It was getting to that time of the project…you know when everybody is trying to avoid discussing the validation plan, but they just can’t seem to hide from it any more…
Bob was not aware that Del Lusional, the Project Manager, was going to ask for a presentation about Validation and the strategy for the project…Had Bob been aware that he would be asked to answer a question, let alone make a presentation, he would never have shown up for the meeting.
Anyway, Del starts the meeting by informing the project team that Bob Andweave will be presenting his ideas on validation and the project strategy…let’s pick up the action as Bob walks in to the meeting late…
“Bob, glad you’re here” says Del…”We were just getting ready for your presentation…”
Bob falls into his chair…he wasn’t listening because he was too busy arranging his snacks for the meeting…(Bob never does anything at the meetings, so he needs a distraction)
“Presentation?!” Bob stammers…”What presentation?…I didn’t know we were having a presentation today!!!…”
“Not having one…Giving one…” Del is closing in for the kill once he remembers that he forgot to tell Bob about his request that a presentation be prepared to explain how the project would be validated…
“How about you get started? Del asks…”After your presentation, we need to review the budget for the complete Validation effort, including Commissioning, Qualification, Quality Plan, Validation Master Plan and protocols and process validation…”
Del has just used every buzzword he knew about Validation in a single sentence…
At this point, Bob has broken out into a cold sweat…His strategy to date for the project was to hire a contract employee to do the work before anyone realized he didn’t know all that much, or anything for that matter, about what it would take to validate a project…no time to let on now…
“Validation is a tricky issue…”Bob starts to stall…”with lot’s of complexities that everyday people like yourselves may not understand…”
“That’s OK, Bob” Del suggests, “we have you to explain the whole issue to us…in fact, why don’t you take this entire meeting and explain what validation is, why it’s important, and how we are going to approach it on our project?”…Del doesn’t want to have to admit that he doesn’t really know what validation is and he is just glad he can get someone else on the spot…(Del likes watching people squirm…)
Bob is working up to a full panic now, as the entire room is waiting for him to begin…
“Validation is like…like…like an…” Bob is stammering, it’s becoming obvious he doesn’y know where he’s going with this…He grabs at his snack, which happens to be an apple today…the inspiration strikes…
“like peeling an apple!!!” Having blurted this out, Bob stops for a quick bite of his apple, for emphasis…Unfortunately, this brief break allows the inane questions to start…
“like peeling an apple? or biting an apple?”…”A long skinny peel? or just chunky ones?…”
Lou DaCris is desperate to look like he knows what he is talking about, and weighs in with his two cents…”I was at an ISPE presentation the other day and the global director of BioPharm Validation from GSK was there…and he seemed like a real smart, knowledgeable guy with a good understanding of these issues, and he said he thinks validation is like an onion…”
“Or an onion…an onion would be good…” Bob agrees…
At that moment, in walks a Senior Project Manager…accompanied by a Junior Vice President…Del leaps to his feet to show he is in control of the meeting and explains that Bob was just comparing validation to fruit, or maybe vegetables…
The Senior Project Manager blurts out something along the lines of, “I heard that and I think we should implement that strategy on this project…
Bob Andweave plays right along…”Yes sir, I was just reviewing how our strategy would employ that very strategy…We will put that in our Validation Master Plan…”
Not to be outdone, the Junior Vice President adds ” I thought I heard that Validation was like a banana peel, be careful you don’t slip up on it…
Bob thinks the JVP went for the joke and laughs…unfortunately everybody just stares at him when they all realize Mister Junior Vice president was serious…
Bob then reveals his fatal flaw…he will always agrees with the most senior person in the room at the time…no matter how many about-face manuevers that takes…
“Yes, sir, the banana strategy…We’ll issue an update to the VMP to document that approach…
The Senior Management bustles out of the room…obviously they have too many big important issues to discuss to be bothered watching the little people work…that plus they don’t really know anything about validation beyond the fact that it seems to cost a lot at their company and it seems to take along time too…
Bob Andweave collapses into a sweat-soaked puddle while muttering about the VMP updates…
Del adjourns the meeting…He is proud he managed to get somebody else under the microscope…He starts looking foward to next week, and starts trying to figure out who he can catch next…
No one even bothers to think about the implications of project strategy being based on a fruit…
Another week off the project schedule, another week at an amazing burn rate…
Another perfect day, back at the Fun E Pharm…