Mike was concerned about the scope of the project. He knew from his own experience that a final formula had yet to be developed, although 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 issues had been resolved and he believed that submission of regulatory documentation would be followed by rapid approval as they already had a letter of approval contingent on final documentation.
But there were also issues in packaging that had to be resolved: development of the packaging design was one of his primary concerns at this time. Ultimately, there will have to be manufacturing procedures in accordance with corporate policies and standards: capital equipment selection and procurement, installation of this equipment and startup.
Mike was concerned about defining the project unambiguously. To that end, he obtained and interview with S.L. Mander, the group vice-president.
When he asked Mander where his responsibility should end, the executive turned the question back to him. Mike had been prepared for this and said that he would like to regard his part for 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 percent yield of product (fully packaged) at a level of 80 percent of the full production goal of 10 million liters per year.
“But I want you to remember,” said Mander, “that you must meet all current FDA, EPA, OSHA regulations and you must be in compliance with our internal specification—the one I’ve got is dated September and is RD78/965. And you know that manufacturing now—quite rightly, I feel—insists on full written manufacturing 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 naïve if you think that you can just 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 their voice to be heard, and you will have to have approvals from every unit that is involved; all of this reviewed by the Executive Committee. You have no trouble if you do your homework, but expect 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 can’t start to establish product specifications (c) until the formula is complete. That’s another three weeks.”
“Yes, but while you are working on the product...