Dr. Bob Strong

How to Perform Root Cause Analysis?

By Sangita Viswanathan
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Dr. Bob Strong

Irrespective of what method you used to perform root cause analysis – the IT IS / IT IS NOT analysis, the 5 Whys analysis or the Fishbone analysis – it is critical to identify ALL possible causes by asking a LOT of questions, about your people, processes, raw materials, equipment, environment, and inspection systems, says Dr. Bob Strong , Senior Consultant at SAI Global Assurance Services.

SAI Global logoDr. Strong was speaking in a recent webinar onThe Importance of CAPA and Root Cause Analysis for the Food Industry, in which he discussed CAPA, Root Cause Analysis and the benefits of these quality systems. We present below the comprehensive list of questions as presented by Dr. Strong.

Questions to ask: People

  1. Does the person know what he’s expected to do in this job?
  2. Is he well trained?
  3. How much experience does the person have?
  4. Does the person have the right tools/ equipment needed to do the job?
  5. Is the workload reasonable?
  6. Does the person have adequate supervision and support?
  7. Do physical conditions such as light or temperature affect their work?
  8. Who does the person contact when problems arise?

Questions to ask: Method

  1. How is the process used defined?
  2. Is the process regular reviewed for adequacy?
  3. Is the process used affected by external factors?
  4. Have any changes been made recently in the process?
  5. What adjustments must the operator make during the process?
  6. How does the operator know if the process is operating effectively?
  7. Have other methods or processes been considered?

‘What would you do if things go wrong,’ this could be the most revealing question you can ask your employees that it may identify a real issue, added Dr. Strong.

Questions to ask: Equipment

  1. How old is the equipment or machinery?
  2. Is preventive maintenance performed regularly on it?
  3. Is the machine affected by heat, vibration, or other physical factors?
  4. How does the operator know if the machine is operating correctly?
  5. What adjustments must the operator make during the process?
  6. Have any changes been made recently in the equipment?
  7. How is the equipment cleaned?
  8. What tools are used to clean the equipment?

Questions to ask: Raw materials

  1. What is the source of the raw material?
  2. Has there been a change in suppliers recently?
  3. How is the raw material produced?
  4. How is the safety of the raw material verified?
  5. How old is the raw material?
  6. How is safety assessed prior to your operation?
  7. What is the level of safety and quality?
  8. How is the raw material packaged?
  9. Can temperature, light or humidity affect the material quality?

Questions to ask: Environment

  1. How are environmental conditions monitored?
  2. How are environmental conditions controlled?
  3. How is environmental control measuring equipment calibrated?
  4. Are there changes in conditions at different times of the day?
  5. Does environmental change affect the processes being used?
  6. Does environmental change affect the materials being used?

Questions to ask: Inspection System

  1. How frequently are products inspected?
  2. How is the measuring equipment calibrated?
  3. Are all products measured using the same tools or equipment?
  4. How are inspection results recorded?
  5. Is there a set of procedures and do inspectors follow the same procedures?
  6. Do inspectors know how to use the test equipment? 

Ask your team ‘what would happen if the systems weren’t calibrated? Are they giving you valid results?’ Probably that’s why you are not in compliance, explains Dr. Strong. 

All this take takes time and effort, and Dr. Strong urges management to devote the resources to go around ask these questions and get the answers.

What is your experience with Root Cause Analysis? Have your used such questions? Do you have more to add? Join the discussion by commenting below.

For more information, visit SAI Global’s Food Safety Resource Center, to access this complimentary, ON-Demand webinar.

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