Probing the Limits: Quality Management and Regulatory Compliance
May 14, 2007
quality professionals taking the easy way out by making themselves regulatory
compliance managers? This may be why the quality department is seen as an
overhead expense rather than a key part of a company’s success.
During the last decade, as quality departments have adopted ISO 9000 and
similar standards, they have become known for managing regulatory compliance.
As other regulatory standards have come along, such as ISO 14000 and RoHS,
often the compliance management for these new standards is given to the quality
department because of its existing expertise with managing standards.
As more of these standards become mandatory, many quality departments have
become burdened with the implementation and maintenance of them. I’ve seen
several quality departments evolve from being focused on getting customers
high-quality products to maintaining compliance to an ever-growing set of
Meeting the requirements of a standard and managing quality are not the same.
While I’m no fan of ISO 9000, I think that even the strongest proponents of ISO
9000 agree that without a culture and focus on high-quality processes and
products, an ISO 9000-registered company may produce some very bad products.
Every quality professional has seen this take place.
One simple way I define quality is “a quality product is a product that you
would feel good about shipping to a close friend.” I think we have all seen
products that didn’t meet this definition, yet passed all the audits that were
required by the many standards in place.
A major issue with this is that quality professionals have let this happen to
the detriment of the profession and the competitiveness of their
organ-izations. Many-but not all-quality professionals supported this migration
away from a Deming style of quality to a standards style of quality.
What do I mean by a Deming style of quality? A Deming quality manager will
stand up in a staff meeting and say, “I know this product meets all of our
testing and is compliant with the requirements of our quality system, but I
don’t think it should ship because the guys on the floor don’t feel good about
some things they are seeing.” A standards-centric quality manager would let it
ship because it meets ISO requirements. On many occasions, I’ve found myself at
a supplier’s shop rolling my eyes at the quality manager’s explanation that our
quality problems with their parts are not a problem because they meet all ISO
I think the second problem with quality departments evolving to become
regulatory compliance departments is that many are voluntarily doing so to make
their job easier. Meeting the requirements of a standard is defined in black
and white, and thus, relatively easy. Quality is hard to define, and you are
fooling yourself if you think black and white requirements can be used to
manage quality. In addition, running a business is not a black and white
undertaking. Business managers don’t operate in a black and white world; they
must make quick decisions with imperfect data and often must make trade-offs
between quality and speed to market.
If quality professionals want to be recognized as contributors to the success
of the company, they must go beyond managing standards and work toward
contributing to the improvement of actual complex product quality issues.
Meeting regulatory requirements and standards is part of doing business these
days, but I hope quality professionals see meeting standards as just a
simplistic foundation of their responsibilities and not the full definition.
Quality professionals have skills that go beyond meeting regulatory
requirements. They should be the ones pushing for quality improvement,
identifying weaknesses in quality and organizing efforts to improve them,
teaching the organization quality improvement techniques, and fighting to
ensure that everyone feels good about what is going out the door.
Quality professionals who understand that managing quality is much more complex
and difficult than passing audits will be the ones most valued by their