as9145 standard - the global voice of quality | asqasq.org/asd/2017/04/as9145-standard.pdf · ·...

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:

APQP phases1 - Planning

2 - Product Design & Development

3 - Process Design & Development

4 - Product Process

Validation

5 - Production

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

A

B

E

C

D

APQP milestonesAPQP supports Product Development Process (PDP)

• 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

Alignment with Product Development Process (PDP)

Cascade through Product Breakdown Structure (PBS)

Sub-system level

System level

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

Components level

1 - Cascade

deliverables and align

timing for each level2 - Bottom up status based

on on-time on-quality

deliverables

Note: Compressed timeline

to support program timing

3 - Report APQP

status at project level

Typical PBS:

system→ sub-system→ component

1 - Planning



4 - Product Process

Validation

5 - Production

1 - Planning



4 - Product Process

Validation

5 - Production

1 - Planning



4 - Product Process

Validation

5 - Production

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




4 - Product Process

Validation

5 - Production

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

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

• 1.02 Technical Design

Requirements

• 1.03 Reliability & Quality

goals

• 1.04 Preliminary Listings

of Critical Items & KC

• 1.05 Product

Specification

• 1.06 Preliminary BOM

• 1.07 Preliminary Process

Flow Chart

• 1.08 Statement of Work

Review

• 1.09 Sub-tier Selection &

Management

• 1.10 APQP Timeline

Phase 1 Planning: Checklist

example

# Question Y* N N/A RYG

1

Was a a cross-functional team used to gather

project inputs including the following as applicable:

Program Management, Quality, Design Engineering,

Manufacturing Engineering, Marketing and Sales,

Procurement?

2 Are applicable regulatory requirements available?

3

Are customer requirements available including:

Project milestones and product delivery date

Projected volumes

Project lifecycle

Product and process assumptions

4

Are all internal data to build product performance

expectations available including:

• Historical problems internal and external

• Warranty

• Reliability requirements

• Quality requirements

• Technical Requriements

5

Have lesson learned been conducted including:

• Best Practices

• Project management

• Quality issues

• Product design guidelines

• Process design guidelines

6

Is the company strategy available including:

• Business plan

• Marketing strategy

• Industrial strategy

• Technical strategy

7

Have the resulting project/product requirements

been referenced/recorded into a repository,

including supporting data?

Data is made available to be used by the project

team?

8Is there a process to keep formal requirements

document up-to-date?

9Has (Have) any potential risk(s) not highlighted by

previous question been identified? If no, describe

this risks?

10

11

X 25% N/A

IP 50%

Status (%):25% - Action Identified 50% - Owner Identified

75% - Action in Progress 100% - Action Closed75% R

100% Y

G

Deliverable RYG Rating

Red: Some questions have a negative answer and no recovery plan is in place or the plans

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.

Yellow: Some questions have a negative answer but a recovery plan is in place which will

prevent impact on timingGreen: All questions have a positive answer (Y) and are ongoing normal program development

Evidence Actions Required

Table 1

Questions

Marking

Evidence

Rating

The

following

slides

show the

principle of

the SCMH

checklists.

Each

phase has

it’s own

checklists


example – questions section

Table 1

Question Y*

Was a a cross-functional team used to gather

project inputs including the following as applicable:

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

Project lifecycle

Product and process assumptions

Are all internal data to build product performance

expectations available including:

• Historical problems internal and external

• Warranty

• Reliability requirements

• Quality requirements

• Technical Requriements

Have lesson learned been conducted including:

• Best Practices

• Project management

• Quality issues

• Product design guidelines

• Process design guidelines

Is the company strategy available including:

• Business plan

• Marketing strategy

• Industrial strategy

• Technical strategy

Have the resulting project/product requirements

been referenced/recorded into a repository,

including supporting data?

Data is made available to be used by the project

team?

Is there a process to keep formal requirements

document up-to-date?

Has (Have) any potential risk(s) not highlighted by

previous question been identified? If no, describe

this risks?

The questions are used to evaluate the quality of

the deliverable attached to the element.

Typical aspects of the deliverable to be

evaluated through the questions are:

1. Quality/availability of the inputs needed to

build the deliverable

2. Cross-functional approach to answer the

deliverables

3. Quality /conformity to a standard if any or to

best practices

4. control of the outcome of the

deliverable (e.g. action plan)


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.

When you put an "R" or "Y" you will

need to complete the "Actions Required" and

subsequent columns.

Y* N N/A RYG Evidence


example evidence & rating

Table 1

Status (%):25% - Action Identified 50% - Owner Identified

75% - Action in Progress 100% - Action Closed75%

100%

R

Y

G

Red: Some questions have a negative answer and no recovery plan is in place or the plans

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.

