2019年09月20日上午09：20左右，115车间操作人员陆朱丹进行

At 09:20 on September 20, 2019, Lu Zhudan, the operator of workshop 115, carried out a large-scale cleaning of the pipeline from ethanol crystallizer R03205 and F03205 / F03206 to ethanol crystallizer R03205, adding 1.4 to the refined two-in-one F03205 and F03206, respectively m³ absolute ethanol, and then turn on the stirring and stirring slow down buttons of the refined two-in-one F03205 and F03206. At around 09:45, Lu Zhudan heard the sound of metal scraping in the refined two-in-one F03205. <br><br>This deviation caused the operator Lu Zhudan to mistakenly turn on the refined two-in-one F03205 mixing and slow-down stirring buttons, resulting in a malfunction. When the stirring was lowered to the lower position, the positioning screw was encountered. Due to H3-TM-10191 》 The maintenance of the height of the positioning screw is missing. The maintenance personnel did not maintain the height of the positioning screw. The low height of the positioning screw was not found and adjusted in time, resulting in contact with the filter plate when the stirring paddle fell to the minimum, so the refined two-in-one When F03205 stirring is turned on, the scraping of the stirring paddle and the filter will produce the sound of metal scraping. <br><br>This deviation occurred at the stage when the lovastatin 3020-E190804 batch production operation was completely completed and underwent large-scale cleaning, so there was no impact on product quality; the refined two-in-one F03206 was added with 1.4m³ of absolute ethanol for large-scale cleaning. The total volume of water ethanol has not changed, so it has no effect on the cleaning quality of the pipeline microfilters F03210, F03211 and ethanol crystallization tank R03205; <br>the absolute ethanol in the refined two-in-one F03205 tank is sent to the three waste treatment after approval by EHS, and has no environmental impact Impact, meets EHS requirements; scraping of the mixing paddle and filter plate of the refined 2-in-1 F03205 may produce iron debris. After the absolute ethanol in the refined 2-in-1 F03205 is discharged, rinse with a large amount of drinking water. The iron filings are taken away to achieve a clear visual lotion without visible foreign objects. Therefore, the cleaning of the refined two-in-one F03205 pipeline meets the requirements; after the maintenance of the refined two-in-one F03205 is completed, it is rinsed with a large amount of drinking water to achieve visual cleaning liquid clarification, no visible foreign objects, and meet the equipment cleaning requirements. This deviation has no effect on cleaning quality and product quality. <br><br>1. Replace the proximity switch of the refined two-in-one F03205 stirring paddle bracket.<br>2. Relocate the refined two-in-one F03205 new replacement proximity switch and positioning screw. <br>3. Repair the damaged filter plate of refined two-in-one F03205. <br>4. Test run the refined two-in-one F03205 and confirm that it is normal. <br>5. Re-train the operators on H3-SOP-65275-11 "Operation Rules of Lovastatin Ethanol Crystallization Post". <br>6. Upgrade the H3-TM-10191 "Multifunctional Filter Operation and Maintenance Regulations" and H3-TM-10191 "Multifunctional Filter Operation and Maintenance Regulations" to increase the maintenance content of the positioning screw height.

