Root cause analysis (RCA) is a method of identifying and solving the underlying problems that cause errors, failures, or defects in a process, product, or service. It can help you prevent recurring issues, improve quality, and save time and money. But how can you apply RCA to different industries? Here are some tips and examples.
Before you start an RCA, you need to understand the specific context of the industry you are working in. Different industries may have different standards, regulations, customers, risks, and expectations. For example, in healthcare, RCA is often used to investigate adverse events, such as medication errors, infections, or patient injuries. In manufacturing, RCA is often used to improve product quality, reduce waste, and optimize processes. In IT, RCA is often used to troubleshoot system failures, bugs, or security breaches. You should research the industry best practices, benchmarks, and challenges before you conduct an RCA.
Irrespective of the Industry there is one thing in common that is there is a challenge/Problem/Customer Complaint/ Audit Non Conformities/ Deviation in the process ...and Root Cause is to be determined so that Team Should know what is the root cause of Specific Problem and Corrective actions may be taken accordingly. A Doctor always prescribes medicines once he tries his best to understand the possible causes based on symptoms described by the patient.
In clinical trials 1 such example I could think of is for an oncology study where the subjects had to provide their blocks for PIK3CA testing but we found that 1 site patients were providing consent for the study but were hesitant while providing the paraffin blocks for testing.
There are many tools and techniques that can help you perform an RCA, such as the 5 Whys, the fishbone diagram, the Pareto chart, or the fault tree analysis. However, not all tools are suitable for every industry or situation. You should choose a tool that matches the complexity, scope, and nature of the problem you are trying to solve. For example, the 5 Whys is a simple and quick tool that can help you find the root cause of a single and straightforward problem. The fishbone diagram is a more comprehensive and visual tool that can help you identify multiple causes and categories of a problem. The Pareto chart is a statistical tool that can help you prioritize the most significant causes of a problem. The fault tree analysis is a logical and graphical tool that can help you analyze the probability and impact of a problem.
The most relevant tool I have witnessed is 5 Whys. Keep repeating the question till you find the dead end and that's the answer or the root cause.
There are various tools such as Fish Bone analysis, Control Charts ,Trend Analysis, 5Whys etc ....however which one is to be used in a specific situation depends on the expertise of Root Cause Analyst. Sometimes a random mixed approach along with commonsense and experience of root cause analyst may be also useful.
An RCA is not a solo activity. You need to involve the relevant stakeholders from different departments, functions, or levels of the organization. Stakeholders can provide valuable insights, perspectives, and feedback on the problem and its causes. They can also help you collect data, verify facts, test hypotheses, and implement solutions. For example, in healthcare, you may need to involve doctors, nurses, pharmacists, patients, and regulators in an RCA. In manufacturing, you may need to involve engineers, operators, suppliers, and customers in an RCA. In IT, you may need to involve developers, testers, users, and managers in an RCA.
In 1 such incident at one of my sites after the adverse event happened, all relevant stakeholders including the PI, trial nurse, site coordinators, and the study participant were interviewed and asked about the adverse event to understand the course of event and its documentation.
This is absolutely critical to involve key stakeholders who were involved in the process. Even interviewing front line workers may be of great help in determining specific Root Cause.
After you complete an RCA, you need to communicate and document the results clearly and effectively. You should summarize the problem statement, the root cause(s), the solution(s), and the action plan. You should also highlight the benefits and limitations of the RCA, such as the expected outcomes, the costs, the risks, and the assumptions. You should use appropriate formats, such as reports, presentations, charts, or diagrams, to convey the results to different audiences. For example, in healthcare, you may need to present the results to senior management, staff, patients, and regulators. In manufacturing, you may need to report the results to quality control, production, suppliers, and customers. In IT, you may need to document the results in code, logs, tickets, and manuals.
An RCA is not a one-time event. You need to monitor and evaluate the effectiveness of the RCA and the solution(s) over time. You should track the performance indicators, such as quality, productivity, customer satisfaction, or profitability, before and after the RCA. You should also collect feedback, data, and evidence to measure the impact and value of the RCA. You should review and update the RCA and the solution(s) as needed, based on the changing conditions, requirements, or expectations. For example, in healthcare, you may need to monitor the incidence, severity, and prevention of adverse events. In manufacturing, you may need to evaluate the defect rate, waste reduction, and process improvement. In IT, you may need to assess the system reliability, functionality, and security.