AEROSPACE SCHEME UPDATES,

FUTURE CHANGES, APQP

Michael Venner & Archie Gemmell

2nd October 2020
 ASXXXX SERIES WEBINAR
YOUR PRESENTERS
MICHAEL VENNER
AEROSPACE DIRECTOR
Mike has over 19 years’ experience in
management system development
and deployment. Specialising in the
AS9100 and AS9120 Aerospace
Management System standards.
An industry expert, widely trusted and
respected amongst peers for
managing an efficient and effective
Aerospace and Automotive business
unit within NQA.
ARCHIE GEMMELL
NQA REGIONAL ASSESSOR
Archie can assess organisations to
many standards such as AS9100,
AS9120, ISO 9001, AS6081, ISO
14001 and ISO 45001 although most
of his time is spent focusing on our
aerospace client base.
Archie was previously employed by
the Royal Air Force where he was an
aircraft lead technician for the
Tornado Aircraft.
 AGENDA

A technical workshop - focusing on:

• AS91XX series NCR Technical Analysis
1pm (1 hour) • AS9104-1 and the impact this will have on your organisation
• The new manday calculation for AS91XX series standards
• Q&A

15 minutes

An overview of APQP and the 5 phases of implementation:

• Phase 1 Planning
• Phase 2 Product Design and Development
2.15pm (1 hour) • Phase 3 Process Design and Development
• Phase 4 Product and Process Verification
• Phase 5 On-Going Production

An opportunity to ask questions with our technical experts

3.15pm – anything scheme or AS standards related.
AEROSPACE
AUDIT TRENDS
AND THE NEW
AUDIT DAY
CALCULATIONS
 OASIS DATA: JANUARY 2018 – MAY 2019

Overall Total Quality 80299 – Total Major 12373 – Total Minor 67576
Top nonconformities: 3500

• 8.4.3 Information for 3000

external providers
2500
• 8.5.1 Control of production
and service provision 2000

• 10.2.1 Nonconformity and

corrective action 1500

• 7.1.5.2 Measurement
traceability 1000

• 8.4.1.1 Control of externally

500
provided processes,
products and services 0

Ma Mi
 OASIS DATA: AMERICAS

Overall Total Quality 44761 – Total Major 5455 – Total Minor 39306
Top nonconformities: 4000

• 8.4.3 Information for 3500

external providers 3000

• 8.5.1 Control of production

and service provision 2500

• 10.2.1 Nonconformity and 2000

corrective action
• 7.1.5.2 Measurement 1500

traceability 1000

• 8.4.1.1 Control of externally

provided processes, 500

products and services 0

Ma Mi
 OASIS DATA: EUROPE

Overall Total Quality 32471 – Total Major 7056 – Total Minor 25415
Top nonconformities: 4000

• 8.4.3 Information for 3500

external providers 3000

• 8.5.1 Control of production

and service provision 2500

• 10.2.1 Nonconformity and 2000

corrective action
• 7.1.5.2 Measurement 1500

traceability 1000

• 4.4.1 Quality management

system and its processes 500

(Different to USA) 0

Ma Mi
 OASIS DATA: ASIA

Overall Total Quality 3067 – Total Major 212 – Total Minor 2855
Top nonconformities: 300

• 8.5.1 Control of production 250

and service provision

• 10.2.1 Nonconformity and 200

corrective action
• 8.4.3 Information for 150

external providers
• 9.2.1 Internal audit 100

(Different)
• 7.1.5.2 Measurement 50

traceability (Different)
• 7.2 Competence (Different) 0

Ma Mi
 CERTIFICATES: MAY 2019

Certificates Globally - 21288

Asia, 4050, 19%

Americas, 9894, 46%

Europe, 7344, 35%

 NCRs RAISED: MAY 2019

Qty of NCRs Globally - 80299

Asia, 3067, 4%

Europe, 32471, 40% Americas, 44761, 56%

 RATIO OF NCRs RAISED: MAY 2019

Ratio of NCRs to Certificates

4.52 4.42
5.00
4.50 3.77

4.00
3.50
3.00
Ratio
2.50
2.00
1.50 0.76

1.00
0.50
0.00
Global Americas Europe Asia
 RATIO OF NCRs RAISED: MAY 2019

Ratio of Majors to Certificates Ratio of Minor to Certificates

3.97
0.96
1.00 4.00
3.46
0.90 3.50 3.17
0.80
3.00
0.70 0.60
0.55 2.50
0.60
0.50 Ratio 2.00 Ratio

