Design With Strut-And-tie Models - Examples

SCMH Section 7.2.
3 APQP
Revision Letter: B
Revision Date: 10-MAY-2017
www.iaqg.org/scmh Section 7.2
Aerospace APQP/PPAP Manual

Guidance material for International Aerospace
Standard 9145
Advanced Product Quality Planning

(APQP) Production Part Approval Process
(PPAP)
May 10, 2017
The intention of this document is to assist organizations with understanding the concept and
process of APQP and is not intended to be a requirement, nor auditable.
SCMH Section 7.2 APQP
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APQP Overview and Element Cards
TABLE OF CONTENTS
Page
APQP Overview 4
Phase 1 Planning - Introduction 13

0.01 Project Inputs 14
1.01.1 Product Design Requirements 16
1.01.2 Producer Product Specification 18
1.02 Project targets – safety, quality/manufacturability, service life,
reliability, durability, maintainability, schedule and cost 20
1.03 Preliminary Listing of Critical Items (CI) and Key Characteristics (KC) 22
1.04 Preliminary Bill of Material (BOM) 23
1.05 Preliminary Process Flow Chart 24
1.06 Statement of Work (SOW) Review 26
1.07 Preliminary Sourcing Plan 28
1.08 Project Plan 29
Phase 2 Product Design and Development - Introduction 31

2.01 Design risk analysis 32
2.02.1 Design records 34
2.02.2 Bill of Material (BOM) 35
2.02.3 Design for Manufacturing and Assembly (DFMA), tolerance, stack-
up analysis, etc. 36
2.02.4 Design for Maintenance, Repair and Overhaul (DMRO) 38
2.03 Special requirements, including product Key Characteristics (KCs)
and Critical Items (CIs) listings 40
2.04 Preliminary risk analysis of sourcing plan 41
2.05 Packaging specification 43
2.06 Design review report
2.07 Development product build plan 45
2.08 Design verification and validation plans, and associated results 47
2.09 Feasibility assessment 49
Phase 3 Process Design and Development - Introduction 51

3.01 Process Flow Diagram 52
3.02 Floor Plan Layout 55
3.03 Production Preparation Plan 57
3.04 Process Failure Mode & Effect Analysis (PFMEA) 59
3.05 Process Key Characteristics 62
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3.06 Control Plan 64
3.07 Preliminary capacity assessment 68
3.08 Work station Documentation 69
3.09 Measurement Systems Analysis (MSA) Plan 71
3.10 Supply Chain Risk Management Plan 74
3.11 Material handling, packaging, labelling, and part marking approvals 76
3.12 Production Readiness Review (PRR) results 78
Phase 4 Product and Process Verification - Introduction 80

4.01 Production Process Runs 81
4.02 Measurement Systems Analysis (MSA) 83
4.03 Initial Process Capability Studies 84
4.04 Control Plan 86
4.05 Capacity Verification 88
4.06 Product Validation Results 89
4.07 First Article Inspection (FAI) 90
4.08 Production Part Approval Process (PPAP) file and Approval Form 92
4.09 Customer Specific Requirements 94
Phase 5 On-Going Production - Introduction 95

5.01.1 Measuring Performance 96
5.01.2 Maintenance, Repair and Overhaul (MRO) KPIs and plan(s) to
reach the established targets 98
5.02 Continuous improvement actions 99
5.03 Lessons learned 101
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1. APQP History
The IAQG Guidance material on Advanced Product Quality Planning (APQP) and
Production Part Approval Process (PPAP) is based upon the principles of quality
planning as pioneered by Deming from the 1950s and the automotive industry during
the later decades of the 20th Century.
- GM, Ford & Chrysler collaboratively wrote and published the first APQP
manual for the automotive industry in June 1994
It is widely recognized by IAQG members that the Aerospace industry some unique
aspects that differentiates them from other industries. To meet the needs of the
Aerospace industry, the IAQG members have collaborated to develop this APQP
guidance material. In doing so, this manual addresses the unique features of this
business, like low volume, long life cycles, and high levels of regulation.
Since the initial publication of this APQP Manual, The Aerospace Industry has
developed and released the internationally harmonized standard 9145 –
Requirements for Advanced Product Quality Planning and Production Part Approval
Process. This new standard was developed by representatives from member
companies from all three sectors of the IAQG, AAQG, (Americas Aerospace Quality
Group), EAQG (European Aerospace Quality Group) and APAQG) Asia Pacific
Aerospace Quality Group).
2. Purpose of APQP
The purpose of APQP is to assure that new products satisfy customer needs and
wants. This includes product needs as well as project timing and delivery. To
accomplish this, necessary steps need to take place at the appropriate time within
the product realization process. A successful APQP project will always start with a
detailed plan based on key customer dates. A project management approach that
continually reinforces identification and mitigation of risks, monitors status of tasks
and deliverables, and escalates issues to management as necessary, is used to
implement the plan. This approach provides effective early warning signals to drive
on-time and on-quality delivery of products. Another success factor of APQP is the
establishment of a cross functional team to ensure alignment of timing,
understanding of deliverables, and avoidance of miscommunications. APQP drives
a proactive and preventative mind-set.
3. Main Pillars of APQP

APQP is supported by three main Pillars. These pillars represent the structural
needs for effective implementation of the APQP principles. (Figure 1)
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Figure 1
APQP Model
• Organizational Commitment & Management Support

Implementation of APQP is a management driven strategic decision that requires
support from the entire organization.
The information generated through the APQP process allows management to
track and pace new/modified product development activities. Highlighting risks
and monitoring status of APQP deliverables, promotes the execution of relevant
actions needed to remove roadblocks that may jeopardize completion of
requirements necessary for on-time product delivery.
• Cross-Functional Team
The use of cross-functional teams builds unity of purpose across the business. It
supports commitment and alignment with project timing and ensures effective
communication across the various business functions. The teams should include
functional representatives and stakeholders as appropriate to the project. Clearly
defined roles and responsibilities will ensure timely completion of tasks in support
of the overall project plan.
• Effective Project Planning

The project plan is based on the customer’s needs. Key targets dates are
cascaded throughout the value stream. All information is formalized into a
project plan. Progress is tracked and reported on a planned schedule.
4. APQP Principles
The APQP principles are defined in terms of phases, elements, and deliverables.
(Figure 2)
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• APQP phases represent distinct stages in the product realization process
where specific activities are completed. The end of each phase is defined
by the accomplishment of specific outputs (milestones) that support the
overall success of the project.
• Elements are the discrete activities that need to be completed during a
specific phase.
• Deliverables are tangible evidence that an activity has been completed
effectively.
Figure 2
APQP Principles
4.1 The 5 Phases of APQP are defined as follows:

• Phase 1 – Planning
Collect project inputs and set the project frame (product and process
requirements, key actors, key tasks and timing plan).
• Phase 2 - Product Design and Development
Design the product considering all identified requirements and risks.
• Phase 3 - Process Design and Development
Design the manufacturing and assembly processes considering all identified
requirements and risks.
• Phase 4 - Product and Process Validation
Validate that the process is producing the specified product at the required
rate.
• Phase 5 – Production
Reduce variation, manage any non-conformity, continuous improvement, and
feed lessons learned back into new product development projects and APQP.
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4.2 APQP Elements

APQP elements are the activities and deliverables completed during each
phase. Effective project management ensures timely completion of activities
and deliverables, and when necessary escalation and removal of roadblocks.
Effective implementation of the APQP plan results in on-time and on-quality
products delivered to the customer.
This section of the SCMH contains a complete set of standard APQP elements
for the aerospace industry. Not all elements will apply to every project. Each
new project should include an evaluation of applicability for each element. The
elements for each phase are as follows:
Phase 1 Planning
0.01 Project Inputs
1.01.1 Product design requirements
1.01.2 Producer Product Specification
1.02 Project targets – safety, quality/manufacturability, service life, reliability,
durability, maintainability, schedule, and cost
1.03 Preliminary listing of Critical Items (CIs) and Key Characteristics (KCs)
1.04 Preliminary Bill of material (BOM)
1.05 Preliminary process flow diagram
1.06 Statement of Work (SOW) Review
1.07 Preliminary sourcing plan
1.08 Project plan
Phase 2 Product Design and Development

2.01 Design risk analysis
2.02.1 Design records
2.02.2 Bill of Material (BOM)
2.02.3 Design for Manufacturing and Assembly (DFMA), tolerance, stack-up
analysis, etc.
2.02.4 Design for Maintenance, Repair and Overhaul (DMRO)
2.03 Special requirements, including product Key Characteristics (KCs) and
Critical Items (CIs) listings
2.04 Preliminary risk analysis of sourcing plan
2.05 Packaging specification
2.07 Development product build plan
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2.08 Design verification and validation plans, and associated results
2.09 Feasibility assessment
Phase 3 Process Design and Development

3.01 Process flow diagram
3.02 Floor plan layout
3.03 Production preparation plan
3.04 Process Failure Mode & Effect Analysis (PFMEA)
3.05 Process Key Characteristics (KCs)
3.06 Control plan
3.07 Preliminary capacity assessment
3.08 Work station documentation
3.09 Measurement Systems Analysis (MSA) Plan
3.10 Supply Chain Risk Management Plan
3.11 Material handling, packaging, labelling, and part marking approvals
3.12 Production Readiness Review (PRR) results
Phase 4 Product and Process Verification

4.01 Production Process Runs
4.02 Measurement Systems Analysis (MSA)
4.03 Initial Process Capability Studies
4.04 Control Plan
4.05 Capacity Verification
4.06 Product Validation Results
4.07 First Article Inspection (FAI)
4.08 Production Part Approval Process (PPAP) file and Approval Form
4.09 Customer Specific Requirements
Phase 5 On-Going Production

5.01.1 Measuring Performance
5.01.2 Maintenance, Repair and Overhaul (MRO) KPIs and plan(s) to reach
the established targets
5.02 Continuous improvement actions
5.03 Lessons learned
Note: Additional details are provided in the Element Card. Click on any
element in the list to go directly to the Element Card.
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4.3 Element deliverables
Deliverables are the specific outputs defined for each element. Evaluation of
the deliverables ensures effective completion of the activity as defined within
the element. This document includes standardized content for some
deliverables (e.g. FMEA, Control plan etc.). Standardized formats should be
used whenever possible.
Each deliverable has an associated checklist. They consist of short sets of

simple, clear, close-ended questions (designed to deliver Y/N answers). The
quality of the deliverables are assessed through the use of these checklists.
The checklist is also used to:

• document references as evidence and records of deviations,
• record corrective actions to correct deviations, and
• establish the first level of Red/Yellow/Green rating; (based on answers to
each questions).
5. APQP Management Process
APQP is applicable to all type of products (no matter their

1. Identify product complexity). It requires an increased planning and monitoring
(new or modified) effort. The organization should define where these
responsibilities lie within the organization.
The scope of the APQP project should be based on a risk
evaluation of the product and its sub-systems. Typically, risk
categories will cover technology, manufacturing processes,
supply chain performance, product criticality, and complexity.
Formally identify all project team members. Their nomination
2. Nominate team
should specify their role within the team. Main roles include
project leader, deliverable owners, and an APQP leader
(responsible for deploying APQP).
Based on product specific attributes, some of the key activities
3. Check element may not be applicable (e.g. design activities are typically not
applicability applicable for a process changed). Each activity will have an
owner identified and/or nominated. See APQP Element
Applicability template at the bottom of this section.
Where appropriate, the final product is broken down into
4. Identify the product manageable sub-components. A formal Statement of Work
breakdown and
create SOW (SOW) that defines what needs to be done and when. The
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SOW also defines the key project milestones that are the basis
for planning APQP activities.
Note: Simple products may not need to be broken down into
sub-components.
It has to be decided if the final product and the sub-
5. Decide make or components (if any) will be designed and made in-house or
buy fully/partially subcontracted. These Make-Buy decisions need
to be made as early as possible in the planning phase.
Requirements are cascaded for each subcontracted product
6. Cascade and/or sub-component. Technical requirements are formalized
requirements to in a specification and non-technical requirements in a SOW.
producer
They are the foundation of the customer/supplier agreement.
APQP element applicability may be revised based on producer

7. Update APQP feedback. For the activities under the responsibility of the
element applicability producer, the activity owner needs to be formally identified and
nominated.
Formalize updated requirements in the SOW. These can

8. Update Statement include both technical and non-technical in nature (i.e. APQP).
of Work This exercise can be done during a formal APQP kick off
meeting
When tasks, responsibilities and timing are defined and agreed

9. Agree on to by all parties, the APQP leader creates the APQP plan. The
assessment timing plan is the basis for determining the frequency of APQP
based on risks or
issues and create assessments.
APQP Plan
Using APQP checklists (key questions are proposed by these

10. Perform documents), quality of the deliverables is assessed regularly to
assessments based ensure their completion is on-time and on-quality.
on deliverables
checklists
A report that includes a summary of the assessment results is

11. Escalate issues provided to management on a regular basis. The reporting
and get management
feedback and support structure is defined by the organization but must remain
simple. Typically a checklist provides a deliverable status of
(Red/Yellow/Green) compiled for each element, and for one
product. Sub-components’ status are compiled through product
layers (as per the product breakdown). Cross layer compilation
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is based on a customer/supplier relationship (a Red status for
a subcomponent may not endanger the customer product
timing and consequently will not be escalated as Red).
6. APQP Reporting
6.1 Project Status - Red/Yellow/Green
Deliverable status is rated as Red/Yellow/Green based on the checklist status.

