Definition: The PED 2014/68/EU is the European Pressure Equipment Directive governing the design, manufacture and conformity assessment of pressure equipment. It is mandatory for placing products on the EU single market.
Definition: A peer review of manufacturing processes is the independent technical assessment of production workflows, process parameters and quality records by qualified external experts. The aim is the objective evaluation of process stability, standards conformity and risk potential. The procedure complements internal audits with a neutral perspective.
Practical relevance: The assessment covers process capability (Cp, Cpk), test planning, validation reports, traceability and compliance with relevant standards (e.g. ISO 9001, IATF 16949). Weaknesses in documentation, parameter settings or test equipment management are systematically identified. The peer review serves to minimise risk before series start-up, certification or investment decisions.
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Typical testing or verification methods: Document audit, on-site inspection, process capability analysis, sample testing.
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Definition: Performance tests are tests of components, assemblies or systems under realistic or defined operating conditions. The aim is to assess the fitness for service, operational safety and fatigue strength in the intended application environment. They complement standardised laboratory and materials tests with practically relevant load combinations.
Practical relevance: Combined loads such as temperature cycling, pressure cycles, mechanical vibration, media contact or electrical loads are simulated. Functionality, wear behaviour, tightness and probability of failure are evaluated. Relevant standards are application-specific, e.g. DIN EN 60068 (environmental testing) or industry-specific codes in mechanical and plant engineering.
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Typical testing or verification methods: endurance tests, pressure-cycling tests, vibration tests, climatic chamber tests, functional test rigs.
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Definition: Positive Material Identification (PMI) is the analytical verification of the chemical composition of a material for unambiguous material assignment. The aim is to prevent material mix-ups in safety-relevant applications. The test is carried out with minimal destruction directly on the component.
Practical relevance: PMI is used in particular in plant, pipeline and pressure equipment construction. Typical methods are mobile X-ray fluorescence analysis (XRF) or optical emission spectroscopy (OES). The alloying elements are checked in accordance with the material specification (e.g. EN 10025, ASTM). Incorrect assignments can lead to corrosion or HTHA damage.
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Typical testing or verification methods: Mobile XRF, spark OES, comparison with test certificates in accordance with EN 10204.
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Definition: Probabilistic safety analyses (PSA) are quantitative methods for assessing the risks of technical systems on the basis of probability models. They analyse the probability of occurrence and the consequences of potential malfunctions or damage events. The aim is the systematic determination and reduction of risk levels.
Practical relevance: PSA are used in particular in nuclear facilities, the process industry, aviation and energy supply. Methods include fault tree analysis (FTA), event tree analysis (ETA) and Monte Carlo simulations. Failure probabilities, frequencies of damage scenarios and risk metrics are assessed. Regulatory requirements arise, among other things, from international safety guidelines and industry-specific regulations.
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Typical testing or verification methods: Fault tree analysis (FTA), event tree analysis (ETA), Monte Carlo simulation, sensitivity analysis.
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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.
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Typical testing or verification methods: Mechanical tests, metallographic examinations, NDT, documentation in the test report.
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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:
Typical testing or verification methods: Process capability analysis, SPC evaluation, auditing, measurement system analysis (MSA).
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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.
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Typical testing or verification methods: Pilot trials, process capability analysis, mechanical materials testing, statistical experimental design (DoE).
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Definition: Production monitoring is the continuous control and documentation of production processes to ensure defined quality requirements. It encompasses the monitoring of critical process parameters, inspection characteristics and test equipment. It is based on quality management systems such as ISO 9001 or industry-specific codes and standards.
Practical relevance: The aspects monitored include dimensional accuracy, material characteristics, process parameters and traceability. Methods such as Statistical Process Control (SPC), inspection plans, initial sampling (e.g. PPAP) and test equipment management reduce scrap and liability risks. Documentation obligations are mandatory in particular in regulated industries such as automotive, aerospace or pressure equipment manufacturing.
Decision-making perspectives:
Typical testing or verification methods: SPC documentation, process capability analysis (Cp, Cpk), audit reports, measurement system analysis (MSA).
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