QMT Features: November 2010
Quality essentials
The strategic importance of quality management systems in embedded markets such as aerospace. 
By Efstratios Petrellis, quality manager, MEN Mikro Elektronik

Certification according to the internationally recognised aerospace standard EN/AS 9100 is an essential precondition for being a supplier in the aerospace market. EN 9100:2003 is equivalent to the AS 9100 Rev. B (America) and to the JISQ 9100:2004 (Asia).

EN/AS 9100 also includes additional requirements which exceed ISO 9001, such as First Article Inspection (FAI). FAI prescribes the testing, verification and documentation of a product from the first series production lot or of a retroactive change. If possible, the FAI should also be carried out at the suppliers.

The quality assurance agreement is a sensible way of passing down this requirement to the sub-suppliers. Consequently, applying the FAI makes it possible to systematically avoid mistakes and resulting rework during series production. The requirement is also met under series conditions, the required product quality is ensured and, at the same time, it is proved that the processes are observed.
Another important requirement regarding quality assurance, (which can be found in standards applying to other sectors, such as  ISO/TS 16949, ISO 13485 or IRIS,) is labelling and traceability, i.e. complete tracing of the whole supply chain of a product.   One way of integrating traceability is to equip all machines and devices with different data acquisition interfaces.

All data is gathered in a data base and is time stamped. Consequently, you can determine, for instance, that a specific board has passed the pick-and-place machine at a specific time. As the parameters of the machine at this time are known, you can trace back the exact board.

This also works for used components, so one can trace which component from which delivery was finally placed on which product. In addition to a production routing document, there is lots of machine data. This data is gathered in a centralized data base server and can be made available in real time e.g. via the company Intranet. This has major benefits: total transparency of the complete production and testing process, and, therefore, short reaction times in case of errors. The system can be an integral part of the ERP (Enterprise Resource Planning) system. In EN/AS 9100 there are additional requirements which significantly exceed ISO 9001:

• Configuration Management
• Risk Assessment
• Obsolescence Management
• Assigning of user rights, especially for releases
• Concept creation for dealing with already shipped faulty products

After successful EN/AS 9100 certification, the supplier is entered in the OASIS data base (Online Aerospace Supplier Information System). This is the presentation platform for companies in the aerospace industry. For OEMs, the entry in the OASIS data base is the proof of a certification based on a standard of the 9100 family. Only an entry in the OASIS data base proves that it is a recognized accredited certificate.

Airbus and GRESS
Based on EN/AS 9100, aerospace companies pass down to their suppliers additional requirements which, from their point of view, are not covered sufficiently by EN/AS 9100. In the case of Airbus, for example, the additional requirements are assured by applying and observing the GRESS (General Requirements for Equipment
Systems Suppliers).

The development process according to GRESS is divided into modules and reaches from the Kick Off Meeting (KOM) to the Final Review (FR). The development progress is measured at fixed and defined Milestones (Reviews) with PASS criteria. These Milestones (Reviews) are represented by the V model.

The purposes of the Milestone Reviews are:

• Checking of the pass criteria defined in the Milestone, deduced from the normative reference with the current state on document level
• Decision whether the current state fulfils the defined pass criteria in the Milestone and is accepted by all relevant parties
• Formal documentation of the current state with evaluation (Milestone Decision) of the pass criterion
• Identification and initiation of necessary actions For ensuring the development process according to GRESS, the observance of the modules in the GRESS has to be guaranteed. These include, for example, project management with key requirements such as:
• Breakdown structures for organization, products and resources
• Risk management
• Product and process assurance
 Another example is engineering for manufacturing with key requirements such as:
• Industrial process monitoring and control (via key figures)
• Change management   Supply chain with key requirements like:
• Materials management (including its inventory management policy)
• Purchasing and procurement risk analysis
• Supplier selection and management processes

A document, the Industrial Quality Dossier (IQD), describes how these processes are to be realised.   If sector-specific standards such as EN/AS 9100 are applied, from the development through production to after-sales support (including the end of the product life cycle), the resulting high-quality products minimize failures or any liability for any possible hazardous defects. If the delivered products meet the required standards, the pre-requisite for a smooth workflow in the project management of the final user is established. This makes it easier to obtain product and project approvals in the aerospace, railway, automotive or medical engineering sectors.l
Author: Efstratios Petrellis, quality manager, MEN Mikro Elektronik     emailL Efstratios.Petrellis@men.de
Contribution: Barbara Schmitz, chief marketing officer, MEN Mikro Elektronik Nuremberg, Germany

MEN is the first German company and one of ten companies worldwide which is certified both according to the aerospace standard EN 9100 and the railway standard IRIS at one location.
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