0.40 1.50
0.30
1.00 0.70
0.20
0.05 0.50
0.10
0.00 0.00
Global Americas Europe Asia Global Americas Europe Asia
 OASIS DATA – NEW REQUIREMENTS

3500

3000

Product Counterfeit
Safety Raw Material
2500

Escape
Prevention
2000

Obsolescence Change
1500
Risk

1000

500

Ma Mi
 IMPACT ON YOU AS A CERTIFIED ORGANISATION

• How are you performing against the industry averages?

You should review your own data within OASIS and see
how you compare. You can pull your own data from
OASIS.

• The information will be used for future assessment audit

calculations.

• Auditors will have KPI targets as an area of focus.

 AS9104/1 UPDATE
CB ACCREDITATION STANDARD
 AUDIT DURATIONS

• New Organisation Certification Analysis Process (OCAP)

• Single site and multiple site structures only (Removed Campus and Several Site)

• Non-applicable processes shall result in audit duration reduction from the established
minimum baseline

• Purchasing no longer mandatory for every audit

• OCAP will be used to drive audit duration increases or allow for decreases, with limitations

• Up to 30% can be conducted remotely

• Can reduce time up to maximum of 50% (through PBS/RP)

 AUDIT DURATIONS – CERTIFICATION BODIES

Audit duration
• New Organisation Certification Analysis Process (OCAP)

• The CB shall be given flexibility to determine the amount of calculated audit duration to be used at
each site. The duration shall be based on the OCAP, justified and supported with documented
information.

• Audit report writing shall be included in audit duration calculations and the baseline minimum shall be
a 10% addition to the final onsite audit calculation. Added time for report writing may be used during
performance of the on-site audit.

• Audit planning time of 10% will also be added to the audit duration calculations

• Auditor rotation for lead or audit team member: requirement to be a maximum of 6 consecutive
audits, unless justification is submitted and approved by AB (to include semi-annual audits)
 AUDIT PLANNING

Certification Bodies:

The CB shall require client participation in the audit planning process by

submitting QMS performance and change data in advance of any audit. The
CB process shall also include a review of the submitted data by the lead
auditor, prior to starting the audit. Documented information shall be retained.
 OCAP-RISK ANALYSIS

Before each site assessment, as part of audit planning and the OCAP Process.

Risk Assessment to include:

• On time delivery performance (meeting customer requirement)

• Customer complaints and returns
• KPI Results
• PEAR Scores
• Internal Auditor Competence
• Size and Complexity of the site

Resulting outcome will be:

• 10 reduction in time
• No change
• 10% addition in time
 OCAP TOOL – AUDIT CALCULATION – MEDIUM RISK

Number of Employees 40

Audit Type
Surveillance 2.0
PBSRP No

Risk Analysis adjustment MED 2.0

Risk Assessement RISK LEVEL
Metric Definition Return
MEDIUM
Performance Based
(See Description Below)
LOW MED HIGH Reductions Exclude
Exclude
Element Ownership Source Low Medium High Site Specific Process Exclusions % Reduction Yes/No
Organizatio
On Time Delivery Organization to define n Exceeds Requirement Meets Requirement Below Requirement No x Management of QMS 0.10 No 0.00
Organizatio
Product/Service Rating Organization to define n Exceeds Requirement Meets Requirement Below Requirement No x Design and Development of Products and Services (e.g. 8.3) 0.20 Yes 0.20
Customer Organizatio
Complaints/Feedback Organization to define n Exceeds Requirement Meets Requirement Below Requirement No x Control of Externally Provided Processes, Products and
AQMS Metric Organization to define PEAR KPI's Exceeds Requirement Meets Requirement Below Requirement No x
Select lowest PEAR score Services (e.g. 8.4) 0.15 No 0.00
Performance LY CB Audit from previous CB audit. PEARs 5 3 to 4 1 to 2 No x
Company Characteristics Control of Production and Services (e.g. 8.5) 0.20 No 0.00
Internal Audit Program Define See Below Aerospace Authenticated Auditors AerospaceTrained Auditors Other Training No x
Company Characteristics Define See Below See Below or MD 5
Variables identified as high risk should drive audit planning activities (e.g. High risk related to External Provider Performance would require
No x Total Reductions 0.20
Calculation
the associated process to be audited during surveillance. 0 7 0
7 0 21 0
MD 5 (Modified) Defintion of High to Low Risk Analysis Status Risk Number
COMPLETE 33%
Total Audit Duration before Additions Maximum reduction 50% 1.6