The basic ranking principles are as follows: (Figure 3)
Red:
Whenever a question cannot be answered with a clear yes, the deliverable
owner should provide an action to recover on-time and on-quality. When an
action plan cannot be provided or is not able to recover initial product timing, a
red should be raised: THERE IS IMPACT TO THE FINAL PRODUCT
DELIVERY SCHEDULE
Yellow:
Yellows are highlighted when the answer to the question is no, but there is a
robust action plan to recover situation: THERE IS NO IMPACT TO THE
PRODUCT DELIVERY SCHEDULE
Green:
All questions have a positive answer (Y) and are ongoing as planned
Figure 3
Red/Yellow/Green Status
6. 2 APQP Reporting
Impact of Red/Yellow status is evaluated from bottom up, i.e. managed on a

producer/customer relationship between product layers. When one product is
late (Red/Yellow), the project team will provide an action plan to recover and
escalate its status to its customer. The customer project team evaluates the
impact on its own product delivery and so on to the top product layer. The
customer layers enable necessary actions to ensure on-time delivery. (Figure 4)
The same type of reporting takes place within the organization or with external
producers. The final objective is to detect potential delays arising anywhere in
the supply chain and implement necessary actions to reduce effects as soon as
possible.
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Figure 4
Escalation Process
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Phase 1 Planning Introduction
Phase Definition:
The goal of phase 1 is to establish the framework of the project. All inputs should be identified
and captured. These inputs come from multiple sources: the customer, regulatory
requirements, benchmark data, lessons learned, company knowledge and strategy.
Comprehensive input supports the building of technical, quality and manufacturing
requirements, identification of parts to be outsourced, building of the sourcing plan, and finally
the building of the APQP plan describing all APQP activities and a schedule aligned with the
project needs. During this phase, the product and process concept becomes available, a
project team is established, and stakeholders understand what tasks need to be completed
along with the timing for their completion. Establishing a robust project plan during the
Planning phase is critical to the success of the project.
Completion of phase 1 is indicated by the finalization of the product concept, availability of the
preliminary BOM, and completion of applicable activities and deliverables defined in the
project plan.
Phase 1 Planning
0.01 Project Inputs
1.01.1 Product design requirements
1.01.2 Producer Product Specification
1.02 Project targets – safety, quality/manufacturability, service life, reliability,
durability, maintainability, schedule, and cost
1.03 Preliminary listing of Critical Items (CIs) and Key Characteristics (KCs)
1.04 Preliminary Bill of material (BOM)
1.05 Preliminary process flow diagram
1.06 Statement of Work (SOW) Review
1.07 Preliminary sourcing plan
1.08 Project plan
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Element 0.01 Project Inputs
Element Owner: Business Development/Program Management Team
Element Definition:
The project inputs should come from as many sources as possible in order to have the most
successful product launch. Project inputs should include the following five main sources:
1. Regulatory Requirements
2. Customer Needs
o Project milestones and product delivery date
o Projected volumes
o Program lifecycle
o Product and process assumptions
3. Product Performance
o Historical problems internal and external including warranty
o Reliability requirements
o Quality requirements
o Technical requirements
4. Lessons Learned
o Best practices
o Project management
o Quality issues
o Product design guidelines/procedures/data from similar product
o Process design guidelines/procedures/data from similar product
5. Company Strategy
o Business plan
o Marketing strategy
o Industrial strategy
o Technical strategy
Project inputs should include lesson learned from previous designs, producer feedback,
benchmark data, current manufacturing capability, internal/external product performance data
and reliability data, warranty data and other relevant sources.
Deliverables:
Requirements document (Statement of Work) where changes are managed and recorded.
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Necessary Inputs: Source of inputs:
Regulatory requirements Customer
Customer needs Regulatory Agencies
Product performance Sales & Marketing
Lessons learned Design Engineering
Company strategy Manufacturing Engineering
Quality Engineering
Project Manager
Resources:
Sales and marketing, design engineering, project manager
Methodology:
1. Gather regulatory and customer requirements, product performance requirements, lessons

learned and company strategy including information from previous programs and applicable
standards.
2. Identify the activities to be performed in a Statement of Work (SOW), which demonstrates
commitment to achieving the established requirements.
3. Review and finalize SOW with customer.
4. Track changes.
Reference Documents:
SCMH Section 7.2.4 Phase 1 Checklist 0.01
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Element 1.01.1 Product Design Requirements
Element Owner: Design Engineer
Element Definition:
The product (technical) design requirements are created by taking customer wants and needs,
as well as regulatory requirements and converting them into clearly defined design objectives.
Product design requirements typically include items such as:
• Functional performance
• Architecture constraints (e.g. space, interfaces, external envelop, etc.)
• Type of material
• Special processing constraints
• Weight
• Specific acceptance criteria based on attribute information (appearance, color, odor,
noise, etc.)
• Regulatory requirements (safety environment and trade compliance, etc.)
• In-house best practices & lessons learned
• Reliability
The product design requirements are intended to define and prioritize the constraints and
expectations of the product. These requirements are reviewed and mutually agreed upon with
the customer. As the result of the prioritization, a preliminary listing of CIs and KCs is defined.
Techniques such as Design for x (DFx) (six sigma, manufacturability, assembly, cost, test,
maintainability, etc.) can help focus the design by considering the specific constraints highlighted
and prioritized in the product technical design requirements, quality goals, reliability goals, &
process requirements.
Deliverables:
Configuration controlled Product (technical) Design requirement document(s) agreed upon
between producer and customer
Inputs: Source of input
Lessons learned (e.g. benchmark, warranty, Customer
performance, etc.) Sales & Marketing
Customer, regulatory & internal requirements Design Engineering
Supporting technical specifications
Resources:
Customer, Design Engineering
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Methodology:
1. Analyze data from previous programs, applicable standards, and information obtained from
customer/market, product/process design guidelines.
2. Create a formal technical requirements document.
NOTE: Concurrent engineering is a best practice to help ensure both customer needs and
supplier knowledge are considered.
NOTE: Quality Function Deployment (QFD) is a tool that can be used to conduct this
exercise.
3. Conduct a design review with the customer.
4. Obtain customer approval as required.
5. Monitor and track changes.
SCMH Section 7.2.4 Phase 1 Checklist 1.01.1
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Element 1.01.2 Producer Product Specification
Element Owner: Design Engineering
Element Definition:
The design organization (producer owned design) demonstrates in a clear product
specification that the customer’s requirements are understood and they have the capability to
support all customer’s requirements (technical, process, reliability and quality, etc.). In this
specification, the design organization will also consider its own best practices and consider
constraints in defining product requirements. The Producer Product Specification should be
reviewed and approved by a competent person within the Design Organization Authority.
Techniques such as Design for x (DFx) (six sigma, manufacturability, assembly, cost, test,
maintainability, etc.) can help focus the design by considering the specific constraints
highlighted and prioritized in the Product (technical) Design Requirements (see 1.01.1),
quality goals, reliability goals, & process requirements.
Deliverables:
Approved configuration controlled Producer Product Specification
Necessary Inputs: Source of Input
Customer reliability and quality targets Quality Engineering
Producer reliability and quality targets Design Engineering
Product KCs Quality Organization
Technical requirements Manufacturing Engineering
Producer design guidelines
Environmental and regulatory requirements
Process requirements
Resources:
Customer, Design Engineering and Manufacturing Engineering
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Methodology:
1. Collect all relevant information to support the creation of the product specification this will
include: customer technical, reliability and quality requirements, preliminary CIs/KCs for
product /program/process, supplier design guidelines, supplier technical know-how and
supplier industrial constraints.
2. Create a product specification, which captures all requirements considering the DFx
constraints identified as part of technical design requirements.
3. Review the product specification with the relevant functions and customer as required.
4. The specification is then passed onto the authorized person(s) for approval and release.
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Element 1.02 Project Targets – safety, quality/manufacturability, service life,
reliability, durability, maintainability, schedule and cost
Element Owner: Program Manager
Element Definition:
Project targets include product safety, performance, quality, manufacturability, reliability, and
service life. These targets should be based on customer expectations, regulatory
requirements, and project specific objectives. Product quality should be monitored throughout
the product lifecycle (development, series production, in service performance) using quality
metrics. The use of quality metrics is especially useful for driving continuous improvement
and customer satisfaction. The following list identifies typical project targets for these
categories:
• Product safety: safety factor of mechanical design (stress related) and λ (failure rate)
in electronic design
• Performance: customer functional requirements
• Quality: Defective Parts Per Million (DPPM), Defects Per Million Opportunities
(DPMO), Customer escapes, warranty returns, field problems, recurrent field and
manufacturing problems, RFTY First Article Inspection Reports (FAIRs) and
Production Part Approval Process (PPAP)
• Manufacturing: through put time (time to go to the whole Manufacturing process),
lead time, Right First Time Yield (RFTY), First Pass Yield
• Reliability: Mean Time Between Failure / Mean Time Between Repair / Mean Time
Between Unplanned Repair, and Operational Reliability
• Service life: time to repair (when failure occurs in service) and quality targets in
service.
Additional targets may include durability, maintainability, schedule, and cost. These targets
can be described as follows:
• Durability may include life time targets
• Maintainability may include mean-time-to-failure, turn-time, operational reliability
targets
• Product schedule target are milestones defined by the organization to execute the
activities to be performed according to their product development process
• Product and Project cost shall include total cost of ownership (development,
production, procurement, logistics and overhead cost).
All targets and metrics should be specific, measurable, agreed, actionable, reportable,
challenging and time bound.
Deliverables:
Agreed upon list of Key Performance Indicators (KPIs) covering safety,
quality/manufacturability, service life, reliability, durability, maintainability, schedule, and cost
for the complete product lifecycle
Necessary Inputs: Source of inputs
All project inputs described in element Project team, Finance
0.01 Sales & Marketing and Engineering
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Customer reliability and quality targets for Quality and Procurement
product and program
Producer (internal/external) capability
Resources:
Quality, Design and Manufacturing Engineering, Procurement, Marketing, Sales and Finance
Methodology:
1. Collect project inputs and product requirements for product and program.
2. Determine the appropriate project targets in order to meet the above.
3. Determine the associated KPIs and get approval from Quality and Program Managers.
4. Flow these goals into product and process design and to the supply chain.
5. Goal validation occurs in phase 2 thru 5.
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Element 1.03 Preliminary Listing of Critical Items (CIs) and Key Characteristics
(KCs)
Element Owner: Design Engineering and Manufacturing Engineering
Element Definition:
CIs are the items which will have a significant impact on product realization and subsequently
its use. KCs are attributes or features whose variation has a significant impact on the CI
and/or product. The impact includes safety, performance, fit, form, function, manufacturability,
service life, etc. These items require specific actions to ensure they are adequately managed
through the design and manufacturing processes.
Customer and supplier knowledge of the product and the manufacturing processes will help
determine the preliminary product and process CIs and KCs.
The determination of preliminary product and process CI/KC is done by a cross-functional
team including Design and Manufacturing Engineering (including supplier Manufacturing
Engineering) supported by Quality. It is a best practice to use Quality Function Deployment
(QFD) and previous DFMEA/PFMEA on similar product/processes.
The list of CIs/KCs becomes part of the technical requirements.
Deliverables:
A preliminary listing of CIs and KCs agreed upon between supplier and customer
Inputs: Source of Inputs
Lessons Learned Design Engineering
Design Standards (Product knowledge) Project Leader
DFMEA/PFMEA on similar products Manufacturing Engineering
Program Requirements Producer
Technical (design and process) Requirements
Resources:
Quality, Program Management, Design Engineering, Manufacturing Engineering experts (as
required)
Methodology:
1. Each involved function (Quality, Program Management, Design Engineering, and
Manufacturing Engineering) should review the technical requirements and data inputs and
create their CIs/KCs proposal.
2. The team meets and agrees on the preliminary CIs/KCs.
3. Flow preliminary CIs/KCs to product and process design and to supply chain when
necessary.
NOTE: QFD is a tool which can be used to conduct this exercise. CIs/KCs are the result.
IAQG Standard 9103 Variation Management of Key Characteristics
SCMH Section 3.2 First Article Inspection
SCMH Section 7.1 Work Transfer Management
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Element 1.04 Preliminary Bill of Material (BOM)
Element Owner: Design engineering
Element Definition:
Complex products are best managed by breaking the product into manageable sub-systems
(Product Breakdown Structure (PBS)). These sub-systems are the basis for the Preliminary
BOM and drive the early make-buy decisions.
The team should establish a preliminary BOM using PBS and considering the early
product/process assumptions. The preliminary BOM will be the starting point for subsequent
product and process design as well as supplier selection activities.
Deliverables:
• PBS for complex products and list of sub-systems showing the product assembly
hierarchy
• Preliminary BOM
Necessary Inputs: Source of input
Producer Product Specification Design Engineering
Cross-functional team
Design Standards (Product knowledge)
Manufacturing Engineering Manager
Lessons Learned Procurement Manager
Producer benchmarking and capability Supplier Performance Management
evaluation
Industrial strategy
Purchasing strategy
Resources:
Design Engineering, Manufacturing Process Engineering, Procurement/Contract, Suppliers
and Quality Organization
Methodology:
1. Design Engineering produces draft PBS.
2. The draft PBS is then reviewed and discussed with the support functions.
3. Based on inputs, the draft PBS is updated and preliminary BOM is developed.
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Element 1.05 Preliminary Process Flow Diagram
Element Owner: Manufacturing Engineering
Element Definition:
The preliminary Process Flow Diagram (PFD) provides an anticipated overview of the
sequence of manufacturing activities, from receiving to shipment to the customer. It should
also take into account the transfer operations from step to step. A well-defined preliminary
PFD supports early process planning, e.g. logistics, supplier selection and engagement,
facilities, equipment, etc.
The preliminary PFD should highlight the most critical activities, such as those requiring
longer lead times or additional qualification(s). Development of the preliminary PFD should
start once the preliminary BOM is complete. Representatives from potential manufacturing
sources should be included, as appropriate.
Deliverables:
Preliminary PFD signed off by design and manufacturing engineering, production,
procurement and quality.
Necessary Inputs: Source of input:
Technical requirements Design Engineering
Preliminary BOM Quality Engineering
Quality requirements Manufacturing Engineering
Manufacturing process expertise Procurement
Key Characteristics and Critical Items
Design Standards (product
knowledge)
Producer performance and capability
Resources:
Design Engineering, Manufacturing Engineering, Quality Engineer, Procurement,
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Methodology:
1. Cross-functional (Engineering, Manufacturing Engineering, Procurement, Quality) team

