You are on page 1of 51

AS9145 standard

Gideon Roth
V.P. Quality & Regulatory
Cabiran (1991) Ltd
Background

• Advanced product quality planning (APQP) is a


process developed in the late 1980s by a
commission of experts gathered around 'Big Three' US
automobile industry: Ford, GM and Chrysler.
The launch of the first APQP manual
was in June 1994.
• APQP is a structured method that deploys
the necessary quality plan that will
assure that a product or a service
satisfies the customer
Background

• In 1982 AIAG (Automotive Industry Action Group)


developed Production Part Approval Process (PPAP) to
affirm product quality planning.
The first manual on PPAP was published in February
1993.
• PPAP is a method that verifies that the supplier’s
production process has the capability to
produce parts at the rate and quantity
specified by the customer and that all the
customer’s engineering design record and
specification requirements are properly
understood.
Background

• In Automotive industry both techniques are implemented


and in use since the 80th of the 20th century
• In Aviation they are in use only in recent years.
• In 2016 a new standard – AS9145 Aerospace Series –
Requirements for Advanced Product Quality Planning and
Production Part Approval Process was released
• The standard was developed by a team nominated by
IAQG.
AS9145 team
Aerospace APQP Model
Introduction

From the standard:


“This standard specifies requirements in a
structured framework to plan and complete
actions of the product realization cycle which
are necessary to ensure quality product(s)
are delivered on time, while satisfying cost
performance targets.”
Introduction
From the standard:
“Successful implementation of APQP
requires:
 management commitment and support from the
beginning of the product development cycle,
 multidisciplinary project teams integrating all
stakeholders and delivering a committed
timeline for executing planned activities.“
Introduction

From the standard:


“APQP has five phases starting with
conceptual product needs and extending
throughout the product life cycle. The actual
duration of each phase will differ depending
upon the scope and timing of the specific
product and/or production development
project.”
The APQP phases:
Alignment with Product Development Process (PDP)

End of End of Production Product


Kick off design readiness validation
concept

Product Development
Process

APQP phases
1 - Planning D 5 - Production
A
E
4 - Product Process
2 - Product Design & Development B
Validation

3 - Process Design & Development

APQP supports Product Development Process (PDP) APQP milestones

• Applies to each item of the product breakdown structure


• Standardizes deliverables for each Aerospace APQP Phase
• Evaluates maturity based on timing and quality of required deliverables
Cascade through Product Breakdown
Structure (PBS)
3 - Report APQP
End of status at project level End of Production Product
Kick off design readiness validation
concept

Product Development
Process

System level 1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development

Sub-system level 1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development

Components level 1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development

1 - Cascade Note: Compressed timeline


deliverables and align to support program timing
timing for each level
2 - Bottom up status based
Typical PBS: on on-time on-quality
system→ sub-system→ component deliverables
APQP 5 Phases

• 1 – Planning: collect project


inputs and set the project.
• 2 - Product Design & Development: Design the product
considering all identified requirements and risks
• 3 – Process Design & Development: Design the
manufacturing and assembly process considering all identified
requirements and risks
• 4 – Products & Process Validation: Validate that the process
is producing the specified product at the required rate
• 5 – Production: Reduce variation, manage any non-
conformity, continuous improvement and feed lessons learned
back into the new product development projects
Phase 1 Planning

End of End of Production Product


Kick off design readiness validation
concept

Product Development
Process

APQP phases
1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development

APQP milestones
Phase 1 Planning: Activities

• Collect the technical and non-technical requirements


applicable to the product and associated project
• Develop a Statement of Work (SOW) for the project
• Define the product and associated project targets
• Develop the product breakdown structure [i.e., high-level
Bill of Material (BOM)] to support source selection
• Coordinate and communicate timing with all applicable
stakeholders
• Schedule all key dates and deliverables in the project
plan
Phase 1 Planning: Deliverables

• Product design requirements


• Project targets – safety, quality/manufacturability,
service life, reliability, durability, maintainability,
schedule, and cost
• Preliminary listing of Critical Items (CIs) and Key
Characteristics (KCs)
• Preliminary BOM
• Preliminary process flow diagram
• SOW review
• Preliminary sourcing plan
• Project plan
Phase 1 Planning: Outputs

