Monday, May 20, 2019
ISM 654 Case DU vocaliser Hospital Products Corp. (Adapted from Meredith and Mantel) D. U. Singer Hospital Products Corp. has done sufficient new product fixment at the research and development level to estimate a gamey likelihood of technical success for a product of assured commercial success A semipermanent antiseptic. Management has instructed Singers Antiseptic Division to make a market entry at the earliest possible time they take for requested a complete plan up to the inaugural of production.Project responsibility is assigned to the divisions research and development group Mike Richards, the wander scientist who develop the product is assigned responsibility for project management. Assistance leave behind be take from other separate of the company Packaging task force, R&D group, Corporate engineering, and Corporate purchasing. Mike was interested some the scope of the project. He knew from his own experience that a final legislation had yet to be developed, alth ough such development was really a routine function.The remaining questions had to do with color, odor, and consistency additives rather than any performance-related modification. Fortunately, the major regulatory issues had been resolved and he believed that submission of regulatory documentation would be followed by rapid compliment as they already had a letter of approval contingent on final documentation. Mike was concerned near defining the project unambiguously. To that end, he obtained an interview with S. L. Mander, the group vice-president.When he asked Mander where his responsibility should end, the executive rancid the question back to him. Mike had been prepared for this and give tongue to that he would like to regard his part of the project as done when the production process could be turned over to manufacturing. They agreed that according to Singer practice, this would be when the manufacturing operation could produce a 95% yield of product (fully packaged) at a level of 80% of the full production goal of 10 million liters per year. But I want you to remember, say Mander, that you must meet all current FDA, EPA, and OSHA regulations and you must be in compliance with our internal precondition the one I wee-wee got is dated September and is RD78/965. And you know that manufacturing now quite officely, I bump insists on fully documented procedures. After this discussion, Mike felt that he had enough information about this aspect to start to pin down what had to be done to achieve these results. His first step in this effort was to meet with P. H. Docent, the director of research. You are naive if you think that you buttocks barely start right in finalizing the formula, said Docent. You must first develop a product rationale (a). This is a formally defined process according to company policy. Marketing expects inputs at this stage, manufacturing expects its voice heard, and you will have to have approvals from every unit of the co mpany that is involved. You should have no trouble if you do your homework, expect to spend a good eight weeks to get this done. That certainly stretches things out, said Mike. I expected to take 12 weeks to develop the ingredient formula (b) and you know that I shadowt start to establish product specifications (c ) until the formula is complete. Thats another 3 weeks. Yes, but while you are working on the product specifications you can get going on the regulatory documentation (d). Full internal specifications are not required for that work, but you cant start those documents until the formula is complete. Yes, and I find it hard to believe that we can push through both preparation of documents and getting approval in 3 weeks, but environmental swears it can be done. Oh, it can be done in this case because of the preparatory work. Of course, I wint say that this estimate of 3 weeks is as certain as our other estimates. All we take away is a change of staff at the Agency and w e are in trouble. But once you have both the specifications, and the approval, you can immediately start on developing the processing system (g). Yes, and how I deficiency we could get a lead on that, but the designers say that there is too much suspicion and they wont move until they have both specifications and regulatory documentation and approval.They are offering pretty fast retort 6 weeks from start to finish for the processing system. They are a good crew, Mike. And of course, you know that you dont have to live on on starting the packaging segment of this project. You can start developing the packaging concept (e) just as in short as the product rationale has been developed. If my experience is any judge, it will take a full eight weeks youll have to work to keep the process from running forever. But as soon as that is finished we can start on the design of the package and its materials (f) which usually takes about six weeks.Once that is done we can start on the pac kaging system (h) which shouldnt take longer than eight weeks, cerebrate Mike. At this point he cleard that although Docent would have general knowledge, he needed to talk direct to the Director of Manufacturing. The first step, which follows the completion of the development of processing and packaging systems, said the Director of Manufacturing, is to do a complete study of the facilities requirements (i). You wont be able to get that done in less than four weeks.And that must precede the preparation of the capital equipment list (j) which should take about three-quarters as long. Of course, as soon as both the process system and packaging system are completed, you could start on preparing the written manufacturing procedures (q). But, said Mike, Can I really finish the procedures before I have installed and constructed the facilities (p)? No, quite right. What you can do is get the first phase done, but the last phase will have to wait for the knowledgeability and construct ion. Then this means that I really have two phases for the writing, that which can be completed without the facility and construction (q), which will take seven weeks, and that which has to wait for those inputs (q? ) which will require 3 weeks. True. Now you realize that the last thing you have to do is to run the equipment in a pilot test which will show that you have reached a satisfactory level? Yes. Since that must include debugging, Ive estimated a six-week period as adequate. The director of manufacturing assented. Mike continued, What Im not sure of is whether we can run all the installation tasks in parallel.