EH&S Articles

5 Steps for a Closed Loop Corrective Action Process

Every organization experiences problems that are related to safety, product quality, production errors and customer satisfaction. Identifying and correcting these problems is vital to corporate success and necessary to meet most ISO standards. A Closed-Loop Corrective Action (CLCA) system is an effective tool to address operational failures and help assure they do not reoccur.

Corrective Action is the action planned or taken to address the problem that has already occurred and anticipate potential problems before they manifest. Closed Loop is the process of identifying and eliminating the root cause of a problem so that it cannot reoccur. Together they are the CLCA components that form the system by which you address the various challenges faced by your organization.

CLCA process includes five steps:

1. Identify Non Conformance or Failures
2. Open a Corrective Action
3. Respond to the Corrective Action
4. Define the Root Cause of the Non Conformance or Failure
5. Implement the Solution

Each step requires specific actions and builds on the ones that come before. A successful CLCA system is one that effectively implements every step, provides real-time status and communication, and documents the actions taken.

The Closed Loop System

A robust CLCA process must capture, analyze, and correct failures the impact a company’s ability to operate at its highest level. When an issue occurs that launches a CLCA response, your company’s system should automatically verify that the corrective action was taken and validate that this action truly corrected the problem without negatively impacting quality or operations. Your system should also track the data and document evidence of actions taken to record your processes for internal review and trend analysis. Your CLCA process is also crucial to document compliance with ISO standards.

An effective, implemented CLCA system is a valuable tool in the event that your organization is audited as it demonstrates that you proactively seek out and correct root causes of problems that negatively impact your business, employees, and customers. Typical questions asked during an audit are:

• Were corrective actions followed-up in a timely fashion?
• Do records document and prove that all actions were completed successfully?
• Were all recommended changes completed and verified?
• Was the root cause identified and how was it validated?
• Was action taken to correct or prevent the problem and ensure it will not happen again?
• Has it been demonstrated that actions taken have no adverse effects?
• Was training performed and communications issued to ensure that all relevant parties understand the situation that occurred and the changes that have been made?

With a comprehensive CLCA program in place, you can give an affirmative answer to these questions and know that you have done all that was possible to address the problem.

Client satisfaction and operational success are at the core of the CLCA process with the goal of rapidly correcting existing problems and preventing future issues. An effective CLCA program allows you to meet necessary industry compliance requirements as well as serve the needs of your company. It should allow issues to be addressed quickly and completely to allow your managers and supervisors to focus on the day-to-day operations of your business and avoid procedural bottlenecks.

The Corrective Action Component

Corrective action has two distinct components, prevention and correction. Preventive actions anticipate potential problems and takes steps to avoid them with the goal of contributing to the overall continual improvement effort. Corrective actions address actual negative situations which have occurred and provides a system to correct the issue and validate that the efforts had the desired effect. A key component of a comprehensive corrective action process is the collection and analysis of data that allows your managers and supervisors to anticipate new potential problems and dovetail with the preventive actions systems.

The coordination and use of both types of actions enables your company to transform itself from a reactive model of operations to a responsive one. Instead of reacting to each failure and problem, you can anticipate where problems are likely to arise and prevent them from occurring. This proactive system allows your business to save time and money while retaining valued customers and positive cash flows.

Improvement of products, goods or processes is also a result of corrective action processes. Through the closed loop model, it becomes part of your company’s ongoing quality and safety systems to achieve continual improvements in all key operations.  

The utilization of corrective actions can cause both breakthrough and incremental improvements that will culminate in quality improvements at each level of your organization. For instance, if your organization’s delivery processes are already effective, though continual monitoring factors may be identified and corrected that result in improved efficiencies. Those efficiencies may lead to decreased administrative and operational costs which in turn can lower the cost of goods and services. As product costs decrease, opportunities arise to lower prices and become more competitive which can increase current customer loyalty and satisfaction while expanding your client base.

Most closed-loop corrective action systems tie in well with the Plan, Do, Check, Act (PDAC) process used by many companies to enact change. At its heart, the CLCA system is an instrument for ongoing change in how operations are performed to achieve improvement. Companies who utilize the PDAC model for organizational change will find CLCA processes a comfortable fit and easily transitioned opportunity.

One of the key features of both systems is the ability to address problems and change in real-time. The continuous monitoring, action and verification allows your organization to respond quickly which results in effective outcomes. Consequently, the CLCA process reduces the number and severity of issues that occur. With data collection and analysis, your organization can build an intelligent knowledge base that allows you to reasonably implement additional preventive actions. This ability to proactively analyze your operations and restructure your systems to further improve processes and operations throughout your organization will have tangible results.  Improved customer satisfaction, increased responsiveness to change and a bottom line that moves in the right direction are benefits you can anticipate from implementing a CLCA process.

In addition to these advantages, a CLCA process ensures that best practices are used to support compliance requirements. This includes proper documentation of incidents and actions as well as historical operational data. Managers can use this information to implement continual improvement plans. This well thought-out, integrated process can help capture and disseminate operational intelligence which result in organization-wide enhancements.

