Automated CAPA with RCA and 5 Why to Make Your Workplace Healthy and Safe

PGT Innovations (PGT), pioneers in the impact-resistant window and door market, started small in 1980. But soon, they were able to fulfill their vision of becoming the nation’s leading manufacturer and supplier of hurricane-resistant windows and doors. Based in Venice, Florida, the company has 3,200 employees and continues to grow rapidly. With growth came the need for scalability and safety, which they found difficult to manage with their legacy system for EHS management. It implemented the single standardized QHSE system from ComplianceQuest and met its quality and safety compliance requirements.

The company automated end-to-end quality and safety management workflow using the CQ QHSE solution. There was a marked improvement in its CAPA (Corrective Action and Preventive Action) process, making it seamless and improving workplace safety manifold.

CAPA to Rectify and Prevent Issues

The Occupational Safety and Health Administration (OSHA) highly recommends a proactive approach to injuries, illnesses, and deaths in the workplace by implementing preventive safety and health programs. Traditionally, businesses had a reactive approach wherein it takes an incident to activate the safety process. This is often knee-jerk and may not address the true cause of the incident. This leaves behind the possibility of recurring incidents. Needless to say, it adds to costs and affects employee morale, productivity, and revenues. The brand reputation can also be affected, leading to lower revenues.

By providing long-lasting solutions to issues, businesses can see a marked increase in their performance due to greater employee engagement and lower cost of safety. CAPA allows incidents to be systematically investigated to identify and remove the underlying causes and conditions. It contains a two-pronged approach. When an incident occurs, there is a need to stop it from becoming larger than it already is and contain it through a corrective course of action. No doubt, this is like firefighting and an essential step.

But the second part is Preventive Action, where the data regarding the causes of the incidents is analyzed, the root cause identified, and either eliminated completely or controlled to prevent the recurrence of the incident.

A Well-designed Process for Root Cause Analysis (RCA)

When an incident occurs, there may be a superficial cause that is addressed to contain the problem. For instance, if there is a fire on the shop floor, it could be due to a spark in the switchboard. Corrective action may be switching off the mains and cutting off the power supply, putting out the fire using an extinguisher, evacuating the shop floor, etc. This may help put out the fire and save lives, equipment, etc., but it may leave the place vulnerable to similar future accidents.

Often, once the fire is out, workers may get back to work by replacing the switchboard and the burnt wires. But why did the fire occur in the first place? How severe was the issue? What is the risk of its recurrence? What was the underlying cause? How can one make sure there is no second or third occurrence of a similar fire?

It is important for the company to dive deep and find out the real cause so that appropriate action can be taken to prevent its recurrence. The root cause analysis may, in fact, throw up more than one root cause. This helps safety leaders and the management to put sufficient safeguards in place and improve the safety of the workplace, eliminate hazards, and control risks.

Root Cause Analysis in CAPA (Corrective and Preventive Action)

Root Cause Analysis (RCA) in part of CAPA. It is a systematic process used to identify the underlying or fundamental reasons behind a quality issue, non-conformity, or problem that has triggered the need for corrective and preventive actions. RCA is a critical step in the CAPA process because it delves beyond the surface symptoms of an issue to uncover its root causes. It involves techniques such as the "5 Whys," Fishbone Diagrams (Ishikawa), and Fault Tree Analysis. The goal is to understand why the issue occurred and what systemic changes are necessary to prevent its recurrence. RCA helps organizations address the source of problems, leading to more effective and sustainable CAPA solutions.

How Are RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Action) Related?

RCA focuses on identifying the root causes of issues. CAPA is the process of implementing actions to correct those issues and prevent them from happening again. RCA is the investigative phase where the causes of a problem are determined. Once the root causes are identified, CAPA is initiated to develop and implement corrective actions to address the immediate issue and preventive actions to prevent its recurrence. The findings from RCA provide crucial information for designing effective CAPA solutions.

Why Is Root Cause Analysis Required for CAPA Analysis?

Root cause analysis is essential in CAPA analysis for several reasons:

Effective Problem Solving: RCA uncovers the fundamental reasons behind an issue, enabling organizations to address problems at their source rather than merely addressing symptoms.

Prevention: Identifying root causes helps organizations implement preventive actions that reduce the risk of similar issues occurring in the future.

• Resource Efficiency: RCA ensures that corrective and preventive actions are targeted and well-informed, optimizing resource allocation.
• Compliance: In regulated industries, understanding root causes is often a requirement to demonstrate a commitment to continuous improvement.

How Do I Avoid Common Root Cause Analysis Problems?

To avoid common problems in root cause analysis, consider the following:

• Use Structured Methods: Employ structured RCA methods such as the "5 Whys," Fishbone Diagrams, or Fault Tree Analysis to ensure a systematic and comprehensive investigation.
• Involve a Cross-Functional Team: Collaborate with individuals from different departments or disciplines to gain diverse perspectives and expertise.
• Data-Driven Approach: Base your analysis on data and facts rather than assumptions or opinions.
• Document the Process: Keep thorough records of the RCA process and findings for transparency and future reference.
• Continuous Improvement: Regularly review and refine your RCA process to learn from previous analyses and improve.

5 Why Analysis Done Right

One of the popular RCA methods is 5 Why Analysis, introduced by Taiichi Ohno of Toyota, Japan. It helps make an informed decision by scientifically arriving at the root of the problem by asking why five times. This provides clarity about the problem and the solution by providing insights into the actual happenings on the work floor.

While doing the root cause analysis, the people from the concerned department should also be involved to provide inputs based on their experience and expertise.

The process involves asking the question "Why?" to find the answer to the problem and continuing to ask "Why?" until there are no further answers available. Five is not a limiting number, and the process can have any number of "Whys" till the RCA team is satisfied that the root cause has been found.

One of the key advantages of this process is that there may be more than one root cause, and each one of these can be explored to improve the effectiveness of the preventive action being taken.

Manual vs Automated CAPA for Safety Management

The 5 Why, root cause analysis, and CAPA are very intricate processes needing visibility and data. Even for the safety leaders to know which incidents are recurring and severe, they need data to prioritize risks to make the effort effective and meaningful.

The traditional manual approach has several limitations:

• There is no central view of all the incidents, and prioritization can become difficult
• Knowing which is the root cause can become difficult due to data being in siloes
• Collaboration between different teams can become difficult
• Data on near misses and observations may not be available due to difficulty in reporting
• Assigning tasks and following up to track and monitor progress can be difficult
• Prevention of recurrence of the hazard can be challenging and ineffective

With an automated, cloud-based solution like ComplianceQuest, the efficiency and efficacy of CAPA can be ensured. The solution has a collaborative 5 Why tool that enables the following:

• Internal and external experts based in different locations to participate in the 5 Why process
• Share inputs
• Identify and pursue the different root causes to their logical end
• Recommend solutions
• Communicate the findings with other stakeholders
• Allow management to review and make informed decisions
• Assign tasks, set deadlines, monitor progress
• Implement CAPA to ensure a safe and healthy environment

Further, the CQ CAPA solution is part of a Quality, Health, Safety, and Environment solution that facilitates the automation of documentation and change management to improve compliance. It is aligned with leading regulatory requirements such as OSHA, FDA, MDR, cGMP, and so on, improving compliance. Audit, Inspection, Incident Reporting and Management, Management Review, Sustainability, and Reports and Dashboards are some of the other features of this solution. Together, they can help ensure a safe and healthy workplace as well as continuous improvement to the safety processes.

To know more, contact us now: https://www.compliancequest.com/contact-us/