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Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

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Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#41

Post by epistasis »

markdown wrote: post #27
endisneigh wrote: post #4

Earlier quoted context omitted.

> Context: Workers at the plant, which had been producing Johnson & Johnson and AstraZeneca vaccines, conflated the ingredients between the two different types of vaccines, destroying 15 million doses of Johnson & Johnson vaccine, according to the Times.

Jesus Christ, this shouldn't happen in a certified cGMP (food) facility let alone a pharmaceutical plant. HACCP would prevent this in any number of ways.

Errors like this happen in every single GMP and clinical facility.

What makes them different is 1) there are ample checks in place to prevent mistakes from ever leaving the facility, and 2) there is process that reduces the chances of having it happen in the first place.

But all of these places will have incident logs of mistakes like this, along with corrective actions that change the procedures and make it less likely to happen a second time.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#42

Post by epistasis »

sebmellen wrote: post #29
hetspookjee wrote: post #26

It's funny to read it as J&J vaccine, while here in the Netherlands where the institute we all call it Janssen because that is the name of the institute. Im also in favor if the title reflected Janssen as well but I guess it's what it is as the article and the rest of America also calls it J&J vaccine. It's just a bit weird that it now gets the American name while they're just the parent company and didn't were invol…

Same deal with the Pfizer vaccine, really. My family in Germany lives near where BioNTech is located, and everyone is very proud to call it the BioNTech vaccine.

I'm not in Germany, but I also get very frustrated when the Pfizer name is applied to what BioNTech created. BioNTech is going to be doing amazing things later on too, with their great tech platform.

I have a feeling that news sources are very guarded about introducing new names to the public, especially ones as difficult to pronounce as BioNTech (I've heard some great butchering of the pronunciation too).

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#43

Post by mulmen »

Guthur wrote: post #39
anitil wrote: post #15

It bothers me that people have expectations of perfection. Of course there will be breaks in the chain the lead to doses being wasted. There are thousands or millions of ways for it to go wrong, and only a few ways for it to go right. It is an astounding miracle of human progress that we can get to this point.

This is a failure of leadership to ensure that a quality product is being delivered by the system they're responsible for. I'd usually be pretty forgiving especially when there is a high degree of novelty. Maybe this particular vaccine is novel and that benefit of the doubt should be extended in this case, I'm not sure though. It's also possible this is common variation but we never hear about it.

Scenario:

An engineer who you pay $200,000.00/yr in salary pushes code to prod which brings your totally unique SaaS product down. Accounting says the incident cost $2,000,000.00.

Do you:

A) Fire the engineer on the spot.

B) Conduct a thorough investigation of your testing and deployment practices and implement changes to avoid such a mistake in the future.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#44

Post by markdown »

eric-hu wrote: post #35
markdown wrote: post #27

Earlier quoted context omitted.

Jesus Christ, this shouldn't happen in a certified cGMP (food) facility let alone a pharmaceutical plant. HACCP would prevent this in any number of ways.

Can you describe in more detail how that process would prevent such an error?

Hard to do without knowing anything about this facility, but maybe just not store the ingredients for two different vaccines in the same place. Basically restrict the set of ingredients available to the person making the batch.

Or have the employee log what he is doing in real time BEFORE he does it. I am adding sugar, I am adding eggs, I am adding wheat flour. Then an alert is triggered when the system (which knows what product is being made) recognises that the ingredient doesn't belong.

This is a multi-billion dollar company... they could have the process live-streamed to 30 independent chemists each one watching the "chef's" every move (this is not a serious proposal).

This stuff is all hashed out when one writes up a HACCP process.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#45

Post by [deleted] »

sp332 wrote: post #40
finolex1 wrote: post #20

Earlier quoted context omitted.

"The error should not affect Johnson & Johnson doses currently being delivered and administered nationwide, as they were produced in the Netherlands. ... The Times says the accident won't stop the U.S. from reaching President Biden's goal of having enough vaccine by the end of May for every adult, but in the global race against the virus, every dose counts." Won't affect vaccine delivery for Americans. Difficult to s…

It's good that it won't hurt the current schedule, but we could have had 15 million doses sooner.

