Abstract
Chapter 8 of EN 9100 is focusing on the core elements of the operational value chain, namely design and procurement as well as production and service provision.
Chapter 8 of the standard begins with the planning of product realisation (Subsect. 8.1), progresses to the identification and evaluation of customer requirements (Subsect. 8.2) and continues (if applicable) with the design process (Subsect. 8.3). The provision of services is concluded with production or service provision that is executed according to clear specifications (Sect. 8.5). The procurement is also defined as a core process (Subsect. 8.4). Chapter 8 ends with requirements for the release of products and services (Subsect. 8.6) and the control of nonconformities (Subsect. 8.7).
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Notes
- 1.
EN 9120 does not include individual requirements here and therefore has a slightly different sequence.
- 2.
If only activities not related to the product or service are outsourced, such as gardening work on the company premises or office cleaning, the standard does not require explicit control and monitoring activities.
- 3.
This section is not applicable to EN 9120 for distributors and stockholders.
- 4.
See EN 9100:2018 (2018), Annex A.4.
- 5.
This is already formally part of CM planning. However, the process framework is usually anchored only once and is therefore explained here separately from the product-specific planning.
- 6.
According to ISO 10007 (2004), Sect. 5.3.1.
- 7.
This section is not applicable to EN 9120 for distributors and stockholders.
- 8.
- 9.
The AS 5553 and the AS 6174 as well as the Supply Chain Management Handbook (SCMH) of the IAQG offer helpful information for the prevention of counterfeit parts.
- 10.
See ISO 9001 Auditing Practice Group—Guidance on: Customer Communication, (2016), P. 2.
- 11.
For information on the various types of requirements, see Sect. 8.2.3 a)–c) and the NOTE.
- 12.
A compliance matrix can be used to determine expenses for example. By using a bottom-up approach man-hours, external services and material for the individual requirements can be estimated.
- 13.
Similar: ISO 9001 Auditing Practice Group—Guidance on: Design and Design Process, (2016), P. 3.
- 14.
For physical products, the fundamental functional and technical requirements subsumed under the so-called “4 F” (form, fit, function, fatigue as well as qualification) can be used as a mental checklist.
- 15.
Similar ISO 9001 Auditing Practice Group—Guidance on: Design and development process, (2016), P. 5.
- 16.
In the design phase, changes are usually controlled by a change request (CR), change proposal (MP) or change notification (MOD).
- 17.
cf. ISO 10007 (2004), Sect. 5.4.3.
- 18.
This shall also apply for reasons of product liability.
- 19.
cf. IAQG (2019).
- 20.
EN 9120 does not include all requirements of Sect. 8.4.3 of the basic standard EN 9100 and therefore has a slightly different sequence.
- 21.
EN 9120 does not include some individual requirements here and therefore has a slightly different sequence. However, the standard for distributors requires additional measures against the consequences of obsolescence (materials, components, resources, products).
- 22.
The Dirty-Dozen concept is a list of the twelve most common reasons for human error. Gordon Dupont, an employee of the Canadian aviation authority, evaluated the most common human errors in aviation accidents at the end of the 1970s and combined them into a conceptual framework. If these twelve types of errors can be minimised or brought under control, a very high percentage of everyday incidents and accidents can be avoided.
- 23.
See IAQG (2019), p. 9.
- 24.
Many modern machines are self-maintaining. Here it is sufficient to document only those maintenance and repair events which are carried out beyond the mechanical self-maintenance.
- 25.
See also Sect. 8.5.4.
- 26.
This section is not applicable to EN 9120 for distributors.
- 27.
See EN 9101:2018, Sect. 4.1.2.5 c.
- 28.
This section is not applicable to EN 9120 for distributors.
- 29.
Further information on the requirements of a FAI can be found in EN 9102 Aerospace Series - First article inspection requirements.
- 30.
See EASA Implementing Rule Continuing Airworthiness EASA Part 145.A.42 (a) (5) und Guidance Material 21A.139 (b) (1).
- 31.
cf. Hinsch (2019), p. 260.
- 32.
This means, for example: If 50 m of hydraulic lines were procured which were installed by the company in three different aircraft systems, it must be known at all times in which aircraft and where the installation took place.
- 33.
Electrostatic discharge.
- 34.
This is mandatory for organisations with an EASA production or maintenance approval.
- 35.
This is mandatory for companies with EN 9110 and EN 9120 certification and EASA production or maintenance approval. However, “spatially separated” does not necessarily mean in another room, but physically separated. Therefore, another shelf also represents a spatial separation.
- 36.
Cff. IAQG Resolution Log of Oct. 2019.
- 37.
If the problem cannot be solved immediately, the nonconforming product must be stored in the quarantine warehouse.
- 38.
If necessary, it should be noted that the certifying staff has been authorised by the design department to perform this activity.
- 39.
This should be documented with the customer’s signature in order to avoid any recourse claims at a later date.
- 40.
With EN 9120, the handling of nonconforming products is limited to the following measures: 1) scrapping, 2) rejection to the supplier, 3) rejection to manufacture for re-validation, 4) submission to the customer or competent EASA Part 21 J operation for release for use in the as-is condition.
References
CEN-CENELEC Management Centre: ISO 10007:2003 Quality management systems. Guideline for configuration management. ISO 10007:2004-12 (2004)
CEN-CENELEC Management Centre: EN 9100:2018—Quality management systems—Requirements for aviation, space and defence organisations. Brussels (2018)
CEN-CENELEC Management Centre: EN 9120:2018—Quality Management Systems—Requirements for aviation, space and defence distributors. Brussels (2018)
CEN-CENELEC Management Centre: EN 9101:2018—Quality management systems—Audit requirements for aviation, space and defence organisations. Brussels (2018)
European Aviation Safety Agency—EASA: Acceptable Means of Compliance and Guidance Material to Part 21. Decision of the Executive Director of the Agency NO. 2003/1/RM (2003)
European Commission: Commission Regulation (EC) on the Continuing Airworthiness of Aircraft and Aeronautical Products, Parts and Appliances, and on the Approval of Organisations and Personnel Involved in These Tasks [Implementing Rule Continuing Airworthiness]. No. 2042/2003 (2003)
Federal Aviation Authority: FAA Unapproved Parts Notifications (UPN). In: http://www.faa.gov/aircraft/safety/programs/sups/upn/. Accessed on 31.01.2020 (2020)
Hinsch, M.: Industrial Aviation Management: A Primer in European Design, Production and Maintenance Organisations. Heidelberg/Berlin (2019)
International Aerospace Quality Group: IAQG 9100:2016 Clarification (Resolution Log). Rev. Date Oct. 2019 (2019)
International Organisation for Standardisation and International Accreditation Forum: ISO 9001 Auditing Practice Group: Guidance on: Design and Development Process (2016)
International Organisation for Standardisation and International Accreditation Forum: ISO 9001 Auditing Practice Group—Guidance on: Customer Communication (2016)
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Hinsch, M. (2020). Operation. In: Guideline for EN 9100:2018 . Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-61367-2_8
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