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Speakers Announced For ASQ Lean Six Sigma Conference

A Massachusetts Institute of Technology…

A Massachusetts Institute of Technology senior lecturer, a motivational speaker, and a communications consultant are among the confirmed keynote presenters at the ASQ Lean and Six Sigma Conference.

Attendees of the conference to be held on February 27 and 28 at the Pointe Hilton Tapatio Cliffs Resort in Phoenix, Arizona, will learn about topics including doing more with less, lean and Six Sigma fundamentals and implementation, and sustaining results. The conference will offer more than 40 sessions on topics including sustaining results from projects to transformation, implementation of lean and Six Sigma, building a successful lean Six Sigma organization, and selling lean and Six Sigma.

Keynote speakers include:

  • Steven Spear—senior lecturer at Massachusetts Institute of Technology’s management and engineering schools, and author of The High Velocity Edge.
  • Thom Singer—author of 12 books on the power of business development and entrepreneurship. Singer has experience working in sales, marketing, and business development for Fortune 500 companies.
  • Jacob Stoller—author of The Lean CEO, a book that features interviews with CEOs who have implemented lean management organization wide. Stoller specializes in the communication between experts and outsiders in areas including information technology, accounting, and engineering.

Other confirmed presenters include Jim Benson—pioneer in applying lean and kanban to knowledge work, and Tonianne DeMaria Barry­—co-founder of Kaizen Camp and Modus Institute. Benson and Barry will co-present. Together, the pair have helped the United Nations, The World Bank, Starbucks, JPMorgan Chase, and others create cultures of continuous improvement.

Click here to view the full program, session descriptions, and to register for the ASQ Lean and Six Sigma Conference.

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Event Highlights Medical Device Regulations and Standardization Processes

Last month the Standards Alliance…

Last month the Standards Alliance teamed up with the National Institute of Quality and the ASTM Latin America Office for phase two of the Peru Workshop on Medical Devices Regulations and Standards: Policy and Technical Aspects in Lima, Peru.

The Standards Alliance is a public-private partnership between the American National Standards Institute and the U.S. Agency for International Development, and is focused on implementing of the WTO TBT Agreement in developing countries.

The event—held on January 24 and 25—was a follow-up to the first medical devices workshop held in November 2015 and focused on the implementation of medical devices quality management systems, quality control, and technical training on biological test methods.

More than 55 Peruvian participants representing the private and public sector attended the workshop. Representatives who provided the U.S. perspective included Dr. Terry Woods from the U.S. Food and Drug Administration, Dr. Spiro J. Megremis from the American Dental Association, Brian Berg from Boston Scientific, Dawn A. Lissy from Empirical Technologies, Stephen Spiegelberg from Cambridge Polymer Group, and ANSI International Policy Manager Jessica Roop.

The National Institute of Quality, Medicines, Supplies and Drugs, the Ministry of Foreign Trade and Tourism, National Institute of Health, and Peru Compras provided Peruvian viewpoints and feedback.

The workshop addressed key topics including:

  • Medical device regulations, standards, and conformity assessments in the United States and Peru with a focus on eliminating unnecessary barriers to trade.
  • Best practices in forging regulations and the use of standards for medical technology products.
  • Health and safety issues including level of risk classifications for medical devices and the effectiveness of standards in supporting these objectives.
  • Technical standards in public purchases and the challenges of medical device quality control.
  • ASTM International’s standardization processes, technical committees and material test methods for assessing and evaluating the performance of orthopedic and cardiovascular devices and test methods for analytical testing and assessing device cleanliness.
  • Inter-laboratory testing and the evolution of dentistry standards.

Click here to view the presentations from the workshop.

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Auditing the Tapestry of ISO 9001:2015 Requirements

Many new requirements in ISO…

Many new requirements in ISO 9001:2015 challenge auditors to look beyond typically prescribed audit evidence and explore the interconnected nature of an organization’s quality management system (QMS) processes. In addition, these new ISO 9001:2015 requirements can be considered from multiple levels of an organization. Figure 1 shows that there are five levels an organization can directly control.