reviews the inputs from product specification, quality goals, preliminary process CIs/ KCs,
Preliminary BOM and other project inputs.
2. Manufacturing Engineering proposes a manufacturing process within which all identified
constraints have been considered.
3. Cross-functional team reaches agreement on the preliminary process flow and verifies
alignment with the BOM.
SCMH Section 7.2.9 Process Flow Diagram Template
Revision Letter: B
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Element 1.06 Statement of Work (SOW) Review
Element Owner: Customer Contract Manager
Element Definition:
The SOW is a formal document that defines the entire scope of the work involved for a
producer and clarifies deliverables and timeline. The statement of work should include:
• Deliverables and due dates
• Tasks that lead to the deliverables, and who these tasks are assigned to
• Resources needed for the project including facilities and equipment
• Specifications and procedures
• Governance process for the project.
The details in the SOW are reviewed by both parties to ensure all customer requirements are
understood and the producer has the capability to comply. A compliance matrix is useful to
summarize how the requirements will be met. Identified exceptions are resolved between
both parties and SOW is revised accordingly.
Deliverables:
• Signed SOW
Necessary Inputs: Source of Inputs:
Customer reliability and quality targets for Design Engineering
product and program Quality Organization
Preliminary BOM Manufacturing Engineering
Preliminary PFD Customer
Technical requirements Program Manager
Product and process CI/KCs
Timing requirements
Specifications and procedures
Resources:
Quality, Design and Manufacturing Engineering, Sales, Program Management, Customer
Revision Letter: B
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Methodology:
1. The customer develops and provides a formal SOW to the supplier.
2. Program Manager summarizes all customer requirements into a compliance matrix.
3. Each function confirms compliance to each item that it is responsible for and proposes
possible recovery actions for noncompliant items.
4. Supplier presents the compliance matrix to the customer for review.
5. Customer determines acceptability of the producer’s proposal and the SOW is revised
accordingly.
6. SOW is formally agreed to by both parties.
Revision Letter: B
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Element 1.07 Preliminary Sourcing Plan
Element Owner: Procurement
Element Definition:
Once the preliminary BOM is developed, the organization will begin making the initial
make/buy decisions, i.e. identify items that will be produced in-house and those that will be
outsourced. This should be done as soon as possible so that producers are engaged early in
the planning process.
A sourcing plan is developed for the identification and selection of producers that will be
supporting the development and production of outsourced items. The sourcing plan should
consider the overall program timing and ensure synchronization with program commitments.
Requirements for flow down to producers should be identified from the SOW and provided to
the producer as early as possible.
Deliverables:
• Make/buy decisions
• Sourcing plan
• Identified requirement to be flowed down to producer
Project targets Design Engineering
Preliminary BOM Manufacturing Engineering
Producer product specification Program Manager
Preliminary PFD Contract Manager
Timing requirements Procurement
SOW
List of approved suppliers and their capabilities
Resources:
Procurement, Quality, Design & Manufacturing Engineering, Program/Contract Management
Methodology:
1. The team performs an analysis for make/buy decisions.
2. Procurement is advised of items to be purchased and is provided the necessary
information regarding product and quality requirement that will be flowed down to
suppliers.
3. Procurement determines supplier’s capability based on supplier’s performance history and
similarity with previously provided products and/or services.
4. Procurement gathers key information (program timing, preliminary BOM) and develops a
sourcing plan considering the above and identifying potential risks.
5. The team agrees to the sourcing plan and the associated risks identified.
6. Mitigation plans are developed as appropriate to the level of risk.
7. Procurement implements and monitors the plan.
Revision Letter: B
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Element 1.08 Project Plan
Element Definition
The project plan defines the scope, activities, and deliverables for Advanced Product Quality
Planning (APQP). APQP activities and deliverables may vary based on product complexity,
associated risk, and customer requirements. The planning team should consider all
deliverables included herein for applicability to the project (reference: Aerospace International
Standard 9145 Appendix B).
The plan includes scheduled start and completion dates for APQP deliverables aligned with
customer, program, or project requirements. At a minimum, the plan should include key
customer driven dates (e.g. first delivery, certification, entry into service). Each activity
identified in the plan should have a designated responsible person.
The Project Plan is used to cascade dates to producers for key deliverables on the sub-
assemblies and components that makeup the product.
Adherence to the project plan ensures that each activity is completed on time and the
necessary resources are available. Progress against the plan should be monitored regularly
and delays escalated through a defined reporting process. Frequency of reviews should be
defined in the plan.
The plan is created during phase 1 and is agreed upon by and communicated to
stakeholders, including customers and suppliers (as appropriate). It will only be modified if the
overall project timing changes. Monitoring the APQP process and adherence to the timeline
is a key to successful implementation. Project Plan is the basis for the team’s commitment
and ensures success of program timing.
Deliverables:
Agreed upon timing plan that includes activities, due dates and responsible parties
Necessary Inputs: Source of input
APQP applicable task lists Cross-functional Team
Project timing requirements Program Manager
Customer
Resources:
Sales, Program Management, Design and Manufacturing Engineering, Procurement, Quality,
Customer Support, Production
Methodology:
1. Program Manager provides the key dates that may affect the project timing requirements
to the team.
2. The cross-functional team determines which APQP elements are applicable.
3. Task owners propose their preliminary timing plan to the Program Manager.
4. Program Manager collates all timing proposals.
5. The team reviews conflicts and agrees to an acceptable timing plan that will support
program targets.
6. Program Manager communicates project plan to all stakeholders.
Revision Letter: B
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7. Tasks are completed by responsible parties according to the plan timing. Risks and
challenges are identified and reported as appropriate.
8. Progress is monitored and reported at specified intervals.
9. Program Manager escalates major issues to upper management.
NOTE: As external producers are identified, they should develop their own APQP project
plan consistent with their customer’s requirements. External producers will monitor and report
their progress as requested.
SCMH Section 7.2.12 APQP Element Applicability Template
Revision Letter: B
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2.0 Phase 2 Product Design and Development Introduction
Phase 2 discusses the translation of the product requirements, as determined in phase 1, into
a controlled, verified and validated product design. During this phase the product key
characteristics, the intended production processes, and potential suppliers used to realize the
product, are identified. In addition, the feasibility of manufacture of the proposed design is
assessed by the intended production source.
Phase 2 Product Design and Development

2.01 Design risk analysis
2.02.1 Design records
2.02.2 Bill of Material (BOM)
2.02.3 Design for Manufacturing and Assembly (DFMA), tolerance, stack-up analysis,
etc.
2.02.4 Design for Maintenance, Repair and Overhaul (DMRO)
2.03 Special requirements, including product Key Characteristics (KCs) and Critical
Items (CIs) listings
2.04 Preliminary risk analysis of sourcing plan
2.05 Packaging specification
2.07 Development product build plan
2.08 Design verification and validation plans, and associated results
2.09 Feasibility assessment
Revision Letter: B
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Element 2.01 Design Risk Analysis
Element Definition:
A Design Risk Analysis is an analytical technique used to identify potential failure modes related
to product performance (i.e. fit, form, function), durability, service life, reliability,
manufacturability, maintainability and cost and to ensure that they have been considered and
addressed by the design of the product. The Design Risk Analysis is performed by the design
responsible organization and should be done early in the design phase to ensure that identified
design risks are mitigated before the design is finalized.
A Design Risk Analysis is a summary of the team’s inputs including an analysis of all
functions/features identifying those that could go wrong based on experience, past or current
concerns, as a system, subsystem or component is designed.
Design Failure Modes and Effects Analysis (DFMEA) methodology can be used as a record of
this activity (reference SAE J1739).
A Design Risk Analysis is a living document that is updated throughout the product life cycle
based on latest performance information, manufacturability, design changes, etc.
Design Risk Analysis for groups or families of parts, components, or assemblies are acceptable
if the materials, parts, components, or assemblies can be confirmed as having been reviewed for
commonality of design, function, and operating environment.
There is a close link between the Design Risk Analysis and the Process Failure Modes and
Effects Analysis (PFMEA). Updates to either may impact the other and should be taken into
account.
A safety or criticality analysis done to fulfill regulatory requirements does not address the same
scope as a Design Risk Analysis and cannot be substituted for or considered an equivalent.
Deliverables:
• Design Risk Analysis highlighting design risks
• Recommended actions for risk mitigation
• Identification of CIs and product KCs
Necessary Inputs: Source of Input:
Technical specification Design Engineering
Past product performance test results Cross-functional Team
Lessons learned
Resources:
Customer, Quality Engineer, Design Engineering, Manufacturing Engineering
Revision Letter: B
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Methodology:
The following steps apply when the DFMEA is used to perform the Design Risk Analysis:
1. Determine the function, features or requirements of design.
2. Identify and document the potential failures.
3. List the effects of the failure.
4. Rank the severity of the failure.
5. List the potential causes of the failure.
6. List the preventive methods taken to eliminate the cause.
7. Rank the frequency of each specific cause occurring.
8. List the detection methodology(s).
9. Rank effectiveness of the detection methodology(s).
10. Determine the Risk Priority Number (RPN), calculated as follows:
• Severity of the risk X Likelihood of occurrence X Ease of detection
• The higher the number, the higher the risk and the need to undertake an action to
remove/reduce/detect the root cause(s) which generates the risk.
11. Select the recommended actions to be implemented, as needed.
12. After implementation of the recommended actions, re-rank Severity, Occurrence, Detection
based on evidence of the effectiveness of the actions.
13. High risk items should generate a Key Characteristic in order to detect and control the risk.
These will be considered during the Process FMEA
SAE J1739 Potential Failure Mode and Effects Analysis in Design (Design FMEA), Potential
Failure Mode and Effects Analysis in Manufacturing and Assembly Processes
(Process FMEA)
SCMH Section 7.2.10 Design FMEA Template
Revision Letter: B
Page 34 of 101

Element 2.02.1 Design Records
Element Definition:
Design Records are the output of the design process and are based on the Product Design
Requirements and the SOW established in phase 1. These records are engineering
documents that define all aspects of the product. They include:
• Physical or electronic/digital drawings
• Electronic/digital models
• Software
• Special process specifications
• Material specifications
• Supplementary specifications
• Customer specifications
• Product Function (Input / Output)
• Product Envelope (Size & Weight)
• Appearance specifications (if any)
• Product KCs.
Design records also include authorized engineering changes not yet incorporated into the
released engineering definition / specification.
Deliverables:
Complete engineering definition / specification of the product, which satisfies the requirements
as defined in phase 1 and is approved by the Design Authority.
Statement of Work (SOW) Customer
Lessons learned Program Management team
Product breakdown structure (PBS) Design Engineering
Design Risk Analysis output Manufacturing Engineering
Resources:
Design Engineering
Methodology:
1. Consider output of phase 1 elements.
2. Incorporate all aspects of the design into the Design Records.
3. Review the Design Records to ensure they satisfy all applicable product requirements.
4. Submit Design Records for Design Review.
5. Implement design changes as defined by Design Review.
6. Approve Design Records and apply configuration control.
7. Provide approved Design Records to the producer(s).
Reference Document
Revision Letter: B
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Element 2.02.2 Bill of Material (BOM)
Element Definition:
The Bill of Material (BOM) is the list of all components and materials contained in the Design
Records required to produce a finished product. The preliminary BOM, defined in phase 1,
continues to mature through the design synthesis of phase 2.
In this phase, the BOM is fully defined and released for production. All future revisions are
controlled through the configuration management process.
Deliverables:
Released BOM
Preliminary BOM Design Engineering
Product breakdown structure
Output of DFMA (element 2.02.3)
Output of DFMRO (element 2.02.4)
Resources:
Design and Manufacturing Engineering, Quality
Methodology:
1. Update the preliminary BOM.
2. Execute cross-functional reviews as appropriate, including outputs of DFMA and DFMRO.
3. Release the BOM and include it in the approved Design Records.
Revision Letter: B
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Element 2.02.3 Design for Manufacturing & Assembly (DFMA), tolerance, stack-up
analysis, etc.
Element Owner: Product Engineering and Manufacturing Engineering
Element Definition:
This element emphasizes the need for collaboration between Product Design Engineers and
Manufacturing Engineers to ensure that:
• The design process considered the manufacturing processes, such that the design
solution delivers quality products, which can be fabricated and inspected in an efficient
and cost effective manner.
• Stack up analysis was performed to confirm that the product will function and can be
assembled as intended.
• The design process has considered the assembly processes and tooling capability such
that the parts can fit together and that the intended tools, including any inspection
devices, could be inserted into and extracted from the assembly needed. This includes
ergonomic considerations of the space for the assembler’s hands or fingers, line of sight,
etc.
• Materials, such as specialized materials, electronic chips, will be available over the life of
the product, and, as needed, a plan for obsolescence and/or alternate material has been
established.
During the design collaboration, additional consideration is to be given to common failure modes
of the manufacturing processes with an approach to design them out. Preliminary PFMEA
should be developed concurrently with the design risk analysis to support this design element.
Rapid prototyping of parts can be used to validate the design analysis.
Deliverables:
A design that meets customer requirements and meets:
• program quality goals for First pass yield (FPY) or Defects per million opportunities (DPMO)
• applicable manufacturing standards
• Factory Standard Cost and lead time goals
• inspection/testing requirements
Manufacturing capability data Manufacturing Engineering
Preliminary process flow diagram Design Engineering
Technical design requirements Quality Engineering
Quality performance data Quality Organization
Process planning
Assembly standard practices
Catalogue of highest risk assembly hazards
Visualization and clash detection software
Resources:
Design Engineering, Manufacturing Engineering, Quality Engineers, Process Planner
Revision Letter: B
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Methodology for Manufacturing:
1. Gather defect data from the manufacturing of similar parts.
2. Review the technical design requirements.
3. Review the design, feature by feature, to understand how each will be manufactured and
inspected.
4. Identify difficult to produce or inspect features or geometric relationships.
5. Identify materials that are difficult to obtain or have high potential of obsolescence.
6. Identify features that drive ‘out of the cell’ process steps or other inefficient manufacturing
practices (such as extra tool passes).
7. Identify features that have been problematic based on the history of prior parts.
8. If possible, modify the design to remove features revealed in 4, 5, 6 and 7.
9. If features from 4, 5, 6 and 7 cannot be removed, task Manufacturing Engineering to look at
alternate manufacturing or inspection approaches to mitigate the risks.
10. Consider error-proofing techniques.
Methodology for Assembly:
1. Gather assembly data of similar assemblies.
2. Review the new design, considering each assembly step and how it can fail or how its
associated inspection can fail, consider error-proofing techniques.
3. Identify difficult to assemble sequences, excess steps, or ‘out of the cell’ sequences.
4. Identify assemblies that have been problematic in the past based on historical assemblies.
5. If possible, modify the design to remove the difficulties identified in 2, 3 and 4.
6. If the assembly cannot be redesigned, task Process Planning to design assembly sequences
and tooling that mitigate the identified risks incorporating error-proofing techniques as
appropriate.
Revision Letter: B
Page 38 of 101

