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Industrial had been producing various types of medical products. One of the manufacture lines is Blade Department. Recently we had received a complained from Headquarter regarding Blade product had quality issue. It was a major hit in term of marketing and trust of company's business wise. Top management had decided engineering department has to step up to resolve this issue to minimize the impact toward consumers and reputation of company's brand.
A study group was formed to study on how to solve and eliminate this issue. The main goal for this project is to eliminate customer complaint and maintain quality of the Blade. There was a recent complaint by a customer (doctor) that a patient was infected after the ear surgery. Upon investigation, it was found that some small metal particles leftover inside the ear of the patient was the causes of the infection.
Feedback from the customer is that, this is the cause of our blades having burrs visible at the blade tips. These burrs can only be visible seen under the microscope. Upon receiving the complaint samples, we investigate the root cause was due to the tips grinding process which generate the burrs and the brushing process after tips grinding did not manage to fully remove the burrs.
Study group had concluded that by implementing sandblasting method to de-burr the burrs on the blade tips are the one-stop solution. This project will involve sandblasting and project management. I'm involving in overall process KAIZEN and assure Blade cutting quality is maintained.
Q. Handling Suspect Material? • Material or items at a Supplier's facility or those received or stored in the warehouse or other construction site location that require PMI-tes
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