Rapid Root Cause Investigation

(rRCI)

Pharmachem Ireland Presentation

31 Mar 2010

Suzanne O Leary (QA Specialist)

Donal McCarthy (IQP Champion at NRL)
Rapid Root Cause Investigation (rRCI): An Introduction

The Novartis Ringaskiddy site (NRL) is an Active Pharmaceutical

Ingredient (API) Manufacturing Site.
There are approx. 450 NRL staff.
Operate a 4 Cycle Shift.
Donal s experience at NRL:
Worked at NRL for 17 years.
Worked in various roles X plant background in Engineering/Automation
Currently working as Process Measurement and Control Manager, looking to support
the Process units to develop and support a RFT culture in the manufacturing
operations.
Suzanne s experience at NRL:
Worked at NRL for 13 years.
Worked in Compliance/QA in various roles over the 13 years.
Currently working as a QA specialist responsible for batch release support, GMP
training for the site and embedding the rRCI culture on site.

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Rapid Root Cause Investigation (rRCI): Why?

The rapid Root Cause Investigation (rRCI) process: Global incentive

brought into the company in last quarter of 2009.

Why?
Regulatory Bodies expect good Process Management.
There is less time to react.
We want to be Right first time every time.
Introduction of a common set of investigation tools across site.

Sep 2009:
3 NRL staff members were trained at a 2 day workshop in Basel/Switzerland.

Oct 2009:
27 staff were trained at a workshop in Cork.
Additional staff members trained on site and there are further training sessions
planned this year.
People selected based on their roles in investigations at NRL.
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Rapid Root Cause Investigation (rRCI): Objective

Objective:
To quickly get to the root cause of Deviations using proven standard tools
and processes.
Critical Deviations where the root cause is unknown.
Fix it right first time, prevent re-occurrence, make sure the solution does
not cause other problems.
Establish the facts, weed out the opinions, theory s, jumping to cause, pre-
conceived ideas, etc.

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 rapid Root Cause Investigation (rRCI): 4 Phases
SCOPE SEEK SOLVE SUSTAIN

fact A
fact B
fact C
PROBLEM
STATEMENT

cause 1 + + +
cause 2 + - +
IS IS-NOT cause 3 + O O
WHAT cause 4 - - O
WHERE CONTRADICTION MATRIX

WHEN CORRECTIVE ACTIONS

HOW PREVENTIVE ACTIONS
MUCH

INVESTIGATION CLOSURE

Process Owner

Documentation

Process monitoring

CHECK ASSUMPTIONS
WITH DATA
RISK ASSESSMENT
(FMEA)
5 WHYS
ROOT CAUSE
CONFIRMED
5 | rapid Root Cause Investigation | IQP | Sep 2009 | Subject | Business Use Only
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Rapid Root Cause Investigation (rRCI): The rRCI Team

rRCI
Facilitator

rRCI
Team Observer
Process
of the
Expert(s) should problem
include

Support
function(s)
e.g. QA

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Rapid Root Cause Investigation (rRCI): The Process

A structural approach to the investigation:

rRCI template in Excel/printout (2 Pages).
13 step process.
Purpose of the template:
Provides focus for the discussion.
Clarifies the information needed
for the subsequent steps.
Group can visualize the thought process

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 rapid Root Cause Investigation (rRCI): 4 Phases
SCOPE SEEK SOLVE SUSTAIN

fact A
fact B
fact C
PROBLEM
STATEMENT

cause 1 + + +
cause 2 + - +
IS IS-NOT cause 3 + O O
WHAT cause 4 - - O
WHERE CONTRADICTION MATRIX

WHEN CORRECTIVE ACTIONS

HOW PREVENTIVE ACTIONS
MUCH

INVESTIGATION CLOSURE

Process Owner

Documentation

Process monitoring

CHECK ASSUMPTIONS
WITH DATA
RISK ASSESSMENT
(FMEA)
5 WHYS
ROOT CAUSE
CONFIRMED
8 | rapid Root Cause Investigation | IQP | Sep 2009 | Subject | Business Use Only
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Rapid Root Cause Investigation (rRCI): Management

Steering Committee:
J Alexander (Site Head), Process Unit Heads, R Farrell (QA)
Meet Quarterly Report monthly

rRCI Lead/Support Team:

D. McCarthy, S. O Leary, Michael O Donohoe, N. Fabiano
Meet Weekly

X Plant
36 Local rRCI Facilitators key troubleshooters
Meet Quarterly

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Rapid Root Cause Investigation (rRCI): The future

Workshop being held on site in April to brainstorm possible

site wide issues that could be solved using the rRCI
process.
The criteria for the selection process will be:
There is a real problem to be solved where the cause is unknown
There is a business impact
The investigation must take < 1 month

Training more people in rRCI on site, e.g. Operators at a

bronze level.
Getting the rRCI Templates on flip charts and/or A4 pads
to be distributed in production.

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The Problem Statement

To keep the focus of the investigation team on the problem

The Problem Statement is made up of:

Object
Deviation associated with it.

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IS/IS NOT Table: Problem Specification
rRCI Facilitator asks
questions to specify the
problem as tightly as
possible under:
- What,
- Where,
- When and
- Extent.
Is not side of the template
asks about what the
deviation could be but is
not. Therefore do not
waste time investigating in
this area.

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Distinctions and Changes

Distinctions and changes are also discussed as part of the IS/IS NOT
Table.
Distinctions: are surprising differences between the IS/IS NOT data.
Changes: Try to identify any changes closely related to the distinctions
found.

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Timeline of Events and Fishbone

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5 WHYS

5 WHYS: A question asking method used to explore the cause/effect

relationships underlying a deviation. Ask WHY 5 times or more if
necessary.

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Contradiction Matrix

O: the fact supports the possible cause

A: the fact supports the possible cause, based on an Assumption.
X: the fact contradicts the possible cause.
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Check Assumptions With Data

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Root Cause Statement/Proposed Solution/FMEA

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CAPAs

Important that we
include sustain in
the solution.

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