AS 13004 Practitioner Guide To Deploying

A Practitioner’s Guide to
Deploying AS13004
to Achieve Zero Defects
Process Failure Mode & Effects Analysis

and Control Plan
Includes the use of Reference PFMEAs
Dr Ian Riggs
Deploying AS13004 to Achieve Zero Defects
2
CONTENTS
CONTENTS 3
LIST OF FIGURES 4
LIST OF TABLES 5
THE AERO ENGINE SUPPLIER QUALITY GROUP (AESQ) 7
FOCUS ON DEFECT PREVENTION 9
INTRODUCTION TO FAILURE MODE & EFFECTS ANALYSIS 13
CHAPTER ONE AS13004 OVERVIEW 19
CHAPTER TWO DESIGN FMEA 25
CHAPTER THREE PROCESS FLOW DIAGRAMS (PFD) 45
CHAPTER FOUR CHARACTERISTICS MATRIX 51
CHAPTER FIVE PROCESS FMEAS 53
CHAPTER SIX CREATING REFERENCE PFMEAS 89
CHAPTER SEVEN USING REFERENCE FMEAS 99
CHAPTER EIGHT CONTROL PLANS 113
APPENDIX A: TYPICAL FAILURE MODE LIBRARY 127
APPENDIX B: SAMPLE REFERENCE PFMEAS (EXTRACTS) 129
APPENDIX C: TERMS & DEFINITIONS 134
APPENDIX D: AS13004 ASSESSMENT CHECKLIST 139
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List of Figures
Figure 1: Defect Prevention System (APQP & Process Control) 10
Figure 2: Relative Resource Requirements for early PFMEA Deployment 15
Figure 3: AS13004 Scope and Relationships 19
Figure 4: New Product Introduction Phases 25
Figure 5: Role of the Design FMEA 26
Figure 6 DFMEA Typical Inputs and Outputs 27
Figure 7: DFMEA Example 30
Figure 8: DFMEA Step 1 (extract) 32
Figure 9: DFMEA Potential Effects and Severity Scoring (extract) 34
Figure 10: RPN Calculation 38
Figure 11: DFMEA Potential Causes and Controls (extract) 39
Figure 12: DFMEA Improvement Actions (extract) 40
Figure 13 PFD Typical Inputs 45
Figure 14 Process Flow Diagram based on AS13004’s Figure C3 Example 47
Figure 15: Process Flow Diagram based on AS13004’s Figure C4 Example 48
Figure 16: Simple Characteristics Matrix example (truncated) 51
Figure 17: PFMEA Inputs and Outputs 55
Figure 18: The PFMEA and its Typical Data Source 56
Figure 19: Process FMEA example (truncated) 57
Figure 20: Team Size Effectiveness 60
Figure 21: Process Function and link to Potential Failure Modes in a PFMEA 66
Figure 22: Potential Causes of Failure in a PFMEA 72
Figure 23: RPN Scoring Example 81
Figure 24: RPN Improvement Actions in a PFMEA 83
Figure 25: Detection Scoring Analogy 86
Figure 26: PFMEA Testing the Logic (Read Left to Right) 87
Figure 27: Overview of Reference PFMEA Elements 89
Figure 28: Typical Reference FMEA Database of Required Processes 90
Figure 29: Typical Features for a Drilling Operation 91
Figure 30: Typical Failure Modes for Drilling Features 92
Figure 31: Reference PFMEA for CNC Hole Drilling: Potential Failure Mode Causes 93
Figure 32: Reference PFMEA Prevention Controls 94
Figure 33: Identifying the Typical Detection Controls in the Reference PFMEA 95
Figure 34: Reference PFMEA Database Structure Example 97
Figure 35: Creating a part specific Shell PFMEA 99
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Figure 36: Completing the Process Step and Requirements Column 100
Figure 37: Hole Pattern Example 101
Figure 38: Determining the Required Reference PFMEAs 102
Figure 39: Compiling the ‘Shell’ Part Number PFMEA using Reference PFMEAs 103
Figure 40: Shell PFMEA example 104
Figure 41: Completing the Effects and Severity Rating 105
Figure 42: Completing the Potential Causes, Prevention Controls and Occurrence Scoring sections. 106
Figure 43: Updating the Detection Controls, Detection Scoring and calculating the RPN 107
Figure 44: Documenting Improvement Actions and Rescoring RPN 108
Figure 45: Prevention & Detection Control Documentation 113
Figure 46: How the Process FMEA Prevention & Detection Controls are managed 114
Figure 47: Typical Inputs to a Production Control Plan 115
Figure 48: Standard Control Plan Template 116
Figure 49: Control Plan Structure 121
Figure 50: Example Production Control Plan for a Drilling Operation 122
Figure 51: Control Plan Data derived from Process FMEA (red text) 124
List of Tables
Table 1: Examples of Relevant Expertise for FMEA Development 21
Table 2: AS13004 Additional Application Guidance for products already in production 22
Table 3: Design FMEA Severity Scoring Criteria 33
Table 4: DFMEA Occurrence Scoring Criteria 35
Table 5: Design FMEA Detection Scoring Criteria 37
Table 6: Some Common Issues with Design FMEA Deployment 41
Table 7: Typical Operations and Symbols for creating a Process Flow Diagram 46
Table 8: Deriving Failure Modes from the Requirements Description 62
Table 9: Problems with Poor Requirements Description in a PFMEA 64
Table 10: Using the Correct Requirements Description in the PFMEA 65
Table 11: Failure Mode Examples 68
Table 12: AS13004 Process FMEA Severity Risk Scoring 71
Table 13: Relationship between Cp value and non-conforming parts
(Parts per Million PPM) outside specified limits 76
Table 14: Data Sources for Scoring Occurrence 77
Table 15: AS13004 Occurrence Rating Table for Process FMEA 78
Table 16: AS13004 Detection Rating Table 80
Table 17: Example Failure Modes 92
Table 18: Some Common Issues with Process FMEA Deployment 109
Table 19: Some Common Issues with Control Plan Deployment 125
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6
The Aero Engine Supplier Quality Group (AESQ)

The origins of the AESQ can be traced back to 2012. The Aerospace Industry was, and still
is, facing many challenges, including;
• Increasing demand for Aero Engines
• Customers expecting Zero Defects
• Increasing supplier / partner engine content
• Increasing global footprint
• A step change in Quality, Cost and Delivery performance is required
The Aero Engine manufacturers Rolls-Royce, Pratt & Whitney, GE and Snecma (now
Safran Aero Engines) began a collaboration project with the aim of improving supply
chain performance.
Recognising that they shared a significant proportion of their supply chain with one
or more other Engine Manufacturers the group set about harmonising their individual
requirements into a single set of standards. The objective was to raise the bar for quality
performance while simplifying these multitude of customer requirements.
This collaboration was formalised under the SAE G-22 Technical Committee in 2013 and the
Engine Manufacturers were joined by four major Aero Engine suppliers GKN, Honeywell,
PCC and Arconic.
AESQ Vision
To establish and maintain a common set of Quality Requirements
that enable the
Global Aero Engine Supply Chain
to be
truly competitive through lean, capable processes
and a
culture of Continuous Improvement
To date the AESQ have published six standards;

AS13000 Problem Solving Requirements for Suppliers (8D)
AS13001 Delegated Product Release Verification Training Requirements (DPRV)
AS13002 Requirements for Developing and Qualifying Alternate Inspection Frequency
Plans
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AS13003 Measurement Systems Analysis Requirements for the Aero Engine Supply Chain
AS13004 Process Failure Mode & Effects Analysis and Control Plans
AS13006 Process Control
The AESQ continue to look for further opportunities to improve quality and create
standards that will add value throughout the supply chain.
Suppliers to the Aero Engine Manufacturers can get involved through the regional
supplier forums held each year or via the AESQ website http://aesq.saeitc.org/
8
Focus on Defect Prevention

It needs no explanation that in the Aerospace industry product quality is critical. In
particular for Aero Engines the consequence of failure can be catastrophic.
On top of this the impact of poor quality is felt through additional costs and delivery
delays.
It is estimated that for many Aerospace organisations today the cost of poor quality is
20 – 25% of sales. This includes not only the cost of scrap, rework and concessions
but also those of missed delivery penalties, consequential losses due to product
reliability, etc.
A recent study has shown that 60% of all delivery problems stem from a quality issue
somewhere in the supply chain.
Getting quality right first time is the only way to maximise profit and minimise disruption,
to the customer and the supply chain.
In addition, we continue to see our customers raising the bar on quality and redefining
what they are prepared to accept.
Traditionally the Aerospace industry has relied heavily on inspection, sorting good from
bad, in order to protect the customer from non-conforming products. Unfortunately,
we know that inspection can never be 100% effective, which means that there will always
be something that gets missed.
This reliance on inspection to sort good from bad means that by the time we find a problem
it may be too late to prevent delivery delays and hence customer disruption.
I have often heard it said that if the Aerospace Industry didn’t allow concessions then we
would never build another aircraft. It’s a sad fact but is probably true, well for today at
least.
The only way to ensure that we only ship conforming parts is to avoid producing
non-conformance in the first place. Defect Prevention must be our aim.
The good news is that the quality tools required for Defect Prevention are available and
are well proven across many industries.
A simple overview of the Defect Prevention tools, and their sequence, is shown in
Figure 1.
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Figure 1: Defect Prevention System (APQP & Process Control)
Advanced Product Quality Planning (APQO) &

Production Part Approval Process (PPAP)
AS9145
Design Design Design for

Design Manufacture /
Proposal / Verification
FMEA Assembly / Service
Requirement Plan
On-going
Process Flow Process Control MSA Initial Process control
Diagram FMEA Plan Capability Deliver
AS13003 (SPC)
AS13004 AS13004 AS13004 AS13006
AS13006
If not okay
Problem Solving
AS13003
There are three key deployment factors that must be adhered to if these defect prevention
tools are to be effective, these are;
i) The Defect Prevention Tools are a ‘System’
These defect prevention tools are designed to work as a system, particularly when
developed as part of Advanced Product Quality Planning (APQP) for a new product.
They all require inputs and outputs from one or more of the other quality tools in order
to be truly effective.
Being good at only one or two of these tools will undermine the effectiveness of the
system.
All of these Defect Prevention Tools are required within the Advanced Quality Planning
(APQP) and Production Part Approval Process (PPAP) requirements defined within
AS9145 for New Product Introduction.
ii) This system of tools must be applied at a unique System / Sub-system or Part Number
level.
The devil is always in the detail. The risk profile of any product will be defined by its
application, the specification tolerances, the process capability and process controls.
These factors mean that every part number will have a unique DNA requiring a unique
solution.
In a Zero Defects approach every feature / characteristic must be included in the
scope of these defect prevention tools too.
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iii) This system of tools must be deployed using a cross functional team
Throughout the application of these tools cross-functional working is critical to ensure

that all knowledge and experience is captured and used. Studies have shown that
using a team rather than relying on an individual raise the chance of success from
59% to 99%.
When things do go wrong we need to understand why. Are there lessons to be learnt from
how the quality tools were applied to explain why we had a problem? If we can find out why
it happened then we can enhance our defect prevention system for future applications.
As you can see in Figure 1 the AESQ has prioritised those standards that align to Defect
Prevention. This is because it is widely recognised that as an industry the maturity of
deployment of these tools is not where it needs to be.
All of the tools have been around for many years and are commonly found in most
aerospace company’s management systems. However close scrutiny has found large
variances in the effectiveness of their deployment. The aim of the AS standards is to
address this concern by providing prescriptive requirements developed from industry
best practice applications.
This is a leadership issue. We must ensure that the organisation has an in depth
understanding about what Defect Prevention means and its implications for the way we
work. It means that the organisation’s leadership creates an environment that is intolerant
of non-conformance.
Training as well as time to conduct these activities must be made available to the business
to enable the effective deployment of these tools.
In many cases it will require a mind-set change across the organisation. This should not
be underestimated. There will potentially be resistance to the new way of working if the
team feel that this change is a criticism of what they have done in the past. It is vital that
the introduction of these AS standards is not just seen as a technical challenge but also
a cultural one.
An effective way to get the businesses attention on this topic is to review the current
defect prevention tools every time you have a customer escape or major disruption due
to product quality. Ask if the current Process FMEA identified the Failure Mode or if we
did a Gauge R&R on that inspection process? By asking these questions each time and
reviewing the actual documents it will become very clear if your organisation is deploying
them effectively.
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12
Introduction to Failure Mode & Effects Analysis

Failure Mode and Effects Analysis (FMEA) is the most effective of all the Defect Prevention
tools, in my opinion, for achieving zero defects.
If done correctly and with the right attention to detail it will enable the organisation to
design products and processes that meet the customer’s requirements at optimal cost.
However, it can also be the most difficult to deploy as it relies not only on technical
knowledge and experience but precision of language and the right level of detail.
If done poorly it will take a lot of resource for very little benefit and runs the risk of
organisations either not to do it at all or only at a cursory level.
The purpose of this guide is to help practitioners of FMEA to understand the key success
factors and care points in creating effective Process FMEAs (PFMEAs) and their related
Production Control Plans.
In order to ensure the process is efficient as well as effective this guide will describe the
use of Reference PFMEAs as core building blocks to create part number specific PFMEAs.
In AS13004 Appendix C it refers to ‘unit FMEAs’ or ‘Library FMEAs’. On face value they
sound as if they may be similar to what we describe in this book as a Reference PFMEA.
However, the standards definition of a Unit FMEA is a ‘re-usable Failure Mode’ and as such
is only one element of what is included within a Reference PFMEA. I would argue that
Failure Modes are finite and can be defined precisely for each type of drawing feature
and characteristic. I have included a list of typical Features and their Failure Modes in
Appendix A.
A Reference PFMEA contains a large amount of knowledge that can be captured and
re-used when creating the PFMEA. It ensures that PFMEAs are created with the most up
to date learning about the process and becomes a key reference for all things important
about the manufacturing and assembly process (see Chapter 6).
For Process FMEAs and Control Plans to be effective following rules must be adhered to;
• They must be part number specific
• The PFMEA must consider all design features and characteristics on the drawing and
related specifications.
• The PFMEA must be completed at the right time in the NPI process.
The role of the PFMEA is to challenge and inform the proposed Process Design and as
such must be done as part of the Process design activity.
The development of the PFMEA can start very early in the Product Design stages as
soon as the initial designs are being created. Conducting a PFMEA after the process
has already been established will be less effective as many of the process elements
may be difficult to change once the investment has been made.
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This is the same principle for DFMEA as related to the Product Design.
• The PFMEA and Control Plan must include all process steps from Receipt through to
Despatch, where the product is transformed (intentionally or unintentionally).
Examples of intentional product transformation are; drilling a hole, welding, cleaning,

assembly, etc.
Examples of unintentional product transformations are; Damage (including scratches,

dents, etc.), Contamination, Foreign Object Debris (FOD), unwanted material conditions
(burrs, pitting, porosity, blemishes, etc.)
• Improvement actions must be identified and implemented for High Severity and High
Occurrence risks identified within the PFMEA
• The PFMEA template must be as defined within the AS13004 standard (see Figure
19). Deviations from this standard template should be discouraged and will require
customer approval to use.
o ensure that the PFMEA and Control Plans are completed efficiently then the following
T
guidelines should be adhered to;
• Part Number PFMEAs should be created using standard Reference PFMEAs. This
enables the best practice solutions to be shared for all new PFMEAs and is the most
efficient way of avoiding a duplication of effort.
• Reference PFMEAs and Part Number PFMEAs should be created in a dedicated FMEA
software tool that can manage the complexity and volume of data created across all
part numbers. There are many standard FMEA software solutions available. Some offer
a fully integrated solution with the ability to connect the DFMEA, PFMEA, Control Plan,
MSA, Initial sample Report, etc.
These software solutions offer the opportunity to greatly reduce the time taken to
produce key documents, for example some software solutions will also automatically
create the Control Plan from the information included within the PFMEA.
• There should be a program to continually update the PFMEAs and to reduce the overall
process risks. There is no value to creating a PFMEA if it does not drive action!
The last point is vitally important. We can create the best PFMEA ever but if we take no
action as a result to improve the process then it is of no value. This is where engineering
judgement comes into play. What risks are you prepared to live with and which ones will
you mitigate or eliminate?
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Based on the current issues we have within the Aerospace Industry regarding product
quality, process yields, etc. I would expect a well-defined PFMEA to fundamentally
challenge the way we do things today. That is not to say we need large investments in
new technology but rather than we should look to ensure that the controls we use are
appropriate to the risks identified. Many of these actions will be relatively simple to
introduce.
To be frank, if there was no concession process many companies would need to change
the way they manufacture parts the way they do today. This is why this PFMEA process is
so key.
The Business must establish a cohort of engineers that are trained in FMEA and FMEA
software tools to support the process. We need to develop expertise in this and all of the
Defect Prevention tools.
How long will it take to complete an AS13004 type PFMEA?

This is one of the first questions we are often asked. From experience the early PFMEAs
created follow a similar pattern (see Figure 2).
Figure 2: Relative Resource Requirements for early PFMEA Deployment
100
90
80
Relative Man hours %
70
60
50
40
30
20
10
0
1st 2nd 3rd 4th 5th 6th 7th 8th 9th 10th
The 1st PFMEA that the team completes will be the hardest. The team will need to learn
how it is done, where to get the data from etc. It will depend on the number of unique
features that need to be considered.
Also remember that the Designer will never have been asked this level of detail before i.e.
what happens if this feature is too large? What happens if that feature is too small?
In one workshop that I was involved in to create the first PFMEA these questions took a
lot of thinking about and discussion, on average I would say 20 minutes per Failure Mode.
Once established and documented the next time they were asked it took less than 30
seconds.
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For the 2nd PFMEA, if using the same team on a similar product, with all the learning from
the 1st PFMEA now captured then if the 1st took 100 man-hours then the second is likely
to take 50 hours.
Similarly, for the 3rd PFMEA, using the same team on a product with a similar level of
complexity, if the 2nd PFMEA took 50 hours, then the third will take around 30 hours.
For the 4th PFMEA and onwards, as the team develops it skills, utilises PFMEA software,
etc. the real time of developing a PFMEA can be accurately determined. It will usually be
70 – 80% less than the first one. It is important to realise that this is a maturity curve that
the team must go through before getting to ‘normal‘ operation. There can be no ‘short
cut’.
NOTE: Process FMEAs within AS13004 describe the application of FMEAs to ensure
product conformance.
It is recognised that FMEA can be used as an improvement tool too and can be applied
in a variety of other situations. The AIAG have produced a version that describes the
application of an FMEA process for Tooling and Equipment (design and maintenance).
Other examples of FMEA application may be to solve a particular process issue such as
CMM programming, paperwork errors, storage and transportation of parts.
This guide is only concerned with the use of PFMEA to prevent product non-conformance
in line with the principles of Advanced Product Quality Planning (APQP) and as described
in AS13004.
Control Plan
This book will also describe the creation of the Control Plan from the part specific
prevention and detection control information contained within the Process FMEA (non
part specific controls may be contained in other documents such as maintenance plans
or asset care requirements).
The Control Plan is a part specific key document that defines the methods of managing
the process to ensure conforming product. It is to be used alongside the Work Instructions
by the operator and should be referred to during manufacture or assembly to ensure that
the right controls are being applied.
The Control Plan is a live document and will be subject to regular review and updates,
linked to the PFMEA.
For me the Control Plan is a simple document to create, once you have a fully completed
PFMEA. It is usual that the Control Plan is around a single page per Operation and provides
a neat summary of the process controls required to be completed by the Operator.
The complexity only comes when the business has duplicate documents to achieve the
same end. Some companies put these controls within the work instructions and manage
to hide the ten critical controls in a 50-page document making the Operator’s job even
harder.
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So, what’s the benefit?
There are a number of companies that have now implemented Process FMEAs using the
AS13004 standard approach. There are those who have followed the intent of the standard
to the letter and by using sound engineering judgment on the introduction of prevention
controls and detection controls have demonstrated the achievement of zero defects.
Some of the process changes they made were very simple such as re-defining tool life on
the CNC machine, installing bar code checking for correct tooling, fixture maintenance
improvements and using SPC.
Others have tried the approach and not seen much benefit. However, when you analyse
this it is typically because they have not applied the standard to the whole scope of the
part number (i.e. not all design features) or they have not identified the right improvement
actions from what the PFMEA had identified.
They made no changes!
As Einstein said, ‘Insanity is doing the same things over and over and expecting a different
result’.
The implementation of AS13004 Process Failure Mode & Effects Analysis must make
us challenge what we do today and identify the changes for what we are going to do
tomorrow.
NOTE: In AS13004 there are many ‘caveats’ that can be applied to reduce the required
application of the PFMEA and Control Plan to just a few features, process steps or even
to allow the use of alternative methods. This is usually done by including the reference
‘if agreed by the customer’.
In this book I am going to describe the application of this standard as part of a Zero
Defects journey and hence I will interpret the standard in a way that will deliver the most
effective results and not ‘the minimum required’.
The key precept is that these defect prevention tools are applied to all features and
characteristics associated with an individual part number. If you apply this approach to
anything less then you are accepting that ‘some non-conformance is inevitable’.
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Chapter One
AS13004 Overview
AS13004 was published in 2017 and immediately adopted by the Aero Engine Manufacturers.
Of all the standards developed by the AESQ thus far this was the one that required each
member company to change the most. None of the AESQ members were deploying the
standard exactly as described in AS13004. It was recognised however that in order to make
the step change in Quality performance demanded by the Industry a different approach
was necessary.
AS13004 is more closely aligned to the deployment approach seen in the automotive
industry with the focus very much on preventing product non-conformance.
As a result of this change of focus, and in order to gain consensus, the standard has a few
areas that need additional interpretation and guidance. That is the purpose of this book.
The standard allows many requirements to be caveated by ‘unless approved by the

customer’ or ‘if specified by the customer’. I will try to present a case for the most effective
and efficient approach to deploy this standard.
The standard actually includes three key linked Advanced Product Quality Planning
(APQP) tools, Process Flow Diagrams (PFD), Process FMEA and Control Plans. Figure 3
shows the scope and relationships of this standard with other APQP elements.
Figure 3: AS13004 Scope and Relationships
Measurement
Product Key
System
Characteristics
Analysis
Design Risk Process failure

