Tag: ISO 9001 : 2015

Carnival of Quality Management Articles and Blogs – December, 2016

Welcome to December, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have already taken up the following topics for the familiarization of different elements of new version of ISO 9001-

For the present episode we will take a brief look at The Road beyond ISO 9001:2015.

Role as a Management Tool

The business performance has several dimensions. One can delve deeper into ISO 901: 2015 and can find ways and means to link up the standard with each of this business dimension. However, within the bounds of our present post, we will cover only a few selected examples that would serve as cases of illustration.

Role in The Strategy:

  • The Business of Innovation – Use ISO 9001:2015 to build innovation into your business strategy – There are still people who carry with them the outdated ideas of the standard and only think linearly… The updated ISO 9001:2015 requirements, more specifically “Leadership” (Clause 5), “Risk Based Thinking” (Clause 6) and “Context of the Organization” (Clause 4), have many components linking QMS standards to business management systems, leadership involvement, and strategic planning that were not previously required. The newly required alignment involves the entire organization, a more comprehensive approach to improved performance, process, and quality…
  • Harnessing Quality and Standards as a Business Strategy – Quality and standards are fast becoming strategic business imperatives in a rapidly evolving global economy. Learn how three local companies adopted standards to help them build trust, enhance their brand image and stay ahead of the competition.

Role in Business Process Management

Role in Financial Domain-related Issues:

Role in Sustainability:

Role in CSR domain:

  • Sarbanes – Oxley Act – Threat or opportunity for Quality professionals is a succinct treatise for CSR and Quality professionals to work in unison.
  • Leveraging ISO 9001 system to Sarbanes-Oxley compliance – Maureen McAllister – ISO 9001 and ISO 14001 are not financially focused. However, their systems, procedures and practices offer a ready-made platform to help demonstrate SOx compliance. ISO standards provide a vehicle for ongoing risk assessment and management. Their internal auditing requirements back up these procedures and assessments with cross checks that ensure proper practices are actually being followed. These standards can put some real teeth into SOx-required attestations about internal controls.
  • A Pathway to ‘CSR Excellence’: the roles of ISO 9000 and ISO 26000 – The paper discusses the roles of ISO 9000 and ISO 26000 quality and social responsibility standards in a journey toward Corporate Social Responsibility (CSR) Excellence.  ISO 9000 plays the role as an operational building block and the ISO 26000 that of a tool to review strategic positioning and operational maturity of organisations.
  • ISO standards for business – An essential link to integrated reporting  – Kevin McKinley 2011 –  Business cannot focus only on satisfying direct customers’ needs – stakeholders in all their forms are becoming more critical of businesses that do not adequately address expectations of good governance, environmental stewardship, sustainability and social responsibility…Standards deal not only with topical business issues, but can also provide rules and guidance for assessing how related business requirements are implemented. Such conformity assessment standards can provide benefits to all links in the value chain.

With this, we will conclude our current series of articles on ISO 9001: 2015 and the articles on elements of QMS that we had been pursuing in previous two years as well.

I plan to revert back to our original model of reviewing the articles/ blogposts on the current topics related to quality and /or quality management from January 2017.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice  in conjunction with ASQ Communications introduces Belur Nanjundiah Jagadeesh Prasad. Jadesh Prasad has applied his knowledge of quality creatively by composing several quality themed poems.

We now watch two of the latest ASQ TV  episode:

Jim L. Smith’s Jim’s Gems for the month of November, 2016:

6 Rules for Improved Standards : Standards can be a part of continuous improvement efforts, with a few key rules that should be considered whenJim's Gems working with internal documents or external standards.. Bottom line, we should encourage everyone to get involved in making standards the best they can be. It can really be a rewarding task to do because standardization is a significant component of an organization’s continuous improvement initiatives.

Clarifying Consensus, Surveys and Polls: How do we really know what people think? In trying to find out, there’s a lot of confusion created. Some of the confusion is intentional, some confusion is an unawareness of fundamental math, some of the confusion is created by a lack of understanding of what data is telling us, or maybe just simple lack of knowledge of how to collect the information.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

With best wishes for a very happy, healthy and meaningful 2017…

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

Carnival of Quality Management Articles and Blogs – November, 2016

Welcome to November, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have already taken up the following topics for the familiarisation of different elements of new version of ISO 9001-

For the present episode we will take an overview of Auditing.

training-internal-audit

Transition to ISO 9001:2015. What will the auditor ask? – Generally, when something changes, that will be what the auditor is going to focus on; the vindictive auditor will try and catch you out, to show they know more than you, and make themselves look good. The professional auditor will focus on the continual improvement approach and appreciate that management systems change and improve over time.

What Is Auditing?  – An audit can apply to an entire organization or might be specific to a function, process, or production step. Find more information in the video, The How and Why of Auditing wherein auditing expert and ASQ fellow Dennis Arter shares tips and advice for auditors and auditees.

The Positives and Pitfalls of Auditing Checklists  – Every auditing course you go on, every book you read about auditing, and every standard that’s been written essentially all say the same thing ­– if you audit you should use a checklist! Now that’s all good and fine, but there are some things to be aware of. The article goes on to explain the good and some of the pitfalls of checklists and then recommends some ways to address them.

Audits that See Below the Surface Evaluate Internal Controls – Peter Chatel draws up a very speaking line that can enable to evaluate the effectiveness of the internal controls in place, that include among other things:
• Defined responsibilities, accountabilities, authority and authorization
• Separation of Duties
• Policies, Programs and Procedures
• Personnel Experience and Development
• Protective Measures
• Internal Verification
• Documentation

Explaining E-Audits: A Method for Remotely Conducting Audits – Auditing expert Shauna Wilson explains how organizations can use e-auditing to remotely audit. Learn how this approach can lead to more efficient audits and what factors organizations must consider when implementing e-audits.

We have collected a few from slew of videos on the subject:

How to survive an ISO Audit

Quality Audit Preparation

What Not to Say during an ISO Audit Part 1 | Part 2 | Part 3

We will now take up a few ISO 9001:2015-centric articles and videos.

The Most Important Audit Questions for ISO 9001:2015 – By Craig Cochran, Project Manager, Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech – ISO 9001:2015 includes a lot of new requirements that have never been part of most audits. In order to expedite your thinking, these are what I believe to be the most important audit questions for ISO 9001:2015.

ISO 9001:2015 – The great leap forward for auditors! – It brings new challenges for auditors to apply their competencies and also brings great opportunity to accomplish their audits.

Objective Auditing Meets ISO 9001:2015 – How auditors can help organizations understand context and risk – Inderjit Arora  – Auditors must also understand how the context of an organization relates to quality management principles. If they do, then they will look for conformities in the management system to ISO 9001:2015 requirements. If during this audit they do find nonconformities based on requirements,

Auditing to ISO 9001:2015 – This presentation has spelt out what is required to be audited w.r.t. ISO 9001: 2015.

How the Auditors View ISO 9001-2015

Internal Auditing, an important type of audit, is seen to be in a different perspective, particularly in view of the structural changes in ISO 9001: 2015.

The Internal Auditing of Management Systems – Graham W Parker – Providing evidence for and confirmation of the confidence that operations are consistent, under control. Effective and efficient, is the primary role of auditing – by looking to the evidences to the contrary.

Preparing for ISO 9001: 2015 using your QMS – Part 5: Internal Audits – The subsection 9.2.2 goes on to be more detailed. Instead of “an audit program shall be planned, taking into consideration the status and importance…”, the new text includes, in part, “…the organization shall: a) plan, establish, implement and maintain an audit program(s)…which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization…”. The results of previous audits are also to be considered per the current requirement.

Five Main Steps in ISO 9001 Internal Audit  – If used properly, the Internal Audit, instead of being a “necessary evil,” can be one of the biggest contributors toward process improvement in the QMS.

