I believe that the disconnect was a larger issue in the past. I feel that companies (at least in my limited experience) actually are actively removing that disconnect. It’s a big issue to have. Rewarding teamwork and speaking your (helpful) opinion is a necessity. Doing a lot of solo work and keeping quiet to not step on any toes is more harmful…[Read more]

These are all fairly obvious reasons for leaving a job to move to a different one. I’m actually curious as to the other, maybe less common, reasons why people leave. What about those who need to leave to take care of a sick family member or be closer to one? Sadly, I feel as though this is a somewhat common occurrence. Others get sick themselves…[Read more]

I will add another fact, that american workers get less vacation than other workers in other countries. One aspect of why they work more that I haven’t seen above is that they want to make a good impression. People who want to move up the ranks will take it upon themselves to work harder and longer than their peers in order to get their work done…[Read more]

I will reinforce an aspect of motivation (as many of you have said above). The main thing a manager needs is to ensure that their subordinates feel like they have a personal stake in the project’s success. That is the best way to ensure that the workers will give their best effort in order to ensure the project’s success. When working on any…[Read more]

This is a very interesting study and I wish i could find more about it. When was it taken, how many people, what age group, etc? All of these are factors on the percentages of each answer. I did expect these to be the generic answers about why most people work. The biggest change I expect would be by age group. Younger people will care more about…[Read more]

I’ll add to what’s been said above. People who work QA usually work with the people who are writing SOPs, change controls, etc. They’re in the office making sure that all of the paper work and paper trail are correct and follow regulation. They catch any issues and send it back for revision. QC people are usually on the floor, checking machinery…[Read more]

Reactive management is sometimes unavoidable. Proper planning is crucial, but there will always be issues that arise that either you couldn’t or didn’t foresee. Things happen. Having a robust system to ensure that any problems are solved quickly is vital. As jb678 said proactive is better than reactive. We’re only human. We can’t always see every…[Read more]

I doubt that changing positions mid-project is something that happens often. If it does, I would still think that they would continue their role in the project or at the very least assist the person who is taking over their old role. They would oversee and train their replacement. Bear in mind that this will only happen if there is no one else…[Read more]

I’d disagree jb678. It really depends on how much it would cost. Being behind schedule costs money, just as being over budget. Being behind schedule might cost just as much if not more. As said before we would really need more information. Whichever saves more money is the best solution. Being over budget but ahead of schedule might give you gains…[Read more]

Well there’s a few factors that affect this. What level employee are you? Managers may have a harder time taking off if they cannot get the appropriate person to hold the reins while they’re away. A lower “grunt” may have an easier time if their work is easy for others to assist with. Personal time is usually always approved weeks if not months in…[Read more]

I agree with jb678. I feel that it’s easier to control creep in some projects rather than others. For example, mirroring a manufacturing facility is easier than building one from scratch. Yet, there are always going to be issues that arise. Having strong plans and documentation to ensure that what needs to get done, and only what needs to get…[Read more]

I may not be as experienced as other people in this class so I can only speak as to what I’ve seen. I’ve never seen a phase skipped over to start the next before the completion of the previous. I don’t think it’s possible from a regulation standpoint. I don’t think it possible from a timeline standpoint either. Unless the phase end is internal…[Read more]

I agree with most of what you’ve said, but it seems you haven’t addressed setbacks, major or minor. Weekly planning meetings, from my experience, deals with changes to the schedule and accommodates any issues that may come up. There may be some setbacks that you can’t account for. Let’s say a vendor had problems with an order that your entire…[Read more]

I think you need to have both. Risk management should be taken into consideration the entire process, but the final approval should be done by different people in risk management. This makes me think of quality teams. They are involved in the process, and they give the final approval (maybe a different person than before). It is more important to…[Read more]

I don’t know what company you’re talking about and I’m not sure if I’m looking in the right place (all I can find is avengers stuff). That’s good that they’re checking each step. There’s a lot of aspects of cGMP but I’m not sure you can narrow it down to just one. Maintaining data integrity and ensuring only certain people get access to certain…[Read more]

Well judging from what I’ve seen a few things could happen. The first is that you notify them and try and fix the problem. If they’re slow to respond then you would start looking into other vendors. I assume that there would be other options that were looked at during the selection process. Those would be the first options. You are dependent on…[Read more]

I agree with what you you guys have said, I just want to add that people with experience on projects are a great asset when determining issues. They may have seen certain things that came up and negatively affected their timelines, or they may know of certain ways of doing things that prevent timing issues in the first place. Good communication…[Read more]

I currently work in a pharmaceutical company, and we are in the process of getting all of our equipment and process verified and validated. We need to ensure sterility, appropriate amounts of product, etc. I am somewhat new to the company so I can’t say I know a lot about the process. We do change controls, CAPAs, etc whenever a problem needs…[Read more]

I’m not sure there is one. Every stage has it’s role to play. Maybe you could say that starting off strong is important, but the others can’t fail or else the entire project is a failure. Did you have one in mind? Project initiating, planning, execution, closing, and monitoring and controlling are all equally important. Each is a link in a chain,…[Read more]