BOO ! !

Root Cause Analysis

in the

Environmental Testing Laboratory

1
Agenda
 Corrective Action Program
 What is corrective action
 Documentation of corrective action
 Examples of administrative and technical
 Cause Analysis Principles
 Definition(s)
 Procedure
 Records
 Follow-up
 Cause Analysis Examples
 Administrative Examples
 Technical Examples

Slide 2
Objectives

 Corrective Action
 Complaints
RCA

 Forms
 Evaluation
 Follow-up
 Principles of Performing Root Cause Analysis
 Based on ISO/IEC 17025
 Examples Root Cause Analysis

Slide 3
Corrective Action

 Corrective action is

the action taken to eliminate the causes of

an existing nonconformity, defect or other
undesirable situation in order to prevent
recurrence
(NELAC 2003 Glossary)

Slide 4
Correction vs. Corrective Action

 Correction-The quick fix

 Get it out the door
 May cause other problems

 Corrective Actions-The thoughtful fix

 Correct the underlying cause
 Do not cause other problems

Slide 5
Corrective Action

 Corrective action needed:

 Departures from policies and procedures
 Not following SOP or QM
 Documenting when things need to be changed
 Technical failures
 Quality control
 PT sample
 Instrument

Slide 6
Corrective Action Steps

 Identify problem, concern, issue, ???

 May include Client Complaints
 Investigate the problem
 Follow-up to ensure the problem is fixed
 Evaluate process to ensure that the fix prevents
recurrence of problem

Slide 7
Administrative Corrective Action
 Identify who assesses the problem
 Identify who determines effect
 Identify who is responsible for taking action
 Define how reported data is treated or client
notified, if applicable
 Specify changes needed to documentation or
process
 Specify how management will review

Slide 8
Technical Corrective Actions

 Identify who assesses QC data

 Identify who is responsible for action
 Define how data is treated when QC fails
 Specify how failing QC is documented
 Specify how management will review QC failures

Slide 9
Follow-up

 Review corrective action implementation

 Timeframe
 Short (1 - 3 months)
 Long (one year)
 Did if fix the problem?
 Has it reoccurred?

Slide 10
CAR Form – Part 1
Corrective A ction Form #____________
Section #1 Origination ___
Initiated By:__________________________ Client:____________________________________

Date Initiated: ________________________ Sample ID:________________________________

Result/Date Analyzed:__________________ Involved Personnel:_________________________

Completion Requested By (Date):__________ SOP Number:______________________________

Source of Issue (Check all that apply)

Data Inquiry [ ] Customer Complaint [ ] SOP [ ] QC Failure [ ]

Sample Receipt [ ] Observation [ ] Log In [ ] Other [ ] ___________________

Complaint or Issue:_______________________________________________________________

_______________________________________________________________________________

Section #2 Investigation/Action
Action Taken (Check all that apply)
Data Reviewed [ ] Reanalyzed [ ] Client Contacted [ ] SOP Reviewed/Revised [ ]
Training [ ] Equipment Service [ ] Other [ ] _________________________________

Attachments: Yes [ ] No [ ] Reanalyzed Result/Date/QC #:_______________________

Attach documentation of root cause investigation such as meeting minutes and include the reason for the
event.

Corrective Action:________________________________________________________________

_______________________________________________________________________________

Completed By Signature:________________________ Date:______________________

Slide 11
 CAR Form – Part 2

Section #3 Follow-up Review

Comments:______________________________________________________________________

QA Manager acknowledges implementation of corrective action. Initials: __________ Date:_________

Section #4 Closure

Corrective Action Classification (Check all that apply)

Timeliness [ ] QC Exceeded [ ] Materials [ ] Reporting [ ] Training [ ]
Equipment [ ] Documentation [ ] Calculation [ ] Other [ ] _________________

QA Manager acknowledges effective corrective action.

QA Manager Signature:______________ Completion Date:________ Total Number of Pages: ____

Slide 12
Root Cause Analysis
 Working Definition

“Root Cause Analysis is determining what

happened, how it happened and why it happened”

 Basic reason for the presence of a defect or problem

 If cause is eliminated, then the problem is prevented from
reoccurring

Slide 13
Root Cause Analysis

 Goal

“The goal of root cause analysis is to

determine what can be done to prevent it from
happening again”

Slide 14
Characteristics of Root Causes

 Root causes are specific underlying causes

 Root causes are those that can reasonably be
identified
 Root causes are those management has control
to fix
 Root causes are those for which effective
recommendations for preventing occurrences
can be generated
Quoted from “Root Cause Analysis for Beginners”, Rooney and Vanden Heuvel, Quality Progress, July, 2004

Slide 15
RCA

 Different
 Tools
 Processes
 Philosophies
 Safety based
 Production based
 Process based
 Failure based
 Systems based - combination of all above

Slide 16
General Principles

 Aim corrective measures at cause

 Not merely treating symptoms
 Perform systematically
 Back conclusions by evidence
 More than one root cause to any problem

Slide 17
Process

 Define the process to perform RCA

 Gather data/evidence
 Identify issues that contributes to the problem
 Find root causes
 Develop solution recommendations
 Implement the recommendations
 Observe the recommended solutions to ensure
effectiveness

Slide 18
Basic Elements

 Materials
 Defective raw materials
 Wrong type for job
 Lack of raw material
 Machine/Equipment
 Incorrect instrument selection
 Poor maintenance or design
 Poor equipment or instrument placements
 Defective equipment or instrument

