May 09, 2015

As the world awaits the new ISO 9001 standard a closer examination of the Draft International Standard [DIS] version shows ISO/TC 176 is determined to retain the Quality Management System focus.

The reluctance to ignore the reality of the global environment allows organizations, consultants and Certification Bodies/Registrars the opportunity to ignore the link between Quality and the everyday business operational activities.

ISO Standards were created to add value and benefits to organization’s who adopt them

ISO standards certainly have the ability to add value, however to add value it requires the organization to consider a number of key issues, namely:

The needs and expectations of its stakeholders and to develop a framework to prioritize these needs and expectations

Quality like finance needs to be an integral part of the organization’s strategic/ or business plan

The organization needs to achieve alignment between the needs and expectations of the stakeholders the strategic/business plan objectives and goals

Top Management needs to become masters of the organization’s process

Organization culture and the behaviour of individual’s working for and on behalf of the organization needs to be given equal weighting to the organization’s document management system

The role and responsibility of middle management and the supervisor/team leads needs to be revisited if tangible benefits are to be achieved from deployment of the Quality Management System

We will now in turn take a closer look at each of these issues.

The needs and expectations of stakeholders and a framework to prioritize these needs and expectations

All too frequently the organization’s QMS does not address the needs of its primary stakeholders. In fact, the organization’s QMS frequently is not linked to the organization’s strategic and business plan. Until the organization’s QMS objectives meets the needs of its stakeholders and is linked to the organization’s strategic and business plan, top management will not see what’s in it for them and more important the culture of the organization will not change.

The result is top management will continue to play a passive role in the organization’s QMS and Quality continue to operate in the second division league in the eyes of management. Finance continues to remain king in the world of business and public sector organizations. What is required is a paradigm shift, where Quality is given equal priority to finance. Top management need to deploy a framework for identifying the needs and expectations of stakeholders, e.g. Hoshin Planning or a balanced scorecard.

The framework should also incorporate risk management using a risk management technique based upon ISO 31010, where top management identify the risks associated with fulfilling its Quality objectives and where an organization risk register is maintained.

Top Management needs to become masters of the organization’s process

The primary purpose of the QMS is aimed at measuring performance and continually improving the effectiveness of the Quality System across the organization’s value chain processes to achieve consumer satisfaction.

ISO defines a process as “Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process”. Between them activities, input and processes make up three of the five elements of a process.

Each process has an owner [Top Manager] responsible for defining, implementing, monitoring and improving it in line with the Continual Improvement principle.

ISO/DIS 9001:2015 is a process based management system standard. ISO/DIS 9001 has its own process model. The process model has not fundamentally changed.

However there are two other and arguably more potent process models organization should consider adopting, namely the business school model where the processes of the organization are grouped into three processes, namely core or value chain processes, support processes and management processes.

There are also industry specific process models, specifically the automotive process model where processes are grouped into customer orientated processes [COPS]; support orientated processes {SOPS] and management orientated processes [MOPS]. The main primary advantage of the latter processes is they arguably enjoy better top management commitment, they facilitate alignment between organization goals and processes and they also facilitate strategic risk management.

ISO/DIS 9001:2015 clause 4.4 a/b requires the organization to identify the processes needed for the QMS, including the sequence and interaction of those processes. However unlike industry specific ISO Quality Management System standards, specifically ISO/TS 16949, the automotive Quality Management System, and ISO EN 9100, the aerospace Quality Management system, ISO/DIS 9001:2015 fails to mandate organization’s adopt process management methodologies like SIPOC, Turtle when defining and documenting their processes. Without the use of appreciate process management methodologies or tools alignment with the organization’s strategic and business goals becomes challenging.

ISO/DIS 9001:2015 clause 4.4c requires the organization to determine the criteria, methods, including measurements and related performance indicators needed to ensure the effective operation, and control of these processes. What is required here is the organization to identify suitable process indicators or metrics, namely KPI’s, PPIs and API’s. Monitoring and measurement of processes is the fourth element of a process. From a systems perspective, a process should have a balance of leading/pro-active and lagging or reactive process indicators.

The identification and selection of process indicators or metrics should be based on the organization’s prioritization and risk evaluation. Process indicators should be aligned with the organization’s strategic and business goals.

ISO/DIS 9001:2015 clause 4.4g requires the organization to determine the methods for monitoring, measuring, as appropriate, and evaluation of processes and, if needed, the changes to processes to ensure that they achieve intended results. To demonstrate effective arrangements or methods for evaluation of process requires the deployment of appropriate process evaluation tools such as PEARS and other Quality tools.