And here are a few video clips related to internal auditing:

Understanding ISO 9001:2015: Internal audits

Meet the Internal Auditor

When I Say Internal Auditor, You Think

Internal Audit – Mastering ISO 9001:2015

7 Deadly Internal Audit Sins

Internal Auditing – A Love Story

How to Succeed as an Internal Auditor

Internal Auditing: A Career for Today, A Career for Tomorrow

Before we end our present discussion, here is one poser – Why Would you Want to be an Auditor?

For the concluding episode in this series, in December, 2016, we will take up The Road beyond ISO 9001:2015.

We will now turn to our regular sections:mr-pareto-head

ASQ CEO, Bill Troy in his ASQ’s Influential Voice has an interesting article as well: Interview With The Creator of Mr. Pareto Head, which is an absorbing interview with Mike Crossen, the creator of the Mr. Pareto Head comic strip. How a hard-core engineer finds humor in quality and how Mr. Pareto Head came to be has many other lessons for professional as well as personal lives. Meet “Mr. Pareto Head”

We now watch two of the latest ASQ TV  episode:

  • Around the World on a Bicycle, with Quality: While some of us only dream about quitting our jobs and traveling around the world, Sunil Kaushik did it. Kaushik, a Six Sigma trainer and consultant based in India, left his job to cycle the globe and teach quality along the way.
  • Gemba Walks Improve Process, Communication, and Culture: Eileen Serrano, Business Optimization Expert, Roche, describes the process her organization went through to establish daily Gemba Walks and how its culture has changed for the better.
  • Quality Memes: In social media lingo, a “meme” is a photo, video or idea that becomes extremely popular online. What better way to promote World Quality Month this November than to share quality-themed “memes”?
  • World Quality Month: Quality is about reliability, improvement and …fun? That’s right! During World Quality Month in November, meet a quality cartoonist and a man who’s sharing quality tools while cycling around the globe. Plus, learn how you can use social media to make quality jobs, tools and concepts accessible to the community beyond quality professionals. Sunil Kaushik’s Travel Blog: www.trainntrot.com World Quality Month Website: www.worldqualitymonth.org

Jim L. Smith’s Jim’s Gems for the month of October, 2016:

  • Leadership’s Five Key Practices: All quality professionals must practice leadership skills to add value – In order to demonstrate these skills, lookJim's Gems for opportunities that surround you every day. Do not wait for someone to ‘call your name.’ Be aware of what’s happening in your organization, raise your hand, and seize those opportunities. Start small but think big. After all, you have much to gain and little to lose.
  • Make IT Happen: You have to get yourself going, sort through all the noise and complexity, roll up your sleeves, get your hands dirty, and make it happen!

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

Carnival of Quality Management Articles and Blogs, September, 2016

Welcome to September, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have already taken up the following topics for the familiarization of different elements of new version of ISO 9001-

For the present episode we will look at Organizational Knowledge, in general, and then move over to what ISO 9001: 2015 has to state on the subject.

Before we closely look at the subject of change in the ISO management system standards, let us quickly recapitulate a broader view of the subject and look at some randomly selected picks from the vast literature available on the subject on the internet.

What is Organizational Knowledge

  1. Organizational knowledge is equated with professional intellect (Quinn, Philip, & Sydney, 1996). Organizational knowledge is a metaphor, as it is not the organization but the people in the organization who create knowledge

 Learn more in: Explicit and Tacit Knowledge: To Share or Not to Share

  1. The body of knowledge contained, but not categorized, within the members of an organization.

 Learn more in: E-Learning Design for the Information Workplace

  1. The organizational knowledge is created and transferred within the organizational context, is rooted in: (1) company and industrial atmosphere (King & Zeithaml, 2003), (2) tacit knowledge (Grant, 2002); and is fitted in firm culture (Saint-Onge, 1996).

Has the following properties: (1) is shared between the members of the organization (2) is connected to organization history, and (3) allows a common language.

 Learn more in: Critical Success Factors and Core Competencies

Defining Organizational Knowledge : The paper starts by defining what is meant by ‘knowledge’ and ‘knowledge management’, and follows on by presenting the knowledge processes which are at the basis of knowledge management practices.

Five Types of Organisational Knowledge : In Knowledge, Knowledge Work and Organisations: An Overview and Interpretation, Blackler builds on Polanyi’s distinction between tacit and explicit knowledge (in Polyani, 1967) and identifies five types of knowledge to be found in contemporary organisations. His ideas provide useful insights into the process of knowledge management. These conceptual distinctions were first suggested to explain the psychological and behavioural aspects of knowledge. They were later adapted to describe the different ‘images’ of knowledge within the organisation.

%d8%b2the-knowledge-pyramid

Knowledge Conversion : The organization should identify and nurture knowledge-building activities that expand and enhance its core competence.

Three Types of Organizational Knowledge:  Implications For The Tacit-Explicit AND Knowledge Creation Debates – Nancie Evans  and  Mark Easterby-Smith-  Lancaster University : The paper theorizes and represents organizational learning and knowledge management as a framework of organizational knowledge  consisting of three distinct knowledge types each with a tacit and explicit dimension.

Organizational Knowledge Sharing Practices : Organizational knowledge (vs. knowledge) has distinct characteristics given its action-centered, contextual and collective nature. It is composed of both explicit manifestations as well as intangible forms of knowledge. The choice of options to implement various knowledge sharing strategies, and enabling technologies, would depend on the forms of knowledge that are the most important to the organization.

Challenges in managing organizational knowledge : IBM Institute for Knowledge-Based Organizations has identified a number of important roadblocks that organizations typically face when implementing knowledge management programs. These roadblocks are:

  • Failure to align knowledge management efforts with the organization’s strategic objectives
  • Creation of repositories without addressing the need to manage content
  • Failure to understand and connect knowledge management into individuals’ daily work activities
  • An overemphasis on formal learning efforts as a mechanism for sharing knowledge
  • Focusing knowledge management efforts only within organizational boundaries.

Journal of Organizational Knowledge Management is a full-fledged journal which covers

the topics of interest, but not limited to:

  • Knowledge management empirical research
  • Knowledge management case studies
  • Knowledge management application is education
  • Legislative issues

Here are two pictorial views TQM way and Life-Cycle Approach, respectively:

tqm_modelknowledge_lifecycle_05

We now take up a few of the many articles available on internet dealing specifically with the subject w.r.t. ISO 9001: 2015.

ISO 9001:2015 Clause 7.1.6 Organizational Knowledge : By introducing the term “knowledge,” ISO 9001:2015 aims to raise organizations’ awareness of the management and linking of know-how in order to position them for the future.

ORGANIZATIONAL KNOWLEDGE AND ISO 9001-2015 – Raghu Malayanuru looks at other clauses where Organizational Knowledge is addressed, knowledge requirements of an organization, documents that may provide evidence of Organization Knowledge. Nacaro Williams in his studied comment, places more emphasis on reliance on the Notes to clause 7.1.6.

Organizational Knowledge Introduced in ISO 9001:2015  – Brian Reece –

ISO 9001:2015 defines requirements for the handling of organizational knowledge in the following four phases, which are analogous to the PDCA cycle:

  1. Determine the knowledge necessary for the operation of processes and for achieving conformity of products and services
  2. Maintain knowledge and make it available to the extent necessary
  3. Consider the current organizational knowledge and compare it to changing needs and trends
  4. Acquire the necessary additional knowledge.

ISO 9001:2015 and Effective Organizational Knowledge   – Andrew Holt analyzes the new organizational knowledge requirement in ISO 9001:2015 through the lens of SECI model.  

Image 1: The SECI Model (Nonanka & Takuchi, 1995).
Image 1: The SECI Model (Nonanka & Takuchi, 1995).

What is Organizational Knowledge in ISO 9001:2015? – It will be imperative that an organization performs its due diligence through risk management when determining what knowledge is necessary and how it is maintained and made available.

ISO 9001: 2015 – Organizational Knowledge Management Requirements Webcast

In this new webcast, standards expert and active member of the U.S. Standards committees, shares some insights on the new elements of knowledge management within ISO 9001:2015, and provides tips for meeting the requirements of documenting, tracking, and making value-added knowledge available, for the health and continuous improvement of the organization.

