarf bay All swarf removed Visual
(minimum)
Operator LLP001

Issue version: 3

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4. Compile the Control Plan BACK Map NEXT

b. c. d. e. f. g.
a.

a. All product, processes and services Characteristics for control are listed
b. Specification / tolerance for each characteristic is entered
c. For each check item the evaluation / verification technique is entered
d. Confirm the verification plan e.g. for multiple machines, all components, sample as
defined. Note the sample check frequency should be defined using process capability
data
e. Define appropriate responsibility for undertaking the inspection / verification activities
f. Instruct the method by which process control is done - usually a Work Instruction or
Standard Operation that details how to undertake the check / verification / inspection
activity
g. Define the reaction plan / escalation procedures to be applied in the event of an
abnormality from the checks. Escalation for non-conformance to standard should be
clearly understood
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Gate checklist 4: Compile the Control Plan BACK Map NEXT

 Control characteristics and associated checks and tolerances have been included in the Control
Plan

 Verification actions including inspection items, specifications / tolerances, sample frequency,

responsibility, method have been defined in the Control Plan

 ‘Confirmation of checks’ process is in place

 An appropriate escalation process has been defined for non-conformance and other abnormality
management

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5. Measurement Systems Analysis BACK Map NEXT

• Measurement System Analysis (MSA) is a structured procedure used to assess the ability of a
measurement system to provide accurate data

• The measurement system should be capable of detecting variation in the process and be able to
distinguish between a conforming part and a non-conforming part

• There are potential sources of variation that may influence the measurement system, eg.
• Measurement equipment capability
• Equipment variation
• Temperature
• Operator technique
• Fixturing
• Gauge inaccuracy / wear Machine to machine
REPEATABILITY OPERATOR VARIANCE
variation
Temperature Operator

• If measurement error is not acceptable the measurement system requires either improving, or an
alternative measurement system should be used with an acceptable level of measurement error
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5. Measurement Systems Analysis BACK Map NEXT

• Gauge Repeatability and Reproducibility (R&R) is a MSA method Gauge R&R

for continuous data systems

• Repeatability assesses whether each person can measure the
Measurement Measurement
same item multiple times with the same device and get the same accuracy precision
value
• Reproducibility assesses whether different people can measure
Stability Bias Repeatability Reproducibility
the same item multiple times with the same measurement device
and get the same average value
• Steps to a Gauge R&R study Gauge Operator

• Plan the study

• Conduct the study Operator- Part-
• Interpret results operator part
• Taking action if results are unacceptable XXX
XXXX
XXX X X
X
• Maintain improvements X
X X
• A calibration process should ensure that measurement X
X
X
X
equipment has suitable resolution and range that is stable over
Precise Accurate
time but not
but not
accurate precise
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Gate checklist 5: Measurement Systems BACK Map NEXT
Analysis
 Measurement systems are capable of detecting variation in the process and are able to distinguish
between a conforming part and a non-conforming part

 Appropriate calibration process is in place to maintain measurement equipment

 There is a good understanding of Gauge R&R and its application

 Gauge R&R study is applied to improve measurement capability

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6. Instruct control items and monitor BACK Map NEXT

• Work Instructions contain work elemental steps and should cover all
process control activities as defined in the Control Plan
• Include the method for measurement, data capture (manual / electronic) and Control Plan
monitoring (eg. SPC charts)

• Work Instructions are updated to reflect any change in the Control Plan
Defined, Work Instruction
understood and
P controlled
process
Defined, understood variables Results in greater
P and controlled input
variables P process capability
and right first time
Process

• During ongoing production, all ‘Build-In Quality’ documents should be live and part of
the continuous improvement process. BIQ documents:
• Are used for future product introduction planning
• Assists root cause analysis and problem resolution
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Gate checklist 6: Instruct control items and BACK Map
monitor
 Quality assurance system effected through the Work Instructions

 Build-in quality process and documents monitored and continuously improved

 Build-in quality facilitates for effective problem solving

© 2019 Rolls-Royce