Process Flow Work
Analysis Mode & Effects Control Plan
Diagram (PFD) Instructions
(aka DFMEA) Analysis
AS13004 Scope
Product
Process Key
Characteristics
19
Many people have pointed out that it would have been even better had AS13004 included
the Design FMEA within the standard. This is true.
Unfortunately, Design subjects are out of scope for the AESQ at this time.
That said, in this book I will include a chapter on DFMEA to show the differences and key
linkages to the PFMEA.
Cross Functional Teamwork (Section 4.1.1)
The standard puts a clear emphasis on the fact that these tools must be completed by
a cross-functional team and provides a list of those functions that are critical to the
successful application of the process. Team members should include all those areas
impacted by the results of the FMEA.
They include (but is not limited to); Manufacturing Engineers, Process Planners, Design
Engineers, Quality Engineers, Process Operators, Inspectors, Maintenance Engineers.
The team should have facilitation expertise too with knowledge of the FMEA process.
At certain phases of the completion of the PFMEA then additional expertise from
component suppliers, equipment suppliers, material experts may also be beneficial. Table
1 shows some examples of the types of representation that may be useful at the different
stages of FMEA development.
Not all will be required to attend the team meetings at the same time and this would not
be practical either. Instead some of these representatives may need to provide specific
input to questions raised by the team during the FMEA development. They may also
be involved in reviewing the output of the FMEA section to check if anything has been
left out.
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Table 1: Examples of Relevant Expertise for FMEA Development
FMEA Phase Relevant Expertise

Customer, Program Management, Service
Functions, Requirements & Expectations Operations, Product Safety, Manufacturing,
Assembly, Packaging, Logistics, Materials
Customer, Program Management, Design,

Product Safety, Manufacturing, Assembly,
Potential Failure Modes
Quality, Packaging, Logistics, Materials,
Service Operations

Effects and Consequences of Failure
Quality, Packaging, Logistics, Materials,
Service Operations
Customer, Manufacturing, Assembly, Quality,

Causes of Potential Failure Modes Packaging, Logistics, Materials,
Maintenance, Equipment Manufacturer

Frequency of Occurrence of Potential Failure Packaging, Logistics, Materials,
Manufacturing, Assembly, Quality,

Application of Current Controls-Prevention Packaging, Logistics, Materials,

Application of Current Controls-Detection
Packaging, Logistics, Materials, Maintenance

Recommended Actions Quality, Maintenance, Equipment
Manufacturer, Packaging, Logistics,
Materials, Service Operations
Applicability of AS13004 (Section 4.2)
AS13004 defines the applicability of this standard to primarily New Product Introduction.
Process Flow Diagrams (PFDs), Process FMEA and Control Plans are a key requirement
within AS9145 Advanced Product Quality Planning (APQP) and Production Part Approval
Process (PPAP).
When directed by the customer, this standard needs to be applied in the following
circumstances to part numbers in current production;
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Table 2: AS13004 Additional Application Guidance for products already in production
Event Clarification
Event Clari�cation
Discovery of an unknown failure mode following an in-

Changes resulting from root
service issue, product quality escape, major quality issue
cause investigation
or manufacturing issue
A change in material, method and/or measurement

Process changes
technique that can potentially affect form, �t or function
Design record modi�cation including the addition of new

Design Changes
Key Characteristics
This standard is not applied to manufacture of standard
Standard parts / commercial- parts and/or commercial-of-the-shelf items unless
off-the-shelf requested by the customer
-
Once invoked the FMEA must be maintained for the whole lifecycle of the product
(Section 4.2.3).
For many products in Aerospace the lifecycle may be 20 – 30 years. It will be critical
therefore to ensure that the language and descriptions used within the document will be
understood by those who will read it in 10, 20 or even 30 years’ time. We should avoid any
form of ‘technical shorthand’.
The requirements of AS13004 should be flowed down by the organisation to any supplier
that manufacturers and/or supplies products and services (Section 4.2.4).
In order to comply with this element, the organisation will need to have a documented
process for flowing down this requirement to their suppliers, and beyond in some cases.
Over time they will be expected to have evidence that this has been done.
Training & Competency (Section 4.3)
These resources must be suitably trained in the PFMEA and Control Plan approach.
In particular the engineering resources, after all this is an engineering discipline. The
organisation should also consider having trained FMEA facilitators who can help the team
to run the FMEA sessions.
Effective FMEA sessions are a difficult thing to achieve. They need to be ‘creative’ while
managing the technical content, team dynamics, energy levels, etc. as well as making
sure that the FMEA is process is adhered to. Having a facilitator manage this while the
Technical resources focus on their input will be key.
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We must not forget that the organisation’s leadership need to understand the Defect
Prevention system approach, and FMEA in particular. They will need support the allocation
of resources (people and time) to make the activity successful. Providing leadership
training and coaching should be considered as a necessary activity to successfully
introduce this standard.
There are many sources of training and consultancy in FMEA available on the open market
mainly as a result of the past 30 years of the automotive industry demanding PFMEAs
from its suppliers.
However, care should be taken in selecting these providers. Ensure that the provider has
tailored their training to meet the intent of this standard and not simply a generic FMEA
course. There are some key points of emphasis with AS13004 that are not necessarily
evident in a more general approach. A list of recognised training providers is available on
the AESQ website.
Also, be aware that although the AS13004 writing team aligned their approach to the
AIAG FMEA Guidebook Forth Edition the automotive industry is evolving their approach
to FMEA and may have a different set of requirements to those of AS13004 in future years.
You must ensure that the FMEA course you select meets the requirements of AS13004.
The training syllabus must include the use of PFD, PFMEA and Control Plans but should
also include the links to DFMEA too. Some available courses also include the use of
Reference PFMEAs.
The organisation must document the minimum training and competency requirements for
conducting PFDs, PFMEAs and Control Plans and ensure that only those team members
that meet these criteria are involved in their deployment.
Organisational Quality System Requirements (Section 4.4)
AS13004 requires organisations to have a defined process within its documented

management system that shows how the business will comply with the requirements of
this standard.
If an alternative approach to that described in AS13004 is to be used it must first be

approved by the customer(s) impacted.
It is expected that this documented process will be included within the scope of the 3rd
Party Certification (ISO9001 or AS9100) audit, as well as the organisation’s internal audit
program, to provide assurance as to its level of compliance and effectiveness.
The standard requires the organisation to fully implement this standard and ensure that it
assessed periodically. An Assessment Checklist to assess compliance is included with the
standard and the AESQ website (see Appendix D).
23
General Requirements (Section 4.5)
As with all of the APQP Defect Prevention tools they must be deployed at a specific part
number level if they are to be truly effective. This maybe a big change for some companies
who use generic or family of parts approaches today.
However, in an industry where we live with the consequences of poor product and
process design for 20 to 30 years or even longer there is a clear business case to apply
these processes with the right level of rigour at the design and development phase. The
customer may provide a documented waiver for this requirement in certain circumstances.
The PFD, PFMEA and Control Plans need to be kept up to date and should be revised at
regular periods with the findings from quality investigations, quality performance data,
product and processes changes, lessons learnt from similar products and processes, etc.
The tools, and the PFMEA in particular, is our knowledge management hub. It represents
everything we know about how to make the product and the controls required to avoid
non-conformance. Once developed it is the most important document we have for
managing quality and quality risks.
When AS13004 talks about Design Risk Analysis, it is referring to Design FMEA or similar
(see Chapter 2). As we will see there is a clear link between the DFMEA and PFMEA when
evaluating the Potential Effects and Severity of the identified Failure Modes. However,
this link is not necessarily as explicit as some may expect.
The PFD, PFMEA and Control Plan should be clearly linked to provide an easy read across
from one to another. One example of how to do this is to have a common Operation
Numbering and Sequencing Reference and Feature Numbering System that will enable
clear read across.
24
Chapter Two
Design FMEA
Although Design FMEA is not included within the scope of AS13004 it has a key role in
the development of the PFMEA and so it is included here to provide insight into their
relationship. AS13004 does refer to Design Risk Analysis in the document and DFMEA
is one example of what can constitute this type analysis. NOTE a Failure Mode Effects &
Criticality Analysis (FMECA) does not address the same scope as a DFMEA and therefore
cannot be considered equivalent (AS9145, Section 4.4.4.1).
The purpose of the DFMEA is very different to that of a PFMEA. Although the FMEA
template is similar and the process steps are the same, it has a completely different
currency.
The DFMEA process should start as soon as possible in the Product Design phase. Figure 4
illustrates the key product and process development phases for New Product Introduction.
As you can see the product Design and Process Design phases begin simultaneously
between the Concept Phase and the program Approval Phase. Both the DFMEA and
PFMEA will begin their development at this stage.
During these phases the DFMEA will be iterative and be refined as new information becomes
available or where the DFMEA identifies design risks that result in design changes.
Figure 4: New Product Introduction Phases
Program
Concept Prototype Pilot Launch
Launch
Planning
Product Design &

Development
Process Design & Development
Product & Process Validation
Ongoing
Production
Feedback Assessment, Corrective Action & Improvement
Product & Feedback Assessment,

Plan & Define Product Design & Process Design
Process Corrective Action &
Program Development & Development
Validation Improvement
25
The DFMEA addresses how a design may fail to achieve the customers specified
requirements, usually expressed as product functions.
Event Clarification
Figure 5: Role of the Design FMEA
Drawings &
Customer
Specifications
(1) Customer Defines
Functional Requirements
(2) Design Engineering Create a Product

Design to meet the Customer’s
Design
iterations
(3) Process FMEA

Feedback to Evaluates how the Design Process may fail to
Customer Produce a Product Design that meets the Functional
Input
Requirements of the Customer
Outputs from the DFMEA are the Design Verification
Plan, Key Characteristics List and Design PFMEA
Improvement plans
Output
Key Characteristics List
Consequence of Product
Failure information
The Design FMEA evaluates the proposed design to identify and mitigate the ways in
which the design may fail to meet the Functional Requirements of the customer (see
Figure 5).
For example, the customer may specify that an engine must have a fuel efficiency of X.
The Design FMEA will evaluate how the design may fail to achieve this requirement. The
Failure Mode in this case would be ‘Fuel efficiency specification not met’.
For a component such as a pipe the customer requirement may be to ‘transfer water at 50
litres per second at a pressure of 50 bar’. In this example one of the Design Failure Modes
would be ‘unable to transfer 50 litres of water per second’.
The DFMEA will then proceed to look for ways in which the Design could fail to meet these
requirements i.e. the Potential Causes. For the pipe example this may include ‘specified
pipe inner diameter too small’.
When completing a DFMEA the team must assume that the part will be made correctly.
Manufacturing failures to meet specification must not be listed as Potential Causes of
Failure Modes.
26
The DFMEA will then identify the prevention and detection controls within the design
process to mitigate the potential for this design failure e.g. computer-modelling, prototype
testing, etc. This will form the basis of the Design Verification program.
The DFMEA will produce a list of key risks (Risk Priority Numbers or RPNs) that the team
will need to address during the design phase i.e. eliminating the risk or mitigating it.
Another output from the Design FMEA will be the key design characteristics that have
been identified and will have an impact on Safety and/or performance of the product to
the customer. Information from the DFMEA can also be used to inform the Process FMEA
of the effects and severity of specific product Failure Modes.
Figure 6: DFMEA Typical Inputs and Outputs
Typical Inputs Typical Outputs

Boundary Diagram, Parameter
Diagrams, etc
Regulations
Interface Diagrams
Schematics
Design
DFMEA Verification
Bill of Materials (BOM)
Plan
Appearance
Service Requirements
DFMEA with risk
reduction action plans
Design for Assembly
Product and Process
KCs
Quality & Reliability History
The DFMEA will identify the Prevention and Detection Controls required to ensure that
the design process is managed effectively. These are captured in the Design Verification
Plan in a similar way to the Control Plan for manufacturing.
It should be noted however that simply reviewing the DFMEA when compiling the Process
FMEA would not be straightforward.
27
The currency used in the DFMEA is very different to that of the PFMEA. The DFMEA
looks at functions whereas the PFMEA will focus on features / characteristics. It will
not be possible to correlate the features on the drawing with a corresponding feature on
the DFMEA.
The DFMEA is a good input for the Design Engineer to bring to the PFMEA session but the
team will need the Engineer’s knowledge to interpret the DFMEA for use with the PFMEA.
Where no Design FMEA is available then the Designer will need to support the Process
FMEA by identifying the Potential Effects of each Failure Mode and quantifying their
Severity from their own knowledge of the product.
The DESIGN FMEA Approach
The purpose of the DFMEA is to reduce the risk of design failures by;
• Providing an objective evaluation of the design and design alternatives
• Evaluating the initial design for manufacturing, assembly, in service and recycling
requirements
• Increasing the probability that Potential Failure Modes and Effects have been
considered in the design and development process
• Developing a prioritised list of Potential Failure Modes, based on the Effects on the
customer’s product
• Providing a knowledge base for future reference
The DFMEA is a living document and should;
• Be initiated before design concept finalisation
• Be updated as design changes occur or additional information is available
• Be fundamentally completed before the production design is released
• Be a source of lessons learnt for future design iterations.
The DFMEA must be developed by a cross-functional team and is typically led by a

responsible Design Engineer. The cross-functional team should include the following
areas, but not limited to, Assembly, Manufacturing, Design, Analysis / Test, Reliability,
Materials, Quality, Service, Suppliers as well as the design area responsible for the next
higher or lower assembly or system, sub-system or component.
28
Considering Manufacturing, Assembly and Serviceability in the DFMEA Development

Process
The DFMEA should include consideration of Potential Failure Modes and Causes that can
occur during the manufacturing or assembly process, only when they are the result of
the design.
These Failure Modes may be mitigated by design changes e.g. a design feature that
prevents a part being fitted in the wrong orientation i.e. error proofed.
If the design does not mitigate such Potential Failure Modes then they must be addressed
in the PFMEA.
The DFMEA should also include the consideration of the servicing of the product as well
as its recyclability.
Preparing for the DFMEA
The DFMEA process begins with collecting the information required to understand
the system, subsystem and component being analysed and the required functional
requirements and characteristics.
To determine the required scope the team should consider;
• What does the product need to interface with?
• What inputs are there from other products or sub system that are required for the
product to meet its own functional design?
• Do the product’s functions include the prevention or detection of a possible Failure

Mode in a linked component or system?
To identify the required functions of a product using a Parameter (P) Diagram or similar
e.g. Functional Block Diagrams.
29
Figure 7: DFMEA Example

Figure 7: DFMEA Example
P a g e | 30 of 152
30
Completing the DFMEA Template
The header fields are quite straightforward. Remember that the DFMEA will be around for
many years and so a traceable history should be prepared. The names of those responsible
for the latest revisions will need to be kept along with every iteration. Not all of this will be
able to be kept on the front sheet so consider developing a separate revision document.
a) Item / Function
This describes the physical items, interfaces or parts under evaluation typically taken
from the P Diagram, or similar.
The function should be described based on the customer’s requirements and the team’s
discussion. If the item or interface has more than one function with different modes of
failure it is recommended that they be listed separately.
b) Requirement
This provides the opportunity to further describe the requirements of each function listed
in the previous column. If the function has more than one requirement then these should
be listed separately.
c) Potential Failure Mode(s)

The Potential Failure Mode is defined as the way in which a component, subsystem or
system could potentially fail to deliver the intended function (as described in the Function
column).
Each function may have several Failure Modes however a large number of Failure Modes
for a function may indicate that the requirement is not well defined. In such cases consider
redefining the Function into a more detailed description.
If there are Failure Modes that will occur only under certain conditions e.g. Humidity, high
vibration, temperature, Foreign Object Debris (FOD), bird strikes, etc. then these will also
need to be included in the evaluation.
Once identified the list of Potential Failure Modes can be evaluated for completeness by
analysing failures from similar products.
31
Figure 8: DFMEA Step 1 (extract)
Potential Failure
Item Function Requirements
Mode
Too much fuel

transferred
1 litre per second @ 50

Fuel Pipe Transfer Fuel
bar pressure
Too little fuel

transferred
d) Potential Effect(s) of Failure
Potential Effects of Failure are defined as the Effects of the Failure Mode on the function,
as perceived by the customer(s).
The customer(s) in this case should include internal customer as well as the end user.
Failures that affect safety or regulations must be clearly identified.
The Effect of Failure may include a description of the effect at different levels of the
component, subsystem or system level e.g. for an Aero Engine, a crack in a turbine blade
could lead to a blade release which may cause damage to the engine turbine subsystem
and lead to whole engine performance degradation.
e) Severity Score
The Effects identified can be ranked using Severity Scoring criteria (see Table 3). The
team should reach consensus on the right score to use for each effect identified. The most
severe (highest) score will be the one used when calculating the Risk Priority Number
(RPN) later in the DFMEA process.
Failure Modes with a severity score of 1 should not be analysed further.
32
Table 3: Design FMEA Severity Scoring Criteria
Ranking Level Criteria
Sudden product failure, safety related. Non-compliance

10 Hazardous
with government regulation.
Potentially hazardous. Able to close down product

9 Serious without mishap. Compliance to government regulations
in jeopardy.
8 Extreme User very dissatis�ed. Product inoperable but safe.
User dissatis�ed. Overall product performance severely

7 Major affected but still operable and safe. Product function
impaired.
User experience discomfort. Overall product performance

6 Signi�cant
is impaired but is operable and safe.
User experiences some dissatisfaction. Moderate effect

5 Moderate
on overall product performance.
User experiences minor annoyance. Minor effect on

4 Minor
overall product performance.
User slightly annoyed. Slight effect on overall product

3 Slight
performance.
2 Very slight Very slight effect on overall product performance.
1 No Effect No effect.
f) Classification
This column may be used to identify high priority Failure Modes and their associated
causes e.g. Safety, Performance or Regulatory impacts. Typically, they are the Key
Characteristics of the Design.
33
Figure 9: DFMEA Potential Effects and Severity Scoring (extract)
Potential Potential
Class.
Sev
Item Function Requirements Failure Effects of
Mode Failure
Poor engine
5
ef�ciency
SFC target
7
Too much missed
fuel Engine over

transferred temperature
leading to
8
potential in
1 litre per
Fuel �ight
Transfer Fuel second @ 50
Pipe shutdown
bar pressure
Lower
7
Thrust
Too little
fuel
transferred Potential for
in �ight 8
shutdown
g) Potential Cause(s) of Failure Mode
These are the Potential Causes associated with how the design could allow the Failure
Mode to occur, described in terms of something that can be controlled.
When identifying Potential Causes care should be taken to use detailed concise statements
e.g. the specified material plating allows for hydrogen embrittlement. Ambiguous phrases
such as ‘poor design’ must not be used.
Typically, there should be several Potential Failure Causes listed per Failure Mode.
34
When preparing the DFMEA the team should assume that the design would be
manufactured and assembled to the design intent. Exceptions can only be made where
the historical data indicates deficiencies in the manufacturing process exist.
h) Occurrence Score
The Occurrence score is a relative ranking, which tries to evaluate the likelihood of the
Failure Mode being caused by the Potential Cause identified in the DFMEA (See Table 4).
The Occurrence number in the DFMEA may not reflect the actual likelihood of occurrence.
The scoring criteria use the maturity of the design as a way of determining its likelihood
of causing the Failure Mode. New designs are therefore scored as a higher risk than
proven, well tested ones.
Table 4: DFMEA Occurrence Scoring Criteria
Dif�cult to Innovative new technology combined with unpredictable

10
predict deployment conditions.
9 Very High New development without any previous experience.
8 High New design employing new technologies with some experience
Moderately New design including technologies with a previously problematic

7
High history, now believed to be mastered.
Technology is new or partly new to us, but there is experience of

6 Moderate
successful comparable usage in the industry.
Design based on earlier successful development, but with little or

5 Low
no market experience.
4 Very Low Design uses proven elements under novel conditions.
3 Remote Design uses well-proven elements but with alterations to detail.
Very Proven design with a long history of use & production without
2
Remote any known failure reports.
Technology is well tried and tested in use & production without
1 Almost nil
any failures.
35
i) Current Design Controls – Prevention
Prevention Design Controls are used to prevent the Potential Cause of Failure from
occurring, or at least to reduce the likelihood.
They include such things as;
• Error proofing
• Design and material standards (internal and external)
• Computer Simulation
It is always preferred to prevent the failure rather than rely on detection. The initial
occurrence rankings will be affected by the identified prevention controls as there will be
no ‘in service data’ to use.
j) Current Design Controls – Detection
Detection Design Controls can be used to detect the existence of the Cause or the
Failure Mode either by analytical means or physical means, before the item is released for
production.
They include such activities as;
• Design reviews
• Pre-production / prototype testing
• Validation testing
• Mock up using similar parts
k) Detection Score
Detection is the rank associated with the best detection control for a particular Failure
Mode and Cause. Where there is more than one Detection Control it is recommended to
include all of them within the FMEA and use the lowest score.
By listing out all of the Detection Controls in place it may help to identify duplicate or
redundant detection activities that can be removed.
When scoring it should be assumed that the Failure Mode has occurred and then assess
the detection control for its capability to detect it.
The Detection Ranking Criteria is shown in Table 5.
36
Table 5: Design FMEA Detection Scoring Criteria
10 Almost impossible No known method available or no check made.
9 Remote Only unproven or unreliable methods available
Durable tests on existing products with design elements

8 Very slight
installed.
Tests on existing products with designelements

7 Slight
installed.
6 Low Tests on similar design elements.
5 Medium Tests on pre-production design elements.
4 Moderately High Tests on early prototype design elements.
3 High Simulation techniques available at early design stage.
2 Very High Proven simulation available at early concept stage.
Proven detection methods available at early concept

1 Almost certain
stage.
l) Risk Priority Number (RPN)
The next stage of the Design FMEA is to calculate the Risk Priority Number (RPN) for each
Failure Mode and Potential Cause.
The calculation is quite simple.
Severity x Occurrence x Detection = RPN
The Severity Score we use is the highest ranked number for the Failure Mode, i.e. the
worst that could happen.
The Occurrence Score for each Potential Failure Mode is used i.e. there will be an RPN
score for every Potential Cause identified for a particular Failure Mode.
The Detection Score is the best (lowest) score identified for the Failure Mode and its
associated Potential Cause (see Figure 10).
37
Figure 10: RPN Calculation
Occurrence
Detection
Severity
Failure
Mode
Potential
Effects
Potential
Causes
Prevention
Controls
Detection
Controls RPN
4 5 5 200
6 8 5
8 2 128
3 3 5
3 72
The Every Occurrence The An

