From Six Sigma to Quality by Design: Advancing Product Quality

Quality by Design

Quality by Design (QbD) is a simple concept. It posits that quality cannot be inspected
into products, but rather is created by processes. Witness the near-constant
retooling and reinvention of manufacturing processes in the automotive,
semiconductor manufacturing and electronics industries who started with Six
Sigma now extending to and fully embraced QbD. The evolution to QbD is a
logical next step since QbD is built on top of Six Sigma and extends into the
design space.

Continual improvement drives Quality

The attitude towards defects should be one of avoidance, prevention and resolution. The aim should be to do things right the first time anyplace, anywhere and
anytime in the product quality lifecycle implementation. When this is applied
throughout the process, the defects will be reduced dramatically and improve the
output of any process. The cost to resolve errors is referred to as the ‘Cost
of Quality’, the further downstream defects or design errors are detected the
more costly they will become to solve. In all cases, defects should be
corrected during design or manufacturing, they should never reach the customer
with the risk of product recalls or damage/harm to the customer. Cost to
correct errors grows exponentially when they are detected later in the process;
it clearly puts the focus on the design. With this in mind, well planned products
with Quality involvement in design as well as in production, will cost less to
manufacture and to maintain. In addition, it will also cost the customer less to own or buy them and will improve satisfaction for the product or service.

Six Sigma principles and the tools are drivers to define and quantify quality
enhancements. The goal is to drive down defects, enhance customer satisfaction
and contribute to the financial results. Key to Six Sigma is a quantitative approach to support the results of the achievements; a variety of statistical tools are used. This process is completely data driven. Computerized systems supporting the storage and analysis of the measurements are critical, both for speed and compliance. A production facility running at a Six Sigma level is close to perfection, meaning that only 3.4 defects per million opportunities or units will be recorded.

Many processes may not reach this level of variation despite the efforts; three or
four level sigma may be the best that can be reached. When you hit this sigma
wall, no process improvements can be further made and the law of diminishing
returns takes over. In these cases there could be a fundamental problem in the
design of the product or service preventing further improvements. Redesign of
the product may be the only possibility to improve the quality level further.

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Cloud Reality: Big Enough – and Small Enough – For All!

In my quest to learn everything I can, I search for and read a lot of material. It’s taken me some time to switch from printed media to electronic formats. There is just something about getting to feel the weight of the book in my hand and the page on my fingertips. Though I’m still drawn to printed material, I have learned to read and manage electronic content. With electronic content I had to devise new ways to organize my books, mark pages and search the content since the techniques I used on paper (physical location to organize, dog earing pages to mark important sections and using pens to take notes and mark important text on the pages) just don’t work well on an LCD. It’s taken me a while and I’m now not only comfortable with the new electronic content, I actually prefer it.

Like my foray into using electronic media, many customers are experiencing a similar situation with Cloud Computing. Customer’s had their systems and all the processes to support them in place. They could touch the computer and documents and move them around as they needed. A high comfort level has been established just like mine with my paper media. Initially I thought small and medium-sized organizations would be the first to show interest in and make the move to the cloud, just like individuals and small groups moved toward electronic media long before large public and corporate libraries. My rational was simple and appeared to be supported by the analogy to electronic media. Being small they have the agility to change their process quickly and the need to minimize their IT costs. To my surprise, the interest in the LABVANTAGE cloud hosting offering has been from customers of ALL sizes.

Thinking about why this would be made me realize my initial set of assumptions was incomplete. Yes, smaller customers were more agile and could switch to a hosted infrastructure with less effort. The driving force of cost savings was apparently just as great for large customers as it was for smaller ones. The assumption I made based on my analogy to electronic media and large libraries was incorrect. Unlike large libraries that initially lacked the infrastructure to support electronic media, my large customers have more experience with and have been virtualizing hardware for longer than smaller customers. Their comfort level with and processes surrounding virtualized infrastructure were more developed and therefore a move to the cloud required less effort.

I learned that simple assumptions or analogies don’t always predict real world events. Regardless of your company’s size, take a look at what the cloud has to offer. You may find your original assumptions about cloud hosting obscured it true potential.

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Training Department’s New Year’s Resolution!

Some statistics first:

  • 45 % of all people typically set New Year’s Resolutions
  • 8% will be successful
  • 25% quit after the first week
  • 35% quit after the first month
  • After 6 months, more than half have given up

So are you up for the challenge??? WE ARE!!

Goals are only achievable if they are clearly defined, well documented, and have supporting principles to back them up… otherwise, another year’s gym membership will quickly fade into another game of “Call of Duty,” tactfully played while maneuvering the remote and a bag of chips at the same time… a loss on all levels for sure.

The Training Team has set a New Year’s resolution by creating some goals of our own. We have re-evaluated our Mission Statement and redefined our principles to make sure we are on track with providing the highest quality of training this 2012… and we aim to stick to our goals!

Our Mission Statement

To provide the highest quality product training for customers, partners, and employees.
Training will be timely, structured, and current with the latest product release.

Easier said than done, right? So how are we planning on achieving and supporting this mission so we don’t join in with the unsuccessful 92% of New Year’s resolvers?

All trainings will be done on fully tested and prepared environments.

With help from the “cloud,” all environments are prepared ahead of all training sessions and are fully tested. Each training environment is specialized to the training version and course taught. They are all current to the latest build, allowing all trainings to be representative of the customers’ environment.

All trainings offer hands-on, pre-configured exercises.

There is no better way to learn than to actually configure the application on your own. Pre-configured exercises walk you through the setup, step by step, so you know exactly which properties and settings are configuring each feature and allow you to spend time on what you don’t know, while not wasting your time setting up those features that you do know.

All trainings offer printed training manuals.

Manuals will allow you to go back through the exercises months after the training if you find a need to refresh your memory. They allow you to go back over those topics you may not use every day, or review those features that you may find yourself implementing later in the life of your LIMS.

Finally, all trainings evaluate the effectiveness of the course.

It’s one thing to follow directions and successfully get through the course materials during the training, but did you learn? All trainings have some means of evaluating the effectiveness of the course. Many trainings offer a 25 question multiple choice exam to blatantly show you what you have learned (or not learned). Other courses have a hands-on assessment on the last day, with the remaining tasks simply asking you to perform certain activities that should be well understood by the end of the training. These provide a means of feedback on whether content is being understood or just followed. It ensures you are getting the most value out of your time.

So as you begin 2012, what are your goals? Are they well defined and supported? Will you be trying to keep a clean desk? Aiming to not be late for a meeting, or are you looking to become more educated in the processes of your LIMS. In the Training Department, we are driven this year to provide you with the highest quality of Training we can. Why don’t you take some time to see how we are doing! We are determined to be among the successful 8% of this 2012. Look us up on the LABVANTAGE training web section to see what we have to offer, or email the LABVANTAGE training department for all inquiries. Let us help make your 2012 successful!

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