GMP / ISO / FDA / CE: Are Your Products Better Now?

I don't think these controls work as intended, but rather give the opportunity for retribution....Somebody dedicated to quality will do so in any case...those that would cut corners, will always find a way....

In my opinion, these "Q" people care more about the documents accompanying the product than about the product itself, and that is a step backwards...

My experience would indicate that they don't understand the product enough and so concentrate on what they do know, which is the paperwork.

Right. I agree with you, but what is more important: the performance of the product or the paperwork? I still have some electric tools purchased by my grandfather in the late 50´s that probably certainly do not comply with any contemporary norm, but they work as good as the first day. Today you buy a good quality cordless drill, and the battery (or any other vital component) will probably be dead one day after expiration of the warranty!

The product generally.

"Somebody dedicated to quality will do so in any case......those that would cut corners, will always find a way....." That sums it up. The attorneys and regulators always go after those with little or no documentation, while the Madoff's of the world run rampant for years.

its business evolving in a lawsuit happy world

You have it nailed.

A quality assurance system does not guarantee a higher quality product. In many ways it may even hamper any product quality improvements.

From Wiki: GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.

A saying we had back in the '70s was "you can't inspect quality into a part". (Substitute drug, etc.)

"First, let's kill all the lawyers". Shakespeare.

Which is first: the henn or the egg? my feeling is that they care so much about the paperwork that they forget the product!

In many instances, the equipment is not a product without the supporting documentation. Would one purchase a new and unfamiliar road vehicle, for example, that did not have an Operating Manual and manufacturer's Warranty as part of the package (rhetorical question - NNTR)?

Why it is that most of the comments do know the definition of quality? As I can remember quality is meeting or exceeding specification. The goodness of the design is another story. Who can keep people working by selling equipment that will last 50 years?

I work for a company that produces under various norms as ISO13485, etc. Once or twice a year we have an audit from a Notified Body during which the auditors sit on a desk for a week reading piles of documents between lines and caring about nonsense. The last day, they take a 5 minutes walk trough the plant ... and that´s it! Nobody spent a second looking at the product itself!

Bridge builders...

A quality system is simply to monitor the quality. The improvement has to come from management. Not all management wants GOOD quality.

Many standards, such as ISO, simply refer to other interior documents such as QA SOP. If Ford Motor Co. wrote an internal SOP for building a vehicle with only 3 tires instead of four, ISO would be perfectly legitimate because of the SOP, but it does not mean the car is drive-able. The double-talk and legalese of these documenting principles is more about CYOA than they are about QA.

I come from the quality control side of a medical device / BioProcess industry and find that the quality systems we have inplace (ISO 9001 / GMP / Eudralex Annex 1 etc) are just a frame work to make sure that what we are doing is what is meant to be done and that it is done in the same way everytime.

If the quality of the thing being manufactured is not factored in from the start then the Quality systems you implement will not improve the quality but will just ensure that the thing is made the same way it always has been.

Quality of a product must always be a concern from management down to shop floor workers not just the department that controls the documentation.