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And then run your mouth about nothing for 15 minutes after that
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Mar 27, 2023 16:41
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FAUXTON posted:folks say this about risk management all the time it's great It’s ok bad things happen to other people if stuff comes up well just adapt then.
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Mar 27, 2023 18:38
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Lord give me the confidence of the person who just asked an office-wide company slack channel for a squatty potty in the bathrooms.
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Mar 27, 2023 18:58
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skipdogg posted:This made my eye start twitching. Same thing where I work. We need to move faster, don't be afraid to fail, we have a blameless culture. Here's mountains of paperwork to slow you down, and boy howdy if you gently caress up we're going to make it so painful for you with weeks of post mortems and reviews that you'll wish we fired you. You won't get fired here, but you almost wish you were if it's bad enough. I gave up adding half of what they wanted on the basis that nobody ever looked for any of the things they claimed to need evidence of, confirming my theory that they solely existed to provide something to fire you for if necessary because it is impossible to actually comply with everything from a practical standpoint so everyone has something they could be pulled up on. This is partly why I'm not sad to be moving from IT and actually running development to being more like a proper product owner setting the overall delivery: I am sick to goddamn death of the paperwork.
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Mar 27, 2023 19:21
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BadSamaritan posted:Lord give me the confidence of the person who just asked an office-wide company slack channel for a squatty potty in the bathrooms. literally King poo poo
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Mar 27, 2023 19:54
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Renegret posted:It's just, his job isn't important, and if him and his entire department fell off the face of the planet, the world wouldn't even notice. This, and I work in marketing, which everybody at my work loudly agrees is pointless. Except when course applications are down. MARKETING! EXPLAIN YOURSELVES! What do you mean you can't press a magic ad lever to make number go up immediately??
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Mar 28, 2023 05:13
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I Told You So, v2.0: There was a 'delta training' today, which is their dumb way of saying that they're training everyone on the changes to something. In this case, it's the quality system associated with investigating things going wrong in our GMP areas. About 1-2 years ago, the system was redesigned to reduce the workload on QA. Investigations were divided into two buckets, which I'm going to call Major and Minor. (They have different names IRL, but I should at least pretend I'm not doxxing myself, right?) The investigation is initiated in the system when something goes wrong, and then the initiator is responsible for determining (in theory, in conjunction with a triage team of subject matter experts and QA folks) whether it is major or minor. A major investigation goes through the whole root cause analysis process, QA approval, CAPA actions, etc. A minor one isn't a big deal and is just trended on the year-end annual investigation trend report. If there's a trend, then it gets addressed in more detail. Minor investigations are closed by the initiator with no input from QA. No QA sign-off, no nothing. Go back in time... Sundae, when this change happened: "So, what stops someone from being in a hurry and picking convenient triage people who aren't going to really question him or no triage people at all, and determining something is minor and closing it on their own? Nobody would see it until trending a year later because there's no QA approval." Change champion (lol): "We know and expect that everyone has the best interests of the company in mind and--" Sundae again: "No, I'm not implying that anyone doesn't. I'm asking, literally, what stops that? It doesn't matter if nobody does it; the process is what matters." Change champion: "We'll have to disagree there. The intent and the history of compliance matter more than the potential gap. And remember... there's an annual trending report. All this stuff will be found." Sundae: again: "This is not going to work out well. I worked in a consent decree environment before coming to [here], and I can assure you the FDA is not OK with this." Change champion: "Of course they weren't. You were under consent decree and we're not. Any questions from anyone else?" Up comes an audit... FDA: "So, what stops someone from being in a hurry and..." *Curb Your Enthusiasm credits start rolling.* Fast forward to the delta training... Trainer: "The FDA cited [here] for having no QA oversight of our Minor Investigation process, and also cited [here] because the annual trend review process was not capturing all the minor investigations due to the trend reviewer had no way of knowing whether their query captured all the relevant events to determine if a trend occurred..." Sundae: "YOU DON'T SAY." Change champion mass e-mail to compliance folks: "We're going to need everyone to do a full review of every investigation their group has originated since Date X to determine if any trends were missed, and also for QA to determine if they agree with the original Minor/Major classifications." Sundae: "Already done. We never stopped getting QA agreement in the first place because we saw this coming a mile away. Our group's report is XXXXXX in [document management system]." So again, "I told you so" is the right answer. I'm sure it would violate some corporate guidelines to do it, but I almost want to put together a poster session of all the times someone here has ignored me and been cited by the FDA for it. 
