Quality management in our Group

A medical device being inspected by machine vision

High quality is the heart of everything we do at Ouneva Group. Our customers trust us with demanding contract manufacturing projects. That trust is built on certified processes, precise inspection methods and a long tradition of engineering expertise. In this article we open the doors to our production environments and show how our quality management practices support consistent manufacturing, reliable deliveries and long term customer success. From modern automation cells to cleanroom level inspection and Group wide cooperation, quality is present in every step of our work.

What does quality management mean?

In this article the term quality management is used as an umbrella term that includes both quality assurance and quality inspection. When we speak about quality inspection we mean the routine activities connected to production processes. These can include integrated measurement equipment, automated machine vision elements or visual inspection performed by our personnel. Quality management at Ouneva Group takes place through certified processes. It contains our established practices and the processes of our quality systems. A high level of quality management is the foundation of all our operations.

 

Our quality inspection methods
We use a wide range of quality inspection methods across our group. A high level of automation throughout the Group ensures excellent product quality in an efficient way. Quality inspection is also carried out visually and through sampling. Quality management does not only focus on outgoing goods. Incoming materials are routinely inspected to avoid surprises during production such as issues caused by defective components.
 
Documentation as part of the quality inspection process

Documentation is an important part of continuous quality follow up. Documentation practices have been developed long term at Ouneva Group. Our companies use extensive electronic documentation systems. Reporting according to customer requirements becomes smoother and more efficient thanks to these systems.

 
Machine vision and automation supporting quality inspection

Most automation cells include an integrated machine vision unit. The unit inspects either every product or selected batch based pieces. Consistent quality is a major advantage of automated mass production. Our own automation department provides specialised expertise for these solutions.
 

A medical device being inspected by machine vision

Tactile measurements

Various forms of tactile measurement are used to confirm that the shapes of products meet requirements. We use tactile measurement for example for sheet metal parts, die-casted parts and injection moulded products. Our measurement equipment represents the top level of our industry across all technologies.
 

Coordinate measuring machine measuring a sheet metal product

Optical inspection for precise components

Optical inspection can be used for example for precision injection moulded components. Our cleanrooms have dedicated inspection equipment which ensures that cleanliness requirements are naturally met during the inspection process. Our cleanroom injection moulding production is certified according to ISO 13485.
 

Machine vision unit optically inspecting medical devices

Inspection in our electronics production

In electronics assembly we use automatic solder paste weight inspection and automated optical inspection. Optical inspection is an efficient way to confirm the quality of component placement and the match to product requirements. X-ray inspection is also used in our electronics production. More information on this follows later in the article.
 

STM line for electronics with integrated quality inspection

Testing ensures the performance of wire harnesses and electrical systems

Various testing methods are also part of our quality inspection tools. Testing is mainly performed for electronics components and electrical systems. Testing can be electrical, functional or both. Test reports can be fully created according to customer requirements and documentation is especially important in this stage. We perform various resistance measurements, component wakeup tests, programming and functional testing in a comprehensive way. These methods form an important part of the quality inspection process for electronics and electrical systems.
 

Testing of an electrical system assembly Automated in-circuit testing for electronics

Tensile tests are an essential part of wire harness quality inspection. Automated tensile tests are carried out for wire harness products and components. Our wire harness products are designed to withstand all weather conditions, special environments and heavy use. This means that testing must support the real use environment and application of the final product. Tensile tests are extremely precise. For example if even one strand of a conductor is missing from a crimped terminal the product does not pass quality assurance. Tensile testing is done for our own connector products as well. We do some testing in-house, and for certification the testing is done in an accredited testing laboratory.
 
Automated quality checks in wire processing

Wire cutting and stripping machines perform cutting, crimping, tensile tests and other inspection stages. These machines operate at a high automation level which increases production efficiency for our customers. The machines monitor cutting lengths, crimp quality and applied forces and perform tensile tests.
 

Cut and crimped wire products

A look inside electronics and die-casted products through X-ray inspection

X-ray inspection is used at Ouneva Group for electronics components and die-casted components. Checking solder joint quality through the component is important. The X-ray equipment for electronics is located in our cleanroom which ensures efficient inspection while meeting cleanroom requirements.

Die-casted parts are inspected in our foundry with modern X-ray equipment. This allows us to view the quality of cast parts inside the structure without breaking the component. For example porosity can be inspected easily. The inspection process is fast and efficient thanks to product specific automatic programs.

X-ray inspection is also part of electrolytic surface treatment where coating quality and thickness are inspected.

Get familiar with our quality management methods also on video:

 

The philosophy of quality assurance at Ouneva Group

Our management system and company specific quality manuals form the foundation of our quality assurance philosophy. The management system is visible in daily operations and it is not written for certification purposes alone. Our values and our commitment to high quality guide our operations and the management system has been built on these principles.

A large part of our ability to produce high quality comes from the commitment and responsibility of our personnel. At every production stage our experienced employees take responsibility for performing their work with high quality and commit to following our operating principles. The quality manuals provide clear boundaries for actions. They help our personnel understand their areas of responsibility.

Certification is a central part of our quality goals. All our companies operate according to the quality standard ISO 9001. To support environmental responsibility all our companies are certified according to ISO 14001. We have invested significantly in the energy efficiency of our facilities and machinery. Ouneva Group also operates under a Group level sustainability strategy.

Some of our companies are certified according to the occupational safety standard ISO 45001 which ensures continuous improvement in factory safety. In the future this certification will be extended to all companies. The quality of medical device manufacturing is ensured with certification according to ISO 13485. This ensures that production processes meet the strict requirements of the industry.

The quality departments across Ouneva Group work closely together. Cooperation is done through internal audits and daily communication. Internal audits are performed annually and their purpose is to share good practices and knowledge between units in quality and environmental matters. Communication between our quality departments ensures fast problem solving and tailored development projects for customers. For system delivery customers this Group level cooperation ensures that requirements and needs are clear to every unit involved in the delivery.

High product quality, high production quality and strong competence of our personnel are the foundation of everything we do. For this article we interviewed the quality managers of our companies.

Contact us regarding your contract manufacturing needs. We are happy to help you.