The ISO 9001:2015 requirements can be viewed from this business ladder structure relative to defining and auditing the QMS activities. The business itself weaves the horizontal layers in a kind of tapestry. As an example, let’s consider ISO 9001:2015 requirement section 4.1 Understanding the organization and its context, which requires organizations to “Determine external and internal issues relevant to its purpose and its strategic direction.”

At the system level, this requirement can be considered from the standpoint of initially defining the QMS and its activities. For example, in defining the scope of an organization’s QMS, consideration is given to such external and internal issues, (illustrated in ISO 9001:2015 section 4.1). The external issues could include markets served and products and services offered. From an internal perspective, the organization’s technical competencies, available equipment, and location, etc., affect the definition of the organization’s QMS scope. Auditors look to the scope of an organization’s QMS to determine what technical expertise is required in auditing that organization’s QMS, as well as in anticipating the types of processes that would be included.

ISO 9001:2015 requirements can also be viewed from a strategic perspective, where the influence changes to the QMS at the system level. Looking at the “Context of the Organization” requirement again, the organization’s leadership would consider external and internal issues when formulating its business plan, whether this is long term (more than five) or near term (one to three years).

Certainly, changes in external and internal issues (refer to ISO 9001:2015 subsection 9.3.2, Management Review Inputs), could shape an organization’s strategic direction going forward. For instance, if new technology alternatives are quickly absorbing market share, the organization would need to consider whether to adopt such new technology or identify an alternative business strategy that may in turn change the scope of the organization’s QMS. Likewise, organizations faced with an aging work force internally need to consider succession planning and retention of organizational knowledge (refer to ISO 9001:2015 subsection 7.1.6) as part of their strategic direction. Auditors will find evidence of consideration for these changing external and internal issues in strategic/business planning discussions, management review results, and even annual reports for publicly traded companies.

For the Planning level of the business ladder, specific customer requirements may also drive external and internal issues that affect the organization’s QMS. If a customer were to request a new product that require the organization to perform extensive development activity, feasibility and risk consideration would highlight potential internal issues. This could include limitations in existing resources (refer to ISO 9001:2015 subsection 7.1.1) and external issues, such as availability of technology and employee competency to support the organization’s development process. Thus, connections between context of the organization, (which is discussed in ISO 9001:2015 section 4.1), actions to address risks and opportunities, (ISO 9001:2015 section 6.1), and operational planning and control (ISO 9001:2015 section 8.1), are recognized. Audit evidence at this level may include results from gathering customer and other project requirements and review of these requirements relative to the organization’s capabilities.

Considering external and internal issues from the process level of the business ladder, organizations encounter daily issues in their ability to consistently control their processes needed for producing products and/or delivering services (refer to ISO 9001:2015 subsection 8.5.1). Daily internal issues could include  attendance of the work force—especially during cold and flu season, unexpected equipment breakdowns, or even a workplace fire or other disaster. External issues that affect an organization’s operations could include availability of material/inputs, especially if there is a supply shortage or disruptions in utility services such as electricity.  Auditors can look for evidence of how organizations identify these issues,  (ISO 9001:2015 section 6.1), communicate them (ISO 9001:2015 section 7.4), and act upon them (ISO 9001:2015 subsection 8.5.1).This evidence might be found in production schedules, daily operations meetings, or shift changeover activities.

Finally, external and internal issues can exist at the the product level of the business ladder, as well. For example, external issues could include near-term changes in customer demand affecting operating schedules and inventory levels. Recalls or other field events of competitors could also affect the sales of an organization’s product. Internal issues at the product level could include processing errors that generate a large quantity of nonconforming outputs (ISO 9001:2015 section 8.7), or inventory inaccuracies that affect availability of product for shipment to customers. These events are excellent triggers for selecting appropriate audit samples to evaluate the effectiveness of an organization’s QMS in consistently fulfilling customer requirements.

To adequately define and audit an organization’s QMS, the application of each ISO 9001:2015 requirement at these different business ladder levels should be considered. In doing so, the interaction of ISO 9001:2015’s requirements—and therefore an organization’s QMS processes—becomes apparent.

