Here’s a checklist for root cause analysis prepared by the experts at EduQuest who have conducted hundreds of investigations of non-conformances, failures and deviations in drug and device manufacturing facilities throughout the world:
√ Testing: Look for any Out-of-Specification (OOS) results that occurred during manufacture of faulty batch or product lot.
√ Batch History/Device History Record: Analyze data from batch history or device history record over time. Determine how many defective lots were produced during that period. Find out if any other product lots had similar problems.
√ Equipment Maintenance and Repairs: Review process flow in detail and list key equipment used in the process. Note repair history for any particular piece of equipment.
√ Validation: Examine validation of processes and qualification of equipment involved. Review validation of all aspects of final product assembly process.
√ Raw Materials: List all raw materials, lot numbers, and suppliers for several recent lots of the product. Note any changes in supplies of the product grade or components.
√ Calibration: Review calibration records associated with manufacturing equipment. Determine at what intervals equipment was calibrated and whether out-of-tolerance measurements were found.
√ Training: Review training documentation for individuals involved in testing and production of product.
√ Other Lots of Same Product: If you identify production or equipment error as the root cause, take corrective action to identify other products that may be affected, and determine what actions are necessary to prevent future failures.
√ Other Products Using Similar Equipment and Processes: Review process flow for other products to determine if faulty process or equipment affects them as well.
Although sometimes you won’t know definitively what caused a failure or deviation, you should at least identify the “most likely” root cause. Your root cause analysis must be followed with specific correction action targeted toward that cause. Document each step of your investigation — concurrently with the investigation, not afterwards.
Need to learn more? Attend EduQuest’s live, 12-hour classroom training class, The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management.