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- Keshav Ram Singhal
krsinghal@rediffmail.com
keshavsinghalajmer@gmail.com
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Friday, December 22, 2023

ISO 9000 Series Standards

ISO 9000 Series Standards

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Standards published under the responsibility of ISO/TC 176/SC 1 (ISO Technical Committee on Concepts and terminology)


One standard published

(1) ISO 9000:2015 - Quality management systems - Fundamentals and vocablary

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Standards published under the responsibility of ISO/TC 176/SC 2 (ISO Technical Committee on Quality systems)


Six standards published

(1) ISO 9001:2015 - Quality management systems - Requirements

(2) ISO/TS 9002:2016 - Quality management systems - Guidelines for the application of ISO 9001:2015

(3) ISO 9004:2018 - Quality management - Quality for an organization - Guidance to achieve sustained success 

(4) ISO 10005:2018 - Quality management - Guidelines for quality plans

(5) ISO 10006:2017 - Quality management - Guidelines for quality management in projects

(6) ISO 10007:2017 - Quality management - Guidelines for configuration management 

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Standards published under the responsibility of ISO/TC 176/SC 3 (ISO Technical Committee on Supporting technology)


Fourteen standards published

(1) ISO/TS 10020:2022 - Quality management systems — Organizational change management — Processes 

(2) ISO 10019:2005 - Guidelines for the selection of quality management system consultants and use of their services

(3) ISO 10018:2020 - Quality management — Guidance for people engagement

(4) ISO 10017:2021 - Quality management — Guidance on statistical techniques for ISO 9001:2015

(5) ISO 10015:2019 - Quality management — Guidelines for competence management and people development

(6) ISO 10014:2021 - Quality management systems — Managing an organization for quality results — Guidance for realizing financial and economic benefits 

(7) ISO 10013:2021 - Quality management systems — Guidance for documented information

(8) ISO 10012:2003 - Measurement management systems — Requirements for measurement processes and measuring equipment

(9) ISO 10010:2022 - Quality management — Guidance to understand, evaluate and improve organizational quality culture 

(10) ISO 10008:2022 - Quality management — Customer satisfaction — Guidance for business-to-consumer electronic commerce transactions

(11) ISO 10004:2018 - Quality management — Customer satisfaction — Guidelines for monitoring and measuring 

(12) ISO 10003:2018 - Quality management — Customer satisfaction — Guidelines for dispute resolution external to organizations

 (13) ISO 10002:2018 - Quality management — Customer satisfaction — Guidelines for complaints handling in organizations 

(14) ISO 10001:2018 - Quality management — Customer satisfaction — Guidelines for codes of conduct for organizations 


For obtaining the relevant standards of your needs, you should contact the International Organization for Standardization (ISO) or the relevant national standards body in your country.

Courtesy Source - ISO

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/ 


For more information on Kindle Book - Implementing An Effective Quality Management System, please Click Here.

 

Thanks.



Wednesday, December 20, 2023

Latest News - ISO/IEC 42001:2023 - An Standard on Artificial Intelligence Published

 Latest News - ISO/IEC 42001:2023 - An Standard on Artificial Intelligence Published

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ISO/IEC 42001:2023 is an international standard that specifies requirements for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS) within organizations. It is designed for entities providing or utilizing AI-based products or services, ensuring responsible development and use of AI systems.


Number of pages - 51

Price - CHF 187

Title - ISO/IEC 42001:2023, Information technology - Artificial intelligence - Management system

Technical committee responsible - Joint Technical Committee ISO/IEC JTC 1, Information technology, Subcommittee SC 42, Artificial intelligence.

Publication date : 2023-12


ISO/IEC 42001:2023 is the world’s first AI management system standard providing valuable guidance for the rapidly changing field of technology. It addresses the unique challenges AI poses, such as ethical considerations, transparency, and continuous learning. For organizations, it sets out a structured way to manage risks and opportunities associated with AI, balancing innovation with governance. 


Main benefits of ISO/IEC 42001:2023 -


- Responsible AI: ensures ethical and responsible use of artificial intelligence.

- Reputation management: enhances trust in AI applications.

- AI governance: supports compliance with legal and regulatory standards.