Element 2.02.4 Design for Maintenance, Repair and Overhaul (DMRO)
Element Owner: Product Engineering, Manufacturing Engineering and Aftermarket Technical
Support
Element Definition:
A unique feature of aerospace products is that the product lifecycle may span decades. This
drives a disciplined maintenance, repair and overhaul activity.
Collaboration is required between Product Design Engineers, Manufacturing Engineers and
Aftermarket Technical Support to ensure that:
• The design solution provides for in-service maintenance features that allow use of
diagnostic tools and consumable components to be easily removed and replaced.
• The design solution results in components that can be repaired on the equipment
available at the repair supplier and re-qualified to overhaul tolerances.
• Where repair is to be made in the installed condition, or away from a repair station, the
design solution should allow for repair using portable tools. This includes ergonomic
consideration of the space for tools, the repair mechanic’s hands or fingers, line of
sight, effects of wind, rain, airborne contaminants, etc.
• The design synthesis considers the needs of disassembly and assembly at overhaul.
• Classed components should have a sufficient range of classes defined on the drawing
to address the range demanded by assemblies with service time.
In the course of the design collaboration, additional consideration is to be given to common
failure modes of the maintenance, repair or overhaul processes with a view to designing them
out where possible (see also Phase 5 Maintenance, Repair and Overhaul (MRO) KPIs and
plan(s) to reach the established targets).
Recommendations should emerge from the design cycle for development tests of the repair
processes to demonstrate successful repair/overhaul sequence execution and repair
durability. Program management should plan to have development hardware available for this
purpose.
Deliverables:
• A design solution that ensures that repair and overhaul of the product meets the lead time
and cost goals established
• A list of recommended tests or repair procedures to be validated in the design verification
and validation test plan.
Revision Letter: B
Page 39 of 101

Manufacturing capability data Manufacturing Engineering
Process planning best practices Design Engineering
Assembly standard practices Customer Services
Catalogue of highest risk assembly hazards
Design software with visualization and
clash detection capability
Maintenance Repair and Overhaul Data
Repair best practices
Overhaul best practices
Maintenance best practices
Resources:
Design Engineering, Manufacturing Engineering, Aftermarket Technical Support
Methodology for Maintenance:
1. Gather defect data from the maintenance, repair and overhaul history of similar products.
2. Review the new design feature by feature to understand how each will be maintained,
restored by repair and rebuilt into the assembly.
3. Create repair time targets.
4. Identify difficult to maintain, repair or rebuild features.
5. Identify features that drive extra maintenance burden or repair process steps or other
inefficient manufacturing practices.
6. Identify features that have been problematic based on the history of prior products.
7. If possible, modify the design to remove features identified in 4, 5 and 6.
Revision Letter: B
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Element 2.03 Special requirements, including product Key Characteristics (KCs)
and Critical items (CIs) listings
Element Definition:
Special requirements have a high risk of not being achieved. Examples include performance
requirements imposed by the customer that are at the limit of the industry’s capability, or
requirements determined by the organization to be at the limit of its technical or process
capabilities. Factors used in the determination of special requirements include product or
process complexity, past experience, and product or process maturity.
Preliminary critical items (CIs) and key characteristics (KCs) are identified in phase 1. During
the design processes and the Design Risk Analysis of phase 2, the preliminary list of CIs and
KCs should be reviewed. Additions to the list will be made when new risks, which cannot be
eliminated by design, need to be controlled by key characteristics. The CIs and KCs are
indicated in the design records. The finalization of critical items and key characteristics is an
output of the Design Risk Analysis and PFMEA.
Deliverables:
List of the CIs and KCs.
Product design Customer
Customer specifications Design Engineering
Design Risk Analysis and PFMEA Manufacturing Engineering
Preliminary CIs and KCs list Quality Engineering
Resources:
Design Engineering, Manufacturing Engineering, Quality Engineering
Methodology:
1. Consult the list of CIs and KCs determined in 1.03 Preliminary listing of Critical Items (CIs)
and Key Characteristics (KCs).
2. Conduct the Design Risk Analysis identifying high risk areas that cannot be designed out.
3. Conduct the design synthesis of DFMA and DMRO identifying high manufacturing risk
areas that cannot be designed out.
4. Identify high manufacturing risk areas from the preliminary PFMEA(s) that cannot be
removed by process changes.
5. During steps 2, 3 and 4, identify CIs and KCs that, when in control, reduces the risks to an
acceptable level.
6. Update the preliminary CIs and KCs list with the new information.
International Aerospace Standard 9103 Variation Management of Key Characteristics
Revision Letter: B
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Element 2.04 Preliminary Risk Analysis of Sourcing Plan
Element Owner: Manufacturing Engineering, Procurement, Program Management
Element Definition:
Risk associated with supplier selection should be identified and mitigated as appropriate and
as early as possible. These risks may be associated with technology, logistics, lead-time,
potential for part obsolescence, authenticity (counterfeit parts prevention), sole source, etc.
Judicious supplier selection is the first step towards minimizing supplier risk.
The sourcing risk evaluation should include:
• Capacity
• Capability
• Performance (quality and delivery history of existing suppliers)
• Financial stability
• Certifications, as required, 9100, 9110, 9120, Nadcap, etc.
• Regulatory requirements e.g. DOD, ITAR and other requirements
• Logistics/Location
• Total cost
• New site/source qualification
• Customer specific requirements.
Selected and/or potential suppliers should provide input to this risk analysis and its mitigation
plan.
NOTE: The risk analysis of the sourcing plan is initiated in this phase and will continue
through all subsequent phases.
Deliverables:
A sourcing plan with identified risks, aligned by each proposed supplier, and the mitigation
plans
Technical Design requirements including: Regulatory Agencies
Product technology requirements Customer
Manufacturing technology requirements Design Engineering
DFMA requirements Manufacturing Engineering
DFMRO requirements Procurement
Approved supplier list Suppliers
Supplier data/performance history (see list
above)
Regulatory requirements
Resources:
Design Engineering, Suppliers, Manufacturing Engineering, Procurement, Quality
Methodology:
Revision Letter: B
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1. Select suppliers that are likely to be capable of supporting the design effort and that are
capable of producing the make to print or proprietary design elements.
2. Review all design requirements or all proposed design features for any risks they pose to
successful manufacture at the rate required by the program. Consider risk related to
technology, logistics, lead-time, potential for part obsolescence, authenticity (counterfeit
parts prevention), manufacturability, etc.
3. Identify areas of concerns.
4. Review and propose appropriate risk mitigation actions and document them in the plan.
5. If applicable, provide input into the design change process and document it.
6. Use Design Reviews to review mitigation activities.
7. Apprise stakeholders of progress and additional resource needed.
Revision Letter: B
Page 43 of 101

Element 2.05 Packaging specification
Element Definition:
To support a successful product launch it is essential that there is proper definition and
planning for all new packaging required to handle and ship the product to subcontractors or to
the customer.
This planning should also consider the refurbishment or modification of any existing
packaging.
Deliverables:
Packaging specification agreed with the customers, where appropriate.
Process flow diagram Manufacturing Engineer
Internal packaging standards Packaging Engineer
Definition of packaging requirements & Customer
standard from customer (where defined) Traffic and Logistics
Import/export regulations
Resources:
Manufacturing Engineering, Procurement (for outsourced processes), Packaging Engineer,
Production, Quality
Methodology:
1. Consider the packaging requirements for transporting product between each process step
from receipt of initial goods through arrival at the customer.
2. Consider customer and regulatory requirements where applicable.
3. Points to consider during packaging design should include:
• Damage prevention (impact, electrostatic damage, etc.)
• FOD (Foreign Object Debris) from inappropriate packaging materials
• Weight and size of packaging/container
• Hazardous materials
• Labeling and marking requirements
• Lessons learned from other projects and from past quality issues
• Test shipment (where feasible) to validate as early as possible
Revision Letter: B
Page 44 of 101

Element 2.06 Design Review Report
Element Definition:
A design review is a systematic and regularly scheduled cross-functional review of
engineering drawings, specifications, functional requirements, material specifications and any
changes to product related requirements. The purpose of a design review is to keep
appropriate members of the organization, management team and customer (if applicable)
apprised of the design activity verification progress, to identify potential problems, propose
corrective actions, review proposed design changes and authorize progression to the next
stage of the development process. Each review should demonstrate how the design
requirements are fulfilled. In addition, the design requirements of DFMA and DFMRO should
be incorporated without compromising conformance to product specification.
Deliverables:
Design review reports highlighting compliance status, design risks and mitigating actions
Engineering drawings Design Engineering
Engineering specs, functional requirements Quality Organization
Material specifications Customer
Changes to drawings or specifications Manufacturing Engineering
Output of design verification and validation
evaluations
Output of Design Risk Analysis, e.g. DFMEA’s
Outputs of DFMA and DFMRO
Resources:
Engineering, Customer, Suppliers, Supplier Quality, Quality, Purchasing.
Methodology:
1. Receive required inputs from appropriate stakeholders.
2. Review status of follow-up actions from previous design review.
3. Systematically evaluate inputs against the plan, including test plans and quality plans.
4. Identify areas of concern.
5. Review and propose appropriate actions to mitigate risks, delays, and other concerns.
6. Apprise stakeholders of progress, planned actions to mitigate identified risks and the need
for additional resources.
7. Obtain concurrence from stakeholders to proceed to the next stage of the design process.
8. Evaluate changes to the design as they are proposed.
9. Provide input into the design change process.
Revision Letter: B
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Element 2.07 Development Product Build Plan
Element Owner: Product Development Team
Element Definition:
A Development Product Build Plan establishes the product manufacturing requirements,
inspections and assembly sequences to be performed to build pre-production products for
product and process evaluations. The plan may need to be approved by the customer.
The plan should define:
• Sources of material, components and assemblies
• Minimum technology and manufacturing maturity levels for each product/part
• Manufacturing processes to be used
• Quantity of parts required
• Detailed schedule for the manufacturing, inspection and reporting activities.
Lessons learned during the manufacture/build process may signal the need for design
changes or process improvements.
Deliverables:
• A Development Product Build Plan that defines the items as detailed above.
• Formal reports documenting the outcome of the manufacture/build process including a
record of the discrepancies that arise along with their proposed solutions.
Product design inputs Voice of the Customer
Customer specifications Design Engineering
Proto parts meeting design intent
Technical Design Requirements (TDR)
Preliminary Statement of Work
Resources: Product Development Engineers, Certification Specialist Engineers
Revision Letter: B
Page 46 of 101

Methodology:
1. Refer to standard work instructions to identify tests/inspections known to validate the
product.
2. Align the build plan with the verification and validation needs.
3. Identify inspection requirements including any additional inspections needed for new
and/or unique features.
4. Identify the resources; product hardware, inspection facilities, assembly tooling needed to
meet the build plan intent. Include the necessary product maturity levels needed for each
build defined in the plan.
5. Create a master build plan that defines the timeline and resources for every validation
event.
• The requirement for formal report of each build activity should be included in the plan.
• The plan should consider the impact of progressive release of design information.
6. Execute the Development Product Build Plan, track and report progress at the Design
Reviews.
Revision Letter: B
Page 47 of 101

Element 2.08 Design verification and validation plans, & associated
results
Element Owner: Product Development Team
Element Definition:
Design verification and validation activities are performed to verify conformance to design
intent and to validate Product Design conforms to customer requirements. These activities
typically include:
• Prototype testing (including trial builds)
• Computer analysis and simulations
• Physical and functional simulations.
The verification and validation plan should include a detailed schedule of the above activities
as well as hardware availability, inspection and reporting activities. Prototype testing, should
include:
• Tests and inspections to be performed on each component or assembly and their
related success criteria
• Test(s) specifically requested by the customer.
Results of the design verification and validation activities are documented in formal reports
and reviewed during the Design Reviews.
Selected reports may be submitted to customers or regulators for certification purposes.
Deliverables:
• A Design Verification and Validation Plan that defines the items as described above.
• Formal reports documenting with objective evidence that the Technical Design
Requirements have been fulfilled.
Product design inputs Customer
Customer specifications Program Manager
Prototype parts meeting design intent Design Engineering
Technical Design Requirements (TDR) Producer
Statement of Work
Resources: Design Engineering, Airworthiness Specialist
Revision Letter: B
Page 48 of 101

Methodology:
1. Ensure that the TDR are updated with all additional requirements that emerge from the
design process.
2. Include all verification and validation activities needed or requested by the customer for
their own product validation needs.
3. Refer to standard work instructions to identify all methods and tests/inspections known to
validate the design.
4. Identify the resources needed to execute.
5. Follow the build plan, which has established the timeline and resources needed for every
validation event.
• The generation of formal reports for each activity is included in the plan.
• The plan should consider the impact of progressive release of design information.
6. Use the Design reviews to track progress to the plan.
7. Each verification and validation activity closes when the formal reporting is completed and
noted discrepancies are resolved.
Revision Letter: B
Page 49 of 101

Element 2.09 Feasibility Assessment
Element Definition:
The design record should be reviewed by the producer for manufacturing feasibility to confirm
that the product can be manufactured to the defined requirements and specifications, qualified
and tested, packaged and delivered, in the quantity desired and within the program budget and
timing targets.
The outcome of the review is a commitment based on the consensus of a producer’s team
typically consisting of design engineering, manufacturing engineering, production and quality.
This commitment should be in a report that scores each element under consideration, as being
favorable or unfavorable, with the noted recommendation to proceed. The report should identify
the impact or proposed changes to meet standards for those elements identified as unfavorable.
Deliverables:
A Team Feasibility Commitment Report which:
• lists all unfavorable issues with their impact and a plan to mitigate/eliminate the issues
• documents the organization’s commitment, if it has been granted, to produce the product
• confirmation by the production source that the part can be made successfully
Manufacturer product specification Design Engineering
List of key characteristics Manufacturing Engineering
Quality Engineering
Resources:
Program Manager, Design Engineering, Manufacturing Engineering, Operations
Revision Letter: B
Page 50 of 101

Methodology:
1. The producer’s planning team compares requirements against current and planned
capabilities with special attention to product nonconformance and develops a report.
2. The outcome of the review is a commitment based on the producer’s ability to meet the
requirements. If gaps are identified proceed to step 3, otherwise proceed to step 6
3. Gaps are highlighted and potential resolutions are proposed.
4. Resolutions that require customer input are shared with the customer. Decisions may be
deferred until the customer agrees to the resolution.
5. Resolutions that can be controlled by the producer are documented in closure plan.
6. Producer documents the commitment to manufacture the product.
Revision Letter: B
Page 51 of 101