In addition, each of these processes along the business ladder that address ISO 9001:2015 requirements should also be viewed from the Plan-Do-Check-Act perspective. This is the “wrap” that holds the tapestry of the organization’s business ladder together.

Rather than viewing ISO 9001:2015’s requirements linearly or only relative to one level of the business, auditors can assist organizations in recognizing the tapestry these requirements weave for defining, implementing, maintaining, and improving their QMS which optimally should function at all levels of the business.

Challenge: Select any ISO 9001:2015 requirement. Identify what processes in your organization’s QMS relate to that requirement at each of the business ladder levels. Also consider what audit evidence would be available in these processes to support the selected ISO 9001:2015 requirement. Remember  audit evidence can be tangible, observation, or statement of fact. Share your ideas in the comments below.

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TÜV SÜD Acquires Advanced Compliance Solutions

Provider of testing, auditing, inspection…

Provider of testing, auditing, inspection and certification, training, and consultancy services, TÜV SÜD, has acquired the assets of Advanced Compliance Solutions Inc. (ACS).

ACS was co-founded in 2001 by brothers Scott and Michael Proffitt and partner Sam Wismer. Together they set out to reduce compliance-testing burdens for manufacturers and streamline the approval process. By providing flexible solutions, ACS maintain a strong focus on customer service, making them an ideal partner for TÜV SÜD.

All five ACS testing facilities in Georgia, Florida, and North Carolina are now part of the TÜV SÜD America organization. The combined organization now serves as a premier provider of testing and certification services for EMC, wireless, product safety, Energy Star, and other quality and performance evaluations.

This union of people, equipment and locations greatly expands the reach and capabilities of TÜV SÜD in the southeast United States.

TÜV SÜD Director of Sales and Business Development Doug Hughes said they are excited to welcome ACS to the TÜV SÜD family.

“They have been one of the most respected and successful service providers in the industry for more than 15 years,” Hughes said. “The integration of ACS into TÜV SÜD demonstrates our continued dedication to growth and excellence in the United States. In addition to anchoring our safety certification and EMC capabilities in the Southeast, it greatly expands our wireless testing and certification portfolio.”

ACS Co-founder and President Scott Proffitt said “if you surround yourself with good people who are the best at what they do, you’ll have a team that is ready to tackle any challenge and overcome any obstacle.

“Our long relationship as a partner lab has strengthened the synergies between our team and the like-minded staff at TÜV SÜD,” Proffitt said.

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Report Reveals Experience of ISO 9001 Market Surveillance

A new report from the…

A new report from the United Nations Industrial Development Organization presents good practices in applying market surveillance methodology to monitor the effectiveness of ISO 9001 certification in manufacturing enterprises and evaluate the performance of respective accredited certification bodies.

“Good practices: Experience in the Market Surveillance of ISO 9001 quality management systems” concludes that the proper use of ISO 9001–based quality management systems assists developing countries in promoting sustainable trade—thereby helping them achieve inclusive and sustainable industrial development and the 2030 development agenda.

The case studies mentioned in the report show that market surveillance methodology can be used or adapted as an effective tool in other regions and contexts—and for other management systems.
Click here to view a full copy of the report.

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ASQ to Recognize Fellows for Their Contribution to Quality

ASQ recently named 18 members…

ASQ recently named 18 members as fellows in recognition of their achievements and contributions to the advancement of quality. Fellow membership status is awarded to ASQ members in good standing and who meet the following criteria:

  • Hold at least 15 years of quality-related experience.
  • Meet requirements across six professional categories.
  • Are sponsored by peers and endorsed by their ASQ section or division.
  • Have been a senior member for five years or longer.

ASQ Chair Eric Hayler said ASQ Fellows are leaders in the quality community, working to improve their organizations and the communities in which they live.

“These are individuals who dedicate their time and expertise to make the world a better place,” Hayler said.