Slide 19
Basic Elements
 Environment
 Workplace cleanliness/clutter
 Layout of work area
 Maintenance of work area
 Techniques or demands of task
 Forces of nature
 Methods
 No or poorly written procedure
 Practice not same as written procedure
 Poor communication

Slide 20
Basic Elements

 Person
 No or poor management activity
 Inattention to task
 Task hazards not guarded properly
 Other - Skill set not defined - Not trained for task
 Stress demands or undue pressure
 Results in improper practice

Slide 21
Basic Elements

 Management System
 Training or education lacking
 Poor personnel involvement
 Poor recognition of hazard
 Previous unidentified hazard or skill set not handled
properly

Slide 22
Five Whys - One Technique

 Explore cause/effect relationship

 Tendency to stop at symptoms rather than going to
lower level root causes
 Lack of support to investigate real problem
 Lack of training to identify cause/effect relationship
 Asking Why five times
 Nature of the problem becomes clear
 Helps get to true cause of problem

Slide 23
Benefit of 5 Whys

 Helps to identify root cause

 Evaluates relationship between different root
causes
 Simple tool
 No statistical analysis

Slide 24
Specific Steps
 Gather team
 One or more people
 Write down problem
 Agree
 Why does the problem happen?
 Write down the answer(s)
 Is this the root cause?
 Check by asking why again and see if there is another reason
the problem may exist
 Loop through the steps until the team agrees that the
problem’s root cause is identified.

Slide 25
Modification of 5 Whys
5 x 5 Whys

 What proof is available that the cause exists?

 Is it measurable?
 What proof is available that this cause leads to the effect?
 What proof is available that the cause resulted in the
problem?
 How do you know that it wasn’t something else?
 Is anything else needed for the stated cause to produce
the effect?
 Is something else needed to product the effect?
 Can anything else besides the cause lead to the effect?
 Are there other explanations that fit the cause better?

Slide 26
Example

 Car will not start

 Why? - Battery is dead
 Why? - Alternator is not functioning
 Why? - Alternator is broken beyond repair
 Why? - Alternator is well beyond service life and has
never been replaced
 Why? - Not maintaining the car as recommended by
the service schedule

Slide 27
Cause Effect Diagram

 Complex Problem
 Identifies All Causes and the Root Cause
 Shows Interactions Among Factors That Affect
Process or Situation
 Enables Effective Corrective Action
 Encourages Focused Brain Storming Session

Slide 28
Ishikawa Diagram
 Graphical Design of Process Influences
 a.k.a: fishbone diagram
 Cause
 6 M’s
 Machine, Method, Materials, Measurement, Man, Mother
Nature (manufacturing industry)
 8 P’s
 Price, Promotion, People, Processes, Place/Plant/Technology,
Policies, Procedures & Product/Service (service industry
 4 S’s
 Surroundings, Suppliers, Systems, Skills (service industry)

Slide 29
Diagram

Category 1 Category 1

Cause 1

Cause 2

Problem
(Write it out here)

Category 3
Category 4

Slide 30
Brainstorming
 Rules
 Encourage participation
 There are no bad ideas
 No judgment given to any idea
 Either positive or negative
 Build on each other’s ideas
 Write Down All Ideas
 Organize Into Diagram to Show Relationship
 Eliminate any that are outside the processes
identified

Slide 31
Process
 Experience Facilitator
 External for more complex problems
 Appoint a Person to Write Down All Ideas
 Use paper chart to record all ideas
 Define Problem
 Layout any criteria for scoring the causes
 No More Than 8 - 10 per Group
 If more then have multiple groups
 Encourage Creativity and Input
 Don’t Dwell to Long on One Idea

Slide 32
Other Techniques RCA
 Statistical Approaches
 Failure Mode and Effects Analysis
 Fault Tree Analysis
 Not Reviewed During this Class
 Pareto Analysis and Charts
 Separates important from trivial causes
 Statistics 80% of problems produced by key causes (20%)
 Bayesian Inference
 Barrier Analysis
 Change Analysis
 Causal Factor Tree Analysis

Slide 33
Failure Mode and Effects Analysis
 FMEA - Used in Manufacturing
 Risk assessment technique
 Identify system or process failure
 Failure is any Errors or Defects
 Affect the client (affect on reported results)
 Can be potential or actual
 Failure Mode
 Ways a product or process can fail
 Product = data in lab
 Effects Analysis
 Studying the consequences of those failures

Slide 34
FMEA
 List Parts of the System
 List Consequences If That Part of the System Fails
 Evaluate the consequences - 3 criteria
 Severity (S)
 Occurrence (O) (May also be referred to as Probability)
 Likely to occur
 Detection (D)
 Ability to control (1= control certain: 10 = no control exists)
 Ranking of each 1 - lowest to 10 highest
 Risk Priority Number (RPN) = S x O x D

Slide 35
FMEA

 Weakness
 Top down tool
 Major failure modes identified only
 Fault Tree Analysis (FTA) Is Better Suited
 FMEA Is Useful to Augment or Complement FTA
 Helps to Identify Failure Modes When Undesired
Effects Are Found

Slide 36
FTA

 Fault or Failure Tree Analysis

 Graphical presentation of fault
 Top down
 Each situation that causes an effect is added to the
tree
 Trees can have numbers on the probability of failure
 Numbers not often available or practical to produce

Slide 37
Summary

 Root Cause
 Systematic approach to problem solving
 Removes the problem
 If cause is really identified
 Allows focus of organization on preventive
actions
 Reduces number of corrective actions

Slide 38
End Course BYE ! !

Any questions?
(before you run out the door)
Slide 39