Lead Auditor Training - IRCA Certified - Ibec - For Irish …file/Lead+Auditor+Brochure.pdfIrish Quality Centre Lead Auditor Training - IRCA Certified Contact: Michelle Reinecke Quain

Irish Quality Centre

Lead Auditor Training - IRCA Certified

Contact: Michelle Reinecke Quain Tel: (061) 431802

E mail: [email protected]

Host Venue: TBA

Dates: TBA

Cost: Life Science Skillnet Members €600pp

Non Member €800pp


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 14001 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, please contact our website at www.iqc.ie

. 2. International Approval:

This programme is internationally approved by IRCA – International Registration Scheme for certified training programme and Auditors


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 19011.

Interpret requirements of ISO 13485 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 value-adding non-conformity reports.

Undertake audit follow-up 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.

Timetable - Day 1

TIME SUBJECT MATTER METHOD USED

MANUAL SECTION

08.45 - 09.00 REGISTRATION - - 09.00 - 09.30 COURSE OBJECTIVES AND COURSE

OVERVIEW Formal Input 1

09.30 - 10.00 INTRODUCTIONS Discussion - 10.00 - 10.15 FUNDAMENTALS OF QUALITY Formal Input 2

10.15 - 10.30 TEA/COFFEE - - 10.30 – 12.30 DRUG GMP REQUIREMENTS 12.30 – 13.30 LUNCH 13.30 – 14.00 INTRODUCTION TO ISO 13485 SERIES OF

STANDARDS Formal Input 3

14.00 - 14.30 INTRODUCTION TO PROCESS

MANAGEMENT Formal Input 3

14.30 - 15.30 EXPLANATION OF SECTION 4 – ISO

13485-QUALITY MANAGEMENT SYSTEMS (QMS)

Formal Input 4, 5

15.30 – 15.45 TEA/COFFEE 15.45 - 16.30 EXPLANATION OF SECTION 5 – TOP

MANAGEMENT RESPONSIBILITY Formal Input 4

16.30 - 17.30 SYNDICATE ON QMS AND TOP

MANAGEMENT RESPONSIBILITY Teamwork and

Group Discussion -

17.30 - 17.45 TEA/COFFEE

17.45 - 18.30 EXPLANATION OF SECTION 6 –

RESOURCE MANAGEMENT Formal Input 4

18.30 - 19.15 EXPLANATION OF SECTION 7 – PRODUCT

REALISATION Formal Input 4

Timetable – Day 2


MANUAL SECTION

08.45 – 09.00 REVIEW OF DAY 1 Formal Input & Discussion

-

09.00 – 09.30 DISCUSSION ON ISO 13485 EXERCISE NO. 1 Group Discussion - 09.30 – 10.30 FEEDBACK ON SYNDICATE ON SECTION 6 & 7 Teamwork &

Group Discussion -

10.30 – 10.45 TEA/COFFEE 10.45 – 11.15 EXPLANATION OF SECTION 8 –

MEASUREMENT, ANALYSIS AND IMPROVEMENT

Formal Input 4

11.15 – 12.45 SYNDICATE ON SECTION 8 PLUS FEEDBACK

Teamwork 5

12.45 – 13.30 LUNCH - - 13.30 – 14.45 REVIEW OF THE PROGRAMME TO DATE Formal Input &

Teamwork 5

14.45 – 15.30 ALBATROSS EXERCISE

(incl. Tea/coffee) Teamwork -

15.30 – 16.45

PLANNING THE AUDIT PROGRAMME - Human elements of auditing - Fundamentals of auditing - Life Cycle - Authority

Formal Input 6/7

- Audit objectives - Extent of audit programme - Procedures - Audit resources - Responsibilities - Auditor Selection, Qualification &

Training - Establishing the audit team - Audit scope, scheduling & frequency

08.45 – 09.00 REVIEW OF DAY 1 Formal Input &

Discussion -

09.00 – 09.30 DISCUSSION ON ISO 13485 EXERCISE NO. 1 Group Discussion - 09.30 – 10.30 FEEDBACK ON SYNDICATE ON SECTION 6 & 7 Teamwork &

Group Discussion -

10.30 – 10.45 TEA/COFFEE 10.45 – 11.15 EXPLANATION OF SECTION 8 –

MEASUREMENT, ANALYSIS AND IMPROVEMENT

Formal Input 4

11.15 – 12.45 SYNDICATE ON SECTION 8 PLUS FEEDBACK

Teamwork 5

16.45 – 17.15 AUDIT PREPARATION

- Feasibility of audit - Understanding auditees organisation - Process approach

Formal Input 8

17.15 – 17.30 TEA/COFFEE

17.30 – 18.00 AUDIT PREPARATION (cont’d)