Yellow: Some questions have a negative answer but a recovery plan is in place which will

prevent impact on timingGreen: All questions have a positive answer (Y) and are ongoing normal program development

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 .


example table 2

Open

Date

Due

Date

Status

%

Actual End

DateActions Required Responsible

For each questions in table 1 you specify the

actions, responsibilities and dates in table 2

Phase 2 Product Design and

Development




4 - Product Process

Validation

5 - Production

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

APQP milestones


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.


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


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



• 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


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

• 2.02.1 Design for

Manufacturing &

Assembly

• 2.02.2 Design for MRO

• 2.02.3 Product critical

items & KC

• 2.02.4 New product

packaging specification

• 2.03 Design Reviews

• 2.04.1 Development

Product / Part Build Plan

• 2.04.2 Verification &

Validation Testing

• 2.05 Design Record

Review by the Production

Source

• 2.06 Management

Support

Phase 3 Process Design and





4 - Product Process

Validation

5 - Production

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

APQP milestones



• 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



• Process flow diagram*

• Floor plan layout

• Production preparation plan

• Operator staffing and training plan (Human Resources)

• PFMEA*

• Process KCs

• Control plan*



• 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


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






4 - Product Process

Validation

5 - Production

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

APQP milestones

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


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*


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




4 - Product Process

Validation

5 - Production

Product Development

Process

End of

concept

End of

design

Product

validation

Production

readinessKick off

APQP milestones

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


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


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


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.


Generic APQP Cabiran

man

ufa

ctu

re

mo

ve

sto

re

self

in

sp

ecti

on

Insp

ecti

on

Decision blockFlow Chart

Ste

p n

um

ber

IF N

OT

OK

GO

TO

IF O

K G

O T

O

WAX INJECTION

RECEIVING

MATERIALS FROM

STORAGE

step AA11

look at control

plan "Reaction

plan" step 0

AA11 step AA15

look at control

plan "Reaction

plan" step AA11

0

Description

We started with the process by a lay out

of all the steps designated for the A350

parts.

The form had 4 symbols:

Circle – Manufacturing

Arrow – Move

Triangle – Storage

Rectangular – Inspection (self)

We added a pentagon - Inspection

man

ufa

ctu

re

mo

ve

sto

re

self

in

sp

ecti

on

Insp

ecti

on


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

DELIVERY OF

WRONG WAX TYPEPart failure 6 Human error 2 Visual Visual 8 96

Wax certificated are

checked prior to

shipment

QASupplier sends

COT6 1 2

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

Pro

po

sed

pre

ven

t acti

on

Resp

on

sib

le / d

ate

Sev

FMEA

Det

RP

N

Occ

Cla

ss

Po

ten

tial C

au

ses

OC

C

Cu

rren

t p

reven

t co

ntr

ol

Cu

rren

t d

ete

cti

on

Det

Acti

on

s d

on

e

Po

ten

tial fa

ilu

re

Po

ten

tial F

ailu

re E

ffects

SE

V


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

DELIVERY OF

WRONG WAX TYPEPart failure 6 Human error 2 Visual Visual 8 96

Wax certificated are

checked prior to

shipment

QASupplier sends

COT6 1 2

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

Pro

po

sed

pre

ven

t acti

on

Resp

on

sib

le / d

ate

Sev

FMEA

Det

RP

N

Occ

Cla

ss

Po

ten

tial C

au

ses

OC

C

Cu

rren

t p

reven

t co

ntr

ol

Cu

rren

t d

ete

cti

on

Det

Acti

on

s d

on

e

Po

ten

tial fa

ilu

re

Po

ten

tial F

ailu

re E

ffects

SE

V


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.

Wax typeWax should match

specification KC3039

visual check of

certificate prior

to shipment

each shipment

supplier does not ship before

certificate are approved by

Cabiran QA. Material not

approved in Cabiran if

certificate not signed by QA.

unapproved material is

RTV

mold I.D. Right moldVisual check of

mold I.D

Each extraction of

mold from store

the operator in the injection

compare the mold to the

product folder and if not right

returns the mold to store

Return the mold to store

Meth

od

an

d e

qu

ipm

en

t

Fre

qu

en

cy

Co

ntr

ol m

eth

od

/in

str

ucti

on

s

Reacti

on

pla

n

Control plan

Pro

du

ct

or

pro

cess c

hara

cte

risti

c

KP

C

KC

C

Req

uir

em

en

ts


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?


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

as9145 standard - the global voice of quality | asqasq.org/asd/2017/04/as9145-standard.pdf · ·...

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