Root Cause Analysis
Here is the beginning process on how to approach the corrective action process from properly identifying the problem statement to implementing irreversible corrective action.
These questions are great tools as you work through the root cause and corrective action process. They ask a series of questions and help guide you in the right direction. The content provided is as follows. If you would like some of the original laminated versions, please call us and we will send them to you.
- Have the problem characteristics been identified?
- Has the problem been defined in measurable terms? Have trends been evaluated? What is the overall magnitude of the problem?
- Has the problem been subdivided into its smallest parts?
- What is the current impact on safety, people, cost productivity, customers, reputation, etc.?
- What is the urgency and seriousness of the problem?
- Is there a final, concise problem statement from which to measure results? Containment Actions
- Has containment addressing the incident been documented, implemented, and verified to be effective?
- Has relevant process data been collected during containment actions?
- Have customers (internal and external) confirmed effectiveness of containment? Systemic Root Cause Analysis
- Has the team identified why the defect escaped and the problem was not detected?
- Are all potential sources of variation identified?
- How many "Whys" from a 5 Why Analysis are represented (1 2, 3, 4 or 5)?
- Has a thorough list of several or more potential root causes been documented and numbered?
- Are potential root causes substantiated by data?
- Has every root cause listed been accepted or rejected based on logic and data?
- Has the cause been verified? Can this root cause(s) turn on/turn off 100% of the problem? Implement Irreversible Corrective Action
- Is there a corrective action identified for every real root cause?
- Do the corrective actions given address the system, or the incident?
- Is the corrective action really irreversible? Could the problem recur in a month, a year?
- What will be the future impact of the Irreversible Corrective Action? What problems (negative side effects) could it cause?
- Have work instructions, training, FMEAs, Control Plans, etc. been updated?
- Is the removal of containment actions documented?
- Does subsequent data support that the problem has 100% disappeared?
- Has the customer concurred that the cause(s) has been eliminated? System Prevent
- Has the team identified the management systems that failed?
- Has the team corrected the management systems that allowed the problem to occur and escape?
- Was the solution applied to similar processes?
- Does the organization's FMEA process anticipate and prevent similar problems?
- Have lessons learned been documented and communicated?
- Have all related documents been changed? Design Standards? Process Flow? FMEA? Control Plan? PPAP?