1. Root Cause Analysis Roger Brauninger
American Association for Laboratory Accreditation Frederick, Maryland
Governmental Food and Feed Laboratories Accreditation Meeting
St. Petersburg, FL
January 23-26, 2017

2. Investigating Sources of Nonconformities
One has to look below the surface...
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3. In it most simple terms…
Root Cause can be described as that cause, which if it were controlled or eliminated would prevent recurrence of the problem.

4. Related Cause Definitions
Cause: A condition that influences an outcome
Proximate (Direct) cause: An attributable event or condition which influences an unwanted outcome (can be human, mechanical, etc.)
Root cause: the factor that created the direct cause

5. What is Root Cause Analysis?
Method for evaluating the reasons an undesired outcome happened
RCA attempts to identify what steps need to be corrected to prevent the problem from happening again
Entire process is based upon availability of reliable documents and records
Useful for looking at systemic nonconformities

6. How do I Start a RCA?

7. Some RCA Tools & Techniques
Flow Charts
Interviews
Five Whys
Diagramming
Checklists

8. Flow Charts
Process flow presented in graphical format starting from beginning of task
Easy-to-follow picture
Identifies linkages between subjects
Boxes connected by lines show workflow
Diamonds signal yes/no decision points
May be of limited use to complex system failures

9. Example Flowchart Problem Yes No Record RCA Yes No CAR Lab Decides
Isolated
Incident
Yes No
Record
RCA
Critical
Issue
Yes No
CAR
Lab
Decides

10. Interviews
Have lab staff (and others) explain their documents and actions
Have the problem explained
May be the only source of information
Helps to understand work flow
Can be subjective or associated with blame

11. 5 “WHY’S START Identify Problem
Identify the causes of the problem “Why did this happen”
Note in a diagram or table
For each cause ask “why” again
Has ”WHY” been asked enough to identify logical root cause No
Yes
Find solutions to the root causes Identified
END

12. How to Complete the 5 Whys
Write down the specific problem. This helps you formalize the problem and describe it completely.
Ask “Why did the problem happen” and write the answer down below the problem.
If the answer doesn’t identify the root cause of the problem, ask “Why” again and write that answer down.
Loop back until you identify a failure in your process that can be fixed to prevent recurrence. Again, this may take fewer or more times than five Whys.
Helpful in tracing the chain of events (starting with the nonconformance and working backwards
Could uncover unknown causes
Need to use other sources (records, documents, interviews) to validate the cause with objective evidence

13. Cause and Effect Presents an accessible picture / diagram
Use headings to organize the RCA
Categorize questions below appropriate heading
Makes the potential causes more apparent by framing situation into “macro view”

14. Ishikawa (Fishbone) Diagram
Material
Measurement
Method
Problem
Measurement: calibrations, appropriate
Human: training, verbal miscommunication, lack of communication, staff changed mid-project
Machines: defective, not maintained or calibrated, overloaded
Environment: temperature, humidity, work area, distractions
Material: incorrect, degradation, certificates of analysis
Method (process): procedures, work instructions, amendments
Human
Machinery
Environment

15. Ishikawa Diagram Categories
Measurement: calibrations, appropriate
Human: training, verbal miscommunication, lack of communication, staff changed mid-project
Machines: defective, not maintained or calibrated, overloaded
Environment: temperature, humidity, work area, distractions
Material: incorrect, degradation, certificates of analysis
Method (process): procedures, work instructions, amendments

17. RCA Checklists
Can be useful to keep track of questions and potential causes.
Helpful to organize overall process.
Needs to be used with other tools to determine specific root cause.

18. Example Checklist Records of Prior Occurrence
Remedial action, interim notices, internal audits, stories
Documents
Reflect process, current revisions, carried to equipment
Plans and Schedules
On-time, milestones met, revisions communicated, resources
Equipment
Enough machines, maintenance, calibration, accuracy to meet standards

19. Example Checklist (cont)
Staff
Documentation, training, supervision, equipment
Material
Received what ordered, lot, expiration, degradation
Data
Communication of trends
Feedback
Complaints, contract review, communication

20. Review of RCA Process
IDENTIFY the problem by defining the unwanted result
RESEARCH the unwanted result by listing facts
DEVELOP a timeline for organizing the facts
EXECUTE a plan for identifying all potential causes
VERIFY the plan by continuing to ask “Why?”

21. Review of RCA Process (Cont.)
BREAK system failures down into smaller components
VERIFY your facts by removing items that are not contributing causes
CREATE solutions for the problem beginning with the root cause and working toward the contributing causes

22. For Further Information
Contact: Roger M. Brauninger
Phone:
American Association for Laboratory Accreditation
5202 Presidents Court, Suite 220
Frederick, MD
I would like to thank you all for your time and attention. If you wish to have further information please contact me at the number above or address. Also our website, in addition to having a searchable scope database, is a good source of information about A2LA, the accreditation process as well as for links to other accreditation bodies and various other sources of information.

23. Questions / Comments