7.2.3 Aerospace APQP Manual 10MAY2017 (1)

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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Revision Date: 10-MAY-2017

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APQP Overview and Element Cards

TABLE OF CONTENTS

APQP Overview

Page

4

Phase 1 Planning - Introduction

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 20

1.03 Preliminary Listing of Critical Items (CI) and Key Characteristics (KC) 22

1.04 Preliminary Bill of Material (BOM) 23

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1.05 Preliminary Process Flow Chart

1.06 Statement of Work (SOW) Review

1.07 Preliminary Sourcing Plan

1.08 Project Plan

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Phase 2 Product Design and Development - Introduction

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, stackup analysis, etc.

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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

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2.05 Packaging specification 43

2.06 Design review report

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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

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

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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 - Introduction

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 - Introduction

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

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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 20 th 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

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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.

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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.

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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.

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Elements are the discrete activities that need to be completed during a specific phase.

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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:

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Phase 1 – Planning

Collect project inputs and set the project frame (product and process requirements, key actors, key tasks and timing plan).

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Phase 2 - Product Design and Development

Design the product considering all identified requirements and risks.

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Phase 3 - Process Design and Development

Design the manufacturing and assembly processes considering all identified requirements and risks.

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Phase 4 - Product and Process Validation

Validate that the process is producing the specified product at the required rate.

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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


1.02 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


1.07 Preliminary sourcing plan

1.08 Project plan

Phase 2 Product Design and Development




2.02.3 Design for Manufacturing and Assembly (DFMA), tolerance, stack-up analysis, etc.


2.03 Special requirements, including product Key Characteristics (KCs) and

Critical Items (CIs) listings


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


3.05 Process Key Characteristics (KCs)

3.06 Control plan


3.08 Work station documentation





Phase 4 Product and Process Verification




4.04 Control Plan






Phase 5 On-Going Production





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:

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document references as evidence and records of deviations,

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record corrective actions to correct deviations, and

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establish the first level of Red/Yellow/Green rating; (based on answers to each questions).

5. APQP Management Process

1. Identify product

(new or modified)

APQP is applicable to all type of products (no matter their complexity). It requires an increased planning and monitoring effort. The organization should define where these responsibilities lie within the organization.

2. Nominate team

3. Check element applicability

4. Identify the product breakdown and create SOW

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 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 may not be applicable (e.g. design activities are typically not 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 manageable sub-components. A formal Statement of Work

(SOW) that defines what needs to be done and when. The


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5. Decide make or buy

6. Cascade requirements to producer

7. Update APQP element applicability

8. Update Statement of Work

9. Agree on assessment timing based on risks or issues and create

APQP Plan

10. Perform assessments based on deliverables checklists

11. Escalate issues and get management feedback and support

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 subcomponents (if any) will be designed and made in-house or 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 and/or sub-component. Technical requirements are formalized in a specification and non-technical requirements in a SOW.

They are the foundation of the customer/supplier agreement.

APQP element applicability may be revised based on producer feedback. For the activities under the responsibility of the producer, the activity owner needs to be formally identified and nominated.

Formalize updated requirements in the SOW. These can include both technical and non-technical in nature (i.e. APQP).

This exercise can be done during a formal APQP kick off meeting

When tasks, responsibilities and timing are defined and agreed to by all parties, the APQP leader creates the APQP plan. The plan is the basis for determining the frequency of APQP assessments.

Using APQP checklists (key questions are proposed by these documents), quality of the deliverables is assessed regularly to ensure their completion is on-time and on-quality.

A report that includes a summary of the assessment results is provided to management on a regular basis. The reporting 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. Subcomponents’ status are compiled through product layers (as per the product breakdown). Cross layer compilation


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APQP Overview and Element Cards 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

Phase Definition:

Introduction

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


1.02 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


1.07 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 needs

Product performance

Lessons learned

Company strategy

Customer

Regulatory Agencies

Sales & Marketing

Design Engineering

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


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:

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Functional performance

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Architecture constraints (e.g. space, interfaces, external envelop, etc.)

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Type of material

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Special processing constraints

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Weight

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Specific acceptance criteria based on attribute information (appearance, color, odor, noise, etc.)

