Because it is impossible to determine whether the injection needle has cracked during sample injection and collection, it is unclear whether it has affected the test result of this sample, and it is necessary to replace the injection needle before re-injecting this sample stock solution for testing. The retest result of the stock solution is 5335μg/mL, which is far from the initial test result of 3259μg/mL, indicating that the needle breakage has affected the test result of the sample, so the report should be output based on the retest result of the stock solution. This deviation is caused by the fracture of injection needle, and has no influence on product quality. Lin Sangyan, an analyst, is a post-transfer employee after maternity leave. The daily inspection work is careful, and there is no deviation, OOS or OOT caused by human factors, so she is still suitable for the current position. This injection needle fracture is the first deviation event of this kind of phenomenon in recent two years, which is a very accidental event and an individual phenomenon.
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