YOU ARE SCREWED!

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Anonymous said:
You still work there and think you know how to fix it? Words here won't help. what are you doing about in your day to day at work?
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Most show up everyday and work hard. YES,there are some very good people thoughout the company.
We have folks in key management positions making poor decisions that greatly effect the business . Cough Cough Hix QA ,Packaging Cough Cough
CEO & Upper Management are so far removed from the problems facing operations .DONT BELIEVE everything you are told. Put the blackberries down and walk the halls .Say hello to a co-worker in the hallway or in the cafeteria,ask workers what challanges they face.
VPs of Quality & MFG battle daily instead of working toward a common good.
Morale blows . No Parking Space,Hot Dog or Friday Blue Jeans are going to fix. If you think they will,you are out of touch with the work force .



Not sure how it can be changed but I'll see you on Monday. I'll be working hard and Walking like I talk it.
 


















Anonymous said:
Most show up everyday and work hard. YES,there are some very good people thoughout the company.
We have folks in key management positions making poor decisions that greatly effect the business . Cough Cough Hix QA ,Packaging Cough Cough
CEO & Upper Management are so far removed from the problems facing operations .DONT BELIEVE everything you are told. Put the blackberries down and walk the halls .Say hello to a co-worker in the hallway or in the cafeteria,ask workers what challanges they face.
VPs of Quality & MFG battle daily instead of working toward a common good.
Morale blows . No Parking Space,Hot Dog or Friday Blue Jeans are going to fix. If you think they will,you are out of touch with the work force .



Not sure how it can be changed but I'll see you on Monday. I'll be working hard and Walking like I talk it.
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And here we go calling out specific departments without saying what the issue is. So easy to do when you're anonymous. Why don't you tell us who you are? You don't have the nerve. Bet you won't even say which facility you work in. At least then tell us what the issue with these departments are. You might be surprised that some of those folks you think are the problem have railed against the poor senior management for years and have made little progress until recently.

Like the other poster said, what are you doing? You say you walk it like you talk it but you only talked smack about other people/departments. Told other people what they should do, but of course you know nothing of the challenges they face so you're making your mind up without a clue. That apparently is how you will walk it. If I'm wrong, tell us how you help the cause and how your walk is different form the talk you post here. How about giving us an example of the poor decisions you speak of. That won't give you away. My bet is you wont.

And another poster made the comment about the HV Compounding Manager being a shaker. You're really just an a-hole. It was plain mean spirited. Not very funny and totally uncalled for. He is one of the few lifers/old timers that sees the need for and helps facilitate change and improvement.

Come on people, if you work there, save the negative comments and work towards a better end point. If you really think that all these people around you are the problem and nothing you do will matter, then please go. We don't need you.
 






You might be surprised that some of those folks you think are the problem have rallied against the poor senior management for years and have made little progress until recently.
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What's been the progress recently? (I'm new to this thread, just want to focus on the positives)
 






Anonymous said:
What's been the progress recently? (I'm new to this thread, just want to focus on the positives)
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I've heard some good things regarding re-validation of current processes, new changes to documents on the shop floor and it sounds like there has been significant capital invested in equipment. There is a better focus on training, but I fear that a training department of one is still insufficient, but still better than what was.

I've heard rumors of further restructuring of the Packaging/Compounding group, but don't have specifics. If you ask me, they just need to re-assign some people and take advantage of the strengths their current staff has and get people in the right roles.

Quality Compliance seems to have been given resources to make some headway although I still think CAPA assignment is not as meaningful as it could be.

Quality Operations/DOC/Stability still seem to be understaffed so I cant tell if they are doing a good job or not. I do know they have the ideas, but seem to be missing manpower.

Sources say they are looking for someone to run the lab, but haven't found the one yet. Outside of that , I'm not sure of the current state of the labs.

Seems like finance has it under control now and Planning has a new mistress overseeing everything so perhaps combined with better equipment, documents and training, we'll be in a better position to run in a JIT fashion.

Cant speak for the other ancillary departments, but this is what I have seen thus far. And I won't speak for my department lest you figure out who I am but suffice to say I have a lot riding on the success of this place.

Peace, love and happiness to all.
 