Audit Duration 2.0

Audit Time 2.4
Added Audit Time
Total Audit Time 2.4

This would currently be 2 days plus 0.5 for report

 OCAP – LOW AND HIGH RISK

Number of Employees 40 Number of Employees 40

Audit Type Audit Type

Surveillance 2.0 Surveillance 2.0
PBSRP No PBSRP No

Risk Analysis adjustment LOW 1.8 Risk Analysis adjustment HIGH 2.2

Reductions Exclude Reductions Exclude

Site Specific Process Exclusions % Reduction Yes/No Site Specific Process Exclusions % Reduction Yes/No
Management of QMS 0.10 No 0.00 Management of QMS 0.10 No 0.00
Design and Development of Products and Services (e.g. 8.3) 0.20 Yes 0.20 Design and Development of Products and Services (e.g. 8.3) 0.20 Yes 0.20
Control of Externally Provided Processes, Products and Control of Externally Provided Processes, Products and
Services (e.g. 8.4) 0.15 No 0.00 Services (e.g. 8.4) 0.15 No 0.00
Control of Production and Services (e.g. 8.5) 0.20 No 0.00 Control of Production and Services (e.g. 8.5) 0.20 No 0.00
Total Reductions 0.20 Total Reductions 0.20

Total Audit Duration before Additions Maximum reduction 50% 1.44 Total Audit Duration before Additions Maximum reduction 50% 1.76

Audit Duration 1.5 Audit Duration 2.0

Audit Time 1.8 Audit Time 2.4
Added Audit Time Added Audit Time
Total Audit Time 1.8 Total Audit Time 2.4
 ANNUAL
QUALIFICATION QUALIFICATIONS

• Completion of one AQMS Cycle • Annual Review Performed

• Annual OCAP Performance • Continue to Meet Qualification
PBS/RP Results Requirements.
QUALIFICATION • Mature Internal Audit Program
• Annual audit of QMS in total
REQUIREMENTS • Continual audit program (not event
driven), risk based
PBS = Performance • Input driven (KPI, customer
Based Surveillance complaints)
• Defined and structured program
that changes based on
RP = Recertification performance/risk
Process • Linked to change management.
• Competent Internal Auditors
• Ethics Policy
• No Major NCRs
• Not Suspended in last 6 years
• Continual Improvement Activity
• Control of Organisational changes
• Exceeding Customer Satisfaction
• No Violations of Regulatory
Approvals.
 TRANSITION TIMELINE

Transition:

• AB, CB, AAB, TPAB & Committees to be provided 12 months from publication

• CB accreditation 18 months from publication

• Existing certificates transition to be linked to re-certification

• Transition should not be dependent on go forward decision on OASIS.

 OTHER NOTABLE CHANGES

• Auditor Time-out is now per audit not per cycle but applies to all auditors not just AEA

• Transfer rule of additional time if less than 12 months on cert has been removed

• Other potential standards being brought into the assessments

• If transferring to another CB, current Lead Auditor can not perform audits within 24
months

• Very strict on major and minor grading being correct

• Clients will receive non-conformances if data provided is not accurate.

 IMPACT ON YOU AS A CLIENT

• More attention will be placed upon audit and KPI performance with regards to audit time, this should be a
key focus of your organisation as may have financial benefits/implications

• Possible changes to your auditors

• What is your site structure, will the changes impact your business and subsequently audit durations?

