In the first part of this blog series we talked about the importance of a quality management system according to standard, IATF 16949 which was aimed at development service providers. In the second part of this blog series we want to show further justifications for this.
When considering the development of E/E systems, a number of support processes are required in addition to the actual development process as a core process. These are largely independent of hardware or software development and can therefore be used for development projects of any kind usually in the same or similar manner.
There are several models that describe the development process of systems.
Every product has a life cycle, which is usually divided into 3 phases: development, production and operation/service. For the development process it is important to know the different requirements during the 3 phases. The requirements must be used to derive clear tasks (work products), definable goals (deadlines, costs, quality) and time limits. Project planning in accordance with the rules of project management makes sense.
Every development process starts with capturing all requirements for the product to be developed. The organization must use a multidisciplinary approach when assessing manageability. The multidisciplinary approach calls for a treatment of the topic in a team that is made up of participants from different areas of a company, but also from suppliers and customers. If the organization outsources the HW or SW development, then of course experts from the external service department have to deal with the requirements (product specifications, system boundaries and interfaces, embedded software, traceability etc.) and evaluate the feasibility of a software for example, according to a defined process.
According to the IATF 16949 requirements, the complete development process (internal or external) must be documented.
Essential elements of the project management are the achievement of defined milestones, comprehensive planning of the required resources. According to IATF 16949 standard, project management methods according to APQP or VDA RGA e.g have to be used. The organization must ensure that external providers are also involved in the process. It’ s often required that all suppliers work on a project according to APQP methods.
Appropriate risk analysis must be carried out (FMEAs). It makes sense, if a company assigns an external development service provider, that the FMEAs are evaluated together. Accordingly, knowledge of FMEA methods must be available on both sides. Development service providers must ensure that employees with responsibility for product development have the necessary expertise and master the applicable development tools and methods to meet the development requirements.
At the development of products with embedded software, the organisation must establish a process for quality assurance of products with internally or externally developed embedded software. A documented self-assessment method must be used.
The development process must be included in the internal and external (supplier) audit program. In the management evaluation, all parameters for predefined development stages must be measured, analyzed and summarized. However, the input from external service providers is also needed here.
Development validation must be performed in accordance with customer requirements. In outsourced HW / SW developments, some prototypes are often completed and validated by development service providers. In addition to the validation requirements, the IATF also requires a control plan for prototype production.
The service provider must also be involved in the product release process (e.g. PPAP). The outsourced development service provider must present the results of the product development in a form that makes a product development verifiable and validatable at all times. After the first production release and thus also the verification of the product development, all development changes have to be evaluated. The changes must be validated against the requirements and released.
For products with integrated software, the organization must record the software and hardware change statuses in the documented change information.
All the above requirements have been derived from the IATF 16949 standard. As you can see there are many interfaces and interactions between stakeholders during the development phase which have to be well defined by project management. The understanding and implementation of such processes is going to be easier if a QMS according IATF 16949 Automotive standard is already implemented.
At the next and last part of this blog series, we will handle the supplier management according IATF 16949 and reference to external development processes.
By Dijaz Maric, Quality Management & Reliability Engineering Consultant
You want to learn more about an internationally recognized Quality Management System (QMS) which enhances organisational performance, customer satisfaction and gives your organisation a competitive advantage? Then join one of our upcoming IATF 16949 training courses in Salzburg. You can find more information here.