2019

STANDARDS OUTLOOK

A Giving Tree

A metaphor explains how ISO 9001 drives the use of quality tools

by L.L. "Buddy" Cressionnie and Paul Palmes

Lean manufacturing and Six Sigma are popular techniques for optimizing manufacturing and service operations. Lean manufacturing techniques identify and minimize nonvalue-added activities and waste, such as overproduction, time spent waiting and during transportation, unneeded motion and ineffective processes that affect the cost of quality.

Former General Electric CEO Jack Welch said, "Six Sigma is a quality program that, when all is said and done, improves your customer’s experience, lowers your costs and builds better leaders."1

Six Sigma techniques and tools are used to decrease process variation to improve product and service quality for the customer while reducing costs. Lean and any of the other tools we will describe, however, are best to rely on some form of input from the larger system in which they exist.

To promote efficiency, effectiveness and a drive for improving customer satisfaction, quality practitioners have used several tools over the years such as:

  • A balanced scorecard (BSC) measurement system—BSC views organizational performance from financial, customer, business process, and learning and growth perspectives to ensure the achievement of vision, strategy and objectives.
  • Root cause analysis tools—These include fishbone (Ishikawa) diagrams, five whys analysis, Pareto charts and scatter diagrams.
  • Design of experiments (DoE)—This answers questions such as, "What are the key factors in a process? "At what setting would the process deliver acceptable performance? and "What are the process interactions, and what would bring about less variation?"
  • Failure mode and effects analysis (FMEA)—This can identify all potential failures during the design or manufacturing process of a product or service.
  • Mistake-proofingIt minimizes human errors by analyzing a process to identify potential errors, and eliminate or reduce their occurrence.
  • Quality function deployment (QFD)—This uses tools such as affinity diagrams, cause and effect diagrams, tree diagrams, matrix diagrams, matrix data analysis, arrow diagrams and process-decision program charts to improve customer satisfaction.
  • Total quality management—The method relies on engagement by all personnel of an organization to participate in improving processes, products and services.

QMS as a tree

But what drives a lean project? When are Six Sigma techniques appropriate? Which quality tools are appropriate for your business? When is a DoE, FMEA or QFD needed?

Our favorite metaphor is that of a tree and its branches: A quality management system (QMS) represents the trunk and root system, while quality tools are the leaves sprouting from sturdy branches. The tools are only as effective as the strength of the management system—similar to branches that gain nourishment from a tree’s trunk and roots.

The trunk

To become world-class, an organization develops a framework that sets minimum expectations for its business: This framework is an operating model that requires definition of purpose and key performance indicators to achieve its goals. The most popular and effective framework is ISO 9001.

The standard has more than 1.6 million certificates issued worldwide, according to a 2014 International Organization for Standardization survey.2 Organizations that want to move from good to great should strongly consider adopting ISO 9001 as the basis for using the tools we’ve mentioned.

Organizations use ISO 9001 to consistently provide products and services that meet customer and regulatory requirements, and to promote internal improvement programs based on careful monitoring and measurements of their processes. Their effectiveness in meeting customer and regulatory requirements is evaluated during required internal audits and, if certification is desired, third-party, external audits.

All of these monitoring activities have potential to create new branches and leaves. The QMS is feeding information up through its trunk and branches, energizing the use of quality tools.

ISO 9001 was revised in 2015 to make it more consistent with the operation of today’s businesses and ensure a greater degree of flexibility in meeting internal, regulatory and external requirements. ISO 9001:2015 is actually a business management system based on seven quality principles, which are consistent with overall business objectives:

  1. Customer focus—Organizations understand, manage and meet the needs of their customers.
  2. Leadership—Vision, direction and values for an organization are established, ensuring necessary resources are allocated.
  3. Engagement of people—There are competent, empowered and engaged people throughout an organization.
  4. Process approach—Organizations manage operations as processes with consistent and predictable results.
  5. Improvement—Performance and customer satisfaction is improved.
  6. Evidence-based decision making—Organizations ensure there is accurate and reliable data to drive improvements.
  7. Relationship management—Organizations understand relevant interested parties’ needs and expectations.

ISO 9001:2015 promotes a process approach for developing, implementing and improving a QMS. The process approach includes understanding and monitoring the context of the organization, which means understanding and monitoring external and internal issues and the needs and expectation of interested parties, determining the management system scope and establishing appropriate processes.

Processes must be monitored and understood, and can be visually represented using supplier, inputs, process, outputs and customers diagrams. The process approach allows organizations to apply the standard consistently in their operations.

The standard also continues to use the plan-do-check-act (PDCA) cycle in planning and implementation. PDCA can be applied to all processes and at all levels in the organization—at a macro level for the entire organization or the micro level on the factory floor.

Great organizations want to be proactive in achieving desired results and customer satisfaction. ISO 9001:2015 introduces risk-based thinking to ensure organizations are proactively addressing their QMSs to achieve intended results, enhance desirable effects and achieve improvements.

The PDCA cycle is the best way to understand QMS processes, and it is a natural window into the world of risk. Risk-based thinking considerations are included throughout ISO 9001:2015 to prevent or reduce undesirable effects, and PDCA begins the process by developing a plan to address one or more defined risks.

The concept of risk mediation as the basis for developing a plan is both old and new to many quality professionals. Having recognized a problem that requires fixing, most people develop a PDCA approach to improve or achieve a desired outcome.

The concept of risk is embedded in the decision to apply the PDCA approach—the risk of not meeting the desired outcome—but the appreciation of PDCA as a risk-mediation tool is largely unrecognized by many. After all, the acronym is not RDCA, but PDCA has always conceptually been inclusive of risk as the basis for planning.

