Trace Matrix: Ensure Requirements Are Implemented, Provide Evidence of Risk Mitigation confidence interval (CI) is a measure of the reliability of an estimate.
1. ] The production manager of a plant that manufactures syringes records the marginal cost of production (Y) for 14 randomly selected months. (Marginal cost is measured as the cost in dollars per 100 units). The sample average and sample standard deviation for the 14 data are and
a.  Construct a 95% confidence interval for the mean marginal cost of syringes manufactured at this plant ()
Since population standard deviation is unknown, use t-distribution: confidence interval&hypothesie test
Product development life cycle contains several steps:
1. Idea Generation based on potential Marketing
2. Brainstorm the idea, collect design requirements to meet corresponding ISO/ANSI requirement and regulations(FDA,FCC)
3. Develop and create concept, discuss with engineers from across the function team (PV&V engineer, Manufacturing Engineer, Quality Engineer, Marketing etc)
4. Prototype and durability build product and machine, test and verify from functionality, performance and capability standpoint, record and correct issues found
5. Prepare assembly sequence and manufacturing/building plan, train operator and initiate the order fulfillment process
6. Launch the product to the market
7. Collect feedback, improve the design
The most challengeable project I have worked on is “Field Sprayer Temporary Cab Support”. The cab is assembled to mainframe at sprayer main assembly line st 5, before the cab could be fastened to mainframe, a couple of wire harness need to be connected underneath the cab. Hence a 6” gap between cab and permanent cab support must be retained. At this moment the cab is only supported by a sling while operators working underneath the cab. Therefore a set of temporary cab supports need to be designed from safety and ergo standpoint.
1. Cab Weight = 2000 lbs.
2. Each cab supports cannot exceed 12 lbs.
3. Adjustability: The top support cradle must be adjustable, with a limit of +/- 2.5 inches, which change the structure of cab support from a straight design to an L shape design. – A leg must be added which extended to the mainframe to increase the support length and hence allow the adjustability.
4. Interference Issue: some parts/subs exist while the cab is resting on the temporary support, hence temporary support cannot get in the way of existing parts. Each support is different from each other.
1. Cab must be made from Aluminum, which potentially reduce the strength (Young’s Modules: only 1/3 of steel).
2. L shape structure.
3. FEA must be conducted to verify the worst case.
A set of cab support are designed, with only Rear Left one exceeds the weight criteria (close to hydraulic reservoir, hydro hoses need to be routed underneath).
FEA analysis: (static analysis)
Connection; Load; Constraints; Material;
Max displacement: 8.2 mm with 35.2 MPa
Duration: 2 month, with modification when fixture came in.
Six Sigma at many organizations simply means a measure of quality that strives for near perfection. Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects (driving toward six standard deviations between the mean and the nearest specification limit) in any process from manufacturing to transactional and from product to service. two Six Sigma sub-methodologies: DMAIC and DMADV. The Six Sigma DMAIC process (define, measure, analyze, improve, control) is an improvement