American manufacturing screws the pooch

[RobDownSouth]

Johnson and Johnson makes and distributes the 'one shot Corona vaccine'.

The first one million doses distributed in America were actually manufactured and imported from the Netherlands.

Johnson and Johnson planned on transitioning to a state of the art manufacturing facility in Maryland last month, once federal permission was obtained.

They ran their first two production runs late last week...15 million doses...and the New York Times reported yesterday that quality control found out that the line workers had not formulated the dosage correctly.

Result: 15 million doses...enough to treat 3% of America...had to be destroyed.

 

[Dribble]

Of course Quality Control blames the line workers. They sit on their asses instead of doing their job. I have seen it hundreds of times.

 

[CornusKousa]

Of course Quality Control blames the line workers. They sit on their asses instead of doing their job.

Pointing out the line workers fuck ups, before anyone gets hosed/hurt IS their job.

I have seen it hundreds of times.

GOOD!!! QC practices aren't perfect but they are beneficial.

 

[Dribble]

You have never worked...how would a traitor know anything about this? Let me inform the ignorant. Line production is given the start-up settings by Quality Control. It is a piece of paper with all settings and the variations line production is allowed to tweak and when they are allowed to tweak them. When a new product is started, Quality Control's job is to make sure those settings are made. It is also their job to pull samples within the first hour, to test...making sure everything is working. Here...you have a new facility...new staff...new product...you are going to rely on line production...that has never done it? Or the people being paid 3-4x the line production WHOSE JOB IS TO MAKE SURE THE PRODUCT IS WITHIN SPEC?

 

[CornusKousa]

You have never worked.

You're a liar and don't know what you're talking about.

Or the people being paid 3-4x the line production WHOSE JOB IS TO MAKE SURE THE PRODUCT IS WITHIN SPEC?

Which is exactly what they did. The inequity of pay is totally irrelevant comrade, cry on your hammer and sickle elsewhere.

Something went wrong, they caught it and determined that one of the new people operating all new systems/formulas/processes, fucked up. Hardly unexpected or unusual for ANY new operation.

It's a new operation dealing with a fuck up....QC caught the fuck up before anything catastrophic or faulty caused any real harm protecting both the consumers AND the company.

Sounds like QC was doing a very important part of their job, if they get the problem fixed, I'm not seeing how that's anything other than them doing exactly what it is they are there to do.

 

[Dribble]

A vaccine consists of many component parts. Some are active ingredients...some are inactive ingredients. Most of these are made by other companies to a standard dictated by the vaccine producer. Everyone on board still?

One of these outside manufacturers produced a batch of an inactive ingredient that was cross-contaminated (i have not found out what it was cross-contaminated with...it could have just been a different concentration of the same product). Now comes the fun part.

Whose job is it for the outside manufacturer to test their batches before they are shipped? Their line manufacturers? Or their Quality Control? I can guarantee...there is a signature associated with that batch.

Now, whose job is it on J&J's end to assure received products meet expected standards? Again...they are tested...and there is a signature associated with this.

Finally, why would an entire batch be produced BEFORE this cross-contamination be discovered?

Here is what I know...no J&J line production employee has dropped the ball. They did their job. Where was the failure? Human error in another company. Human error that should have been discovered by that company's Q&A and by J&Js QA in receiving.

 

[adrina]

I am thankful the error was caught. It would have been worse if it had not.

 

[phrodeau]

Operation Warp Speed - eliminating red tape and improving America’s quality of life.

 

[oggbashan]

Operation Warp Speed - eliminating red tape and improving America’s quality of life.

In the 1950s, the USA continued its wartime policy of deregulating industry and letting manufacturers decide for themselves, within some minor limits.

Unlike Nazi Germany which had a very regulated and bureaucratic control on everything, US manufacturers during the war had been producing masses of equipment quickly.

But the UK didn't learn. they kept the restrictions and controls they had had during the war - mainly due to a shortage of materials. Even though the UK had far outperformed German factories, the UK government kept a tight control after the war.

The UK result was stagnation until the late 1950s.

 

[Dribble]

I am thankful the error was caught. It would have been worse if it had not.

