Hectic!

Okay - so at the risk of sounding like a whiner - I need to air some crazy to you.

I start school tomorrow for the summer semester and I am freaking out. Last semester I was going part time (now I will be fill time) while working full time. My husband is in school part time and we are both taking care of our one year old son.

At work we have a huge project going to start all new packaging, a new sterilization process, new parts, new documentation, updated processes and new kits. My job is to update all the documentation and help set up all the manufacturing processes. (No pressure right?) Normally this wouldn't be a huge issue as the launch is August 1st but all the documentation hasn't even been started. Every time I try to get a new document through or a current document changed, it turns in to an epic battle of wills - me vs. marketing, me vs. R&D, me vs. whoever. What I find most infuriating is that someone will say "This is how I want it done" but they don't realize that the way a quality system works does not allow for each person to do whatever they want.

For example, you want to change Document A. Step 1 says "place the label on the box." You want to change it to say "Place the label, approximately centered, on the front of the box." In order to make that change, you need to make the changes and initial and date. Then you fill out a cover page that says "Step 1 was updated to say..." And the rationale (i.e. "to eliminate confusion about where the label should be placed") is also written out. The redline and cover sheet go to specific people who review it and say "yes that makes sense." The redline and cover sheet go into a file, the original document moves from the master file to the history file and the new document goes into the master file. The master file contains the most recent version of all documents.

Person 1 wants the original version, the redline and the final version attached to the cover sheet "just in case someone is looking at this cover sheet and wants to see the final version." (Why not just go to the master file like you are supposed to?)

Person 2 wants to review all documents that could effect this change, any documentation showing this change is needed, and have a meeting to discuss why everyone else agreed to the changes without researching everything first.

Person 3 wants to release the new version but use the old version until they have had time to test any risks associated with changing the label placement.

Person 4 doesn't want to sign anything until person 2 and 3 are satisfied.

Person 5 wants it to say "The blue label should be affixed to the center of the box. The label should be centered on the top side of the box, as indicated by the company logo which is printed on the top side of the box. The label should also be firmly pressed onto the box to ensure the entire body of the label, as well as all edges and corners attach securely to the box surface."

Person 6 hates periods and commas in lists, on labels and in some steps of processes and won't sign anything until you take them out.

Needless to say, getting all these documents released is going to be a nightmare. The best part is that they (person 1 through person 6) have imposed a deadline of June 1st on me. What they don't realize is how many documents need to change and how long that process takes.

So I have that going on as well as inspection for all the new parts and all my regular duties of inspection, documentation and clinical trial patient follow-up.

Now that I am starting school tomorrow full time I have less time to devote to work and will have twice as much homework. The worst part is that I feel like I don't give my family nearly enough. At the same time I feel like I am doing all of this for them. So I don't know what to do.

The part that upsets me most is that my one year old is ridiculously cute and always happy to see me but on Tuesdays and Thursdays I will leave home at 6:30AM and not get home until 10:30PM. I will be gone for 16 hours. I will be missing those cute little moments that always put a smile on my face. However, I also see that I am missing these moments but I will be done before he is 3 and he won't even remember that I was gone a lot or doing homework all the time. And I know my degrees will help me in my career and, in return, help my family.

It just seems a little overwhelming at the moment. And I am irriated with Persons 1-6 listed above that never seem to realize that I might, in fact, know a little bit about what I am talking about. Ah to be young...