TOM HW #6- Process Quality in Wound Closure

TOM HW #6- Process Quality in Wound Closure - — Quality...

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Unformatted text preview: — Quality Management Page 1 of 3 DATE: g5 OEM TOM Homework #6 I Quality Management - Process Qualit in Wound Closure A recent (fictional) start-up called Surgi-Stik, lnc. (SSl) has developed a wound closure adhesive intended for surgeons to use as a substitute for sutures after surgery. At the point in the surgical procedure when the patient is ready for "closing", the doctor holds the incision closed between thumb and forefinger and applies this liquid adhesive to the wound from a small uni-dose tube. The adhesive acts immediately and the incision is sealed within five seconds. The adhesive contains an active pharmaceutical ingredient which comes into contact with the patient’s exposed tissue (skin, underlying muscle, etc.), consequently precise delivery of the adhesive is crucial. The tube is designed to deliver enough adhesive to close one average-sized incision, but must not deliver excess active ingredient to the incision. SSl’s product has become very popular with surgeons and demand is sky-rocketing. They must begin to scale their operation and automate the tube fil ' 5e ‘ ' . SSI has sought proposals from custom filling machine producers to meet both their technical and business requirements. SSl’s development team is particularly concerned about control of adhesive volume in the tube, thus their technical evaluation will entail analysis of the machines process capability for precise volume filling. SSI and their surgeon advisers have determined that each tube must be filled with betweeré 33.5 and 38.5 grams 3 of the adhesive. An over—filled tube would deliver more active ingredient than the patient can to erate and si e effects may occur. An under—filled tube would deliver inadequate adhesive to properly close the incision, requiring the surgeon to intervene with sutures — a costly and time consuming alternative. Two filling machine suppliers, Fill-N—Seal Corporation and Acme Filling Inc. are competitively bidding to supply the automated filling machines to SSi. As a final test SSl has asked for 50 filled tube samples from the two suppliers, each filled using the machine design the companies are proposing. SSI has evaluated each filled tube by precisely weighing the contents; the results of the test are presented in the two tables in Figure 1. The shaded table contains the results from Fill—N-Seal and the un-shaded table contains the results from Acme Filling. Both sets of data are normally distributed about the mean. Measure for units... 41 to 50 Measure for units... Measure for units... 1 to 20 38.0 37.1 35.7 35.5 34.5 35.3 35.1 36.7 35.1 Measure for Measure for units... 21 to 40 36.1 35.1 36.3 35.1 37.0 36.5 36.0 Measure for units... units... 41 to 50 1 to 20 37.0 36.1 36.7 34.5 37.0 35.9 36.1 34.5 35.7 36.5 36.9 36.0 36.1 36.1 35.1 36.1 35.5 i 36.0 36.7 36.5 36.2 35.1 37.0 36.5 35.7 i 35.9 36.5 35.5 37.5 36.5 36.0 36.2 36.3 37.5 36.0 Mean = 36.0 36.0 36.228 36.0 37.0 36.150 37.4 35.9 35.3 35.0 36.5 36.1 36.0 36.0 37.4 36.9 so = 36.5 38.0 $0 = 35.0 36.5 0.8096 35.4 35.7 0.7341 35.7 36.5 36.3 36.0 36.0 37.0 35.9 35.5 36.1 36.0 37.0 36.0 FIGURE 1 Fill ’N Seal Results (in grams) Acme Filling Results (in grams) q i he I ’2' fi 36.33;»3363337. 3 L? E 5.533 “ w» OEM TOM Homework #6 — Quality Management Page 2 of 3 DATE: NAME: 1. Judging only by these data sets, are the two companies offering machines with capable filling processes? Which supplier should SSI prefer and why? Substantiate your answer using both mathematical analysis and a graphical representatioE. x "03L"?th P M °‘ L, g l: ‘- ., fix“ 1'. 6 “Mswgwmmemvmmm w . i ‘3 m i) Fill 'N Seal Corporation H 3 £5 é {a 1‘" _- {a} WW~»~»~~~~w-w~~w a i i C3“? ii) Acme Fillingl Inc} fl _ fl .,,,__4—— r — — v~>-——’—--~—~~~—».Ww~,_ 4mm _ V E a \1, . gs * 11-4 was 33,;, 6;, 501M339 2. If the SSI team decides to work only with a machine supplier capable of meeting the specifications with Six Sigma quality levels, what values for standard deviation would be required, assuming a A? a" centered process? m "- v _ jg 332) a“ 3 H l V K” J b l, (j: WWWW I, . » . :3, . j; I; 3 g i \«J OEM TOM Homework #6 — Quality Management Page 3 of 3 NAME: DATE: m a 3. Which vendor do you think would be more able to modify their machine process to meet the new requirements of Six Sigma Quality? Please explain your answer. {7 ...
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