How to meet the Knowledge Management requirement within ISO 9001

  • As part of a Knowledge Management Strategy, you define your critical knowledge needs
  • You create a Knowledge Management Framework for your organization that ensures knowledge is created, discussed, captured, synthesized, and re-used. This framework contains the four critical enablers; Roles, Processes, Technologies, Governance. The contents, scale and complexity of this framework will vary enormously – from very simple (in the case of a small company) to sophisticated and complex for major multinationals.
  • You run a scan or audit of your critical knowledge topics, to ensure each of these is in an acceptably managed state

How to manage knowledge of the organization according to ISO 9001 – Mark Hammar – It is specific knowledge to the organization, generally gained by experience, which is used and shared to achieve the objectives of the organization. This can come internally, such as intellectual property, lessons learned from failure and successes, or the results of improvements; or it can come externally from conferences, customer knowledge, or supplier knowledge.

Knowledge Management and ISO 9001:2015 – This newsletter explores the implications of the ISO 9001:2015 knowledge clause, and how this can impact Knowledge Managers (and their Quality department colleagues) worldwide.

Organizational knowledge in ISO 9001:2015 – The ‘glass-half-full’ here is that Knowledge Management has started to appear in ISO 9001. The ‘glass-half-empty’ is that it is so very high-level in its stated requirement. It’s barely even a guideline.

7.1.6 Organizational knowledge – When implementing this clause or when explaining to the auditor, how this clause is implemented, some basic understanding of knowledge management can be useful.  Knowledge can be classified into two broad categories.

  • Explicit Knowledge or Formal Knowledge is one that can be formally documented
  • With Tacit Knowledge, people are not often aware of the knowledge they possess or how it can be valuable to others. Effective transfer of tacit knowledge generally requires extensive personal contact, regular interaction and trust. Example: how to ride bicycle.

Let us look at a few videos on the subject:

Organizational Knowledge

How to Manage Organizational Knowledge Effectively? by David Hershfield, SVP at Redcats

KM Audit & Measurement

Knowledge Management – Managing Tacit and Explicit Knowledge

ISO9001:2015 Transition Part 14: Organizational Knowledge, Job Insecurity, and Change Resistance

It appears to be quite an obvious case that the introduction of this subject as requirement has challenges at different levels, but is not yet fully deciphered as to how and to what it can be gainfully shown to have been implemented.  So, for the time being, we rest our discussions on the today’s topic here.

For the October, 2016 episode, we will take Control of Human Errors w.r.t. Quality Management, in the new versions of these management standards.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice ‘August Roundtable: Integrating Technical Quality and Human Management Systems’ has set the tone for our next month’s subject.

We now watch two of the latest ASQ TV  episode :

  • Quality and Sports – Learn about the ever-growing connection between quality and sports: How assessing one’s ability to adjust to failure can lead to better performance in athletics—and beyond.

Jim L. Smith’s Jim’s Gems for the month of August, 2016 does not have any article.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

Carnival of Quality Management Articles and Blogs – August, 2016

Welcome to August, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have already taken up the following topics for the familiarization of different elements of new version of ISO 9001-

For the present episode we will look at Change Management, in general, then move over to what ISO 9001: 2015 has to state on the subject, ending the present discussion with how two other major management system standards also look at the subject.

Before we closely look at the subject of change in the ISO management system standards, let us quickly recapitulate a broader view of the subject and look at some randomly selected picks from the vast literature available on the subject on the internet.

Change Management process has 5 key phasesAdaptive HVM Ltd.’s Change Management process has 5 key phases

Torben Rick’s blog on his website Meliorate, we find a full section dealing with is posts on change management. We have picked up four among these ones here:

Top 20+ awesome quotes on change management: Here are a couple of representative ones:

The key to change …… is to let go of fear – Rosanne Cash

People don’t resist change. They resist being changed! – Peter Senge

Top 12 reasons why people resist change. Again a pick at some:

Misunderstanding about the need for change/when the reason for the change is unclear

Fear of the unknown

Poor communication

Top 12 change management comic strips has quite a representative messages delivered through the medium of cartoon strips —

Top 12 change management comic strips

Organizations don’t change. People do – or they don’t

Organizations don’t change. People do – or they don’t

Change Management Iceberg

The change management iceberg suggested by Wilfried Kruger emphasizes that manager mainly consider the hard issues for change i.e. cost, quality and time. These issues represent only the tip of iceberg i.e. only about 10% of the total issues.

Most of the issues – soft issues – are below the surface.

Change Management Iceberg

Change affects 4 types of people in the organization:

  • Promoters – People those who support the change
  • Potential promoters – People who may support change when fully convinced
  • Opponents – People against change
  • Hidden opponents – People who appear to support change but secretly are against it.

Therefore attitudes – perceptions and beliefs, and behavior – power and politics, need to be managed.

There is additional related material too:

We also have picked up a few videos as well:

Overcoming Resistance to Change – Isn’t It Obvious? – The World with Theory of Constraints

Management of Change vs Change Management  – Life Cycle Engineering

How to Lead Change Management – DeAnne Aguirre, senior partner with Strategy&Buisness

Change Management vs. Change Leadership — What’s the Difference? – Dr. John Kotter

Kotter’s 8-Step Organizational Change Model – Steven Thomsen

How to Conduct a Management of Change (MOC) – Baker Hughes

We now move over to a closer look at how ISO Management System Standards address the subject:

5 Practices for Managing Change When ISO 9001:2015 Arrives – Terrance Holbrook, Senior Product Manager, MasterControl – While there is no single one-size-fits-all change management methodology, there are established practices that can be adopted and customized to better manage change and cultivate opportunity.

  1. Accept the changeManaging Change When ISO 9001-2015 Arrives
  2. Communicate change
  3. Engage employees
  4. Provide adequate training
  5. Introduce change gradually

ISO 9001:2015 Addressing Change : Once the organization has identified its context and interested parties and then identified the processes that support this linkage, addressing changes becomes an increasingly important component of continued success.

How change management is addressed in ISO 9001 2015 Standard? – Any change – may be it is in process, manpower, machinery, instruments, technology, raw materials, suppliers, customer requirements, legal requirements etc.…. shall be go through a defined change management process.

Change Management and ISO 9001:2015 – Raghu Malayanuru has described in details clauses of ISO 9001:2015 that focus on change management. For the purpose of maintaining brevity of our episode, we have listed out the clauses here:

  1. Clause 4.4.1( g);
  2. Clause 5.3 (e);
  3. Clause 6.3
  4. Clause 7.5.3.2
  5. Clause 8.1;
  6. Clause 8.2.1 (b);
  7. Clause 8.2.4
  8. Clause 8.3.6;
  9. Clause 8.5.6;
  10. Clause 9.2.2 (a)
  11. Clause 9.3.2 (b)
  12. Clause 10
  13. Clause 10.2.1(f)

The essence is captured here:

Change Management and ISO 9001_2015

ISO’s Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) has also published an explanatory paper – How Change is addressed within ISO 9001:2015

How to manage changes in an ISMS according to ISO 27001 A.12.1.2 – Antonio Segovia states that the requirement exists, but there are no particular instructions on how to implement the control (i.e., Change procedure is not a mandatory document), so in this article he suggests one of the ways to manage changes.

What is “Management of Change?” – Thea Dunmire explains requirements related to management of change were added in section 4.3.1 of OHSAS 18001: 2007…In addition, reference to Management of Change was also included in section 4.4.6.

These new requirements cover four important concepts:

  • Identification of the hazards associated with “change”
  • Assessment of the risks associated with “change”
  • Consideration of OH&S hazards and risks prior to the introduction of the “change”
  • Implementation of the controls needed to address the hazards and risks associated with the “change”

For purposes of management of change within an OH&S management system, the changes that need to be addressed include:

  • Organizational changes (e.g. personnel or staffing changes)
  • Activity changes (e.g. changes to processes, equipment, infrastructure, software)
  • Material changes (e.g. new chemicals, packaging)
  • Changes to the OH&S management system (e.g. procedures)

Ineffective management of change is one of the major contributing factors in many of the incident investigations conducted by the U.S. Chemical Safety and Hazard Investigation Board (CSB).  To check it out, go to the CSB web site at http://www.csb.gov  and enter “management of change” as your search term at the link “Search this Site.”

