QMS Enhancement - II _ July'2024 - Copy.pptx

it describe the QMS

1. ISO 9001:2015 Quality Management System 4 TH March 2025

2. ISO Standard History ISO 9001 History Plan-Do-Check-Act Concept IMS Flow Process & QMS Process Vision, Mission & the Quality Policy IMS Flow Chart AGENDA

3. ISO’s Story began in 1946 In London, in 1946, 65 delegates from 25 countries meet to discuss the future of International Standardization. In 1947, ISO officially comes into existence with 67 technical committees (groups of experts focusing on a specific subject

4. ISO'S FIRST OFFICES In 1949, ISO moves into offices in a small, private house in Geneva. In the early 1950s the Central Secretariat has 5 members of staff

5. ISO'S FIRST STANDARD In 1951, the first ISO standard (called Recommendations at this time), ISO/R 1:1951 Standard reference temperature for industrial length measurements, is published. Since then, the standard has been updated numerous times and is now ISO 1:2016 Geometrical Product Specifications (GPS) - Standard reference temperature for geometrical product specification.

6. The ISO Journal Since its creation ISO has published monthly information about its technical committees, the standards published and administrative changes to the organization and its members. This is the cover of the ISO Journal from May 1952.

7. ISO GENERAL ASSEMBLY - STOCKHOLM In 1955.. ISO members gather in Stockholm for the 3rd General Assembly. At the beginning of 1955, ISO has 35 members and 68 standards (called recommendations). Henry St Leger is the Secretary General.

8. ISO in 2022 As of 2022, there are  167 national members  representing ISO in their country, with each country having only one member. ISO has three membership categories member bodies are national bodies considered the most representative standards body in each country. These are the only members of ISO that have voting rights..

9. 1987 : International Standard 1994 : Revision International Standard 2000 : Revision International Standard 2008 : Amendment International Standard 2015 : Revision International Standard ISO 9001 History

10. ISO 9001:2015/Amd1:2024 – 4.1 Understanding the organization and its context. The organization shall determine whether climate change is a relevant issue. 4.2 Understanding the needs and expectations of interested parties. Relevant interested parties can have requirements related to climate change ISO 9001 NEW CHANGE (AMD1:2024)

11. PLAN-DO-CHECK-ACT CONCEPT Plan: Recognize an opportunity and plan a change. Do: Test the change. Carry out a small-scale study. Check: Review the test, analyze the results, and identify what you've learned. Act: Take action based on what you learned in the study step.

12. IMS FLOW PROCESS Top Management Context – Scope, Policy Sales, Design, Ext. Providers Production Service Controls Customer Satisfaction Management/ Support Process Operational Process QMS Objectives QMS Programs Continual Improvement Safe Workplace Reduced Env. Impact QMS

13. Q MS FLOW PROCESS Top Management Context, Scope Quality Policy Quality Objectives Quality Programs Improvement Sales Design External Process Infrastructure Manufacturing Services Releases Customer Management establishes the quality policy of the QMS Management establishes the context, scope and boundaries of the QMS The core processes of the QMS and their interactions are determined Performance Indicators are established for the core processes Controls are established to ensure customer requirements are met Quality Objectives are selected with programs established to achieve the objectives

14. VISION, MISSION & QUALITY POLICY Vision: What the organization aspires to be. How the future will look if the organization achieves its mission. Mission: What our organization is all about. Who we are, who are our customers, what we do and how do we do it. Quality Policy: A guide as how the organization should provide products and services to our customers.

15. R R KABEL LIMITED VISION, MISSION Vision: Inspired thinking brings a meaningful change to the lives we touch around the world. Mission : Delivering products & services that promises superior technology, performance and enhanced value to consumers, stakeholders, employees, and the society at large.

16. R R KABEL LIMITED QUALITY POLICY RR Kabel Ltd. aims to achieve customer satisfaction by consistency meeting the needs and expectations related to its products and services and those related to climate change.   In its pursuits of excellence, RR Kabel Ltd. will set and achieve Quality Objectives at all levels, meet the applicable requirements – legal and others (including the requirements of the standard ISO 9001:2015 and Amd. 1:2024 ), make continual improvements in order to have a robust Quality Management System.