• You will be penalised for not supporting the audit planning process, do you currently complete the data
gathering forms issued to you?

• Ensure your data is true and accurate

• How is your OTD and Quality Performance? This forms part of the risk review and time allocation

• What training have your internal auditors received? This will impact your time allocation

• What are your PEAR scores? These will impact your time allocation.
Q&A
BREAK
(15 MINS)
ADVANCED
PRODUCT
QUALITY
PLANNING
 WHO SHOULD APPLY AS9145 / APQP / PPAP

• Intended for larger organisations but can be applied to any

• You can apply certain phrases and not others depending on your business

• Will be flowed down through contract document.

PRODUCT DEVELOPMENT APQP MODEL
APQP and PPAP Elements
Typical Situation without APQP
After implementing APQP
 3 PILLARS OF APQP

1. Organizational commitment and management support

The information generated through the APQP process allows
management to track and pace new/modified product development
activities.

2. 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 implementation of the APQP relies on many different
personal within the organization.

3. Effective project planning

The project plan is based on the customer’s needs. Key target dates
are cascaded throughout the value stream.
 5 PHASES OF APQP

• Phase 1 – Planning

• Phase 2 – Product Design and Development

• Phase 3 – Process Design and Development

• Phase 4 – Product and Process Validation

• Phase 5 – On-going Production , Use, and Post-Delivery Service

 PHASE 1 – PLANNING INPUTS

• Regulatory Requirements • Lessons Learned

- Best practices
• Customer Needs - Project management
- Project milestones and product deliver date - Quality issues
- Projected volumes - Product design guidelines/procedures/data
- Program lifecycle from similar product
- Product and process assumptions - Process design guidelines/procedures/data
from similar product
• Product Performance
- Historical problems internal and external • Company Strategy
including warranty - Business plan
- Reliability requirements - Marketing strategy
- Quality requirements - Industrial strategy
- Technical requirements - Technical strategy
 PHASE 1 – ELEMENTS AND DELIVERABLES

• Project Inputs • Preliminary Bill of Material (BOM)

- Requirements document (Statement of Work) where - PBS for complex products and list of sub-systems
changes are managed and recorded showing the product assembly hierarchy
• Product design requirements - Preliminary BOM
- Configuration controlled Product (technical) Design • Preliminary process flow diagram
requirement document(s) agreed upon between producer - Preliminary PFD signed off by design and
and customer manufacturing engineering, production, procurement
• Producer Product Specification and quality.
- Approved configuration controlled Producer Product • Statement of Work (SOW) review
Specification - Signed SOW
• Project targets – safety, quality/manufacturability, • Preliminary sourcing plan
service life, reliability, durability, maintainability, - Make/buy decisions
schedule, and cost - Sourcing plan
- Agreed upon list of Key Performance Indicators (KPIs) - Identified requirement to be flowed down to producer
covering safety, quality/manufacturability, service life, • Project plan
reliability, durability, maintainability, schedule, and cost for - Agreed upon timing plan that includes activities, due
the complete product lifecycle dates and responsible parties.
• A preliminary listing of Critical Items (CIs) and Key
Characteristics (KCs)
- A preliminary listing of CIs and KCs agreed upon between
supplier and customer
 PRODUCT DESIGN AND DEVELOPMENT

This phase is very detailed and lots of elements come together

to create the design including suppliers, key characteristics and
manufacturing instructions.
PHASE 2
A key deliverable of the process is the design risk analysis, the
risk analysis will ascertain whether the design will meet
performance requirements and costs. Design Failure Mode and
Effects Analysis is one method that is commonly used to
complete this process.