Exactly. They caught it. So they loss one batch. Not a biggie in the scheme of things. I have worked with Q&A way too much. They are not hourly...but salary...and therfore do not do what they should all the time...and when they get caught...oh it was production.

 

[KeithD]

I am thankful the error was caught. It would have been worse if it had not.

Not only was caught, but was publicly acknowledged and is being cleaned up. Accidents happen. Overall this rollout is a miracle--one that wouldn't happen, taking what did happen over the past four years into account, if a new, competent and caring administration hadn't taken over.

 

[RobDownSouth]

Not only was caught, but was publicly acknowledged and is being cleaned up. Accidents happen. Overall this rollout is a miracle--one that wouldn't happen, taking what did happen over the past four years into account, if a new, competent and caring administration hadn't taken over.

It goes without saying that if this mistake had occurred during a second Trump administration, the mistake would have been classified under "National Security" law and the vaccine shipped with a wink and a nudge.

 

[adrina]

Not only was caught, but was publicly acknowledged and is being cleaned up. Accidents happen. Overall this rollout is a miracle--one that wouldn't happen, taking what did happen over the past four years into account, if a new, competent and caring administration hadn't taken over.

It goes without saying that if this mistake had occurred during a second Trump administration, the mistake would have been classified under "National Security" law and the vaccine shipped with a wink and a nudge.

Sadly the reality of the last administration is that if Covid was WW2, we'd all be speaking German.

 

[TJX]

Never miss a chance to make something political that isn’t political to start with. The issue is 15 million ruined doses of vaccine you political hacks.

 

[Bud_Spencer]

A vaccine consists of many component parts. Some are active ingredients...some are inactive ingredients. Most of these are made by other companies to a standard dictated by the vaccine producer. Everyone on board still?

One of these outside manufacturers produced a batch of an inactive ingredient that was cross-contaminated (i have not found out what it was cross-contaminated with...it could have just been a different concentration of the same product). Now comes the fun part.

Whose job is it for the outside manufacturer to test their batches before they are shipped? Their line manufacturers? Or their Quality Control? I can guarantee...there is a signature associated with that batch.

Now, whose job is it on J&J's end to assure received products meet expected standards? Again...they are tested...and there is a signature associated with this.

Finally, why would an entire batch be produced BEFORE this cross-contamination be discovered?

Here is what I know...no J&J line production employee has dropped the ball. They did their job. Where was the failure? Human error in another company. Human error that should have been discovered by that company's Q&A and by J&Js QA in receiving.

FDA regulations say that if a validated production process has to be followed or the batch is put to drain. Period. Even if it tests fine, because the procedure to make it wasn't within estabished limits, it cannot be trusted. That goes doubly for injectables.

You're right, someone screwed the pooch by letting an off-spec batch of precursor get near a reactor of final product.

 

[Dribble]

Never miss a chance to make something political that isn’t political to start with. The issue is 15 million ruined doses of vaccine you political hacks.

They aren't ruined...give them to Republicans. They are better than what they think works

 

[RobDownSouth]

Details emerging about the plant where the vaccine botch occurred. Seems they had pretty poor plant managers who didn't think much training was needed for line workers. Line workers are just replaceable cogs, don'tcha know. And safety? What's that?

 

[Wrong Element]

Of course Quality Control blames the line workers. They sit on their asses instead of doing their job. I have seen it hundreds of times.

Isn't the whole idea of "quality control" to prevent this sort of thing prior to 15 MILLION doses being ruined?

Heads should roll, but I doubt that will happen.

 

[KeithD]

Isn't the whole idea of "quality control" to prevent this sort of thing prior to 15 MILLION doses being ruined?

Heads should roll, but I doubt that will happen.

Umm, no. Sometimes it's to catch a big screwup before it gets bigger--and, in this case, before it gets sent out to be dispensed. God, the whole process is very complex. Accidents can happen--even big ones.

 

[Dribble]

It was caught....that is what matters.

Line production are trained by other line production members...usually because they want out of the position. How can you train something that isn't done frequently? It should have been caught earlier.

When product changes happen, it is the Quality guys job to assure the changeover was done correctly. Like I said...the production line is given an order. All the production line does is enter the numbers they are given. It isn't rocket science.