Change Management in ISO 14001:2015 – Ivana Strgacic states that unlike the changes in ISO 9001:2015, there is no “Planning of Changes” section.  So where can we find change management in the new standard?

The change all starts with the environmental aspects,

“When determining environmental aspects, the organization shall take into account: a) change, including planned or new developments, and new or modified activities, products and services;”

Once we identify the changed aspects, then there is a cascading or domino effect on the rest of the environmental management system.

While maintaining processes, it needs to underlined that some of the triggers that will result in a change to a process are:

  • changes to aspects,
  • changes to compliance obligations,
  • changes to controls.

Management review (element 9.3) requires the specific inputs of change into the process.  Specifically changes in:

  • external and internal issues that are relevant to the environmental management system,
  • the needs and expectations of interested parties, including compliance obligations,
  • its significant environmental aspects,
  • risks and opportunities.

The resulting output includes decisions related to any need for changes to the environmental management system systems, including resources.  Without managing change, the EMS cannot remain effective.  Change, through maintenance and continual improvement of the management systems, are the core tenets of the Plan-Do-Check-Act model.

We rest our discussions on the today’s topic here.

For the September, 2016 episode, we will take Organizational Knowledge in the new versions of these management standards.

We will now turn to our regular sections:

Among several update posts by ASQ CEO, Bill Troy in his ASQ’s Influential Voice we have picked up two ‘author interviews’ for our current episode:

It should be interesting to revisit one of the HBR classics, by Francesca Gino and Bradley Staats on the subject: Why Organizations don’t learn?

We now watch two of the latest ASQ TV  episodes that deal with ISO 9001: 2015:

  • Change Management – Change management experts discuss key steps to consider when approaching employees with change and helping them through the process. Learn about the carrot-and-stick technique—which can be used to motivate employees—and a tool that can make meetings more efficient and keep change management plans on track.

Read Sunil Kaushik’s Quality Progress article regarding the carrot-and-stick method as well as additional motivational strategies.
Watch the full interview and read the Quality Progress article about the Joint Commission’s improvement initiatives.

  • Explaining Annex SL and Top Management’s New Roles – Annex SL is considered the common language and text that new ISO standards are being built around. John DiMaria, senior product manager at BSI Americas, discusses how this affects ISO 9001:2015, as well as the standard’s new roles for top management with regard to responsibility, objectives and compliance.

Here are two more which also are very interesting points of view in understanding the present scenario:

  • Quality in India – This episode takes a look at quality in India, from the perspectives of leaders at the Quality Council of India (QCI) and the National Accreditation Board for Education and Training.
  • The State of Quality in India in 2015 – What’s the state of quality in India in 2015? Dr. Himanshu Trivedi, chair of ASQ’s local member community in Ahmedabad, India, reflects.

In Jim L. Smith’s Jim’s Gems for the month of May, 2016, we have –

Jim's GemsKey management support, or lack of support, manifests itself in many ways. One way is that mid-lower level management won’t get on board so initiatives encounter all sorts of hurdles; therefore, results don’t generally live up to expectations. .. Additionally less support for quality initiatives usually results in underfunding and cuts in resources. So what do you do.. (Please read on the article)..

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

Carnival of Quality Management Articles and Blogs – July, 2016

Welcome to July, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have already taken up the following topics for the familiarization of different elements of new version of ISO 9001-

For the present episode we will see how ‘Leadership’ in the Other ISO Management Standards’ is addressed.

Leadership – Leadership may therefore be the most important lever in an (ethical) system designed to support (ethical) conduct.

In The Expanding Role of Leadership in Management System Standards Chad Kymal states that new versions of ISO 9001, ISO 14001, and ISO 45001 set clear expectations. He also has drawn a broader canvas of the expanding role of the leadership in MSS.

In a very lucid white paper – The Importance of leadership in Management System Standards – BSI concludes that “many of the leadership responsibilities are contained in the standard text of Annex SL. So the principles and requirements for the other management system standards will be very similar, but with a focus onto the respective discipline, for instance environmental management or health and safety management.”

In Top Management Commitment: What Are The Standards , Syed Mahammud Wasif has postulated 10 initiatives that set the tone for the top management commitment.

Leadership for the Many, Not the Few – Beth Zimmerman states that all members of the Evans team are supported in exercising and strengthening their leadership skills in ways that align with their personal passions and Evans’ corporate goals. We also make additional investments to ensure that those with people-management responsibilities have strong skills in, and a consistent approach to, supporting those they manage in succeeding in their respective roles. Evans applies a mix of practices to bolster leadership – Coaching, Tools for Success, Mixed-level Teams, Internal and External Opportunities for Growth, Training for People Managers,

We also have a few videos on the subject:

  • ISO revisions – All about leadership in the new standards
  • Management and Leadership overview
  • Teaching leaders “What to Stop”

Obviously, before we can expect many more articles on the actual practices, we will have to wait for some more time as more and more organizations take up the implementations of the newer versions of these management system standards.

For the August, 2016 episode, we will take Change Management in the new versions of these management standards.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice has a guest article by Scott Rutherford – What Do We Expect from Senior Leaders? – that also looks at our current subject of leadership. Scott Rutherford recalls a 1986 Quality Progress review  by Dr. Joseph Juran.  The quote is:

“It is most important that top management be quality-minded. In the absence of sincere manifestation of interest from the top, little will happen from below.”

We now watch the latest ASQ TV  episodes:

In Jim L. Smith’s Jim’s Gems for the month of May, 2016, we have –

  • The Magic Ingredient for Success – is attitude! Successful people have a way of looking at things, a way of seeing obstacles as opportunities, and a way of “hanging in there” to make the most of every possibility. This is an attitude of positive affirmation that almost always guarantees success….The good news about attitude is that it can be altered, and we, not anyone else, are in charge of our own attitudes. What’s your Jim's Gemsattitude? If it’s not going to bring you success, then change it!
  • Where Should Organizations Focus their Greatest Efforts?… On Process or People? – Peter Drucker, the late author and management consultant, wrote that “neither technology nor people determine the other, but each shapes the other.” …..In planning how to evaluate claim data quality, building a framework of systems-thinking proved extremely helpful. Namely, the process principles of statistical thinking formed the conceptual foundation of a quality improvement plan which included: (1) All work occurs in a system of interconnected processes; (2) Variation exists in all processes; and (3) Understanding and reducing variation are keys to success….a translation from process to a greater attention on people suggests the following principles: (1) All work is done by individuals; (2) An individual’s work is variable; (3) Key to quality improvement is reducing variation by getting the right person into the right job….a predominant focus on people can lead either to management paralysis or to process tampering, when people are primarily held accountable…..Success stems from having the right processes and the right people in place. The development of this leadership style has been shaped by envisioning processes first and then providing people the opportunity to engage those processes.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

Carnival of Quality Management Articles and Blogs – June, 2016

Welcome to June, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have taken up familiarisation of different elements of new ISO 9001-

In the present episode, we will take up one more key change in the 2015 version of ISO 9001 – Leadership and Commitment.

What Does ‘Top Management’ Commitment Mean for Management Systems?

The article lists lot of actions, objectives and ‘ensuring’ for Top Management to do! Yes, such listing is just a superficial summary of the clauses from the ISO 9001 standard. For a detailed discussion on these specific requirements, their implementation or demonstrated effectiveness, a full-fledged article is called for.

How to comply with new leadership requirements in ISO 9001:2015 – Mark Hammar

In many ways, the leadership requirements in the (draft version of) the 2015 update to ISO 9001 are not new. ISO 9001 has always had the leadership importance of top management as one of the seven quality management principles that form the basis of the standard.