Highest Score Lowest RPN
Severity Detection Score
Score Score For every
Potential
Cause
Once the RPNs for each Failure Mode and Potential Cause have been calculated they can
be ranked in order of RPN Score (Pareto principle).
Being able to see the Risk Profile of the complete process is useful for us to be able to
identify those process steps with the highest risk however such as a simple analysis is not
enough to prioritise the actions that need to be taken.
38
Figure 11: DFMEA Potential Causes and Controls (extract)
Occurrence
Detection
Potential Potential
Class.
Potential Prevention Detection
RPN
Sev
Requirements Effects of Causes of
Failure Mode Controls Controls
Failure Failure
Speci�ed Design
Poor engine
5 diameter Standard 3 None 10 240
ef�ciency
oversize FSX012.B
SFC target
Too much 7
missed
fuel Fuel
transferred pump
Engine over Design Engine
pressure
temperature Standard 2 Simulation 1 16
speci�ed
leading to FP35.L Test
8
is too
potential in high
1 litre per �ight
second @ shutdown
50 bar
pressure
Speci�ed
Design
pipe
Lower Thrust 7 Standard None 10 240
diameter
FSX012.B
too small
Too little fuel

transferred
Fuel
Potential for pump Design Engine
in �ight 8 pressure Standard Simulation 1 16
shutdown speci�ed FP35.L Test
too low
m) Improvement Actions
For all of the rigour of a Design FMEA, if done well, if we do not then react to the risk
profile then it is of no value.
The key focus must be on those risks that scored high for severity, regardless of the other
scores. What further action do we need to take to reduce the RPN of these items through,
ideally, improving the prevention of the Failure Mode, or if not, improving the Detection
of the Failure Mode.
Remember the only way to reduce the Severity score is usually to redesign the product
or to remove the functionality.
39
Next, we should focus on reducing the Occurrence Ranking. This can be achieved through
the removal or control of one or more of the Causes of the Failure Mode e.g. error proof
the design. Revised drawing tolerances, add redundancy, etc.
Detection is a last resort but there are things we can do to reduce risk. The preferred
method is through mistake proofing although increased design validation and testing may
also reduce the Detection score.
Some companies use an RPN threshold value to select which RPNs they are going to
improve. This can be dangerous as teams soon learn how to get a score that falls below
the threshold value (it is not an exact science after all).
Remember the continual reduction of the overall risk should be our aim – this is an on-
going process that never stops.
Improvement actions should be documented in the DFMEA and once implemented and
verified the RPN can be recalculated to measure the effect of the improvement action.
Figure 12: DFMEA Improvement Actions (extract)
Occurrence
Occurrence
Detection
Detection
Severity
Potential Resp. &
Prevention Detection Recommended Action
RPN
RPN
Causes of Target
Controls Controls Action taken
Failure Date
Implement
simulation
testing at Actions
Speci�ed Design S.
early design in
diameter Standard 3 None 10 240 Seward 8 3 2 46
stage. place
oversize FSX012.B 3.7.18
Validate at 3.7.18
prototype
engine stage
Fuel
pump
Design Engine
pressure
Standard 2 Simulation 1 16
speci�ed
FP35.L Test
is too
high
Implement
simulation
Speci�ed testing at Actions
Design S.
pipe earlydesign in
Standard None 10 240 Seward 8 3 2 46
diameter stage. place
FSX012.B 3.7.18
too small Validate at 3.7.18
prototype
engine stage
Fuel
pump Design Engine
pressure Standard Simulation 1 16
speci�ed FP35.L test
too low
40
Table 6: Some Common Issues with Design FMEA Deployment
DFMEAs are only done for key systems, sub-systems and components.
If we consider that the application of Defect Prevention tools must be applied as a ‘system’ to each
and every part number then it is only logical that the DFMEA must also be done for all systems,
sub-systems and components.
This risk analysis helps to ensure that the appropriate risk mitigations are implemented for the
design process (Design Veri�cation Plan) and will help to inform the risk pro�le within the Process
FMEA later.
Manufacturing Engineering expect DFMEAs to have feature by feature commentary on Effect

of Failure and Severity Scores as an input to the PFMEA.
The Design FMEA is looking at the risk of the design not meeting the functional requirements
needed, as de�ned by the customer and other stakeholders.
As its currency is ‘Functions’ not ‘Features’ it is unlikely that many feature speci�c elements will be
listed within the DFMEA and therefore the analysis required for the Process FMEA needs to be
done by a Design Engineer, armed with the knowledge of the DFMEA, to interpret this document
to answer the questions raised by the PFMEA.
The DFMEA team does not include the supplier where the part is to be made.
We discussed the importance of having the right cross - functional team assembled to develop the
DFMEA and this must include the person(s) responsible for the manufacturing or assembly
processes. If this is being done by an external supplier it is vital that they are included within the
team so that their input can be gathered and used to inform the design team of potential risks.
The same will be true for Design for Manufacture and Assembly activities.
The DFMEA is completed after the Design has already been �nalised.
One common issue experienced is that the DFMEA is completed after the design has already been
�nalised.
This means that the DFMEA is only capturing what has already been designed. That is not the
purpose of the DFMEA.
The DFMEA is a tool to help re�ne and enhance the design of the part and therefore must be
started, as the design is �rst being considered and iterated as the design develops.
The same is true for Process FMEAs.
The Detection Control refers to obtaining Manufacturing or in-service data.
The Detection Controls must rely on testing during the Design Phase. If we wait for data to become
available once in production it will be far too late to validate the design and may lead to expensive
re-work or investment to address design weaknesses.
41
Further Reading:
“Potential Failure Mode and Effects Analysis (FMEA), 4th Edition, AIAG, 2008
DFMEA Key Questions:
1. Has the DFMEA been conducted by a cross functional team, including Design,
Manufacturing Engineering, Service, Quality and Supplier (as applicable)?
2. Has the Cross Functional Team been trained in FMEA?
3. Has the DFMEA been started at the correct time in the program?
4. Are the DFMEA inputs complete and have they been used to scope the DFMEA
e.g. Functional Diagrams, Voice of the customer, Production / Assembly capability,
Measurement capability, Service history, quality history, etc.
5. Has the DFMEA been completed using the correct template?
6. Do the Design Failure Modes describe how the design could fail to meet the functional
requirements?
7. Are multiple Potential Effects identified for each Failure Mode? Have the Severity
Scores been assigned in line with the scoring criteria?
8. Are there multiple Potential Causes identified for each Failure Mode? Do they describe
how the design process could cause / allow a Failure Mode to occur?
9. Has the Scoring criteria for the Occurrence of the Design Potential Causes been
done using the approved scoring criteria based on Product Maturity? Has it been
applied consistently?
10. Have Prevention Controls been identified to eliminate / reduce the likelihood of the
Potential Cause from occurring? How effective are they?
11. Have Detection Controls been identified to detect the presence of the Failure Mode
and/or Potential Cause? How effective are they?
12. Has the Detection Scoring been carried out using the correct criteria? Has it been
13. Have Improvement Actions been identified based on the following priority (i) High
Severity scores (ii) High severity and high occurrence combinations, or (iii) High
RPNs.
14. Has the Design Verification Plan been developed using the DFMEA Controls identified?
42
Design Verification Plan
The output of the DFMEA is used to inform the Design Verification Plan (DVP). It is an
iterative process that requires the team to ensure that the identified prevention and
detection controls listed within the DFMEA are documented.
The DVP is similar to the Production Control Plan discussed later. It is a summary of
all of the required Verification activities to evaluate that the design meets the design
requirements. It will include such things as;
• Simulation studies
• Prototype testing
• Design reviews
• Validation testing
Special Product & Process Characteristics
Special Product and Process Characteristics can be identified by the Customer or the
business responsible for the design and manufacture based upon the knowledge of the
product and process.
The purpose of identifying these special characteristics is to ensure that they are
highlighted for special attention through the APQP and Process Control phases of design,
manufacture and service.
Typically, they are identified through the use of DFMEA, PFMEA and historical knowledge
of other similar parts and processes.
Some customers may require these characteristics to be designated using a specific

symbol on the drawings and associated documentation.
43
44
Chapter Three
Process Flow Diagrams (PFD)
The Process Flow Diagram (PFD) is a representation of the process steps required to make
or assemble a product, in sequential order, from receipt through to shipment.
When developing a PFD there are a number of inputs that maybe useful, these are shown
in Figure 13.
Figure 13: PFD Typical Inputs
Typical Inputs
DFMEA
Design Records
Bill of Materials
Product & Process KCs

Process Flow Process
Tooling & Equipment
Diagram (PFD) FMEA
Handling Equipment &
Packaging
Subcontracted Process Steps
PFD from Similar Products
Quality History from Similar

Products
The PFD needs to be sufficiently detailed to describe the key activities required to make
and assemble the product including part movement and storage.
The PFD does not need to include the processes for purchased materials, components
and assemblies. Instead the supplier of those materials, components and assemblies would
be expected to define their own Process Flow Diagrams in line with AS13004, after all this
standard must be flowed down through the supply chain.
Typical operations to be included in a PFD are shown in Table 7.
45
Table 7: Typical Operations and Symbols for creating a Process Flow Diagram
Typical Symbols Operation Description
 Administration
 Packaging Interaction
 Lift (mechanical / other)
 Load / Install
 Fabrication / Transformation
 Move
Δ Store
☐ Inspect
Rework
Other (Specify)
There are many systems in use today that allow organisations to document the Process
Flow. AS13004 provides two examples to illustrate what the PFD could look like. One such
example is shown in Figure 14 (included in AS13004 Appendix C as Figure C3).
46
Figure 14: Process Flow Diagram based on AS13004’s Figure C3 Example
Packaging Interaction
Transformation
Administration
Classi�cation
Fabrication /
Load / Install
rework
Inspect
Other
Move
Store
Operation Product Process Control
Lift
Operation Step
Description KC KC Methods
      Δ ☐
Scan bar
100 CNC Select
Drill - Set
Up
1  correct NC
programme
code on
batch
card
Laser
100 CNC
Load tools tool
Drill - Set 2 
into CNC checker
Up
on CNC
100 CNC
Load billet Bar code
Drill - Load 3 
material check
material
100 CNC Fuel port
CMM at
Drill - Drill 4  Drill holes KC inner
OP250
holes diam.
100 CNC Visually

Visual
Drill - Drill 5 ☐ inspect hole
standard
inspection condition
150 CNC
Visual
Drill - 1  Deburr
standard
Deburr
The Process Flow Diagram in Figure 14 shows a level of detail for illustration purposes.
In practice the business may need to add additional detail such as specifying the hole
specifications, addition activities, etc. This needs to be defined by the business and what
it finds to be of value.
Figure 15 shows the second example of a PFD template included within AS13004 for the
same operation and steps as Figure 14.
It is a simple text-based format but includes the same types of data as for Figure 14’s
example.
The notes along-side this template in the standard indicate that the columns for Inputs,
Outputs and Controls are not mandated by the standard but are considered good practice.
In other words, to satisfy the intent of the standard the PFD only needs to contain the
sequence of Operations and a description of the steps within that Operation.
This makes sense to some degree as the Characteristics Matrix will include the sequence
of inspection operations aligned to where the feature was created and the Control Plan
will provide details of the inspection requirements.
47
Figure 15: Process

Figure Flow
15: Process Diagram
Flow based
Diagram basedon
onAS13004’s FigureC4
AS13004’s Figure C4 Example
Example
P a g e | 48 of 152
48
The PFD is a key input when developing a Process FMEA. The FMEA will follow the same
sequence as defined in the PFD.
The PFMEA shall include all operations listed in the PFD. Details of the steps within each
operation shall be used in the PFMEA based on risk (Section 4.7.4). For example, in the
process steps for OP 100 listed in Figure 14 not all of these details would be transferred
to the PFMEA in the Operation, Step and Requirements columns.
The PFMEA focuses on those steps where the product can be transformed, intentionally
or unintentionally. Therefore, in this example we would not include the details for;
Step 1 – Administration – load Machine Tool Program
Step 2 – Load tools
Step 3 – Load material
Step 5 – Drilled hole inspection
That is not to say that these steps are not considered elsewhere within the PFMEA, they are.
Typically, they would feature as Potential Causes of Failure not as Process Requirements
or Failure Modes.
For example, if we take ‘load CNC program’ as a step the logical Failure Mode would
be ‘load wrong CNC program’. What would the effect be? It’s hard to say. If it was just a
version control issue then maybe it would just have some alternative features whereas if
it was the totally wrong program then the machine may crash and damage the machine
and the loaded part.
Therefore ‘load incorrect program’ is really a Potential Cause of a Failure Mode of ‘severe
damage’. Similarly, ‘load incorrect tools’ can be linked as a Potential Cause for ‘hole
oversize or undersize’, ‘load incorrect material’ is a Potential Cause for ‘part made from
incorrect material’.
Inspection processes will be listed in the PFMEA Detection Controls column for ‘Drill Hole’
and does not need to be considered as a process step in its own right.
This is true for all inspection operations. The only reason to include an Inspection
operation, as a step in the PFMEA would be to consider the possibility of unintentionally
transforming the part e.g. damage, FOD, etc.
49
This is a key care point as there have been occasions where Manufacturing Engineers
have interpreted section 4.7.4 of the standard, which states “Details of steps within each
operation shall be considered and included [in the PFMEA] based on potential risk” as an
opportunity to pick and choose what can be left out of the PFMEA.
The explanation above shows that all steps that transform the product (intentionally or
unintentionally) must be included. There will be some, based on risk, that can be omitted
on that basis e.g. Load tooling, documentation checks, etc.
The evaluation of the inspection process capability is done through AS13003 Measurement
Systems Analysis (MSA).
Further Reading:
“AS13004 Process FMEA and Control Plan for Aerospace”, AESQ, 2017
“Potential Failure Mode and Effects Analysis (FMEA), 4th Edition, AIAG, 2008
PFD Key Questions:
1. Where available, have all identified inputs to the PFD been included?
2. Does the PFD include detail of all operations in sequential order from receipt of
materials through storage and shipment of finished product?
3. Does the PFD provide a clear and complete description of the process required to
receive, make, inspect, test, protect, store and ship conforming product?
4. Does the content of PFD align to the requirements of AS13004?, if not, has this been
agreed with the customer?
50
Chapter Four
Characteristics Matrix
AS13004 does not provide any details on what a Characteristic Matrix is although it does
list it as one of the inputs for a PFMEA. In my opinion this is one of the most important
inputs to developing a PFMEA.
A Characteristics Matrix is a simple but important document. It shows the relationship

between the operations and the features (including specification details) created at that
operation. In addition, it also shows where that 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 (directed heat source), etc.
It allows the Planning Engineer to ensure that all features are included in the process and to
assess the potential for minimising inspection operations, problems with transformations,
etc.
In AS13004 the PFMEA should include all operations and all features. The Characteristics
Matrix is the only document that includes this detail and the sequence in which the
features are created.
Some companies may not include all specification requirements in the Characteristics
matrix such as material properties, damage, surface finish properties, etc. In such cases
the team will also need to refer to the relevant specifications and standards. Figure 16
shows an example of a simple Characteristics Matrix.
Figure 16: Simple Characteristics Matrix example (truncated)
Feature Details  Operations Sequence 
Feature OP100 OP150 OP200 OP250 etc.

Description Speci�cation
Number Drill Deburr Clean CMM 
Fuel Port
10.50 mm +/-
1 Inner X A I
0.1 mm
Diameter 1
Fuel Port 1450 (x), 761

2 X
Location (y), 600 (z)
Oil Port Inner 18.50 mm +/ -

3 X A I
Diameter 1 0.3 mm
Oil Port 1150 (x), 200

4 X
Location (y), 45 (z)
etc. 
Key: X = Feature Created, A = Feature Affected, I = Inspected
51
52
Chapter Five
Process FMEAs
Process FMEA in a Nutshell
The Process FMEA will evaluate every feature and specification required defined by
the product design and ask the question ‘What are the potential ways I could make this
wrong?” [Potential Failure Modes]
The team will then use the FMEA methodology to understand the potential impact on the
customer and the business if the product was made wrong [Potential Effects & Severity
Score].
For each Potential Failure Mode, the team will determine the adverse process conditions
that would need to occur to create it [Potential Cause(s)].
With this knowledge the team can then identify ways to prevent the adverse process
conditions from occurring [Prevention Controls]. The Team will then work out how likely
the Failure Mode and the Potential Causes are likely to Occur (Occurrence Score].
In addition, the Team will identify ways to detect the Failure Mode and/or the Potential
Cause if they were to occur in Production [Detection Controls].
The Team can then calculate the Risk Profile Number for each Failure Mode and associated
Potential Cause [Risk Priority Number (RPN].
The team must use their judgement to determine whether the controls in place are
sufficient or whether further improvement actions are required.
It’s that simple!
Cross Functional Team Approach
As previously discussed the Process FMEA is a highly detailed assessment and needs
to be conducted by a cross functional team including Manufacturing Engineering,
Process Planners, Process Operators, Quality Engineers, Design, Inspectors, Supplier(s)
(if appropriate), Maintenance, as a minimum.
The team must have the right experience and knowledge of the product and process to
add value to the PFMEA.
Not all Functions will need to be present for all FMEA sessions. The FMEA Facilitator
should ensure that the right people are present for each session. There is nothing worse
than sitting in an FMEA session with nothing to contribute to the discussion.
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PFMEA Scope
For a Process FMEA to be effective it must evaluate ALL the features / characteristics on
the design drawing and related specifications and consider every process step (where
the product is transformed or has the potential to be transformed including inadvertently
such as ‘damage due to storage & handling’ (Section 4.7.7.2).
A Process FMEA is required for every individual part number (Section 4.5.1).
Section 4.7.7.5 appears to provide a caveat to the requirement for all features to be
included in the PFMEA. It states, ‘If specified by the Customer, all product features and
potential failure modes shall be documented within the PFMEA to ensure that each are
evaluated’.
The wording suggests that you only need to consider all features if the Customer requires
it. However, it provides no details on how to select a sub set of features either.
I have seen some approaches suggested to select these ‘important features’ but none are
convincing if we really want to prevent all non-conformance.
One proposal to reduce the time taken to complete a PFMEA is to select only those
features or process steps where it is believed that are important to the Design, i.e. Design
KCs.
In all my years of having to evaluate reasons for customer escapes I cannot remember any
that were for Design KCs. This method of identifying important features would also limit it
to only 1 – 3% of all the features on the drawing. This significantly reduced scope would
not provide me with much confidence that we had completed an effective risk assessment.
In addition, remember that what Design sees as important from the DFMEA they are
looking at the product through a very different lens to that in Manufacturing & Assembly.
Their focus is usually on Safety and Performance issues.
We know that Manufacturing & Assembly can take, what Design would judge to be, a very
benign feature, and under certain circumstances make it a very disruptive quality issue.
There are numerous examples where this ‘pre-selection’ of what is important has failed to
consider something that has gone on to have a significant impact to the customer.
The PFMEA is a tool that can evaluate all process steps and product features in order
to identify where the risks in the process are. Therefore, if we do not consider all design
features and process steps then the risk assessment will always be compromised.
54
This may appear to be a daunting task, particularly for those organisations that are new
to PFMEA. However, through the use of computer software and a structure of ‘Reference
FMEAs’ the time taken to create a Process FMEA can be greatly reduced and still remain
effective. This approach is described in Chapter’s Six and Seven.
Don’t fall into the trap of spending valuable time selection where to start first and select
key features or process steps on a priority basis.
Once established the PFMEA process will be best deployed by starting and the first
operation and working your way through to the last one. I have seen teams spend more
time on this prioritisation process than actually doing the PFMEA.
Inputs for a PFMEA
AS13004 identifies a number of inputs required to create a PFMEA and a number of

outputs from the PFMEA. These are shown in Figure 17.
Figure 17: PFMEA Inputs and Outputs
PFD
Identification of all steps

within each operations
Non conformance data from

similar products / processes
Control
PFMEA
DFMEA
Plan
PFMEA for similar products
Products KCs PFMEA with action

plans
Process KCs Product and Process

KCs
Control Plan from similar

processes
I would also add one more input, Reference PFMEAs. We shall discuss this later in
Chapter 6.
To show how some of these sources are used to create the content of a PFMEA Figure 18
shows a relationship between the data needed in the PFMEA and its source.
55
Figure 18: The PFMEA and its Typical Data Source
Designer armed with Quality Metrics

Process Flow
A DFMEA (Cpk, Scrap, Rework, Escapes, etc)
Classification
Occurrence
Detection
Severtiy
Process Failure Potential Prevention Detection
RPN
Requirements Effect
Step Modes Causes Controls Controls
Process Flow
Characteristics Drawings & Reference
Matrix Engineering PFMEA
Specifications (or team knowledge)
The following notes are intended as a guide of what to look for to ensure that the Process
FMEA has been conducted effectively.
Although the example we use here is a CNC machining one the principles can be applied
to any process including Processing, Assembly, Casting, Coating, Welding, Surface
Preparation, Raw Materials, etc. There are some examples of these applications in
Appendix B.
Figure 19 shows a part completed Process FMEA for a machining operation that is required
to drill four holes to a specified diameter. AS13004 requires organisations to use this
template, or one with equivalent content. Any deviation to the use of this template shall
be approved by the customer (Section 4.7.6.1).
Similarly, the Ranking criteria for Severity, Occurrence and Detection documented in the
standard should be used although alternative criteria may be acceptable if approved by
the customer (Section 4.7.6.2).
It is vital that the descriptions included within the PFMEA are detailed enough to be
understood by engineers who were not directly involved in the creation of the document.
These documents will be in use for many years, maybe up to 30 years or more, and it is
vital that future teams can read and understand the intent of what has been captured in
the PFMEA.
The precision of the use of language in a PFMEA is paramount.
How to complete a Process FMEA using the AS13004 PFMEA template:
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Figure 19: Process FMEA example (truncated)

Figure 19: Process FMEA example (truncated)
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a) Part Number & Description