17. How to enhance Quality Management System at Organization?

18. GOOD DOCUMENTATION PRACTICES It is a good record-keeping practice, and it is a set of internationally accepted guidelines that ensure the reliability, integrity, and veracity of data collected during the research, development, manufacturing, and testing of products and services. Cost for Poor/No Documentation Cost for Good Documentation

19. MASTER LIST Master List – ( Annexure – 1 )   RR KABEL LIMITED, WAGHODIA, GUJARAT Doc. No. : RRKLW/ML/XYZ-00 MASTER LIST OF (XYZ SUBJECT) Rev. No. : 00 Rev. Date: 00.00.0000 Date of issue : 15.11.2018 Page: 0 of 0 Sr.No. Doc.No. Document Name Rev. No. Revision Date Issue Date Storage Type ( Hard Copy / Soft Copy ) Retention Period for records (In Years) Document Ownership Master Controlled                                         * Method of Disposal of Documents/Records/Formats: Hard(Shred)/Soft(Delete) * Review Frequency of Documents/Records/Formats: As when required Prepared By Approved By Issued By

20. QUALITY OBJECTIVES - MONITORING Ref: RRKL/DI/6.2.1/09/TC QUALITY OBJECTIVE MONITORING AS PER ISO 9001:2015 Sr. No. Objective Targets Programs Jul-24 Aug-24 Sep-24 Evaluation (for the month of July 2024 - Sep 2024) Action Plan (For the month of July 2024 - Sep 2024) 1 Attain customer delight by meeting their needs and expectations 1. Timely & 100% calibration 1.Ensure 100% Timely calibration.           2. Zero repetitive complaints 2.Train Team members.           2 Identify all legal and other requirements related to Technical Cell and comply with them 1. Maintain a list of legal and other requirements 1.Seek status of the rules , regulations, etc. from official website, magazines, Government gazette, trade association (CII/GEO) Mailers.           2. Check compliance status every quarter & report in Management review meeting 2. Educate all employees on the applicability of the legal & other requirements and consequences.           3 Make at least two improvements per quarter 1.Quantify improvements & their resulting benefits. 1.     Prepare before and after scenario.           2.Share the improvments with other teams. 2. Communicate with other departments.          

21. W ORKPLACE POLICY VISUALIZATION Old Quality Policy Visualize at Workplace New Quality Policy Visualize at Workplace

22. W ORKPLACE GOOD HOUSE KEEPING VISUALIZATION Old Quality Policy Visualize at Workplace New Quality Policy Visualize at Workplace

23. NEXT 03 MONTHS WORKS Implementing - “Good Documentation Practices”. Documents/Formats – Submitted at QMS MR for Controlling QMS. Documents/Formats - collect at one place “ MASTER LIST ”. Documents/Formats – Streamlining (Document/Format No., Revision Status, etc.) Final Documents/Formats - “ MASTER ” and that document are submitting at “MR” and take a “ CONTROLLED ” copy. Brainstorming Session on QMS – Every Month. Monitoring of Quality Objectives & Risk & Opportunity – A. Quality Objectives – “ Monthly Basis ” & B. Risk & Opportunity – “ Quarterly Basis ”. Visualization – Works on “NOTICE BOARD”

24. Risk and opportunity AGENDA

25. TYPES OF RISK AND OPPORTUNITY Types of Risks: Operational Risks Compliance Risks Supplier Risks Technological Risks Human Factors Risks Environmental Risks Strategic Risks Reputation Risks Types of Opportunities: Process Improvement Opportunities Technology Adoption Opportunities Customer-Centric Opportunities Innovation Opportunities Employee Development Opportunities Cost Reduction Opportunities Sustainability and Green Opportunities Market Expansion Opportunities

26. DEFINATION Addressing risks and opportunities is a key component of continuous improvement and maintaining the effectiveness of the system. Identifying, assessing, and managing both risks and opportunities helps an organization improve its processes, enhance customer satisfaction, and maintain compliance with standards. Risk : A risk is the possibility that an unwanted or undesirable event could happen, potentially affecting the quality of products or services, processes, or the overall success of the organization . Opportunity : An opportunity refers to a situation or condition that, if leveraged, can enhance the organization’s ability to achieve its objectives, improve processes, or provide value to customers.

