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Measurement System Analysis

MSA documents whether the measured characteristic values reflect reality to a sufficiently reliable degree. To this end, it measures to what extent the system is “capable”. Evidence of the capability of a measurement system can be provided with various methods.

Before analyzing the measurement system, it should be checked whether the resolution of the measuring device is sufficient for analyzing the corresponding case. The measuring equipment must have a resolution of ≤ 5% of the tolerance of the characteristic. MSA procedure 1 is usually conducted to assess a new or changed measurement system. This takes place before it is used to measure characteristic values. Using the measuring equipment’s capability value, the suitability of the equipment for the application can be determined. MSA procedure 2 takes place to assess new and existing measurement systems before the acceptance test at the final installation site. This procedure is also used as part of routine audits or for intermediate inspections. The measurement system is assessed under conditions that are as real as possible. The prerequisite is thus that the examination is conducted:

- At the operation site
- With original measurement objects
- With the testers on site
Glossary Technical terms at a glance

M

Malfunction analysis MDD-Directive MDR Measurement System Analysis Mechatronic FMEA Mechatronics Medical device Medical Devices Act Medical Device Regulation

O

One Piece Flow Operating period Operating state

P

PDCA PDCA cycle Poka-yoke Population PPAP Product development process Production control plan Property

Q

QFD QMS Quality Quality management Quality management standard