Why is Quality Control Important? Ask Johnson & Johnson

Yeah there are plenty of people who think having a Quality Manual and Operating procedures is enough, without actually working to them.
Del
_{(The rest of the people don't even know the manual and procedures exist)}

Anyone who's ever been involved in an ISO 9000 or later certification process probably feels like the cat. Endless paperwork that ultimately bores you to tears and doesn't really seem to change the way you were doing things in the first place. What was that thread I read the other day about the .03% failure rate? I think I believe in individual pride in workmanship. I'm the best judge of the quality of my work.

*** rant warning*** read on at your peril. Impending brevquot violation.

Indeed.
The conclusion being that the proces is not fit for purpose and lacks clarity and understanding?
I find auditing from BSI pretty much a waste of time.
Last year they were trying to sell us information about quality standards in our sector gleaned from their audits... D'uh, what about client confidentiality? I told 'em I thought it was a cynical money grabbing ploy of dubious legality.
I had one auditor once tell me that my hand written signature on a document wasn't as valid as a printed name.
Another classic is I argued about the distinction between verification and validation and in the end the people at BSI couldn't agree.
Basically they have taken a simple concept and padded it out with waffle so they can sell it and then audit it until the cows come home.

It's about the people at all levels wanting to do a good job.
Don't get me wrong, I'm not anti quality systems.
I'm just against making them so complicated that no one refers to them.
I'm also against inventing barking mad 'key performance indicators' which no one will ever look at just to keep some fatuous auditor employed.

From my experience 99% of the time the people at the top just pay lip service to quality systems and will throw them out the window as soon as they want that rush job out the door. Maybe it's because 99% of the people at the top aren't engineers?

If I was in charge I'd sharpen up the quality system and stop paying BSI.
But I'm not in charge so I've gone down to a 2 day week and I'll be at home making my bows, where the paper work is done with sand paper
Del

By the way Del, isn't it about time for another bow riddle?

Maybe if you are all really good I'll post some stuff in the new year, mean while here's a pic of me riding my horse.

Clippety clop... neigh.
It's really great for using a draw knife or spokeshave on my bows. The foot operated clamp works a treat, good old fashioned lo-tech solution. I drew it up on the CAD at work before starting the build but modified it as I went along. The legs just slot in.
Here's a close up of the foot lever thingy during the development phase

The top steel clamp bar has a wooden block which slides over it to act as a soft jaw.
If you want a silly riddle... What's brown, hairy and swims underwater?

Del
(do you think anyone will notice I've gone off piste)

Love the horse! ga

good pics, those planks on your jig look to be pretty good sized (thickness).....were they custom cut?

That's a quarter of a Yew log that me & my big Sis cut waaaay back last February on a glorious sunny frosty day, followed by a pub lunch.
I sawed it on my bandsaw.

For anyone who wants to follow my bow making exploits live just google 'Bowyers Diary' I show my work warts and all, I've had a good year, learned plenty and sold a few which has covered the cost of my hoby.
Del

good for you. And to be able to cover you costs double good. I'll check it out. Thanks

You are right on so many levels, especially the complacency.
We have a small steel component pressed out of sheet, it's been no problem for about 5years... then one day problems occur in the field and we find that the component is all skewed and no one had noticed (small company, no goods in inspection, new employee doing the job who doesn't actually understand the function and working of the part...)
The day you think your quality is fine is the days the phones will start ringing red hot with field problems.
Much to my chagrin, I've even had a bow suddenly bend in an unballanced manner after several weeks of use, fortunately I hadn't delivered it and I re-worked
it, pride comes before a fall.
Del

I do think that quality management is an important thing voor a company to use in its communication. Is its more of marketing benifits but it also helps to work more efficient. I recently made some text about iso 9001 and its benefits. It seems you have a lot of expertise. Could you take a look at the iso 9001 information on my site to judge wheter it really got this right. I would really appriciate it, when you would also judge my iso 27001 webpage. Probably you will have some feedback....i love to hear it.....thanks a lot.

your quality control proceedures can be appended at anytime. And it's not the quality control proceedures that can create paper work. What creates paper is not following the quality control proceedures. Case in point....Johnson and Johnson.

sorry... you are WAY off tack on this reply.. and after Christmas I will explain.

great....in the mean time happy holidays to you.

