PSCR & Specialist FMEA

PSCR:

• Act as internal and external contact person for the issues related to product safety parts and processes (Development, Production, Quality, Logistics, Purchasing etc). Guide and contribute in this role in the internal working groups. Contact person in the plant for any potentially product safety relevant non-conformances and issues.
• Contribute to Process FMEA and Control plan approval in relation to the product safety for the plant specific product field. Independently perform and arrange for regular verifications of the process, production, materials and products in series production with the purpose to confirm product safety for the determined and predictable (mis-) use. Implement and follow up on (immediate) actions for the relevant non-conformances.
• Monitor the definition of the system and its content related to the traceability of the safety critical parts.
• Monitor the implementation of the system and its content related to the traceability of the safety critical parts.
• Identify nonconforming aspects in the systems and processes (e.g. against the law, norms, guidelines, customer specific requirements). Develop corresponding working packages as recommendations for the responsible management circles.
• Plan, lead and initiate line walks / mis-use trials (Error proofing reviews) on the safety critical products / processes, including audits results documentation in the regions CKD/Series. Indicate corrective actions at non-conformances. Verify efficiency of the implemented systematic actions in the corresponding plant / organizational unit.
• Define, monitor and validate communication routes to the product safety topics within the organization and to the customer.
• Lead the teams on the areas and plant levels in the product field Electrical in case of safety relevant escalation. This should be supported with relevant documentation for the internal and external communication in agreement with the central Electrical Product Safety responsible.
• Push forward and support product safety culture and understanding in the product field.
• Identify general development needs related to the product safety and product liability in different functions, departments, management levels of the plant. Plan and perform complex training related to the product safety and product liability in different functions, departments, management levels of the plant.
• Monitor and identify long and short term trends in the product field. Suggest recommendations. Summarize, analyze and verify information through the systems and processes. Develop specific solutions and suggestions. Perform field observation of the plant related products, verify corresponding documentation and inform relevant functions and departments.
• Evaluate breakdown risks and frequency of the affected products in case of failure. Consult about quality and confidentiality of the communication and information related to the product safety (clear specifications / formulations to the failure, cut off, breakdown risks etc) Calibration process in QSYS and sample parts control.

FMEA:

• Creation, maintenance and further development of process FMEA as moderator and a core team member of control plan.
• Evaluation of preventive- and detection actions related to norm- and customer specifications.
• FMEA update during series phase.
• Present the FMEAs an explain the FMEA method for customer representatives and auditors.