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Regulatory requirements (safety environment and trade compliance, etc.)

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In-house best practices & lessons learned

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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:

Lessons learned (e.g. benchmark, warranty, performance, etc.)

Customer, regulatory & internal requirements

Supporting technical specifications

Source of input

Customer

Sales & Marketing

Design Engineering

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


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

Product KCs

Technical requirements

Producer design guidelines

Design Engineering

Quality Organization


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


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:

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Product safety: safety fa ctor of mechanical design (stress related) and λ (failure rate) in electronic design

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Performance: customer functional requirements

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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)

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Manufacturing: through put time (time to go to the whole Manufacturing process), lead time, Right First Time Yield (RFTY), First Pass Yield

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Reliability: Mean Time Between Failure / Mean Time Between Repair / Mean Time

Between Unplanned Repair, and Operational Reliability

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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:

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Durability may include life time targets

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Maintainability may include mean-time-to-failure, turn-time, operational reliability targets

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Product schedule target are milestones defined by the organization to execute the activities to be performed according to their product development process

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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

Source of inputs Necessary Inputs:

All project inputs described in element

0.01

Project team, Finance

Sales & Marketing and Engineering


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Customer reliability and quality targets for product and program

Producer (internal/external) capability

Quality and Procurement

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


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:

Lessons Learned

Source of Inputs

Design Engineering

Design Standards (Product knowledge)

DFMEA/PFMEA on similar products

Program Requirements

Technical (design and process) Requirements

Project Leader


Producer

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


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:

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PBS for complex products and list of sub-systems showing the product assembly hierarchy

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Preliminary BOM

Necessary Inputs:

Producer Product Specification

Design Standards (Product knowledge)

Lessons Learned

Producer benchmarking and capability evaluation

Source of input

Design Engineering

Cross-functional team

Manufacturing Engineering Manager

Procurement Manager

Supplier Performance Management

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


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:


Preliminary BOM

Quality requirements

Manufacturing process expertise

Key Characteristics and Critical Items

Design Standards (product knowledge)

Producer performance and capability

Design Engineering

Quality Engineering


Procurement

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



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Element 1.06 Statement of Work (SOW) Review

Element Owner: Customer Contract Manager


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:

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Deliverables and due dates

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Tasks that lead to the deliverables, and who these tasks are assigned to

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Resources needed for the project including facilities and equipment

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Specifications and procedures

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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:

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Signed SOW


Customer reliability and quality targets for product and program

Source of Inputs:

Design Engineering


Preliminary BOM

Preliminary PFD


Product and process CI/KCs

Timing requirements

Specifications and procedures


Customer

Program Manager

Resources:

Quality, Design and Manufacturing Engineering, Sales, Program Management, Customer


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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 acceptabilit y of the producer’s proposal and the SOW is revised accordingly.

6. SOW is formally agreed to by both parties.




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Element 1.07

Preliminary Sourcing Plan

Element Owner: Procurement


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

Preliminary BOM

Producer product specification

Preliminary PFD

Design Engineering


Program Manager

Contract Manager

Procurement Timing requirements

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.




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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 subassemblies 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

Project timing requirements

Cross-functional Team

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.


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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 custome r’s requirements. External producers will monitor and report their progress as requested.



SCMH Section 7.2.12 APQP Element Applicability Template


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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




2.02.3 Design for Manufacturing and Assembly (DFMA), tolerance, stack-up analysis, etc.


2.03 Special requirements, including product Key Characteristics (KCs) and Critical

Items (CIs) listings


2.05 Packaging specification


2.07 Development product build plan

2.08 Design verification and validation plans, and associated results

2.09 Feasibility assessment


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Element 2.01

Design Risk Analysis



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

Past product performance test results

Lessons learned

Design Engineering

Cross-functional Team

Resources:

Customer, Quality Engineer, Design Engineering, Manufacturing Engineering


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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



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Element 2.02.1


Design Records


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)

Lessons learned

Product breakdown structure (PBS)

Design Risk Analysis output

Resources:

Design Engineering

Methodology :

Customer

Program Management team

Design Engineering


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



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Element 2.02.2


Bill of Material (BOM)


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

Product breakdown structure

Output of DFMA (element 2.02.3)

Output of DFMRO (element 2.02.4)

Source of Input:

Design Engineering

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.




