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Seminars

Root Cause Analysis of Failures & Deviations

Introduction:

Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This course highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis. The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. Emphasis is placed on the application and practical, hands-on aspects of how to facilitate root cause analysis. Additionally, the course will provide attendees with the principles and techniques involved in identifying failures and deviations, categorizing problems, assigning responsibility and tracking team activities.

Course Objectives:

By the end of this course delegates will be able to:

· Learn the clarification of regulatory expectations and guidance

· Identify the essential skills necessary to ensure effective and efficient investigations

· Examine each step of the investigation process from failure identification and notification through documentation

· Practice root cause analysis techniques

· Identify corrective and preventive actions towards successful remediation and closeout

· Gain a perspective of effective interviewing and writing skills

· Discuss common pitfalls, and develop tips and techniques for thorough investigations and elimination of recurring failures and deviations

· Learn through hands-on activities such as group discussions and case studies tailored to regulated industries

Who Should Attend?

Craft, first line supervisors, engineers, reliability and maintenance engineers, and managers who may participate in root cause analysis investigations of chronic equipment problems, or serious incidents related to the environment or safety. Upper level managers who want to understand how rigorously applying Root Cause Analysis techniques can bolster bottom line results should also attend.

Course Outline:

Awareness of the Investigation Process

· Why investigations are important

· Roles and responsibilities

· Sources (types and categories) of investigations

· Company culture

Regulatory Expectations for Investigations

· FDA (21 CFR and Guidance Documents)

· EU (Eudralex, Volume 4)

· ICH

· Review of FDA 483s and Warning Letters

· Landmark case

Investigation Process Overview

· Elements of a thorough investigation process

· Members of the Investigation Team

· Investigation planning, action items and documentation

· Classification levels

· Escalation action assessment

Skills and Tools of an Effective Investigator

· Interview and exploration techniques

· Active listening and writing

· Reading and documentation practices

· Technical writing

· Root Cause Analysis (RCA) facilitation

Introduction to Root Cause Analysis (RCA)

· Principles of root cause analysis

· Description of problem statement

· Why the emphasis on problem cause?

· Methods for, and how to document RCA

Identifying Root Cause

· Process mapping

· Critical interviewing

· Brainstorming tools

· "Is/Is Not" technique

· 5 Whys

· Ishikawa diagrams (Fishbone)

· Failure Modes and Effects Analyses (FMEA)

· Challenges

Corrective and Preventive Actions (CAPA)

· Define corrective action and preventive action

· Identification of corrective actions

· Discuss robustness and effectiveness review

· Abuses of the CAPA system

· Negative impact and re-validation

Effective Documentation of the Investigation Process

· Writing the technical report

· Compliant document extensions and interim reports

· Properly organize and document information

· Management communication and notification

· Interim controls, timetables and other reports

· Maintaining an Efficient Investigation System

· Common barriers and solutions

· Policy and Standard Operating Procedures

· Defined roles and responsibilities

· Metrics and trending

· Investigator training

COURSE LOCATIONS

Code	From	To	City	Fee
RM06	03 Feb 2020	14 Feb 2020	Kuala Lumpur	US$ 7500	Book
RM06	12 Apr 2020	23 Apr 2020	Dubai	US$ 7000	Book
RM06	01 Jun 2020	12 Jun 2020	Istanbul	US$ 7500	Book
RM06	02 Aug 2020	13 Aug 2020	Cairo	US$ 6500	Book
RM06	12 Oct 2020	23 Oct 2020	London	US$ 8000	Book
RM06	21 Dec 2020	01 Jan 2021	Bangkok	US$ 7500	Book

DUBAI OFFICE

Ittihad Deira Building,
Al Ittihad Rd, Deira
Dubai,
UAE
info@petrogas-training.com

USA OFFICE

642 E14 Street,
10009-13 Manhattan,
New York (NY)
USA
info@petrogas-training.com

EGYPT OFFICE

52 General Kamal Hejab Street,
Suez Bridge,
Cairo,
Egypt
info@petrogas-training.com

COURSE CERTIFICATE

Certificate of Completion will be provided to the candidate(s) who successfully attend and complete the course. Training hours attendance percentage of 75% is required.

TRAINING HOURS

Standard course hours: 8:30 A.M. to 3:30 P.M. Informal discussions: 4:30 P.M. to 5:30 P.M.

TRAINING METHODOLOGY

We use a blend of interactive and hands-on methods, active participation, a variety of instructional techniques, dynamic presentations, individual and group exercises, in depth discussion, DVD’s, role-plays, case studies, examples. All of the information, competencies, knowledge and skills acquired within our training programs, are 100% transferrable to the participants’ workplace.

ASSESSMENT & EVALUATION

Pre-Test and Post-Test Assessment are applied on 5-day and 10-day programs. Also, post course evaluation and candidate’s evaluation are applied to add another level of quality measurement. Candidates’ feedback is highly appreciated to elevate the training service quality.

ORGANIZATIONAL IMPACT

A- Have staff trained in the latest training and development approaches

B- Support nationalization and talent management initiatives

C- Have properly trained and informed people who will be able to add value

D- Gain relevant technical knowledge, skills and competencies

PERSONAL IMPACT

A- Develop job related skills

B- Develop personal skills in subject matter

C- Have a record of your growth and learning results

D- Bring proof of your progress back to your organization

F- Become competent, effective and productive

G- Be more able to make sound decisions

H- Be more effective in day to day work by mastering job-related processes

I- Create and develop competency to perform job well

FREQUENT NOMINATIONS SCHEME

A- 10% discount after 05 candidates’ registration.

B- 15% discount after 10 candidates’ registration.

C- 20% discount after 20 candidates’ registration.

D- 25% discount after 25 candidates’ registration.

E- 30% discount after 30 candidates’ registration

F- Higher discount rates will be offered based on work volume with different clients.

SEVERAL NOMINATIONS ON THE SAME COURSE SCHEME

A- One extra free seat is offered on 4 candidates on the same course and dates.

B- Two extra free seats are offered on 6 candidates on the same course and dates.

C- Three extra free seats are offered on 8 candidates on the same course and dates.

D- Four extra free seats are offered on 10 candidates on the same course and dates.

E- Five extra free seats are offered on 12 candidates on the same course and dates.

REGISTRATION POLICY

Nominations to our public courses are to be processed by the client’s Training and/or HR departments. A refund will be issued back to the client in the event of course cancellation or seat unavailability. A confirmation will be issued to the relevant department official(s).

CANCELLATION POLICY

If a confirmed registration is cancelled less than 5 working days prior to the course start date, a substitute participant may be nominated to attend the same course or a 20% cancellation charge is applied. In case of a no-show, a 100% fee will be charged.

PAYMENT POLICY

Payment is due upon receiving the course confirmation, invoice and/or proforma invoice. However; the fee due can be wire transferred to our bank account directly after course completion. Our bank details are illustrated on the confirmation, invoice and proforma invoice, as well. The above documents can be communicated electronically, i.e., in a soft copy or/and in hard copy based on customer’s request.

COPYRIGHT

© 2017. Material published by PETROGAS shown here is copyrighted. © 2017. All rights reserved. Any unauthorized copying, distribution, use, dissemination, downloading, storing in any medium, transmission, reproduction or reliance in whole or any part of this course outline is prohibited and will constitute an infringement of copyright.