Quality Auditing Techniques Main Examinations November 2018 Question 1 The organisation" Green Light" is located in Longhua. It is an organisation that transforms LED components into LED end products, and was founded in the year 2000. Each production line is managed by total quality control to ensure the quality of LED production in operations, engineering, ware-housing and customer satisfaction. The Quality Manager of "Green Light" organisation has approached you as the Audit Team Leader together with the audit team to conduct an external audit on ISO 9001:2015 requirements. After you have completed the audit activities, the following non-conformances have been identified. Finding 1 The organisation has not identified, documented and analysed "External Issues" that can affect customer satisfaction and delivery of quality products and/or services Finding 2 An auditor has interviewed the QA Manager and it was found that no risk and opportunities were identified and documented for each process of the LED production Finding 3 Management review is conducted on a regular basis once per year. Records of the last management review was conducted last Dec 2017 (12th). However, these records do not show the results and effectiveness of each process since no Key Performance Indicators (KPIs) were initially planned Finding 4 The auditor is shown "internal audit reports" from the last audit. These include a nonconformity report stating that 5 people in the LED Department had not been trained in the wafer fabrication stage. The corrective action taken was to train the 5 members of staff. The management epresentative tells you that no further investigation was made as the corrective action was obvious, however there was no training records to verify that the 5 members had been trained Finding 5 It was discovered that a few instruments did not have calibration tags to indicate expiration date or the status of the calibration Finding 6 Quality objectives (GL.Q0.001P.FM001) were posted in the workshop, but 60% of the people that were interviewed were not aware of these objectives Page 2 of 6Quality Auditing Techniques Main Examinations November 2018 1.1 Determine the "audit objectives" and "audit scope" with regards to the case study above (3) 1.2 Compile a *question layout checklist" relevant to the case study above (6) 1.3 What objective evidence did the auditor look for to conclude his findings? (12) 1.4 Produce an "audit report" including the nonconformity, type of non-conformance (Critical, Major, Minor) and state the clause number/'s from the ISO 9001:2015 standard (see annexture]) that is/are not been followed for each incident. (30) 1.5 Based on finding 3 above: Management review is conducted on a regular basis once per year. Records of the last management review was conducted last Dec 2017 (12th). However, these records do not show the results and effectiveness of each process since no Key Performance Indicators (KPIs) were initially planned 1.5.1 List 3 possible causes and determine the root cause using the 5 WHY 1 H Analysis method. (8) 1.5.2 Study the non-conformance above and design and complete a corrective/preventive action report form. Note: Complete the root cause of the non-conformance, requirements for effective resolution and proposed action plan to correct the non-conformance. (10) 1691 Question 2 2.1 The Quality policy and its effective deployment can only be truly assessed based on the overall results of an audit. Explain what audit methods can be used to collect as evidence to satisfy the requirements of the policy (6) 2.2 Demonstrate how you would apply an Audit Trail by giving a relevant example at your work place. (6) Page 3 of 6Quality Auditing Techniques Main Examinations November 2018 2.3 Outline the advantages of using Audit Trail in report writing. (4) [16] Question 3 3.1 The evaluation of auditor competence should be planned, implemented and documented in accordance with the audit programme. One of the evaluation processes is to determine the competence of audit personnel to fulfil the needs of the audit programme. Discuss the above statement in relation to: 7.2.2 Personal Behaviour (10) 7.2.3 Generic knowledge and skills of management system auditors (10) B. Management system and reference documents (5) C. Organisational Context (4) 7.2.3.3 Discipline and sector -specific knowledge and skills of management system auditors (6) (35] Total marks=120 *Good Luck* Page 4 of 6Quality Auditing Techniques Main Examinations November 2019 Annexure 1: ISO 9001:2015 Content 4. Context of the organisation 4. 1. Understanding the organisation and its context 4.2. Understanding the needs and expectations of the interested parties 4.3. Determining the scope of the quality management system 4.4. Quality management system and its processes 5. Leadership 5.1. Leadership and commitment 5.1.1. General 5.1.2. Customer focus 5.2. Policy 5.2.1. Establishing the quality policy 5.2.2. Communicating the quality policy 5.3. Organisational roles, responsibilities and authorities 6. Planning 6.1. Actions to address risks and opportunities 6.2. Quality objectives and planning to achieve them 6.3. Planning of changes 7. Support 7.1. Resources 7.1.1. General 7.1.2. People 7.1.3. Infrastructure 7.1.4. Environment for the operation of processes 7.1.5. Monitoring and measuring resources 7.1.6. Organisational knowledge 7.2. Competence 7.3. Awareness 7.4. Communication 7.5. Documented information 7.5.1. General 7.5.2. Creating and updating 7.5.3. Control of documented information 8. Operation 8.1. Operational planning and control 8.2. Requirements for products and services 8.2.1. Customer communication 8.2.2. Determining the requirements related to products and services 8.2.3. Review of requirements related to products and services 8.2.4. Changes to requirements for products and services 8.3. Design and development of products and services 8.3.1. General 8.3.2. Design and development planning 8.3.3. Design and development inputs 8.3.4. Design and development controls 8.3.5. Design and development outputs 8.3.6. Design and development changes 8.4. Control of externally provided processes, products and servicesQuality Auditing Techniques Main Examinations November 2019 3.4.1. General 8.4.2. Type and extent of control 8.4.3. Information for external provides 8.5. Production and service provision 8.5.1. Control of production and services provision 8.5.2. Identification and traceability 8.5.3. Property belonging to customers or external providers 8.5.4. Preservation 8.5.5. Post-delivery activities 8.5.6. Control of changes 8.6. Release of products and services 8.7. Control of nonconforming outputs 9. Performance evaluation 9.1. Monitoring, measurement, analysis and evaluation 9.1.1. General 9.1.2. Customer satisfaction 9.1.3. Analysis and evaluation 9.2. Internal audit 9.3. Management review 9.3.1. General 9.3.2. Management review inputs 9.3.3. Management review outputs 10. Improvements 10.1. General 10.2. Nonconformity and corrective action 10.3. Continual improvement Page 7 of 7