The new fellows will be honored at a ceremony at ASQ’s World Conference on Quality and Improvement to be held May 1 – 3 in Charlotte, N.C., USA. The new ASQ fellows are:

Eric Alden, Xerox Corp., Canandaigua, N.Y. — For outstanding contributions in measurement, design of experiment and reliability modeling techniques; Six Sigma coaching; developing and teaching workforce development courses; developing and sharing data analysis techniques using Pivot Table and statistical software; utilizing multivariate analysis to improve hospital board knowledge, and leadership in the ASQ Rochester Section.

David Dewayne Butler, TI Automotive, Auburn Hills, Mich. — For outstanding leadership in advancing quality tools and methodologies in supplier quality development in the automotive industry facilitated by the Automotive Industry Action Group and direct supplier leadership; and long-term support of ASQ at the divisional level with impact on quality professions through talks, papers, and teaching.

Rajeev Chadha, National Research Council of Canada, Edmonton, Alberta, Canada — For outstanding contributions to the professional quality movement in Canada and meritorious achievements in the application of Lean Six Sigma, quality and continuous improvement technologies in the Canadian mining industry.

Julie Furst-Bowe, Chippewa Valley Technical College, Eau Claire, Wis. — For numerous contributions in the application of quality improvement principles and practices in the higher education sector and numerous contributions to the field of quality improvement in education though presentations, publications and leadership roles in ASQ and other professional organizations dedicated to achieving and maintaining educational excellence.

Vinay Goyal, Abbott Laboratories, Fullerton, Calif. — For exceptional contributions in developing, promoting and inspiring the advancement of quality and safety practices across diverse industries including medical, commercial, aerospace, and defense organizations. For developing innovative applications of quality methods, educating through mentoring and academia, and continuing to support ASQ and external organizations as a contributor and leader.

Michael Hamada, Los Alamos National Lab, Los Alamos, N.M. — For significant research contributions in the design and analysis of experiments, measurement system assessment and reliability; leadership in interdisciplinary collaborations to improve the practice of science for national security; and dedicated service to the practice of quality.

Bart Hamilton, Consultant, Akron, Ohio — For outstanding leadership in quality education within ASQ and academia for more than 50 years, professional competence in quality management in the tire industry, and mentoring the ASQ Akron-Canton Section and industry in education and training of quality principles.

Michael Kent Hart, Consultant, Kanata, Ontario, Canada — For inspirational leadership of his section’s achievements in their journey to excellence, outstanding contributions to process improvement theory and application, and professional competence in quality management and organizational excellence.

James Miller, Roche, Muncie, Ind. — For outstanding leadership in quality education activities at ASQ, at university and in business; devoted section leadership; and professional competence in quality management within the consumer electronics industry and medical diagnostics industry.

Mark Neal, Global Quality Systems, Prosper, Texas — For significant contributions to the quality profession in quality principles, reliability, safety/risk management and process improvement used in high reliability, safety-critical, and embedded systems. For exceptional long-term corporate leadership in the application of quality principles in products to save or improve lives, and contributions to the ASQ Software Division.

Owen Ramsay, Lloyd’s Register Quality Assurance, Laurelton, N.Y. — For outstanding contributions in advancing process understanding and deployment of Lean Six Sigma rapid improvement methodology initiatives; planned and spontaneous talks at ASQ-sponsored events and other technical forums; and promoting and influencing the expansion of diversity within ASQ and non-ASQ leadership communities.

Abbas Saghaei, Azad University, Tehran, Iran — For effective training of students at universities and professionals across multiple industries, implementing quality practices across organizations that deliver quantifiable financial benefits, outstanding contributions to the quality movement in Iran, and significant research and publications at a national and international level.

Donald Singer, GlaxoSmithKline Pharmaceuticals, Phoenixville, Pa. — For sharing expertise and knowledge in speeches, articles and books for the betterment of society with respect to pharmaceuticals, serving ASQ Quality Press as a committee chair for 35 years, and willingness to help others when needed.

Nicholas Skovran, Quality Horizons LLC, Pittsburgh, Pa. — For outstanding contributions advancing quality practices in health care and other industries, leadership in organizing and delivering quality education and improvement programs from introductory to highly advanced levels, and devoted leadership and support of the ASQ Pittsburgh Section.