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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


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

Preliminary process flow diagram

Technical design requirements

Quality performance data

Process planning


Design Engineering

Quality Engineering


Assembly standard practices

Catalogue of highest risk assembly hazards

Visualization and clash detection software

Resources:

Design Engineering, Manufacturing Engineering, Quality Engineers, Process Planner


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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.




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Element 2.02.4 Design for Maintenance, Repair and Overhaul (DMRO)

Element Owner: Product Engineering, Manufacturing Engineering and Aftermarket Technical

Support


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.


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Manufacturing capability data

Process planning best practices

Assembly standard practices

Catalogue of highest risk assembly hazards

Design software with visualization and clash detection capability

Maintenance Repair and Overhaul Data


Design Engineering

Customer Services

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.




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Element 2.03

Special requirements, including product Key Characteristics (KCs) and Critical items (CIs) listings



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


Design Risk Analysis and PFMEA


Customer

Design Engineering


Quality Engineering Preliminary CIs and KCs list

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



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Element 2.04

Preliminary Risk Analysis of Sourcing Plan

Element Owner: Manufacturing Engineering, Procurement, Program Management


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:

Product technology requirements


Regulatory Agencies

Customer

Manufacturing technology requirements

DFMA requirements

DFMRO requirements

Approved supplier list

Supplier data/performance history (see list above)

Regulatory requirements

Design Engineering


Procurement

Suppliers

Resources:

Design Engineering, Suppliers, Manufacturing Engineering, Procurement, Quality

Methodology :


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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.




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Element 2.05 Packaging specification



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

Internal packaging standards

Source of inputs:

Manufacturing Engineer

Packaging Engineer

Definition of packaging requirements & standard from customer (where defined)

Import/export regulations

Customer

Traffic and Logistics

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




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Element 2.06 Design Review Report



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

Engineering specs, functional requirements

Material specifications

Changes to drawings or specifications

Output of design verification and validation evaluations

Output of Design Risk Analysis, e.g. DFMEA’s


Design Engineering


Customer


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.




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Element 2.07 Development Product Build Plan

Element Owner: Product Development Team


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


Proto parts meeting design intent

Technical Design Requirements (TDR)

Preliminary Statement of Work

Voice of the Customer

Design Engineering

Resources: Product Development Engineers, Certification Specialist Engineers


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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.




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Element 2.08 Design verification and validation plans, & associated results

Element Owner: Product Development Team


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


Prototype parts meeting design intent

Technical Design Requirements (TDR)

Customer

Program Manager

Design Engineering

Producer

Statement of Work

Resources: Design Engineering, Airworthiness Specialist


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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 .




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Element 2.09 Feasibility Assessment



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

List of key characteristics

Design Engineering


Quality Engineering

Resources:

Program Manager, Design Engineering, Manufacturing Engineering, Operations


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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.




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Phase 3 Process Design & Development


Introduction

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


3.05 Process Key Characteristics (KCs)

3.06 Control plan


3.08 Work station documentation






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Element 3.01 Process Flow Diagram



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 Risk Analysis e.g. DFMEA

Design Records

Bill of Material

Key Characteristics

Tooling and Equipment

Outsourced Processes

Packaging Specification

Design Engineering

Quality Engineering


Procurement

Resources:

Manufacturing Engineering, Quality Engineering, Process Planner


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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


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SCMH Section 7.2.9 Process Flow Diagram -Template

AS13004 Process Risk Mitigation



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Element 3.02

Element Owner: Manufacturing Engineer


Floor Plan Layout

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

Equipment list

Existing plant layout plan

Value Steam Map & Spaghetti Diagrams (if available)

Building Layout

Resources:



Facility Management

Lean Experts

Manufacturing Engineering, Operations Manager, Quality Engineering, Quality Manager,

Facility Engineering, Lean Experts, Health Safety & Environment Representative


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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.