The requirement is to include the full Part Number and a brief description of the part. The
description should include the Model / Engine Name, e.g. Engine X and a brief name of
the part e.g. Fan, Compressor Blade, etc.
The Process FMEA should be specific to an individual part number or assembly. Rarely
will it be appropriate for a single Process FMEA to cover more than one part number /
assembly.
The two main reasons often cited for the use of non-part specific PFMEAs are;
Generic Processes
It is often thought that processes such as Heat Treatment or Cleaning are exempt from the
specific Part Number approach of a PFMEA.
On the face of it, this is how it may appear; however, there are always examples where
impact of the Failure Mode created by the process is unique.
An example may be two similar looking parts, Part A and Part B, with the same function,
made out of the same material, with a requirement to be hardened by using a Heat
Treatment process.
One Failure Mode is that the material is insufficiently Hardened (too soft). The causes of
the Failure Mode are the same, as are the Prevention Controls and Detection Controls. So,
would the PFMEA be the same? No.
The trouble is that this misses out the fact that Part A, if too soft, may only cause minor
performance issues for the end product.
However, Part B, although similar, is part of a differently designed system and is operated
in a different way. If Part B remains soft then it may lead to a high severity event. If we
know this then we may decide that we need additional Prevention and Detection Controls
when processing Part B because of this analysis.
If we only did a Generic PFMEA on the Heat Treatment process we would have missed
this difference. Unfortunately, I am aware of many, many instances where this type of
approach has missed vital differences such as this.
Therefore, it is recommended that these processes are considered in the same way as a
machining process and unique to each part number that goes through it.
Just as with other processes such as machining, the consequences of a process failure are
likely to be specific to the part number specific application.
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Part Families
It is often proposed that many parts can be grouped together in a ‘part family’ and be
considered as a single entity for Process FMEA analysis.
The risk profile of a PFMEA is based on 3 things;
a) The consequence of failure derived from the purpose of the feature [Potential Effects
& Severity]
b) The likelihood of Occurrence derived from the specification (tolerance) and the
relevant process capability [Occurrence Score], and
c) The Detection Method derived from the measurement strategy or use of error proofing
[Detection Score]
If the features on the different parts within the family have the same risk profile then it
will need to demonstrate that it has the same features, with the same purpose, identical
specifications, and identical detection methods. Very few parts with a different part
number will share all of these attributes; if they did why create a separate part number?
There are some examples of where this approach can be used though. Some parts will
have variants that may require 80% of the features to be identical with some other features
modified, removed or added.
For example, a Cylinder Head used on a V8 5V engine is also used on a high-powered

derivative. In the derivative the cylinder bores are honed to a tighter specification but all
other features remain the same. This is an example where the Family of Parts approach
can be taken and the additional PFMEA analysis needs only to be completed for the
modified cylinder bores.
b) Core Team
The requirement is to list the core team members and their positions that were responsible
for the original document.
We should remember that this document will be regularly updated for the life of the part
and therefore the team members will change over time.
It is important that the team is comprised of the right resources to be able to identify
and assess potential product Failure Modes and Potential Process Causes. As a minimum
it would be expected to include Manufacturing Engineering, Design Engineering,
Operations, Quality and Maintenance.
59
It may also be appropriate for a Customer and/or a relevant Supplier representative to be

involved at certain stages of compilation or review to capture their insights.
Not all members of the team need to be present for all stages of creating the FMEA as
their input may be limited to specific aspects e.g. The Design Engineer has input into the
effect and severity of the identified Product Failure Modes but may not have knowledge
of the process to add any real value.
When compiling PFMEAs it is always best to keep the team relatively small and manageable,
with those resources applicable to the phase being discussed.
Too many team members will only serve to slow the process down and will have little
added value.
Figure 20: Team Size Effectiveness
100
90
80
Effectiveness %s
70
60
50
40
30
20
10
0
0 1 2 3 4 5 6 7 8 9 10
Team Size
Once completed, the Part Specific PFMEA can be circulated to a wider group for additional
input and sanity checking.
c) Original date / Revision date

The Process FMEA will be a live document and as such revision control is vital to provide
a traceable history of updates etc.
Revisions to a Process FMEA will be expected if any of the following occur;

• Product definition changes
• Process changes (including inspection processes)
• Updates from 8D investigations / Continuous Improvement actions
• Quality Performance data that may influence the RPN scores
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d) Operation / Step
The Process FMEA must include all process steps where the product is transformed even
where the transformation may be inadvertent, such as during handling and storage.
The Process FMEA must include all steps from the first operation through to dispatch.
Care must be taken not to fall into the trap of only completing the PFMEA on processes
that are seen to be ‘important’.
The Process Steps should be defined on a Process Flow Diagram that shows the sequence
of operations and the purpose (required outcomes) of each operation. A Characteristics
Matrix should be developed to show where the features are created, transformed and
inspected at each operation.
Some common mistakes observed are;
• Transactional processes are included e.g. complete batch card, load CNC program.
These in themselves are not relevant to the Process FMEA although they may appear
as a Potential Cause of a failure if a link can be made.
• Similarly, processes such as ‘Load Tools into CNC’ similarly do not belong in a PFMEA
as a process step. There can be no product Failure Modes created at this process
step, as it is not used to ‘transform the product’.
If the loading of tools has any impact on product quality then this will be recorded as a
‘Potential Cause’ of a defined ‘Failure Mode’, for example ‘oversize hole diameter [Failure
Mode] due to tool damage [Potential Cause]’ in the PFMEA in a later process step.
• Measurement processes are included as a process step in their own right and identified
as the cause of dimensional non-conformance.
For example, CMM Measurement of dimensional features [Requirement] can have a Failure
Mode of incorrect measurements [Failure Mode] due to Poor calibration [Potential Cause
1] or incorrect CMM programming rules used [Potential Cause 2].
In the context of PFMEA the CMM does not create non-conformance, the manufacturing
process does. The Measurement Process will be validated using Measurement Systems
Analysis (MSA) separately to prove its capability.
If we use the definition of only evaluating process steps that ‘transform the product,
intentionally or inadvertently’ then at the Measurement Operation Step the only aspect
we should be evaluating it the potential for Damage, Contamination, FOD, or similar due
to part handling and/or storage.
The Measurement method is considered at each process step as part of ‘Detection Method’.
NOTE: The PFMEA Case Study in the Appendix of AS13004 (Fig C5 – Case Study PFMEA) is
not a great example of how to word the Operation Step or Function Description.
61
On the first line of the PFMEA it states ‘Set up drill’ in both the Operation and Function
Description columns. However, the Requirements column describes the hole diameter
that the drill is required to produce.
The Failure Mode then describes how the diameter can be made wrong (too big, too
small).
In other words, the PFMEA is not describing the set-up of the drill at all but actually the
drilling operation.
On the fifth line of the PFMEA when the Process Function does state ‘Drill hole’ it is clear
from the Requirements column that it is only talking about the hole depth feature.
Once over these initial steps the logical flow carries on as we would expect to see it.
e) Process Function / Requirement
For each Operation the function (purpose) and the required outcome (Requirement)
should be defined clearly, accurately and concisely.
The Potential Failure Mode (next column) should be able to be derived straight from the
Function / Requirement description. Some examples are shown in Table 8.
Table 8: Deriving Failure Modes from the Requirements Description
Requirement Failure Mode
Hole too big

Drill hole 10mm +/- 1 mm
Hole too small
Grind Surface with a Max Surface

Surface too rough
Finish of 3 RA
Weld bead with porosity to meet

Porosity exceeds spec xyz
spec xyz
Seal �tted in wrong orientation

Fit seal in correct orientation
Seal not �tted
Fit seal without any damage to

surface Seal surface damaged
62
At this step it is important to identify all of the requirements that help to define a feature
as conforming or non-conforming.
For example, many features will have a general specification associated to it that is not
necessarily apparent on first glance.
A drilled hole feature will have geometric tolerances but also may be subject to an
Engineering Specification that specifies ‘no white layer’ or similar. All requirements
whether on the drawing or written in a related specification must be included.
In the AS13004 standard there are some conflicting requirements regarding the scope
of what needs to be included in this column. Section 4.7.7.2 states that ‘all product and
process characteristics, including KCs shall be documented in the PFMEA’ while Section
4.7.7.5 states ‘If specified by the customer, all product features and potential failure modes
shall be documented in the PFMEA’.
This implies that unless the customer specifies the requirement for all features the supplier
is able to set their own threshold although no guidance is given for how this is to be done.
The PFMEA is a tool for assessing the level of risk associated with manufacturing /
assembling a product. If features / requirements are excluded from this analysis then the
output of the PFMEA will be compromised.
Any defect will cause additional costs, delays and performance issues and therefore if we
are to apply PFMEA to avoid such defects then it must consider all features to begin with.
Simple Mistakes
If we are to identify the right Failures Modes (product related) it is critical that the
Requirements are defined accurately. However, it is a common mistake to see the team
identify the wrong requirements from the input documentation such as the Process Flow
Diagram.
Consider the case for cleaning operations using a chemical etch process. The process flow
diagram provides the details of the steps of the process as described in the Requirements
column in Table 9.
With this description it is easy for the team to fall into the trap of deriving the Failure Mode
from this poor Requirements description. As you can see the Failure Mode describes
process non-compliance, and not the product condition.
63
Table 9: Problems with Poor Requirements Description in a PFMEA
Class.
Potential
Sev
Requirements Potential Effects of Failure Potential Causes of Failure
Failure Mode
Removes metal from part and

In bath for too Timer faulty.
makes non-conforming. Scrap 7
long Operator distracted
part
Put part in acid Contamination & grease

bath for 45 In bath for too Timer faulty.
remains on part. Needs 5
seconds short a time Operator distracted
rework.
Depends on the acid type.

Wrong Acid 7 Operator error.
Maybe scrapped or reworked.
In bath for too Timer faulty.

Nothing 2
long Operator distracted
Place Part in
water bath for 3
minutes
In bath for too Acid residue remains on part. Timer faulty.
5
short a time Rework required. Operator distracted
Because we now have process non-compliance in the Failure Mode column our analysis
goes off track and we exacerbate this error by now describing the effect and severity of
the process non-conformance rather than that of the product. This analysis will tend to be
inward looking as it does not include the impact on the system or the customer.
By the time we get to identify the potential causes of this process error, we will be
focussing on a very limited number of options and these are not connected to the Part
non-conformance.
Using this logic, the PFMEA also loses its ability to be connected to the Design FMEA
through the Failure Mode description in the PFMEA.
What should we have done?
The purpose of this cleaning operation is to remove grease and dirt prior to the E Beam
welding operation. Any contamination left on the part may lead to weld porosity, which
in turn could lead to a weld failure. If the weld was to fail then it could cause an engine
shutdown during operation (high severity issue).
With this description the PFMEA will turn out very differently. As you can see in Table 10
the Requirements column did not need all of the individual detail from the Process Flow
Diagram. The Failure Mode Column talks about how the product would not conform to
requirements, not the process faults.
This in turn has led to a better Potential Effects description and one that includes the
impact on the customer. The Design Engineer has derived this from the DFMEA.
64
Also, the Potential Causes now cover a wider range of issues linked to the process that
could cause the part to still be contaminated after the cleaning process.
It is this ‘richness’ of process Potential Causes that we are seeking to identify and then
mitigate using the PFMEA process.
Table 10: Using the Correct Requirements Description in the PFMEA
Class.
Potential Potential Effects of
Sev
Requirements Potential Causes of Failure
Failure Mode Failure
Potential for Porosity

at the next Acid strength too low
Operation (E Beam
Welding)
9
This could lead to a
weld failure and an
in�ight shutdown Acid bath contaminated
without warning.
Clean Part
(remove grease
and surface Part not clean Y Insuf�cient cleaning time
contamination)
Can be reworked a
maximum of 3 times
4 Water bath (rinse tank) contaminated
if found during
production
Environmental contamination in
cleaning area / storage
Part pro�le not to Acid strength too high

speci�cation leading
Do not remove to loss of
Base material
any base aerodynamic �ow 7
removed
material resulting in lower
than required
ef�ciency Acid Cleaning cycle too long
Dealing with Manufacturing Tolerances

Some businesses use the practice of stage drawings or manufacturing drawings that
include specifications that differ from the Design Drawing. This may be because the
manufacturing process needs to work to tighter tolerances because of later tolerance
stack up issues or uncontrolled transformations that occur later in the process.
The PFMEA must include Manufacturing Tolerances that are used to manufacture of the
part. Ideally these Manufacturing Tolerances will be identified in some way within the
PFMEA to make it clear that it is a Stage Drawing or Manufacturing tolerance requirement
and not a design one (e.g. a designated symbol in the characteristics column or other
means).
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Manufacturing tolerances can also refer to processes required for a successful

manufacturing step. For example, a cleaning operation may be included prior to welding
to ensure there is no contamination that could cause porosity.
Although this may not be specified in the drawing or specifications there is an internal
requirement to ensure the part is clean prior to welding. Therefore, at the cleaning
operation it is allowable to include ‘clean part’ as a process requirement (the cleaning
process may also be referenced as a potential cause of ‘porosity defects’ when evaluating
the welding process).
Figure 21: Process Function and link to Potential Failure Modes in a PFMEA
Potential
Operation Step Function Requirements
Failure Mode
Drill hole
Too Big
CNC Machining 10 0 mm
10 1
Drill diameter
+/- 0.1 mm
Too Small
In this example we can see that the Potential Failure Mode is a logical step from the way
in which the requirement was described.
This is particularly important for assembly operations where the level of detail required
may not be so obvious.
For example, when fitting two parts together the characteristics of success are not so
explicit on the drawing or design notes. Therefore, the Process FMEA (and later the
Process Instructions) must provide the detail required. For example;
‘Fit Part A to Part B in the correct orientation without causing any damage to surface ‘D’
and fix with a single threaded bolt and nut to a torque value of 100N +/- 2 N and an angle
of 360 degrees’.
66
Hence from this description the following Failure Modes could be derived;
• Incorrect orientation
• Damage to surface D
• Torque too high
• Torque too low
• No torque
• Bolt not fitted
• Angle not achieved
We must take care not to infer requirements that are not there. There are examples where
the requirement was for a drilled hole at 10mm +/- 0.2 mm and the team went on to list other
Failure Modes such as ‘hole not round’. Unless there is a specific roundness specification
called out on the drawing then this is not relevant and should not be included.
There may also be some general drawing specification requirements that need to be
considered at certain operations. These include such things as;
• No Damage / Damage not to exceed specified limits
• No Sharp edges / burrs
• No Foreign Object Debris (FOD) / No FOD above specified limits
If appropriate to the operation these should be considered as additional requirements of
the operation and hence will have associated Potential Failure Modes.
f) Potential Failure Modes
As described in the previous section the Potential Failure Mode is the way in which the
product could fail to meet the design intent (drawing or specification).
It is critical that the Potential Failure Mode describes a product feature / characteristic
and not a process failure. If this column is not completed correctly all of the subsequent
work in the FMEA columns to the right of this one will be irrelevant.
A simple question to ask is ‘does the Potential Failure Mode describe something on the
product that is not right to the drawing or specification?’ It should not describe the ways
in which the process could fail, that will be considered in the Potential Causes column.
There are likely to be several Potential Failure Modes per feature / characteristic. This is
another good way to check if sufficient rigour has been applied to the PFMEA, if there are
only single Failure Modes identified then something is likely to be wrong.
Care should be taken not to simply list ‘degrees of error’ though. For example, ‘hole too
small’ is often adequate to describe a Failure Mode and its consequences. Avoid using
‘hole just undersize’ along with ‘hole 10% undersize’, and ‘hole twice tolerance undersize’,
etc. If there is a series of consequences due to ‘hole too small’ then this should be captured
in the Potential Effects’ column.
67
For example, if we consider ‘hole oversize’ as a Failure Mode then the Potential Effects
listed could include;
1. Part would become loose, vibrate and may eventually crack during operation (this
would need the hole to be very oversize e.g. 100% above specification)
2. Part may allow some movement and cause difficulty in assembly operation (oversize
by u
p to 50% of tolerance)
3. Part may be non-conforming but acceptable on concession (oversize by a max of 10%
of tolerance)
Table 11: Failure Mode Examples
Invalid Process Failure Mode

Valid Failure Mode Description
Descriptions
Hole too big / too small Drill broken
Surface �nish too rough Machine failure
Torque applied above speci�cation Wrong torque setting used
Pro�le shape incorrect Scrap parts
Missing feature Wrong CNC program used
Porosity in weld material Damaged tooling
Hole out of position Incorrect coolant pressure
Part �tted in wrong orientation Operator �ts part incorrectly
Another good ‘sanity check at this stage is to review the identified Failure Modes against
known non-conformance on similar parts e.g. customer escapes, scrap causes, rework
causes, etc. Have all of these Failure Modes been captured?
It is important to capture all potential Failure Modes and not just those that have happened
before. This is a Risk Analysis and therefore if it could happen, we must capture it (Section
4.7.7.4).
g) Potential Effect of Failure
This is a key point where the link to the Design FMEA and Design Engineering has an
important role to play.
Every feature will have a design purpose, otherwise why would it be there?
Therefore, if the feature was not present or was nonconforming we must understand the
impact that will have on the final product (as seen by the customer or end user) as well as
the impact on the manufacturing plant / business.
68
This is one of the factors that help to explain why ‘process based (generic) PFMEAs’ as
opposed to ‘product focused PFMEAs’ are not effective.
In a process based PFMEA the risk would be assumed to be equal for all holes drilled
during that operation and hence scored identically. The different purposes of each hole
mean that the effect and hence the impact for each hole may be different. This would not
be identified unless the PFMEA focuses on the specific Product Features.
Using the process based PFMEAs also means that the link to the Design FMEA is irrelevant.
All relevant effects should be listed for each Potential Failure Mode. We would expect to
see multiple effects for most Potential Failure Modes (another good check to make).
The most important effects to highlight are those that will be experienced by the customer
or end user, particularly if there are safety implications.
Internal effects should also be listed e.g. scrap, rework and for certain product Failure
Modes where there may be a significant safety impact to the operator, these should be
included too (see Severity Scoring guidelines).
Providing the Right Level of Detail for the Potential Effects Description
When describing the Potential Effects of Failure, it will be important to understand the
conditions that need to be present for the Effect to be realised.
For example, a dimensional defect may have a range of potential effects depending upon
the scale of the non-conformance. This means that the defect may sometimes be cleared
on a concession, reworked or scrapped. But to say this is not enough, we need to explain
when it is ok to concess it or scrap it.
So, for this type of Failure Mode we would expect to see three types of effect description;
1. If the defect is oversize then it may be possible to rework the dimension and bring it
inside the specified tolerance
2. If the dimension is marginally out of the bottom of tolerance and therefore cannot
be reworked then Design may be able to grant a concession to allow the product to
proceed
3. If the part cannot be reworked or concessed then the part will be rejected (scrapped)
There may be times where a Failure Mode in one process could cause a different Failure
Mode later in the process. For example, contaminated part is a Failure Mode for a cleaning
process and one Effect of Failure could be ‘Porosity in weld’ at a later operation. In this
example the team must be as specific as possible in the description of the Effect.
NOTE: Operator safety impacts should only be considered if they are resulting from
a product failure not a process one, and then only if it meets the criteria specified in
the Severity Scoring table i.e. not for minor HSE issues. Safety Risk Assessments are a
separate activity.
69
h) Severity Rating
The severity of each potential effect of failure is made using the scoring table in AS13004,
and shown below in Table 12.
When calculating the Risk Priority Number (RPN) later on the highest (most severe) score
will be used for this Potential Failure Mode.
There is sometimes a misconception that the Engineers can look up the effects and
severity of a non-conforming feature straight from the Design FMEA. This will rarely be
the case. The Design FMEA is focussed on Functional requirements and how the design
process could fail to achieve them. It will not necessarily identify specific features.
For example, the DFMEA when evaluating the design of a fuel pipe may identify that ‘if
50 litres of fuel will not be transferred at a pressure of 50 bar in 1 minute then the engine
may stall’.
The design will specify a pipe diameter as one of the critical features to enable this
functional requirement to be met. In the PFMEA it will identify Potential Failure Modes
of diameter ‘too big’ or ‘too small’. This will require the Designer to evaluate the effect
and severity of these Failure Modes, informed by the DFMEA, but it is not a simple
‘look up’.
The presence of the Design Engineering representative is crucial to both identify the
potential effects and score the severity.
In the same way, even if there is no DFMEA available, having the right Design input can
enable an effective Process FMEA to be created.
If the Severity Ranking for a Failure Mode is scored as 9 or 10 then this should be reviewed
with the Design Authority to see if it can be mitigated in some way.
Typically, the only way to reduce a Severity score would be to change the design or
remove the need for the Functionality.
Failure Modes with a Severity rating of 1 should not be analysed further.
70
Table 12: AS13004 Process FMEA Severity Risk Scoring
Severity of Effect on Process

Effect Severity of Effect on Product Rank Effect (Manufacturing / Assembly
Effect)
Potential failure mode affects

May endanger operator,
safe operation and / or involves
Failure to 10 Failure to machine or assembly without
non-compliance with regulations
meet safety meet safety warning.
without warning.
and / or and / or
Potential failure mode affects
regulatory regulatory May endanger operator,
safe operation and / or involves
requirements 9 requirements machine or assembly with
non-compliance with regulations
warning.
with warning.
Loss of primary function (product 100% of product may have to be
Major
inoperable, does not affect safe 8 scrapped. Line shutdown or stop
disruption
Loss or operation). ship.
degradation of A portion of the production run
primary Degradation of primary function may have to be scrapped.
Signi�cant
function (product inoperable but at a 7 Deviation from primary process,
disruption
reduced level of performance). decreased line speed or added
manpower.
Loss of secondary function
(product operable but service life 100% of production may have to
greatly reduced, convenience 6 be reworked of�ine and
items inoperable, customer accepted.
Loss or
dissatis�ed.
degradation of Moderate
Degradation of secondary
secondary disruption
function (product operable but
function A portion of production may
appearance affected,
5 have to be reworked of�ine and
convenience items operable but
accepted.
at a reduced level, customer
dissatis�ed.
Appearance, �t and �nish type
100% of production may have to
items do not conform, defect
4 be reworked in station before
noticed by most of customers
further processing.
(>79%) Moderate
Appearance, �t and �nish type disruption
A portion of production may
items do not conform, defect
Annoyance 3 have to be reworked in station
noticed by half of customers
before further processing.
(50%)
Appearance, �t and �nish type
items do not conform, defect Minor Slight inconvenience to process,
2
noticed by discerning customers disruption operation or operator.
(<2%)
No Effect No discernible effect. 1 No effect No discernible effect.
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i) Potential Cause(s) of the Failure Mode

In this section we are looking to identify the things in the manufacturing or assembly
process that could cause the Potential Failure Mode to exist.
This is the reason it is referred to as a Process Failure Mode & Effects Analysis i.e. we are
looking for the Process Risks of producing product non-conformance.
We would expect to see multiple Potential Causes per Failure Mode.
Figure 22: Potential Causes of Failure in a PFMEA
Class.
Potential Potential Effects of
Sev
Requirements Potential Causes of Failure
Failure Mode Failure
Wrong drill used (oversize)