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Mar 28, 2023 05:31
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"So i can see in your business chemistry results you're a Guardian, so,"
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Mar 28, 2023 06:00
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Sundae posted:I Told You So, v2.0: Lead from every seat. Find an excuse to get my group involved.
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Mar 28, 2023 08:07
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You really should get yourself a little whiteboard, put a nice dividing line in the middle and have "number of times I've called out your poo poo"/"number of times the poo poo I called out came back to haunt you". Whenever people start trying to shoot you down as you call them out, start tapping the board loudly and update the number on the left without breaking eyecontact. You'll either get them to stop including you in the meetings or you'll get written up for creating a hostile working environment.
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Mar 28, 2023 08:58
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I got voluntold today to talk for a couple of minutes in my org's ~200 person all-department weekly zoom about the importance of employee voice. Guess who balled up their courage, smiled with faux confidence and introduced themselves and their talking piece on mute?
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Mar 28, 2023 10:46
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bee posted:I got voluntold today to talk for a couple of minutes in my org's ~200 person all-department weekly zoom about the importance of employee voice. Guess who balled up their courage, smiled with faux confidence and introduced themselves and their talking piece on mute? Probably the best possible way to underscore the importance of employee voice. Have a pizza party, you earned it! - mgmt
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Mar 28, 2023 10:48
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Sundae posted:I Told You So, v2.0: So did the change champion buffoon ever work in a GMP environment before? Because last time I checked the quality units job is to oversee quality events of all types.
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Mar 28, 2023 12:45
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This is my go to (well in the six months since it’s been published) whenever someone tries to get around QA / QC or otherwise “reduce their workload” http://www.tsb.gc.ca/eng/rapports-reports/aviation/2021/a21w0045/a21w0045.html Tl;dr: helicopter part manufacturer stored rods by size, not by composition. Someone grabbed a Rod of stainless steel instead of tool steel, QA was delegated to untrained randos so they didn’t catch it, OEM certified parts made it into the supply chain that shouldn’t have been certified, helicopter tore itself appart and returned to its natural state of being a pile of debris on the ground. One dead. Shareholders sure got some value from the QA savings though. FrozenVent fucked around with this message at 14:07 on Mar 28, 2023 |
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Mar 28, 2023 14:02
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Sundae posted:So again, "I told you so" is the right answer. I'm sure it would violate some corporate guidelines to do it, but I almost want to put together a poster session of all the times someone here has ignored me and been cited by the FDA for it. I know you know this but keep that in your back pocket for when someone tries to pull "why didn't you warn us this could happen".
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Mar 28, 2023 14:10
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FrozenVent posted:Shareholders sure got some value from the QA savings though. A happy ending
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Mar 28, 2023 14:10
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Can't imagine the amount of money and time that went into my company creating a "Principles Handbook" that apparently gives such sage advice as "maybe try communicating with your team" and "life can be hard but try to not let it affect your work".
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Mar 28, 2023 15:49
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dpkg chopra posted:Can't imagine the amount of money and time that went into my company creating a "Principles Handbook" that apparently gives such sage advice as "maybe try communicating with your team" and "life can be hard but try to not let it affect your work". It's like the constant barrage of internally generated email I get announcing all the things sales and marketing are doing. Somebody (probably more than one) got hired to write that stuff and dammit they're gonna justify their job and do it. Hats off to them, I hope they don't mind that nobody actually reads any of it.
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Mar 28, 2023 15:54
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to be fair there are a ton of people who should try communicating with their team
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Mar 28, 2023 15:55
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Motronic posted:It's like the constant barrage of internally generated email I get announcing all the things sales and marketing are doing. Somebody (probably more than one) got hired to write that stuff and dammit they're gonna justify their job and do it. Hats off to them, I hope they don't mind that nobody actually reads any of it. I mean, as long as adequately large checks clear, I wouldn't.