Here are some things that are important to show that top management has a commitment to the Quality Management System:

  • QMS effectiveness is measured, and management is involved in assessing this.
  • The Quality Policy and objectives are in place per management direction, communicated in the organization, and tracked for progress.
  • The QMS is part of the business processes, not a side project.
  • Resource needs are reviewed and addressed by management.
  • Continual improvement is promoted and supported by management.
  • There is a way to ensure customer, statutory, and regulatory requirements are understood and met, and people understand why this is important.
  • There is a management focus on customer satisfaction.
  • Organizational roles, responsibilities, and authorities are assigned, understood by the person who is assigned, and known to those employees who need to assess a person in a certain role.

Role of Top Management in ISO’s 2015 – Leadership or Management? – Cliff Poon

 Leadership - Cliff Poon

Leadership impacts behaviour of individual whereas Management focuses on processes.

Correlation matrices between ISO 9001-2008 and ISO 9001-2015

Leadership and commitment 9001-2015

ISO 9001 Responsibilities of Top Management is initiated right from the design stage and spans through the implementation and maintenance of the QMS after registration stage:

  1. Define ‘quality’ in the form of objectives to help internal communication of what is to be achieved (product and service requirements, process effectiveness and efficiency, customer perception etc.)
  2. Show that the business is central to the system: use your normal business language, not ‘quality’ or ISO 9001 terms.
  3. Produce a simple top-level, “big picture” of your business processes to show how the system improves results by focusing on the improvement of processes.
  4. Demonstrate your commitment to continual improvement by focusing on the next improvement and by taking it seriously.
  5. Show that the ‘quality’ approach is becoming instituted by integrating reviews into normal management cycles.
  6. Ensure that records are turned visibly into management information so that people keeping them understand their importance.

The Changing Role Of The Quality Management Representative (QMR)

“For increased leadership and commitment by top management to be successful, top management must not see quality management as an appendix in addition to the actual requirements of business processes”, explains Ulrich Wegner, Technical Head of TÜV SÜD Management Service GmbH. “Instead, quality management should be closely intermeshed with strategic planning and, where possible, the management control system, and thus with actual corporate management. To reach this goal, organisations must clearly define the roles and responsibilities of managers and executives in the field of quality management.”

Those rare organisations in which QMRs are still operating as ‘lone warriors’ will definitely need to undertake some adjustments to meet the requirements defined in the new ISO 9001.

10 Ways Leaders Can Drive Continual Improvement

  • State Your Belief in Continual ImprovementContinual-Improvement - 10 leadership ways
  • Explain Why Continual Improvement is Important
  • Empower, but be a Servant Leader
  • Participate in Continual Improvement Yourself
  • Ask for Continual Improvement Ideas and Opportunities
  • Don’t Require Every Improvement to be an Event or Project
  • Emphasize Small Ideas
  • Ask for More than Just Cost Savings
  • Look at Processes Instead of Blaming People
  • Keep Asking for Continual Improvement

Top Managers management of Management System

Management-of-Management-System Jan Olsson

A Management System is a tool for top management to enable successful business. Often this tool is managed by an Operational Development manager. Top management shall transform strategic directions, threats and opportunities together with stakeholder interests in to requirements on processes, organization structures and controls. Operational Development manager will design the details of the management system in close cooperation with operational management. Managers will drive and ensure utilization and performance will be monitored. Top management will then be involved in the evaluation of the Management System performance Review and additional or changed requirements will be given in order to improve the Management System.

Success without top management commitment?

Top Management

ISO 9001:2015 – Practical Leadership – .

Practical Leadershp-Website-Blog-In-Article

 

“True *Freedom* is not the absence of structure but rather a clear structure which enables people to work within established boundaries in an autonomous and creative way.” – Rosabeth Moss Kanter[i]

 

 

These video clips also help in understanding the subject :

Understanding ISO 9001:2015: Top management – Peter van Nederpelt

ISO 9001:2015 Leadership and Top Management Commitment – Warren Alford

ISO 9001 2015 Clause 5 Leadership

The new version of the management system standards now requires the organization’s top management to be far more proactive and involved. We will expand the subject and take up the ‘Leadership’ in the Other ISO Management Standards in our July, 2016 episode.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice had mentioned about ASQ’s World Conference on Quality and Improvement, held May 16-18, 2016 in Milwaukee. We now have the updates on the event:

Top 10 Books for Those New to Quality would prove to be a very handy reference to quality professionals of all hues:

  1. The Quality Toolbox, Second Edition by Nancy R. Tague
  2. The ASQ Quality Improvement Pocket Guide: Basic History, Concepts, Tools, and Relationships edited by Grace L. Duffy
  3. The ASQ Pocket Guide to Root Cause Analysis by Bjørn Andersen and Tom Natland Fagerhaug
  4. Process Improvement Simplified: A How-to Book for Success in any Organization by James B. King, Francis G. King , and Michael W. R. Davis
  5. The Certified Quality Improvement Associate Handbook, Third Edition: Basic Quality Principles and Practices edited by Russell T. Westcott and Grace L. Duffy
  6. Performance Metrics: The Levers for Process Management by Duke Okes
  7. The Memory Jogger 2, Second Edition: A Pocket Guide of Tools for Continuous Improvement and Effective Planning by Michael Brassard and Diane Ritter
  8. The Essential Deming: Leadership Principles from the Father of Quality by Joyce Nilsson Orsini PhD.
  9. Principles of Quality Costs, Fourth Edition: Financial Measures for Strategic Implementation of Quality Management edited by Douglas C. Wood
  10. Outcomes, Performance, Structure: Three Keys to Organizational Excellence by Michael E. Gallery and Stephen C. Carey

June, 2016 Roundtable: Employee Engagement discusses the question – To what extent do organizations engage employees about the importance of quality? How should companies approach this issue, and how can they avoid “sloganeering” and make a real difference?

We now watch the latest ASQ TV  episodes:

  • Employee Engagement: This episode discusses the importance of having engaged employees to boost initiative and creativity in the workplace, which ultimately leads to breakthrough performance. Determine whether changes are necessary in your business operations.

Workplace spirit: LINK
Maintenance Required: LINK

  •  Alternatives to Brainstorming: Carol Knight-Wallace, principal, Knight Vantage Consulting, says the traditional form of brainstorming is no longer effective. In this brief interview, Knight-Wallace, explains why you should look to other forms of brainstorming and what you should be looking for in the tool.
  • 2016 ASQ World Conference Recap on Quality and Improvement

In Jim L. Smith’s Jim’s Gems for the month of May, 2016, we have –

  • Use Six Sigma Selfishly – Quality professionals should apply DMAIC six sigma processes to enhance their careers.

Jim's GemsFirst, define your career’s purpose and scope. Then determine how you are going to reach these milestones. Write down actions to needed to make the adjustments. Assess your current situation w.r.t. the requirements for attaining the milestones so as to identify the gaps. Now analyze your career process using these two important questions: do you now know better where you stand; and how to get where you need to be in order to fulfill your career goals? In this stage, it is helpful to involve a friend or mentor. An outsider can often help determine whether you have taken the appropriate steps or how realistic your process has been up to this point. In the control phase the challenge is to maintain your progress by learning from the past.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

[i]  Rosabeth Moss Kanter at TEDxBeaconStreet : Six Keys to Leading Positive Change

Carnival of Quality Management Articles and Blogs – May 2016

Welcome to May, 2016 edition of Carnival of Quality Management Articles and Blogs.

We have taken up familiarization of different elements of new ISO 9001-

December, 2015: the changes in the Revision of ISO 9001 (:2015)

January, 2016: Process Approach in 9001:2015

February, 2016: Risk-Based Thinking in 9001:2015

March, 2016: Risk-Based Thinking – a general perspective

April, 2016: Context of the Organization in ISO 9001: 2015

In the present episode, we will take up an important element of the Context of the organization – The Relevant Interested Parties.

The Cambridge Business English dictionary defines Interested Parties  as ‘any of the people or organizations who may be affected by a situation or who are hoping to make money out of a situation’.

For the purpose of the ISO Management System standards, an interested party is anyone who can affect, be affected by, or believe that they are affected by a decision or activity.

any of the people or organizations who may be affected by a situation, or who are hoping to make money out of a situation any of the people or organizations who may be affected by a situation, or who are hoping to make money out of a situation.

