I do agree with you, but from my experience that even when the SOP is correct and up to the standers, sometimes it is a production issue that by human mistake is not following the BOM list and SOP even though everything is defined very clearly. SO I think it is hard to eliminate any mistakes by locking the SOP or have a preventive action on it. Also sometimes you have to come up with a solution that meets customer requirements but doesn’t fully fulfill the standers rules. For example, in my current company, they build DRAM for a mission-critical application that required a special connector that does not full JDEC. in this case, it was built for this special project but we could not market the product as stander product like can be offered for other customers. For this case, it is not a medical device or life-threatening which is okay but I don’t think it will be like that for FDA.