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Element 3.03 Production Preparation Planning



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

Current and Future Plant layout

Capacity analysis

Specifications for all tooling and equipment


Production Planner

Human Resources

Quality Engineering

Skills assessment

Manpower assessment

Resources:

Manufacturing Engineering, Quality Engineering, Procurement, Program Manager,

Operations, Facility Engineering, Human Resource Manager, Health Safety & Environment

Representative


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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.




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Element 3.04 Process Failure Mode and Effects Analysis (PFMEA)



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 P FMEA 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.



Quality performance data (similar parts & processes)

PFMEA (similar parts & processes)

Design Risk analysis, e.g. DFMEA

Key Characteristics

Control Plan (similar parts & processes)


Design Engineering (internal or customer)


Quality Engineering


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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


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•

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



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Element 3.05

Process Key Characteristics (Process KCs)



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


Key product Characteristics

PFMEA

Lessons Learned

Company knowledge (best practices)

Source for inputs:

Design Engineering

Customer


Quality Engineer

Resources:

Manufacturing Engineering, Quality Engineering, Operations


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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.




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Element 3.06 Control Plan

Element Owner: Manufacturing Engineer and Quality Engineer


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


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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

Product KCs

Process KCs

Process flow chart

Design Engineering


Quality Engineering

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


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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:

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Inclusion of all process steps, as appropriate,

•

Identification of Product KCs and Process KCs,

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Accuracy of tolerances specified,

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Appropriateness of inspection and control methods and sampling frequency,

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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.


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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


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Element 3.07 Preliminary Capacity Assessment

Element Owner: Manufacturing Engineer / Industrial Engineer


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

Capacity data for existing tooling/equipment,

Inspection/test equipment

Existing facilities and personnel


Process capability data with respect to design requirements

Functional Test requirements

Project schedule

Customer


Industrial Engineering

Quality Engineering

Design Engineering

Facilities Management

Logistics/Production Planner

Project Manager

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



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Element: 3.08 Work Station Documentation



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.

•

V isual 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

Control Plan

Maintenance Plan

Best Practice

Operator Experience



Quality Engineer

Facility Maintenance

Operators

Resources:

Manufacturing Engineering, Quality Engineering, Facility Maintenance, Operators


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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


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Element 3.09 Measurements Systems Analysis (MSA) Plan

Element Owner: Manufacturing or Quality Engineer


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

Key Process Characteristics

Control Plan

Inspection Plan

Work Instructions

Quality Engineer



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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


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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


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Element 3.10 Supply Chain Risk Management

Element Owner: Procurement


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

Bill of Material


Producer/Supplier

Procurement

Supply Chain performance data

Producer capability/capacity assessment

List of high-risk components

Resources:


Design Engineering

Supplier Quality

Procurement, Quality, Production Control & Planning, Finance


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Methodology :

1. Establish the elements of the risk analysis, e.g. producers experience level, introduction of new designs, part complexity, part and/or suppl ier 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


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Element 3.11 Material handling, packaging, labelling and part marking approvals

Element Owner: Manufacturing Engineer and Quality


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

Environmental and safety requirements

Drawing and specifications

Customer

Environmental, Health and Safety Specialist

Facilities management

Manufacturing Engineer Process Flow Diagram (PFD) and the PFMEA

Resources:

Manufacturing Engineering, Packaging Engineering, Operations, Facilities Management (as appropriate)


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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


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Element 3.12 Production Readiness Review (PRR)



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


Manufacturing Engineering Equipment, tooling and fixtures, gages, software programs

Assessment of supply chain readiness

Subcontracted material availability confirmed

Procurement

Industrial Engineering

Workstation documentation

Assessment of operator readiness, i.e. skills matrix, training, certifications, etc.