Jennifer Joy Stepniowski, Pro QC International, Tampa, Fla. — For drive and passion in raising the voice of quality, in addition to the ongoing dedication to developing and instructing quality education accessible to all, and continuous support of local section activities and management excellence via a demonstration of professional competence in quality across industries and global cultures.

Sandra Storli, Zimmer Biomet, Gurnee, Ill. — In recognition of 30 years of quality-related experience supporting highly regulated organizations with quality systems, clinical trials and regulatory affairs compliance; and activities within the quality community including the ASQ Northeastern Illinois Section, ASQ Food, Drug and Cosmetic Division, ASQ Audit Division, and ASQ Learning Offerings.

William Taraszewski, Meda Pharmaceuticals, Decatur, Ill. — For outstanding leadership in quality management in the pharmaceutical industry, devoted section leadership, and career-long professional development in pharmaceutical analysis.

Rajesh Kumar Tyagi, Telfer School of Management, University of Ottawa, Kirkland, Quebec, Canada — In recognition of continuing leadership in advancing and promoting quality principles in academia and the service industry, tireless efforts to teach and promote the development and benefits of process improvements and service scorecards to an international audience, and participation in national and local conferences.


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Auditor Profile: Six Decades of Auditing

At 80, Dr. Andrew Perry…

At 80, Dr. Andrew Perry has recently renewed his auditor certifications to ISO 9001:2015, ISO 13485:2016, and AS9100D. He’s been conducting audits for almost 60 years. Although now semi-retired, he still conducts 10–15 audits per year and plans to continue working from his Southern California home as long as he can.

Perry started performing audits in 1960 for the Inspector of Naval Material at Westinghouse Baltimore-Washington Friendship Airport Division, which later became part of Defense Contract Administration Services.

In the mid 1960s, he joined the Hughes Aircraft Co. in El Segundo, California, as a project quality assurance engineer on the Surveyor project, the first spaceship that went to the moon and gathered soil samples for analysis.

From there, he moved to the Apollo program where he helped audit all phases of design and production of the Apollo instruments. These audits consisted mainly of basic assessments without checklists to discover problems in design and manufacturing and create corrective actions.

After working with the Apollo program in Minneapolis, Perry moved to Los Angeles, where he worked on various space projects for Hughes Aircraft. He later moved to Hughes’ Santa Barbara Research Center, where he audited suppliers to the former aerospace standard checklist NPC 200 1, 2, and 3.

In 1976, Perry began his career in the nuclear field working on reactor electric penetration assemblies for Bunker Ramo Amphenol. Here, Perry reflects on his long career in the auditing profession.


What was the profession like when you performed your first audits? When I performed my first audits, companies worldwide were trying to implement various concepts of the Fathers of Quality: W. Edwards Deming’s 14 Points of TQM, Joseph M. Juran’s Quality Control Handbook, Armand V. Feigenbaum’s Total Quality Control book, Philip B. Crosby’s book Quality Is Free and his zero defects program (which we tried to implement on the Surveyor Project), and Professor Kaoru Ishikawa’s handbook, What Is Total Quality Control? defining quality circles.

What were you looking for? Audits were mainly product audits and inspection/test system audits, looking for production controls, product conformance through inspections, and tests.

How did you present the audit report? Audit reports were usually issued to affected managers and professional personnel in the form of memos, detailing findings observed in quality control and each of the production departments visited. Sometimes I added photos to the report.

How have you seen auditing change over the years? I’ve seen notable changes, from the simple self-made audits described above, to audits performed by superbly trained auditors in accordance with applicable standards and ISO 19011:2011.

How often are you performing audits now? Now, being semi-retired, I can afford to pick and choose what audits I perform, based on my interest in the company and product line, as well as how I relate to their management.

Do you plan to retire at any point? I plan to continue as long as I can, sharing with as many as possible the practical applications I have learned in my 60 years of industrial experience.