- Practical guidance: manages AI-specific risks effectively.

- Identifying opportunities: Encourages innovation within a structured framework.


Organizations of any size, involved in developing, providing, or using AI-based products or services, can use this standard. This standard is designed to be applicable across various AI applications and contexts.


An AI management system, as specified in ISO/IEC 42001:2023, is a set of interrelated or interacting elements of an organization intended to establish policies and objectives, as well as processes to achieve those objectives, in relation to the responsible development, provision or use of AI systems. ISO/IEC 42001:2023 specifies the requirements and provides guidance for establishing, implementing, maintaining and continually improving an AI management system within the context of an organization.


The ISO/IEC 42001:2023 standard offers organizations the comprehensive guidance they need to use AI responsibly and effectively, even as the technology is rapidly evolving. Designed to oversee the various aspects of artificial intelligence, it provides an integrated approach to managing AI projects, from risk assessment to effective treatment of these risks.


Other ISO Standards for AI - 


ISO has a number of standards that help mitigate the risks and maximize the rewards of AI, including ISO/IEC 22989, which establishes terminology for AI and describes concepts in the field of AI; ISO/IEC 23053, which establishes an AI and machine learning (ML) framework for describing a generic AI system using ML technology; and ISO/IEC 23894, which provides guidance on AI-related risk management for organizations.


As a management system standard (MSS), ISO/IEC 42001 can be considered as an overarching document for the sound governance of an organization in relation to AI. It provides a practical way of supporting decisions resulting from the implementation of an AI management system.


More information can be obtained from IEC / ISO headquarters or national standards body of your country, who is member of ISO.


Regards,

Keshav Ram Singhal


Courtesy - ISO and IEC



 

Friday, September 8, 2023

New Kindle Book - Implementing An Effective Quality Management System

New Kindle Book - Implementing An Effective Quality Management System

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ASIN ‏ : ‎ B0CHM9D2NL

359 pages
Price ₹300
For more details, Please visit Amazon site - CLICK HERE.

Request friends to support and post book-review at Amazon site.

Thanks,
KRS



Thursday, September 7, 2023

My Efforts got Recognition

 Sir,

Greetings.


My Efforts got Recognition

========

25 Best Quality Management Blogs & News Websites - Please CLICK HERE.

My blog lists at number 13.


Top 10 Quality Management Blogs in 2020 - Please CLICK HERE.

My blog lists at number 9.


This is for your information.


Thanks,

Keshav Ram Singhal 


Saturday, September 2, 2023

Adding Value to Internal QMS Audit

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Adding Value to Internal QMS Audit

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Internal audit is used as a tool to monitor and determine the health of the quality management system implemented in the organization. Internal audit is carried out to measure the effectiveness of the quality management system. The findings of internal audit can help in initiating appropriate measures.

 

Clause 9.2 of ISO 9001:2015 QMS standard stipulates the requirements of the internal audit. Please go through the chapter #43 on ‘Internal Audit’ in this book. If we compare the requirements of the internal audit with the earlier version, there is nothing new in the internal audit requirements of ISO 9001:2015 QMS standard. However, we find that ISO 9001:2015 QMS standard has less focus on ‘documented information’ and greater focus on achieving outcomes and results. Many clauses in ISO 9001:2015 QMS standard do not mention any requirements to maintain or retain any documented information and it is a challenge before an auditor or internal auditor how to audit compliance of standard’s requirements in such a situation.

 

A few of the tips are mentioned below for the benefit of the auditor or internal auditor, by which the auditor can add value to the audit:

 

·       Understand the intent of ISO 9001:2015 QMS standard and its concepts, such as context of the organization, risk-based thinking, addressing risks and opportunities, etc.

 

·       Make use of ISO 19011:2018, Guidelines for auditing management systems, as your guidance manual for auditing ISO 9001:2015 quality management system.

 

·       Make use of ISO 9001:2015 QMS standard as a reference standard.

 

·       Study the guidance papers and presentations issued by International Organization for Standardization (ISO) and International Accreditation Forum (IAF) and other publications, literature on ISO 9001:2015 QMS.

 

·       Get auditor’s competence by attending the relevant training. Make a habit to attend ISO 9001 related training, conference and seminar.