Quality Engineering

Logistics/Production Planner

Human Resources

Resources:

Manufacturing Engineering, Operations personnel, Quality Engineering


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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


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Phase 4 Product and Process Validation


Introduction

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




4.04 Control Plan







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Element 4.01 Production Process Run(s)



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


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Necessary Inputs: Source of Inputs:

Production equipment, e.g. tooling, fixtures, gauging

Work Station Documentation

Trained Operators

Control Plan

Maintenance plan

Design records

Key Characteristics


Quality Engineering

Facility Management

Design Engineering

Production management

Training coordinator

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


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Element: 4.02 Measurement Systems Analysis (MSA)



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

Necessary Inputs: Source of Inputs:

MSA Plan

Key Characteristics (KCs)

Control Plan

Design Engineering


Quality Engineering

Inspection Instructions

Measurement devices, e.g. gauges, fixtures

Trained Inspector/Operator

Training Management


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


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Element 4.03 Initial Process Capability Studies



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)

MSA results

Control Plan

Inspection Instructions

Measurement devices, e.g. gauges, fixtures

Trained Inspector/Operator

Quality Engineer

Operations

Resources:

Manufacturing Engineering, Quality Engineering, Production Operator, Inspection Technician


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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 resubmitted for characteristics affected by change.



SCMH Section 3.1.4 Variation Management of Key Characteristics



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Element 4.04 Control Plan

Element Owner: Manufacturing Engineer and Quality Engineer


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)

PFMEA


Design Engineering


Quality Engineering Process Flow Diagram

Pre-production control plan

Resources:

Quality Engineering, Manufacturing Engineering, Operations personnel


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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


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Element 4.05 Capacity Verification

Element Owner: Manufacturing Engineer and Operations Management


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 losses,

Planned and unplanned downtime history

Operating configuration (shifts, operators, machines)

Testing capacity

Supply chain capacity




Procurement

Operations Management

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.




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Element 4.06 Product Validation Results

Element Owner: Manufacturing / Test Engineer


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

Product Specifications

Parts from “Production Run(s)” and/or parts made via processes intended for serial production

Design Engineering

Operations personnel


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.




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Element 4.07 First Article Inspection (FAI)

Element Owner: Quality Engineering


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

First Production Run Parts

Control plan

Inspection results


Design Engineering


Quality Engineering

Supplier Quality Engineering

Operations personnel Functional Test Results

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


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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



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Element 4.08 Production Part Approval Process (PPAP) file and form

Element Owner: Quality Engineer


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

Design Records

Design Risk Analysis (e.g., DFMEA);


FMEA

Control Plan

MSA

Initial Process Capability Studies

Packaging, Preservation, and Labelling

Approvals

FAIR

Customer PPAP Requirements

PPAP Approval Form (or equivalent)


Customer

Operations personnel

Design Engineering


Quality Engineering

Resources: Quality Engineering, Manufacturing Engineering, Operations Personnel,

Customer


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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



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Element 4.09 Customer Specific Requirements

Element Owner: Quality Engineer


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.




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Phase 5 On-going Production, Use, and

Post-delivery Service


Introduction

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






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Element 5.01.1

Element Owner: Project Manager


Measuring Performance

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

External performance data

Internal performance data


Customer


Procurement

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.


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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.




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Element 5.01.2 Maintenance, Repair and Overhaul (MRO) KPIs and plan(s) to reach the established targets

Element Owner: Customer Support


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

System service performance data

Customer use trends or forecasts

Customer

Customer Service

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


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Element 5.02 Continuous Improvement Actions

Element Owner: Quality Engineer, Manufacturing Engineering


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

Field data

Financial data


Customer

Quality Engineer


Cost of poor quality

Customer complaints (escapes)

Finance

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).


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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


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Element 5.03 Lessons Learned

Element Owner: Project Manager


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

Customer feedback

Management feedback

Data from performance metrics (cost, schedule adherence, quality, etc.)

Project Team

Customer

Management

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

7.2.3 Aerospace APQP Manual 10MAY2017 (1)

Aerospace APQP/PPAP Manual

Guidance material for International Aerospace

Standard 9145

Advanced Product Quality Planning

(APQP) Production Part Approval Process

(PPAP)

TABLE OF CONTENTS

APQP History

2. Purpose of APQP

3. Main Pillars of APQP

4. APQP Principles

4.1 The 5 Phases of APQP are defined as follows:

4.2 APQP Elements

Click on any element in the list to go directly to the Element Card.

4.3 Element deliverables

5. APQP Management Process

6. APQP Reporting

6.1 Project Status - Red/Yellow/Green

Yellow:

Green:

6. 2 APQP Reporting

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