27. Importance of Managing Risks and Opportunities ​ Why It’s Important : ​ Helps mitigate potential problems that could affect product or service quality. ​ Promotes proactive decision-making, preventing disruptions before they occur. ​ Identifies areas for improvement, enabling the organization to stay competitive. ​ Enhances customer satisfaction by delivering consistent and high-quality products/services . Supports compliance with ISO 9001 and other quality standards.​

28. Risk Management Process ​ Risk Identification :​ Identify potential risks that could impact product quality, process performance, or customer satisfaction.​ Sources of Risks: Supplier issues, equipment failures, regulatory changes, resource constraints, human error, etc.​ Risk Assessment :​ Likelihood: How likely is the risk to occur?​ Impact: What would be the effect if the risk occurs?​ Risk Matrix: Assess the risk using a matrix (Low, Medium, High) based on likelihood and impact.​ Risk Mitigation/Control :​ Develop strategies to mitigate or reduce the likelihood of the risk occurring (e.g., process redesign, employee training, backup plans).​ Implement control measures to reduce the impact if the risk occurs (e.g., quality checks, contingency planning).​ Monitor and Review :​ Continuously monitor risks and review mitigation actions to ensure effectiveness.​ Adapt the approach based on changing conditions and lessons learned.​

29. Opportunity Management Process ​ Opportunity Identification :​ Recognize areas where improvements or enhancements can be made to deliver greater value to customers or the organization.​ Sources of Opportunities : Technological advancements, new market trends, customer feedback, employee suggestions, process optimization.​ Opportunity Evaluation :​ Evaluate the potential benefits of each opportunity and align it with the organization's objectives.​ Potential Benefits : Increased efficiency, improved product quality, cost savings, customer loyalty, market differentiation.​ Opportunity Exploitation :​ Develop action plans to leverage the identified opportunities.​ Allocate resources and assign responsibility to ensure opportunities are capitalized upon.​ Monitor and Review :​ Track the implementation of opportunities and evaluate their effectiveness.​ Adjust strategies as needed to ensure maximum benefit.​

30. Example of Risks and opportunity in QMS ​   Operational Risks :​ Equipment failure, production delays, supply chain disruptions.​ Compliance Risks :​ Non-compliance with industry regulations, ISO standards, or customer specifications.​ Human Factors Risks :​ Inadequate training, employee errors, turnover, or labor disputes.​ Technology Risks :​ Cybersecurity issues, software malfunctions, outdated systems.​ Environmental Risks :​ Natural disasters, climate change impacts on production facilities.​ opportunity Process Improvement :​ Streamlining workflows to reduce waste and improve efficiency.​ Automation of repetitive tasks to reduce human error and save time.​ Customer Satisfaction :​ Developing stronger customer relationships through more personalized services or better communication.​ Innovation and New Products :​ Expanding the product line or adopting new technologies to meet emerging customer needs.​ Employee Engagement :​ Empowering employees to contribute to process improvements or innovation, leading to a more motivated workforce.​ Regulatory Compliance :​ Using changes in regulations as an opportunity to improve internal systems and gain a competitive advantage.​

31. AGENDA

32. Risk and Opportunity Management Tools​ SWOT Analysis (Strengths, Weaknesses, Opportunities, Threats):​ A strategic planning tool that helps identify both internal and external factors that could be leveraged or mitigated.​ Risk Register :​ A document used to track identified risks, their potential impacts, likelihood, mitigation strategies, and status.​ Failure Mode and Effects Analysis (FMEA) :​ A systematic method for evaluating processes to identify potential failure points and their effects.​ Root Cause Analysis :​ A problem-solving technique used to identify the underlying causes of risks or issues.​

