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 ApproachDan 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 9001:2015Ben 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 ProcessSusannah 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…………