[deleted]

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#46

Post by Guthur »

mulmen wrote: post #43
Guthur wrote: post #39

Earlier quoted context omitted.

This is a failure of leadership to ensure that a quality product is being delivered by the system they're responsible for. I'd usually be pretty forgiving especially when there is a high degree of novelty. Maybe this particular vaccine is novel and that benefit of the doubt should be extended in this case, I'm not sure though. It's also possible this is common variation but we never hear about it.

Scenario: An engineer who you pay $200,000.00/yr in salary pushes code to prod which brings your totally unique SaaS product down. Accounting says the incident cost $2,000,000.00. Do you: A) Fire the engineer on the spot. B) Conduct a thorough investigation of your testing and deployment practices and implement changes to avoid such a mistake in the future.

Missing a lot of information to actually answer that question.

Was the engineer wilfully negligent of checks and balances put in place. Was he wilfully negligent because of undue pressure to deliver more in the same time and without any system changes. Did his mother recently die and he couldn't take time off to grieve properly.

There are many aspects that make up the analysis of a failure in quality, and that is the job of leadership.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#47

Post by fermienrico »

mulmen wrote: post #43
Guthur wrote: post #39

Earlier quoted context omitted.

This is a failure of leadership to ensure that a quality product is being delivered by the system they're responsible for. I'd usually be pretty forgiving especially when there is a high degree of novelty. Maybe this particular vaccine is novel and that benefit of the doubt should be extended in this case, I'm not sure though. It's also possible this is common variation but we never hear about it.

Scenario: An engineer who you pay $200,000.00/yr in salary pushes code to prod which brings your totally unique SaaS product down. Accounting says the incident cost $2,000,000.00. Do you: A) Fire the engineer on the spot. B) Conduct a thorough investigation of your testing and deployment practices and implement changes to avoid such a mistake in the future.

Obviously, option A. Improves the morale instantly.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#48

Post by mulmen »

Guthur wrote: post #46
mulmen wrote: post #43

Earlier quoted context omitted.

Scenario: An engineer who you pay $200,000.00/yr in salary pushes code to prod which brings your totally unique SaaS product down. Accounting says the incident cost $2,000,000.00. Do you: A) Fire the engineer on the spot. B) Conduct a thorough investigation of your testing and deployment practices and implement changes to avoid such a mistake in the future.

Missing a lot of information to actually answer that question. Was the engineer wilfully negligent of checks and balances put in place. Was he wilfully negligent because of undue pressure to deliver more in the same time and without any system changes. Did his mother recently die and he couldn't take time off to grieve properly. There are many aspects that make up the analysis of a failure in quality, and that is the…

Ok let me expand the choices then.

C) Fire the engineer's manager.

D) Resign.

Re: Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines

#50

Post by fermienrico »

epistasis wrote: post #42
sebmellen wrote: post #29

Earlier quoted context omitted.

Same deal with the Pfizer vaccine, really. My family in Germany lives near where BioNTech is located, and everyone is very proud to call it the BioNTech vaccine.

I'm not in Germany, but I also get very frustrated when the Pfizer name is applied to what BioNTech created. BioNTech is going to be doing amazing things later on too, with their great tech platform. I have a feeling that news sources are very guarded about introducing new names to the public, especially ones as difficult to pronounce as BioNTech (I've heard some great butchering of the pronunciation too).

May be its just easier to pronounce Pfizer than BioNTech?

Not everything needs to be distilled down to nationalistic undertones.

I am getting sick of this kind of discussion permeating on HN - It is extremely juvenile and damaging to the spirit of HN. In this regard, Reddit seems to be a lot better. Go on any vaccine related thread and there is absolutely none of this. There is so much more global cooperation observed on Reddit than on HN.

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