Part may vibrate
during operation
K
leading to bracket 9
C
fatigue & system
failure Drill oversize from supplier (non-
Too Big
conforming)
Part would need to

CNC Spindle alignment out of
be scrapped if found 6
tolerance
during manufacture
Drill Hole
10 0 mm
Diameter
+/- 0.1 mm Tool wear
Unable to �t bracket 4
Incorrect drill used (too small)
Too Small
Marginal �t causing
raised stress and
K Drill supplied undersize from supplier
bracket fatigue 9
C (non-conforming)
leading to system
failure
The key success factor here is to produce a list of Potential Causes that are ‘controllable’
in other words where there is a direct ‘cause and effect’. Good examples are ‘incorrect
drill used ‘oversize’’ or ‘spindle alignment not true’. In other words, if these things were
to happen then the outcome would almost certainly result in non-conforming product.
These examples allow us to take a specific action to control them.
72
Common problems here are where the team has identified a long list of Potential Causes that
are quite ‘tenuous’. For example, ‘operator incorrectly follows procedure’, ‘maintenance
error’. These descriptions are of no value in creating an effective Process FMEA and the
required actions will be difficult to define.
The team should assume that the incoming parts / materials are correct. The team may
make exceptions to this but only where the historical data suggests that this is a known
problem. We would expect the PFMEA for the manufacture of the incoming parts to
provide the risk assessment for their own processes.
Resist too much detail!
However, we should also avoid going into unnecessary detail too.
In an example where the location of a weld could be misplaced the team identified that
one of the Potential Causes could be that the part was incorrectly located in the fixture.
This is true.
The team went on to list all of the reasons why the part may be incorrectly loaded in the
fixture e.g. operator error, fixture worn, fixture damaged, etc. This additional detail adds
no further value to the PFMEA than ‘part incorrectly located in fixture’.
Great care must be taken to avoid unnecessary detail that will prevent us from ‘seeing the
wood for the trees’.
Teams can often ‘over think’ this section of the PFMEA. The use of Fishbone diagrams to
create long lists of Potential Causes by brainstorming ‘machine’, ‘method’, ‘environment’,
‘manpower’, ‘maintenance’, etc. is rarely required and in my experience actually discouraged.
Only bring out this brainstorming tool if the team is struggling to identify any potential
causes and then ensure you hone the results into a few meaningful descriptions.
The knowledge of the process is usually well understood by the Manufacturing Engineer,
Maintenance Engineer and Operator (for example). Using the logic from the PFMEA
template it is more usual that a simple list can be created easily from this combined
knowledge.
The list should be evaluated for opportunities to group similar causes together or to
challenge if the potential cause is really linked to the Failure Mode.
Typically, we would only expect to see 5 – 7 Potential causes per Failure Mode. If there
are more then we should evaluate them to see if they can be more concisely described.
Prevention & Detection Control Requirements in AS13004
AS13004 again adds a potentially contradictory note in Section 4.7.10.1 about the need for
the control of characteristics and features.
73
It suggests that control is only required where ‘the occurrence and detection ranking
is high and/or if the failure is severe’. It does not specify what it means by ‘high’ in this
context.
While I agree that the extent of control should be determined by the severity ranking
and/or by the Occurrence and Detection scores it is the default position of all Aerospace
companies, based on the Regulations we comply to, that all features must be inspected
(Detection Control) or error proofed (Prevention Control) as a minimum. Inspection may
be done through sampling in certain circumstances.
Therefore, all features will require some description of how it is controlled, whether
through Prevention or Detection, within the PFMEA and the Control Plan.
j) Prevention Controls
For each Potential Cause identified we now need to identify what controls we have in
place (or not) to ensure that the Potential Cause cannot happen.
The best form of Prevention Control is Error Proofing e.g. Fixtures that prevent the part
being loaded incorrectly. For high severity features (Severity 9 or 10) we must strive for
this type of control.
There are some controls, whilst not mistake proofing, do offer some protection of
preventing the Potential Cause from happening e.g. Calibration, Maintenance routines,
etc.
For example, one of the Potential Causes for ‘hole oversize’ is ‘spindle alignment out
of specification’. In this case the business has recognised this issue and introduced a
Maintenance Schedule to check for spindle alignment using two methods;
a) a weekly ball bar check completed by the operator and
b) a quarterly laser alignment check conducted by the Maintenance Team.
Provided that these two activities are done to schedule and any actions identified through
the checking process are addressed then we would expect to see very few ‘oversize hole
conditions’ caused by spindle alignment error.
Another example would be ‘tool oversize – wrong tool used’, it may be logical to include
‘checked by operator during set up’ but this can only be included if it is clearly demonstrated
that the set-up checks really would find this error e.g. one of the set-up checks requires
a bar code reading of the tool in each tool holder.
If it is not a defined activity or check and just down to luck then it should not be included.
Unacceptable Prevention Controls
Another example to be careful of is the use of ‘Operator Training’ or ‘Work Instructions’

as a Prevention Control. Is this really going to ‘prevent’ a potential cause from happening?
74
The danger is that having put this comment in the box the team move on without really
questioning ‘what better controls could we have’. If the only control was ‘Operator Training’
then we should be wary of its effectiveness and it may be better not to include it at all.
If there are no current Prevention Controls for this specific Potential Cause then be
prepared to write ‘none’ in this column or leave blank. It may be that addressing this gap
will become one of the improvement actions.
CARE POINT: The controls we identify must be things that can genuinely ‘prevent’ the
cause from happening not just ‘sound like a good thing to do’. They will be activities
that stop the cause from happening not find it afterwards. AS13004 lists ‘Visual Aid’ as a
Prevention Check, I would not be convinced by this.
Another common mistake is to list things in here that detect the Potential Cause rather
than prevent it. For instance, a tooling check at the end of the process to ensure that it is
not broken is not a Prevention Control but a Detection Control.
k) Occurrence Rating
The occurrence rating looks to evaluate the potential for the Potential Cause of Failure to
occur. Again, as for the Severity Rating, this is done on a scale of 1 to 10 where 10 is ‘will
happen nearly always’ and 1 is ‘will never / unlikely to happen’ (see Table 15).
Each Potential Cause identified needs to be rated separately using the criteria included
in Table 15 i.e. How many times per million opportunities would we expect to see the
defect (PPM), Likelihood of the Potential Cause occurring or how often have we seen this
type of defect (time-based examples).
Typical data sources include: customer escapes, process capability performance data
(Cp, Cpk), Parts per Million (PPM), maintenance results, warranty metrics, etc.
Let’s use the example of ‘hole oversize’ where the potential causes identified were (a)
wrong drill used (oversize), (b) drill oversize from supplier, (c) CNC spindle alignment
out of specification and (d) part able to move in fixture. How would we calculate the
Occurrence scores for this part number?
If we consider that the PFMEA will be developed at a time when we may not have produced
any of these specific parts the data we will use will need to be based from similar parts
and similar processes.
First let’s determine the expected number of defects we are likely to see related to ‘hole
diameter too large’.
In this case the nominal diameter is 10mm +/- 0.1 mm. To calculate the expected %
non-conforming we can use the understanding of our process capability.
75
Using drill diameter measurements with a similar (not necessarily identical) diameter we
can determine the amount of variation seen by calculating the standard deviation of the
measured results (usually a minimum of 30 data points) and multiply by 6. This number
can then be compared to the specification tolerance to calculate the Cp value;
Process Potential (Cp) = Total Design Tolerance
6 x Standard Deviations of the process
If the standard deviation of our current process were 0.02 then the Cp would be;
Process Potential (Cp) = 0.2 / 0.12 = 1.67
Once we have determined the Cp value we can estimate the number of conforming parts
that the process will produce by using a conversation table (Table 13).
Table 13: Relationship between Cp value and non-conforming parts

(Parts per Million PPM) outside specified limits.
PPM Defective if the process PPP Defective if the process was allowed to
Cp Value
was perfectly centred move +/- 1.5 Standard Deviation from nominal
0.5 133,614 500,000
0.67 45,500 308,538
0.83 12,419 158,655
1 2,700 66,807
1.17 465 22,750
1.33 63 6,210
1.5 6.8 1,350
1.67 0.6 233
1.83 0.04 32
2 0.002 3.4
2.17 0.00008 0.3
Therefore, in this example, with a Cp of 1.67 and using the PPM that includes a 1.5 offset
to represent true production conditions, the result would be 233 PPM. This equates to an
Occurrence score of between 4 and 5 in Table 15.
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This score is the total non-conforming PPM expected. If this is centred then half would be
above top limit and half would be below bottom limit, therefore for the Failure Mode of
‘hole oversize it will still be a score of 4 in Table 15.
The next step is to score the individual Potential Causes. Some approaches to do this are
shown in Table 14.
Table 14: Data Sources for Scoring Occurrence
Quality History
Potential Failure Capability Inspection (escapes, scrap,
Maintenance Local
Cause Data Records concessions, warranty, Records Knowledge
etc)
Wrong drill used

(oversize)
X X
Drill above limit

(from supplier)
X X X
CNC Spindle
alignment out of X X X X
speci�cation
Part allowed to
move in �xture
X X X X
Important Care Point when scoring Occurrence Ratings
The ability to be able to rate the occurrence individual Potential Causes will depend
upon the data captured by the company. In many cases this may not be available for the
identified individual causes.
Therefore, the scoring guidelines for Occurrence provide some options to determine the
relative frequency, which can be informed by data and/or team knowledge and experience.
As we can see this is not an exact science but we need to ensure that we do not ‘under
call’ individual causes and therefore avoid taking any actions later. A temptation is to
score these individual causes very low so that no action will be required.
This may be OK for Failure Modes that never happen but if you know that the Failure
Mode occurrence has scored a 6 in the table then this needs to challenge the individual
scores the team has listed for the linked Potential Causes.
77
Table 15: AS13004 Occurrence Rating Table for Process FMEA
Likelihood Likelihood Time based

Process Time based
Rank Description of Cause of cause example
PPM example
(AIAG) Low volume production
Very high persistent failure

>500,000 100% of
10 (failure is almost > 1 in 10 > 1 per shift >1 per shift
PPM production
inevitable)
Very high persistent failure

50,000 50% of
9 (failure is almost as likely > 1 in 20 >1 per day >1 per day
PPM production
to happen as not)
High frequency of failure 20,000 >1 per 3 20% of

8 > 1 in 50 >1 per 3 days
(repeated failures) PPM days production
High frequency of failure 10,000 10% of

7 > 1 in 100 >1 per we ek >1 per w eek
(failures occur often) PPM production
High moderate – 5,000 >1 per 2 50% of

6 > 1 in 5 00 >1 per month
occasional failures PPM weeks production
Moderate occasional
1,000 >1 per 0.5% of
5 failures (minor > 1 in 2 ,000 2 per year
PPM quarter production
proportions)
Moderate low: infrequent > 1 in >1 per 6 0.1% of

4 100 PPM 1 per year
failures 10,000 months production
0.05% of
3 Low; relatively few failures 10 PPM 1 in 100,000 >1 per year 1 per 5 years
production
Low: failures are few and

<1 in 0.01% of
2 far between (isolated 1 PPM <1 per year 1 per 10 years
1,000,000 production
incidents)
Remote: failure is Less than

1 eliminated through 0 zero Never 0.01% of <1 per 10 years
prevention controls. production
There is no guidance in AS13004 to determine what is meant by ‘low volume production’.

When asked, the team who developed the standard refer to ‘pre-production volumes’ or
prototype parts, not production parts.
In practice these scores are comparative within the FMEA and therefore provided that
the scoring system is used consistently across the whole document there is very little
difference to the outcome.
l) Detection Controls
This is a description of all of the ways in which the Potential Failure Mode (and key Potential
Causes) are checked or inspected for conformity throughout the process.
78
Typically, it will take the form of in process checks by the operator, automated controls or
mistake proofing, or formal inspection routines.
The team should document all of the applicable controls in place and score each one
using the Detection Scoring Table.
As we know that each Potential Cause will have its own RPN value it is important to
recognise that each Detection Control must therefore be aligned to each Potential Cause.
For example, if we inspect hole diameters using a co-ordinate measuring machine at the
end of the line then this detection method would score 7 in our Detection Rating chart
(see Table 16).
This score would be read across to all Potential Causes for against each Failure Mode
identified for ‘Hole Drilling’.
If there are any other detection methods used for certain Potential Causes then these
should be listed against that particular Potential Cause and scored appropriately. See
‘PFMEA RPN Scoring Worked Example’ for further details.
m) Detection Ranking
The team will evaluate each of the Detection Controls identified in the previous column
using the criteria contained within the Detection Scoring Table.
The question they must answer is ‘If the Potential Failure Mode did occur how confident
are we that we would detect it before it was despatched to the Customer?’
The focus of the ranking is on the methods deployed to inspect or prevent the Failure
Mode and the stage of the process where the inspection is conducted i.e. at the point the
Failure Mode could be created or later on in the process.
Particular points to note on this rating table are;
• There is no reference to the capability of the gauging method. It assumes that whatever
gauging method or inspection process is used that is has been proven capable (see
AS13003 MSA).
• The only way to score lower than a 5 on the scale is to employ automated controls to
detect the Failure Mode (rank 2 to 4) or an automated control to prevent the Failure
Mode Potential Cause (rank score of 1). Automated Controls such as these should be
our objective.
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Table 16: AS13004 Detection Rating Table
Likelihood of Detection
Rank by Process Control - Likelihood of Detection by Process Control - Criteria
Category
No current process control; Cannot detect or compliance analysis / MSA not

10 Absolute uncertainty
performed .
Defect (Failure Mode) and / or Error (Cause) is not easily detected (e.g.
9 Dif�cult to detect
random audits, GR&R above acceptance thresholds) .
Defect detection post Defect (Failure Mode) detection post processing by operator through visual /
8
processing tactile / audible means with no boundary samples.
Defect (Failure Mode) detection in station by operator through visual / tactile /

Defect Detection at
7 audible means or post processing through use of attribute gauging (go/no go,
Source
manual torque checks, clicker wrench, etc.) with no boundary samples.
Defect (Failure Mode) detection post processing by operator through the use
Defect Detection Post of variable gauging or in station by operator through the use of attribute
6
Processing gauging (go / no go, manual torque checks, clicker wrench, etc.) with
boundary samples.
Defect (Failure Mode) or error (cause) detection in-station by operator

Defect Detection at through the use of variable gauging or by use of automated controls that will
5
Source detect discrepant part and notify operator (light, buzzer, etc.). Gauging
performed onsetup and �rst piece check (for set up causes only).
Defect Detection Post Defect (Failure Mode) detection post processing by automated controls that
4
processing will detect discrepant part and lock part to prevent further processing.
Defect (Failure Mode) detection in-station by automated controls that will

Defect Detection at
3 detect discrepant part and automatically lock part in station to prevent
Source
further processing.
Error Detection and / or Error (Cause) detection in-station by automated controls that will detect
2
Defect Prevention error and prevent discrepant part from being made.
Error (Cause) prevention as a result of �xture design, machine design or

1 Detection not applicable
part design.
n) Risk Priority Score

The next stage of the Process FMEA is to calculate the Risk Priority Number (RPN) for
each Potential Cause of a particular Failure Mode.
The calculation is quite simple.
Severity x Occurrence x Detection = RPN
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The Severity Score we use is the highest ranked number for the Failure Mode, i.e. the
worst that could happen.
The Occurrence Score for each Potential Failure Mode is used i.e. there will be an RPN
score for every Potential Cause identified for a particular Failure Mode.
The Detection Score is the best (lowest) score identified. This means that, provided that
all parts go through each inspection point, the most effective detection activity will catch
the Potential Failure Mode before it is shipped to the customer.
Figure 23: RPN Scoring Example
Occurrence
Detection
Severity
Failure
Mode
Potential
Effects
Potential
Causes
Prevention
Controls
Detection
Controls RPN
4 5 5 200
6 8 5
8 2 128
3 3 5
3 72
The Every Occurrence The An

Highest Score Lowest RPN
Severity Detection Score
Score Score For every
Potential
Cause
Figure 23 shows that to calculate the RPN for the Failure Mode we select;
1. The HIGHEST Severity score, multiplied by,
2. EACH Potential Cause Occurrence Score, then multiply by
3. The LOWEST Detection score for each related to each Failure Mode and Potential
Cause (if relevant).
Therefore, there are three RPNs, one for every Potential Cause.
It can often be worth doing a quick sanity check by calculating the ‘overall RPN for a
Failure Mode.
81
1. It is easy for us to identify the Severity Score for a particular Failure Mode so we
should use that
2. The Occurrence Score for an individual Cause can be quite difficult to get but the
overall failure rate for the Failure Mode should be relatively easy so we can use that.
3. The Detection Score, especially that associated with Inspection, is also quite easy to
get hold of so we can use that.
Calculating these three scores will give us an approximation of the Risk profile for that
Failure Mode that we can then compare to our individual RPNs for each Potential Cause.
We can then adjust the Occurrence Scoring if required for the individual scores if
necessary.
Process Key Characteristics (Section 4.7.16)

One of the Outputs from the PFMEA is the identification of Process Key Characteristics
(KCs). The team should determine these through an evaluation of the risk scores of Severity
x Occurrence or from the RPN result. These will be in addition to Product KCs that were
identified through the Design process.
Product and Process KCs should be identified within the PFMEA and the Control Plan
within the Classification columns.
o) Improvement Actions
For all of the rigour of a Process FMEA, if done well, if we do not then react to the risk
profile then it is of no value.
The key focus must be on those risks that scored high for severity, regardless of the other
scores. What further action do we need to take to reduce the RPN of these items through,
ideally, improving the prevention of the Failure Mode, or if not, improving the Detection
of the Failure Mode.
Remember the only way to reduce the Severity score is usually to redesign the product.
High RPNs do need to be addressed. There is no set way of doing this. There is a judgement
required. How much risk are you prepared to tolerate?
Some RPNs will ‘stand out’ using the pareto principle as being excessive and will clearly
need to be improved.
Some companies use an RPN threshold value to select which RPNs they are going to
improve. This can be dangerous as teams soon learn how to get a score that falls below
the threshold value (it is not an exact science after all).
Another strategy is to look at the profile and see where the data suggests a ‘levelling out
of RPNs’. The risks to the left of this point should be considered for improvement.
82
Remember the continual reduction of the overall risk should be our aim – this is an
on-going process that never stops.
Improvement actions should be documented in the PFMEA and once implemented

and verified the RPN can be recalculated to measure the effect of the improvement action.
Figure 24: RPN Improvement Actions in a PFMEA
Action Results
Occurrence
Occurrence
Detection
Detection
Severity
Potential Resp. &
RPN
RPN
Causes of Target
Failure Date
Tooling bar
Wrong Drill
code auto
Used 2 12 6
check on
(oversized)
machine
Tool
Drill oversize
presetting 2 126
from supplier CMM
process
Inspection 7
at OP 450
Move inspection
Weekly ball G. Davies
to within OP100 12. 3.18 9 2 5 90
bar check 15.03.18
process
CNC Spindle
alignment out
4 252
of
speci�cation Quarterly Increase
A.
laser frequency of
Bonthron 22.4.18 9 2 5 90
alignment laser alignment
27.04.18
check check to monthly
Tool life
Tool CMM speci�ed to 10
C. Mellish
Tool Wear presetting 4 Inspection 7 224 parts max. 10.5.18 9 2 5 90
10.05.18
process at OP 450 before tool
change
83
PFMEA RPN Scoring Worked Example

Let’s assume that the Failure Mode is ‘hole diameter too big’. The team have identified
four potential effects;
1. Minor deviations may need to be concessed, minor operational disruption, customer

would not notice = Severity Score of 2
2. Could cause sub system vibration impacting product performance noticed by the
customer = Severity Score of 6
3. Could cause vibration in engine leading to premature wear and potential product
failure (not safety related) = Severity Score of 8
4. Could cause vibration noise that would be noticeable to customer = Severity Score
of 5
Therefore, in this example the Severity score used will be the highest, which is 8.
The team has identified three Potential Failure Causes;
5. Wrong Drill used (oversized). There is no defined Prevention Control for this potential
cause.
6. Spindle wear on CNC Machine. The business has two ways of preventing this potential
cause (a) weekly ball bar checks conducted weekly by the operator and (b) laser
alignment checks conducted by the maintenance function every 6 months.
7. Damaged tool (drill). The machine has a built-in program that uses a vision comparator
system for each tool before it is used to check for damage.
There will be an Occurrence score for each Potential Cause identified.

Occurrence Scoring
The team know that this is a problematic feature with a tight tolerance. It causes around
2% of non-conforming parts, most of which are concessed (minor deviation). This would
score an Occurrence rating of 8.
The team do not have data to show how this non-conformance can be accurately attributed
to each of the three causes so they have decided on the following logic.
1. Most likely reason is spindle condition. The data shows a wide spread of results and
a Cp of less than 1 which could be due to the machine inaccuracy. They also know
that the Maintenance checks sometimes find alignment errors and have reduced the
frequency of Ball Bar checks as a result. They have assigned the score of 7 as they
believe it is the biggest contribution but does not explain all of the variation.
2. The team knows that incorrect tooling used has happened before, although
infrequently (once or twice per year), and as there is no prevention activity for this
potential cause they have put a score of 4.
84
3. The tooling vision system has prevented broken tools from being used since its
implementation over 9 months ago. They decided to score it as a 2 rather than a 1 as
it is still relatively new.
Detection Methods and Scoring

The hole diameter is measured using a variable gauge in process by the operator, that
would be a score of 5 for Detection.
For the three Potential Causes this Detection Score will be shown against each as a
starting point.
The Detection Methods for both ‘Wrong Tool Used (oversize) and ‘Spindle Wear’ rely on the
Operator inspection of the Failure Mode, in-station using a bore micrometer. Therefore,
these have both been scored a ‘5’ using the Detection Scoring Guidelines.
The Potential Cause for ‘Damaged Tool’ can be detected automatically using the vision
system built into the CNC machine. The team have used the same logic as for Occurrence
scoring and assigned this a Detection Score of ‘2.’
Calculating the RPN

Therefore, in our worked example the three RPN Scores (one for each Potential Cause)
would be;
Potential Cause 1: Wrong Drill Used (oversize)
Severity 8 x Occurrence Score of 4 x Detection of 5 = 160
Potential Cause 2: Spindle wear
Potential Cause 3: Damaged Tooling
Why use the lowest Detection Score?

