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    Home > Medical News > Medical World News > BYD's wave of three foldS N95 mask final certification California side will continue to fulfill the June contract

    BYD's wave of three foldS N95 mask final certification California side will continue to fulfill the June contract

    • Last Update: 2020-07-09
    • Source: Internet
    • Author: User
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    TextsThe process of building trust between the California government, the certification body NIOSH and the Chinese company BYD in the cooperation is impressive,on the morning of June 9th, Beijing time (On the afternoon of June 8, U.STime), California Governor Newsom announced that BYD N95 masks have been certified by NIOSH (National Institute of Occupational Safety and Health), and BYD will continue to supply N95 masks to Californiajust a day earlier (on the morning of June 8, Us and West Time, June 7), NIOSH was certified by BYD N95 masksthis certification passed, only half a month after BYD submitted the N95 mask certification application to NIOSH for the second time on May 20"Communication with NIOSH has been smooth, they respond quickly and tell us very clearly what the review is focused on." A person familiar with the certification process saidin March, BYD first submitted niOSH certification for N95 masks, but the first application failed because Paper work failed to meet NIOSH certification requirements, and directly affected the fulfillment of a $1 billion order with the California governmentin April, the California government signed an order of more than $1 billion from BYD to buy 300 million N95 masks for $3.30 million over two months, and another 100 million medical surgical masks for $0.55 and $495 million in advancebecause of the failure of the first NIOSH certification, BYD had to return an advance payment from the California government for a May order in advance of 150 million N95 masks, totalling $247 million, the California government and BYD later revised the contract to extend it until the end of Maythe California government and BYD and NIOSH have maintained three-way communication during BYD's second application for NIOSH certificationWhen the schedule for the NIOSH review plant (the last link of certification, the review of the plant) had to be postponed until June 4, the California government expressed its understanding and again revised the contract with BYD to extend the contract until June 12California government press release also mentioned that in the next few days, the 150 million BYD N95 masks previously stipulated in the contract will be shipped to California and distributed to health care workersThe contract also ensures that California will have sufficient supplies of masks in the future if neededBYD said that on the afternoon of June 7 received the N95 mask NIOSH certification through the information, to get the production code, the factory began to rush production, is expected to advance delivery to the California governmentN95 mask is one of nine NIOSH certified particle protection masks The protection rating is N95, which means that the mask filter has a filtration efficiency of 95% for non-oilborne particulate matter (e.g dust, acid mist, lacquer fog, microorganisms, etc.) under the testing conditions specified in NIOSH standards "Apply for NIOSH certification for the second time, we are fully prepared The person involved in BYD's N95 certification said submitted its NIOSH certification application in March, BYD was confident it would be able to pass it within a month and a half But they ignore the importance THAT NIOSH attaches to written material " was rejected for the first time because NIOSH was not satisfied with the document control part of our research and development process "It's a good thing, " he said When BYD decided to produce masks, because of the speed, in a very short period of time several research and development teams to do the program at the same time, resulting in the submission of the version of the material and the actual version of the error there are some errors NIOSH was very rigorous, even in the sample test ingon and the final trial, BYD performed well, but because of the written material problems, still rejected the application The Wall Street Journal's May 14 interview with NIOSH also mentioned the reasons why NIOSH rejected BYD's certification application: "Byd's filing of a review of the mask design, production and quality inspection documents is worrying "