ISO/DIS 9001:2015 clause 4.4f requires the organization to determine the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them. In summary, organizations will now be required to conduct a risk assessment of its process. This is the fifth element of a process.

It remains to be seen if Certification Body/Registrar QMS auditors will have the competency to identify and successfully audit different organization process models; methodologies, monitoring and measurement controls and assessing their significance in terms of performance of the Quality System including meeting and exceeding the needs and expectations of stakeholders.

To-date Automotive and Aerospace QMS Auditors are required to complete relevant auditor training on the effective application of process management models, methodologies, and evaluation tools. Currently ISO 9001 Auditor/Lead training courses do not cover process management models, methodologies and evaluations tools unless specifically inbuilt into the course design by the Training Provider. All Kelmac Group® Auditor/Lead Auditor courses cover process management.

An organization’s culture and behavior is generally the missing link to achieving superior performance

Organization culture is set by top management. Quite often top management in a QMS plays a passive role. They very often delegate and transfer the responsibility for the establishment, development, implementation and effectiveness of the QMS to the Quality Department/Function. It is often said leaders, lead from the front, practicing what they preach. Sadly all too often Certification Bodies/Registrar Auditors do not challenge top management and/or the culture of the organization.

With the result Top Management’s attitude to Quality is very much re-enforced and Quality is seen as a commodity, a business necessity but let’s spend the least amount of money on it, and certainly let’s not spend any money on it unless we absolutely have to.

It is little surprising, then that middle management, supervisors or team leads demonstrate a mixed behavior towards Quality. A key role of managers, supervisors and team leads is to coach and mentor Associates or Employees. Today, the majority spend almost all their time in meetings, reviewing or generating reports with the result a critical element of Quality control is missing.

It is surprising, how the small and silly things that cause customer and consumer complaints, product recalls and emergencies are very often associated with the lack of or poor Associate or Employee supervision. ISO/DIS 9001:2015 is designed to be a preventative tool, and the majority of these small and silly problems are preventable.

The knock on effect of the above is Associate behavior towards Quality may be low or non-existent. Associate or Employee behavior towards Quality is directly related to that of their immediate Manager, Supervisor or Team Lead. I was once asked by a company to talk to Associates or Employee’s about the diligent completion of records.

Very often records are only partly completed or their contents are so generic they offer like confidence in effective controls. The company produced polystyrene which is used in the production of bicycle helmets. The company organized a town hall meeting where all Associates attended.

Management by agreement agreed to not attend the town hall meeting. I started by asking the Associates how many of them had children who cycled either a as pastime or hobby. Approximately 40% of the audience indicated they fell into this category.

I then painted a scenario that described a fictitious situation where their child was cycling home from school but they fell off the bike and hit their head off the surface of the road. Upon impact the helmet cracked and their child was seriously injured.

I then asked the Associates what they would do if they were informed the bicycle helmet contributed to their child’s injury and that upon legal discovery the record created by the Associate showed the QMS was not followed.

It then dawned on all Associates the importance of QMS records and their due diligence responsibility. The Associates immediately indicated the Supervisor focused on production and Quality came second. At this stage I invited management into the town hall meeting. This example illustrates the importance of the role of the Supervisor in setting the culture and behavior of Associates.

Summary

ISO management system standards are designed to create value, namely help the organization achieve excellence and improve its competiveness. Achievement of excellence, improvement of competiveness, including superior performance in 3rd party ISO certification audits can only be achieved if the organizations fully embrace the requirements of ISO/DIS 9001:2015 and the core issues outlined in this article. For details of how the Kelmac Group® consulting and training services can assist organization’s fully realize the benefits of ISO/DIS 9001:2015, see the Kelmac Group® consulting and training brochures or go to the Kelmac Group websites.

About Gerard

Gerard is one of the Founders and current CEO of the Kelmac Group®. Gerard’s diverse role of instructor, keynote conference speaker, and seminar leader, senior executive advisor, consultant, author, lead auditor and successful businessman means he brings a unique experience into the management systems consulting, training and audit environment. He has over 28 years’ experience in the conformity and compliance industry and he is passionate about the role ISO management systems can play in helping organization achieve excellence and improve their competitiveness. Today he leads and manages the global Kelmac Group® professional services delivery team; the design and development of the Kelmac Group® training curriculum; Gerard practices what he preaches, he is a Lead Instructor, Principal Consultant and Lead Auditor, delivering Kelmac Group® services in over 28 countries.