Lead Auditor Training - IRCA Certified

Transcription

1 Irish Quality Centre Lead Auditor Training IRCA Certified Contact: Michelle Reinecke Quain Tel: (061) E mail: Host Venue: Dates: Cost: Michelle.ReineckeQuain@ibec.ie Galway Feb / Dublin March / Tullamore April / Cork May 413 Feb / 412 Mar / 816 April / 614 May IMDA SKILLNET Members 680pp Non Member 800pp

2 Irish Quality Centre 1. About IQC: IQC (Irish Quality Centre) is one of Ireland's leading providers of consultancy, customised training, and networking solutions in Quality, the Environment and Continuous Improvement. We assist organisations by integrating standards such as ISO 9001, Good Manufacturing Practice (GMP) and ISO with their business strategies. Our internationally approved ISO 9001 and Auditor Training programmes are used across Europe and throughout the USA through our USA affiliate network. Hundreds of personnel in organisations as diverse as the European Space Agency, the USA Army, Allied Irish Banks, Guinness Ireland and Boston Scientific are trained annually. For further information or contact 2. International Approval: This programme is internationally approved by IRCA International Registration Scheme for certified training programme and Auditors

3 Irish Quality Centre 3. Course Objectives: By the end of the course participants will be able to: Describe the purpose of a quality management system and explain the 8 principles of quality management. Explain the purpose, content and interrelationship of ISO 9000, ISO13485, ISO 9004 and ISO Interpret requirements of ISO in the context of an audit. Manage an audit programme. Understand the different types of audits. Describe the roles and responsibilities of auditors and lead auditors. Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to: a) plan and prepare effectively b) gather objective evidence, through effective interviewing, observation, sampling and note taking. c) analyse and interpret information in order to determine conformance with requirements. Report the audit, including writing valid, factual and valueadding nonconformity reports. Undertake audit followup activities, including evaluating the effectiveness of corrective action. Professionally liaise with external auditors. During the 5 days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.

4 4. Timetable Day 1 TIME SUBJECT MATTER METHOD USED MANUAL SECTION REGISTRATION COURSE OBJECTIVES AND COURSE OVERVIEW Formal Input INTRODUCTIONS Discussion FUNDAMENTALS OF QUALITY Formal Input TEA/COFFEE DRUG GMP REQUIREMENTS LUNCH INTRODUCTION TO ISO SERIES OF STANDARDS INTRODUCTION TO PROCESS MANAGEMENT EXPLANATION OF SECTION 4 ISO 13485QUALITY MANAGEMENT SYSTEMS (QMS) Formal Input 3 Formal Input 3 Formal Input 4, TEA/COFFEE EXPLANATION OF SECTION 5 TOP MANAGEMENT RESPONSIBILITY Formal Input SYNDICATE ON QMS AND TOP MANAGEMENT RESPONSIBILITY TEA/COFFEE and Group Discussion EXPLANATION OF SECTION 6 RESOURCE MANAGEMENT EXPLANATION OF SECTION 7 PRODUCT REALISATION Formal Input 4 Formal Input 4

5 Timetable Day 2 TIME SUBJECT MATTER METHOD USED REVIEW OF DAY 1 Formal Input & Discussion MANUAL SECTION DISCUSSION ON ISO EXERCISE NO. 1 Group Discussion FEEDBACK ON SYNDICATE ON SECTION 6 & 7 & Group Discussion TEA/COFFEE EXPLANATION OF SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Formal Input SYNDICATE ON SECTION 8 PLUS FEEDBACK LUNCH REVIEW OF THE PROGRAMME TO DATE Formal Input & ALBATROSS EXERCISE (incl. Tea/coffee) PLANNING THE AUDIT PROGRAMME Formal Input 6/7 Human elements of auditing Fundamentals of auditing Life Cycle Authority Audit objectives Extent of audit programme Procedures Audit resources Responsibilities Auditor Selection, Qualification & Training Establishing the audit team Audit scope, scheduling & frequency