September 20, 2019 at about 09:20 am, 115 workshop operator Lu Zhudan to carry on ethanol crystallization tank R03205 and F03205/F03206 to ethanol crystalline tank R03205 pipeline large Clean, add 1.4m3 waterless ethanol to the refined 2-in-1 F03205 and F03206, respectively, and then turn on the stirring and stirring slow-down buttons of the refined 2-in-1 F03205 and F03206. At about 09:45, Lu Zhudan heard the sound of a metal scratch in the refined two-in-one F03205. <br><br>This deviation for the operator Lu Zhudan error opened the refined two-in-one F03205 stirring and stirring slow-down button, resulting in a fault occurred, stirring down to the lower position when the positioning screw, due to the H3-TM-10191 "multi-function filter maintenance procedures" lack of positioning screws High maintenance content, maintenance personnel did not maintain the height of the positioning screws, positioning screw height is not found in time and adjusted, resulting in the lowest mixing paddle contact with the filter plate, so refined two-in-one F03205 stirring open, stirring paddleand and filter scraping produce shaving sound of metal scraping. <br><br>The deviation occurred in the Lofastatin 3020-E190804 batch production operation completely ended, the stage of large cleaning, so there is no impact on product quality;<br>The refined two-in-one F03205 can of waterless ethanol after The EHS consent to send to three waste treatment, no impact on the environment, in line with The Requirements of EHS; Therefore, the refined two-in-one F03205 line cleaning in line in line with the requirements, refined two-in-one F03205 repair, the use of a large number of drinking water flushing, to achieve visual lotion clarification, no visible foreign objects, in line with equipment cleaning requirements. This deviation has no effect on cleaning quality and product quality.<br><br>1. Replace the refined two-in-one F03205 mixer prop proximity switch.<br>2. Reposition the newly replaced proximity switch and positioning screw for the refined 2-in-1 F03205.<br>3. Repair the damaged filter plate of the refined two-in-one F03205.<br>4. The refined two-in-one F03205 is trial run and confirmed to be normal.<br>5. Retrain the operator h3-SOP-65275-11 "Lovastatin ethanol crystallization post operating procedures".<br>6. Upgrade of h3-TM-10191 "Multi-Function Filter Operating Maintenance Procedure" and upgrade of H3-TM-10191 Multi-Function Filter Operating Maintenance Procedure, increasing the maintenance content of positioning screw height.

At about 09:20 a.m. on September 20, 2019, Lu Zhudan, the operator of workshop 115, cleaned the pipelines from ethanol crystallizing tank r03205 and f03205 / f03206 to ethanol crystallizing tank r03205, added 1.4 m3 anhydrous ethanol into the refining two in one f03205 and f03206 respectively, and then opened the mixing and slow down buttons of refining two in one f03205 and f03206. At about 09:45, Lu Zhudan heard the sound of metal scraping on the refined two in one f03205.<br>This deviation resulted in the operator Lu Zhudan mistakenly turning on the two in one refining f03205 mixing and mixing slow down button, which led to the failure. When the mixing was lowered to the lower position, the positioning screw was touched. Due to the lack of maintenance content for the height of the positioning screw in h3-tm-10191 maintenance specification for multifunctional filter, the maintenance personnel did not maintain the height of the positioning screw, and the height of the positioning screw was not too low It was found and adjusted in time, which led to the contact with the filter plate when the mixing paddle dropped to the lowest level. Therefore, when the refining two in one f03205 was started, the scraping of the mixing paddle and the filter screen produced the sound of metal scraping.<br>The deviation occurred at the stage when the batch production of lovastatin 3020-e190804 was completely completed and large-scale cleaning was carried out, so there was no impact on the quality of the product; the refined two in one f03206 was added with 1.4 m3 anhydrous ethanol for large-scale cleaning, and the total volume of anhydrous ethanol did not change, so there was no impact on the cleaning quality of the pipeline Microfilters f03210, f03211 and ethanol crystallizer r03205;<br>The anhydrous ethanol in the refined two in one f03205 tank will be sent to the three wastes treatment after EHS approval, which has no impact on the environment and meets the EHS requirements; scraping between the mixing paddle and the filter plate of the refined two in one f03205 may generate iron filings. After the anhydrous ethanol in the refined two in one f03205 is discharged, a large amount of drinking water will be used to wash away the possible iron filings, so as to make the visual washing liquid clear and impossible See foreign body. Therefore, the cleaning of refined two in one f03205 pipeline meets the requirements; after the maintenance of refined two in one f03205, a large amount of drinking water is used to wash, so as to make the visual washing solution clear and free of visible foreign matters, meeting the requirements of equipment cleaning. This deviation has no effect on cleaning quality and product quality.<br>1. Replace the proximity switch of refined two in one f03205 agitator blade bracket.<br>2. Replace the new proximity switch and positioning screw of refined two in one f03205.<br>3. Repair the damaged filter plate of refined two in one f03205.<br>4. Test run the refining two in one f03205 and confirm it is normal.<br>5. Retraining the operators in h3-sop-65275-11 operation procedures for lovastatin ethanol crystallization post.<br>6. Upgrade h3-tm-10191 operation and maintenance specification of multi-functional filter, h3-tm-10191 operation and maintenance specification of multi-functional filter, and add maintenance content of positioning screw height.