Wiki

Definition: Procedure qualification tests are qualifying tests to confirm that a technical process reproducibly delivers the required properties under defined conditions. They serve to demonstrate process capability and process stability. The requirements arise from standards or project-specific specifications.

Practical relevance: Examples include welding procedure qualification tests (DIN EN ISO 15614), brazing/soldering procedure qualification tests or qualifications of additive manufacturing processes. Mechanical characteristic values, microstructure, dimensional accuracy or leak-tightness are assessed. The documented range of validity defines the permissible parameters and material groups.

Decision-making perspectives:

• Technical decision-makers: Ensuring that processes achieve the required quality under series production conditions.
• Purchasing/project management: Requiring valid qualification certificates before awarding a contract.
• Science: Analysis of process parameters and their influence on material properties.
• Insurance/law: Proof of standard-compliant process qualification in the event of damage.

Typical testing or verification methods: Mechanical tests, metallographic examinations, NDT, documentation in the test report.

FAQ:

• What is the purpose of a procedure qualification test?
• The formal proof that a defined procedure reproducibly achieves the required quality under specified parameters.

Definition: Process analysis is the systematic examination of technical production or testing processes to assess their performance, stability and reproducibility. It identifies influencing variables, weak points and optimisation potential. It is based on technical metrics and statistical evaluations.

Practical relevance: The aspects assessed include process parameters, process capability (Cp, Cpk), reject rates, tolerance compliance and the status of test equipment. Methods such as FMEA, SPC and cause-and-effect analysis support structured assessment. Process analysis is central to series production launch, quality deviations or process changes.

Decision-making perspectives:

• Technical decision-makers: Optimisation of critical parameters and safeguarding of stable series processes.
• Purchasing/project management: Assessment of supplier processes and investment requirements.
• Science: Modelling of process chains and statistical validation.
• Insurance/law: Evidence of proper process monitoring in quality disputes.

Typical testing or verification methods: Process capability analysis, SPC evaluation, auditing, measurement system analysis (MSA).

FAQ:

• What is the difference between process analysis and production monitoring?
• Process analysis assesses processes in a fundamental and optimising way, whereas production monitoring ensures ongoing control.

Definition: Process development is the structured process of designing, testing and optimising technical manufacturing or testing methods. The aim is to achieve defined quality, performance and economic efficiency requirements. It comprises experimental investigations, parameter studies and validation steps.

Practical relevance: Typical steps are laboratory trials, pilot applications, scaling up to series production conditions and process validation. Process stability, reproducibility, characteristic values (e.g. strength, hardness, dimensional accuracy) and economic efficiency are assessed. Methods such as Design of Experiments (DoE) or statistical experimental design support the optimisation.

Decision-making perspectives:

• Technical decision-makers: Development of robust processes with defined tolerance and quality windows.
• Purchasing/project management: Assessment of investment requirements, time-to-market and scalability.
• Science: Investigation of cause-and-effect relationships between process parameters and material properties.
• Insurance/law: Documentation of validated processes as evidence of technical due diligence.

Typical testing or verification methods: Pilot trials, process capability analysis, mechanical materials testing, statistical experimental design (DoE).

FAQ:

• When is structured process development necessary?
• For new products, materials or changed requirements that existing processes do not meet.