Question: Engineering Ltd. (Great) was engaged by BigPharma to design a new production line at its pharmaceutical plant in Ontario. In addition to preparing the design,
Engineering Ltd. ("Great") was engaged by BigPharma to design a new production line at its pharmaceutical plant in Ontario. In addition to preparing the design, Great would provide professional services during the installation of the project. You are a professional engineer employed by Great. The president of Great (who is also a professional engineer) has been very impressed with your work over the years and has personally requested that you be assigned to BigPharma's project to act as project manager. This is a very important job for Great and the assignment represents an important career opportunity for you by providing potential promotion opportunities. The completed design of the new production line includes a sophisticated new proprietary quality control system (designed and manufactured by Labeltech Corp. ("Labeltech)). The system employs laser coding and machine vision to accurately identify and label injection bottles containing various drugs that will be produced at the new facility. The technology uses a laser to code the cap of each injection bottle immediately after it is filled. After the bottles are sterilized, filled and transported through the system, a scanner reads the laser codes on the bottle caps and the appropriate labels are automatically printed and applied to the bottles. With the system, wrongly labelled bottles would be eliminated. The project has progressed well (both on schedule and on budget) and is ready for start up, commissioning and testing. Unfortunately, during testing, the quality control system malfunctions and incorrectly labels 20% of the bottles. Labeltech's technical personnel at the site are able to fix a number of problems contributing to the malfunction, and the error rate is reduced to 3%. Labeltech advises you that it will be unable to eliminate the remaining error without redesigning, manufacturing and testing a scanning component; a process which is expected to take at least two months. You e-mail the bad news about the delay to BigPharma. The next day, BigPharma's project representative sends you an e-mail instruction that the production line be accepted with the 3% error rate. BigPharma's project representative explains that BigPharma is planning to use the new production line to manufacture a new patented drug which will benefit thousands of people, saving many lives. Given the immediate demand for the drug, a two-month delay is not acceptable. The representative also indicates that BigPharma's and Great's presidents have already discussed the problem and have agreed that BigPharma would assume responsibility by legally indemnifying Great for any liability that could arise from the incorrect labelling. Using PEO's Codes of Ethics and Professional Misconduct as your guide.
(a) Discuss your duties to the public. How do you evaluate the impact on the public interest? Does the drug's potential benefit to thousands of people affect your duties? Discuss. (10)
(b) Do you have any duties to BigPharma and to your employer? What are they? (5)
(c) Are you able to fulfill all of your duties above? If not, what should you do? (5)
(d) What are the potential consequences to you if you do not fulfill your duties? Does BigPharma's promise to assume responsibility change things? (5)
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