Tag Archives: Quality

“Quality” based on effective use of Quality Tools

by Roy Kinkaid, Quality Consultant

Basic Quality Tools

The question I have been pondering for many years now is – why in the year 2016 are there still organizations that do not use the basic quality tools to drive improvement and impact the bottom line? ASQ describes the 7 basic quality tools as: cause and effect diagram (also known as Ishikawa or fishbone diagrams) check sheets, control charts, histograms, Pareto charts, scatter diagram, and stratification of data for trends. The companies I am referring to are small to medium size companies of less than 500 employees.

The Company

The company can be a manufacturing, service or non-profit. The operating philosophy is, get an order, produce and order, ship an order, and invoice the customer. Receive a request for service, deliver the service, and invoice the customer. If the customer complains they will react as needed. They can be owned by a larger company – with only financial reporting to the larger organization (sales, costs, P&L, etc.).

The company is financially successful. They understand budgeting, cost cutting and profit and loss. Financial data abounds. Process data – not so much! They often have a Balanced Scorecard – most measures are financial (someone read a book and decided it was the thing to have).

When asked if they have process data, or know how their key processes (or can identify their key processes) are performing – which leads to financial results, the response is a quizzical look. Monthly management meetings consist of reviewing the numbers. Reaction typically is this month’s number in relation to last month’s number. Trend charts are not utilized (as Deming said “plot the dots”).

Quality the Program

When asked about quality they understand the word, and identify themselves as a quality company – who would say otherwise?

They relate being a quality company to being certified to an industry or quality standard (e.g. ISO) as required by the customers or by the industry sector they operate in.

Quality Staff

Someone in the organization has quality in their title. Responsibilities can cover a wide range: vendor quality, process quality, final quality (service, product), registrations, certifications, audits, and response to customer complaints. Said person can also be responsible for other functions (e.g. safety). They may have a quality certification – CQE, CQA, Certified ISO Auditor, Certified Quality Manager or Lean/Six Sigma Certification. However the basics tools of quality are not being used to the advantage of the organization (there is no lack of knowledge). There are no identifiable process improvement projects underway (there is more to quality than maintaining certifications and passing audits) or process performance measures (trend charts for key processes). They have not implemented Cost of Quality, identified non-value added activities and waste (Lean) as part of the quality effort (to quote Deming again “defects are not free, someone gets paid to make them”).

The Customer

They react to customer complaints – apologize and pacify the customer. No root cause analysis is performed to eliminate the cause and prevent reoccurrence. A Pareto has not been used to stratify complaints and drive improvement. Customer satisfaction surveys are not performed on a routine basis. If surveys have been performed they have been performed unsuccessfully (low response rate).

The Basic of Quality – the Tools and Process Improvement

When the basic quality tools are mentioned and their application to   process improvement (again where are the trend charts?), the response from management can be: we are successful, we are certified to a quality standard, we are a small company, that doesn’t apply to us.

The Issue

I have often used the phrase – ‘they don’t know what they don’t know and don’t seem to want to know it’. In the year 2016 organizations still do not use some or all of the basic quality tools. 7 basic quality tools include cause and effect diagram (also known as Ishikawa or fishbone diagrams) check sheets, control charts, histograms, Pareto charts, scatter diagram, and stratification of data for trends. I have worked companies where trend/run charts are a foreign concept, not to mention the use of statistical process control charting. And they are not aware how the quality tools can be used to improve processes and have an impact on the bottom line.

The Point

So, the question is – how do we, the quality profession, make companies, (management) aware of the world of the basic quality tools (one last time, how about trend charts at a management meeting) to bridge the knowledge gap and the benefits of applying the tools? Training/workshops are available through our ASQ Philadelphia 0505 Section. Check our web site for the schedule. And remember ASQ training – it’s not just for quality professionals only – management can and will benefit – so please invite them! It’s the “quality” thing to do!

Roy Kinkaid is an independent quality consultant (25+ years of experience) with an extensive background in the implementation of various quality management systems – Six Sigma, Baldridge, Continuous Improvement, ISO and the Carnegie Mellon Capability Maturity Model. Roy has a degree in management/ statistics from Philadelphia University, certification in Six Sigma, and is a member of ASQ, the SEI, and IEEE Software Society. He has practical process improvement experience in manufacturing, service, software, and electronic commerce industries, helping companies to achieve six sigma quality performance levels. In addition Roy has hands on experience with change management, coaching and the facilitation skills necessary to implement a quality program. He has extensive experience working in Europe, the UK and Asia.

