K. R. Singhal
Hariharan Jairam once writes in the ‘Quality World’ – “Quality! Call it a concept, an approach, a way of life, a tool for achievement or merely a word. Whatever definition you give or whatever approach you take, this subject has made people think and think in a big way.” Girdhar J. Gyani says, “Quality today has many dimensions. Gone are the days when quality was identified with product alone.” Dr. R. H. G. Rau opines, “Management of quality is not a one-shot affair. It covers all transactions. Continuous creation of value addition is possible only when we manage change; that too proactively.” Continuous creation of value addition has now become the expectation of consumers. Presently ‘constant’ quality is no longer good enough and ‘continual improvement’ is needed.
There is a need of continual improvement in the effectiveness of the quality management system because:
- ‘Continual improvement’ is needed by customers because of their changing expectations
- ‘Continual improvement’ is one of the quality management principles on which your quality management system is based
- ‘Continual improvement’ is one of the requirements of ISO 9001:2008 QMS Standard and you are required to comply with it. Organizations, implementing ISO 9001:2008 QMS, must understand that continual improvement is a must requirement of 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.
We need to improve the effectiveness of the quality management system, but how can we do such improvement, that’s a relevant question. In this regard ISO 9001:2008 QMS Standard mentions use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review to continually improve the effectiveness of the quality management system. Clause 8.5 of the ISO 9001:2008 QMS Standard specially deals with the requirements for improvement. Continual improvement is a defined requirement of the Standard. (Clause 8.5.1)
If you wish to improve the power of your quality management system, achieve performance excellence through continual improvement.
General requirements (Clause 4.1) of ISO 9001:2008 QMS Standard stipulate that the organization must continually improve the effectiveness of its QMS in accordance with the requirements of the Standard. The Standard also stipulates to ensure top management to include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. (Clause 5.3)
Clause 5.5.2 of ISO 9001:2008 stipulates responsibility and authority of the management representative to report to the top management on the performance of the quality management system and any need for improvement. The requirements for management review (Clause 5.6.1) stipulate that management review must include assessing opportunities for improvement and need for changes to the quality management system, including the quality policy and quality objectives. Review input requirements (Clause 5.6.2) include information on recommendations for improvement. Review output requirements (Clause 5.6.3) include any decisions and actions related to improvement of the following:
- the effectiveness of the quality management system,
- the effectiveness of the processes, and
- product related to customer requirements.
ISO 9001:2008 QMS Standard takes care to determine and provide resources needed to continually improve the effectiveness of the quality management system. (Clause 6.1) The Standard also stipulates the requirements (Clause 8.1) for the organization to plan and implement monitoring, measurement, analysis and improvement processes. This is required to demonstrate conformity of the product, to ensure conformity of the quality management system and to continually improve the effectiveness of the quality management system.
Clause 8.5 of ISO 9001:2008 Standard specially deals with requirements for improvement. Continual improvement is a defined requirement of the standard (Clause 8.5.1). Accordingly, the organization is required to improve the effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, corrective action, preventive action and management review.
Use of Quality Policy and Quality Objectives: Quality policy must include a commitment to comply with requirements and continually improve the effectiveness of the quality management system. It must also provide a framework for establishing and reviewing quality objectives. Quality objectives must be measurable and consistent with the quality policy of the organization. The organization must also ensure to review quality policy for continuing suitability. Framework for reviewing provides a way for improvement as review include assessing opportunities for changes to the quality management system, including quality policy and quality objectives. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.3, 5.4.1, 8.5.1)
Use of audit results: QMS audit is a systematic process and conducted at defined intervals. Audit evidences are input to QMS audit process and audit results are its output. Audit results become the input to management review process, which provides opportunities for improvement. When any nonconformity are detected during QMS audit, ISO 9001:2008 QMS Standard requires to eliminate such nonconformities and their causes. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.6.2, 8.2.2, 8.5.1)
Use of analysis of data: One purpose of analysis of data is to evaluate where continual improvement in the quality management system can be made. The organization is required to determine, collect and analyze appropriate data relating to customer satisfaction, conformity to product requirements, characteristics and trends of processes and products (including opportunities for preventive action), and suppliers. Analysis of data helps organization to solve problems and also helps to improve effectiveness and efficiency. Analysis of data can help organizations to determine the root cause of existing and potential problems, and therefore guide decisions about corrective and preventive actions needed for improvement. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.4, 8.5.1)
Use of corrective action: ISO 9001:2008 QMS Standard requires to take action eliminate the causes of nonconformities in order to prevent recurrence. Corrective action is a major tool in the quality management system to achieve improvement. It should be noted that corrective action is agenda item for management review. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.5.1, 8.5.2)
Use of preventive action: ISO 9001:2008 QMS Standard requires to take action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive action is a major improvement tool in the quality management system. (Relevant Clauses of ISO 9001:2008 QMS Standard – 8.5.1, 8.5.3)
Use of management review: Management review is conducted at defined intervals to ensure continuing suitability, adequacy and effectiveness of the quality management system. Management review includes assessing opportunities for improvement and need for changes to the quality management system. Output to management review to include any decisions and actions relating to – (i) improvement of the effectiveness of the quality management system, (ii) improvement of the effectiveness of the processes of the organization, (iii) improvement of product related to customer requirements, and (iv) resources needs of the organization. (Relevant Clauses of ISO 9001:2008 QMS Standard – 5.6, 8.5.1)
ISO 9000:2005, Quality management systems – Fundamental and vocabulary, identifies eight quality management principles to be used by the top management of the organization in order to lead the organization towards improved performance. Among eight principles stated in this fundamentals and vocabulary standard, continual improvement is one of the quality management principles. It states that continual improvement of the organization’s overall performance should be a permanent objective of the organization.
