Shortcomings of Compliance Focus Quality Management System (QMS)

[Chance]

ASQ QP August 2011 edition (by Karim Lokas) talks about QMS to concentrate on the product instead of compliance.
"QMS began 20 years ago and since then it has widely deployed all over the world. Yet the number of adverse events – quality failures has increased significantly since 2000 (FDA reports).
This is because traditional compliance-focused QMS was designed to support in achieving regulatory compliance. They were not built to support an enterprise quality process focused on the continuous improvement of products." Any comments on this?

[Jennifer Kirley]

Those of us who focus on compliance versus performance are getting our industry hineys kicked by those who focus on performance.

What's difficult is understanding and appreciating perfomance as an organization, and why the added effort to go just that inch or so farther than the minimum is worthwhile to us both personally and as a group.

[Chance]

In Reply to Parent Post by Jennifer Kirley

Those of us who focus on compliance versus performance are getting our industry hineys kicked by those who focus on performance.

What's difficult is understanding and appreciating perfomance as an organization, and why the added effort to go just that inch or so farther than the minimum is worthwhile to us both personally and as a group.

Jen,

That means we should continue to focus on compliance?

[Jennifer Kirley]

In Reply to Parent Post by Chance

Jen,

That means we should continue to focus on compliance?

Not in my view - in my view, compliance is a single result of an effective system. The other result is a happy customer base.

And therein is the rub. The customer base may be wishing for the same things as regulations ask for, including not damaging the environment and not violating labor laws. But as a rule customer wishes are more plainly directed at delivery of a product/service that fulfills their expectations, whatever they are: fit/form/function, availability when/where desired, etc. Most regulations don't cover this.

Nor do regulations cover cost as a rule, but customers who aren't focused on features and fitness for use do look at cost. Industry has done all sorts of things to cut costs, but very often there is an eventual backlash that doesn't get recognized, such as the effects of what is termed Corporate Anorexia.

In short, it's possible to stay compliant with regulations but still fail competitively.