The selection of the lowest Detection Score rather than the highest can often cause some
confusion.
Think of it as if each Detection Control is like a filter paper of different grade (1 to 10). If
you have three detection methods scored at 2, 6 and 8 then if the Failure Mode was to try
to pass through them (in series) then the one scored at 2 would be the most effective and
hence that is the score we would use. See Figure 25.
It will allow us to challenge if we need all three Detection Activities, why not just use the
best one and remove the others?
85
Figure 25: Detection Scoring Analogy
Failure Modes & Potential Causes
Detection
Filters
(scores)
Filter Size 8 Detection Control 1
Some Failure Modes & Potential Causes will always get through
Once the RPNs for each Failure Mode and Potential Cause have been calculated they can
be ranked in order of RPN Score (Pareto principle).
Being able to see the Risk Profile of the complete process is useful for us to be able to
identify those process steps with the highest risk however such as a simple analysis is not
enough to determine what actions should be taken.
Process FMEA - A Simple Check
We have discussed how important the precision of the language we use in the PFMEA is
to its effectiveness. An easy check to see if we have applied this correctly is to read the
contents from Left to right and see if the logic flows from one column to the other. An
example is shown in Figure 26.
86
Figure 26: PFMEA Testing the Logic (Read Left to Right)
.
.
. .
87
88
Chapter Six
Creating Reference PFMEAs
Reference Process FMEAs are a useful way to create the re-useable building blocks of
what is required to define the part specific Process FMEA required by AS13004.
Many of the practices discussed in Chapter Five will be applicable when creating the
Reference PFMEA, for example they should be developed using a cross-functional team.
We may not necessarily need those people with specific product knowledge as this is
really a process for capturing Process Information.
Ideally, Reference PFMEAs should be kept at a company level and maintained by the
accountable Manufacturing Process Owner. They should be used across the business to
create part specific PFMEAs in the most efficient manner.
Reference PFMEAs are not simply a ‘cut and paste’ solution. They are simply using the
knowledge from similar features and processes that once created, are relevant for multiple
features included in the Part Specific PFMEA.
Figure 27 shows what can be included within a Reference PFMEA and why.
Figure 27: Overview of Reference PFMEA Elements
The purple columns require part specific information and therefore can only be completed
when completing the part specific Process FMEA.
89
STEP 1: Select the Process for Evaluation

A reference Process FMEA will be specific to a process type e.g. CNC machining, Electron
Beam Welding, Torque Fastening, Grit blasting, etc.
The Team should identify the Reference PFMEAs it needs to complete a full part number
specific Process FMEA. Once the list is completed the team can select one specific process
type to begin (remember that these Reference PFMEAs, once created can be used for all
new PFMEAs).
Figure 28: Typical Reference FMEA Database of Required Processes
CNC Drilling CNC Milling CNC Turning CNC Grinding
E Beam Chemical Etch

Casting Forging
Welding Cleaning
Manual Intelligent Manual Torque

Part Marking Torque
Assemble Fastening Fastening
Some processes will have several sub process types. For example, CNC machining may
have sub process types of;
• Turning
• Grinding
• Milling
• Drilling
The team would focus on one of these elements to create a Reference PFMEA.
The Reference PFMEA may also be equipment specific. Some CNC machines will
be constructed in a unique way and therefore the Potential Causes of Failure may
be unique to that equipment type. The Team will need to decide if the best approach
is to create a universal Reference PFMEA or to allow derivatives to be developed also.
90
Step 2: Define the typical Features and Characteristics of the Process being evaluated
Each Process Type will have the potential to create certain features and characteristics.
The team should list these out for the process / sub-process under evaluation.
A typical characteristics matrix or Assembly Instruction for the process may help to identify
these features and characteristics. The team also need to refer to typical drawings and
related engineering specifications.
For example, in Figure 29 it shows the typical features for a drilling process on a CNC
machine.
Figure 29: Typical Features for a Drilling Operation
Location
No
Diameter
Damage
Drilling
Through
Roundness
hole
Depth
The Reference PFMEA should be structured in such a way that the team can select specific
features from the process / sub-process to be used in the creation of a Part Specific
PFMEA (see Figure 34)
Define all Features and Characteristics needed before moving onto the next step.
Step 3: Define Typical Failure Modes for each Characteristic
Design Features and Characteristics will have a universal and finite number of Potential
Failure Modes associated with them, irrespective of how they are produced. The team can
brainstorm these as a start to helping define the Reference FMEA database.
91
Figure 30: Typical Failure Modes for Drilling Features

Wrong location
Location
No Too Big
Damage
Diameter Too Little
Damage
Drilling
Through
Missing feature Roundness Out of round
hole
Depth
Too Deep
Too Shallow
It can be useful to record these Features and Failure Modes in a document for future
reference and to ensure that any new Failure Modes are captured. Some typical examples
are shown in Table 17 (see also Appendix B).
Table 17: Example Failure Modes
Requirement Potential Failure Mode(s)

Correct orientation Wrong orientation
Speci�ed quantity Wrong quantity
Too big
Diameter
Too small
Too deep
Depth
Too shallow
Location Incorrect location
No Damage Damaged
Pro�le Shape Incorrect pro�le
Too rough
Surface Finish
Too smooth
Fit part Part missing
92
In addition, there may be universal Potential Failure Modes on the Drawing or related
Specifications that the team should also consider e.g. Damage, FOD, Surface Finish
requirements, cleanliness, etc. These are not necessarily feature specific but are applicable
to the process under evaluation e.g. CNC Drilling.
STEP 4: Identify Potential Causes of Failure by Process Type

The Potential Causes of each Failure Mode will depend upon the process that is being used
to create the Feature / Characteristic.
For example, drilling a hole with a diameter of 10mm +/- 1 mm the Failure Modes will be the
same i.e. Too Big or Too Small. However, the Potential Causes of ‘Hole too Big’ if created on a
CNC will be different to those if created using, for example, laser drilling.
Therefore, Reference FMEAs now need to become specific to a process type.
In this example we shall consider ‘hole drilling’ on a CNC machine. The team will need to
decide if CNC drilling is a single Reference PFMEA or if there are different types of CNC
machines that may require their own Reference PFMEA.
This can be decided by looking at the list of Potential Causes for each. If they are similar then
we should strive to have only one Reference PFMEA if they are significantly different (due
to the mechanical nature of the equipment for example) then separate Reference PFMEAs
should be created.
The team should consider all of the direct causes that could create the Product Failure Mode.
Figure 31: Reference PFMEA for CNC Hole Drilling: Potential Failure Mode Causes
Potential Potential
Class.
Sev
Operation Requirement Failure Effects of Potential Causes of Failure

Mode Failure
Wrong drill used (oversize)
Drill oversize from supplier (non-

Too Big conforming)
CNC Spindle alignment out of

Diameter tolerance
Tool wear
Too Small Incorrect drill used (too small)

Drill Hole
Drill supplied undersize from
supplier (non-conforming)
Incorrect tool setting
Too Deep
Tool offset incorrect
Depth Tool setting incorrect

Too CNC program offset incorrectly set
Shallow
Tool wear
93
STEP 5: Identifying the Prevention Controls aligned to the Identified Potential Causes
in the Reference PFMEA
In the next step the team should identify the Prevention Controls that can prevent the
Potential Cause(s) identified. Again, great care should be taken to ensure that these
Prevention Controls are actually able to prevent the Potential Cause and that they are in
place and effective.
In practice the Prevention Controls may be unique to a particular plant or site and therefore
great care must be taken when reviewing the Part Specific PFMEA to confirm that those
listed are ‘actual practice’ and not just recording another business’s best practice.
It can be useful however to have a ‘starter list’ for teams to review and to challenge them
on the application of best practice.
Figure 32: Reference PFMEA Prevention Controls
Potential Potential
Class.
Potential Causes of
Sev
Requirement Failure Effects of Prevention Controls

Failure
Mode Failure
Incorrect drill used Bar code reader veri�es correct

(oversize) tooling
Drill oversize from

Too Big supplier (non- Tool preset check
conforming)
Monthly ball bar check
CNC Spindle alignment
(MC001) & Quarterly laser
Diameter out of tolerance
alignment check (MC015)
Tool setting to max. 10 parts
Tool wear
before removal.
Incorrect drill used (too Bar code reader veri�es correct
Too Small small) tooling
Drill supplied undersize
from supplier (non- Tool preset check
conforming)
Incorrect tool setting Tool preset check
Too Deep
Tool offset incorrect None
Tool setting incorrect Tool preset check

Depth
Too Shallow CNC program offset
None
incorrectly set
Tool setting to max. 10 parts
Tool wear
before removal.
Do not be afraid to write ‘None’ in the Prevention Controls column if there really is nothing
that is done. It is always preferred to writing in something tenuous. An empty cell in
an FMEA will attract attention from the team and challenge them to think of ways to
address it.
94
STEP 6: Identifying the Typical Detection Controls for the Failure Mode in the
Reference PFMEA
The next task is to identify the typical Detection Controls for the Failure Mode. These will
be used as a guide only and should include the latest thinking from the business experts.
As with the Prevention Controls these are often plant / site or business specific and will
need to be reviewed closely to confirm that they reflect the actual condition for the
application under review (the Part Number specific PFMEA).
There may be minimum standards defined for certain Detection Controls and these must
be adhered to. For example, there may be a standard method for measuring surface finish
inside a bore that requires specific measuring equipment. Mandated Detection Controls
should be identified within the column with a comment.
If the part specific PFMEA identifies that the mandated Detection Controls are not in
place then this should be identified as an improvement action within the PFMEA
Figure 33: Identifying the Typical Detection Controls in the Reference PFMEA.
Occurrence
Potential Potential
Class.
Potential Causes of Prevention Detection

Sev
Requirement Failure Effects of

Failure Controls Controls
Mode Failure
Bar code reader

Incorrect drill used
veri�es correct
(oversize)
tooling
Drill oversize from
supplier (non- Tool preset check
Too Big conforming)
Monthly ball bar
CNC Spindle check (MC001) &
alignment out of Quarterly laser
tolerance alignment check CMM
Diameter (MC015) Inspection at
Tool setting tomax. OP 450
Tool wear 10 parts before
removal.
Bar code reader
Incorrect drill used
veri�es correct
Too Small (too small)
tooling
Drill supplied
undersize from
Tool preset check
supplier (non-
conforming)
Incorrect tool setting Tool preset check
Too Deep CMM
Tool offset incorrect None Inspection at
Tool setting OP 450
Tool preset check
incorrect
Depth
CNC program offset
Too None
incorrectly set
Shallow
Tool setting to max.
Tool wear 10 parts before
removal
95
Organising the Reference PFMEAs
In a mature state the business will have a database of all of the Reference PFMEAs it
requires to create part specific PFMEAs. This database will represent the ‘best practice’
for each process and be a knowledge management hub recording all of the company’s
insights into managing the process.
The Reference PFMEA database should be updated whenever new information comes to
light so that it can be shared across the business forming a key part of the continuous
improvement activity.
As there are no product specific details held within the Reference PFMEA it should be
possible for them to be made available to the external supply chain for them to use as
well. This will also enable the knowledge management database to be updated by the
experienced and knowledge held within the external supply chain as well as within the
business making the approach even more powerful.
NOTE: Always check with your company experts on the classification of Intellectual
Property and Export Control before sharing these files to prevent potential violations.
Care must be taken when designing the Reference PFMEA file structure to make it easy
to access and find the right element.
The typical structure will include three levels.
Level 1: The Process Group
This is the common name for the process and is usually defined by the equipment or
process. Examples include CNC Machining, Joining, Surface Preparation
Level 2: Process Type
This is where the process can be made more specific and will take the form of the
equipment used or more detailed process description. For example, CNC Grinding, CNC
Drilling, CNC Turning, Joining by E-Beam Welding, Joining by Inertia Welding, Surface
preparation by grit blasting, etc.
Level 3: Process Characteristics / Features
The Reference PFMEA now needs to identify the typical features / characteristics that the
process / equipment is designed to create. E.g. for the CNC grinding operation using the
Mazak this could include;
• Size (length, height, etc.)
• Radii
• Angle
• Surface finish
This structure is shown in Figure 34.
96
Figure 34: Reference PFMEA Database Structure Example
1.0 CNC MACHINING REFERENCE FMEA LIBRARY
97
98
Chapter Seven
Using Reference FMEAs
In this Chapter we shall describe the steps needed to create a part specific Process FMEA
using Reference PFMEAs.
STEP 1: Select the Part Number for the PFMEA activity & collate all related documentation
required to complete the PFMEA
PFMEAs must be completed for a specific part number or assembly.
The scope will include all process steps and all features that are created to meet the
design intent.
In order to create a part specific PFMEA the team will require;
1) Part / Assembly Drawing(s)
2) Related specifications called up on the drawing(s)
3) Process Flow Diagram detailing the method of manufacture
4) Product Characteristic Matrix that specifies the features created at each process step
5) Assembly Instructions (if relevant)
The documents should be reviewed to ensure that they are complete and have the
required detail to make the PFMEA meaningful.
These documents will be used to create the shell PFMEA for the specific part number
using the appropriate Reference PFMEAs, as shown in Figure 35.
Figure 35: Creating a part specific Shell PFMEA
Reference PFMEAs
Part Drawing
Process Flow Diagram

Shell Part
PFMEA PFMEA
Part Specifications
Assembly Instructions
99
STEP 2: Complete the Process Step and Requirement columns of the PFMEA using the
information collected in STEP 1.
For each Operation / Process Step list out the design features and characteristics to
be created at that step (taken from the Characteristic Matrix, Part Drawing, Assembly
Instructions and related Specification(s)).
The description of the design requirements must be in sufficient detail so that the Failure
Modes can be easily identified. Include the specifications or acceptance criteria for each
feature listed
Figure 36: Completing the Process Step and Requirements Column
Potential Potential
Class.
Sev
Operation Requirement Failure Effects of Potential Causes of Failure
Mode Failure
Hole 1
Diameter
10mm +/- 0.1
Hole 1
Depth 100mm
+/- 1.5
OP100
Drill Hole
Hole 2
Diameter
15mm +/- 0.1
Hole 2
Depth 80mm
+/- 1.5
Ideally this step should be completed in dedicated FMEA software so that it can easily link
to the Reference PFMEAs.
Although PFMEAs should be completed for every feature included within the Design
Definition there are some allowable exceptions and care points that should be considered.
A) Patterns of Features
The Risk Profile (RPN) of a feature within a PFMEA is derived from three attributes;
• Potential impact of the non-conformance (Severity Score), related to the purpose of

the feature,
100
• Probability of it happening (Occurrence Score), related to the process capability and

hence specification(s) limits, and
• Ability to detect it, if it was nonconforming (Detection Score).
Thus, if there are multiple features that have the same purpose, same specification, made
in the same way (and at the same step), and inspected in the same way then these features
may be considered as a pattern and a single line item within the PFMEA.
An example of this may be the bolt holes used to secure one part to another. Let’s say there
were 26 holes, all with the same specification, created on the same machining process,
using the same tooling, inspected in the same way, then these could be considered as one
feature in the PFMEA.
This approach can have a significant impact on the number of features needed to be
evaluated in the PFMEA.
Figure 37: Hole Pattern Example
B) Profile Features
Some parts may have a specified profile with multiple inspection points identified to define
how this should be inspected. Do not confuse inspection points with features. The feature
in the PFMEA is ‘Profile Shape’ and not the 100 inspection points that may be identified
on the drawing.
101
For example, on a Fan Blade there are several profile areas (or zones) defined along the
Blade with different Design Consequences if they were non-conforming.
The profile areas are specified on the drawing to take account of this. Each profile area
that is separately defined should be included on the PFMEA as a separate ‘feature’.
STEP 3: Add the relevant REFERENCE PFMEA information for each characteristic listed.
To determine the Reference PFMEAs required the Characteristics Matrix should be

reviewed to identify the process types and features used to create the part.
For example, a Crank Shaft uses the following processes to create the defined features:
Figure 38: Determining the Required Reference PFMEAs
In this example there are four main types of Reference PFMEAs used.
102
At feature level there are 10 different Reference PFMEA required to cover the features
listed.
The Reference PFMEA information will (typically) include;
• Potential Failure Mode
• Potential Causes of Failure
• Prevention Controls
• Detection Controls
Figure 39: Compiling the ‘Shell’ Part Number PFMEA using Reference PFMEAs
Classi�cation
Occurrence
Potential
Detection
Severity
Potential Potential
Op No. / Process Effects Prevention Detection
Failure Causes of RPN
Step Requirement of Controls Controls
Mode Failure
Failure
OP100 Length
CNC 100mm +/-
Grinding 1mm
OP100
Angle 75o
CNC
Grinding +/- 2o
OP100 Surface
CNC Finish MAX
Grinding 1.5 RA
OP200
Ø50mm +/-
CNC
Turning 0.5mm
OP300 Length
CNC 250mm +/-
Grinding 3mm
OP300
Angle 55o
CNC
Grinding +/- 2o
OP300 Surface
CNC Finish MAX
Grinding 2.5 RA
OP400 20 hole Ø
CNC 40mm +/-
Drilling 0.2mm
OP400 Depth
CNC 120mm +/ -
Drilling 0.5mm
OP400
No white
CNC
Drilling layer
Weld
OP500
EB Weld
position
120,X 350,Y
Porosity
OP500
EB Weld
within spec
ABC
Bead length
OP500
EB Weld
25mm +/-
1mm
103
The typical data included in the Reference PFMEA is shown in Figure 40. In this example
we have used the Reference PFMEA for ‘CNC Machining – Hole drilling’. We have only
shown an excerpt from the full Reference PFMEA.
The information included in the Reference PFMEA should be used as a starting point only.
Figure 40: Shell PFMEA example
Occurrence
Potential Potential
Class.
Sev
Operation Requirement Effects of Causes of
Failure Failure
Wrong Bar code

Drill used reader on
(oversize) machine
Drill
Tool
oversize
presetting
from
check
supplier
OP100 Hole 1 CMM
Diameter Hole Too Big Inspection
Drill Hole 10mm +/- 0.1 Weekly ball at OP 450
bar check.
Spindle
Monthly
out of
laser
alignment
alignment
check
Swarf pick
None
up on tool
STEP 4: Complete the Part Specific PFMEA with Cross Functional Team
Once the Part Specific PFMEA ‘shell’ has been populated with the information in STEPS
2 and 3 then the Cross Functional Team should be brought together to review the Shell
PFMEA.
The Cross Functional team should include Manufacturing Engineering, Design Engineering,
Operations, Maintenance and Quality (as appropriate). At certain points other experts
may also be required e.g. machine tool supplier, part suppliers, etc.
The team will need to ensure that the information taken from the Reference PFMEA is
accurate for the Part Number being considered and make any necessary changes.
They will need to review the Shell PFMEA and decide if there are any other Potential
Failure Modes, Potential Causes, Prevention Controls or Detection Controls that need to
be included.
104
The next step is to complete the part specific information in the columns not covered by
the Reference PFMEA.
It can be useful to complete this in three sub steps.
4(a) C
omplete the Effects and Severity score columns for each identified Failure Mode
(Figure 41).
This is where it is vital to get the input from the DFMEA and/or the Design Team to reflect
the key consequences should the Failure Mode occur. The team should concentrate on
the effect to the customer along with the severity score.
Internal Effects and Severity Scores associated with consequences such as scrap, rework,
etc. should also be considered and recorded, recognising that this should focus on major
effects and not all minor or insignificant ones. The scoring of the RPN will focus on the
highest severity score.
This step cannot be completed without the input of the Design Team.
Figure 41: Completing the Effects and Severity Rating
Occurrence
Potential Potential
Class.

Sev

Failure Failure
Bracket
vibration,
leading to Wrong Bar code
crack and 8 Drill used reader on
potential (oversize) machine
engine
failure
Part may
be Drill
Tool
concessed oversize
4 presetting
if from
check
OP100 Hole 1 approved supplier CMM
Diameter Hole Too Big by Design. Inspection
Drill Hole 10mm +/- 0.1 at OP 450
Part may Weekly ball

need to be bar check.
Spindle
scrapped Monthly
5 out of
if found laser
alignment
during alignment
process. check
Swarf pick
None
up on tool
105
4(b) Review the Potential Causes and Prevention Controls taken from the Reference
PFMEA (Figure 42).
The team should review what has been included in the Shell PFMEA and modify to reflect
the reality for this particular part number. The team may add or delete elements from the
Shell PFMEA if appropriate.
In this example we have added an additional Potential Cause and Prevention Control (see
blue text).
The team then review the relevant performance data to allow them to complete the
Occurrence Score element of the PFMEA using the Scoring Guidelines in Chapter
Five e.g. customer escapes, DPU (incl. feature RFT), concessions, Maintenance
Records, etc.
Figure 42: Completing the Potential Causes, Prevention Controls and Occurrence
Scoring sections.
Occurrence
Potential Potential
Class.