Phase 3 Process Design & Development Introduction
Phase Definition:
During phase 3 the processes and methods for producing the product are designed and
developed. This activity includes producers, both internal production and the external
suppliers. Phases 1 & 2 constitute necessary inputs to ensure that the teams developing the
manufacturing processes clearly understand the customer’s requirements, the design
requirements, and the manufacturing organization’s requirements. Planning for the
manufacturing processes is started as soon as sufficient product information is available. The
design and development activities should include early engagement of producers, as
appropriate, to ensure that requirements are understood and can be consistently fulfilled by all
producers in the supply chain. The Production Readiness Review (PRR) at the end of this
phase, held at the intended manufacturing site, provides the team and the customer with
confidence that the process is capable of producing product consistently and in compliance
with customer and producer requirements.
Phase 3 Process Design & Development

3.01 Process flow diagram
3.02 Floor plan layout
3.03 Production preparation plan
3.04 Process Failure Mode & Effect Analysis (PFMEA)
3.05 Process Key Characteristics (KCs)
3.06 Control plan
3.07 Preliminary capacity assessment
3.08 Work station documentation
3.09 Measurement Systems Analysis (MSA) Plan
3.10 Supply Chain Risk Management Plan
3.11 Material handling, packaging, labelling, and part marking approvals
3.12 Production Readiness Review (PRR) results
Revision Letter: B
Page 52 of 101

Element 3.01 Process Flow Diagram
Element Definition:
The Process Flow Diagram (PFD) is a representation of the sequence of operations required
to manufacture the product from receipt goods to shipment of finished product to the
customer. This encompasses the movement of product internally from one-step to the next, as
well as movement to and from external operations. It also includes alternate processes, i.e.
different processes used to achieve the same output (e.g. backup equipment, secondary
sources, d sequence change). The PFD requires sufficient detail for each step to clearly and
completely describe the process required to make the product.
This activity should start once the preliminary design is released and should build upon the
preliminary process flow diagram created in phase 1.
The Process Flow Diagram is updated as changes to the process sequence are made.
Once this document is released, changes should be revision controlled.
Deliverables:
Process Flow Diagram approved by Engineering, Operations and Quality.
Preliminary Process Flow Diagram Design Engineering
Design Risk Analysis e.g. DFMEA Quality Engineering
Design Records Manufacturing Engineering
Bill of Material Procurement
Key Characteristics
Tooling and Equipment
Outsourced Processes
Packaging Specification
Resources:
Manufacturing Engineering, Quality Engineering, Process Planner
Revision Letter: B
Page 53 of 101

Methodology:
1. The Preliminary PFD is updated to reflect the latest design, BOM, and process details.
2. The team reviews PFD to ensure that:
• all process steps are included and completely describe the process required to
receive, make, inspect, test, protect, store, and ship product,
• alternate processes are included, and
• movement to internal and external operations are included.
3. The KC’s and CI’s are incorporated into the Process Flow Diagram.
4. The proposed PFD is reviewed by Engineering, Operations, and Quality, and approved or
amended as appropriate.
5. Update PFD as changes are incorporated into the process
Revision Letter: B
Page 54 of 101

SCMH Section 7.2.9 Process Flow Diagram -Template
AS13004 Process Risk Mitigation
Revision Letter: B
Page 55 of 101

Element 3.02 Floor Plan Layout
Element Owner: Manufacturing Engineer
Element Definition:
The floor plan layout will clearly show the position and layout for all processes used to
manufacture, inspect, and test product. Quality Control location points should be identified on
the layout.
Synchronous material flow and floor usage optimization should be taken into account when
performing the layout in an effort to economize space usage, increase the value added
efficiency of floor space, and minimize travel and handling of materials, parts, and assemblies.
Lean Principles such as Value Stream Mapping (VSM) and Spaghetti Diagram techniques can
be used in support of this effort.
Deliverables:
Plant layout plan approved by the Operations and Quality Managers.
Process flow chart Manufacturing Engineering
Equipment list Facility Management
Existing plant layout plan Lean Experts
Value Steam Map & Spaghetti Diagrams (if
available)
Building Layout
Resources:
Manufacturing Engineering, Operations Manager, Quality Engineering, Quality Manager,
Facility Engineering, Lean Experts, Health Safety & Environment Representative
Revision Letter: B
Page 56 of 101

Methodology:
1. Manufacturing Engineer develops a draft layout plan to map a physical flow which is
appropriate to produce the product including Quality Control locations.
2. Cross-functional review with Production, Quality, Facilities, and Maintenance to optimize
the draft plan using relevant experience, lessons learned, and best practice
benchmarking.
3. Equipment relocated/placed (when it becomes available) as planned.
4. Manufacturing Engineer updates the layout plan in accordance with the inputs, and
obtains formal agreement from Operations and Quality Managers.
Revision Letter: B
Page 57 of 101

Element 3.03 Production Preparation Planning
Element Definition:
The producer should identify and plan for equipment, tooling, fixtures, and jigs required to
produce and qualify product. This activity includes the following:
• Analyzing the capacity of existing equipment and facilities,
• Assessing the need for additional capacity on existing equipment and/or the refurbishment
or modification of any existing equipment, tooling, jigs, or fixtures and testing equipment
• Determining the need for new equipment, tooling, and facilities for new processes
• Identifying skills, training, and manpower required, including external certifications
The producer should develop a Production Preparation Plan and track progress on a regular
basis to promptly identify and react to delays or problems. Status of the plan is communicated
to the customer as required.
Deliverables:
• A Production Preparation Plan covering all aspects of obtaining and qualifying human
resources, tooling, facilities, and equipment
• An Agreed progress reporting schedule
Process Flow Diagram Manufacturing Engineering
Current and Future Plant layout Production Planner
Capacity analysis Human Resources
Specifications for all tooling and equipment Quality Engineering
Skills assessment
Manpower assessment
Resources:
Manufacturing Engineering, Quality Engineering, Procurement, Program Manager,
Operations, Facility Engineering, Human Resource Manager, Health Safety & Environment
Representative
Revision Letter: B
Page 58 of 101

Methodology:
1. Determine facility/equipment/tooling/personnel necessary to meet the customer demand

rate.
2. Analyze the capacity of existing equipment and facilities.
3. Determine if additional capacity on existing equipment and/or the refurbishment or
modification of any existing equipment, tooling, jigs, or fixtures and testing equipment is
needed.
4. Identify the need for new equipment, tooling, and facilities for new processes or expansion of
capacity.
5. Define skills, training, and manpower required, including external certifications
6. Develop a plan to include all aspects of obtaining and qualifying human resources, tooling,
facilities, and equipment.
7. Obtain cross-functional agreement on the production preparation plan and establish a
schedule for regular reviews to monitor progress.
Revision Letter: B
Page 59 of 101

Element 3.04 Process Failure Mode and Effects Analysis (PFMEA)
Element Definition:
A PFMEA is a structured method for analyzing process risk by ranking and documenting potential
failure modes within a 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),
and
• identification and results of actions taken to reduce or eliminate risk.
The producing organization performs a risk analysis of the manufacturing process and identifies
mitigation plans for high risks using the PFMEA methodology (reference SAE J1739). The PFMEA
assists in the identification of process KCs, helps prioritize action plans for mitigating risk, and
serves as a basis for continuous improvement, and a repository for lessons learned.
The PFMEA is developed by a cross-functional team during the design and development of the
manufacturing process. The PFMEA should be under continuous review and updated
appropriately, as the process is being developed.
Special attention is given to high Severity rankings. Risk reduction activities are prioritized based
on Severity Occurrence (SO), Severity Detection (SD) and Risk Priority Numbers (RPN) derived in
the PFMEA process. Further information on the PFMEA and the assignment of RPN’s is available
in the SCMH Section 2.1 Quality Aspects of New Product Development and in AS13004 Process
Risk Mitigation.
CIs and KCs, identified in the design records, Design Risk analysis, and by customers, are
documented and evaluated in the PFMEA.
The PFMEA is continually updated as process changes occur, non-conformances arise, and risks
are identified and addressed.
There is a close link between the PFMEA and the Design Risk Analysis. Updates to either may
impact the other and should be considered.
Deliverables:
Completed approved PFMEA and a plan to reduce high priority risks.
Process Flow Diagram Design Engineering (internal or customer)
Quality performance data (similar parts & processes) Manufacturing Engineering
PFMEA (similar parts & processes) Quality Engineering
Design Risk analysis, e.g. DFMEA
Key Characteristics
Control Plan (similar parts & processes)
Revision Letter: B
Page 60 of 101

Resources:
Manufacturing Engineering, Quality Engineering, Operations representative, Design Engineering,
Facilities Management, Health, Safety & Environment (HS&E) Representative
Methodology:
1. Form a cross functional team, consisting of manufacturing and quality engineers, operations
personnel, and manufacturing process experts.
2. The team Identifies and documents the potential failures for each operation and associated
process steps contained in the Process Flow diagram.
3. For each failure mode, the team:
• lists the effects of the failure,
• ranks the severity of the failure,
• lists the potential causes of the failure,
• lists the preventive methods taken to eliminate the cause,
• ranks the frequency of each specific cause occurring,
• lists the detection methodology(s),
• ranks effectiveness of the detection methodology(s), and
Revision Letter: B
Page 61 of 101

• determines the Risk Priority Number (RPN), calculated as follows:
o severity of the risk X Likelihood of occurrence X Ease of detection,
o the higher the RPN number, the higher the risk and the need to undertake an action to
remove/reduce/detect the root cause(s) generating the risk.
11. Select the actions to implement as needed.
12. After action implementation, recalculate RPN based on evidence of the effectiveness.
SCMH Section 7.2.11 Process FMEA Template
SCMH Section 2.1 Quality Aspects of New Product Development
AS13004 Process Risk Mitigation
Revision Letter: B
Page 62 of 101

Element 3.05 Process Key Characteristics (Process KCs)
Element Definition:
Process KCs can be inputs to, or outputs from the manufacturing process. Key process inputs
are the process parameters which, if measured and controlled within prescribed limits, will
guarantee the capability of the production process. Key process outputs are the product or
process attributes which, when measured and compared to prescribed limits, validate the
capability of the process. In other words, these are the key parameters which when
controlled, will minimize process variation that could impact product quality. Most process KCs
are derived from the PFMEA, however; they can come from customer requirements and/or
best practices.
Control of process key characteristics via Statistical Process Control (SPC) charts or other
means, enables a preventive approach to quality. Process drift can be recognized and
addressed before it leads to nonconformance.
Deliverables:
List of Process KCs
Necessary Inputs: Source for inputs:
Key product Characteristics Design Engineering
PFMEA Customer
Lessons Learned Manufacturing Engineering
Company knowledge (best practices) Quality Engineer
Resources:
Manufacturing Engineering, Quality Engineering, Operations
Revision Letter: B
Page 63 of 101

Methodology:
1. Identify high-risk items from PFMEA where Detection x Occurrence, Severity x Detection
or RPN cannot be reduced by reducing the occurrence or severity through a design action.
2. Identify potential process KCs by reviewing the process steps related to the high-risk items
identified in step 1.
NOTE: Typically Process KCs are assigned to those process inputs that drive variability of
the output.
3. Finalize the list of process KCs and insure their inclusion in the manufacturing operating
instructions and control plan.
NOTE: The process KCs are typically reviewed by the Quality Engineer and operations
personnel.
NOTE: Process KCs should be monitored as designated through the control plan by
either 100% checking or SPC.
Revision Letter: B
Page 64 of 101

Element 3.06 Control Plan
Element Owner: Manufacturing Engineer and Quality Engineer
Element Definition:
The Control Plan is a written description which links 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.
The purpose of the control plan is to document control methods imposed on the product and
process including: identification of product features and process control settings to be
monitored, the measurement methods to be used, and sampling sizes and frequencies along
with associated control limits to assure reduced variation and maintain the desired quality
level.
The control plan details how product quality is controlled and confirmed at each stage of the
manufacturing process, including defining the actions to be taken when the process becomes
unstable and/or nonconforming product is detected (i.e., reaction plans). The control plan
should be sufficiently detailed to clearly define who is responsible for completing the specified
quality control tasks/activities at each stage of the process. The control plan is agreed to by
the supplier’s quality and production departments, and by the customer (when required).
1. Phases of the Control Plan
The control plan is developed and matured throughout each phase of product development.
During the pre-production phase, the number of controls is generally much higher than during
serial production since the producer has not yet identified and removed all sources of
variation.
2. Content of the Control Plan
At a minimum, the control plan contains the following information:
• Organization's name/site designation,
• Part number(s),
• Part name/description;
• Engineering change level (i.e., revision level),
• Phase covered (e.g., pre-production, production),
• Process name/operation description,
• Operation/process step number,
• Product or process related Key Characteristics (KCs) and Critical Items (CIs),
• Product or process specification/tolerance,
• Evaluation/measurement technique,
• Sample size and frequency,
• Control method, including error-proofing, and
• Reaction plan
Revision Letter: B
Page 65 of 101

The control plan is revised and updated throughout the life of the product in response to new
quality issues and/or product/process changes.
Deliverables:
Control plan signed and approved by: Quality and production and the Customer upon request.
PFMEA & Design Risk Analysis Design Engineering
Product KCs Manufacturing Engineering
Process KCs Quality Engineering
Process flow chart Operations
Inspection standards
Design Records
Quality performance data
Process capabilities (similar parts & processes)
Process Change (to update the control plan)
Resources:
Design Engineering, Manufacturing Engineering, Quality Engineering, Operations, Supply
Chain, Facilities Management
Revision Letter: B
Page 66 of 101

Methodology:
1. Review all inputs into the Control Plan including DFMEA and PFMEA for identification of
Key Characteristics and Process Key Characteristics.
2. Verify completeness and accuracy of the control plan by reviewing the following:
• Inclusion of all process steps, as appropriate,
• Identification of Product KCs and Process KCs,
• Accuracy of tolerances specified,
• Appropriateness of inspection and control methods and sampling frequency,
• Thoroughness of reaction plans and identification of persons responsible for execution
of reaction plans.
3. With the Control Plan in hand, walk the process during the initial production run to validate
implementation of controls.
4. Evaluate controls during the initial product run for effectiveness.
Revision Letter: B
Page 67 of 101

5. Update the Control Plan as necessary to ensure the required controls are in place for
production.
6. Finalize Control Plan when all issues are resolved.
7. Obtain customer approval as required and release the Control Plan.
SCMH Section 7.2.9 Process Flow Diagram Template
SCMH Section 7.2.13 Control Plan Template
Revision Letter: B
Page 68 of 101

