SYSTHINKFINALS PDF - Quality Management Systems

Chapter 7 TECHNOLOGICAL FACTORS - include technological aspects like new process International Organization for adaption, R&D activity, automation, Standardization - is an international non- technol...

Chapter 7 TECHNOLOGICAL FACTORS - include technological aspects like new process International Organization for adaption, R&D activity, automation, Standardization - is an international non- technology incentives and the rate of governmental organization made up of technological change. national standards bodies that develops and publishes a wide range of proprietary, ENVIRONMENTAL FACTORS - include industrial, and commercial standards. ecological and environmental aspects such as weather, climate, and climate ISO 9001 - is defined as the international change. standard that specifies requirements for a quality management system (QMS). LEGAL FACTORS - include the statutory Organizations use the standard to and regulatory compliances associated demonstrate the ability to consistently with the system. provide products and services that meet Risk-based thinking is a process of customer and regulatory requirements. addressing both risk and opportunities SWOT Analysis as a basis for increasing the effectiveness of the quality management system, Strength achieving improved results and Weaknesses preventing negative effects on the Opportunities achievement of an organization’s strategic Threats and operational objectives. PESTEL Analysis Where is risk addressed in ISO 9001:2015? POLITICAL FACTORS – are basically how the government intervenes in the Clause 4 (Context) - organization is economy. Specifically, political factors required to determine its QMS processes have areas including tax policy, labor law, and address its risks and opportunities. environmental law, trade restrictions, Clause 5 (Leadership) - top tariffs, and political stability. management is required to: ECONOMIC FACTORS - include Promote awareness of risk-based economic growth, interest rates, thinking. exchange rates, and the inflation rate. Determine and address risks and SOCIAL FACTORS - include the cultural opportunities that can affect aspects, customs, festivals, lifestyle, product/service conformity. area, and locality. Clause 6 (Planning) - organization is required to identify risks and opportunities related to QMS performance and take appropriate actions to address them. Clause 7 (Support) - organization is required to determine and provide necessary resources. Clause 8 (Operation) - organization is required to manage its operational processes. Clause 9 (Performance evaluation) - organization is required to monitor, measure, analyze and evaluate the effectiveness of actions taken to address risks and opportunities. Clause 10 (Improvement) - organization is required to correct, prevent or reduce undesired effects and improve the QMS and update risks and opportunities. Note, risk is implicit whenever suitable or appropriate is mentioned (clause 7 and 8). 7SYSTHNKNG - QUIZ # 4: 11-20. FALSE Write A if the statement is TRUE, and B if it 11. Risk-based thinking ensures risk is not is FALSE. considered from the beginning and 1-10. TRUE throughout. 1. ISO stands for International 12. Risk-based thinking reduces the Organization for Standardization. probability of reaching objectives. 2. ISO 9001 is defined as the international 13. Risk-based thinking increases the standard that specifies requirements for a probability of negative results. quality management system (QMS). 14. Risk is output to Management Review. 3. Risk is about what could happen and 15. Risk-based thinking is just the what the effect of this happening might responsibility of management. be. 16. Risk-based thinking must not become 4. Opportunity can lead to adaptation of an integral part of the organizational new practices. culture. 5. Risk-based thinking is already part of 17. Risk is the effect of uncertainty on the process approach. objectives or unexpected results. 6. Risk-based thinking is everybody's 18. Risk-based thinking addresses both business. risk and opportunities as a basis for 7. Risk-based thinking is an element in decreasing the continual improvement process that the effectiveness of the quality is focused on prevention. management system. 8. Opportunity is not always directly 19. The concept of risk has not always related to risk but it is always related to been implicit in ISO 9001. the objectives. 20. Risk-based thinking establishes a 9. Risk is the possibility of events or reactive culture of improvement. activities impeding the achievement of an organization's strategic and operational objectives. 10. Risk-based thinking makes preventive action part of strategic and operational planning. 7SYSTHNKNG- QUIZ #5: 5. Process performance continually improved through incremental and Write the number of maturity level on innovative technological improvements. 5 each item. 6. Causal Analysis and Resolution. 5 Level 1- Initial - Processes are unpredictable, poorly controlled, and 7. Organizational Process Performance. 4 reactive. 8. Decision Analysis and Resolution. 3 Level 2 – Managed - Processes are 9. Configuration Management. 2 planned, documented, performed, 10. The process performance may not be monitored, and controlled at the project stable. 1 level. 11. This provides a confused or wobbly Level 3 – Defined - Processes are well environment for the processes. 1 characterized and understood. Processes, standards, procedures, and 12. Integrated Project Management. 3 tools are defined at the organizational 13. Organizational Performance level. Management. 5 Level 4 - Quantitatively Managed - 14. Measurement and Analysis. 2 Processes are controlled using statistical and other quantitative techniques. 15. Quantitative Project Management. 4 Level 5 – Optimized - Process 16. Process and Product Quality performance continually improved Assurance. 2 through incremental and innovative 17. Organizational Process Definition. 3 technological improvements. 18. Requirements Management. 2 1. Processes are planned, documented, performed, monitored, and controlled at 19. Organizational Process Focus. 3 the project level. 2 20. Organizational Training. 3 2. Processes are controlled using statistical techniques. 4 3. Processes are unpredictable, poorly controlled, and reactive. 1 4. Processes are well characterized and understood. 3