Risk Management in Product Design and Development


Is your product characterized by high Reliability and Quality? Or do you want to introduce a product with sufficient reliability at lower price? We can help you realize your Risk Management policy at a reasonable level.

Risk identification and management will significantly reduce future costs of failures, accidents, shutdowns, product recalls and insurance costs. AL Safety Design have managed projects for e.g. in the following technologies: energy and process systems, heavy machinery, electronics, medical devices, space technology etc.

Risk Management Audits

  • We can assess your organization’s ability to design and produce reliable products

  • Audit report contains: improvements, recommendations and action items for your organization and product design  to reach and control the selected level of reliability according to your strategy.

Product Development of Machines and Equipment

  • Independent 3rd party: selecting the methods and performing the analyses in your projects

  • Risk identification and criticality classification, residual risk estimation and acceptability

  • Risk Management Plan: Reliability targets allocated to subsystems, configuration management, reliability and risk analyses, bottleneck identification, reliability follow-up and data collection

  • Programmable systems: Risk management procedures, machine safety, CE-marking

  • High reliability systems (space): Product Assurance (PA) 

Availability Performance and Maintenance

  • Availability analysis of systems and machines: RAM analysis. Estimating unavailability and production losses with costs

  • Availability and reliability data collection systems and using data to calculate RAM parameters

  • Availability allocation to subsystems. Calculation of improvement potentials.

  • LCC (Life Cycle Cost) and RCM (Reliability Centered Maintenance). Allocation of maintenance to critical equipment 

Conformance Engineering

  • Documents such as ’Risk Magement Plan’, Safety Integrity Requirements Specification’ etc.

  • We support you in product certification negotiations with the Notified Bodies and authorities

  • Reliability calculations: MTBF estimations, FMEDA analysis, reliability of electronics

  • Programmable systems: EN 61508, EN 62061, EN 13849.

  • Machines: EN 14121, EN 1050. Railroad: EN 50125.

  • Processes and equipment: EN 61511, SIL/LOPA-analysis

  • Medical devices: EN 60601-1, ISO 14971, CE-compliance