√ The product concept is frozen (milestone A) and a


pre-design is available

√ Concurrent product design and process design can


start
Phase 1 Planning: Checklists

In the IAQG/SCMH you will find the following


checklists:
• 1.01 Project Inputs • 1.06 Preliminary BOM
• 1.02 Technical Design • 1.07 Preliminary Process
Requirements Flow Chart
• 1.03 Reliability & Quality • 1.08 Statement of Work
goals Review
• 1.04 Preliminary Listings • 1.09 Sub-tier Selection &
of Critical Items & KC Management
• 1.05 Product • 1.10 APQP Timeline
Specification
Phase 1 Planning: Checklist
example
Table 1
# Question Y* N N/A RYG Evidence Actions Required
Was a a cross-functional team used to gather
project inputs including the following as applicable:
1 Program Management, Quality, Design Engineering,
Manufacturing Engineering, Marketing and Sales,

2
Procurement?
Are applicable regulatory requirements available? Evidence
Are customer requirements available including:
Project milestones and product delivery date
The
3 Projected volumes
Project lifecycle
Product and process assumptions
Marking following
Are all internal data to build product performance
expectations available including:
• Historical problems internal and external
• Warranty
slides
4
• Reliability requirements
• Quality requirements
• Technical Requriements
show the
Have lesson learned been conducted including:
• Best Practices
• Project management
principle of
5 • Quality issues
• Product design guidelines
• Process design guidelines
the SCMH
Is the company strategy available including:
• Business plan
checklists.
6 • Marketing strategy
• Industrial strategy Questions
• Technical strategy
Have the resulting project/product requirements
been referenced/recorded into a repository,
Each
7 including supporting data?
Data is made available to be used by the project
team?
phase has
it’s own
Is there a process to keep formal requirements
8 document up-to-date?
Has (Have) any potential risk(s) not highlighted by
9 previous question been identified? If no, describe

10
this risks?
Rating checklists
11
X 25% N/A Deliverable RYG Rating
IP 50%
Red: Some questions have a negative answer and no recovery plan is in place or the plans
25% - Action Identified 50% - Owner Identified identified will have an impact in program timing. Support is required. When an item is
Status (%): 75% R
75% - Action in Progress 100% - Action Closed highlighted Red an assessment on the impact to the WP timing needs to be provided.
100% Y Yellow: Some questions have a negative answer but a recovery plan is in place which will
G prevent impact
Green: All on timing
questions have a positive answer (Y) and are ongoing normal program development
Phase 1 Planning: Checklist
example – questions section
Table 1
Question
Was a a cross-functional team used to gather
project inputs including the following as applicable:
Y*
The questions are used to evaluate the quality of
the deliverable attached to the element.
Program Management, Quality, Design Engineering,
Manufacturing Engineering, Marketing and Sales,
Procurement?
Are applicable regulatory requirements available?

Are customer requirements available including:


Project milestones and product delivery date
Projected volumes
Typical aspects of the deliverable to be
Project lifecycle
Product and process assumptions
Are all internal data to build product performance
evaluated through the questions are:
expectations available including:
• Historical problems internal and external
• Warranty
• Reliability requirements
1. Quality/availability of the inputs needed to
• Quality requirements
• Technical Requriements
Have lesson learned been conducted including:
• Best Practices
build the deliverable
• Project management
• Quality issues
• Product design guidelines
• Process design guidelines
2. Cross-functional approach to answer the
Is the company strategy available including:
• Business plan
• Marketing strategy
• Industrial strategy
deliverables
• Technical strategy
Have the resulting project/product requirements
been referenced/recorded into a repository,
3. Quality /conformity to a standard if any or to
including supporting data?
Data is made available to be used by the project
team?
Is there a process to keep formal requirements
best practices
document up-to-date?
Has (Have) any potential risk(s) not highlighted by
previous question been identified? If no, describe
this risks?
4. control of the outcome of the
deliverable (e.g. action plan)
Phase 1 Planning: Checklist
example marking section
Y* - Put an "X" if complete and is
OK or "IP" if in-progress as planned.
N - Put an "X" if it is Not OK .
N/A - Put an "X" if you have agreed with your customer that this
question is Not Applicable.
RYG - Put an "R" here if the answer to the question is not
acceptable and there is no recovery plan. Put a "Y" here if there
are problems with the question but is recoverable with an action
plan in place. Put a "G" if it is on track or satisfactorily
complete. Y* N N/A RYG
When you put an "R" or "Y" you will
need to complete the "Actions Required" and
subsequent columns.
Phase 1 Planning: Checklist
example evidence & rating
Table 1

