AS EN9145 summary

AS 9145 Summary

Introduction

AS9145 specifies an integrated framework to plan and complete the requirements of a product realization cycle. 

This is to assure the customers that quality and affordable products will be delivered on time. 

Production Part Approval Process (PPAP) is an output of Advanced Product Quality Planning (APQP). 

The production process must exhibit the potential to produce products while operating at the customer demand rate. 

The five phases of APQP:

  • Phase 1: Planning 
  • Phase 2: Product Design and Development
  • Phase 3: Process Design and Development
  • Phase 4: Product Process and Validation
  • Phase 5: Ongoing Production, Use, and Post-Delivery Service

This standard applies to all product developments ,whether new or old. This can be implemented on to the last product or selected level parts.

If the standard gets cited, APQP and PPAP shall proceed to apply to all approved products.

Chapter 1: Scope

This standard defines rules and procedures for carrying out actions and maintaining records of APQP and PPAP. 

It aims to establish a consolidated approach to product realization across the aerospace industry.

“Shall” implies it is required.  “Should” indicates a proposed task. 

Chapter 2: References

9100 – Requirements for Aviation, Space, and Defense Organizations

9102 – Aerospace First Article Inspection Requirement

9103 – Aerospace Series

9110 – Requirements for Aviation Maintenance Organizations

ASTM E 2782 – Standard Guide for Measurement Systems Analysis

IEEE 1490:2011 – Guide – Adoption of the Project Management Institute Standard

ISO 9000 – Fundamentals and Vocabulary

SAEJ J1739 – Potential Failure Mode and Effects Analysis in Design

Chapter 3: Terms and Definitions

Bill of Material (BOM) – List of parts and items stated in the record program of a product

Commercial Off-The-Shelf (COTS) – Available applications defined by the industry

Control Plan – Papers that contains key review and control activities

Critical Item – Important components on the realization of a product

Deliverables – Completed outputs of the APQP process

Design Risk Analysis – Analytical techniques to identify potential failure mode of a product

Failure Mode and Effects Analysis (FMEA) – A planned method to analyze the risks by ranking and recording the possible collapse of a product

Inspection/Test Plan – Detailed reports of key monitoring and testing tasks performed during specific manufacturing tasks

Measurements System Analysis (MSA) – Study on accuracy, preciseness, and doubt measures of a product

Phase – A period in the assembly procedures of products

Post-delivery service – Service rendered to the end users

Pre-design – Offers an understanding on the principle of methods and a high-level structure

Preliminary Bill of Material (BOM) – A set of pattern-related activities which renders an initial project concept based on product details and status

Preliminary Capacity Assessment (PCA) – Assessment to determine essential resources to perform the products according to requests of the consumers

Process Capability Study – A comparison of the result of a controlled handling and its specification limits

Process Validation – Confirmation that a specific method produces capable products

Product Breakdown Structure – Breakdown of minor and major components of a product

Product Development Process (PDP) – Tasks necessary to make and produce the products

Product Validation – Assurance that a product fulfills the desires and needs of the customers

Product Verification – Rating of a product’s compliance to the standard

Production Part Approval Process (PPAP) File – A record that contains the aim of the PPAP requirements

Production Preparation Plan – Identifies all required sources to develop products in enough amount to please the demands of the customer

Production Readiness Review (PRR) – To verify  the documentation and appropriateness of the manufacture processes 

Stakeholder – Involves all persons part in the product growth, customers, and suppliers

Standard Part – Parts that exhibit conformity to the recognized and accepted rules by the industry

Chapter 4: Advanced Product Quality Planning Requirements

When the organization cites this standard, the product processes must follow the established requirements.

The group must assign roles and duties to manage and meet APQP and PPAP factors and to distribute resources . 

The company must define how APQP applies to their own PDP, which comprises:

  • Appointing a project leader
  • Executing a controlled approach to communication
  • Developing and managing a plan 
  • Monitoring and reporting output status
  • Holding project reviews

Phase 1: Planning

Completion Indicators:

  1. Ultimate product design
  2. Preliminary BOM
  3. List of activities and deliverables 

The group must determine, record, and review the product and post-delivery service design input requirements

A defined product breakdown structure is important at this phase. 

The group must develop a service program to establish the extent, tasks, and outcomes for APQP. The planning team must regard all necessary factors 

The result is the final product design and availability of its pre-design. 

Phase 2: Product Design and Development

Completion Indicators:

  1. Launch of the design files
  2. BOM
  3. Verified and validated product design

The plan for the product has to be verified and validated. 

