PARTICIPANTION FEES

Members: RM 700 per participant

Non-Members: RM 850 per participant

WHO SHOULD ATTEND

QMR, QA/QC technicians/QA Inspectors, Middle management (Supervisors, Executives & Engineers) & Top management (Senior Engineers, Head of Department, Managers)

REGISTRATION

Registration is on a first-come-first-served basis. Cheques made in favour of the “FMM Institute - NS” should be forwarded one week before the commencement of the programme. Completed registration form, that is faxed, mailed or e-mailed to FMM Institute, would be deemed as confirmed.

REPLACEMENT / CANCELLATION

All cancellations must be made in writing. There will be no charge for cancellation received 10 or more working days before the start of the programme. Cancellation received 6 – 9 working days before the start of the programme is subject to a cancellation fee of 50% of the course fees. Cancellation received 5 working days and below before the start of the programme is subject to a cancellation fee of 100% of the course fees. If the participant fails to attend the programme, the full course fees are payable. However, replacement can be accepted at no additional cost.

CORRECTIVE & PREVENTIVE ACTION

(CAPA) MANAGEMENT

Date : NOVEMBER 13-14, 2013 Time : 9.00 am - 5.00pm Venue : FMM Institute NS Branch, Seremban 2, NS

SBL

Claimable

Company Stamp

REGISTRATION FORM

FMM Institute Negeri Sembilan Branch Fax : 06-603 1628 Required vegetarian meal

Attn : Pn Lina / Pn Liza

Name Designation Email

1.

_______________________________________________________________________________________________________________________________________________________________

2.

_______________________________________________________________________________________________________________________________________________________________

Payment :Enclosed cheque/Bank Draft no . _____________________ for RM ____________ being payment for __________ participant (s) made in favour of “FMM Institute - NS”

Submitted by : Please tick / FMM Member NON– Member

Name : _________________________________________________ Designation : _____________________________________

Company : __________________________________________________________________________________________________

Address : ___________________________________________________________________________________________________

Tel : __________________________ Fax : __________________________ Email : ____________________________________

For further enquiries kindly contact: Lina : akmalina@fmm.org.my

Liza : aliza@fmm.org.my Tel: 06-6031616 / 26 / 27

Closing Date Nov 12, 2013

INTRODUCTION

Corrective action and preventive action (CAPA, also called correc-tive action / preventive action) are improvements to an organiza-tion's processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manu-facturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action). Corrective actions are implemented in response to customer complaints, undesired levels of internal nonconformity, nonconformities identified during an internal audit or adverse or unstable trends in product and process monitoring such as would be identified by SPC. Preventive actions are implemented in re-sponse to the identification of potential sources of non-conformity. To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal. CAPA is part of the overall quality management system (QMS). OBJECTIVES 1. Better management of CAPA process to meet ISO 9001:2008 requirements. 2. To leverage this key component for improvement in a quality management system to benefit your organization. 3. Identify opportunities for improvement in the participant’s organization that can be acted upon after the course. 4. Improve company's existing approach to problem-solving and make it more effective and less time-consuming .

COURSE CONTENTS (Day 1-2)

SO 9001:2008: Corrective & Preventive Action (CAPA) Management

ISO Clause 8.5.2: Corrective action ISO Clause 8.5.3: Preventive Action Non-Conformance Report (NCR) Issuance NCR CAPA writing

NCR Follow Up/Timeline Development 2-3 Case Study based on OMYA NCR Verification Methods for CAPA Effectiveness NCR/CAPA Microsoft Excel Based Database/Tracking

Management Review CAPA reporting

TRAINER

Selva Ganabathy holds a Bachelor of Science (B.Sc) with Honours majoring in Microbiology from Universiti Kebangsaan Malaysia. He also has Certi-fied Quality Engineer status which is registered with American Society for Quality (ASQ) and ISO 9001:2000 QMS Lead Auditor—Certification Transition Training . Previously he work at Philip Morris (M) Sdn Bhd. , Hovid Berhad, and Sampoerna JL Sdn. Bhd. He has a lots of experience in Training & Consultancy pertaining to ISO 9001:2008 & ISO 17025 Certification & Maintenance such as Gap analysis, Coaching on developing con-tents of Standard Operating Procedure (SOP) , Competency Awareness Training, MR Skills Coaching Program, Document controller Coaching pro-gram, Internal Quality auditing skills training and Live on-site audit, Documentation Tidy up before Stage 1 Adequacy Audit, Coaching on Manage-ment Review Meeting, Mock audit before Certification Audit.