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Mar 28, 2023 16:02
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Dammit I hosed up and tapped a link in outlook ios from an obvious IT phishing email so now I am going to have to go to the goddamn training.  I got too excited to get a new laptop and they preyed on my weakness  Seriously they send these out every week and usually I spot em but I was on vacation last week and got rusty.
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Mar 28, 2023 16:21
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priznat posted:Dammit I hosed up and tapped a link in outlook ios from an obvious IT phishing email so now I am going to have to go to the goddamn training. If you dig into the email headers you can figure out which company they use and setup some outlook rules to send them to a phishing folder or deleted items... Not that I as an IT professional would recommend or even do such a thing.....
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Mar 28, 2023 16:30
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Do you have the kind of evil IT that sends out fake phishes with upcoming_layoffs.xlsx attached?
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Mar 28, 2023 16:32
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Eric the Mauve posted:Do you have the kind of evil IT that sends out fake phishes with upcoming_layoffs.xlsx attached? They are always nice things like “employee recognition award” or “choose your new laptop” which is really quite the tease  But at least it’s non terrifying.
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Mar 28, 2023 16:44
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Shrieking Muppet posted:So did the change champion buffoon ever work in a GMP environment before? Because last time I checked the quality units job is to oversee quality events of all types. I'm gonna take off my self-aggrandizing hat for a post or two and be fair here. Long post: There's a very understandable culture issue/difference here at this site in particular that explains a lot of these weird-rear end problems. Historically, my company was pure R&D and then transferred their products to the mothership to do scale-up and GMP production. They filled the ranks with seriously top-notch scientists, but who had little to no GMP experience. They didn't need to have that experience, because they didn't have to deal with any of the GMP side. Their jobs were to create new poo poo and then toss it to the mothership to sort out. The change champion probably never worked in any GMP environment ever. However, meanwhile, the mothership has been getting more and more risk-averse when it comes to new tech and new products. They started saying that molecules / peptides / whatevers from us didn't fit their risk profiles, and they kept refusing to develop them (while at the same time complaining about our output being down). This led to our internal leadership at Subsidiary Inc saying "well gently caress you, we'll do it ourselves then," and they built GMP manufacturing facilities and systems within our own leadership structure. We were able to do this in spite of being owned by Mothership because the buyout agreement had our R&D function taken out of the chain of command for Mothership and only reporting directly to the CEO himself. Meanwhile, the very extremely swiss billionaire family who still own a majority share of the mothership's public stock have made it their "thing" to show up at shareholder meetings with only one question: "Are you continuing to grow the R&D budget? Yes? Here's my rubber stamp. If you ever cut R&D, I will have you killed." Then, they retreat to their yachts and chateaus, and do whatever horrific things they do in their spare time until the next meeting. So, our R&D-heavy subsidiary built out its own GMP stuff so that they could work on their own products that Mothership didn't want to deal with. They filled the ranks of these new organizations with the best and brightest of their scientists at the top, and the worst and dullest of contract agency recruits at the bottom. (No, most of them are not actually the worst or the dullest, but consider that statement from the perspective of what someone with a PhD + 20yrs + Superiority Complex would think about floor operations folks.) Meanwhile, the best and brightest have no idea what GMP means and think they can science their way past regulations. They've never been in an environment where that wasn't true. The actual floor workers (as I uncharitably called them, the worst and dullest) aren't paid enough to give a poo poo and the "real" scientists wouldn't listen to them anyway, so they mostly keep their mouths shut. Somewhere along the way, my building was built to handle scale-up of non-biologics and GMP production at Subsidiary Inc. Except, they hosed up and hired a trio of engineers who were both loud-mouthed and knew what we were talking about. My boss came from a series of high-throughput GMP manufacturing facilities in Puerto Rico. I came from an aseptic sterile injectables production facility in Indiana plus time at an OTC pharma facility operating under consent decree. My boss worked for that same company. Our third engineer (who has left the company since then) worked for a Japanese pharma company and got to deal with JP pharma regulations, which are both harsh and hosed up in their own way. She also started her career as a floor operator. We regularly shoot off our mouths at these people, most of the time being ignored because wtf do we know. We're just engineers. So, that's where the culture war is sort of ongoing - a bunch of scientists used to the wild west of traditional R&D environments got promoted into leadership over GMP and quality functions where "the process" is everything. Some of them just don't get it or don't want to get it, but as more and more of them get punched in the face by regulatory agencies, they'll eventually figure it out or get KO'd and replaced. It's just irritating to see them keep loving up when we're telling them how to avoid stepping on the rakes in the first place.