Element 3.07 Preliminary Capacity Assessment
Element Owner: Manufacturing Engineer / Industrial Engineer
Element Definition:
A Preliminary Capacity Assessment is performed early in the process planning and
development phase to determine resources (e.g., people, equipment, facilities) necessary to
produce product at the customer’s demand rate. The assessment should include a review of
the capability and capacity of existing tooling/equipment, inspection /test equipment,
trained/qualified personnel and facilities to determine if they are adequate to meet the
customer’s demand profile. If additional equipment/resources are needed, a detailed plan
should be developed to ensure capacity needs are achieved to support project timing (see
Production Preparation Planning). The plan should be continually monitored to drive on-time
completion of tasks. Delays and roadblocks should be escalated as necessary.
Deliverables:
• Capacity analysis
• A capacity plan to close any identified gaps
Customer demand rate Customer
Capacity data for existing tooling/equipment, Manufacturing Engineering
Inspection/test equipment Industrial Engineering
Existing facilities and personnel Quality Engineering
Process Flow Diagram Design Engineering
Process capability data with respect to design Facilities Management
requirements
Logistics/Production Planner
Functional Test requirements
Project Manager
Project schedule
Resources:
Manufacturing Engineering, Industrial Engineering, Logistics/Production Planner, Operations
Personnel, Facilities Management, Supply Chain (for purchased items)
Methodology:
1. Determine facility/equipment/tooling needs required to meet the customer demand rate.
2. Analyze the capacity of existing equipment and facilities.
3. Determine if additional capacity on existing equipment and/or the refurbishment or
modification of any existing equipment, tooling, jigs or fixtures and testing equipment is
needed.
4. Identify the need for new equipment, tooling and facilities for new processes.
5. Include the details for obtaining additional tooling, facilities and equipment in the
Production Preparation Plan.
6. Obtain cross-functional agreement on the plan and establish a schedule for regular
reviews to monitor progress.
7. Obtain Escalate issues as needed.
SCMH Chapter 7.7 Capacity Management, Ordering and Logistics
Revision Letter: B
Page 69 of 101

Element: 3.08 Work Station Documentation
Element Definition:
Appropriate workstation documentation is needed for all products and all phases of
production, i.e. prototype, production trials and serial production.
Process documentation should contain all controls specified in the control plan to ensure
product and process compliance.
Work Station Documentation includes:
• Travelers and Routers – documents containing sequential activities needed to produce the
product.
• Work instructions: Detailed instructions for the process step, including tools, materials
and methods needed, quality criteria may also be included.
• Inspection instructions: Detailed instructions for inspecting product, including gages,
tools, fixtures and record keeping requirements.
• Maintenance schedules and instructions: Instructions for maintenance activities that are
performed at the workstation by operators, including tools and materials needed to
perform the tasks as well as the record keeping requirements to confirm that the
maintenance has been performed as required.
• Data collection check sheets and SPC charts: Worksheets and SPC charts designed to
collect process and/or product data to confirm that requirements have been fulfilled.
These documents should include a record of dates and times the task was performed and
operator identification.
• Visual displays for collecting “real –time” process status, safety information, etc.
All work stations documents are controlled documents, which are maintained to reflect the
current process and design information at all times.
Deliverables:
All applicable work station documentation accessible at the work stations
Process Flow Chart Manufacturing Engineer
Control Plan Quality Engineer
Maintenance Plan Facility Maintenance
Best Practice Operators
Operator Experience
Resources:
Manufacturing Engineering, Quality Engineering, Facility Maintenance, Operators
Revision Letter: B
Page 70 of 101

Methodology:
1. Review process flow chart and define detailed product routing.

2. Configure Manufacturing Execution System (e.g. MRP) to reflect the defined product
routing.
3. Determine all process steps that require detailed Work Station documentation.
4. Create required detailed Work Station documentation.
5. Validate Work Station documentation with operators and quality engineer.
NOTE: Workstation documentation contains highly detailed information that is subject to
error in its preparation. Therefore, therefore they should be reviewed and approved by a
Quality Engineer.
6. Issue documentation and make available at workstation.
7. Manage any changes through configuration control.
Revision Letter: B
Page 71 of 101

Element 3.09 Measurements Systems Analysis (MSA) Plan
Element Owner: Manufacturing or Quality Engineer
Element Definition:
Measurement systems specified in the Control Plan must be capable of evaluating product
and process conformity. In phase 3, gages and other measurement methods are selected and
a MSA Plan is established to ensure that they will be appropriately validated in phase 4 when
the actual MSA is performed. The MSA plan should include at a minimum: responsibility to
ensure gage linearity, accuracy, repeatability, reproducibility and correlation of duplicate
gages.
Measurement systems exhibiting excessive variation used in the evaluation of
product/process may result in erroneous decisions about product and process conformity.
MSA evaluates variation from the Inspector, Inspection Method, Component, Measuring
Equipment, and Environmental conditions. The purpose of MSA is to identify the nature of
variation and create corrective actions to reduce variation to the acceptable level.
The key areas to be assessed are:
• Precision
o Repeatability – variation due to a single operator or piece of equipment
o Reproducibility – variation between operators
• Accuracy
o Resolution - ability to measure small changes based on defined tolerance
o Bias - a consistent difference in the measurement versus known standard
o Stability - bias over time
o Linearity - bias throughout the measurement range
During this phase, the accuracy elements of the measurement system, i.e. resolution, bias,
stability, and linearity can be assessed using the planned measuring equipment, existing
calibration data, and prototype parts. Precision is assessed during the MSA activity in phase 4
when actual parts and final measuring equipment is available.
Deliverables:
Plan identifying all measurement systems to be evaluated, including persons responsible for
evaluating them and the timing for accomplishing the tasks.
PFMEA Customer
Key Product Characteristics Quality Engineer
Key Process Characteristics Manufacturing Engineer
Control Plan
Inspection Plan
Work Instructions
Revision Letter: B
Page 72 of 101

Methodology:
1. Review Control plan and/or inspection plan to identify all product and process characteristics
to be measured.
2. Review the measurements to be taken and the appropriateness of the selected measurement
gages and methods.
NOTE: Appropriateness of gages is determined through the accuracy elements of the MSA
study (resolution, bias, stability and linearity).
3. Where the gages or methods are determined not appropriate, investigate and update control
plan as needed.
4. Identify which measurements will need to undergo MSA. Criteria to consider include:
o Criticality of the measurements (as a minimum anything linked to a Product and/or
process KC)
o Past experience of using the measurement system and evidence of its capability
Revision Letter: B
Page 73 of 101

5. Create a plan showing when each measurement will be validated. The plan should consider
tooling, measurement equipment, and part availability as well as operator training and the
overall program plans. The plan identified who is responsible for each activity and the due
date.
6. As further controls are added to the control plan, the MSA Plan must be updated to reflect
these changes.
AS13003 Measurement Systems Analysis Requirements for the Aero Engine Supply Chain
SCHM Section 3.11 Measurement Systems Analysis MSA
Revision Letter: B
Page 74 of 101

Element 3.10 Supply Chain Risk Management
Element Owner: Procurement
Element Definition:
Risk within the supply chain is identified and managed to ensure on-going quality and delivery
performance. Now that all producers involved in the manufacturing process are selected, a
supply chain analysis should be performed to identify and evaluate risks. Producers that are
high risk or provide high-risk components (complex, high severity failure ranking on features,
material availability, etc.) should be included in the analysis. Special attention should be
given to any producer whose design may be new (unique and/or difficult) or outside their
normal or typical design/operating limits.
The analysis should identify producers’ names, locations and other information such as,
capacity data (launch and peak), quality and delivery performance, lead time, stocking
locations inventory levels, logistics methods, financial performance, necessary to evaluate
risk.
Risks identified should be evaluated and prioritized. Action plans should be put in place to
minimize the highest priority risks.
Deliverables:
• Risk analysis
• Risk mitigation plan
List of selected producers Producer/Supplier
Bill of Material Procurement
Supply Chain performance data Manufacturing Engineering
Producer capability/capacity assessment Design Engineering
List of high-risk components Supplier Quality
Resources:
Procurement, Quality, Production Control & Planning, Finance
Revision Letter: B
Page 75 of 101

Methodology:
1. Establish the elements of the risk analysis, e.g. producers experience level, introduction of
new designs, part complexity, part and/or supplier history, producer’s location and/or
capacity, etc.
2. Identify producers that are high-risk or provide high-risk component and document the
producers’ names, locations and risk data gathered for each producer.
3. From the analysis, identify the high-risk producers.
4. Develop a mitigation plan for the high-risk producers.
5. Where risks may not be fully mitigated, contingency plans are developed.
Revision Letter: B
Page 76 of 101

Element 3.11 Material handling, packaging, labelling and part marking
approvals
Element Owner: Manufacturing Engineer and Quality
Element Definition:
Establishing proper material handling methods ensure that products are adequately protected
from damage, corrosion, or contamination during manufacturing processes, movement
between operations, transit to external operations, and during storage. This should also take
into account controls specific to Foreign Object Damage (FOD) and Electrostatic Discharge
(ESD).
Planned packaging ensures that the product or material is not physically damaged, nor will the
packaging degrade in performance through the normal course of transportation, delivery, and
storage. Packaging materials and methods are designed to conform to the internal and/or
customer-defined requirements, satisfy standards for environmental safety, and pose no
hazards to operators. Consider both primary and secondary packaging, as well as use and
recycling of packaging materials as applicable. When determined necessary, a packaging
evaluation is completed in phase 4 when product becomes available.
Labeling and part marking are typically specified by the customer via drawings and
specifications. During this phase, the producer should confirm that labeling and part marking
requirements are understood and can be executed as planned. Customer approval is
obtained when required.
Deliverables:
• Material handling methods defined and documented
• Packaging, labeling, and part marking requirements defined, understood and approved as
required
Internal and customer requirements Customer
Environmental and safety requirements Environmental, Health and Safety Specialist
Drawing and specifications Facilities management
Process Flow Diagram (PFD) and the PFMEA Manufacturing Engineer
Resources:
Manufacturing Engineering, Packaging Engineering, Operations, Facilities Management (as
appropriate)
Revision Letter: B
Page 77 of 101

Methodology:
1. Material Handling
a. Review internal and customer drawings and specifications to identify handling
requirements.
b. Review the PFD and the PFMEA to identify potential handling risks.
c. Assess methods and process to confirm compliance to requirements and mitigation of
potential risks.
d. Revise, update methods as necessary.
2. Packaging
a. Review internal and customer drawings and specifications to identify packaging
requirements.
b. Define and document packaging requirements and materials.
c. Validate that:
• defined packaging ensures product/material safety, as well as the safety of those
who will handle the product/material, and,
• all customer packaging requirements will be fulfilled.
d. Procure the necessary packaging materials.
e. Test and/or evaluate packaging as required.
f. All issues, including packaging damage, ergonomic, special handling needs, are
evaluated and actions taken to resolve.
g. Obtain customer approval as required.
3. Labeling and part marking
a. Review internal and customer drawings and specifications to identify labeling and part
marking requirements.
b. Confirm understanding of requirements with customer and/or design engineering as
necessary.
c. Define and document labeling and part marking methods.
d. Plan labeling and part marking processes and obtain equipment and materials.
e. Demonstrate and evaluate labeling and part marking as required.
f. Obtain customer approval as required.
Revision Letter: B
Page 78 of 101

Element 3.12 Production Readiness Review (PRR)
Element Definition:
The producer conducts a PRR to verify that the manufacturing process is accurately
documented and is ready to produce product that will meet customer requirements. The
review is performed by a cross-functional team, which at a minimum, is comprised of,
Manufacturing Engineering, Quality engineering, and Operations personnel. The review
should include both a desktop review of all workstation documentation as well as a physical
review of the manufacturing facilities and equipment. The review should also include an
assessment of supply chain readiness either in advance of or as part of the PRR. The review
will cover all aspects of the manufacturing process including equipment, gages, tools, fixtures,
software programs, material availability, supply chain readiness, operator training, work
station documentation, control plan, and associated measurement tools.
The results of the review, including corrective action to resolve identified risks or issues, are
recorded. Management should confirm that all outstanding actions are satisfactorily closed or
mitigated before the significant production run can be started.
The production process is finalized at this stage and ready for initial production. Process
changes after this review should be managed through the producer’s change management
process.
Deliverables:
• Finalized documented manufacturing process
• Action plan for resolution of identified risks or issues
Equipment, tooling and fixtures, gages, Manufacturing Engineering
software programs Procurement
Assessment of supply chain readiness Industrial Engineering
Subcontracted material availability confirmed Facilities Management
Workstation documentation Quality Engineering
Assessment of operator readiness, i.e. skills Logistics/Production Planner
matrix, training, certifications, etc.
Human Resources
Resources:
Manufacturing Engineering, Operations personnel, Quality Engineering
Revision Letter: B
Page 79 of 101

Methodology:
1. A cross-functional team reviews the status and confirms satisfactory completion of:
• work station documentation,
• equipment, tooling and fixtures, gages, software programs,
• supply chain readiness, including material availability, and
• operator readiness, i.e. skills matrix, training, certifications, etc.
2. Gaps are identified and documented
3. Develop action plan to close gaps
4. Conduct a formal review at the management level to confirm that all outstanding actions
will be satisfactorily closed or mitigated before the significant production run is initiated.
Revision Letter: B
Page 80 of 101

Phase 4 Product and Process Validation Introduction
Phase Definition:
The goal of phase 4 is to demonstrate that the manufacturing and assembly processes can
produce conforming product at the customer’s demand rate. At this point, the product
definition has been finalized and the process design has been verified by the producer
through the PRR in the previous phases. Phase 4 starts with the initial production runs where
product is produced at the planned production rate using production equipment and
processes. This is done to gain knowledge of production capability as well as product
conformity. Of particular interest are measurement systems, control plans, capacity
verification and First Article Inspection (FAI).
PPAP (Production Part Approval Process) is the key element in phase 4 where product and
process validation occurs. PPAP combines First Article Inspection and process qualification.
Final product approval is established once the PPAP file is submitted and approved by the
customer. The PPAP requirement extends through the life of the product. In other words, all
applicable PPAP elements must be updated by the producer any time the process and/or the
product is changed and, when required by the customer, a PPAP resubmission may be
necessary.
Phase 4 Product and Process Validation

