NEAR Automotive Quality Assurance
Failure mode and effects analysis (FMEA)
- System-FMEA (S-FMEA)
- Design- und Konstruktions-FMEA (D-FMEA)
- Process-FMEA (P-FMEA)
The comprehensive Risk Management System considers all aspects involved:
- Risk Assessment
- Risk Evaluation
- Risk Control
- Periodic reviews
and represents a key element of quality assurance. NEAR supports its clients to succeed this challenge.
Digital Mock-up (DMU)
All activities to contribute and to describe a product
Quality Management System (QMS)
Business processes focused on consistently meeting customer requirements and enhancing their satisfaction
NEAR QualityAssurance – Special Topics
Agile Maturity Management (aRGM – agilesReifegradmanagement)
- Maturity Management in different stages of product development of process
- Specific methodology in early phases of product development of process
- Time Pressure within the development process is continuously growing: more and more shorter product development cycles are required.
- With a new conception of a dynamic and agile maturity level of NEAR GmbH and MR PlanFabrik GmbH the release processes of the product development department that is traditionally oriented to maturity levels can be innovated.
- The core points are the contextual expansion of the maturity level and the implementation of modern development procedures. This methodology will result in a shortened and at the same time qualitatively improved release and development process.
- At the same time, the often-existing conflict of goals between developers, suppliers, buyers and production planners is dissolved, in which a new form of cooperation is established with the new degree of maturity.
This concept was designed to be applicable to companies of different sizes.
NEAR has become within the last 15 years in vehicle development for Automotive OEM one of the most important suppliers for tolerance management. Tolerance Management is a proven method within vehicle development process to meet functional and visual specifications.
Tolerance management makes it possible to avoid potential quality problems before they occur.
NEAR’s methodologies of tolerance management makes our clients able to achieve high product quality without rework.
NEAR Services in Tolerance Management:
- Specification of functional dimensions
- Specification of joint scheme
- Performing of statistical tolerance analysis
- Creates recommendations for Design and Maturity Management Processes
Quality Target Management
- Target description Product
- Target description Manufacturing Process
- Target description Q-Process organization
Quality Risk Management
- Risk identification
- Risk evaluation
Quality Problem Management
- Planning of measurement process
- Performing of measurement process
- Problem solving process
Warning Letter Quality Support
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) that it has found that a manufacturer or other organisation has violated some rule in a regulated activity.
NEAR is helping the organisations to resolve the requests of corrections the Warning Letter is issued for by:
- Gap analysis of GxP compliant quality management system
- Qualification of IT infrastructure with validated computerised systems
- Validation and qualification of equipment and processes
- Supplier quality management process – evaluation of robustness
- Training of staff according to the latest GxP standards
- Gap assessment to adequate quality control
- Fit-for-purpose (risk-based) audit program
- A regular proactive risk assessment of process performance and product quality to ensure continual improvement of your business