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

Investigating Sources of Nonconformities One has to look below the surface... (c) FreeFoto.com

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.

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

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

How do I Start a RCA?

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

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

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

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

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

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

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”

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

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

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.

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

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

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?”

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

For Further Information Contact: Roger M. Brauninger Phone: 301 644 3233 Email: rbrauninger@a2la.org American Association for Laboratory Accreditation 5202 Presidents Court, Suite 220 Frederick, MD 21703 www.a2la.org 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 e-mail 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.

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