Intersted Parties 2

ISO 9001:2015 – Interested Parties – Sara Gulo – So far in the evolution of this standard through the years and through the different stages of development, the customer has been almost the sole focus, mentioning suppliers, employees and regulators as carriers of key requirements but not specifically involving any other entity that could have had an impact on the actual results achieved. Not even owners of the organization….the new standard drills deeper in the risk based thinking, widening the view for all probable actors that could pose any risk to the customer. That is why interested parties were included in the new standard: they are probable sources for risks for customers. Consequently they matter and their requirements shall be considered.

Interested parties could be split into three different groups:

– Usually enforced interested parties: this group includes those stakeholders that could seldom be disregarded because of their usual impact on outcome and customer satisfaction such as customers (obvious), employees, suppliers, owners, and regulators, all them in different shapes and modalities.

– Possible interested parties: this group includes those stakeholders that could or could not affect the outcome and customer satisfaction such as unions, banks, neighbours, etc. but it could be valid to analyse their eventual impact.

– Openly interested parties: this group includes those stakeholders that for some reason the organization believes they are important to assure the outcome and customer satisfaction, even though its relationship is not that obvious.

How to determine interested parties and their requirements according to ISO 9001:2015 – Mark Hammar – The ISO 9001:2015 standard has several requirements that involve the knowledge you have acquired when determining the relevant interested parties and their requirements

  • The QMS scope needs to include the requirements of relevant interested parties (Section 4.3).
  • The Quality Policy is to be made available to relevant interested parties when appropriate (Section 5.2.2).
  • Measurement traceability needs to be maintained when this is an expectation of relevant interested parties (Section 7.1.6).
  • Requirements for products and services may need to include those from relevant interested parties (Section 8.2.3).
  • Design and development activities need to take into account requirements of relevant interested parties, including how much control is expected in the design and development process (Section 8.3).
  • Management review needs to include issues that concern relevant interested parties (Section 9.3).

Are all interested parties equally interested in the organization?  – Once you have identified the interested parties the next step you can take is to analyze these interested parties on two parametersPower vs. Interest model (the standard does not require this but this might help you in understanding your interested parties better).

  • Power
  • Interest

Depending upon these two factors you can choose the appropriate approach. Stakeholder analysis is typically used in the project management.

We have also picked up some video clips on the subject:

Understanding ISO 9001:2015: Interested parties –

How you can decide and demonstrate which interested parties are relevant to your Quality Management System and / or your Environmental Management System?

– Dixon Brian

Alar Sistok

How to make an analysis of interested parties?

The new version of the management system standards now requires the organization’s top management to be far more proactive and involved. We will take up, the Leadership in the ISO Management Standards in our June, 2016 episode.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice talks about ASQ’s World Conference on Quality and Improvement, held May 16-18 in Milwaukee. We will have an update on the event in our June 2016 issue.

We now watch the latest ASQ TV  episodes:

  • The Voice of the Customer – This episode discusses converting the voice of the customer (VOC) into critical-to-quality-characteristics by looking at how to make the perfect cup of coffee. You’ll also learn how social media has amplified today’s VOC, and how organizations are responding to and leveraging online customer information with big-data analysis.

In Jim L. Smith’s Jim’s Gems for the month of April, 2016, we have –

  • Quality Professionals Should Lead the Parade – It is not uncommon to blame senior management Jim's Gemsfor most of what ails an organization. However, it is past time to rethink this attitude! The ultimate question is: “Are you prepared and willing to put in the time and effort to demonstrate the power of the basic quality techniques?” Are you ready to lead the parade or do you find it easier to complain?
  • Remain Determined – If you’ve ever been disappointed by the results of your first effort to “take something on,” that’s no reason to quit. As James Whitcomb Riley says, “The most essential factor is persistence—the determination never to allow your energy or enthusiasm to be dampened by the discouragement that must inevitably come.”
  • Give Your Best – When there’s a job to be done, do more than just getting it done. Do remember what John Wooden, the great basketball coach, said, “Just do the best you can. No one can do more than that.”[i]

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites who have the copyrights for the respective images.

[i] The Difference Between winning and Succeeding

Carnival of Quality Management Articles and Blogs – April, 2016

Welcome to April, 2016 edition of Carnival of Quality Management Articles and Blogs.

We commenced the familiarizing ourselves with the changes in the Revision of ISO 9001 (:2015) with the December, 2015 episode of our blog carnival. Then, in the January 2016 episode, we took up Process Approach in the 2015 revision of the standard, as our first topic. In February, 2016, we had taken up first part of Risk-Based Thinking that primarily addressed the concept as has been taken up in ISO 9001: 2015, followed by Risk-Based Thinking, in the general perspective in March, 2016,

Now, in this month’s episode we will take a look at the subject that aims to align the organization’s QMS with the Context of the Organization.

Context of the Organization & ISO 9001:2015 – Kevin Gholston –

According to the Merriam Webster Dictionary the word “context” has the following meaning:

context
noun con·text \ˈkän-ˌtekst\

The words that are used with a certain word or phrase and that help to explain its meaning; the situation in which something happens; the group of conditions that exist where and when something happens

Full Definition of CONTEXT

1:  the parts of a discourse that surround a word or passage and can throw light on its meaning
2:  the interrelated conditions in which something exists or occurs

Context-of-the-Organization-Overview

What is the Context of the Organization? – Itay Abuhav –

The context of the organization, in the ISO 9001:2015 is the set of functions, processes, inputs and outputs and limitations that creates the business environment of an organization. It is how business entities (functions or subsystems –intern or external) of an organization relate together and how the information travels through these elements.

The context of the organization is shaped through the integration of the business entities. The ISO 9001:2008 expresses it with the words” the relation and sequences between the main processes” (Chapter 4.1,b) and requires for example a diagram that describes those relations.

Context of the Organization

How to identify the context of the organization in ISO 9001:2015 – Strahinja Stojanovic

Context of the organization is a new requirement in ISO 9001, stating an organization must consider both the internal and external issues that can impact its strategic objectives and the planning of the QMS. It pretty much changes the concept and application of clause 4. Requirements regarding the context of the organization do sound a little bit vague, so what does this clause actually require?

Clause 4 of ISO 9001:2015, Context of the organization, requires the organization to evaluate itself and its context. This means that you need to define influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It is also a means to detect risks and opportunities regarding the business context.

Where to start?

First, you need to determine which of the new requirements are already met in your existing documentation, because some of the requirements related to the Quality Manual in ISO 9001:2008 are now transferred into this new clause

To determine external context, you should consider issues arising from its social, technological, environmental, ethical, political, legal, and economic environment. Examples of external context may include:

  • government regulations and changes in the law
  • economic shifts in the organization’s market
  • the organization’s competition
  • events that may affect corporate image
  • changes in technology

Basically, all this information is in the heads of the CEO and other members of management, but it was never put on paper; the best way to gather it is by organizing some brainstorming. Systematization of all this information can be very valuable and demonstrate where you stand as an organization.

ISO 9001:2015 Revision Explained: ‘Context of the Organisation’ – by Alastair Atcheson

While there is no prescribed method of determining the context of the organisation in relation to the ISO 9001, a simple and pragmatic approach to understanding your organisation’s context consists of four steps:

  1. Identify the internal issues that can affect your organisation’s products, services, investments and interested parties.
  2. Identify the external issues that can affect your organisation’s products, services, investments and interested parties.
  3. Identify who are the interested parties and what are their requirements.
  4. Institute a system for regular review and monitoring of the internal issues, external issues and interested parties as identified above.

Internal issues can include the organization’s

  • regulatory requirements
  • strategies to achieve its policies and objectives
  • relationship with its staff and stakeholders, including partners and suppliers
  • resources and knowledge (e.g. capital, people, processes and technologies)
  • internal risk appetite
  • assets
  • product or service
  • Standards, guidelines and models adopted by the organisation
  • information systems

ISO 9001:2008 vs. ISO 9001:2015 – Context of the Organization By Itay Abuhav

With the ISO 9001:2008 it is necessary to evaluate whether the organization’s quality management system follows the general requirements. Wr.t. the ISO 9001:2015 and the requirements of  context of the organization – the organization shall analyze which issues (external as well as internal) that may affect its QMS or already have an effect.