6 AUDIT PREPARATION Feasibility of audit Understanding auditees organisation Process approach Formal Input TEA/COFFEE AUDIT PREPARATION (cont d) Overview Of Organisation AUDIT PREPARATION (cont d) Critical Success Factors Audit Plan Initial auditee contact Systems Audit Preliminary visit Studying Documentation & Information No formal documented system Work Documents AUDIT PREPARATION (cont d) Preparation of Audit Checklist END OF DAY 2

7 Timetable Day 3 TIME SUBJECT MATTER METHOD USED REVIEW OF DAY 2 Formal Input & Discussion MANUAL SECTION DISCUSSION ON ISO EXERCISE NO. 2 Group Discussion AUDIT PREPARATION (Cont d) Audit team assignments Classification of nonconformity Classifying nonconformities Guidelines for Productive Meetings Formal Input Individual exercise Formal Input TEA/COFFEE CARRYING OUT THE AUDIT Opening Meeting Auditing a process Audit methods Audit sequence Collecting Information sources communications audit sampling performance & improvement auditing audit evidence audit findings audit conclusions Preparation for Closing Meeting Closing Meeting PARTICIPANTS TO CARRY OUT AN AUDIT Preparation of an Audit Plan and Opening Meeting Exercise Formal Input LUNCH Preparation of an Audit Plan (cont d) PARTICIPANTS TO CARRY OUT AN AUDIT Brief and Preparation OPENING MEETING

8 AUDIT TEA/COFFEE PARTICIPANTS PREPARE FOR CLOSING MEETING PARTICIPANTS CARRY OUT CLOSING MEETING DISCUSSION AND LEARNING POINTS Group Discussion PREPARATION OF AN AUDIT PLAN TO ISO (incl.tea/coffee) LEAD AUDITOR STYLES Defining leadership Blake and Mouton Styles of leadership and Leadership abilities and skills Tannenbaum and Schmidt BRIEF AND PREPARATION FOR LIVE AUDIT ON DAY 4 Formal Input Individual Exercise Formal Input Individual Exercise 11

9 Timetable Day 4 TIME SUBJECT MATTER METHOD USED MANUAL SECTION MEET AT ORGANISATION FOR LIVE AUDIT Reflection AUDIT Opening Meeting Tour Preparation Audit Preparation for closing meeting Closing meeting LUNCH FEEDBACK FROM LIVE AUDIT AND LEARNING POINTS Reflection THE AUDIT REPORT Formal Input REPORT ON LIVE AUDIT (Including Break) CORRECTIVE ACTION Formal Input 10 Individual Exercise AUDIT PROGRAM REVIEW AND IMPROVEMENT Formal Input SITUATIONAL ASSESSMENTS AND RESPONSES & Group Discussion END DAY 4

10 Timetable Day 5 TIME SUBJECT MATTER METHOD USED MANUAL SECTION PERFORMANCE AUDITING (incl. tea/coffee) THE RELATIONSHIP BETWEEN THE 8 QUALITY MANAGEMENT PRINCIPLES AND ISO AUDIT GUIDES Formal Input REGISTRATION OF AUDITORS Formal Input LUNCH SYNDICATE AND DISCUSSION ON OVERALL PROGRAMME & Group Discussion EXAMINATION Each participant COURSE EVALUATION Each participant

11 Irish Quality Centre 5. Course Presenter: Martin Reddington Worked as Quality Manager in the Healthcare and Textile industries. Over 20 years experience in developing and implementing Quality, Management Systems and training. Has trained hundreds of staff at all levels within organisation in Quality Management principles. Developed and implemented a Quality Service initiative with AIB. Registered Lead Auditor with IRCA. Has extensive knowledge of Excellence Through People and has implemented ETP in many organisations. 6. Some of Our Clients: Abbott Vascular Ireland Allergan Ltd B Braun Hospicare Beckman Coulter Boston Scientific Celestica Creganna Medical Devices Lake Region Manufacturing Merit Medical Rottapharm Schering Plough