Branches and leaves

Several clauses in ISO 9001:2015 directly or indirectly represent a check of a QMS’s effectiveness. These branch out from the trunk to spur improvement activities through use of one or more quality tools.

Management review: ISO 9001:2015 requires introspection and internal examinations at user-defined intervals. The most formal of these moments are defined in subclauses 9.3.2 and 9.3.3 (management review inputs and outputs).3, 4

At its core, a management review is a full examination of an organization’s abilities, successes and areas requiring improvement. Essentially, all management review discussions and determinations culminate in subclause 9.3.3.c—resource needs.5 This is a primary gateway to use tools for improvement.

For example, organizations needing to improve profitability may create a cost of poor quality program to address operational costs. Organizations that must determine key factors in a process, acceptable performance and what could bring about less variation might use DoE to gather and report information to top management.

Internal or third-party audits: ISO 9001:2015, subclauses 9.2 (internal audit) and 9.2.2.e (requiring an organization to take appropriate action without undue delay in response to audit findings) also are drivers for quality professionals to use their arsenal of tools.6, 7 A well-structured process audit that uncovers important issues becomes a tool that drives the use of other improvement tools.

Nonconformity and corrective action: ISO 9001:2015’s subclause 10.2 (nonconformity and corrective action) is perhaps the most obvious subclause to advocate using quality tools.8 After all, a vibrant and accepted corrective action program is at the heart of problem solving in ISO 9001:2015-certified organizations. Several required outputs provide valuable inputs to use any number of tools for improvement.

Other clauses

Several other subclauses in ISO 9001:2016 directly or indirectly ask for a check of a QMS’s effectiveness:

  • Subclause 10.3 (continual improvement) is a call to use management reviews and analysis outputs to improve (also see clause 9.1.3—analysis and evaluation). It’s an umbrella clause capturing the concept that a source of improvement efforts can arise from almost anywhere in a QMS and by extension allows organizations to apply quality tools.9, 10
  • Subclause 8.5.1 (control of production and service provision) requires organizations to carefully analyze all facets of production—from call centers to computer numerical control machinery—to ensure the process is safe, efficient and capable of producing the desired outcomes.11 The required measurement and analysis activities in the subclauses are opportunities to use several lean techniques. In fact, lean is the natural tool for production or service-related improvement opportunities identified through the application of this subclause’s requirements.
  • Clause 8.3 (design and development) contains opportunities to use quality tools, especially in subclause 8.3.4 (design and development controls).12, 13 Furthermore, world-class design planning relies on including lean and other tools to ensure effective production techniques and zero-defect performance.
  • Clause 8.1 (operational planning and control), and especially subclauses 8.1.b and 8.1.d, are open invitations to apply many quality and production-related tools.14 This also is true for subclause 7.1.5 (monitoring and measuring resources) in which an organization is required to plan and implement an effective and appropriate measurement and calibration program.15
  • Subclause 6.1 (actions to address risks and opportunities) addresses the determination of risks and opportunities within the organization’s processes.16 This is a natural place to use process monitoring as input for applying quality tools to improve lagging results.

Ensuring survival

Many successful organizations use these methods. A QMS drives the use of quality tools, and each is designed to accomplish a specific task based on QMS input. But our metaphor has one last component—gathering needed nutrients to ensure the tree’s survival.

Perhaps the most fitting area in ISO 9001:2015 that encourages enriching, motivating and inspiring attention to detail is subclause 5.1 (leadership and commitment).17 Central to establishing and ultimately preserving the strength and purpose of an organization is the requirement that top managers demonstrate leadership and commitment with respect to a QMS, its purpose and the people who contribute to its success.


References and notes

  1. "What Is Six Sigma? iSixSigma.com, http://tinyurl.com/what-is-six-sigma.
  2. "ISO Survey, ISO.org, www.iso.org/iso/iso-survey.
  3. International Organization for Standardization (ISO), ISO 9001:2015—Quality management systems—Requirements, subclause 9.3.2—Management review inputs.
  4. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 9.3.3—Management review outputs.
  5. Ibid.
  6. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 9.2—Internal audit.
  7. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 9.2.2—The organization shall.
  8. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 10.2—Nonconformity and corrective action.
  9. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 10.3—Continual improvement.
  10. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 9.1.3—Analysis and evaluation.
  11. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 8.5.1—Control of production and service provision.
  12. ISO, ISO 9001:2015—Quality management systems—Requirements, clause 8.3—Design and development of products and services.
  13. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 8.3.4—Design and development controls.
  14. ISO, ISO 9001:2015—Quality management systems—Requirements, clause 8.1—Operational planning and control.
  15. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 7.1.5—Monitoring and measuring resources.
  16. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 6.1—Actions to address risks and opportunities.
  17. ISO, ISO 9001:2015—Quality management systems—Requirements, subclause 5.1—Leadership and commitment.

L.L. "Buddy" Cressionnie is the Americas Aerospace Quality System Committee (AAQSC) chair and AAQSC leader of requirements, projects and AS9100. He is active in standards development as a liaison member to International Organization for Standardization Technical Committee 176 Working Group 24 in writing ISO 9001:2015, and he serves on the U.S. Technical Advisory Group Interpretations Committee. Cressionnie worked for more than 30 years in aviation, space and defense and is a certified AS9100, AS9110 and AS9120 aerospace-experienced auditor.


Paul Palmes is principal consultant with Business Systems Architects Inc. He is chairman of the U.S. Technical Advisory Group to the International Organization for Standardization Technical Committee 176 (ISO/TC 176), and also chairman of ISO/TC 176, subcommittee 1, responsible for ISO 9000:2015. He is the author of Process Driven Comprehensive Auditing, second edition (ASQ Quality Press, 2009), and The Magic of Self-Directed Work Teams (ASQ Quality Press, 2006).


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