 

·       Pursue the outcomes from the previous audits, if any, both internal and external, to identify any specific issues or concerns still require improvement.

 

·       Understand the organization, its processes, its stakeholders, risks and opportunities, applicable legal requirements.

 

·       Seek adequate time for auditing.

 

·       Focus more on the process, process performance and its outcomes and results.

 

·       Understand and remember seven quality management principles (QMPs) and use of PDCA approach to evaluate the process effectiveness.

 

·       Look for objective evidence.

 

·       Use 5 W’s and 1 H – What, Why, Where, Who, When and How – appropriately to obtain objective evidence.

                                

·       Provide adequate opportunity to the auditee to correct any nonconformities, if noticed.

 

·    Make efforts to identify the root causes of problems or nonconformities. Don’t see who is responsible. Rather consider why and what caused the problem or nonconformity.

 

·       Adopt a ‘holistic’ approach while gathering objective evidence during audit.

 

·     Analyze the findings and relate them to the organization’s ability to provide products and services that meet customer and applicable legal requirements.

 

·       Report audit findings.

 

·       Also emphasize positive findings as appropriate.

 

·   Consider solution and corrections proposed by the auditee in response to the ‘negative findings’ (nonconformances).

 

·       Carry out process audit by following the path the auditee takes to carry out the process.

 

·       Don’t make the audit difficult by adding on requirements. Do not add any additional requirements, which are not required.

 

Value added auditing aims to add value, the organization will find useful. Value added auditing encourages result-focused systems, with minimum bureaucracy. It helps to identify strong and weak points and focus on the ways to improve. Value added auditing provides confidence that the quality management system is the king and the organization is consistently providing conforming products and services to its customers.

 

Case Study

 

Ram Dubey, a Chartered Accountant, held the position of Finance Manager at ABC Manufacturing's headquarters, overseeing two ISO 9001:2015 Quality Management System (QMS) certified manufacturing plants. Ram often visited these plants for financial management and financial audits. One day, the CEO of ABC Manufacturing praised Ram's work and requested him to conduct an internal audit of the plants’ QMS within 15 days, as the certification surveillance audit was scheduled for the following month. The CEO provided Ram with copies of ISO 9000:2015 and ISO 9001:2015 standards, blank nonconformance report forms, the quality manual, and an internal audit file. The CEO also explained the significance of opening and closing meetings, as well as the process for raising and resolving nonconformities. The CEO expected Ram to identify at least 10 nonconformities in each plant to demonstrate compliance with the company's quality manual. Ram learned that internal audits were to be conducted annually, as stated in the quality manual.

 

After dedicating two days to studying the relevant standards and the company's quality manual, Ram felt confident about conducting the audit, drawing on his financial audit experience as a chartered accountant. A week later, he visited both plants and identified more than 10 nonconformities in each.

Some of these nonconformities, along with the relevant standard clauses and actions taken to address them, were as follows:

 

1.              No records were maintained for determining external and internal issues - Clause 4.1. The nonconformity was closed with the auditee's explanation that the standard did not require such records.

 

2.              No records were kept for determining interested parties and their requirements - Clause 4.2. The nonconformity was resolved with the same explanation provided by the auditee.

 

3.              The quality policy was not displayed in the fabrication and purchase sections, and employees were unaware of it - Clause 5.2. The plant manager promptly supplied copies of the quality policy to all employees and displayed it in the relevant sections.

 

4.              No specific individuals were assigned duties and responsibilities for QMS monitoring - Clause 5.3. The plant manager claimed to perform these duties personally.

 

5.              No formal risk register or risk records were maintained - Clause 6.1. While a risk register wasn't required, the auditee affirmed that risks were identified, and preventive actions were taken.

 

6.              The painter in the painting section couldn't state the quality objectives for his department - Clause 6.2. The head of the painting section provided the quality objective and demonstrated the related register tracking product reception, painting, and storage.

 

7.              Weighing equipment for raw materials and weighing balances were not calibrated or checked for accuracy regularly, as legally required - Clause 7.1.5. The concerned staff was unaware of the requirement but agreed to perform the necessary calibration and checks.