What advice would you give new auditors? Start out with training to your applicable ISO/AS/TS standard and ISO 19011:2011, conducted by a registrar, certification body, or other internationally recognized entity. Keep current with applicable courses and ASQ meetings, qualify as an Exemplar Global Lead Auditor, and try to become a coach in your company.

Is there a standard you believe could be improved? All the current standards are excellent and are constantly being reviewed by experts worldwide.

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ANSI Seeks Comments on Integrating a Business Excellence Framework with Management System Standards

The International Organization for Standardization…

The International Organization for Standardization (ISO) has circulated a proposal to study how to integrate a business excellence framework with management system standards. Those interested in commenting on the proposal have until March 4 to submit their comments to American National Standards Institute (ANSI).

The Standards Council of Canada (SCC) submitted the proposal to ISO, which states that organizations simultaneously implementing management systems with business excellence frameworks are often challenged by lack of alignment. This is due to multiple factors, including organizational design and structure, responsibilities matrix, contextual understanding of the linkages and interdependencies, silo mentality, and turf protection.

The proposal reads: “‘Guidelines on Integrating a Business Excellence Framework with ISO Management System Standards’ will provide the roadmap on integrating the national/international business excellence frameworks with management system standards, for enhancing organizational efficiency, facilitating effective decision-making, and promoting transparency, innovation, and continuous improvement.”

The field of work will exclude the development of an ISO business excellence standard and/or development of ISO management system standards. Instead, it will focus on the integration aspects, available best practices, and provision of useful practical tips for better organizational management.

Relevant stakeholders would include industry and commerce in large industry, SMEs, government, standards application businesses, and nongovernmental organizations, among others.

All interested stakeholders are invited to review the proposal, which includes the full listings of relevant documents at the international, regional, and national levels, as well as affected stakeholder categories that may benefit from or be impacted by the proposed standard.

Please submit comments to Steven Cornish, ANSI senior director of international policy (scornish@ansi.org), by close of business on Friday, March 3, 2017. Based on the input received, the ANSI ISO Council will then be asked to approve an ANSI position and comments to be submitted to ISO before its April 12, 2017, deadline for voting on this proposal.

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Taking Auditing to New Level with International Standard Under Revision

ISO’s popular standard for auditing…

ISO’s popular standard for auditing management systems is under revision and has just reached the first voting stage, a crucial step in its development.

Organizations are increasingly turning to management systems in a quest to be more effective and save time and money. Many companies have several different management systems, each focusing on different areas, such as IT, information security, quality, and environmental management. ISO 19011, Guidelines for auditing management systems, will help with the effective audit of those management systems to ensure continuous improvement, allowing harmonization across systems and a uniform approach of the auditing process where there are multiple systems in place.

The standard is currently being revised to reflect the growing number of management system standards (MSS) and the recent revisions of some of the most widely used, such as ISO 9001 for quality and ISO 14001 for the environment. It has just reached Committee Draft (CD) stage, meaning those countries involved in its revision have an opportunity to make comments on the draft.

Denise Robitaille, chair of ISO/PC 302, the ISO project committee responsible for the revision, said that when the standard was last published in 2011, there were 11 management system standards, but that number has since grown significantly to 39, with 12 others in development.

“As organizations see the benefit and need for management systems, there has been an increase in the number of sector-specific standards to respond to the mandate.

“There are now MSSs that cover areas such as health and medical, environment, services, information technology and more. In addition, the two most popular MSSs – ISO 9001 and ISO 14001 – have recently been updated, so the auditing of these systems needs to reflect the variety and number of standards being developed.”

ISO 19011 is applicable to all organizations that need to conduct internal or external audits of management systems or manage an audit programme. It is intended to apply to a broad range of potential users, including auditors, organizations implementing management systems and organizations needing to conduct audits of management systems for contractual or regulatory reasons.

ISO 19011 also provides guidance on external audits, including certification and supplier, which support the implementation of the MSS.

The revised version of ISO 19011 is due to be published mid-2018.

This article has been republished in full with permission from ISO.

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A Little Data’ll Do Ya

An introduction to basics statistics…

An introduction to basics statistics and data analysis for auditors

So what is a process approach anyway? Wait a minute. Hold up! This article is about data analysis for auditors isn’t it? Well yes, but before we can talk about how auditors can analyze data we need to understand the processes from which this data comes.