Sev

Failure Failure
Bracket
vibration,
leading to Wrong Bar code
crack and 8 Drill used reader on 2
engine
failure
Part may
be Drill
Tool
concessed oversize
4 presetting 2
if from
check
approved supplier
by Design.
OP100 Hole 1 CMM

Diameter Hole Too Big Part may Weekly ball Inspection
Drill Hole 10mm +/- 0.1 need to be bar check. at OP 450
Spindle
scrapped Monthly
5 out of 4
if found laser
alignment
during alignment
process. check
Swarf pick
None 3
up on tool
Part able
Set up
to move in 3
�xture check
�xture
106
4(c) R
eview the Detection Controls and Detection Score. Calculate the RPN for each Potential
Cause (Figure 43).
The team now review the Detection Controls that have been taken from the Reference
PFMEA input and amend as necessary. Detection Controls refer to the part specific checks /
inspections carried out to detect the Potential Failure Mode and Potential Causes.
Typical Detection Controls are measurement of features, visual inspection, mistake proofing
(jigs, fixtures), etc.
Once the Detection Controls and Scoring have been confirmed the team can now calculate
the Risk Priority Number (RPN) for each Potential Cause listed in the PFMEA.
The RPN is calculated by multiplying the Highest Severity Score for the Potential Failure
Mode by EACH Potential Cause Occurrence Score and by the best (lowest) Detection Score
i.e. there should be an RPN score for each Potential Cause identified in the PFMEA.
As you can see the Cross Functional Team is now only required to discuss the items in red text.
It will cut down the time required to complete a part number specific PFMEA by around 80%.
Figure 43: Updating the Detection Controls, Detection Scoring and calculating the RPN
Occurrence
Detection
Potential Potential Potential
Class.
Requirem Prevention Detection
RPN
Sev
Op No. Failure Effects of Causes of

ent Controls Controls
Mode Failure Failure
Bracket
vibration,
leading to Wrong Drill Bar code
crack and 8 used reader on 2 96
engine
failure CMM
Inspection 6
at OP 450
Part may
be Drill oversize Tool
concessed 4 from presetting 2 96
if approved supplier check
by Design.
OP
Hole 1
100
Diameter Hole Too Part may Weekly ball
10mm +/ - Big need to be bar check.
Drill
0.1 scrapped if Spindle out Monthly
Hole 5 4
found of alignment laser 160
during alignment
process. check
In process
check
Swarf pick 5 120
None 3 using
up on tool vernier
Part able to
Set up 120
move in 3
�xture check
�xture
107
Step 5: Prioritising Improvement Actions
The team must now review the output of the PFMEA and identify the key risks and required
improvement actions.
This is done in a defined sequence;
1. What are the high severity scores (regardless of Occurrence and Detection scores) and
are we comfortable with the mitigation in place? We should always strive to mistake
proof Potential Failure Modes with Severity scores of 9 or 10.
2. What are the high severity scores (8, 9 and 10) where occurrence is also high (7, 8,
9 and 10)? – do we have sufficient Prevention and Detection Controls to mitigate the
Potential Failure Mode?
3. What are the high RPN scores and are we comfortable with the current mitigation?
4. Are there any simple controls that can be introduced to reduce the overall RPN?
NOTE: Not all RPN scores need an improvement action. It is OK to leave blank if the team
feel that there is no action required, based on the rules 1 to 4 above.
Actions must be defined in the PFMEA along with the name of the accountable person
and the target date for completion.
The revised RPN can be calculated based on the improvement action to predict the impact
of the improvement but it will only be confirmed once the action has been implemented
and proven to work.
Figure 44: Documenting Improvement Actions and Rescoring RPN
Action Results
Occurrence
Occurrence
Detection
Detection
Severity
Potential Resp. &

RPN
RPN
Causes of Target
Failure Date
Weekly
ball bar
check.
Spindle out
Monthly 4 160
of alignment
laser
alignment
check
In process
check
5
using
Swarf pick vernier
None 3 120
up on tool
Introduce air
Part able to Set up detection system M. Davies
move in �xture 3 120 on �xture to 02.5.18 8 1 5 40
�xture check ensure part is 05.05.18
loaded correctly
108
Table 18: Some Common Issues with Process FMEA Deployment
The Process FMEA is done at a generic process level and is not part speci�c.
PFMEAs must be done for a speci�c part number, as should all of the defect prevention tools.
The Product Risk (RPN) is dependent on three things (a) the purpose of the feature and the
consequences if it is non-conforming (severity) (b) the likelihood of it occurring (Occurrence) and (c)
the ability to detect the non-conformance if it happens (Detection).
Therefore, if the PFMEA does not consider the part speci�c features this Risk Pro�le cannot be
calculated.
The PFMEA cannot be completed as there is no DFMEA available.
There is often a belief that the Process FMEA team should have a copy of the DFMEA to allow
them to score the severity rating for each identi�ed Failure Mode.
In practice this is not the case. Where DFMEAs are available they are not necessarily going to
discuss individual features in the same granularity, as the PFMEA requires. It will always need the
Design representative to interpret the DFMEA to answer these questions.
Thus, even if there is no DFMEA for the part available the Design representative will be able to
describe the effects and severity of all Failures Modes in the PFMEA.
The PFMEA has been conducted by Manufacturing Engineering only.
The PFMEA is the collected knowledge from the organisation and hence for it to be accurately
captured it requires all functions that can in�uence the design and manufacturing process to be
included, in particular Design, Operations, Maintenance, Quality and the supplier (if relevant).
The PFMEA only covers ‘key features’ or ‘key process steps’.
The purpose of the PFMEA is to identify the key risks of manufacturing a speci�c product on the
proposed manufacturing / assembly process.
These risks will determine what is critical to success and hence ‘key’. If we prejudge this outcome
by only selecting what we think is key from other similar products we may miss something
important.
Therefore, it is vital for PFMEAs to be effective that they consider all process steps and features.
The PFMEA covers more than one part number grouped as a ‘family of parts’.
There is often a misconception as to what constitutes a ‘family of parts’. For this to be the case for
the PFMEA then the part must have a high level of commonality to each other i.e. more than 80% of
features are the same (purpose, speci�cations, manufacturing process, inspection process, etc.).
The PFMEA can then be ‘read across for the 80% of identical features and those which are unique
will need to be covered by an appendix PFMEA. In reality there will be very few of these, typically
only where a part number may have a variant due to design up issue or a performance variant.
109
The PFMEA has identi�ed too many Potential Causes per Failure Mode.
Often the PFMEA team will come up with a large number of Potential Causes, using such tools as
Cause and Effects analysis, to brainstorm as many ideas as possible.
If these Potential Causes are not simpli�ed then the size of the PFMEA will become excessively
large with limited value. Often many of the brainstormed ideas are actually varian ts of a single
theme e.g. Part not held in �xture could be described as ‘incorrect clamping on �xture’ ‘operator
loading causes part not be held securely’, ‘lack of �xture maintenance allows part to move during
machining’, ‘�xture damaged’.
Care must be taken to rationalise these effectively so that the issue can be clearly seen and
controlled through prevention or detection controls.
The Prevention Controls are not really ‘prevention’ controls.
Prevention Controls should be controls that can prevent the identi�ed Potential Cause from
happening. Often the Prevention Controls listed include such things as ‘Work Instructions’,
‘Operator Training’, ‘Use correct �xture’ or similar. These controls will not PREVENT the cause from
happening even though the y are ‘necessary things’ to have in place.
Prevention Controls should be things which can actually prevent the cause from happening e.g.
Fixture designis error proof and so prevents part being �tted in wrong orientation or CNC vision
system checks tool for damage before machining operation begins.
Actions are not driven based on Risk Severity.
However good the PFMEA is done it is of no value unless it drives action to eliminate or reduce
unacceptable risks from the process.
In particular for High Severity Risks Management must not allow the process to be developed that
does not mitigate the risk through error-proo�ng.
Too many times we see PFMEAs simply as a way of documenting ‘what we do today’ and not ‘what
we NEED to do’.
If the PFMEA does not identify changes to the process then it is not doing its job.
The PFMEA is completed after the manufacturing / assembly process has been de�ned.
The purpose of the PFMEA is to help in the identi�cation and development of capable
manufacturing and assembly methods. The outcome of a good PFMEA should be a number of
process changes (including measurement processes).
If the PFMEA is only being done after the method has been agreed The PFMEA will be of limited
value.
110
Further Reading:
“Potential Failure Mode & Effects Analysis (FMEA)”, 4th Edition, AIAG, 2008
PFMEA Key Questions:

1. Has the PFMEA been conducted by a cross functional team, including Manufacturing
Engineering, Design, Service, Quality and Supplier (as applicable)? Are they trained
in FMEA?
2. Is the PFMEA part number specific?
3. Has the PFMEA been started at the correct time in the development program?
4. Is the scope of the PFMEA all process steps and design requirements (features and
specification requirements)?
5. Has the PFMEA been completed using the correct template?
6. Do the Process Failure Modes describe how the design intent could fail to be met
during manufacture / assembly? i.e. product characteristics.
7. Are multiple Potential Effects identified for each Failure Mode? Have the Severity
Scores been assigned in line with the scoring criteria?
8. Are there multiple Potential Causes identified for each Failure Mode? Do they describe
how the manufacturing / assembly process could cause / allow a Failure Mode to
occur?
9. Has the Scoring criteria for the Occurrence of the Potential Causes been done using
the approved scoring criteria? Has it been applied consistently?
10. Have Prevention Controls been identified to eliminate / reduce the likelihood of the
Potential Cause from occurring? How effective are they?
11. Have Detection Controls been identified to detect the presence of the Failure Mode
and/or Potential Cause? How effective are they?
12. Has the Detection Scoring been carried out using the correct criteria? Has it been
13. Have Improvement Actions been identified based on the following priority (i) High
Severity scores (ii) High severity and high occurrence combinations, or (iii) High
RPNs.
14. Was the PFMEA completed before the Process Design was formally approved?
15. Is the PFMEA up to date and reflect learning from events?
See also the Compliance Assessment Checklist in Appendix D.
111
112
Chapter Eight
Control Plans
Creating Production Control Plans from the Process FMEA
The Production Control Plan provides a structured approach to the definition of value
added process and product controls necessary to ensure conforming product.
The Control Plan is designed to work alongside Work or Operator instructions and
provides a written summary of the controls required when producing a specific part.
The Process FMEA identifies the necessary prevention and detection controls required to
manage the associated risks for the part number being manufactured.
These controls may appear in various documents. The Control Plan and Work instructions
will typically capture the controls that are part specific whilst other controls such as
equipment calibration, coolant strength, environmental temperature and lighting, will
typically be contained within the maintenance plan or asset care requirements. This is
shown in Figure 45.
Figure 45 : Prevention & Detection Control Documentation
The cross functional team will use the Process FMEA to ensure that all of the prevention
and detection controls are adequately defined in the appropriate documentation.
An example of this is shown in Figure 46.
113
Figure 46: How the Process FMEA Prevention & Detection Controls are managed
The Production Control Plan describes the required controls required at each step
of production, from goods receiving through to despatch. It will include product
feature checks and inspections e.g. diameters, lengths, surface finishes, evidence of
damage, etc. as well as key process checks such as temperatures, pressures, torque
values, etc.
AS9145 requires the Control Plan to include all Design Requirements as well as those from
the DFMEA and PFMEA.
The aim of the Control Plan is to control the sources of variation of the product and process.
It will promote defect prevention controls, usually through the process characteristics
and seek to verify output at the earliest possible operation / step within the process
(Section 4.8.3).
It is a living document and must be updated as changes to the process, product design or
process capability are made. It should retain a link to the Process FMEA.
The Control Plan should be created using a cross-functional team using information
shown in Figure 47;
114
Figure 47: Typical Inputs to a Production Control Plan
Process Flow Diagram
Key Characteristics List
Process FMEA Control

MSA
Plan
Lessons learnt from
similar parts
MSA
Team knowledge
The Control Plan methodology is typically used at three stages of the Product Life Cycle,
these are;
1. Prototype
This is a description of the inspections and tests to be carried out at the prototype stage
of design, typically dimensional measurements, material properties and performance
tests.
2. Pre-launch
This is a description of the product verification processes, typically dimensional,

material and performance tests, used as part of APQP and PPAP used to validate the
product meets the design intent.
3. Production
These Control Plans provide a summary of the required checks of the product
and process during normal production to ensure conforming product through
the control of the sources of variation (product and process)
A standard Control Plan template is shown in Figure 48. Alternatives may be used provided
that it contains the same information (as a minimum) and has customer approval.
115
FigureFigure
48: Standard Control
48 : Standard Plan
Control Template
Plan Template
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116
A description of what is required in each part of the Control Plan is as follows;

1) Prototype / Prelaunch / Production
Tick the box to indicate the Control Plan type i.e. Prototype, Pre-launch or Production.
2) Control Plan Number
Every Control Plan should have a unique identification number.
3) Part Number / Latest Change Level
Enter the part number of the system, sub-system or component being controlled along
with the engineering change level and/or issue date of the drawing.
4) Part Name / description
Enter the name and description of the product being controlled e.g. Crank shaft,
turbine blade, etc.
5) Organisation / Plant
Enter the name of the division / plant where production is taking place.
6) Organisation Code (Supplier Code)
Enter the identification number e.g. Customer supplier code, as requested by the
customer (if applicable).
7) Key Contact / Phone and other contact information
Enter the name, telephone number and other contact information e.g. e-mail of the
primary contact responsible for the control plan
8) Core Team
The names, telephone numbers and other contact information such as e-mail
addresses, etc. for the team preparing the control plan. It is recommended that this
list be appended to the control plan and kept up to date.
9) Organisation / Plant Approval / Date
This is evidence that the responsible manufacturing plant has approved the control
plan.
10) Date (Original)
The date that the original control plan was compiled (published).
11) Date (Revision)
This is the date of the latest revision of the control plan.
12) Customer Engineering Approval / Date
Obtain the customer engineering approval for the control plan (latest revision), if
required by the customer.
117
13) Customer Quality Approval / Date

Obtain the responsible customer quality representative approval for the latest revision,
if required by the customer.
14) Other Approval / Date
Obtain any other approvals (if required).
15) Part / Process Number
This provides a link to the Process Flow Diagram (PFD) and/or the PFMEA – required
details of the part being manufactured and the process step / sequence number.
16) Process Name / Operation Description
A brief description of the operation being performed should align to the description
in the PFD and PFMEA. For example, CNC Drilling, manual assembly, etc.
17) Machine, Device, Jig, Tools for Manufacturing
For each operation described identify the processing equipment required e.g.
machine, device, jig or other tools for manufacturing as appropriate.
This is critical if the process approvals are specific to a particular equipment type or
machine number.
Characteristics
The features, dimensions or properties of a process or its output (product) on which
variable or attribute data can be collected.
18) Number
This is the feature number referenced from the drawing or specification and linked to
the PFD, Characteristics Matrix and PFMEA.
19) Product
Product Characteristics are the features or properties of a part, component or assembly
that are described on the drawing. This information can be taken from the PFMEA (if
compliant to AS13004) or the Characteristics Matrix.
The core team should identify the special product characteristics that are a compilation
of important product characteristics from all sources (DFMEA, PFMEA, Customer
inputs, etc.) All special characteristics must be listed on the control plan.
In addition, the Control Plan must include reference to all other product characteristics,
and related process characteristics, that are required to be controlled during normal
operations.
That is not to say that they must all be listed individually. Consider how they are
controlled. For example, a machining operation may produce 100 individual features.
118
The operator inspects all of these on a CMM after machining. This one activity controls
all 100 features and therefore we can group these together as a single line e.g. Features
1 to 100 on the Characteristics Matrix.
If, however in addition to this the operator is required to check a feature using a manual
gauge independently of the CMM inspection then this should be listed separately.
20) Process
Process Characteristics are the process variables that have a cause and effect
relationship with the identified product characteristic as identified within the PFMEA.
A process characteristic can only be measured at the time it occurs. The core team
should identify process characteristics for which variation must be controlled to
minimise product variation. There could be more than one process characteristic for
each product characteristic listed.
In some processes one process characteristic may affect several product characteristics.
21) Special Characteristic Classification
Use the appropriate classification as required by the customer to designate the type
of special characteristic or this field can be left blank for undesignated characteristics.
Methods (includes items 22 - 25)
A systematic plan using procedures and other tools to control a process;
22) Product / Process Specification / Tolerance
The specification requirements may be found on the drawing or other documents

such as the PFMEA, assembly documents, etc.
23) Evaluation / Measurement Technique
This column identifies the measurement system being used. This could include gauges,
fixtures, tools and /or test equipment required to measure the part or process.
AS9145 requires Measurement Systems Analysis (MSA) to be carried out on all

measurement systems and attribute inspection activities (including visual inspection)
included in the Control Plan. The MSA acceptance criteria are specified in AS13003.
24) Sample Size & (25) Frequency
When sampling is allowed, list the corresponding sample size and frequency.
119
26) Control Method
This is one of the most critical elements to an effective control plan. This column
contains a brief description of how the operation will be controlled, including reference
to detailed procedures / instructions where applicable.
The control method utilised should be based on the risk evaluation conducted when
compiling the PFMEA (as a minimum).
Typical control methods can include SPC, inspection, attribute data, mistake proofing
and sampling plans.
The method used for control should be continually reviewed for effectiveness.
Changes in product and process capability should lead to an evaluation of the control
method.
27) Reaction Plan
The reaction plan specifies the corrective actions necessary to avoid producing
non-conformance or when operating ‘out of control’. The actions should normally be
the responsibility of the people closest to the process i.e. the operator, team leader,
technical support function, and be clearly identified in the reaction plan. Any actions
taken must be documented.
Suspect and nonconforming products must be clearly identified and quarantined, and
disposition made by the responsible person designated in the reaction plan.
This column may also refer to a specific reaction plan number and identify the person
responsible for the reaction plan.
The Control Plan should be created to align to individual processes. The Control Plan
should be displayed (or made available) at the area where the production activity takes
place for use by the production team.
Therefore, the Control Plan should be structured by Operation Number so that only
the appropriate pages are shown in the area (see Figure 49).
They should work alongside the work / operator instructions and are a quick reference
guide for the operator.
120
Figure 49: Control Plan Structure
The Control Plan should describe what the operator must do during production.
Figure 50 shows how the dimensional features at a CNC drilling operation have been
grouped into a single line where the CMM inspection operation inspects all 72 dimensional
features created at this operation.
It also shows how Dimension No. 1 is required to be measured by the operator as a first off
check. This is listed separately.
Depending upon the number of features inspected at a single operation the team may
decide to list all features within the control plan. It is important that the Control Plan
remains an easy to read, simple document.
Where the features created at one operation are not inspected until a later process step
then they will not be included where they are created but at the operation where they are
inspected.
Typically, a Production Control Plan for a single operation step should be no longer than
a single page.
Controls and Reaction Plans specified within the Control Plan shall be documented within
a work instruction and/or Inspection Plan.
AS13004 describes the Control Plan as a document that can work alongside the
Inspection Plan. In my experience the Control Plan is the Inspection Plan. Personally,
I see no need for both documents to exist.
121
Figure 50: Example Production Control Plan for a Drilling Operation

Figure 50 : Example Production Control Plan for a Drilling Operation
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122
The Control Plan includes a lot of information that is also in the related part number
Process FMEA. Many FMEA software products have the ability to automatically create
the Control Plan straight from the Process FMEA, with minimal additional intervention
required.
Figure 51 shows the typical information in our Control Plan example that can be derived
straight from the Process FMEA (in red text).
NOTE :
Many companies use Manufacturing Execution Systems to deliver information to the
operator on the shopfloor via integrated software. These systems will often include the
information required in the Control Plan as described in this chapter. There is no need to
duplicate this by using a stand-alone Control Plan.
However, when submitting the Control Plan for review or as part of the PPAP Evidence
pack then it is recommended that this template is used.
123
FigureFigure
51: Control PlanPlan
51: Control Data derived
Data from
derived Process
from ProcessFMEA
FMEA (red text)
(red text)
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124
Table 19: Some Common Issues with Control Plan Deployment
The Control Plan is not available at the work station.

The purpose of the Control Plan is to be a ‘quick reference guide’ for the operator to see exactly what
checks are required to be carried out when producing / assembling a specific part number.
Therefore, along with the work instructions, these are key production reference documents that should
be referenced every time that specific part is manufactured / assembled.
The Control Plan is too large.

The Control Plan needs to be of a manageable size for the Operator to clearly see what needs to be done.
It may refer to other documents e.g. Work Instructions, for more details.
It should not list out all features that need to be inspected if they are actually measured on the CMM, for
example. This can be covered on a single line within the Control Plan.
Typically, the Control Plan will be formatted so that they are aligned to an individual operational sequence
e.g. OP10, OP20, etc. You would expect the Control Plan for a single Operation to be no more than one
page.
The Control Plan is not linked to the PFMEA and updated regularly.
The Control Plan is one of the documents that define what needs to be controlled as identified within
the PFMEA. There must be a clear link between the PFMEA and the Control Plan to ensure what was
identified has been transferred into the production controls.
Changes to the Control Plan should come from a change to the PFMEA. For example, if there has been a
customer escape and the production area has implemented a containment check then this needs to have
been derived from the PFMEA update and flowed down into the Control Plan. Once the investigation has
been concluded and the containment check is removed then this will also need to be derived from the
review / change to the PFMEA.
125
Further Reading:
“Advanced Product Quality Planning (APQP) and Control Plan”, 2nd Edition, AIAG, 2008
Control Plan Key Questions:
1. Have Control Plans been developed from the information contained in the PFMEA?
2. Does the Control Plan cover all product and process checks required during
production / assembly to ensure conforming product is produced?
3. Has the correct Control Plan Template been used?
4. Are the relevant elements of the Control Plan available at the workplace for use by
the Operator?
5. Are Key Characteristics identified on the Control Plan?
6. Are clear instructions given on what action to take if nonconforming product or out
of control conditions are found by the operator?
7. Are the non-product specific controls identified in the PFMEA included in the relevant
maintenance schedules, tooling maintenance and asset care schemes?
See also the Compliance Assessment Checklist in Appendix D.
126
Appendix A: Typical Failure Mode Library
Type Characteristic Typical Failure Modes
Too Long
Length
Too Short
Too Deep
Depth
Too Shallow
Too Wide
Width
Too Narrow
Too Big
Diameter
Too Small
Too Big
Radii
Too small
Geometry Too big

Angle
Too small
Position / Location Out of position / location error
Flatness Not �at
Too rough
Surface Finish
Too smooth
Too thick
Thickness
Too thin
Parallelism Not parallel
Circularity Not circular
Squareness Not square
127
Type Characteristic Typical Failure Modes
Concentricity Out of speci�cation
True Position Out of True position
Pitch too large

Geometry Thread Pitch
Pitch too small
Pro�le of a Line Pro�le not to speci�cation
Pro�le of a Surface Pro�le not to speci�cation
Non-porous Porosity above allowable limits
Splatter free Splatter above allowable limits
Pitting Pitting above allowable limits
Scratches Scratches above allowable limits
Too Hard
Material
Hardness
Properties
Too Soft
Free from burrs Burrs present
No sharp edges Sharp edges present
Clean Contaminated
Damage free Damaged
Part not �tted

Fit part
Wrong part �tted
Correct orientation Incorrect orientation
Over torqued
Assembly Torque to value Under torqued
Not torqued
No FOD FOD present
Too much
Apply Adhesive (any similar
material) Too little
Incorrect location
128
Incorrect location
Appendix
Appendix B: Sample B: Sample
Reference Reference
PFMEAs PFMEAs (extracts)
(extracts)
Appendix B.1 CNCB.1
Appendix Drilling – Hole Diameter
CNC Drilling – Hole Diameter
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129
Appendix B.2 Manual Assembly – Fit Seal

Appendix B.2 Manual Assembly – Fit Seal
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130
Appendix B.3 CNC Drilling – Hole Depth

Appendix B.3 CNC Drilling – Hole Depth
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131
132
Reference Failure Mode and Effects Analysis (FMEA) Manual Torque Fastening