Context-of-the-Organization - tongue in cheek view

Context of the Organization” and the Power of SWOT Analysis

ISO9001-2015_at__a_glance-CLAUSE4_SWOT

We will take up, “Interested Parties”, one of the vital considerations for understanding the ‘Context of the Organization’, in our May, 2016 episode.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice blog-column, has presented a roundtable discussion on the Voice of Customer – What exactly should voice of the customer mean to the quality professional? How important is it? What are the best ways to gather it?.  Luciana Paulise discusses some new tool to capture the voice of the customer. Pam Schodt considers the best way to gather VoC standards is through face-to-face meeting followed up by written and verified specifications. To Dr, Suresh Gettala, key is to hear from horse’s mouth and not to surmise about what the customer wants. Luigi Sille attaches equal importance to data gathering its use

We now watch the latest ASQ TV  episodes:

  • Metrics for Management – Tim Adams, Engineering Assurance Specialist, NASA, spent a few minutes with ASQ TV to talk about some of the main ideas of his 2015 ASQ World Conference on Quality and Improvement presentation. In this interview, Adams discusses some of the finer points of identifying and using metrics.
  • Benchmarking – Today, we’ll learn the basics of benchmarking, review the recommended six phases of a successful benchmarking process, and finally, we’ll get reacquainted with one vital ingredient in benchmarking: metrics.
  • The Torque Chain of Quality Large – For more information go to www.srtorque.com   Daily torque testing is becoming more common place because it makes good business sense. But is daily testing error proofing? No, and far from it. …. If your torque wrench is out of spec, using a torque wrench to prevent errors only leads to a false sense of security. What if the torque tester you are using is out of spec and you don’t know it?   This video and the subsequent series take you through every link in the chain of quality in order to help you understand all the places where the wheels can fall off. Specifically it takes a look at the places we tend to overlook or take for granted.

In Jim L. Smith’s Jim’s Gems for the month of March, 2016, we have –

Jim's Gems♦ Integrate DFSS with Existing Design Processes – Many organizations make a mistake when trying to replace their design process with Design for Six Sigma. DFSS was never intended to completely replace an organization’s existing design process.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Note: The images depicted here above are through courtesy of respective websites, and have the copyrights for the respective images.

Carnival of Quality Management Articles and Blogs – February 2016

Welcome to February 2016 edition of Carnival of Quality Management Articles and Blogs.

We commenced the familiarizing ourselves with the changes in the Revision of ISO 9001 (:2015) with the December, 2015 episode of our blog carnival. Then, in the January 2016 episode, we took up Process Approach in the 2015 revision of the standard, as our first topic.

Now, in this month’s episode we will look up as to how Risk-Based Thinking has been addressed in the 2015 revision of the standard.

We first take up the what the Standard itself states in Clause A.4, sub clause 0.3.3 of this concept –

Risk-based thinking is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analyzing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.

To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects.

Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.

Risk Management is the foundation of ISO 9001_2015

As its continuing initiative, to explain the new concepts in the revision of the Standard, ISO/TC 176/SC2 has presented on its site –

In the revised standard, ISO 9001: 2015,

  • in Clause 4.1 the organization is required to determine the risks which can affect its ability to meet these objectives
  • in Clause 1.2 top management are required to commit to ensuring Clause 4 is followed
  • in Clause 1 the organization is required to take action to identify risks and opportunities
  • Clause 8 – the organization is required to implement processes to address risk
  • Clause 1.3 and 9.3.2 the organization is required to monitor, measure, analyze and evaluate the risks and opportunities
  • In Clause 10 the organization is required to improve by responding to changes in risk

ISO 9001:2015 – Risk based thinking – Declan Cahill – Risk Based thinking is now present in so many standards….Examples include – ISO 14971, OHSAS 18001, ISO 14001 and ISO 31000. For most organizations, it is a mind-set that many are comfortable communicating and operating with on a daily basis.  By alignment with these standards, the ISO 9001 standard itself is being continually improved in order to minimize the work involved where requirements of various standards are integrated…..Where there are risks and the enterprise has put in actions or fixes to prevent or minimize the occurrence of these specific risks, every enterprise should be careful to consider how strong these fixes are and what these fixes are dependent on, i.e. human behavior, infrastructure & utilities.

Risk 4.1

“Risk Based” vs. “Threat Based” Thinking – Risk based thinking is entrenched in historical facts. It examines the past for clues to the future. Risk based thinking operates under the premise that if it has not happened in the past then it is not likely to happen in the future…..Threat based thinking is formed when it is understood that just because an event has not occurred in the past, that does not rule out the potential for it to occur in the future.

Risk - Lewis2005

A risk-based-thinking-model for ISO 9001: 2015 – Bob Deysher states that the concept of “risk” in the context of international standards relates to uncertainty in achieving the core objectives of the standards, viz. to provide confidence in the organizations’ consistent ability to provide customers with conforming goods and services and to enhance customer satisfaction. The risks and opportunities have to be identified in the context of the organization.

ISO 9001:2015 – Risk Based Thinking – One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to risk, rather than treating it as a single component of a quality management system. Risk-based thinking is something we all do automatically and often sub-consciously. e.g. if I wish to cross a road I look for traffic before I begin. I will not step in front of a moving car. Risk-based thinking is already part of the process approach. e.g. to cross the road I may go directly or I may use a nearby footbridge. Which process I choose will be determined by considering the risks. Risk-based thinking makes preventive action part of the routine. Risk is often thought of only in the negative sense. Risk-based thinking can also help to identify opportunities. This can be considered to be the positive side of risk. Crossing the road directly gives me an opportunity to reach the other side quickly, but there is an increased risk of injury from moving cars. The risk of using a footbridge is that I may be delayed. The opportunity of using a footbridge is that there is less chance of being injured by a car. Opportunity is not always directly related to risk but it is always related to the objectives.

Risk-Based Thinking and ISO 9001:2015 – Chad Kymal and R. Dan Reid – Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO)… SO 9001 focuses on “risk-based thinking,” although it stops short of actual “risk management.”…. In ISO 9000:2015, “Quality management systems—Fundamentals and vocabulary,” risk is defined as the “effect of uncertainty.” Notes in the definition further describe risk as a “deviation from the expected,” either positive or negative. The term “uncertainty” is clarified as a lack of information or knowledge about an event that can be expressed in terms of consequences the likelihood of occurrence. Lastly, ISO 9000 states that risk is related to potential events, and that it’s typically expressed as a result of the likelihood and consequence of such an event…..Risk appears in the normative parts of ISO 9001 eight times, and risk-based thinking appears once. Risk and risk-based thinking appear many times more when we study the informative portions of the standard.

Here is a video of the Interview with Chad Kymal: Risk-based thinking and ISO 9001:2015,

Some more videos on the subject:

Corrective or Preventative Action – The new risk based methodology for ISO 9001:2015?

The Process Approach and Risk-Based Thinking – posted by T. D. Nelson – this webinar provides a more general education about the process approach and risk-based thinking as well as their implications for quality management system definition, documentation, and assessment.

We have far more material than what can be accommodated in one post. So we will continue our discussion on the subject of Risk Based Thinking in ISO 9001: 2015 in the March, 2016 episode as well.

We will now turn to our regular sections:

ASQ CEO, Bill Troy in his ASQ’s Influential Voice blog-column, in Changing Company Culture: December Round Up, takes up Luciana Paulise’s views about what determines organizational culture and how factors define a company’s culture and sums up the reflections of Influential Bloggers on how culture is changed within an entire organization in response of Luciana’s ideas.

