Digitally Integrated ‘5 Why’ Root Cause Analysis Process with a Next-Generation EQMS Solution from ComplianceQuest

5 Why is one of the most commonly used root cause analysis methods. Typically, it is done with a manual, paper-based process and remains outside of the EQMS system. However, this manual approach is not very effective because data and findings from the 5 Why process would have to be added manually into the QMS after the investigation; collaboration would have to be done outside the QMS with important files and documents remaining outside. Thus, the data and findings do not roll up to other team members, and siloed data is not very useful.

A manual approach also leads to increased chances of miscommunication and lack of collaboration while planning corrective or preventive actions. Ideally, we need a 5 Why system that is digitally integrated with your organization’s EQMS.

Digitally Integrated 5 Why Tool from ComplianceQuest: Seamless Collaboration across the Entire QMS

Realizing the benefits of digitizing root cause analysis, ComplianceQuest has introduced the CQ 5 Why Whiteboard which:

• Allows hybrid teams to conduct effective RCA. A facilitator can document the details on the 5 Why whiteboard while brainstorming the possible causes with the rest of the team members.
• The CQ 5 Why Whiteboard can enable performing RCA on complex problems. Instead of a linear approach, it supports the creation of multiple branches on the problem statement. At each branch level, further ‘Why’ analysis is enabled.
• The users can create action plans or assign them to the appropriate team members using the CQ 5 Why whiteboard and set due dates from the same page after the root cause is documented.
• The root cause(s) identified with the 5 Why RCA can be classified using category, sub-category, and code. Any of the criteria can be used to create Pareto and trending analysis charts for identifying systemic issues.

The 5 Why Whiteboard can help increase the effectiveness of a CAPA. It also promotes the use of best practices across teams and minimizes variations in how RCA is performed. Documentation can also be standardized.

Some of the key features of ComplianceQuest’s ‘5 Why Root Cause Analysis’ include:

• Addition and deletion of Why nodes
• Customize Settings
• Mark whether a particular cause is a root cause or an expected problem
• Add action plans
• Add objective evidence
• Create breadcrumbs
• All activities are timestamped for audit trails

Also, one can download the detailed 5 Why RCA document as a pdf and share it with users who do not have access to the 5 Why Whiteboard such as external regulatory bodies like FDA that might be auditing the system.

If you would like to benefit from this new feature for root cause analysis from ComplianceQuest, contact us now.

The Process of ‘5 Why’

From a Quality Management standpoint, a problem may be reported in an organization from one of the following processes:

• Complaints
• Nonconformance
• CAPA
• Safety Incidents
• Safety Observations

Since a problem may have its origin elsewhere, drilling down and asking the right questions is not a boardroom activity but requires the people on the shop floor, the quality team, and other stakeholders to get involved. A typical and effective process would include:

• Assembling a Team: The first step would be to assemble a team of people that consists of relevant stakeholders. It is critical to appoint someone as a facilitator — to keep the team focused on identifying effective, corrective and preventive measures.
• Define the Problem: The second step would require writing a clear problem statement that all team members agree on.
• Start the ‘Why’ Process: The next step would be to ask the first “Why?” to identify the reason because of which the problem occurred. The ‘Why’ needs to be answered based on facts and data analysis.
• The Subsequent Whys: As the answer to the first ‘why’ emerges, the second ‘why’ will have to be framed and the process goes on till the root cause is identified. It could be after three ‘whys’ and does not necessarily have to be five; or, it could be more depending on the complexity of the problem.

Benefits of a Seamless 5 Why Root Cause Analysis Process

Digitally integrating the 5 Why Root Cause Analysis with your EQMS can help in many ways, including:

• Enable Collaboration between Different Teams: 5 Why Root Cause Analysis requires members from different teams to come together. Integrating it with the EQMS can facilitate greater transparency and collaboration.
• Improved Document Management: Root Cause Analysis is a regulatory requirement, be it ISO, FDA, and others. By integrating it with the EQMS, businesses can meet these requirements easily with the support of documented records and data points.
• Improved Tracking, Storage, and Access: Tracking, storing, and monitoring the progress based on the root cause analysis can become difficult in a manual system. Digitalizing the process makes it easier to drive change management efforts and take corrective action with agility.
• Looping back to the Source: Making the root cause analysis part of the EQMS helps in linking back to the source from where the problem was reported. This can help ensure that corrective and preventive actions are taken to resolve the problem in a timely and appropriate manner, across the lifecycle.
• Measuring Progress: Digitizing the RCA process can make it easier to collect and review key performing indicators/metrics and effect continuous improvement.
• Cost-Effectiveness: Both time and costs can be saved by digitizing the RCA process by enabling even geographically disparate teams to collaborate online.

If you would like to benefit from this new feature for root cause analysis from ComplianceQuest, contact us now.