I haven't spent much time working in manufacturing and I was hoping someone could help me understand a bit more about equipment qualification.
Having read a number of existing threads, I understand that per ISO 13485:2016 section 7.5.6, process validation is only required when "the resulting output cannot be or is not verified by subsequent monitoring or measurement".
1. If a MPI (Manufacturing Process Instructions) requires someone to cut a wire to length using a ruler/caliper (calibrated), does the ruler need an IQ/OQ?
My first thought is IQ would be covered by the calibration and the OQ would be required. I am thinking that the OQ will mainly be discussing rather the ruler is "appropriate" for this task. However, if the MPI later verifies the length of the wire using the same ruler, does this mean IQ/OQ can now be justified as not necessary?
2. How about fixtures that aid in the manufacturing process, like a microscope for soldering? or a clamp fixture that helps in the soldering process?
Again, I am pretty new to the regulations around manufacturing and please excuse me if these are simple questions. I am thankful for any help.
Having read a number of existing threads, I understand that per ISO 13485:2016 section 7.5.6, process validation is only required when "the resulting output cannot be or is not verified by subsequent monitoring or measurement".
1. If a MPI (Manufacturing Process Instructions) requires someone to cut a wire to length using a ruler/caliper (calibrated), does the ruler need an IQ/OQ?
My first thought is IQ would be covered by the calibration and the OQ would be required. I am thinking that the OQ will mainly be discussing rather the ruler is "appropriate" for this task. However, if the MPI later verifies the length of the wire using the same ruler, does this mean IQ/OQ can now be justified as not necessary?
2. How about fixtures that aid in the manufacturing process, like a microscope for soldering? or a clamp fixture that helps in the soldering process?
Again, I am pretty new to the regulations around manufacturing and please excuse me if these are simple questions. I am thankful for any help.