Input evidence of the answer to the question (e.g.:


document reference) here. If an "X" is in the preceding N
column then describe the issue here including root cause in
order to identify proper actions .
25% - Action Identified 50% - Owner Identified
Status (%): 75%
75% - Action in Progress 100% - Action Closed
100%

Red: Some questions have a negative answer and no recovery plan is in place or the plans
R identified will have an impact in program timing. Support is required. When an item is
highlighted Red an assessment on the impact to the WP timing needs to be provided.
Y Yellow: Some questions have a negative answer but a recovery plan is in place which will
G prevent impact
Green: All on timing
questions have a positive answer (Y) and are ongoing normal program development
Phase 1 Planning: Checklist
example table 2

Open Due Status Actual End


Actions Required Responsible Date Date % Date

For each questions in table 1 you specify the


actions, responsibilities and dates in table 2
Phase 2 Product Design and
Development

End of End of Production Product


Kick off design readiness validation
concept

Product Development
Process

APQP phases
1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development

APQP milestones
Phase 2 Product Design and
Development
• The purpose of this phase is to ensure design
features and characteristics are formalized and ready for
process design and development.
• During this process the intended production phases and
potential supplier used to realize the product are identified.
• During this phase the organization shall identify &review the
production process design input requirements, including:
– Product design records.
– Targets for productivity, process capability, quality, and cost.
– Customers and regulatory requirements, including customer demand
rate.
– Lessons learned.
Phase 2 Product Design and
Development: Activities
The phase includes the following:
• Turning product specifications into robust product definition
– Design risk analysis
– Design for Manufacture and Assembly (DFMA)
– Design for Maintenance, Repair, and Overhaul (DFMRO)
– Identification of product KCs
– Product error proofing
• Create BOM
• Conduct design reviews
• Validate and verify product design
• Conduct design record review at production
sources to evaluate manufacturing feasibility
Phase 2 Product Design and
Development: Deliverables

• General note – in the next phases an * means that this is an


element of the PPAP file and may be required for the PPAP
submission
Phase 2 Product Design and
Development: Deliverables
• Design risk analysis*
• Design records and BOM* addressing the findings of the design
risk analysis
• DFMA, tolerance, stack-up analysis, etc.
• Special requirements, including product KCs and CIs listings
• Preliminary risk analysis of sourcing plan
• Packaging specification
• Design review report
• Development product build plan
• Design verification & validation plans, and associated results
• Feasibility assessment
Phase 2 Product Design and
Development: Outputs

 Design record and BOM


 Design verification and validation plans, and associated
results
 Specified prototype testing (e.g. simulation & functional
testing) have been completed
 The product design is verified and validated (milestone B)
by the design organization

Any design changes after this phase requires change management


Phase 2 Planning: Checklists

In the SCMH you will find the following checklists

• 2.01 DFMEA • 2.03 Design Reviews


• 2.02.1 Design for • 2.04.1 Development
Manufacturing & Product / Part Build Plan
Assembly • 2.04.2 Verification &
• 2.02.2 Design for MRO Validation Testing
• 2.02.3 Product critical • 2.05 Design Record
items & KC Review by the Production
• 2.02.4 New product Source
packaging specification • 2.06 Management
Support
Phase 3 Process Design and
Development: Activities

End of End of Production Product


Kick off design readiness validation
concept

Product Development
Process
APQP milestones
APQP phases
1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development