A process can be thought of as an activity that transforms inputs into outputs. In manufacturing, the 6Ms—man, machine, material, measure, method, and mother nature—are often identified as process inputs, with the understanding that problems with process outputs typically come from problems with process inputs. This is shown in figure 1.

In other words, the root causes of nonconforming outputs tie directly back to the process inputs. You don’t always need to use the 6Ms though. It’s only important to identify inputs that make sense for your organizational processes. Data from most process outputs align themselves in a normal distribution, or bell-shaped curve. The bell-shaped curve is a graphical representation of process variation, of which there are two kinds. Common cause variation is that which is normal to any process. Special cause variation is that which is outside of the  +/- three sigma control limits caused by an external factor.  Special cause variation should be investigated to determine root cause and apply corrective action.

Having a normal distribution is important because bell curves allow for a more profound understanding of process behavior through the use of statistical tools and methods. For example, understanding whether a given process is producing normal variation or if some special cause is adversely affecting it. It can also show if there’s a statistically significant difference between two events. Additionally, we can make certain predications about a population based on the bell curve, such as how likely something is to be true or whether it will fall within a certain range.

These benefits are so important that when process data doesn’t fall into a normal distribution pattern, the data is often transformed. Transformation is a kind of “statistical hocus-pocus” that seeks to answer the question: What would this data look like if it was normally distributed and which statistical tools can we apply based on this theoretical model?  Data transformation is thankfully outside of the scope of this article.

The process width of six standard deviations (+/- 3 standard deviations from the process center) is considered the voice of the process. This is the portion underneath the bell-shaped curve where 99.7 percent of the data falls, as shown in figure 2.

A Little Data’ll Do Ya

Someone way smarter than me years ago decided that 99.7 percent was a high enough percentage of the population to draw conclusions about the entire population. It’s this plus or minus three standard deviations from the process center where control chart control limits are set. Note that uncontrolled doesn’t necessarily mean out of specification. You want control limits to be within specification limits so that if a control limit is passed, you have time to either troubleshoot the process or make adjustments before parts begin to consistently go out of specification. The two most important things to understand about a process are: Is it stable and in control? Is it capable?

A Little Data’ll Do Ya

Process capability is simply the ability of a process to consistently make parts to specification. Process capability indices compare the process width to the difference between the upper specification limit and lower specification limit. The most commonly used capability indices are Cp, Cpk, Pp, and Ppk. When voice of the process equals voice of the customer then the capability index is one. Less than one and the process is not capable. An industry rule of thumb when a capability requirement is called out in a specification is Cp/Cpk of greater than or equal to 1.33 and Pp/Ppk greater than or equal to 1.67.

Cp/Cpk shows short-term variation. Pp/Ppk shows long-term variation, which captures more special cause variation. It is for this reason that Pp/Ppk will always be lower than Cp/Cpk. Cpk and Ppk are the preferred methods for evaluating process capability, as they both account for  process location and width.

Though statistical software often shows capability indices as a part of the control chart graphic, it’s important to understand that capability indices are not an element of control charts. Control charts (graphical) and capability indices (analytical), although complimentary of one another, are two separate and distinct tools.

 A Little Data’ll Do Ya


Now that we have covered the basics, let’s talk about data review. As we review an organization’s data analysis program you want to ask what information is reviewed, by whom, and what the data is used for. When looking at data you want to not just look at whether or not it’s within specification or even control. You also want to understand trends in data. Understanding how to respond to uncontrolled conditions or negative trends is an often overlooked portion of the less mature QMS.

“Decisions based on the analysis and evaluation of data and information are more likely to produce desired results” –ISO 9000:2015

What does this mean to us as auditors? As auditors we should be looking to confirm the maxim below.

  • Don’t collect data if you aren’t going to plot it.
  • Don’t plot data if you aren’t going to analyze it.
  • Don’t analyze data if you aren’t going to do anything with the results.