 

8.              Employee competence records were not available at the plant - Clause 7.2. It was suggested that these records be kept at the company headquarters, which was confirmed by the HRD section.

 

9.              No evidence was provided to determine applicable statutory and regulatory requirements - Clause 8.2.2. The Plant Manager clarified that this was managed by the Product Research Cell at the company's headquarters.

 

10.           Re-evaluation of suppliers had not been conducted as required by the established procedure - Clause 8.4. The head of the purchase department assured that re-evaluation would be completed by the end of the month and shared the re-evaluation proforma sent to suppliers.

 

11.           Nonconforming products were found without proper marking - Clause 8.7. The plant manager committed to segregating nonconforming products with special markings.

 

Upon returning to headquarters, Ram submitted his audit report to the CEO, who was pleased with his work. Ram was promoted to Chief Manager, and his emoluments were increased by 20%.

 

Analysis of Ram Debey’s Internal Audit by the CEO

 

Ram Dubey saved the company from a non-compliance in the upcoming certification audit by conducting an internal audit.   

 

Ram Dubey conducted a thorough internal audit of the quality management system of the company’s plants. Within a short duration, he demonstrated a good understanding of ISO 9001:2015 QMS standard and the company’s quality manual. He identified more than 10 nonconformities in each plant addressing various aspects of the quality management system, such as documentation, policy implementation, risk management, competence, supplier evaluation, segregation of nonconforming products, calibration etc.

 

According to the CEO, Ram Dubey’s internal audit appears to be of good quality. He followed ISO 9001:2015 QMS standard requirements and the guidelines set out in the company’s quality manual. His ability to identify relevant nonconformities and document them with clause number accurately indicates his competence in conducting internal audit. This internal audit added significant value to ABC Manufacturing. By identifying nonconformities and suggesting corrective actions, he helped the company address potential issues in its quality management system. This proactive approach ensures that the company is better prepared the upcoming certification surveillance audit.  

 

Independent Analysis of Ram Debey’s Internal Audit

 

If we consider the above case study with an open eye, we will have different outcomes. With an independent analysis, it is now evident that Ram Dubey’s internal audit had more significant shortcomings. He neglected several critical areas of the quality management system and did not measure the effectiveness, adequacy, and performance of the quality management system in many key clauses of ISO 9001:2015 QMS standard.

 

Many areas were left by Ram Dubey, where he has neither raised any nonconformities nor he submitted any compliance reports meeting requirements, such as:

 

·       Scope of the quality management systems – 4.3

·       Leadership and commitment – 5.1

·       Design and development activities – 8.3

·       Production and service provision – 8.5

·       Release of products and services – 8.6

·       Monitoring, measurement, analysis and evaluation including customer satisfaction – 9.1

·       Internal audit – 9.2

·       Management Review – 9.3

·       Improvement – 10.1, 10.2, 10.3

 

From the omitted audit areas, it is clear that Ram Dubey’s internal audit lacked thoroughness and professionalism. His limited knowledge of quality management system audit and the absence of formal training in ISO 19011:2018, combined with his lack of understanding of ABC Manufacturing’s production processes, raised serious concerns about the quality of the audit.

 

While Ram Dubey identified nonconformities in some areas, the overall effectiveness and reliability of his internal audit are questionable because:

 

·       Ram Dubey omitted critical audit areas, such as the scope of the QMS, leadership and commitment, design and development activities, production and service provision, release of products and services, monitoring, measurement, analysis and evaluation, internal audit, management review and improvement. This incomplete audit scope raises concerns about the comprehensiveness of the internal audit.

 

·       Ram Dubey’s lack of knowledge about ISO 19011:2018 management systems auditing standard highlights a significant deficiency in his audit approach. This standard provides guidance on auditing principles and techniques and is essential for conducting effective internal audits. Ram Dubey has limited expertise and knowledge in quality management system auditing.

 

·       Considering the gaps in the audit and Ram Dubey’s limited expertise in quality management system auditing, it raises questions about the motives behind the audit. It appears that the audit may have been conducted primarily to please the CEO, rather than to genuinely assess the quality management system of ABC Manufacturing.

 

·       Ram Dubey’s lack of formal quality management system audit training is a critical shortcoming. Proper training is essential to conduct thorough and effective audits, and his background as a financial professional may not adequately prepare him management systems auditing.