4.01 Production Process Runs
4.02 Measurement Systems Analysis (MSA)
4.03 Initial Process Capability Studies
4.04 Control Plan
4.05 Capacity Verification
4.06 Product Validation Results
4.07 First Article Inspection (FAI)
4.08 Production Part Approval Process (PPAP) file and Approval Form
4.09 Customer Specific Requirements
Revision Letter: B
Page 81 of 101

Element 4.01 Production Process Run(s)
Element Definition:
Production Process Runs are conducted to validate that all production processes, intended for
serial production, can achieve production quality and meet customer demand rate. In order to
accomplish this, the producer should ensure that only final production processes are
employed; specifically tooling, fixturing, gauging, and trained operators. Project team
members should be available to support the production runs in order to identify and resolve all
issues that may arise.
Attention should be placed on observing safety and ergonomic issues, as well as the potential
for Foreign Object Damage (FOD). In addition to producing product, the production run(s)
should also focus on verifying the manufacturing support system (e.g. component supply,
preventative maintenance, FOD and handling damage prevention, tool and equipment
changeover, the logistics system).
During the production run, processes should be closely observed. Data should be collected
and problems recorded as they are identified.
Data collection may include:
• production performance (cycle time, equipment breakdowns, changeover time, actual
run time, production line work balance, and capacity data),
• availability and accuracy of all production documentation at work station,
• adherence to work instruction,
• quality data as per control plan,
• risks or concerns observed,
• potential sources of FOD,
• safety and ergonomic issues, and
• effectiveness of fixtures, tools, equipment, gauges, etc.
Products produced from the Production Run(s) are used to provide data for PPAP submission,
including data for determining initial process capability.
Problems identified during the significant production run should be used to correct/improve the
production process and associated documentation in order to reduce risk and variation in
series production.
Deliverables:
• Adequate quantity of products necessary to complete FAI and PPAP deliverables
• Confirmation that the manufacturing system will support production needs
• Identification of issues
• Action Plan to track issues to closure
Revision Letter: B
Page 82 of 101

Production equipment, e.g. tooling, fixtures, Manufacturing Engineering
gauging Quality Engineering
Work Station Documentation Facility Management
Trained Operators Design Engineering
Control Plan Production management
Maintenance plan Training coordinator
Design records
Key Characteristics
Resources:
Manufacturing Engineering, Quality Engineering, Production Operators, Inspection
Technicians, Production Supervision
Methodology:
1. Produce parts using approved tooling, fixturing, gauging, and work station documentation.
The quantity of parts to be produced will be the quantity required by the customer or the
quantity of parts required in order to satisfy FAI and PPAP requirements.
2. Collect data as planned.
3. Segregate any non-conforming (NC) product in accordance with NC product procedure.
a. Identify the source and nature of defects.
b. Take corrective action as necessary.
4. Immediately involve the appropriate support functions (Engineering, Quality, Production
Control, etc.) to identify and document all issues.
5. Assign issues to appropriate support staff and track issues through to resolution.
6. Update all relevant documents (Manufacturing Process Documents, FMEA, Control Plan,
etc.) after the issues are solved and/or the process changes implemented.
7. When the producer is unable to achieve targeted quality levels after applying corrective
actions to the process, issues should be escalated to top management and the customer
should be informed accordingly.
Revision Letter: B
Page 83 of 101

Element: 4.02 Measurement Systems Analysis (MSA)
Element Definition:
The purpose of the Measurement Systems Analysis is to implement the MSA Plan, as defined
in phase 3, and assess variation introduced by the measurement systems. The sources of
variation include measurement device, fixtures, operators and shop floor environmental
conditions.
The organization should demonstrate that all measurement methods and checking aids
included in the control plan are suitable, capable, and supports the customer demand rate. At
a minimum, measurement analysis should be performed for each of the measurements that
require validation as established in the MSA plan.
Where the minimum acceptable level of error due to the measurement system (as defined in
the MSA Plan) is not achieved, action should be taken to reduce the variation/error. For
acceptable measurement system analysis results refer to AS13003, Table 2.
Deliverables:
• MSA results per MSA plan
• Action plan for those measurement systems not meeting acceptance criteria
MSA Plan Design Engineering
Key Characteristics (KCs) Manufacturing Engineering
Control Plan Quality Engineering
Inspection Instructions Training Management
Measurement devices, e.g. gauges, fixtures Facilities Management
Trained Inspector/Operator Metrology Specialist
Resources:
Quality Engineering, Manufacturing Engineering, Production Operators, Inspection
Technicians
Measurement System Methodology:
1. Review the MSA Plan.
2. Collect the appropriate number of parts from the Production Process Run(s).
3. Perform the required measurements and record data in accordance with the MSA Plan.
4. Analyze data and compute measurement variation/error (e.g. Bias, linearity, stability,
precision to tolerance and/or precision to total variation).
5. Take actions as necessary to reduce the variation/error below the targeted value.
AS13003 Measurement Systems Analysis Requirements for the Aero Engine Supply Chain
SCMH Section 3.11 Measurement Systems Analysis MSA
Revision Letter: B
Page 84 of 101

Element 4.03 Initial Process Capability Studies
Element Definition:
Initial process capability studies demonstrate that the combination of people, machine,
methods, material, and measurements have the potential to produce product that will
consistently meet the design requirements. Initial process capability studies should be
performed on product and process Key Characteristics identified in the control plan.
For initial process capability, data is collected on product and process KCs during the early
Production Process Run(s) and will continue until sufficient data is collected to allow the
calculation of process capability using Cpk (or Ppk as appropriate) indices. The minimum
number of samples considered for a capability study should be determined between the
Customer and the producer. A typical quantity for establishing process capability is 25, but
may be lower as long as the acceptance criterion is statistically valid.
Where the target Cpk (or Ppk as appropriate) indices are not achieved, action should be taken
to reduce the variation to below the targeted value.
Deliverables:
• Calculated Cpk (or Ppk as appropriate) indices from production products
• Action plan for variation reduction where Cpk indices are below the established
acceptance value
Product from Production Run(s) Manufacturing Engineer,
Key Characteristics (KCs) Quality Engineer
MSA results Operations
Control Plan
Inspection Instructions
Measurement devices, e.g. gauges, fixtures
Trained Inspector/Operator
Resources:
Manufacturing Engineering, Quality Engineering, Production Operator, Inspection Technician
Revision Letter: B
Page 85 of 101

Methodology:
1. Collect sufficient product samples (as agreed upon with customer) from production
process runs.
2. Collect data on Key Characteristics as indicated in the control plan.
Note: If it is not possible to perform a Preliminary Process Capability Study due to the low
production volume, it may be accepted by the Customer to have Process capability indices
(Cpk, Ppk as appropriate) calculation coming from a similar part using same process (tool,
equipment, environment, etc.).
3. Determine if the process is statically stable (i.e. normal distribution).
Note: Process capability indices (Cpk or Ppk as appropriate) can only be calculated after
the process is determined to be stable. A process is not stable over time if special causes
of variations are present. Those causes must be identified and removed.
4. Calculate the Cpk (or Ppk as appropriate) indices.
o If capability studies do not meet ≥1.33, then 100% inspection is expected until 1.33 is
achieved.
Note: Capability studies can be affected by Engineering Changes, Process Change
Requests, Design Change Requests, or part tolerance changes, and therefore must be re-
submitted for characteristics affected by change.
SCMH Section 3.1.4 Variation Management of Key Characteristics
Revision Letter: B
Page 86 of 101

Element 4.04 Control Plan
Element Owner: Manufacturing Engineer and Quality Engineer
Element Definition:
The Control Plan details how quality is controlled and confirmed at each stage of the
manufacturing process, including as necessary the actions taken when deviations are found
(reaction plans). All controlled characteristics must be listed on the Control Plan. The Control
Plan should consider the process dominant variables (e.g. set-up, tooling, operator) and
determine the appropriate level of control.
The development of the control plan is initiated in phase 3 (typically with the pre-production
Control Plan) forming the basis for the Production Control Plan. The early Production Process
Run(s) provide opportunity to evaluate the process output, review the control plan, and make
appropriate changes to the process and control plan. The production control plan should be
completed and approved as required, during to the early production runs.
The Control Plan is updated throughout the life of the program to reflect the current controls in
place in the production process.
Deliverables:
Completed approved production Control Plan
Design Risk Analysis (DFMEA) Design Engineering
PFMEA Manufacturing Engineering
Process Flow Diagram Quality Engineering
Pre-production control plan
Resources:
Quality Engineering, Manufacturing Engineering, Operations personnel
Revision Letter: B
Page 87 of 101

Methodology:
1. Review all inputs and incorporate all appropriate information into the Control Plan
including results from Design Risk Analysis (DFMEA) and PFMEA for identification of Key
Characteristics and Process Key Characteristics.
2. Observe the process during the Significant Production Run(s) using the Control Plan to
validate implementation and effectiveness of the planned controls.
3. When irregularities (e.g. unplanned variation, non-conformance, measurement issue, etc.)
are observed and the process is modified during the run, the Control Plan and other
affected workstation documentation is updated.
4. Publish the Production Control Plan when all issues are resolved and accepted by the
customer as required.
SCMH Section 7.2.13 Control Plan Template
Revision Letter: B
Page 88 of 101

Element 4.05 Capacity Verification
Element Owner: Manufacturing Engineer and Operations Management
Element Definition:
Capacity Verification is performed to demonstrate the ability of the producer to meet the
demand profile of the customer as established in the production forecast. When verifying
capacity, the producer will evaluate, equipment uptime, planned downtime (e.g. changeover,
equipment maintenance), cycle time, yield, and defect rate, to verify that the available capacity
satisfies the production demand forecast. Consideration should also be given to overall plant
capacity, testing capacity, and any capacity shared with other customers (e.g. parts run on the
same tooling and/or equipment). Capacity verification extends to all tiers of the supply chain.
Deliverables:
Verified capacity to satisfy the customer demand profile
Cycle time, changeover time, production Manufacturing Engineering
losses, Facilities Management
Planned and unplanned downtime history Procurement
Operating configuration (shifts, operators, Operations Management
machines)
Testing capacity
Supply chain capacity
Customer demand
Resources:
Manufacturing Engineering, Operations personnel, Procurement, Facilities personnel
Methodology:
1. Obtain demand profile for all customers using the same equipment/processes/testing
facilities.
2. Determine needed capacity based on the demonstrated cycle time, change overtime,
yield, etc.
3. Determine the available capacity based on calendar working days, shifts/day, hours/shift,
expected downtime, etc.
4. If the needed capacity is below available capacity, create an action plan to resolve
shortfall.
Revision Letter: B
Page 89 of 101

Element 4.06 Product Validation Results
Element Owner: Manufacturing / Test Engineer
Element Definition:
Validation Testing is the functional testing performed for the product/material to ensure
customer-engineering requirements are satisfied. This testing should be performed using
product/material produced from production tooling and processes wherever practical.
Deliverables:
• Results of all tests performed per the design validation plan
• Test results demonstrating conformance to requirements
Design validation plan Design Engineering
Product Specifications Operations personnel
Parts from “Production Run(s)” and/or parts Manufacturing Engineering
made via processes intended for serial
production
Resources:
Test Engineering, Manufacturing Engineering, Operations personnel, Quality Engineering
Methodology:
1. Test product produced from the initial production run(s) as specified in the design
validation plan.
2. Compile test results into a test summary report.
NOTE: The validation test report should include the test(s) performed, date, test
parameters, specification limits, test results, and outcome (pass/fail). Applicable material
certifications should also be included as required.
3. Evaluate results to determine if all requirements have been achieved.
4. Take corrective action where requirements are not achieved.
Revision Letter: B
Page 90 of 101

Element 4.07 First Article Inspection (FAI)
Element Owner: Quality Engineering
Element Definition:
The purpose of the FAI is to provide objective evidence, based on an assessment of the first
production article produced during the initial production run, that all engineering, design, and
specification requirements are correctly understood, accounted for, recorded, verified, and
fulfilled.
First Article Inspection is a complete, independent, and documented physical and functional
inspection process to verify that prescribed production processes have produced an
acceptable item as specified by engineering drawings, purchase order, engineering
specifications, and/or other applicable design documents. This element must comply with the
requirements of Aerospace Standard 9102 when contractually required by the customer.
Deliverables:
Approved First Article Inspection Report
Design Characteristics Design Engineering
First Production Run Parts Manufacturing Engineer
Control plan Quality Engineering
Inspection results Supplier Quality Engineering
Functional Test Results Operations personnel
Material Certifications
Lab Certifications
Design Record
Manufacturing Process Documentation
Non-conformance Documentation, as
applicable
FAI report for all sub components
Resources:
Manufacturing Engineering, Quality Engineering, Supplier Quality Engineering,
Operations/Inspection personnel
Revision Letter: B
Page 91 of 101

Methodology:
1. Compile FAI documentation as specified in the International Aerospace Standard 9102.
NOTE: FAI planning should begin in the early APQP phases to ensure that all customer
requirements are clearly understood and accounted.
2. Perform product inspections/tests using the initial production part produced during the first
production run.
3. Complete all FAI documentation requirements and submit for internal review.
4. Perform the FAI review and approval.
a) Review workstations documentation developed in phase 3 (e.g., routing sheets,
manufacturing/ quality plans, manufacturing work instructions, etc.) and verify that the
manufacturing system is adequately defined and documented.
b) Review FAI data for completeness and correctness. At a minimum, this review should
include:
o inspection data,
o test data (including Acceptance Test Procedure),
o nonconformance documentation (and associated action plan);
Note: International Aerospace Standard 9131 may be used as guidance,
o material certifications as applicable, and
o FAI reports for subcomponents
c) Verify that approved Special Process sources are used (as applicable).
d) Verify that all design characteristic requirements are fulfilled and documented in the
FAI Report
e) Verify that KCs requirements are satisfied as applicable.
NOTE: Many customers have special requirements specific to KCs and variation
management thereof, including but not limited to those defined in the International
Aerospace Standard 9103.
f) Verify all production equipment including part specific gages and/or tooling are
qualified and traceable, as applicable.
g) Document completion of the review in the FAI Report (9102 Form 1).
5. Obtain customer approval as required.
International Aerospace Standard 9102 First Article Inspection Requirement
International Aerospace Standard 9103 Variation Managements of Key Characteristics
International Aerospace Standard 9131 Nonconformance Data Definition and Documentation
Revision Letter: B
Page 92 of 101