Potential Failure Potential Cause(s)
Process Step Requirements Effect(s) of Controls Controls RPN
Mode of Failure
Severity
Detection
Failure (examples) (examples)
Occurrence
Classification
P a g e | 140
Part ki�ng boxes
Visual check at end of
Not all bolts fi�ed Missed opera�on presents the correct
opera�on by fi�er.
number of bolts to fi�er
Tool out of calibra�on Tool Calibra�on

None
(with error) schedule
Bar code check for

Over Torque Wrong tool used operator sequence and None
correct tooling
Appendix B.4 Manual Torque Fastening
Fi�er check prior to

tool is damaged None
opera�on
Opera�on not
Torque 10 M10 bolts None None
completed
OP 300 (part number xyz) into
Assembly of Outer bolt holes (1,2, to 10) at
Manifold to Hub 50 Nm and 120 degree
angle Tool out of calibra�on Tool Calibra�on
None
(with error) schedule
Under Torque
Bar code check for
Wrong tool used operator sequence and None
correct tooling
Tool incorrectly set None None
Fitter visual
No Torques applied Missed operation None inspection within
operations
Angle too big
Angle too small
Bolt damaged
Thread damaged
Appendix
Appendix B.5 Manual
B.5 Manual Paint Spraying
Paint Spraying
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133
Appendix C: Terms & Definitions
ADVANCED PRODUCT QUALITY PLANNING (APQP): This defines the set of activities
required to develop new products and processes that will ensure customer quality, cost
and delivery targets can be met.
APQP includes the entire key Defect Prevention Tools described in this book. The output
(evidence) of APQP completion is captured within the Production Part Approval Process
(PPAP) and this is evidence is used to evaluate the effectiveness of the APQP activity.
AS9145 defines the APQP & PPAP requirements for the Aerospace Industry.
AIAG: This refers to the Automotive Industry Action Group established by the automotive
industry to establish harmonized quality standards and guidance material for the
automotive industry.
Their Guidance Manuals on Defect Prevention tools such as APQP, PPAP, FMEA, Control
Plans, Measurement Systems Analysis (MSA) and Statistical Process Control are still
regarded as seminal after almost 30 years since their original publication.
BOUNDARY SAMPLE: This is a physical sample of a part that has an example of an

attribute defect that is at the limit of acceptability or non-conformance. It is a useful aid
for inspectors to make judgments when sentencing parts as good or bad.
CHARACTERISTICS MATRIX: An analytical technique for displaying the relationship

between product features, inspections, product transformations to the Operations
Sequence.
CONCESSION: A process to approve the use of a product with minor non-conformance

that has been assessed as having no impact to Safety or performance.
CONTROL PLAN: A documented description linking manufacturing process steps to key

inspection and control activities. The intent of a Control Plan is to control the design
characteristics and the process variables to ensure product quality.
CRITICAL ITEMS (CI): Those items (e.g., functions, parts, software, characteristics,
processes) having significant effect on the provision and use of the products and
services; including safety, performance, form, fit, function, producibility, service life,
etc., that require specific actions to ensure they are adequately managed. Examples of
critical items include safety critical items, fracture critical items, mission critical items, key
characteristics, etc. (refer to AS9100).
CUSTOMER: Person or organization that could or does receive a product or a service that
is intended for or required by this person or organization (refer to ISO 9000).
134
DEFECT PREVENTION TOOLKIT: These are the quality tools designed to prevent the
potential for non-conformance to be made. They include as a minimum Design FMEA,
Process FMEA, Control Plan, Measurement Systems Analysis, Process Capability Analysis,
Error Proofing and Statistical Process Control (SPC).
Typically, these are all requirements of Advanced Product Quality Planning (APQP) and
Production Part Approval Process (PPAP) although they can also bring benefits when
applied retrospectively.
DESIGN CHARACTERISTICS: Those dimensional, visual, functional, mechanical, and

material features or properties, which describe and constitute the design of the article, as
specified by drawing or Digital Product Definition requirements.
NOTE: Within AS13004 Design Characteristic is also known as Product Characteristic.
DESIGN RECORDS: The records of the engineering definition/specification, which fully

define the product (system, part, component, or assembly), including physical or electronic/
digital drawings, electronic/digital models, software, or other associated information.
This includes records of authorized engineering changes not yet incorporated into the
released engineering definition/specification.
DESIGN RISK ANALYSIS: Analytical techniques used by the design responsible organization
to identify, to the extent possible, potential failure modes related to product performance
(i.e., fit, form, and function), durability, manufacturability, and cost. A Design FMEA is one
tool that provides Design Risk Analysis.
DESIGN VERIFICATION PLAN: This is summary of the required Prevention and Detection
Controls within the design process to ensure that the proposed design meets the functional
requirements of the customer. It is derived from the Design FMEA in the same way as the
Control Plan is derived from the PFMEA.
DETECTION CONTROL: Control to detect the cause of the failure mode or the actual
failure mode after it has occurred.
FAILURE MODE AND EFFECTS ANALYSIS (FMEA): A structured method for analyzing risk
by ranking and documenting potential failure modes in a system, design, or process. The
analysis includes:
• Identification of potential failures and their effects
• Ranking of factors (e.g., severity, frequency of occurrence, detectability of the

potential failures)
• Identification and results of actions taken to reduce or eliminate risk
135
The FMEA assists in the identification of CIs as well as Key Characteristics, helps prioritize
action plans for mitigating risk, and serves as a repository for lessons learned. These
may include: System FMEA, Interface FMEA, Design Failure Mode and Effects Analysis
(DFMEA), and Process Failure Mode and Effects Analysis (PFMEA).
INSPECTION PLAN/TEST PLAN: A detailed description of inspection and test activities

(e.g., tolerances, methods, gauges) for features or attributes to be performed during
specific manufacturing operations. Meets the same intent as a Control Plan.
KEY CHARACTERISTIC (KC): An attribute or feature whose variation has a significant

effect on product fit, form, function, performance, service life, or producibility, that
requires specific actions for the purpose of controlling variation (refer to AS9100).
This definition is further explained as follows:
• Product or system KCs are those selected geometrical, material properties, functional,
and/or cosmetic features; which are measurable, and whose variation control is
necessary for fulfilling customer requirements and enhancing customer satisfaction.
• Process KCs are those selected measurable characteristics of a process whose control
is essential to manage variation of product or system KCs.
• Substitute KCs may be identified when a customer defined KC is not readily measurable,
within the production/maintenance setting, and other characteristics may need to be
controlled to ensure conformance.
NOTE: Design output can include identification of CIs that require specific actions to
ensure they are adequately managed. Some CIs shall be further classified as KCs because
their variation needs to be controlled.
ORGANIZATION: Person or group of people that has its own functions with responsibilities,
authorities and relationships to achieve its objectives (refer to ISO 9000).
PREVENTION CONTROL: Prevention control describes how a cause and/or failure mode is
prevented or how the rate of occurrence is reduced. It is used as input to the occurrence
ranking when integrated as part of the process.
PROCESS: A combination of people, material, machines, tools, environment, and methods

that produce a product or service.
PROCESS CHARACTERISTICS: Process variables that have a cause and effect relationship
with design characteristics. Process characteristics can only be measured at the time they
occur.
136
PROCESS FLOW DIAGRAM (PFD): A representation of the sequential steps of the process
which includes all operations from receipt of the material through to storage, packaging,
and shipment.
PRODUCT: Any intended output resulting from the product realization process, which in
the context of this standard includes finished detailed parts, sub-assemblies, assemblies,
forgings and castings (refer to AS9102).
PRODUCT QUALITY ESCAPE: Any product released by an internal/external supplier or

sub-tier supplier that is subsequently determined to be nonconforming to contract and/
or product specification requirements (refer to AS9131).
PRODUCTION PART APPROVAL PROCESS (PPAP): This is essentially an evidence pack

of the key APQP activities that can be evaluated by the organization, and customer if
required, to show that the required activities have been completed successfully.
PPAP typically requires the following documents to be included; Design FMEA, Process
Flow Diagram, Characteristics Matrix, Process FMEA, Control Plan, Measurement Systems
Analysis, Initial capability Studies, Inspection Report.
AS9145 defines the APQP & PPAP requirements for the Aerospace Industry.
REACTION PLAN: A plan that specifies actions necessary to avoid producing

nonconforming product, operating out of control and details containment plans to be
invoked when nonconforming product is detected.
REFERENCE PFMEA: These are PFMEAs that capture the process specific elements of a
Process FMEA that are common irrespective of the part being evaluated. They include
typical definitions for related Failure Modes, their Potential causes as well as typical
Prevention & Detection Controls.
They enable the team to quickly provide a ‘shell FMEA’ in order to create the part specific
level.
RISK PRIORITY NUMBER (RPN): The product of the severity, occurrence, and detection
rankings and is calculated for each unique failure mode and cause combination.
Example calculation:
Severity (7) X Occurrence (3) X Detection (5) = RPN 105
SHELL PFMEA: This is one of the key steps in creating the part specific PFMEA. It is where
the Reference PFMEAS have been assembled to meet the requirements of the specific
part number i.e. all features in process step order. The only columns not completed in a
Shell PFMEA are Potential Effects, Severity Score, Occurrence Score, Detection Score
and RPN.
137
The team may need to add in additional detail where they were not included within the
Reference PFMEA (or take things out that are not applicable).
SUPPLIER: Organization that provides a product or service (refer to ISO 9000).
WORK INSTRUCTION: Description of how to carry out the operations of a particular

process.
Work instruction information can include “Operation Sequence List”, “Router”, “Traveller”,
or “Shop Order”.
UNIT FMEA: AS13004 defines this as a list of ‘re-useable Failure Modes’ as shown in
Appendix A of this guide. Also known as ‘Library’ Failure Modes.
138
Appendix D: AS13004 Assessment

Appendix Checklist
D: AS13004 Assessment Checklist
Checklist Complies
Clause
Reference Category Question Comments
Reference Yes No
Number
4.1 Have the tools and methods defined within
1 Process Risk 4.1.1 this standard been deployed using a cross
Identification, functional team?
Assessment, Has the design organization completed a
Mitigation and Design Risk Analysis that identifies risks
2 4.1.2
Prevention associated with safe and proper operation of
Overview the product?
Has AS13004 been applied to all New Product

3 4.2.1
Introduction programmes?
Has AS13004 been applied to products

and/or services currently used in production
4 4.2.2 following manufacturing process changes,
transfer to a new location or being addressed
4.2 for improvement?
Applicability
Once invoked, is AS13004 being applied
throughout the lifecycle of a product, process
5 4.2.3 risk being reviewed on a continual basis and
mitigation actions being taken and actioned
on a frequent basis?
Has AS13004 been flowed to all suppliers
6 4.2.4 that manufacture and/or supply products
and services?
Are competency and training requirements
defined to support the effective
4.3
implementation of tools and methodologies
7 Training and 4.3.1
defined in AS13004? Have these been met
Competency
by the cross functional team leading the
implementation?
4.4 Does the organization have a documented
Organizational and fully implemented process within its own
8 4.4.1
Quality System quality system which meets the requirements
Requirements of AS13004?
Unless agreed with the customer, are the
PFD, PFMEA, and Control Plan part number
specific?
9 4.5.1
If process family PFD, PFMEA and Control
Plans are used, are part specific issues
identified?
Has a mechanism been defined within the
4.5
organizations quality system to ensure that
the PFDs, PFMEAs and Control Plans are
10 General 4.5.2
regularly reviewed and updated to capture
Requirements
product, process and inspection changes and
new knowledge gained during production?
Has the PFD, PFMEA and Control Plan been
11 4.5.3
linked to provide ease of read across?
For all documents produced to AS13004, is
12 4.5.4 the operation numbering and sequencing
consistently recorded?
P a g e | 149 of 152
139
Checklist Complies
Clause
Reference Yes No
Number
Where available, have all identified inputs
13 4.6.1
to the PFD been included?
Does the PFD include detail of all
operations in sequential order from
14 4.6.2
receipt of materials through storage and
4.6 shipment of finished product?
Does the PFD provide a clear and
Process Flow complete description of the process
15 Diagram (PFD) 4.6.3 required to receive, make, inspect, test,
protect, store and ship conforming
product?
Does the content of PFD align to the
16 4.6.4 requirements of AS13004?, if not, has this
been agreed with the customer?
to the PFMEA been included?, If not is
17 4.7.1
there a plan to revisit the PFMEA once
further information becomes available?
Does the PFMEA include all operations
18 4.7.4
identified within the PFD?
Have the PFMEA severity, occurrence and
detection rankings been reviewed,
updated and reprioritized following
19 4.7.5 changes to the product or process,
identification of nonconformance or when
new controls are implemented or existing
controls modified?
Does the content of PFMEA align to the
20 4.7.6.1 requirements of AS13004?, if not, has this
Have risks identified within the PFMEA
been assessed against the severity,
occurrence, and detection ranking criteria
21 4.7.6.2 as defined within AS13004?, If an
alternative ranking criteria has been used,
4.7
was this agreed in advance with the
customer?
Process Failure
Do failure modes identified within the
Mode and Effects
PFMEA consider all potential ways in
Analysis (PFMEA)
22 4.7.7.1 which the product could fail to meet
requirements or deliver the intended
function?
Are all product and process characteristics
23 4.7.7.2 and KCs associated with a potential failure
mode documented in the PFMEA?
Are all failure modes documented in the
24 4.7.7.3 PFMEA in terms that relate it to design
records?
Are all failure modes documented in the
25 4.7.7.4 PFMEA aligned to the process step in
which they be caused?
Have the effects for each potential failure
mode been identified and documented
within the PFMEA?, Do they describe,
where known, the impact on the product
26 4.7.8.1 or system performance in terms of what
the customer might notice or experience
and identify clearly if the effect of a
failure mode includes noncompliance to
regulations?
P a g e | 150 of 152
140
Clause
Reference Yes No
Number
13 4.6.1
to the PFD been included?
Deploying
Does the PFD include detail of all AS13004 to Achieve Zero Defects
operations in sequential order from
14 4.6.2
receipt of materials through storage and
4.6
shipment of finished product?
Does the PFD provide a clear and
Process Flow complete description of the process
Checklist Complies
15 Diagram (PFD) 4.6.3
Clause required to receive, make, inspect, test,
Reference Category Question
protect, store and ship conforming Comments
Reference
Number product? Yes No
Does the content of PFD align to the
16 4.6.4 Have all identified
requirements potential effects
of AS13004?, of this
if not, has
failure been ranked for
been agreed with the customer? severity?,
27 4.7.9.1 Where multiple effects of failure have
been identified has the highest severity
to the PFMEA been included?, If not is
17 4.7.1 been used as the severity ranking?
there a plan to revisit the PFMEA once
Have all information
further identified potential
becomes effects of
available?
failure been ranked for severity
28 4.7.9.2 Does the PFMEA include all operations
18 4.7.4 independently from the occurrence
identified within the PFD?
and detection rankings?
Have the PFMEA severity, occurrence and
Has the potential cause been identified
detection rankings been reviewed,
and documented in the PFMEA for
updated and reprioritized following
each potential failure mode?, Where
19
29 4.7.5
4.7.10.1 changes to the product or process,
multiple potential causes are
identification of nonconformance or when
identified, are these documented on
new controls are implemented or existing
separate lines within the PFMEA?
controls modified?
Have prevention and detection
Does the content of PFMEA align to the
controls been identified and
30
20 4.7.11.1
4.7.6.1 requirements of AS13004?, if not, has this
documented during the development
of the PFMEA?
Have risks identified within the PFMEA
Has the likelihood of the cause of
31 4.7.12.1 been assessed against the severity,
failure been raked for occurrence?
occurrence, and detection ranking criteria
21 4.7.6.2 Has the likelihood
as defined within of cause of failure
AS13004?, If an
been rankedranking
alternative for occurrence
criteria has been used,
32 4.7.12.2
4.7 independently from the severity
was this agreed in advance with and
the
detection
customer? rankings?
Process Failure Has the likelihood of detection of the
Do failure modes identified within the
Mode and Effects failure
33 4.7.13.1 PFMEAbeen ranked
consider all taking
potentialintoways
account
in
Analysis (PFMEA) detection
22 4.7.7.1 which thecontrols
productincould placefailwithin the
to meet
process?
requirements or deliver the intended
Has the likelihood of detection of the
function?
failure
Are allbeen ranked
product and independently
process characteristics
34 4.7.13.2
23 4.7.7.2 from the severity
and KCs associated and occurrence
with a potential failure
rankings?
mode documented in the PFMEA?
Has
AreaallRPN beenmodes
failure calculated for eachin the
documented
35
24 4.7.14.1
4.7.7.3 unique
PFMEAfailure
in termsmodethatand cause
relate it to design
combination
records? identified?
Has
Areaallprioritized list ofdocumented
failure modes risk prevention in the
36
25 4.7.14.2
4.7.7.4 and/or mitigation actions
PFMEA aligned to the process been step
defined
in
based
whichon RPN?
they be caused?
Has
Havethetheprioritized
effects for listeach
of risk
potential failure
prevention
mode beenand/or mitigation
identified actions
and documented
37 4.7.15.1
been documented within the
within the PFMEA?, Do they describe, PFMEA
document?
where known, the impact on the product
26 4.7.8.1 Have owners
or system and target completion
performance in terms of what
dates for the prioritized
the customer might notice list of
or risk
experience
38 4.7.15.2 prevention and/or mitigation
and identify clearly if the effect actions
of a
been defined
failure mode and documented
includes noncompliancewithin to
the PFMEA document?
regulations?
Have process KCs been identified as an
output from the PFMEA in line with
39 4.7.16.1
customer requirement and/or
organizational policy?
Have both product and process KCs
40 4.7.16.2 been recorded within the PFMEA
document?
P a g e | 150 of 152
P a g e | 151 of 152
141
Deploying AS13004 to Achieve Zero Defects Deploying AS13004 to Achieve Zero Defects
Checklist Complies
Clause
Reference
Number Yes No
Where available, have all identified

inputs to the Control Plan been
41 4.8.1 included? If not, is there a plan to revisit
the Control Plan once further
information becomes available?
Is the Control Plan aligned to the PFD
42 4.8.2 and list the controls as identified within
the PFMEA?
Has the Control Plan been prepared and
43 4.8.3 applied as early as possible in process
4.8
development?
Does the control plan comply with the
Control Plan 4.8.4 /
44 minimum requirements defined within
4.8.5
AS13004?
Have all controls identified and
documented within the Control Plan
45 4.8.6
been captured within a Work Instruction
and/or Inspection Plan?
Does the content of the Control Plan
align to the requirements of AS13004?,
46 4.8.7
If not, has this been agreed with the
customer?
P a g e | 152 of 152
142
143
© 2018 Rolls-Royce plc
The information in this document is the property of Rolls-Royce plc and may not be copied or
communicated to a third party, or used for any purpose other than that for which it is supplied
without the express written consent of Rolls-Royce plc.
This information is given in good faith based upon the latest information available to Rolls-Royce plc,
no warranty or representation is given concerning such information, which must not be taken as
establishing any contractual or other commitment binding upon Rolls-Royce plc or any of its subsidiary
or associated companies.
www.rolls-royce.com Version 1.0, November 2018

AS 13004 Practitioner Guide To Deploying

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A Practitioner’s Guide to

Process Failure Mode & Effects Analysis

THE AERO ENGINE SUPPLIER QUALITY GROUP (AESQ) 7

FOCUS ON DEFECT PREVENTION 9

INTRODUCTION TO FAILURE MODE & EFFECTS ANALYSIS 13

CHAPTER ONE AS13004 OVERVIEW 19

CHAPTER TWO DESIGN FMEA 25

CHAPTER THREE PROCESS FLOW DIAGRAMS (PFD) 45

CHAPTER FOUR CHARACTERISTICS MATRIX 51

CHAPTER FIVE PROCESS FMEAS 53

CHAPTER SIX CREATING REFERENCE PFMEAS 89

CHAPTER SEVEN USING REFERENCE FMEAS 99

CHAPTER EIGHT CONTROL PLANS 113

APPENDIX A: TYPICAL FAILURE MODE LIBRARY 127

APPENDIX B: SAMPLE REFERENCE PFMEAS (EXTRACTS) 129

APPENDIX C: TERMS & DEFINITIONS 134

APPENDIX D: AS13004 ASSESSMENT CHECKLIST 139

The Aero Engine Supplier Quality Group (AESQ)

• Increasing demand for Aero Engines

• Customers expecting Zero Defects

• Increasing supplier / partner engine content

• Increasing global footprint

• A step change in Quality, Cost and Delivery performance is required

To date the AESQ have published six standards;

AS13006 Process Control

Focus on Defect Prevention

Figure 1: Defect Prevention System (APQP & Process Control)

Advanced Product Quality Planning (APQO) &

Design Design Design for

i) The Defect Prevention Tools are a ‘System’

Throughout the application of these tools cross-functional working is critical to ensure

Introduction to Failure Mode & Effects Analysis

Examples of intentional product transformation are; drilling a hole, welding, cleaning,

Examples of unintentional product transformations are; Damage (including scratches,

How long will it take to complete an AS13004 type PFMEA?

So, what’s the benefit?

They made no changes!

The standard allows many requirements to be caveated by ‘unless approved by the

Figure 3: AS13004 Scope and Relationships

Design Risk Process failure

Cross Functional Teamwork (Section 4.1.1)

Table 1: Examples of Relevant Expertise for FMEA Development

FMEA Phase Relevant Expertise

Customer, Program Management, Design,

Customer, Program Management, Design,

Customer, Manufacturing, Assembly, Quality,

Customer, Manufacturing, Assembly, Quality,

Manufacturing, Assembly, Quality,

Customer, Manufacturing, Assembly, Quality,

Customer, Program Management, Design,

Applicability of AS13004 (Section 4.2)

Table 2: AS13004 Additional Application Guidance for products already in production

Discovery of an unknown failure mode following an in-

A change in material, method and/or measurement

Design record modi�cation including the addition of new

Training & Competency (Section 4.3)

Organisational Quality System Requirements (Section 4.4)

AS13004 requires organisations to have a defined process within its documented

If an alternative approach to that described in AS13004 is to be used it must first be

General Requirements (Section 4.5)

Figure 4: New Product Introduction Phases

Product Design &

Process Design & Development

Throughout the application of these tools cross-functional working is critical to ensure

Examples of intentional product transformation are; drilling a hole, welding, cleaning,

Examples of unintentional product transformations are; Damage (including scratches,