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Sunday, July 30, 2023

ISO 9001:2015 QMS Awareness – Increasing the power of Quality management system – Importance of Improvement

ISO 9001:2015 QMS Awareness – Increasing the power of Quality management system – Importance of Improvement

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This article deals with the importance of improvement in organizations. Continual creation of value addition in product / service is the common expectation now a days and continual improvement in product / service, therefore, is expected by consumers / users / customers.

 

There is a need of improvement in the quality management systems because:

 

(1)   Improvement is needed by consumers / users / customers because of their changing expectations.

 

(2)   Improvement is one of the seven quality management principles on which ISO 9001:2015 QMS standard is based.

 

(3)   Continual improvement is one of the requirements of ISO 9001:2015 QMS standard and organizations, implementing ISO 9001:2015 QMS standard, are required to comply with the such requirements mentioned in the standard.

 

Continual improvement is a recurring (step-by-step) activity followed by –

 

(i)              Identifying opportunities for improvement and their justification,

 

(ii)             Deciding how to improve on the available resources, and

 

(iii)            Implementing (carrying out) improvement.

 

The organization needs to continually improve the suitability, adequacy and effectiveness of its quality management system, but how the organization does such continual improvement, that’s a relevant question. In this connection, the organization should use quality policy, quality objectives, audit results, analysis of data, risk-based thinking, correction, corrective action, management review to continually improve the suitability, adequacy and effectiveness of its quality management system.

 

If an organization wishes to improve the power of its quality management system, achieve organization’s performance excellence through improvement. Following clauses specially mention improvement requirements –

 

Clause 4.4.1 – Improve the processes and the quality management system

 

Clause 5.1.1 – Top management of the organization needs to demonstrate leadership and commitment with respect to the quality management system by promoting improvement.

 

Clause 5.2.1 – Top management of the organization needs to establish, implement and maintain a quality policy that includes a commitment to continual improvement of the quality management system.

 

Clause 6.1.1 – When planning for the quality management system, the organization needs to consider the issues related to the organization and its context and the requirements related to the needs and expectations of interested parties and determine the risks and opportunities that need to be addressed to achieve improvement.

 

Clause 9.1.3 – The results of analysis need be used to evaluate the need for improvements to the quality management system.

 

Clause 9.3.2 – The management review must be planned and carried out taking into consideration of opportunities for improvement.

 

Clause 9.3.3 – The outputs of management review must include decisions and actions related to opportunities for improvement.

 

Clause 10 of ISO 9001:2015 QMS standard specifically deals with the requirements for improvement. Continual improvement is also a defined requirement of the standard (clause 10.3)

 

Why improvement needed, and what are the key benefits of improvement? ISO 9000:2015, Quality management systems – Fundamentals and vocabulary, provides the answer to these questions.

 

Why improvement needed? Because the successful organization has continuing focus on improvement. Improvement is essential to maintain the required level of performance, to react to changes and to create new opportunities.

 

Key benefits of improvement are –

 

(i)              Improved process performance,

 

(ii)             Improved organizational capability,

 

(iii)            Improved customer satisfaction,

 

(iv)           Enhanced focus on root cause analysis followed by risk-based thinking, correction and corrective action,

 

(v)             Enhanced ability to predict and react to the determined risks and opportunities,

 

(vi)           Enhanced consideration of incremental / breakthrough improvement,

 

(vii)          Regular use of improved learning for improvement,

 

(viii)         Enhanced drive for innovation,

 

(ix)           Reduction in nonconforming outputs etc.

 

How improvement can be achieved? Following actions will be helpful to achieve improvement –

 

(i)              Identifying areas of improvement through analysis and evaluation of the existing situation,

 

(ii)             Establishing objectives for improvement,

 

(iii)            Searching for and evaluating possible solutions to achieve the objectives,

 

(iv)           Making a selection from the possible solutions and implementing the selected solutions,

 

(v)             Measuring, verifying, analyzing and evaluating results of the implementation of selected solutions to determine whether the established objectives have been achieved, and

 

(vi)           Formalizing changes.

 

Results should be reviewed to determine further opportunities for improvement. Accordingly, improvement is a continual activity to be undertaken by the organization. The top management of the organization has important role to play in this regard. To identify opportunities for further improvement, following actions may be useful:

 

(i)              Obtaining feedback from customers and other interested parties,

 

(ii)             Audit results, and

 

(iii)            Review of the quality management system.

 

Breakthrough improvement vs Small-step improvement

 

Improvement process may lead to breakthrough improvement or small-step ongoing improvement. Let us understand the distinction between these two, which can be understood as under:

 

(i)              In small-step ongoing improvement, people involvement working in the process remains, while in breakthrough improvement, cross-functional teams involvement remains outside routine operation.

 

(ii)             In small-step ongoing improvement size of changes remain small, while the size of changes is big in breakthrough improvement.

 

(iii)            In small-step ongoing improvement results show small improvements, while results show big jump in breakthrough improvement.

 

(iv)           Cost is low (within operating budget) in small-step ongoing improvement, while cost is high (may involve additional capital investment) in breakthrough improvement.

 

(v)             Types of changes in small-step ongoing improvement include modification in practices, procedures, equipment, elimination and simplification of activities, while types of changes in breakthrough improvement include process reengineering, major process upgrades, changes in technology, addition of new equipment etc.

 

A cross-functional team is a group of individuals from different functional areas or departments within an organization who come together to work on a specific project or solve a particular problem. Since the individuals are from different functional areas or departments, the team members bring diverse skills, expertise, and perspectives from their respective areas to collaboratively address the issue at hand. In the context of improvement activities, a cross-functional team is often assembled to tackle complex problems or pursue breakthrough improvement. The members of such team can be from different functional areas or departments, including managers, engineers, frontline employees, frontline employees, external consultants etc.

 

The purpose for forming a cross-functional team is to ensure a well-rounded and comprehensive approach to problem-solving or breakthrough improvements. By including individuals from different areas, the team can better understand the various implications of the problem and address breakthrough improvement. On the other hand, in small-step ongoing improvement, the focus is generally on continual improvement or enhancement to existing processes. In such cases, the improvement activities often involve people who are directly working with the process.   

 

Create Awareness

 

It is necessary to create people awareness in the organization on continual improvement and this may be created by forming small groups in the organization, selecting their group leaders, allowing people to control and improve their workplace and developing people’s knowledge, experience and skills. The role of the top management is important in continual improvement of the effectiveness of the quality management system and the top management should take effective steps to do so.

 

Best wishes,

Keshav Ram Singhal

 

Please have your comments / reaction.

 

To train your employees with ISO 9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN: B093YFFY7Z), which is available worldwide at Amazon. Please search this Training Handbook in Amazon Website of your country. 

 

 You may also supply your employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/ (ii) Applying Risk-based Thinking in an Organization Implementing ISO 9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/

 

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