PS7 V1 F23

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Jan 9, 2024

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CHEME 5610: Product Design/Lean Operations Design Problem Set #7 (40 Points): Assigned October 26, 2023 Due: November 9, 2023 Page 1 of 2 Fall 2023: AW Homework Problems: 1. A large pharma. company has recently gotten feedback that one of their vaccines will have an increase in demand for syringe based product instead of vial based product. In anticipation of this increase in demand you as the lead process engineer for the area have been assigned to analyze the process and define recommendations for improvements that will ensure the line can meet demand and also potentially reduce costs. Demand for the syringe product is expected to be at 52 million syringes per year. The production facility is run 24/7 all year long except for a 3 week shutdown in the winter and a 2 week shutdown in the summer each year to do site maintenance. The operators on the floor work 2X12 hr. shifts with 1 hr. for lunch and 3X20 minute breaks per shift. The process starts with boxes of clean empty glass syringes shrink wrapped (sealed) having to undergo a sterilization process via E-Beam irradiation prior to filling. The boxes are delivered to the sterilizer from the warehouse by the warehouse people and the operators take the boxes in loads of 10 and load them into the sterilizer chamber. Each box contains 1000 syringes. The sterilizer cycle is run for its validated run time of 30 minutes. The boxes are then removed from the chamber and the next group/batch loaded. The load and unload time is all called “set-up/change-over”. The set-up/change-over data that your team collected ranges from 30 minutes to 90 minutes for each load. There are 3 employees that work in this operation. The sealed sterilized boxes are then placed in a small vault for storage until needed in the next step. There are typically 50 boxes in this vault area. The sterilized syringes are then feed into an automated syringe filling station that runs at the machine rated capacity of 160 ppm (pieces per minute). The unit has demonstrated 20% downtime with the downtime associated with glass breakage clean-up, machine jams, and stopper jams. Glass breakage accounts for 10% defects that are discarded in this step. Two people work on the line to help minimize downtime along with supply the parts to the machine to keep it running. Directly adjacent to the filling station connected by a conveyor belt is the inspection station where each syringe is inspected by optical devices looking for over/under fills, extraneous matter, cracked syringes). The inspection machine has a rated capacity of 140 ppm and runs with an excellent uptime performance of 97%. However, the inspection process results in approx. 15 syringes per minute being rejected. Causes for the rejection are attributed to cracked syringes, under fills (below target volume specifications), and crooked stoppers on the syringes. The syringes are packed off the line in flat boxes that contain 500 syringes per box. Two people work the inspection systems to ensure maximum uptime by minimizing downtime issues. Currently in the warehouse there are 10,000 boxes of filled/inspected syringe inventory waiting for packaging. Final packaging for the customer is performed in the adjacent building. The boxes of filled syringes are loaded in the packaging unit. The packaging unit then takes the individual
CHEME 5610: Product Design/Lean Operations Design Problem Set #7 (40 Points): Assigned October 26, 2023 Due: November 9, 2023 Page 2 of 2 Fall 2023: AW syringes and packs them into final customer boxes of 5 syringes each. The packaging unit can process syringes through to final pack at a rate of 140 syringes per min. The uptime for the packaging line is running at 85% due to cartoner jams. Four people work on the packaging unit feeding the syringes and moving completed customer boxes to the shipping dock along with addressing equipment jamming. 1) (10 pts) What is the takt time (minutes/syringe) and thus the resulting minimum rate (pieces per minutes a.k.a. syringes per minute) the line must run in order to meet demand? Show all calculations 2) (15 pts) Draw the current condition of the process from glass syringe feed through to final pack to the customer. Clearly show all relevant data such as design run rates (capacity) in syringes per minute for each, uptime, actual run rates, defect streams/rate, FTEs, etc. 3) (2 pts) Is the line balanced? If not, why and where? 4) (3 pts) Can the line meet demand as it is currently running? Explain your reasoning along with data. 5) (8 pts) What kaizens do the production floor personnel need to focus on in order to sustainably meet the demand? 6) (2 pts) What can be done to reduce lead-time? 2. Extra Credit: (10 pts) Read Sections II and IV in “The Toyota Way”. Summarize the key points in no more than a single page/single spaced and come to class prepared to discuss.
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