Ideally you would want to see process data even distributed around the process average, as shown in figure 5.

A Little Data’ll Do Ya

Some examples of commonly seen trends that would warrant further investigation are shown in the following figures. You will note that some of these changes can be subtle, so you will need to be on the lookout for them.

A Little Data’ll Do Ya

A Little Data’ll Do Ya

A Little Data’ll Do Ya

A Little Data’ll Do Ya

There’s a set of rules developed by Westinghouse in the 1980s called the “Westinghouse Rules” that gives additional examples of plotted data that might require investigation. However, you don’t need to be a statistical expert and remember every guideline for when to launch an investigation based on data. You should, however, be able to recognize when there is the possibility of special cause variation indicated by plotted data and know what questions to ask.

Some of the questions that an auditor might ask when reviewing the process monitoring program are:

  • What do you do when an adverse trend is encountered?
  • What do you do when an out of control condition is encountered?
  • How do you know what to do when an out of control condition or adverse trend is encountered?
  • If Cp/Cpk or Pp/Ppk data is captured, ask if there is a minimum requirement?
  • How do yields or other process data compare across shifts or between similar lines?
  • Is there a structured program in place for review of and response to adverse trends/conditions in data?
  • How do you identify positive trends that may point to an opportunity to transfer a best practice from one process or work center to another?
  • What training is provided in SPC and data analysis?
  • Are the daily metrics captured aligned with organizational goals and objectives?
  • How were the control or specification limits selected? Don’t assume that a statistical or even logical method was used.

In our data-driven society, more data is available than ever before. It’s important to not just understand the data that we are looking at but to also know which data to review.

When looking at data analysis an organization, it’s important to understand how flow down of strategic goals and objectives as called out in ISO 9001:2015 is accomplished. It should be clear how operational targets support tactical objectives, which in turn support strategic goals. Each goal and objective should have an associated metric that will indicate when the goal or objective has been met. When there is not a clear link between goals, objectives, and metrics it may sometimes be the case that unnecessary metrics are being tracked. Let’s look at the following example of proper flow down of corporate vision.

Vision: Become marketplace leader within the next five years.

Strategic goal: Increased market share

  • Metric: Industry ranking


Tactical objective: Improved quality

  • Metrics: Reduced customer return rate and increased customer satisfaction survey scores


Operational targets: Reduce process variation.

  • Metric: Lower scrap rate


We seek to derive insights from the review of data. Through those insights, data is transformed into information upon which can be based decisions.

Reviewing data doesn’t just occur by reviewing charts on the manufacturing floor. Often as part of an audit we are called upon to review validation reports. This may appear to be a daunting task. However, you don’t have to have a degree in statistics to provide a thorough review. Here are some basic tips below:

  • Is the data that was specified in the protocol in the report?
  • Have all of the required signatories signed off?
  • Have all the success criteria been met?
  • If all of the success criteria has not been met, were appropriate procedures followed?
  • Any red lines crossed on the graphs?


Auditors play an important role in their assessment of an organization’s data analysis program.  Understanding basic statistical tools and techniques will allow an experienced auditor to provide a thorough review, regardless of their background. I will close with this quote by W. Edwards Deming: “In God we trust. All others please bring data.”


About the author

Lance B. Coleman has more than 20 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the medical device, aerospace, and other regulated industries. He has a degree in electrical engineering technology from the Southern Polytechnical University in Marietta, Georgia and is an American Society for Quality Senior Member, Certified Quality Engineer, Six Sigma Green Belt, Certified Quality Auditor, and Biomedical Auditor. He is also an Exemplar Global Principal QMS Auditor. Coleman is chair of U.S. TAG 302 and a voting member U.S. TAG 176.

He is the author of Advanced Quality Auditing: An Auditor’s Review of Risk Management, Lean Improvement and Data Analysis (Quality Press, 2015) which has been nominated for an ASQ Crosby Award. Additionally, Coleman is an instructor for the ASQ Certified Quality Auditor Exam Preparatory and FMEA courses. As principal consultant of Full Moon Consulting, he has presented, trained, and consulted throughout the United States and abroad.

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