The Audit Process Input Internal audit Output Managing Audit Audit Report programme Findings/CARS Planning & Follow-up Preparation Improvement Conclusions The above figure illustrates the Inputs & Outputs of an audit process Question 1 An audit programme should include information and resources necessary to organise and conduct its audits effectively and efficiently within a specific time frame. 1.1 Discuss the following in relation to Establishing audit programme objectives (10) Roles & Responsibilities of the person managing the audit programme (10) Establishing the extent of an audit programme (10) Establishing audit procedures (10) Page 2 of 4Quality Auditing Techniques Supplementary Examinations November 2018 1.2 Discuss Planning & Preparation in relation to: Preparing work documents and performing document review (7) Preparing an audit plan (10) 1.3 With reference to Figure 1, express the role management plays in the Auditing Process (10) 1.4 Explain what resources an auditor needs to perform an audit effectively (5) 1.5 With reference to Figure 1, explain the following under Outputs: Conducting an audit follow up (5) 1.6 The Auditor asked the Supervisor whether the instruments are calibrated regularly. The Supervisor replied that an Engineer from the Engineering Department comes every six months and attends to the instruments. He was not sure what the Engineer does and generally he is not around when the instrument is checked. He only calls in the Engineer when the recorder stops working. However there was no evidence off next calibration date 1.6.1 List 3 possible causes and determine the root cause using the 5 WHY 1 H Analysis method (8) 1.6.2 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) 195] Page 3 of 4Quality Auditing Techniques Supplementary Examinations November 2018 Question 2 2.1 A combination of evaluation methods should be used to ensure an outcome that is objective, consistent, fair and reliable. Critically discuss this statement, including examples. (18) 2.2 Explain what quality management knowledge and skills an auditor should possess when auditing in this discipline (7) [25]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 3. 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 services Page 5 of 6Quality Auditing Techniques Supplementary 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