 

·       It is clear that Ram Dubey’s internal audit was not conducted to the level of quality and professionalism expected in the field of quality management system auditing. It may have lacked objectivity, depth, and compliance with auditing standards and guidelines. The internal audit carried out by Ram Dubey was inadequate.

 

·       Since Ram Dubey’s lack of formal quality management system audit training, he did not develop an audit plan or criteria for selecting audit areas. A structured plan could improve the efficiency and effectiveness.

 

·       During the audit, Ram Dubey focused his attention on finding and reporting the nonconformities, he omitted to note those objective evidence that showed compliance with ISO 9001:2015 QMS standard requirements.

 

Learning from the Case Study: From the above case study, we find that Ram Dubey lacked formal quality management system audit training and also lacks of knowledge about ISO 19011:2018 management systems auditing standard. Had he been given the formal training he would have been a competent QMS internal auditor and the outcome of his internal audit would have been different. With formal training, he could have added value the quality management system internal audit.

 

Concluding Summary

 

This write-up emphasized the essential concepts and considerations for conducting a value-added internal audit within the framework of ISO 9001:2015 QMS. The key takeaways are:

 

·       Internal auditor should grasp the intent of ISO 9001:2015, understand its requirements including its new concepts, like context, risk-based thinking, addressing risks and opportunities.

 

·       ISO 19011:2018 provides valuable guidelines for management systems auditing, serving as an indispensable resource for the auditor.

 

·       A holistic, solution-oriented approach is crucial. The auditor should focus on processes, outcomes and root-causes while emphasizing positive findings alongside nonconformities.

 

·       Continual training and development are vital for an auditor to stay updated and competent in its role.

 

·       The case-study given in this chapter demonstrated practical application, highlighting the importance of thoroughness, competence of the auditor, and a balanced perspective in the internal audit.

 

In conclusion, value-added internal audit goes beyond mere compliance checking. It serves as a means to drive continual improvement, enhance organizational performance, and ensure effectiveness of the quality management system. By adhering to value-added internal audit, the internal auditor helps the organization to achieve greater confidence in its ability to consistently provide quality products and services to ita customers.

 

Best Regards,

Keshav Ram Singhal

(This write-up is a part of a forthcoming book on ISO 9001 being written by Keshav Ram Singhal)

Friday, September 1, 2023

Striving for Change

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Striving for Change

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Change (verb) = To become different or to make somebody/something different

 

Change (verb) = To become a different thing; to make somebody/something take a different form

 

Change (noun) = The process of becoming or making something different

 

Change (noun) = Something different 

 

Change is brought with improvement. The train of improvement brings the change.

 

ISO 9001:2015 QMS standard strives for change, it addresses changes to the quality management system through its requirements mentioned in a number of clauses. In this connection, please have a look to the following clauses and their requirements:

 

4.4 – Continually improve the quality management system including the processes

 

5.3 – The top management of the organization needs to assign responsibilities and authorities within the organization to ensure the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

 

6.3 – Planning of change – Carry out change planning in a planned manner by considering purpose of change, potential consequences of the change, the integrity of the quality management system, availability of resources, the allocation or reallocation of responsibilities and authorities. This clause makes a reference of clause 4.4 of the standard.

 

8.1 – Operational planning – (i) Controlled planned changes, (ii) Review the consequences of unintended changes, and (iii) Taking necessary actions to mitigate (reduce) any adverse effects, as necessary. (Unintended changes = Changes that are not planned or desired.)

 

8.3.6 – Design and development changes – Identify, review and control (take action) design and development changes to ensure no adverse impact on conformity to requirements. Also need to retain documented information (records) on design and development changes.

 

8.5.6 – Control of changes – Review and control changes for production or service provision to the extent necessary to ensure continuing conformity with requirements. Also need to retain documented information (records) describing the results of the review of changes, personnel authorizing the change, and any necessary action arising from the review.

 

9.2 – Internal audit – Consider importance of changes during planning, establishing and implementing an audit programme.

 

9.3 – Management review – Inputs of management review to consider external and internal issues relevant to the quality management system. Outputs of management review include taking decisions and actions related to any need for changes to the quality management system.