What is the aim of continual improvement? ISO 9000:2005 provides the answer. According to Clause 2.9 of ISO 9000:2005, the aim of continual improvement of the quality management system is to increase the probability of enhancing customer satisfaction and also satisfaction of other interested parties. Following actions are needed for improvement:
- Identifying areas of improvement through analysis and evaluation of the existing situation
- Establishing objectives for improvement
- Searching for and evaluating possible solutions to achieve the objectives
- Making a selection from the possible solutions and implementing the selected solution
- Measuring, verifying, analyzing and evaluating results of the implementation to determine whether the objectives have been met, and
- Formalizing changes
Results should be reviewed to determine further opportunities for improvement. Accordingly, improvement is a continual activity to be undertaken by the organization and the top management has the important role to play in this regard. To identify opportunities for improvement, following actions may be useful:
- Obtaining feedback from customers and other interested parties
- Audit results, and
- Review of the quality management system
Process for continual improvement is given in Annex B of ISO 9004:2000, a QMS guidelines Standard for performance improvement. It briefly describes the distinction between breakthrough improvement and small-step ongoing improvement. The distinction between the two may be understood as under:
(i) In small-step ongoing improvement there remains involvement of people working in the process, while in breakthrough improvement there remains involvement of cross-functional teams outside routine operation (such as managers, engineers, consultants)
(ii) In small-step ongoing improvement size of changes remain small, while these are big in breakthrough improvement.
(iii) In small-step ongoing improvement results show small improvements, while the results show big jump in performance 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, change in technology and addition of new equipment.
ISO 9004:2000 Standards provides steps involved in the method of continual improvement that include:
- Identification of a process problem
- Selection of area of improvement
- Noting the reason for improvement
- Evaluating effectiveness and efficiency of the existing process
- Collecting relevant data
- Analyzing relevant data to discover the generally occurring problems
- Selecting a specific problem
- Setting objective for improvement for such specific problem
- Identifying and verifying the root causes of the problem
- Identifying possible solutions as well as exploring alternative solutions
- Evaluating effects to conform that the problem and its root causes have been eliminated or their effects reduced
- Implementing and standardizing new solutions by replacing old process with improved process as a preventive action
- Evaluating effectiveness and efficiency of the process
Since the above steps provide improvement solution to a specific process problem, so the above steps should be repeated on remaining other identified problems, thereby making the improvement as real and effective.
John E. (Jack) West in his article ‘Continuous Improvement and Your QMS’ says, “Piecemeal improvements are no improvements at all.” He also suggests, “First, let’s review what continual improvement is and what it’s not. Continual improvement isn’t necessarily improving everything in the organization. However, it does not entail identifying and planning changes to those products, processes or systems that will improve the organization performance.”
John E. (Jack) West correctly opines, “Sometimes sustained improvement isn’t achievable unless several processes are changed. In the case of improving a product design, it might be necessary to change not only the design and development process but also the process for hiring designer’s, the capital allocation process and the process for understanding customer requirements. In such a case, overall systems changes are needed; just starting a new product design project may be the organization’s worst approach.”
It is necessary to create people awareness in the organization on continual improvement and this may be created by forming small groups, 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 and management representative are important in continual improvement of the effectiveness of the quality management system and they should take effective steps to do so.
Courtesy Source References
- ISO 9001:2008 QMS Standard
- ISO 9004:2000
- ISO 9001 for small businesses – What to do (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001:2000 – A workbook for service organizations (Joint publication from International Organization for Standardization and International Trade Centre UNCTAD / WTO)
- ISO 9001 Fitness Checker – A practical, easy to use checklist designed to help SMEs assess their readiness for ISO 9001 certification
- Implementing ISO 9001:2000 Quality Management System – A Reference Guide, Dr. Divya Singhal and K. R. Singhal (Publication from PHI Learning Pvt. Ltd., New Delhi)
- Article ‘Standard Approach – Continuous Improvement and Your QMS’, John E. (Jack) West, Quality Digest, USA, April 2006
- Article ‘Increasing the power of quality management system: Performance excellence through continual improvement’, Publication series ‘Management Systems Awareness’ – Issue 5, August 2006
- Quality World, New Delhi
- Quality Striving for Excellence, NCQM, Mumbai
Note
Author’s profile may be seen at http://www.linkedin.com/in/krsinghal
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