Lean Six Sigma as a Performance Multiplier

by Jay Armstrong

Internal and external issues are significantly escalating pressure on the pharmaceutical industry to improve their output of drugs, while managing costs.  This is a difficult balancing act, as there are shrinking drug pipelines, an imminent patent cliff and the emergence of generics as an alternative to the traditional drug manufacturers.  Additionally, R&D productivity and spending have declined, even as new global markets are emerging with substantial, unmet therapeutic needs.

You can’t improve a process if you do not understand the variables and factors that impact it. The industry must now try to find ways of improvement while meeting product, customer, regulatory and efficiency demands. Lean Six Sigma has been used by some of the world’s most successful companies leading to savings of billions of dollars, striking increases in speed and capacity and achieving better customer relationships.

Lean Six Sigma focuses on a smaller number of critical projects to ensure higher profitability and faster solutions. Organizations traditionally face two potential scenarios – First, there is an already existing process that is working reasonably well – this requires the application of “DMAIC” – Define, Measure, Analyze, Improve and Control.  Motorola and GE were early adopters and powerful champions of DMAIC.  Indeed, their dramatic cost savings and improvements can be directly traced to the adoption and embedding of these principles.  In the second instance, an organization may have no process at all.  This situation requires a distinctly different path – DFSS – Design for Six Sigma.  This process utilizes the IDOV strategy – Identify, Design, Optimize and Validate.  This thinking is a radical departure from traditional lean Six Sigma solutions in that quality is essentially designed into the process during its creation. DFSS has attracted the interest of the FDA, because it closely mimics “Quality by Design” (QbD)

One way that a pharmaceutical company is able to do this is referred to as an “Open Innovation Strategy.”  Open innovation distances itself from traditional R&D, wherein the company itself owns and manages the entire R&D process chain, rather than leveraging outside help to stimulate innovation. R&D in an open system assumes that even the most capable organization needs to identify and work alongside external companies as a means to enhance innovation.  Thus, pharmaceutical companies have been seeking to work with universities, hospitals government, private research institutions, and biotech companies to enhance their innovation processes.

To be able to optimize the benefits of Lean Six Sigma, it is important that the work in all areas of the organization utilize the same mind-set. There is data indicating that significant benefits can be realized by including non-manufacturing activities, since these are only about 70% efficient.    As General Electric continued to develop the Six Sigma system originally created at Motorola, they realized that the potential of Lean Six Sigma was far greater than the current applications on their manufacturing processes. This ensures that the root causes for variation or bottle necks are truly eliminated and not just moved along in the system. Sadly, even though the pharmaceutical industry is highly regulated to ensure that the companies meet all the requirements from regulatory agencies, many core processes are not meeting the requirements of today’s market.  The arduous process of drug development as a prime example. One potential solution to the business issue and challenge of high costs and long time lines for product development is the use of Six Sigma. Companies implement Six Sigma for a number of reasons and some of the main targets when implementing Six Sigma in the R&D organization include decreased costs, decreased time to market and improving the process and product quality.

When starting implementation of Six Sigma the entire organization needs to be evaluated to see where to start the implementation work. During this process it is important to be open-minded and think out of the box to ensure that an area with great potential is chosen to start with. The initial successful implementation work will send out a message (to all the company staff) and facilitate future work.

Lean Six Sigma thinking has evolved far beyond its traditional manufacturing roots and is now recognized as  a cogent driver for operational excellence and competitive advantage.  We believe that substantial and sustainable cost and time savings, as well as quality improvements can be realized through a broad and deep application of Lean Six Sigma principles and tools.

Jay Armstrong holds certification as an ASQ Six Sigma Black Belt and advanced degrees from Stanford, University of Pennsylvania, Johns Hopkins in fields such as Biotechnology, Management, Biomedical Technology. He holds certificates in Project Management, and Decision/Risk Management. He has led workshops in employee coaching, designing and fundamentals with led to eight Kaizen events, and five discovery events. He was the leader in launching of the process workshops for clinical trials, and developed and led a clinical trials E-2-E work-stream which identified 10 clinical process area improvements. He is responsible for leading of five R&D process-improvement teams in delivering major cycle time, cost, and resource reductions of up to 80%, leading to $11M savings.