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Mar 28, 2023 17:08
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docbeard posted:I know you know this but keep that in your back pocket for when someone tries to pull "why didn't you warn us this could happen". "I Told You So" is only something you can enjoy in telling a co-worker or a dead gay comedy forum.
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Mar 28, 2023 17:08
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Cheesus posted:"I Told You So" is only something you can enjoy in telling a co-worker or a dead gay comedy forum. Yep. My engineering team and I laugh and roll our eyes during our team meetings, but that's about it.
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Mar 28, 2023 17:14
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Cheesus posted:There's no counter that won't lead to "Why didn't you warn us more forcefully?" and so forth. “While <employee> has good business sense, they have opportunities to grow their ability to effectively inspire and influence key stakeholders to align on a recommended course of action. We look forward to seeing this growth in the coming year. Rated Meets Expectations, 2.5% raise”
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Mar 28, 2023 17:15
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Now, you know I don't like to point the "This will come back to bite us in the rear end" cannon at people, but I don't think you heard me.
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Mar 28, 2023 18:30
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My favourite IT phishing training was at LastJob, where because they copy pasted a template from wherever, the fake phishing email looked more professional that anything IT ever sent out. I caught it because the link in the email went to an actual website, not one of our lovely in-house attempts at software that requires you to be in the office to access. In other news this is making the rounds: 
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Mar 28, 2023 19:37
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The phishing emails you really gotta watch out for are emails like “donuts in the breakroom” or “come see the cute puppies!” It’s cruel to lie about such things, but bad actors will go to any length to take Good Companies down.
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Mar 28, 2023 19:46
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Speaking of cruel lies I've wanted for YEARS to do the thing where you mix M&Ms, Skittles, and Reeses in a bowl and leave it in the break room but April 1st lands on a loving Saturday this year. No fair.
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Mar 28, 2023 19:54
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priznat posted:They are always nice things like “employee recognition award” or “choose your new laptop” which is really quite the tease My first week as an FTE they got me with an "HR has gift cards for you" test nine days before Christmas. I don't feel tooooo bad about that.
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Mar 28, 2023 20:02
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Renegret posted:Speaking of cruel lies You have a break room??
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Mar 28, 2023 20:09
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Quackles posted:You have a break room?? Coffee machine has to go somewhere.
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Mar 28, 2023 20:13
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Eric the Mauve posted:Do you have the kind of evil IT that sends out fake phishes with upcoming_layoffs.xlsx attached? The last one I got had literally THIS IS A PHISHING EMAIL in the text, so I think someone in our IT dept was feeling a bit of despair that day.
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Mar 28, 2023 20:15
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ThePopeOfFun posted:The phishing emails you really gotta watch out for are emails like “donuts in the breakroom” or “come see the cute puppies!” "The guy who delivers the coffee for the whole building has jury duty this week. We've arranged for a backup delivery service, but there will be some delays in getting it out to the whole site. Please check the link for the expected delivery schedule".
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Mar 28, 2023 20:37
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Surprised we haven’t seen a surge of “due to issues with our payroll processing bank we require everyone to log in to this company portal and verify their bank account details”.
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Mar 28, 2023 20:50
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"Would you take a paycut in exchange for a bit more equity? It's a win-win!" Time to head for the exit
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Mar 29, 2023 00:04
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Omne posted:"Would you take a paycut in exchange for a bit more equity? It's a win-win!" Like the loving Road Runner. BEEP BEEP and -phew-, nothing left but a cloud of dust shaped like a question mark.
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Mar 29, 2023 00:09
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