Hi and I hope you had a great Xmas.

In reply to your post.. and having read it again, first I must state that you are NOT "way off tack".. just a little bit, and I will explain as promised.

first I am a ISO9000 IRCA Lead Auditor, been doing it for quite a few years now, so to continue...

Yes QC documents are "live" and should be reviewed using a regular time table and amended if and when they do not fit or are "not fit for purpose". That then requires the following;

Someone, maybe an internal (company) auditor (not to be confused with what I do) who is trained only to work with/on company procedures etc to audit the policies and procedures.. They would raise a NCR (Non Conforming Report) or it could be raised by those people using the procedure in question. In that NCR they would state why the procedure is not working or not fit for purpose. That report should then be passed to the QC manager who in turn will add it to the agenda for the Monthly Management Meeting(MMR), who review NCR's and other issues on a monthly basis and decide on what action to take.

Action taken could be either... do nothing (highly unlikely) it is more likely to be work out amendments and then implement them, and the QC manager will issue new procedures recalling the old one(s), and updating the records to log the changes, plus ensure that those staff using the NEW procedure(s) are aware and trained. Then and only then would the NCR be considered closed, and this would be part of the Quality Management System (QMS) records

However if the NCR is of importance and deemed to be to be a "Major Issue" the QCM can make immediate changes without the consent of the and at the MMR advice the meeting and record the changes after the event.

So my point is that even if you follow the QC procedures they will generate the same amount of paperwork as if you don't.

What happens if QC is not followed??

First, people are not trained for their job and therefore they have no idea what they should be doing, then the NCR's are not written be it by the end user (shop floor worker) or the internal auditor, then not followed up and not closed. The question is why were they not being followed in the first place?

Again it goes back to... No training given to the shop floor in QC policies and procedures and no real procedures that were considered "live" by management.. so no NCR's, no checks on incoming materials for QC, that is, up to spec. This area alone, "Goods received" ALWAYS generates more NCR's, only because materials from suppliers fall short of specification. So as no-one was trained, management did not implement the QC policies and in general didn't care.. then yes it would not generate paperwork, because no-one knew they could inform someone about the problems, thats if they were aware in the first place. And I've not even covered the QC data check sheets that should follow the product though its production.

So in a nutshell, and this is the short version of what I'd originally written, Quality Control procedures, irrespective if the company ISO certified or not, should be audited frequently, their procedures and QC documents and records of the audits kept. NCR's should be passed to a MMR and dealt with and closed out. Policies and procedures should be updated and staff should be trained at regular intervals, and the paperwork/records updated every time something is changed, amended or someone trained.

So following a QC policy does generate paperwork, not following it will also do the same. But by not having the ability to monitor your production would be like trying to work with the lights off.... if you see nothing wrong, then you can't report it or fix it

The whole purpose of a QMS is to bring order to chaos.

J&J had neither intelligence or ability to implement any of it.....

Johnson and Johnson are also facing lawsuits over their hip implants, which are reported to have a 13% failure rate.

But there seems to be a bigger underlying "quality" issue here - a lack of interest in the quality of treatment for the patients, in favor of making sales at any cost. As a result, this company is in trouble with the law,

for falsely advertising a product as safer than other products,

for promoting off-label uses for a product,

and for paying kickbacks to increase prescription of antipsychotic products to elderly patients in nursing homes - patients who have little or no control of the medication they will be forced to take. And the drugs increased mortality for these patients.

So it looks like the sound business ethic of building reputation on quality and customer satisfaction has been entirely lost.

J & J appears to have fallen into a trap so many have. Quality Assurance systems are not continuously functional upon installation. Auditing helps, but ultimately management at all levels from the top down bears the full responsibility for the quality culture and continuous improvement.

Everyone has a process to manage. Focusing on satisfying your immediate and ultimate customers (maybe even exceeding their expectations) should drive the ongoing change to not just maintain but improve your quality performance. Everyone really wants to take pride in their daily work. Management sets the priorities......"survival is not mandatory"!

This goes beyond quality control. When I looked into why Tylenol was suddenly removed from the shelves, I came across the "mouldy smell from the pallets" explanation, which seemed pretty weak. I would like to hear from a chemist about this detail.

Call me paranoid, but I get the feeling there is much more to this than what we are being told. I only hope that the "quality issues" do not involve some negative effects from past use.