He also presents a guest post, Evolving Quality to Enable and Support a Global Digital Organization by Prem Ranganath, who blogs @ The Art of Quality. In Prem Rangnath’s experience, the top three trends that shaping the future of quality in IT, based on current and emerging customer expectations are:

  1. Quality has a strategic role in enabling successful digitization and digital product management
  2. Focusing on a Minimum Acceptable Product (MAP) is important for Minimum Viable Products (MVP) to succeed
  1. Expectations for quality are increasingly focused on collective experiences

We now watch the latest ASQ TV episode:

Advice for Quality Careers – In this episode, learn why quality can benefit anyone’s job, how to develop qualifications employers seek in quality professionals, and see why salary trends are looking up for jobs in quality…

In the third year of ASQ TV, please take a moment to complete this brief survey. Your feedback is vital to the ASQ TV continuous improvement plan. Take the survey

Whilst on the subject of Quality as a career, tips for others in the field, and how Michael Jordan relates to the quality profession, read Jim Gem’s “13 Steps to Get Ahead”

In Jim L. Smith’s Jim’s Gems for the month of January, 2016, we have.

Jim's Gems

  • Four Thoughts about Selling Ideas – “In my work with quality professionals, I am constantly amazed at how many lament that their wonderful ideas did not see the light of day because ‘short-sighted’ management didn’t endorse them.”
  • Choose to Make This Year Great – To have the best year you’ve ever had, live each of the coming days as the best person you’ve ever been.
  • Think Positively, Then Do It! – To achieve your dreams and aspirations, choose to put your time and energies into living and working toward your highest intentions.

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………

Carnival of Quality Management Articles and Blogs – January 2016

Welcome to January 2016 edition of Carnival of Quality Management Articles and Blogs.

In the previous episode of our blog carnival, we have taken up an overview of the changes in the just published Revision of ISO 9001 (:2015). From the present episode, every month we will take up each key change individually for a closer look.

We first take up the most fundamental underlying concept – Process Approach..

The present version of the standard now “promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. {Ref: Introduction – Clause 0.3.1} The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

Schematic representation of the elements of a single process
Schematic representation of the elements of a single process

The ISO Technical Committee 176 has published a paper The PROCESS APPROACH in ISO 9001: 2015 (ISO/TC 176/SC 2/N1289) and a detailed presentation on the PROCESS APPROACH in ISO 9001:2015

ISO’s Process Approach also lucidly presents concepts like Process Approach, Process Definition, Process Examples, Inputs and Outputs – outputs could include not only services, software, hardware, and processed materials, but also decisions, directions, instructions, plans, policies, proposals, solutions, expectations, regulations, requirements, recommendations, complaints, comments, measurements, and reports. Clearly, an output could be almost anything – Process interactions, Process-based QMS.

Three Ways ISO 9001:2015 Will Encourage a Process Approach – Dan Nelson –

Instead of being suited to ISO 9001, a QMS is supposed to be suited to the unique operations of an organization. A process approach demands that an organization’s real, operational; core processes are developed in accordance with the “plan” phase of the plan-do-check-act cycle (PDCA). These are the processes needed for a QMS.

Second, also in the ‘Introduction, sub-clause 0.3 -Process approach’, the standard explains that the process approach is based on the PDCA cycle, mentioning W. Edwards Deming by name.

Finally, in ISO 9001:2008 sub-clause 4.1—General Requirements, contain requirements seemingly adequate to verify whether a process approach has been applied.

Process Approach

QMS is made up of a network of value-adding processes, like Customer Oriented Processes (COPs), Support Oriented Processes (SOPs), Management Oriented Processes (MOPs), Quality Managed Processes (QOPs), Outsourced Processes (OPs) that link, combine and interact with one another to collectively provide product or service. These processes are inter-dependent and can be defined by complex interactions. In order to plan and implement QMS using the ‘Process Approach’, one must:

  • Identify the processes needed for the QMS.
  • Determine their sequence and interaction (show the sequence and interaction of COP’s). There are many ways to document this, e.g., a high level flowchart or a process map.
  • Determine the application of QMS processes throughout the organization (show how MOP’s; SOP’s and QMP’s are applied to each COP and to each other). There are many ways of documenting this. A popular way is through graphical representation, e.g. process maps.
  • Determine (plan) the criteria, methods, information, controls and resources needed for each QMS process.
  • Identify the internal/external customer-required output.
  • Describe the process activity that produces the output.
  • Identify the resources needed for the process activity.
  • Identify the inputs for the process – information, materials, supplies, etc.
  • Define the process methods, procedures, forms etc., that may be needed to produce the output.
  • Define the controls to prevent or eliminate risk of errors, omissions, or nonconformities in process activity. controls may come from the IS standards; customer; regulatory and your own organizational requirements
  • Interaction with sources that provide the inputs (internal process or external supplier), uses the output (internal process or external customer), or provide the resources (internal support process) to perform the process activity.
  • Implement QMS according to the plan.
  • Monitor, measure and improve each QMS process and its interaction with other processes. Performance indicators to monitor and measure process performance may come from the IS standard, customer, regulatory and organization’s own requirements. Performance indicators may relate to the process output as well as the process activity.
  • Performance indicators for process output must focus on meeting customer and regulatory requirements. Performance indicators for process activity should focus on measuring process effectiveness and efficiency.

PROCESS MANAGEMENT REQUIREMENTS IN ISO 9001 (2015) – Lennart Brandt -By application of the definition of “process”, the number of processes concerned by the requirements in ISO/CD 9001 could be considered to be at least about 275.

ISO 9001:2015 – The Process Approach Approacheth – focuses on the new standard’s “process approach” requirements, how it differs from the current version, and the many problems companies and auditors will have interpreting it.

ISO 9001 series, Part 3: The Process Approach in ISO 9001:2015 – Ben Saxton, Business Development Manager and Alastair Atcheson, Digital Marketing Executive @ Qualsys – Auditors should be looking at the effectiveness of processes over exact compliance to procedure. This is in line with PDCA, which forms a basis for the process approach to begin with. A process approach is the best way to manage a QMS, not just in terms of the audit process, but as a business strategy in general. Auditors and organisations alike should remember that the process approach is being emphasised because fundamentally, it makes sense.

The Joy of Process – Susannah Clarke says a process approach can inspire innovation and creativity – In Morecambe & Wise Make Breakfast, watch the brilliant example of how a process approach inspires innovation and creativity:

We will now turn to our regular sections:

Future of Quality - Report - 2015Since 1996, ASQ has published seven issues of the Future of Quality Report. The latest edition explores 11 topic areas—already impacting consumers, businesses, and society—that will have a profound effect on the future of quality. These thought-provoking, personal, and detailed essays are written by distinguished experts from around the world. The “2015 ASQ Future of Quality Report: Quality Throughout” challenges, enlightens, and sparks action. ASQ CEO, Bill Troy ASQ’s Influential Voice in Top 11 Insights From ASQ’s Future of Quality Study has compiled the “key” insights from each of the 11 essays in the Future of Quality research.

We now watch the latest ASQ TV episodes:

Strategic Thinking – Business Skills – In this ASQ® TV episode, the concept of strategic thinking is examined. Learn how strategic thinking varies in theory and practice and be introduced to the analytic hierarchy process—a method that breaks down decision making into a series of comparisons. Watch now:

Strategy and Leadership: In this episode, learn a four-step method for setting organization-wide strategy that fosters employee engagement and empowerment, and get ideas for structuring your organization and communicating strategy … to employees to help achieve success. Read: Peter Merrill’s QP article on self-managed teams.

Making Strategy Visual – It is essential your staff connect goals, metrics and projects to get them engaged in the organization’s strategy. Hear how North Bay Regional Health Center in Ontario achieves this important goal by making strategy visual to employees and customers.

We would add Jim L. Smith’s Jim’s Gems as our regular feature from this month.

Thought PowerJim's Gems: Choose to think the best about yourself, your world, and those people who are there to support you.

Dealing with Challenges:  Learning to overcome our challenges is what builds character and resilience.

Embrace efforts: Decide to embrace and enjoy the effort, and you’ll reap wonderful benefits from it.

20 Most Popular Posts on the Curious Cat Management Blog in 2015

I look forward to your active participation in enriching the blog carnival as we pursue our journey in exploring the happenings across quality management blogs…………