Root Cause Analysis Tools

MJCross 22MAR2007

Applying RCA
Not always necessary
Focus on re-occurring and complex
investigations
Different applications of RCA in CAM
UAM for Deviation - owner
Review of Operational Investigation
Participant in investigation team
MJCross 22MAR2007

RCA - Definition
A structured, focused investigation that is
conducted to identify the true, distilled
cause of a problem resulting in a clear path
to the corrective actions necessary to
eliminate it
- Most of the time its not the obvious answer
- Need to be objective
- Sometimes asking right questions is tough, contra
to status-quo, RCA takes work!
MJCross 22MAR2007

Successful RCA Components

Requires
A well defined problem statementdrill to the
null
Need accurate info and datano assumptions
Willingness to face the facts
A solid toolbox to aid in the investigation
Management buy-in and commitment
Practice, Practice, Practice.
MJCross 22MAR2007

RCA First Steps

Ask if this issue warrants a true Root Cause
Analysis?
Example:
If the sandwich shop you visit recently sold you a
bad meatball sub, do you pursue resolution or just
go to Subway?
Hint: Always look-out for re-occurring
problemmay not be the sub shop, could be; the
water, mayo, produce, fridge,electric company
MJCross 22MAR2007

Tools for Root Cause Analysis

Tools are Designed to:
Efficiently eliminate false investigative paths
Provide a common process to standardize issue
review and resolution
Facilitate free thought while driving to true root
cause and issue identification
Organized approach to discussions allowing
logical analysis with traceable results
MJCross 22MAR2007

Review of the popular tools

Brainstorming
Great for small to larger teamsnot too large
Structured free-thought to saturate a discussion
and expose all investigative avenues
Can be combined with other tools such as
Fishbone diagram or Process Flow review
Requires a strong leader, open minds &
experienced team, no bias, time
Watch out for bullies and know when to Quit
Brainstorming is most common tool used
MJCross 22MAR2007

Review of the popular tools (cont.)

Fishbone (Ishikawa) Diagram
Preferred for more complex investigations
Used to structure brainstorming sessions and
focus on standardized categories of root cause
areas
6 Ms: Machine, Methods, Materials,
Measurement, Mother Nature (Environment),
Man
OrResources, People, Process, Mgt
MJCross 22MAR2007

Review of the popular tools (cont.)

Fishbone (cont.)
Called a Fishbone due to common set-up
Each Family or Root is reviewed
Allows for structured means of documenting
potential causes
Good fit for process failure investigations in
biotech environment
Cam investigation templates model this outline
(i.e. Materials, Methods, Equipment, etc are
standard report sections)
MJCross 22MAR2007

Fishbone Diagram
Management

Resources
-

- Adequate planning of resources and

expectations
- Communication adequate
- Adequate oversight?
- Leadership and guideance available
- Are there defined mgt systems? (i.e. plan, do,
check, act)

Is the equipment appropriate?

Facility design adequate?
Right number of people?
Equipment capacity? Capable?
People allocated correctly?

Problem

People

Process

- Are people of the appropriate experience do

perform assigned duties?
- Is the training effective?
- Is there accountability and appropriate
responsiblility?
- Are employees empowered to contribute to
quality?

- Is the process running in a state of control?

- Are the procedures governing the process
adequate?
- Are the test methods and in-process checks
adequate?
- Is continuos commiment practiced?

MJCross 22MAR2007

Review of the popular tools (cont.)

Repetitive Why Analysis
Effective for all applications
Most versatile
Allows for the reduction of issue to true root
cause => Drive to the Null
Requires an accurate problem statement
Can be tricky in some instances, may mislead

MJCross 22MAR2007

Review of the popular tools(cont.)

Repetitive Why Analysis
Requires training, practice, and
persistence
Quick litmus test for true root cause.do
you need to go further????
Use Why or which was caused by
Resolve the system flaw, dont focus on
just the situation at hand
MJCross 22MAR2007

Applying some concepts

Micro not sampling new WFI valve site for
~ 10 Weeks
Mixer used in mfg uncalibrated for 4 years
Lost Avonex DS batches due to inadequate
mixing at purification stages

MJCross 22MAR2007

MJC Takeaways
Practicestart thinking and applying RCA
in everyday problem solving situations
Drive to the null.
Re-occurring warrants special attention
Dont be shy about applying concepts
Investigation=RC=CAPA=Problem
Elimination
MJCross 22MAR2007

Root Cause References

Introduction to Investigations and Root Cause Analysis (Lehecka Pratt Associates,

2000)

Problem Solving with Quality Tools for Sustained Improvement (Biogen/ASQ

Collaboration, Debra Owens Instructor)

Root Cause Analysis: Improving Performance for Bottom-Line Results

(Robert and Kenneth Latino)

MJCross 22MAR2007