The inputs to this overall process are the deliverables from

phase 1, most importantly the project plan. At the end of the
phase, a feasibility study shall be performed to determine if the
design can be manufactured, assembled, tested, packaged, and
delivered in sufficient quantity on schedule and at the correct
price target.
 PHASE 2 – PRODUCT DESIGN AND DEVELOPMENT –
ELEMENTS AND DELIVERABLES
• Design risk analysis
- Design Risk Analysis highlighting design risks
- Recommended actions for risk mitigation
- Identification of CIs and product KCs
• Design records
- Complete engineering definition / specification of the
product, which satisfies the requirements as defined in
phase 1 and is approved by the Design Authority
• Bill of Material (BOM)
- Released BOM
• Design for Manufacturing and Assembly
(DFMA), tolerance, stack-up analysis, etc.
- 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
• Design for Maintenance, Repair and Overhaul
(DMRO)
- 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.
• Special requirements, including product Key
Characteristics (KCs) and Critical Items (CIs)
listings
- List of the Cis and KCs
• Preliminary risk analysis of sourcing plan
- A sourcing plan with identified risks, aligned by each
proposed supplier, and the mitigation
- plans
 PHASE 2 – PRODUCT DESIGN AND DEVELOPMENT –
ELEMENTS AND DELIVERABLES

• Packaging specification
- Packaging specification agreed with the customers, where appropriate
• Design review report
- Design review reports highlighting compliance status, design risks and mitigating actions
• Development product build plan
- A Development Product Build Plan that defines the items.
- Formal reports documenting the outcome of the manufacture/build process including a record of
the discrepancies that arise along with their proposed solutions
• Design verification and validation plans, and associated results
- 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
• Feasibility Assessment
 PROCESS DESIGN AND DEVELOPMENT

This phase is all about setting up your manufacturing

process and proving its capabilities. If an organization is
being given the design by the customer then they are
PHASE 3
likely to get more involved at this stage. They might have
been involved in earlier stages to help with the feasibility
of manufacturing but this is where they start to get dirty.

The key deliverable at the end of the phase is the

Production Readiness Review (PRR). The PRR provides
the team and the customer confidence that the process
is capable of producing the product consistently and in
compliance with customer and producer requirements.
 PHASE 3 – PROCESS DESIGN AND DEVELOPMENT –
ELEMENTS AND DELIVERABLES
• Process flow diagram
- Process Flow Diagram approved by Engineering,
Operations and Quality
• Floor plan layout
- Plant layout plan approved by the Operations and
Quality Managers.
• Production preparation plan
- A Production Preparation Plan covering all aspects
of obtaining and qualifying human resources, tooling,
facilities, and equipment
- An Agreed progress reporting schedule
• Process Failure Mode & Effect Analysis
(PFMEA)
- Completed approved PFMEA and a plan to reduce
high priority risks
• Process Key Characteristics (KCs)
- List of Process KCs
• Control plan
- Control plan signed and approved by: Quality and
production and the Customer upon request
• Preliminary capacity assessment
- Capacity analysis
- A capacity plan to close any identified gaps
• Work station documentation
- All applicable work station documentation accessible
at the work stations
• Measurement Systems Analysis (MSA)
Plan
- Plan identifying all measurement systems to be
evaluated, including persons responsible for
evaluating them and the timing for accomplishing the
tasks
• Supply Chain Risk Management Plan
- Risk analysis
- Risk mitigation plan
 PHASE 3 – PROCESS DESIGN AND DEVELOPMENT –
ELEMENTS AND DELIVERABLES

• Material handling, packaging, labelling, and part marking approvals

- Material handling methods defined and documented
- Packaging, labelling, and part marking requirements defined, understood and
approved as required

• Production Readiness Review (PRR) results

- Finalized documented manufacturing process
- Action plan for resolution of identified risks or issues
 PRODUCT AND PROCESS VALIDATION

This phase is all about approving those initial products using tools such as
First Article Inspection Reports and more importantly PPAP as mentioned
earlier. The key deliverable of this phase is the PPAP but to make up the
PPAP you need to have a number of elements completed.
PHASE 4
The first production runs are trials to prove the process, the PPAP
document is the records to demonstrate the production run has been
successful and meets the initial design input requirements. You are
proving the capability of production to meet demand as per the plan
produced in the previous phases. Depending on the product, the
production run could run into multiples of products, not just a single part,
you may need to provide tooling so will produce a number of parts. All of
this should be planned.

