1.Tell me about your self. 2.Tell me about your job roles & responsibilities. 3.About FMEA 4.About MSA 5.About PPAP element according to IATF (19-Elements) 6.About PPAP Levels (5-Level) 7.Difference b/w Verification & Validation 8.Sixsigma concept and values (1,2,3,4,5,6) 9.About ISO/TS16949 10.About ISO 13485:2016 11.About ISO 14971:2007

Question

Accepted Answer

I am a Product Design Engineer with experience in FMEA, MSA, PPAP, ISO standards, and Six Sigma concepts.

Job roles include designing products, conducting FMEA analysis, implementing MSA techniques, preparing PPAP documentation, ensuring compliance with ISO standards, and applying Six Sigma principles.
FMEA (Failure Mode and Effects Analysis) is a systematic method for identifying and preventing potential failures in a product or process.
MSA (Measurement System Analysis) is used to assess the measurement system's capability and reliability.
PPAP (Production Part Approval Process) involves submitting documentation to demonstrate that all customer engineering design record and specification requirements are properly understood and fulfilled.
ISO/TS16949 is an international quality management standard specifically for the automotive industry.
ISO 13485:2016 is a quality management system standard for medical devices.
ISO 14971:2007 is a standard for risk management of medical devices.
Verification ensures that the product meets the specified requirements, while validation confirms that the product meets the customer's needs and intended use.
Six Sigma is a set of techniques and tools for process improvement, with values of 1, 2, 3, 4, 5, and 6 representing the standard deviations from the mean.
PPAP Levels range from 1 to 5, with increasing levels of documentation and validation required.