- Overview Of Organisation Teamwork -

18.00 – 19.15 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

19.15 - 19.45 AUDIT PREPARATION (cont’d)

- Preparation of Audit Checklist

19.45 END OF DAY 2

Timetable – Day 3


MANUAL SECTION

08.45 - 09.00 REVIEW OF DAY 2 Formal Input & Discussion

-

09.00 - 09.30 DISCUSSION ON ISO 13485 EXERCISE NO. 2 Group Discussion - 09.30 - 09.45 09.45 - 10.00 10.00 - 10.15

AUDIT PREPARATION (Cont’d)

- Audit team assignments - Classification of non-conformity - Classifying non-conformities - Guidelines for Productive Meetings

Formal Input

Individual exercise

Formal Input

10.15 - 10.30 TEA/COFFEE

10.30 - 12.15 CARRYING OUT THE AUDIT - Opening Meeting

Formal Input 9

- 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

12.15 – 12.45

PARTICIPANTS TO CARRY OUT AN AUDIT - Preparation of an Audit Plan and Opening Meeting Exercise

Teamwork

-

12.45 - 13.45 LUNCH 13.45 - 14.30 14.30 – 15.00 15.00 – 15.15

- Preparation of an Audit Plan (cont’d) PARTICIPANTS TO CARRY OUT AN AUDIT - Brief and Preparation OPENING MEETING

Teamwork

Teamwork

- -

15.15 - 15.45 AUDIT

15.45 - 16.00 TEA/COFFEE

16.00 - 16.15 PARTICIPANTS PREPARE FOR CLOSING MEETING

Teamwork -

16.15 - 16.30 PARTICIPANTS CARRY OUT CLOSING MEETING

Teamwork -

16.30 - 17.00 DISCUSSION AND LEARNING POINTS

Group Discussion

17.00 - 19.00 PREPARATION OF AN AUDIT PLAN TO ISO 13485 (incl.tea/coffee)

Teamwork

19.00 - 19.30 LEAD AUDITOR STYLES - Defining leadership - Blake and Mouton - Styles of leadership and Leadership abilities

and skills - Tannenbaum and Schmidt

Formal Input

Individual Exercise

Formal Input

Individual Exercise

11

19.30 - 20.15 BRIEF AND PREPARATION FOR LIVE AUDIT ON

DAY 4 Teamwork

Timetable – Day 4


MANUAL SECTION

08.45 – 09.00

MEET AT ORGANISATION FOR LIVE AUDIT

Reflection

09.00 - 01.00 AUDIT

- Opening Meeting - Tour - Preparation - Audit - Preparation for closing meeting - Closing meeting

Teamwork

-

01.30 – 02.15 LUNCH 02.15 – 03.45 FEEDBACK FROM LIVE AUDIT AND LEARNING

POINTS Reflection -

03.45 – 04.15 THE AUDIT REPORT Formal Input 10 04.15 – 05.00 REPORT ON ‘LIVE AUDIT’

(Including Break) Teamwork

05.00 – 05.45 CORRECTIVE ACTION Formal Input 10 Individual Exercise 05.45 – 06.15 AUDIT PROGRAM REVIEW AND IMPROVEMENT Formal Input 10 06.15 – 07.30 SITUATIONAL ASSESSMENTS AND RESPONSES Teamwork &

Group Discussion -

07.30 END DAY 4

Timetable – Day 5


MANUAL SECTION

08.45 - 11.00 PERFORMANCE AUDITING (incl. tea/coffee)

Teamwork -

11.00 - 12.15 THE RELATIONSHIP BETWEEN THE 8 QUALITY

MANAGEMENT PRINCIPLES AND ISO 13485 Teamwork

-

12.15 - 12.30

AUDIT GUIDES Formal Input 12

12.30 - 12.45 REGISTRATION OF AUDITORS

Formal Input 12

12.45 - 13.45 LUNCH

13.45 - 14.15 SYNDICATE AND DISCUSSION ON OVERALL

PROGRAMME Teamwork & Group

Discussion -

14.15 - 16.15 EXAMINATION Each participant -

16.15 - 16.20 COURSE EVALUATION Each participant - -


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


7. Fees:

TBA

8. Cancellation

If the programme is cancelled within 14 days of commencement date, a full cancellation fee is charged.

9 Method of Payment

Work is invoiced each month for work completed in that month

Payment needs to be made in advance of the programme taking place.

If proposal is acceptable, please forward Purchase Order prior to commencement of work