    rejected by NIOSH in early May and by May 20 by BYD to resubmit the application materials, during which time the two sides have maintained continuous communication, NIOSH continues to provide BYD with improvement advice and audit key points BYD's four research and development departments in China, 24-hour shifts to improve the quality management system "This time in the writing of the material, these departments are in a system modification, coupled with the improvement of the quality management system, the entire material to the actual process than the last organized." submitted on May 20, two people who had previously participated in the first BYD NIOSH certification review reported that the improvement was significant Within three days, NIOSH passed BYD's sample test and the review of written materials On May 23, the last link in NIOSH certification, the date of the trial, was set for June 4 even though the last trial of the factory is basically smooth, in May, BYD on the site quality management system again upgraded and adjusted This time, the team will target the trial at "zero finding" (zero defects) Despite the uncertainty surrounding the timing of NIOSH certification, BYD has built up sufficient trust in its engagement with the California government The cooperation between the California government and BYD on 200 million ($110 million) of disposable medical masks has been ongoing, and by BYD's quality of masks, and the timely and even advance delivery dates, the California government feels that the cooperation with BYD is going well On May 29, , California Gov John Newsom held a news conference as the state government first revised its contract with BYD An American journalist at the meeting asked an extremely pointed question: "Are you confident that BYD will be certified by the end of May?" Newsom gave a positive answer He noted that the California government has received 50 million disposable medical masks from BYD, all earlier than expected The masks have been distributed to front-line workers in the health care system and other public service providers, and the state will not spend a penny on uncertified masks, he said, adding that he is pleased with the speed at which BYD's N95 masks are certified and is close to success from May 20 thinly available by BYD to provide NIOSH certification materials for N95 masks again, to the passage of the materials and the date of the trial, BYD has been keeping the information in sync with the California government On May 23, NIOSH passed a sample test of BYD's N95 mask and a paper work review, and finally finalized the trial on June 4 The California government knew for the first time that it was not BYD's responsibility to push back the date at the same time, the California government also separately with NIOSH to understand THE situation of BYD N95 masks, NIOSH told the California government: "BYD is a responsible company, has been in accordance with NIOSH requirements of continuous improvement." "As a result, the California government, in accordance with the NIOSH certification schedule, again revised the contract with BYD to extend the contract to June 12 On June 4, (Beijing time), the NIOSH team came to the BYD plant in Shenzhen to complete the audit Although there is a "minor flaw" in the trial site, which generally requires improvement, it does not affect the passing of NIOSH certification three days later, BYD received the final notification of NIOSH certification "The last time the California government withdrew an advance payment for BYD's N95 mask order in May, because the NiOSH certification of the N95 had not yet come down, and BYD had not produced the N95 mask, so it had not caused any damage A BYD insider said now that the state and BYD are in place for a contract for 150 million N95 masks in June, it will not be determined until the end of June whether the state will continue to order them "In the terms of the contract, i'm going to write about the possibility of renewal." DESPITE THE UPS AND DOWNS IN NIOSH CERTIFICATION, BYD'S MASK SALES DO NOT APPEAR TO HAVE TAKEN A HIT The Seattle Times reported on June 8 that Washington State Enterprise Services (DES) had ordered 55 million BYD N95 masks for $178 million, but had been waiting for NIOSH certification to pass to complete the order NIOSH certification passed the same afternoon, BYD staff continue to receive customer requirements for N95 mask scheduling requirements and a month ago, HNA and BYD signed a strategic cooperation agreement the beginning of the new crown epidemic, the airlines passenger, especially the lucrative international passenger transport suffered a huge impact, the international "break-" so that airlines revenue plummeted, are seeking new exports , "passenger change", is a number of airlines to change the profit growth point of the important model HNA used all the wide-body aircraft that could carry cargo for cargo, flying 300 flights a month in May to carry Chinese-made anti-epidemic supplies to the world BYD is HNA's "big customer" In May, HNA loaded BYD's one-time medical mask, KN95 mask to the United States "passenger change" flights, an average of 2 flights a day, the entire May reached 60 In early June, before BYD's NiOSH certification for N95 masks, BYD's face mask products were scheduled to fly to the U.S nearly double that month from May, bringing the total to 110 a month airlines responsible for THE transport of BYD masks to the United States, in addition to HNA, China Eastern Airlines is also involved In addition, BYD's masks are also sold to South America, Europe and Canada, according to another airline source.
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