The design should align with the project plan and be approved by the customer. 

The results of the design risk analysis should identify and focus on risk activities.

Design FMEA may be utilised as a file or record for this level of product procedure. 

The team must track and review the risks associated with the initial supply plan. 

The review could regard chances on technology, logistics, authenticity, administration, etc. 

The planning committee must test the feasibility of the proposed product concept. 

All actions and risks must be recorded. 

Phase 3: Process Design and Development 

Completion Indicators:

  1. PRR
  2. Completed deliverables or tasks

Deliverables:

  1. Process flow diagram
  2. Process key characteristics
  3. FMEA
  4. Control plan
  5. PPP
  6. PCA
  7. Necessary record files
  8. Approvals

The group must determine and reevaluate the production process with design input requirements.

A process flow diagram involves all procedures written in a consecutive manner from storing and shipping of the ultimate product. 

The producing company must execute a risk analysis of all the development methods. 

They must specify plans for top-level danger products.

The process flow diagram is a traceable plot that permits tracking of key products. 

A control plan must list all product characteristics that need monitoring. This will be initiated in the next phase. 

The packaging, preservation, and product labelling must get internal and customer approval. 

PRR must be conducted to verify the manufacturing process.

Phase 4: Product and Process Validation 

The completion of this phase is by validating the partial product employing the planned production processes.

Product and process validation must be performed on all products of the company. 

Production processes must be conducted at production sites under excellent production status and terms.

A suitable amount of the products will determine process capability and if it satisfies the required standards. 

Capability studies should regard external parts such as effects of people, machines, tools, methods, material, measurements, and environmental conditions.

Product and data collected during manufacturing processes support control plan, first article inspection report, capacity verification, PPAP file, and initial process capability studies.

The company must forge corrective actions if MSA results do not please internal and customer’s approval. 

Capacity verification exhibits the ability of a company to satisfy a customer’s demand profile. 

The company must submit the complete documents about PPAP requirements. 

Other factors such as dimensional, material, and procedures results may confirm the product according to PPAP. 

Phase 5: Ongoing Production, Use, and Post-Delivery Service

This continuous phase extends until the end of a product’s life cycle. 

At this level, APQP objectives determined in Phase 1 should be satisfied.

Chapter 5: Production Part Approval Process Requirements

 The company must:

  • Identify important PPAP factors
  • Generate a PPAP file for all the products
  • Follow PPAP submission requirements
  • Ensure easy access to the PPAP record
  • Notify customer for product and process changes
  • Establish a resolution scheme for failed PPAP requirements 

Necessary documents in the PPAP file:

  • Design records
  • Design risk analysis
  • Process flow diagram 
  • Process failure mode and effects analysis
  • Control plan 
  • Measurement system analysis
  • Initial process capability studies
  • Packaging, preservation, and labelling approvals
  • First article inspection report
  • Customer PPAP requirements
  • PPAP approval form

A PPAP submission can be:

  • Approved – necessary files are present, resulting to the team permitted to export the products
  • Interim approval – few files are missing, but the company can ship the products under customer restricted orders
  • Rejected – requirements are not present, and the group is not authorized to transfer the products

If there are changes or revisions, a PPAP resubmission is essential. 

Chapter 6: Notes

Changes to the previous issue of this standard is indicated by a change bar placed at the left margin. Its principal purpose is for ease of the user. 

Appendix A: Acronym

Most important acronyms used in this document:

APQP – Advanced Product Quality Planning

BOM – Bill of Material

DFMEA  – Design Failure Mode and Effects Analysis

FAIR – First Article Inspection Report

MSA – Measurement System Analysis

PPAP – Production Part Approval Process

Appendix C: Control Plan

A control plan is necessary to record control procedures performed on the products and their certain processes. 

It contains detail on how the quality of the products are controlled and confirmed at every stage of the development process. It also lists actions executed to unstable products and processes.

At every phase, the control plan develops and matures. It is a living document of a product in response to new quality issues or changes. 

  

Appendix D: Production Part Approval Process Form Elements

Required Fields – mandatory informationConditionally Required Fields- completed only when applicable
Part numberPart nameOrganization nameAddress (Street, City, State, Country, Postal Code)Submission typePPAP elements providedCustomer PPAP element acceptanceDeclarationCustomer use onlyPart revision levelDrawing numberDrawing revision levelAdditional changesCustomer purchasing requirementPurchase order numberSupplier/Vendor codeAction plan