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BS EN 9145:2018

BS EN 9145:2018

$167.15

Aerospace series. Requirements for Advanced Product Quality Planning and Production Part Approval Process

Published By Publication Date Number of Pages
BSI 2018 34
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This standard establishes requirements for performing and documenting APQP and PPAP. APQP begins with conceptual product needs and extends through product definition, production planning, product and process validation (i.e. PPAP), product use, and post-delivery service. This standard integrates and collaborates with the requirements of the EN 9100, EN 9102, EN 9103 and EN 9110 standards.

The requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.

1.1 Purpose

The purpose of this standard is to establish a uniform approach to product realization across the aviation, space and defence industry ensuring that quality products are delivered on time, while satisfying cost performance targets.

1.2Convention

The following conventions are used in this standard:

  • the word “shall” indicates a requirement;

  • the word “should” indicates a recommended action (content or path), but not mandatory application;

  • words “typical”, “example”, “for reference” or “e.g.” indicate suggestions given for guidance only;

  • “NOTES” are used for additional clarification;

  • words or phrases with specific meaning pertaining to this document are defined in 3 (Terms and definitions).

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 European foreword
8 Introduction
0.1 General
9 0.2 Application
10 1 Scope
1.1 Purpose
1.2 Convention
2 References
11 3 Terms and definitions
15 4 Advanced product quality planning requirements
4.1 General requirements
4.1.1 The organization’s processes for product realization shall fulfil the requirements of this standard for the products within the organization’s design and/or manufacturing responsibility.
4.1.2 When this standard is invoked by the organization or flowed down as a general contractual requirement, the scope of products for which it applies shall be established.
4.1.3 The organization shall define the roles and responsibilities for managing and accomplishing APQP and PPAP elements and allocating resources appropriately.
4.1.4 The organization’s planning for product design and process changes shall include the appropriate application of APQP to ensure that all product and process changes are effectively executed.
4.1.5 The organization shall include supply chain management planning to support the project, identify supplier related risks and define mitigation actions (as appropriate) including the flow down of this standard’s requirements (see 4.3.2.2).
4.2 Advanced product quality planning project management
16 4.3 Phase 1 requirements — planning
4.3.1 The organization shall identify, document and review the product and post-delivery service design input requirements, including the following:
4.3.2 The product breakdown structure or high-level BOM shall be defined, as deemed appropriate, by the organization.
4.3.3 The organization shall establish a project plan to define the scope, activities and deliverables for APQP. The planning team should consider all deliverables included in Annex B for applicability to the project.
17 4.3.4 Finalization of the product design concept and availability of the pre-design shall be an output of the planning phase.
4.4 Phase 2 requirements — product design and development
4.4.1 The product design requirements (e.g. product safety, performance, service reliability, service life, maintainability, manufacturability, cost) shall be expressed in terms that can be verified and validated.
4.4.2 The product design deliverables (see Annex B) shall include, but are not limited to:
4.4.3 The design verification and validation plan(s) shall be established and fulfilled in alignment with the project plan and approved by the customer (as required).
4.4.4 The design responsible organization shall ensure that a design risk analysis related to performance (i.e. fit, form and function), durability, service life, reliability, manufacturability, maintainability and cost is performed and appropriate risk m
18 4.4.5 The organization shall review and evaluate risk associated with the preliminary sourcing plan. The review should consider risk associated with technology, logistics, lead-time, obsolescence, authenticity (counterfeit parts prevention), etc.
4.4.6 The organization’s planning team (e.g. design, manufacturing, quality, procurement, product support, maintenance) shall assess the feasibility of the proposed design and document that the proposed design can be manufactured, assembled, tested, packa
4.5 Phase 3 requirements — process design and development
4.5.1 The organization shall identify and review the production process design input requirements, including:
4.5.2 The process design deliverables shall include, but are not limited to:
19 4.5.3 A process flow diagram that includes all operations in sequential order from receipt of materials through storage and shipment of finished product shall be generated. This encompasses alternate processes and movement of product to and from external
4.5.4 The producing organization shall perform a risk analysis of the manufacturing process and identify mitigation plans for high risks using the PFMEA methodology (reference SAE J1739), unless an alternate method is required and/or approved by the custo
4.5.5 Process KCs shall be identified using PFMEA or other methods in order to establish variation control of product KCs and CIs.
4.5.6 The organization shall:
4.5.7 A control plan shall:
4.5.8 The organization shall ensure that the methods of packaging, preservation and labelling of production materials and product conform to the internal and/or customer defined specifications and obtain customer approval (as required).
20 4.5.9 The organization shall conduct a PRR to verify that their manufacturing process is documented and ready for production. At a minimum, the review shall include the process design deliverables (see 4.5.2) and applicable customer requirements.
4.6 Phase 4 requirements — product and process validation
4.6.1 Product and process validation shall be performed on product produced from the processes intended for on-going serial production (i.e. processes evaluated in the PRR).
4.6.2 Product and data from the production process run(s) shall be used to support the following, as required:
4.6.3 MSA shall, at a minimum, be performed on the measurement methods for KCs (product and process) identified in the control plan (reference ASTM E2782). The analytical methods and acceptance criteria used shall conform to the organization and/or custom
21 4.6.4 The organization shall complete a FAIR in accordance with customer and/or organization requirements (e.g. EN 9102). Evidence of the conforming FAIR shall be included in the PPAP submission.
4.6.5 Initial process capability studies using industry recognized statistical methods shall be completed for product and process KCs identified within the design record and supporting control plan.
4.6.6 The organization shall conduct capacity verification to demonstrate the ability to fulfil the demand profile of the customer.
4.6.7 When the customer specifies additional PPAP requirements not included in this standard, the organization shall include records of compliance for these requirements in the PPAP file.
22 4.6.8 The organization shall complete the PPAP submission in accordance with the PPAP requirements (see 5).
4.7 Phase 5 requirements — on-going production, use and post-delivery service
4.7.1 The organization shall evaluate and determine if the APQP project objectives established in Phase 1 have been fulfilled. If the objectives have not been fulfilled, the organization shall take appropriate action.
4.7.2 The organization shall establish a process for capturing and including lessons learned to improve the product realization process and future products.
4.7.3 The organization shall identify improvement opportunities necessary to increase customer satisfaction (e.g. delivery, cost, efficiency, variation reduction). Appropriate actions should be implemented when improvement opportunities are identified.
5 Production part approval process requirements
5.1 Process requirements for production part approval process
23 5.2 Production part approval process file and submission
5.2.1 When PPAP requirements have not been completely fulfilled, the organization may proceed with the PPAP submission, as directed / allowed by the customer. In such cases, the organization shall indicate an incomplete submission on the PPAP Approval For
5.2.2 The organization shall identify authorized PPAP approvers including those acting as customer delegates and/or receiving internal PPAP submissions.
5.3 Production part approval process disposition
5.3.1 Production part approval process submission disposition
5.3.2 Recording the production part approval process disposition
24 5.4 Production part approval process resubmission
25 Annex A (informative) Acronym log
27 Annex B (informative) Advanced product quality planning phase activities, deliverables and outputs
30 Annex C (informative) Control plan
31 Annex D (informative) Production part approval process approval form

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BS EN 9145:2018
$167.15