33. AGENDA Monitoring and Reporting ​ Key Metrics to Monitor :​ Number of risks identified and mitigated.​ Effectiveness of risk mitigation actions.​ Number of opportunities capitalized upon.​ Results from opportunity exploitation (e.g., improved customer satisfaction, reduced costs).​ Regular Reviews :​ Perform periodic reviews of both risks and opportunities.​ Adapt strategies as necessary based on results and external changes.​

34. Benefits of Effective Risk and Opportunity Management​ Risk Reduction :​ Proactively managing risks minimizes their likelihood and impact, ensuring smooth operations. ​ Enhanced Organizational Agility :​ By identifying opportunities, the organization can adapt to changes quickly and improve its competitive edge. ​ Continuous Improvement :​ Regularly assessing risks and opportunities leads to a culture of ongoing refinement and innovation. ​ Increased Customer Trust :​ Delivering high-quality, reliable products/services helps build customer loyalty and satisfaction. ​ Compliance and Sustainability :​ Risk and opportunity management ensures alignment with industry regulations and long-term sustainability​

35. AGENDA Rating Evaluation guideline Severity Occurrence 1 Process corrects by itself when the risk occurs  Incident has never happened during the last five years  2 Risk correction takes place by the process owner  Incident has happened only ONE time in the last five years 3 Risk correction takes place by intervention of the HOD Incident has happened at least one time every year  4 Risk correction takes place by intervention of other seniors  Incident has happened at least one time every six months 5 Risk correction takes place by intervention of external providers (consultants etc.)  Incident has happened at least one time every month The purpose of this procedure is 1.       To promote risk-based thinking as required under ISO 9001:2015 2.       To provide guidelines for assessment of risk priority number  The risk in any process will be assessed be calculating its SEVERITY and OCCURRENCE. Both of these will be rated on a scale of 1 to 5 in an objective manner, as detailed below :

36. AGENDA Rating Evaluation guideline 1 2 3 4 5

37. Risk Priority Number RPN Risk Priority Number will be represented as ‘SO’ where ‘S’ is the severity rating and ‘O’ is the occurrence rating.  Accordingly, the risk will be classified as follows:  Risk Category SO Number  From To Very Low risk  11 15 Low risk  21 25 Medium risk  31 35 High risk  41 45 Very high risk  51 55 The RPN will have a further sub-clause: For Occurrence rating more than 2, focused attention will be given to improve the process and bring down the occurrence value. 

38. Risk and Opportunity Analysis  Department: OPERATIONS Ref: RRKL/DI/6.1.1/08a  dated 07/11/2016  Rev: 01  FEB-2025 Sr. No. Process Risks  Severity Occurrence Risk priority number (RPN) Controls/Actions to mitigate risk  Action Status 1 Planning  Wrong order received from marketing and processed  2 2 22 Train person making the order N.A. Standard not specified  1 2 12 Incorporate mentioning 'Standard:' in order  N.A. Wrong GTP generated  3 1 31 Counter checked and sign by a senior  N.A Error in typing  3 1 31 Train person to be alert. Counterchecking N.A

39. Hazard Identification, Risk Assessment   Department: Technical Cell RRKLW/DI-4505/HIRA/01/TC, Issue Date: 01-Jan-2020 Revision:05 Date, 24 July-2024 Last Reviewed: 24 July 2024 Sr. No. Area Activity Routine/Non-Routine (R/NR) Hazard Description of Risk involved Intial Risk Existing controls measures Final Risk Additional Control Measures Sev Occ RPN Sev Occ RPN 1 Incoming Inspection Sample collection for testing. R Person may get minor injury due to fall down of packing materials  Physical Hazard 3 4 12 Use of safety shoes  3 3 9 2 Tensile Strength & Elongation  Test R Chances of eye injury may happen if any partcles gets dropped in eyes Eye injury 2 4 8 Safety Shoes & Goggles 2 3 6 3 PVC Mould preparation R Person may get minor skin burning while removing sample from the mould after mould formation. Burn injury 2 4 8 Use of Heat Resistant Hand gloves & safety shoes 2 3 6 4 Sample cutting and preparation for testing R Person may get minor injury while using knife for sample cutting Cut injury 3 3 9 Sample is prepared by wearing cut proof hand gloves. 3 2 6