You need to have in place all of your production equipment and tooling,
correct suppliers in place etc. it’s not like when you do a prototype and you
could possibly use alternatives, you need to use the actual processes and
products defined within the design.
 PHASE 4 – PRODUCT AND PROCESS VALIDATION -
ELEMENTS AND DELIVERABLES
• Production Process Runs
- 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
• Measurement Systems Analysis (MSA)
- MSA results per MSA plan
- Action plan for those measurement systems not
meeting acceptance criteria
• Initial Process Capability Studies
- Calculated Cpk (or Ppk as appropriate) indices from
production products
- Action plan for variation reduction where Cpk indices •
are below the established acceptance value
• Control Plan
- Completed approved production Control Plan
• Capacity Verification
- Verified capacity to satisfy the customer demand
profile
• Product Validation Results
- Results of all tests performed per the design
validation plan
- Test results demonstrating conformance to
requirements
• First Article Inspection (FAI)
- Approved First Article Inspection Report
• Production Part Approval Process (PPAP)
file and Approval Form
- Approved PPAP
Customer Specific Requirements
- Identification and fulfilment of Customer Specific
Requirements
 ONGOING PRODUCTION, USE, AND POST-
DELIVERY SERVICE
Phase 4 will get the products released and approved for
production, phase 5 is all about the ongoing monitoring of
the product through the lifecycle.
PHASE 5
One of the key deliverables is capturing lessons learnt from
the production process but also field data such as from
warranty claims. This information should be used to improve
the current product and also future products. As much data
as possible should be collated and analysed, FMEAs should
be maintained throughout the lifecycle and updated as
necessary with lessons learned. If savings within the process
can be made, ether time, efficiencies, costs or process
variations they should be implemented if appropriate.
 PHASE 5 – ONGOING PRODUCTION, USEM AND POST-
DELIVERY SERVICE – ELEMENTS AND DELIVERABLES

• Measuring Performance
- Metrics that clearly demonstrate actual performance against targets and requirements
- Action plan to implement corrective actions as needed
• Maintenance, Repair and Overhaul (MRO) KPIs and plan(s) to reach the
established targets
- A plan to provide the necessary MRO services
- Improvement plan as necessary
• Continuous improvement actions
- On-going data analysis and planned improvement actions
• Lessons Learned
- Record of lessons learned
- Successful activities captured and standardized for future programs
- Action plan(s) for improvement activities
CONTROL
PLANS
 BENEFITS OF A CONTROL PLAN

Improves Product Quality Improves Efficiency/Cost

• Improves ability to prevent • Reduces waste in a process,

nonconforming products
• Identifies and manages sources of
variation (input variables), and
reduces variation in product
characteristics (output variables)
• Reduces scrap and rework
improving throughput/manufacturing
efficiency
• Reduces costs without sacrificing
quality
 BENEFITS OF A CONTROL PLAN
Improves Customer Satisfaction
• Focuses resources on the
product/process characteristics most
important to the customer and the
organisation
• Prevents nonconforming product from
reaching the customer
Improves Process Management
• Establishes a plan for responding to
changing process conditions
• Communicates changes in
product/process characteristics, control
method, and measurement methodology
• Monitors processes and assures that
process improvements are maintained
over the life cycle of the product
• Employ prevention rather than detection
(e.g. use of error-proofing instead of
operator dependant work or inspection)
 INPUTS

• Process Flow Diagram (FPD, flowcharts, swimlanes, SIPOC, Turtles etc)

• Process Failure Mode and Effects Analysis (PFMEA)
• Design Reviews (If you are the design authority)
• Product Key Characteristics (From Design Failure Mode and Effects Analysis
CONTROL PLAN or could already be identified on the drawing if you are manufacturing only).
• Process Key Characteristics
• Measurement System Analysis (MSA)
• Special Characteristics Matrix
• Lessons learned from similar parts
• Cross-functional team knowledge about the process
• Field or Warranty Issues

The intent of the control plan is to align the plan with your process flow diagram
and focus the attention on the high-risk process points as identified in your
PFMEA. Is it advised to start the process as early on as possible during the initial
stages of development, you should identify what controls you need to put in place
to further reduce the risks within the processes.

Prevention is always better than cure so the control plan should focus on using
tools such as error-proofing instead of operator dependant work or inspection.
Q&A
THANK YOU

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