Element 4.08 Production Part Approval Process (PPAP) file and form
Element Owner: Quality Engineer
Element Definition:
The purpose of PPAP is to demonstrate that the planned production process has the potential
to produce product consistently meeting design and specification requirements, as
demonstrated during initial production runs at the production rate required to meet customer
demand.
The process requires the producer to submit a PPAP file containing evidence that a specified
set of requirements are fulfilled. To realize the benefits of the APQP, it is essential that PPAP
artifacts be produced within the appropriate APQP phase as defined in this manual (reference:
International Aerospace Standard 9145).
The PPAP submission is dispositioned by the customer as:
• approved; i.e. all PPAP requirements have been fulfilled,
• interim approved; i.e. partial fulfillment of PPAP requirements with applied restrictions,
or
• rejected; minimum PPAP requirements not fulfilled.
The PPAP submission should be dispositioned as approved or interim approved by the
customer before the producer can release product for shipment. The completed PPAP
Approval form is a record of the PPAP disposition.
Changes to the product design and/or manufacturing process may require PPAP
resubmission depending on the nature of the change (reference: International Aerospace
Standard 9102) and customer requirements.
Deliverables:
PPAP approval
Parts from initial Production Runs Customer
Design Records Operations personnel
Design Risk Analysis (e.g., DFMEA); Design Engineering
Process Flow Diagram Manufacturing Engineering
FMEA Quality Engineering
Control Plan
MSA
Initial Process Capability Studies
Packaging, Preservation, and Labelling
Approvals
FAIR
Customer PPAP Requirements
PPAP Approval Form (or equivalent)
Resources: Quality Engineering, Manufacturing Engineering, Operations Personnel,
Customer
Revision Letter: B
Page 93 of 101

Methodology:
1. Customer and producer agree on the content required for PPAP submission, the schedule
for submission, and the timescales for customer approval.
2. Producer collects data and prepares documentation.
3. Producer submits PPAP package per customer PPAP requirements including the required
artifacts (evidence of completion).
4. Customer reviews and dispositions the PPAP submission using the PPAP Approval form
(International Aerospace Standard 9145, Appendix D) or equivalent document.
5. Customer notifies the producer of PPAP disposition.
6. Producer is authorized to release product in accordance with the PPAP disposition,
7. Producer resubmits PPAP as required (e.g. for rejected, interim approval, changes to
product, and/or process).
International Aerospace Standard 9102 First Article Inspection Requirement
SCMH Section 2.1.3 Quality Aspects of New Product Development
Revision Letter: B
Page 94 of 101

Element 4.09 Customer Specific Requirements
Element Owner: Quality Engineer
Element Definition:
The Customer may specify activities and/or artifacts that exceed those required in the
International Aerospace Standard 9145. These items are referred to as Customer Specific
(PPAP) Requirements in the PPAP submission.
Customer Specific Requirements may specify additional requirements or provide clarification
of requirements, deliverables, and/or data submittals. These requirements should be
identified during the project-planning phase, with timing established and assigned to the
appropriate functional organization.
Deliverables:
Identification and fulfillment of Customer Specific Requirements
Customer Specific Requirements Customer
Resources:
Quality Engineering, Manufacturing Engineering, Production Engineering, Design
Engineering,
Methodology:
1. The producer reviews the customer requirements to determine if there are any unique
requirements (i.e. those requirements not included in 9145)
2. Customer unique requirements are included in the project plan with timing and
responsibilities assigned.
3. Evidence of completion is included PPAP submission as required.
Revision Letter: B
Page 95 of 101

Phase 5 On-going Production, Use, and Introduction
Post-delivery Service
Phase Definition:
This phase describes the activities that are to be performed post PPAP. Activities include
defect reduction, improved cycle time, product improvements and cost reductions. As
issues/opportunities arise, the established process and controls will be evaluated and updated
as necessary.
Maintenance, repair and overhaul services after delivery to the customer may be required in
the aerospace industry, including provisions for repair or replacement of parts, resources and
training required.
A “Lessons Learned” activity should also be conducted. The organization should periodically
review and evaluate the effectiveness of the product quality planning effort and tools used.
Appropriate actions should be identified and initiated as necessary to improve the APQP
process.
Phase 5 On-going Production, Use, and Post-delivery Service

5.01.1 Measuring Performance
5.01.2 Maintenance, Repair and Overhaul (MRO) KPIs and plan(s) to reach the
established targets
5.02 Continuous improvement actions
5.03 Lessons learned
Revision Letter: B
Page 96 of 101

Element 5.01.1 Measuring Performance
Element Owner: Project Manager
Element Definition:
It is important to ensure that product produced continues to meet all requirements. The
producer should establish a means for monitoring performance in the manufacturing
environment as well as in the customer environment and act on this information as it becomes
available.
Key Performance Indicators (KPIs) are used to gage various functions and processes
important to achieve organizational goals. Typical KPIs include program cost targets,
customer satisfaction ratings (Quality, On-time delivery (OTD), Responsiveness), customer
escapes, supplier performance, cost of poor quality, warranty costs, product field performance
(mean-time-to-failure), etc.
Quality indices provide a quantitative measure of the producer’s ability to maintain and
improve the consistency of product within specification and to meet performance targets.
Typical quality indices include e.g. Cpk, Parts Per Million (PPM), rejection rates, Defects Per
Million Opportunities (DPMO), First Pass Yield (FPY), etc.
On-time delivery of product must be maintained at or above the level desired by the customer
throughout the life of the program. The capacity analysis should demonstrate the ability of the
producer to meet the demand profile of the customer over the foreseeable time horizon.
Changes is in the demand profile should be identified and addressed as soon as they are
communicated by the customer.
At a minimum, when the project targets are not achieved and/or product is not performing to
the customers’ desired levels, actions should be taken to determine root cause and implement
corrective actions.
Deliverables:
• Metrics that clearly demonstrate actual performance against targets and requirements
• Action plan to implement corrective actions as needed
Customer satisfaction ratings Customer
Quality Organization
External performance data
Procurement
Internal performance data Program Office
Customer Service
Resources:
Customer, Sales and Marketing, Customer Support, Manufacturing, Quality
Methodology:
Quality and KPI
1. Identify quality indices and KPIs.
2. Collect and analyze performance data.
3. Communicate results to responsible organizations.
4. Develop and initiate corrective actions as necessary.
Revision Letter: B
Page 97 of 101

Capacity model
1. Obtain forecast from customer(s).
2. Determine capacity needed to meet customer demand.
3. Determine available capacity.
4. Calculate difference between available and required capacity.
5. Develop an action plan to meet demand profile where required.
Revision Letter: B
Page 98 of 101

Element 5.01.2 Maintenance, Repair and Overhaul (MRO) KPIs and plan(s) to reach
the established targets
Element Owner: Customer Support
Element Definition:
MRO services includes documentation, specialized training, inventory of spare parts and
tooling necessary for maintenance of product in the field or at designated location. This also
includes access to individuals with the technical capability to address product deficiencies in
the field.
It should be a goal of the organization to provide MRO services on-time and defect free. The
organization should establish appropriate KPIs (i.e. mean-time-to-failure, turn-time, customer
feedback, operational reliability) and plans to monitor and achieve the customer’s expected
service level.
Planning should anticipate the need for facilities, documentation, tooling, recurrent repair and
replacement parts. Overhaul acceptance criteria may be different and should be determined
as part of the quality planning. Additionally, all documentation, tooling, repair and test
procedures should be validated. MRO planning should be considered during phase 2 product
development phase (see element 2.02.4 Design for Maintenance, Repair and Overhaul)
The organization should continually drive to lengthen mean-time-to-failure as well as reduce
turn-times for MRO activities to provide the best service to the customer.
Deliverables:
• A plan to provide the necessary MRO services
• Improvement plan as necessary
Historical data on spare parts and tooling needs Customer
System service performance data Customer Service
Customer use trends or forecasts Sales
Warranty data MRO Organization
Resources: Production Operations, Customer Support, Quality, Sales & Marketing, Customer
Methodology:
Quality and KPI
1. Identify quality indices and KPIs.
2. Collect and analyze performance data.
3. Communicate results to responsible organizations.
4. Develop and initiate corrective actions as necessary.
MRO Planning
1. Evaluate like designs, review performance and warranty data to establish maintenance,
repair and overhaul requirements.
2. Prepare maintenance, repair and overhaul documents.
3. Establish spare parts inventory.
4. Train maintenance, repair and overhaul personnel.
SCMH Section 7.2.8 Phase 5 Checklist 5.01.1 Checklist 5.01.2
Revision Letter: B
Page 99 of 101

Element 5.02 Continuous Improvement Actions
Element Owner: Quality Engineer, Manufacturing Engineering
Element Definition:
An effective customer/producer partnership is essential to improve product performance,
quality, cost, delivery and overall customer satisfaction. The producer should investigate,
evaluate and incorporate improvements to cost, delivery and lead time as well as
opportunities to enhance product performance and overall customer satisfaction during its
service life.
At a minimum, when the product is not performing to the customers’ desired levels, actions
should be taken to determine root cause and implement corrective actions. Product
deficiencies may be related to design and/or production deficiency. In either case, the
responsible organization should lead the root cause investigation and required corrective
actions (reference (Aerospace Recommended Practice – 9136 Root Cause Analysis and
Problem Solving (9S) Methodology)
Identification of sources of variation and its subsequent reduction is a key aspect of enhanced
product performance, and a driver of continuous improvement initiatives focused on product
quality. Variation reduction consists of monitoring of the production processes, with special
attention given to Key Characteristics (KCs). Data analysis using statistical techniques (Cp
and Cpk) is the preferred method for identifying variation reduction opportunities.
Improvement opportunities are prioritized; action plans are developed and implemented.
Actions that result in changes to the product and processes may require customer notification
and updates to product and process documentation (i.e. Design records, design risk analysis,
Process Flow diagram, PFMEA, Control Plan, etc.). An updated PPAP submission is typically
required.
Deliverables:
On-going data analysis and planned improvement actions
Production data Customer
Field data Quality Engineer
Financial data Manufacturing Engineering
Cost of poor quality Finance
Customer complaints (escapes) Program Office
Resources:
Quality Engineer, Design Engineer, Manufacturing Engineer, Operations, Finance, Program
Manager
Methodology:
1. Review quality indices and KPIs to identify improvement opportunities.
2. Prioritize improvement opportunities based on cost, timing, customer impact, etc.
3. Communicate opportunities and make recommendations to stakeholders.
4. Develop and implement action plan (obtain customer approval as required)
5. Validate improvement(s).
Revision Letter: B
Page 100 of 101

6. Update documents as necessary (i.e. Design records, design risk analysis, Process Flow
Chart, PFMEA, Control Plan, etc.).
International Aerospace Standard: 9103 Variation Management of Key Characteristics
Aerospace Recommended Practice APR/prEN/SJAC 9136 Root Cause Analysis and Problem
Solving (9S) Methodology
SCMH Section 3.1 Product and Process Variation in Support of 9103
SCMH Section 7.4 Root Cause Analysis and Problem Solving
SCMH Section 7.2.8 Phase 5 Checklist 5.01.1 Checklist 5.02
Revision Letter: B
Page 101 of 101

Element 5.03 Lessons Learned
Element Owner: Project Manager
Element Definition:
The purpose of a Lessons Learned is to prevent the reoccurrence of problems previously

experienced as well as build on those activities that went well. The organization should have
a process for capturing and including lessons learned to improve the product realization
process (APQP) and future products. Input should be requested as phases are completed
and can originate from any functional group. Inputs may include: cost to budget, adherence
to schedule (APQP plan, delivery), design changes, early field failures, corrective action plans,
initial quality data, customer satisfaction, cost of poor quality, etc.
Lessons Learned reviews are intended to provide a forum by which candid discussions can
take place regarding past issues. Action should be taken where opportunities for
improvement are identified. Operating and design standards should be updated where
needed.
The APQP project is closed when necessary actions are taken to achieve targets and
Lessons Learned are documented.
Deliverables:
• Record of lessons learned
• Successful activities captured and standardized for future programs
• Action plan(s) for improvement activities
Project team feedback Project Team
Customer feedback Customer
Management feedback Management
Data from performance metrics (cost,
schedule adherence, quality, etc.)
Resources: All members of APQP team
Methodology:
1. Gather and analyze appropriate data.
2. Develop and implement improvement action as needed:
• Transfer knowledge to similar projects and products,
• Record Lessons Learned in appropriate documents,
• Update APQP process as needed.
SCMH Section 7.2.8 Phase 5 Checklist 5.01.1 Checklist 5.03

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SCMH Section 7.2.

Aerospace APQP/PPAP Manual

Advanced Product Quality Planning

APQP Overview and Element Cards

Phase 1 Planning - Introduction 13

Phase 2 Product Design and Development - Introduction 31

Phase 3 Process Design and Development - Introduction 51

APQP Overview and Element Cards

Phase 4 Product and Process Verification - Introduction 80

Phase 5 On-Going Production - Introduction 95

APQP Overview and Element Cards

3. Main Pillars of APQP

APQP Overview and Element Cards

• Organizational Commitment & Management Support

• Effective Project Planning

APQP Overview and Element Cards

4.1 The 5 Phases of APQP are defined as follows:

APQP Overview and Element Cards

4.2 APQP Elements

Phase 2 Product Design and Development

APQP Overview and Element Cards

Phase 3 Process Design and Development

Phase 4 Product and Process Verification

Phase 5 On-Going Production

APQP Overview and Element Cards

4.3 Element deliverables

Each deliverable has an associated checklist. They consist of short sets of

The checklist is also used to:

5. APQP Management Process

APQP is applicable to all type of products (no matter their

APQP Overview and Element Cards

APQP element applicability may be revised based on producer

Formalize updated requirements in the SOW. These can

When tasks, responsibilities and timing are defined and agreed

Using APQP checklists (key questions are proposed by these

A report that includes a summary of the assessment results is

APQP Overview and Element Cards

6.1 Project Status - Red/Yellow/Green

Deliverable status is rated as Red/Yellow/Green based on the checklist status.

Impact of Red/Yellow status is evaluated from bottom up, i.e. managed on a

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

1. Gather regulatory and customer requirements, product performance requirements, lessons

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

1. Cross-functional (Engineering, Manufacturing Engineering, Procurement, Quality) team

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

APQP Overview and Element Cards

Phase 2 Product Design and Development