Phase 3 Process Design and
Development: Activities

• Complete source selection and establish a supply chain risk


management plan
• Create a process flow diagram
• Conduct Process Failure Mode and Effects Analysis (PFMEA) on
the proposed process(es) and identify process KCs
• Update the process based on the PFMEA risk mitigation plans,
focusing on process KCs
• Create the control plan including results of the PFMEA and KCs
identification
• Create process manufacturing instructions and documentation
• Evaluate production readiness
Phase 3 Process Design and
Development: Deliverables

• Process flow diagram*


• Floor plan layout
• Production preparation plan
• Operator staffing and training plan (Human Resources)
• PFMEA*
• Process KCs
• Control plan*
Phase 3 Process Design and
Development: Deliverables

• Preliminary capacity assessment


• Work station documentation
• Measurement Systems Analysis (MSA) Plan
• Supply Chain Risk Management Plan
• Material handling, packaging, labeling, and part marking
approvals*
• Production Readiness Review (PRR) results
Phase 3 Process Design and
Development: Outputs

 The process is defined, established, verified (production


readiness review - milestone C) and ready for validation.
 Production process defined and deployed
 Successful completion of the PRR
Phase 4 Process Design and
Development: Activities

End of End of Production Product


Kick off design readiness validation
concept

Product Development
Process

APQP phases
1 - Planning APQP milestones 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development


Phase 4 Product and Process
Validation: Activities

• Conduct a First Article Inspection (FAI)


and assemble Production Part Approval Process (PPAP) file
• Completion of a production product run(s)
• Conduct a capacity analysis
• Collect data to demonstrate the manufacturing and assembly
processes can produce conforming product at the customer
demand rate
• Conduct the MSA per the MSA Plan
• Review the results of production process runs and determine
corrective actions, as needed
• Subsequent to corrective actions being implemented, determine
process readiness for entry into serial production
Phase 4 Product and Process
Validation : Deliverables

• Product from production process run(s)


• MSA*
• Initial process capability studies*
• Control plan*
• Capacity verification
• Product validation results
• First Article Inspection Report (FAIR)*
• PPAP file and approval form*
• Customer specific requirements*
Phase 4 Product and Process
Validation : Outputs

 Validation that intended manufacturing process and the


associated product conforms to specified requirements
 Approved FAI
 Approved PPAP
Phase 5 On-going Production, Use,
& Post-Delivery Service

End of End of Production Product


Kick off design readiness validation
concept

Product Development
Process
APQP milestones
APQP phases
1 - Planning 5 - Production

4 - Product Process
2 - Product Design & Development
Validation

3 - Process Design & Development


Phase 5 On-going Production, Use, &
Post-Delivery Service: Activities

• Monitor product and process performance and


compare to the defined Phase 1 targets, including:
• - Reliability, quality, and customer satisfaction
• - Product post-delivery performance (including warranty)
• - Maintenance, Repair, and Overhaul (MRO) operations
• Implement actions to reduce product and process variation in
associated production and MRO activities
• Document sources of variation in support of continual
improvement efforts
• Capture lessons learned and integrate into other design
activities, as appropriate
• Update FMEAs based on lessons learned
Phase 5 On-going Production, Use, &
Post-Delivery Service : Deliverables

• Quality indices [e.g., CpK, Parts Per Million (PPM), rejection rates]
• Key Performance Indicators (KPIs) reflecting product quality and
reliability
• Evidence that project targets have been met
• On-time Delivery (OTD) and capacity KPIs
• OTD and capacity improvement plan
• MRO KPIs and plan(s) to reach the established targets
• Project closure recommendations
• Continuous improvement actions
• Lessons learned
• Updated design risk analysis, PFMEA, and control plans
Phase 5 On-going Production, Use, &
Post-Delivery Service: Outputs

 Project closure
Personal view and experience

Cabiran (1991) Ltd is an Aluminum Investment Casting


located in Israel. It is a fully integrated company and offers its
customers complete design, engineering, rapid prototyping,
casting and post-cast services under one roof.
In 2010 Cabiran signed a contract with Honeywell for several
Airbus A350 castings and finished parts.
I, as the V.P. for Quality received a notice from Honeywell that
Airbus requires it supply chain for the A350 to
perform APQP
Personal view and experience