The 5 Steps of the CLCA Process

A Closed-Loop Corrective Action process can have as many steps as you choose, however the more complicated the system the less effective it is. We believe that a robust and effective system consists of the five steps presented above. Each step is unique and necessary to the entire process to achieve successful and long-lasting improvement.

Step 1: Identify Non Conformance

Before you can identify non conformance you must first define them and this will be different for every organization. At its core, a non conformance is a deviation from a specific procedure, standard, stated process, or system requirement. This requires a review of your operations and determine what actions or processes conform to your quality, efficiency and effectiveness expectations then identify the outliers that have a negative impact on them. These are your non conformance.

As part of defining your non conformance, you need to determine the potential severity of the impact they could have on your organization. A severe non conformance would have a negative impact on your management systems and operations. A minor would be less serious and usually involve isolated incidents such as documentation/work instruction errors or inaccuracies.

The process allows managers to better characterize problems and assemble the best possible cross-functional team of people to successfully tackle them. Having a good grasp of the non conformance also helps managers write procedures and design actions that will be taken when a corrective action plan is launched.

Non conformance and CLCA

You should also search for non conformance within your existing CLCA systems. Common issues are:

• Inadequate documentation of corrective action requirements
• Failure to communicate following a corrective action
• Inadequate lessons learned training following a corrective action
• Corrective actions that are not completed as scheduled
• Corrective actions that are closed without validation
• Failure to monitor following a corrective action

Since your CLCA process enables your company to avoid or minimize the occurrence of impactful problems, it is important that it be upgraded to minimize these non conformances as it is a vital component of your overall continual improvement process.

Step 2: Opening a Corrective Action

Opening a Corrective Action is a process that begins when a non conformance occurs that must be addressed. As stated above, it is critical to identify the types of non conformance within your company to allow an appropriate response.

Some organizations open a corrective action for every non conformance event regardless of its severity or potential impact. This can create bottlenecks as employees efforts on their corrective actions take away from their day-to-day responsibilities. Having the same intensive response to every non conformance can also create an environment of chaos within your organization, distracting your core purpose and impeding your continuous improvement efforts.

Regulatory requirements offer a similar perspective that response should be commensurate with the non conformance. ISO 9001:2008 states that when planned results are not achieved, appropriate corrective action shall be taken. It expands on this issue by directing managers to evaluate the entire situation when determining suitable actions, suggesting that they should consider the type and extent of monitoring or measurement they plan to undertake. This requirement is similar for many other ISO standards.

To be meaningful and effective, corrective actions should be appropriate to each process related to the problem and be considered in relation to their impact on conformance to product requirements and the management system. Problems can arise if the CLCA system monitors the wrong data or the data is inaccurate or incomplete. If your company bases actions and assigns resources based on faulty data, you can waste resources and money.

Corrective Action and Risk Assessment

Risk assessment allows you to avoid bottlenecks and over reactions by utilizing risk matrices to assign values to your non conformance based on their potential severity and impact, which allows you to respond appropriately. Risk matrices are a great tool to determine the size of a risk and whether or not that risk is sufficiently controlled. It also looks at how severe an unwanted event is and how likely it is to occur. Using risk matrices, managers and teams can clearly define risk, severity, and potential impact.

Risk matrices can also determine which procedures, designs, and controls best define expected performance. The higher the risk of a non conformance, the more likely it will be necessary to launch a corrective or preventive action.

In addition to predicting non conforming events, risk assessment may advise monitoring a particular aspect of a process or product. Through this monitoring, your organization collects measurements and analysis that will help your managers to spot trends that in turn will justify the opening of a corrective action. There are many software tools available to provide a framework for this analysis, which is critical to an effective corrective action process.

Step 3: Responding to a Corrective Action

If a corrective action has been opened, we know from the risk management component that the issue is severe enough to go forward. Response should start with the formation of a cross-functional team that evaluates the event and clearly defines the (potential) problem. This process includes:

• Consulting any document and/or data that provides evidence that a problem exists.
• Taking into account the source of the information and data to assess its reliability and accuracy.
• Obtaining or drafting a detailed description of the event.
• Evaluating the situation to determine both the need for action and the level of action required.

As part of the evaluation process, the team must consider the potential impact the problem will have on your company and its customers. Depending on the level of risk, they will determine if immediate action is required. Documentation is a critical component of the process and the team must create a report that states why the problem is a concern and the impact it may have on your organization and its customers. Typical impact issues can include:

• Costs
• Production Functions
• Product Quality
• Safety
• Reliability
• Customer and Consumer Health, Safety and Satisfaction

When the potential impact and risk assessment indicates the need for immediate action to create a short-term remedy for the situation, the team must have the authority and ability to do so. While this temporary solution is in place, a permanent solution must be developed and implemented. If the remedial action adequately solves the problem, the corrective action can be closed. It is vital that the team document the rationale for its decision and complete appropriate follow-up to validate effectiveness of the action.

Documentation

For the purposes of action validation, trend analysis and regulatory compliance, the team must document the specific sources of the information it gathered as it responded to the corrective action. This information helps to:

• Investigate the incident
• Develop an action plan
• Evaluate the effectiveness of the action plan
• Communicate how the problem was resolved.

