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Practical Guide for Root Cause Investigations – Methodology & Tool Kit

Methodology & Tool Kit
Nov 08 - Nov 09, 2018 |
Nov 09, 2018 |
MELIÁ SEVILLA | Seville, Spain
  • Conference
  • Europe
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This engaging two-day workshop teaches a step by step, proven process ideal for researching any change/decline in the performance of a product or work process/system, whether it be physical or virtual. It is appropriate for individuals new to this discipline, as well as those who are seasoned veterans looking to improve/refresh their skills, regardless of industry or function within the organization. Simply put, this is one of the most practical and applicable trainings available!

On day one, the participants are introduced to the seven step methodology. A Roadmap is provided to guide the participants through the steps and suggest appropriate tools to ensure the right questions are being asked, the right data is being collected, and the right documentation is being made. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). On day two, several hours are devoted to strengthening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.

Participants will be emailed a set of electronic templates. These templates, plus the Roadmap, guide the investigator through the methodology and provide the basis for documentation.

Who Should Attend

Alumni of this program typically (though not exclusively) have a background in:

  • Quality
  • Risk management
  • Regulatory affairs
  • Compliance
  • Manufacturing
  • Product development
  • CAPA
  • Supply chain & purchasing
  • Production
  • Engineering
  • Project management
  • R&D
  • Fraud management and more

Learning Objectives

Upon completion of the workshop, participants will able to immediately, effectively, and efficiently apply the methodology to:

  • Identify the technical root cause(s), that is, the change(s)
    that occurred.
  • Identify systemic root cause(s), that is, any underlining
    breakdown in the organizations broader systems that
    allowed the change(s) to occur.
  • Implement a comprehensive corrective and/or preventive
    action plan to restore performance.
  • Implement a control plan to minimize and/or prevent
    recurrence.

Instructor

Rob Weaver, President of Weaver Consulting
Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and operations improvement consultants who focus their business exclusively on root cause analysis. With a combined 40+ years’ experience and a client base that expands worldwide, they have helped organizations across a multitude of highly regulated industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecommunications, semiconductors, and many more, successfully implement their premier root cause analysis methodology, Root Cause Investigation for CAPA. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company.

Thursday, 8 November 2018

9:00
Welcome & Introduction

  • Define technical CAPA problem
  • Common investigation mistakes
  • Investigation Roadmap template
  • Introduce 1st participant real life case study

10:00
Step 1: Define the Performance Problem

  • Introduce instructor case study
  • Problem statement
  • Problem description

10:30
Coffee Break

11:00
Step 1: Continued

  • Problem description continued
  • Workshop
  • Flow chart process(es) being investigated & identify key inputs
  • Workshop
  • Time of events
  • Team charter including performance & cost savings goals

12:00
Lunch Break

13:00
Step 2: Collect Data

  • Determine data needed
  • Data collection tools & techniques
  • Data measurement plan
  • Workshop

15:00
Coffee Break

15:30
Step 3: Identify Possible Causes

  • Time of changes
  • Differences between Is & Is Not facts
  • Workshop
  • Changes associated with identified differences
  • Review risk analysis
  • Brainstorming techniques
  • Workshop

16:30
Step 4: Test Possible Causes

  • Test possible causes against facts
  • Summarize testing leveraging contradiction matrix
  • Historical perspective of investigations
  • Workshop

17:30
Step 5: Identify Technical & Systemic Root Causes

  • Verify assumptions
  • Conduct studies/experiments
  • Identify technical root cause(s)

18:00
End of Day 1

Friday, 9 November 2018

9:00
Step 5: Continued

  • Identify systemic root causes

9:30
Step 6: Determine Corrective/Preventive Actions

  • Mistake proofing techniques
  • Variation reduction & optimization techniques
  • Corrective/preventive actions
  • Acceptance criteria

10:30
Coffee Break

11:00
Step 6: Continued

  • Risk mitigation
  • Control plan
  • Workshop

11:45
Step 7: Verify Corrective/Preventive Actions

  • Implement & measure corrective/preventive actions
  • Evaluate control plan
  • Determine additional preventive actions

12:00
Lunch Break

13:00
Second Participant Real Life Case Study

  • Introduction
  • Workshop to develop problem statement, problem description, identify possible causes
  • Workshop to collect data
  • Workshop to test possible causes

15:00
Coffee Break

15:30
References, On-line Resources and Final Remarks

  • Workshop to determine corrective/preventive actions including risk mitigation, control plan, acceptance criteria

16:00
Closing Remarks

  • Compare/contrast this investigation methodology with traditional approach
  • Shortcuts
  • Simple investigations
  • Difficult investigations
  • Investigation report
  • Return on investment
  • References

16:30
End of Training Course

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

MELIÁ SEVILLA
Calle Dr. Pedro de Castro 1
41004 Sevilla
Spain
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 12th September 2018

Book Your Room for the PDA Group Rate

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*Rates are per room and night, including the following services and benefits free of charge:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.

Parking

Parking available upon request at the registration desk.

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4494

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