Upon checking with my colleagues in the Israeli ASD industry


the general reaction was:
“APQP? what is that?”
To understand the subject I attended a seminar by the Israeli
automotive industries.
Honeywell nominated a quality representative who came to
Israel and helped me and my organization to implement, step
by step the APQP process.
The most important phase was creating the
PFMEA for the organization.
Personal view and experience

Generic APQP Cabiran

Flow Chart Decision block


We started with the process by a lay out
self inspection
manufacture

Inspection

IF NOT OK GO TO
move

store

of all the steps designated for the A350


IF OK GO TO
Step number

Description

parts.

self inspection
The form had 4 symbols:

manufacture
RECEIVING look at control

Inspection
0 MATERIALS FROM step AA11 plan "Reaction
STORAGE plan" step 0

move

store
 Circle – Manufacturing
 Arrow – Move
 Triangle – Storage
look at control

 Rectangular – Inspection (self)


AA11 WAX INJECTION step AA15 plan "Reaction
plan" step AA11

 We added a pentagon - Inspection


Personal view and experience

FMEA

Proposed prevent action


Potential Failure Effects

Current prevent control

Responsible / date
Current detection
Potential Causes
Potential failure

Actions done
Class

OCC

RPN
SEV

Occ
Sev
Det

Det
Wax certificated are
DELIVERY OF Supplier sends
Part failure 6 Human error 2 Visual Visual 8 96 checked prior to QA 6 1 2
WRONG WAX TYPE COT
shipment

WRONG MOLD Wrong part 5 Human error 1 Visual Visual 8 40

We continued with a FMEA (the next part of the same form)


and assessed for each stations the possible risks.
These were evaluated by – severity, occurrence
and detection
Personal view and experience

FMEA

Proposed prevent action


Potential Failure Effects

Current prevent control

Responsible / date
Current detection
Potential Causes
Potential failure

Actions done
Class

OCC

RPN
SEV

Occ
Sev
Det

Det
Wax certificated are
DELIVERY OF Supplier sends
Part failure 6 Human error 2 Visual Visual 8 96 checked prior to QA 6 1 2
WRONG WAX TYPE COT
shipment

WRONG MOLD Wrong part 5 Human error 1 Visual Visual 8 40

The result of these 3 values was a number – RPN.


It was agreed upon that all items above 96 shall be handled.
For each a proposed preventive action was made and a new
RPN was calculated
Personal view and experience
Product or process characteristic

Control plan

Control method/instructions
Method and equipment
Requirements

Reaction plan
Frequency
KPC
KCC

supplier does not ship before


visual check of certificate are approved by
Wax should match unapproved material is
Wax type certificate prior each shipment Cabiran QA. Material not
specification KC3039 RTV
to shipment approved in Cabiran if
certificate not signed by QA.
the operator in the injection
Visual check of Each extraction of compare the mold to the
mold I.D. Right mold Return the mold to store
mold I.D mold from store product folder and if not right
returns the mold to store

Last phase was to assign a control plan for each of the >96
risks.
This tool exposed Cabiran in a structured process
to identify risks unknown or assumed to be not important.
Personal view and experience

1. We have today 4 such forms per the different processes


2. In the longest one there are 134 risks identified.
3. The ones >96 were resolved
4. We continue with the lower rated ones
5. The Cabiran quality team added to the non-conformance
procedure a requirement – to check when completing an
investigation if the problem was identified in the FMEA.
6. If not - add it to the form
7. If yes – was the preventive action not sufficient? Do we
need another action?
Personal view and experience

Summary:
1. Cabiran does not design and therefore could perform only
APQP’s phase 3 and on.
2. The process helped focusing on risks and preventive
action that improved the process
3. The FMEA is a living document and should be maintained
constantly
4. Failure rate and scrap were reduced, supply improved and
process is more efficient.
Thank you

You might also like