Anonymous said:
How about giving us an example of the poor decisions you speak of. My bet is you wont.
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Fix the disconnect between departments. Sales/Maketing should drive what's needed down to planning>purchasing>quality>mfg>warehouse shipping. This does not currently happen.Lack of priority & communication continues to bite us in the tookus.

Poor CAPAs , pull some investigations out and read. If you can change this knee kerk behavior it would go along way. Many just slow down the operation and add no value.

Validation reports & Protocols. Lock all the parties that are required to sign off on these in a room until they are completed.

Most folks want to "do it right" and help the company succeed.
 






Anonymous said:
Fix the disconnect between departments. Sales/Maketing should drive what's needed down to planning>purchasing>quality>mfg>warehouse shipping. This does not currently happen.Lack of priority & communication continues to bite us in the tookus.

Poor CAPAs , pull some investigations out and read. If you can change this knee kerk behavior it would go along way. Many just slow down the operation and add no value.

Validation reports & Protocols. Lock all the parties that are required to sign off on these in a room until they are completed.

Most folks want to "do it right" and help the company succeed.
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Sales/Marketing should drive what's needed in Quality? You are out of your mind. No need to go any further.
I agree with the CAPA's. I also understand the unreasonable FDA Inspectors we have had in recent years and the need sometimes to just do something. This is a tough one. No easy answers.
Lock the parties in a room? You realize that the hold up sometimes is simply a lack of resources, don't you? You lock them in a room and then they're not taking care of day to day biz, not approving docs in the EDMS, not communicating with the other areas that need them, not working on FDA remediation, etc... I'm not saying it's always the case, but it is often.

These blanket statements arent helping anyone.
 










































Anonymous said:
Why is that though? I'd like a fact-based answer and not a rant thank you. I truly would like to hear the reasons.
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Equipment release time is extended due to additional required paperwork, all mix times substantially extended, recirculation time substantially extended, three additional mix times added, burdensome bulk weighing procedure.
Our "quality improvements" are killing efficiency. We just focus on making a good product and don't worry about how long it takes. The quality directives come from outside the department, so there's nothing we can do about it anyway.
 






Anonymous said:
Equipment release time is extended due to additional required paperwork, all mix times substantially extended, recirculation time substantially extended, three additional mix times added, burdensome bulk weighing procedure.
Our "quality improvements" are killing efficiency. We just focus on making a good product and don't worry about how long it takes. The quality directives come from outside the department, so there's nothing we can do about it anyway.
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That was an honest answer. But let me challenge you on it a little.

While I understand that the process is now longer, was it perhaps artificially brief in the past? In my experience, the controls now in place in MV/HV are pretty routine when compared to other pharmaceutical companies I have been in.
With all the investigations, recalls, FAR's and batch rejections you have had the last several years, is it not best to put quality first?

Some of the shortcuts you use are unheard of in other companies. There are supposed to be hard parameters that you stick to, over and over again. The batch record needs to show ALL critical steps performed and the results of them. This is nothing new. It has been a compliance requirement since the day of the flood.

My guess is that this place is just too used to doing things as they wish without as much regard for control as they should have. Again, in my short time there this is what I see.

Still seems like a worthwhile place to work though. Lots of bright, talented people. I see a lot of people under a lot of pressure and yet they are still reasonably pleasant to work with.

Plus the cafeteria is cheap! Love the fried chicken and French Fries!
 






Anonymous said:
Equipment release time is extended due to additional required paperwork, all mix times substantially extended, recirculation time substantially extended, three additional mix times added, burdensome bulk weighing procedure.
Our "quality improvements" are killing efficiency. We just focus on making a good product and don't worry about how long it takes. The quality directives come from outside the department, so there's nothing we can do about it anyway.
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Was the addition of extended mix times ,recirculation times and three additional mix times based on validated scientific data or quality directives from ouside the department ?

Does the additional paperwork and bulk weighing procedure make a more compliant /better A+ D ?
 












Anonymous said:
And another poster made the comment about the HV Compounding Manager being a shaker. You're really just an a-hole. It was plain mean spirited. Not very funny and totally uncalled for. He is one of the few lifers/old timers that sees the need for and helps facilitate change and improvement.
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Dont think the poster was speaking about the Hicksville Compounding Manager. Youre 100% right.....he's one of the good ones.
 






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