 

10.2 – Nonconformity and corrective action – When a nonconformity occurs, make changes to the quality management system, if necessary.

 

Thus, we see that addressing changes becomes an increasingly important component for the quality management system in the standard.

 

Changes are inevitable. Changes are part of the system. No one can avoid changes. Changes may be needed. Changes can be related to any elements of a process. Changes when planned are to be beneficial. Changes need to be carried out as planned. It is better to consider risks and opportunities associated with the change.

 

An organization can have a better change management to achieve the benefits associated with changes. The organization should consider all types of changes that may need to happen in the quality management system. Changes may be generated in processes, documented information, resources, competence, awareness, operation, performance evaluation, improvement initiatives, and many more. PDCA methodology is an effective tool for a successful change management, which may have following steps:

 

·       Plan – (i) Define – What needs to be changed? (ii) Determine specific tasks, (iii) Make a plan – How to do? What resources required for the change? What information needed for the change? Who will supervise? What will be the budget? What will be the timeline? (iv) Develop a communication plan.

 

·       Do – Engage people, train them, improve their awareness, knowledge and competence, use resources and carry out the change.

 

·       Check – Measure the effectiveness of the change

 

·       Act – Correct and improve, if needed.

 

Case study – Change in the System

 

Background: ABC Manufacturing’s design and development department received a nonconformity report from its internal auditor, highlighting that a specific procedure had not been followed by XYZ, the individual responsible for designing a product. An enquiry into this nonconformity uncovered several key points.

 

Issues identified:

 

1.     Lack of Procedure Awareness: It was discovered that XYZ was unaware of the newly established procedure. When the procedure was introduced, employees were scheduled for awareness training. Unfortunately, on the day of training, XYZ was on leave. This situation raised to a question of why XYZ had not been sent for training on a later date or why he had been assigned a task that required knowledge of a procedure he was unaware of.

 

2.     Lack of Training: It became apparent the ABC Manufacturing’s system did not have any documented training process in place. This lack of structured training system was a contributing factor to XYZ’s unawareness of the procedure.

 

Change Introduced: In response to the above findings and as an improvement initiative, ABC Manufacturing’s management decided to implement a documented training process. This change aimed to address the issue of procedure awareness and enhance the overall competence of its employees.

 

Application of PDCA Methodology

 

ABC Manufacturing followed the PDCA methodology to successfully implement the change by applying following steps:

 

Plan:

·       Define the issue: Lack of procedure awareness led to nonconformity.

·       Set objectives: Develop a documented training process

·       Identify resources and stakeholders: Training institutions, trainers, training material etc.

·       Create a detailed plan: How training process will work, including scheduling, content, reporting, assessment etc.

 

Do:

·       Implement the training process: Employees being provided training as per the training process. XYZ was also provided training of the specific procedure.

·       Monitor progress: Track participation and evaluate the effectiveness of the training.

 

Check:

·       Assess the impact: Measure whether employees are having necessary awareness, skills and competence after attending the training and their performance and productivity impact

·       Feedback: Solicit feedback inputs from employees to identify any issues or improvements needed in the training process.

 

Act:

·       Make improvement: Based on feedback and performance data, refine the training process as necessary.

·       Continually improve: Regularly review and update the training process to ensure it remains effective and aligned with the needs of ABC Manufacturing.

 

This application of PDCA methodology ensures that the change, in this case, the introduction of a documented training process, is not a one-time event but an ongoing cycle of improvement.  This case study provides an example of how the PDCA methodology can be applied in change management.

 

Concluding Summary

 

ISO 9001:2015 QMS standard strives for change, it addresses changes to the quality management system through its requirements mentioned in a number of clauses. Changes are inevitable. Changes are part of the system. No one can avoid changes. Changes may be needed. Changes can be related to any elements of a process. Changes when planned are to be beneficial. An organization can have a better change management to achieve the benefits associated with changes. The organization should consider all types of changes that may need to happen in the quality management system. PDCA methodology is an effective tool for a successful change management.

 

Best Regards,

Keshav Ram Singhal

(This write-up is a part of a forthcoming book on ISO 9001 being written by Keshav Ram Singhal)