Sources of quality information that may be used in the corrective action response are:

• Service Requests;
• Customer Complaints;
• Internal Audits; and
• Staff Observations.

Trend data may also be obtained from Quality Assurance (QA) inspections, process monitoring, and risk analysis. To have a valued impact on your organization, the data gathered must be properly organized and shared in real-time through an accessible software system.  When this data is properly organized and disseminated it becomes your operational intelligence and can be leveraged by the entire organization to help improve performance.

Step 4: Defining the Root Cause

After the corrective action response is complete and operations have continued, you may need to determine the root cause of the non conformance if it is not apparent so you can assure that it does not occur again. This should start with a problem statement which identifies impacting factors of the situation and provides a clear and concise description of the issues that need to be addressed by the assembled team.

The goal is to create a meaningful, easily understood description of the problem and its impact on the organization. Supporting data should be included and presented in as uncomplicated a manner as possible while still presenting valid information. Once the team has reviewed and adjusted the problem statement to assure it is as accurate and concise as possible, they may decide to perform a root cause analysis.

This detailed investigation delves into the circumstances that created the problem to identify the root cause. Eliminating the root cause is the only way to prevent the reoccurrence of the problem and there are many problem-solving techniques that can be employed to assist in this phase of the process which can include:

• The Five-Whys. Iterative questioning process to help learn about the cause and effect of an issue or event.
• Fishbone Diagram. Problem solving process that looks at the 5 Ms (Model, Manpower, Machines, Methods and Measurements). Cause-and-effect diagrams are used to reveal key relationships among various components of the issue or event and help learn about possible causes.

Regardless of the method used, root cause analysis requires asking a series of questions to identify all of the possible causes that could explain why the problem occurred. It may also identify why the problem was not noticed earlier. Once causes are identified, they must be verified.

The identification of the root cause allows the team to create an effective solution to avoid a repetition of the problem. Depending on the severity of the non conformance, this may include implementing preproduction, process or design experiment programs to quantitatively confirm that the identified solution will in fact resolve the problem. Once a valid solution is identified, it must be implemented.

Step 5: Implementing the Solution

The solution to the problem must be developed into an action plan that identifies key tasks, persons responsible, and due dates for completion. With the right CLCA software system, the action plan can be fully automated to trigger reminder emails and notices to team members when tasks have or have not been completed, including reporting and other documentation elements. An automated system can also verify that all of the required tasks described in the action plan are initiated, completed, and documented. To be fully effective and support potential external audits, employee training should be part of the solution action plan and an automated system will document these efforts.

Part of the implementation process is making necessary changes to documents, processes, procedures, or other system components. These modifications must be described in a clear, concise manner with a goal of specifying the desired outcome of the changes made. This is a complex process that requires looking beyond the basics of the action plan to appreciate the impact a change may have on seemingly unrelated processes. For this reason, the implementation team may need additional members who can anticipate and respond to organizational changes that are triggered by the solution implementation.

Once the permanent solution is in place, the team needs to ensure that it has recorded of all actions taken throughout the process. A new action plan should be implemented to follow-up, verify, and assess the effectiveness of the implemented solution that will be triggered at pre-determined time period. Proactive measures should also be taken to prevent a reoccurrence of this non conformance and all similar types of problems.

Communication is key to this process and all modifications and changes must be disseminated to all persons, departments, suppliers, etc. that were or will be affected. Many CLCA software packages automate this communication to assure that all stakeholders have received and acknowledged the information.

The Transformative Effect of CLCA

The Close-Loop Corrective Action process allows for continual improvement throughout your organization. It is an optimal approach whereby resources are managed as a series of interconnecting processes that result in effective non conformance identification and response. The result is improved efficiencies, increased customer satisfaction and a healthy bottom line.

To maximize the CLCA benefits, an automated system is strongly recommended. Utilizing CLCA-specific software you can manage the process in real-time, assure all communications are handled efficiently, document each stop of the process, and create actionable corporate intelligence. Through data analysis you can identify potential problems and address them before they occur, saving you time and money while avoiding unhappy customers.

Bottom Line

The benefits of a CLCA system are extensive and reach beyond solving problems to avoiding them. The cost of inaction is high and may include:

• Ad Hoc Investigation of Incidents;
• Unclear Assignment of Accountability;
• Non Conformance Causing Loss of Production;
• Assets Over or Under Protected; and
• Fines or Suspensions Levied By Regulatory Authorities.

Using a CLCA software system allows you to effectively address the problems that arise within your company in the most cost-effective and efficient way possible. Through automated communications and documentation processes, you can meet regulatory and internal requirements while minimizing the impact of non conformance. Utilizing a software system makes the CLCA process easier to understand and complete which encourages its use by managers and other team members.

Want to learn more about corrective actions? See the article Tips for Online Corrective Action Management.

Implementing a CLCA system can save you time and money, and utilizing a CLCA software system can improve its success.  The integrated EHS Software suite from EHSSoftware.io is a user-friendly system that is easily customized to meet your CLCA needs. Contact us today to learn more.