W. Edwards Deming said
"Quality begins with the intent, which is fixed by management" and
"Quality is everyone's responsibility." Every Quality Manager who takes an entry level "Quality 101" class learns about Deming's philosophies as one of the "Grandfathers of Quality".
Joseph Juran said
"..every successful quality revolution has included the participation of upper management. We know of no exceptions." His handbooks are well-known and utilized widely by quality practitioners still to this day. .
Phillip Crosby said "Quality is Free".... meaning (loosely translated) that it will cost your company money if you have to perform rework or provide replacements for quality-related problems. General Motors, Chrysler, Motorola, Xerox and many hospitals benefitted from his concept of "Zero Defects."
Deming, Juran, Crosby, and some of the other early/mid 20th Century gurus didn't have ISO standards, consensus standards, or ERP systems back then to help with their processes. However they generally said the same sort of logical, business savvy things that the current 21st Century quality standards do when you examine them closely.
It has often been said that a "quality system" is a bit of a misnomer - - actually, a good "quality system" is a well orchestrated set of business practices, policies, and principles. Delivering them consistently in an FDA regulated environment gets you to the satisfying point of operating "in compliance". Operating in compliance keeps you in good graces with regulators, and should allow you to deliver product with a low cost of quality.
In our opinion, quality and compliance go hand in hand, and are essentially flip sides of the same coin. In many larger companies, "Quality" and "Compliance are often treated as "Business Departments", or perhaps "operating disciplines". It might take work to fulfill both paradigms simultaneously, but it is possible.
Compliance with FDA and global regulatory requirements require an instilled quality worldview, some well planned business systems, and the continuous ability to fulfill your clients' needs consistently and fully. It's really just that simple. If we were to put on a quality guru hat to further clarify the general tenets of quality for business in the 21st century, it would read something like this:
- Think about what you're doing.
- Plan it all out.
- Write it all down.
- Deliver what you plan.
- Take action when bad things happen. Sometimes, life doesn't go according to the best plans.
- Behave like the Hippocratic oath says and "do no harm." If there might be a "harm" - react immediately. Risk Management techniques help with the planning of and reaction to problems so that "do no harm" is a built-in mechanism.
- Listen when somebody has an issue, then go fix it.
- Be humble and be persistent. Your first try might be a little off the mark. Heinz 57 didn't work on the first 56 tries.
- Know your data. Measure whatever you can in your processes. This works for design, sales, marketing, Management Review, production, operations, and R&D.
- Document, Document, Document. Remember timeliness and presentation matter.
- Listen some more. Collect feedback. Check out your competition.
- Reflect. Revise. Reinvent if necessary.
- Treat your customers and suppliers like they want to be treated - and always be nice. Your workforce, your customers, your supply chain, and your regulators deserve it.
- An error in making "the right choice" can be a great downfall and cause repercussions that hurt you or your end user. Weigh the alternatives when you are faced with a tough call, and choose wisely.
If you miss the mark on any of those objectives, in all likelihood, you may miss your target on quality and operations goals. If you miss on a few, including timeliness and documentation lapses, there might be an FDA 483 or a list of ISO nonconformance observations issued at your next inspection.
The general concepts here are what good Quality process is built on, and could be used as a framework for executing a Quality Management System (QMS). How well does your QMS fit that framework? Is it time to revisit your quality goals for 2015?
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