Emily Ysaguirre, Content Marketing Writer, VERSE Solutions09.20.16
Today, the life sciences are faced with an enormous amount of competition and compliance challenges. More often than not, these issues escalate into the corrective action process before proper evaluation is made. This leads to routine problems, rather than eradication of adverse events.
A corrective action process is designed to respond to critical, systemic issues with the intent to investigate and resolve them in the best way possible. This should put a stop to the event, record the data, and mitigate its risk of future occurrence. However, in reality, many organizations find that they relive this action daily.
This is not an effective means of correcting events and can actually work against an organization.
A Corrective and Preventive Action (CAPA) process should be thought of as three separate parts:
There are a number of factors responsible for redundant CAPAs. Initially, users must respond to critical and systemic issues through investigation and root cause identification. Once the event is fully understood, organizations can see the issue for what it is and set controls. Without this step, each event is treated in the same manner.
Where the CAPA Begins
If every event is issued a CAPA, the process becomes weak. With so many actions and processes to investigate, it is important to recognize exactly where and when a CAPA is needed. Often, events in the system are assigned a corrective action by default, regardless of criticality. This is because some companies may choose the “better safe than sorry” approach, which actually does more harm than good. Taking this approach may appear effective at first, but can be detrimental in the long run. If a corrective action is opened for all events within the system, it soon becomes impossible to keep track of which are most critical and should take priority. Soon, the system is overloaded with minor, easily correctable events that are keeping the most crucial events hidden from view.
Keep the CAPA Process Healthy
For an effective corrective action process, it is necessary to determine which events are most critical to business and ensure they are made visible. The corrective action system facilitates this with investigations or pre-corrective actions to record adverse events without having to go through the entire process.
Once a corrective action system can tell the difference between minor and detrimental events, it speeds up the system. Opening too many corrective actions can work against the process, hindering the visibility of critical events. This is not to say that all events do not deserve resolution, but rather organizations must have the tools necessary to recognize more crucial events. Before a company can effectively handle detrimental events, it must first determine the risks and identify any trends in those risks.
How to Leverage Risk Tools to Break the Cycle
Risk tools are not new, but they are becoming more frequent in relation to recent ISO standards and other regulations. If used effectively to identify critical events as they are recorded in the system, they can initiate an investigation and a CAPA to properly solve the problem and reduce the chance of recurrence.
Many events entering the system can be fixed immediately without initiating a corrective action. These minor events that pose no systemic threat to the company should have their own process for elimination. For events that do pose a threat, there is a certain level of priority that should be followed—this is where risk tools come into play.
Risk management tools allow organizations to assign parameters to the events flowing into the system such as the consequence, frequency, and potential outcome of the situation. Through the risk-based filtering that these tools offer, the system can automatically assign a priority level to incoming events. This capability ensures that users see which events are most detrimental with enough time to solve them before they strike, and ensures the process is objective and becomes systematic over time.
How to Use CAPA Effectively
Once a system can determine differences between events, problems can be fixed permanently. Part of the CAPA process is accomplished through action plans, which drive the action process. An action plan identifies the people involved in each role and assigns them deliverables and necessary actions to prove the system’s success.
Workflows and intelligent business rules help to streamline the process and ensure goals are met on time. Action plans outline the process that must be followed to complete tasks correctly and in a timely manner during the root cause and corrective action phases. It is important not to assign too many CAPAs to the same owner; this can overwhelm the system and cause distraction. It is also important to drive CAPAs based on realistic deliverables (rather than nebulous timelines) and set sensible timeframes. Delays in decisions and actions can occur during the CAPA process, but remember not to lose sight of the end goal.
Verification of Effectiveness
Once a corrective action is linked to the process, employees must identify and measure its effectiveness. Did the first plan work? Risk tools again become evident here to prove if the action was effective and whether more steps to correction should be issued. The corrective action’s ability to integrate with risk management applications ensures that any corrective actions were made within correct risk parameters. If not, the action taken will have to be revisited.
Importance of Reporting on All Events
Reporting on events is critical to success. There is often so much information flowing into corrective actions that reporting becomes necessary to keep track of it all. Integrating corrective actions with automated reporting functionality enables users to see the status of all corrective actions in real-time, which phase the action is in, and the associated risks of each.
Keeping all of this information on display with charts that drill down information to the core helps protect the enterprise in future situations. An extensively granular report illustrates the success of the approach to managing the actions. It also relates future similar events to past events for simplified clarification and clearing away.
The life sciences industry is data-driven. At any given point, employees could be faced with decisions that cannot be improved or changed without data in front of them. Reporting and analytic tools are designed to help organizations make sense of data in order to make better decisions.
Logical tools help organize data, as well as create configurable views to visualize it in various ways that make sense to the team. Keeping data in a centralized platform lets users locate data anywhere, at any time, and allows deeper digging into compliance.
Knowing about problems as they happen, or even before, is something that automated software helps to regulate. The trouble is that reporting is typically designed to analyze existing events. This is useful for continuous improvement, but if users want to be notified about specific events as they happen, an alert tool helps to get the job done. Setting the criteria for certain events notifies users when a specific event is encountered. This allows employees to:
When issued correctly, corrective action processes endow organizations with greater confidence in dealing with critical and minor events. The ability to see systemic issues and ensure that all actions have been corrective to the process enables compliance.
Creating an inherent workflow in the corrective action process results in an effective corrective action solution. Corrective action is an essential part of any system
because it helps to identify the source of adverse events and pinpoint any other issues in need of resolution. However, the corrective action performs more effectively when paired with like tools, such as risk management and reporting.
Last, but not least, not every event needs to be a CAPA—only those that are systemic issues and pose a critical impact on the business. If an event can be corrected immediately, correct it and don’t waste time.
Conclusion
Corrective actions are a very important part of compliance, especially when implemented and used efficiently. Too many corrective actions, not enough data, or a disjointed workflow can hinder the success of a corrective action. Therefore, it is important to maintain the proper elements: workflow types for different types of corrective actions; integrating adverse events into corrective action processes; specifically creating CAPAs when (and only when) necessary; filtering; action plans; the measurement of effectiveness; the linkage of corrective action to change management; and last, but of utmost importance, traceability and reporting.
A corrective action system is meant to be an effective tool, essential to business needs today. It is the best method for tracking the source and cost of all adverse events by providing the visibility needed to filter events. Filtering and prioritizing events by level of urgency can take time to get started, but is well worth it in the end. Implementing a corrective action system integrated with other automated solutions helps an organization ensure that the corrective action process works efficiently. Automated software solutions provide the flexibility, integration, intuitiveness, and means for operating systematically—all of which help put a stop to repeat CAPAs.
Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com
A corrective action process is designed to respond to critical, systemic issues with the intent to investigate and resolve them in the best way possible. This should put a stop to the event, record the data, and mitigate its risk of future occurrence. However, in reality, many organizations find that they relive this action daily.
This is not an effective means of correcting events and can actually work against an organization.
A Corrective and Preventive Action (CAPA) process should be thought of as three separate parts:
- Correction: The action taken to eliminate the nonconformity (i.e., “putting out the fire”).
- Corrective Action: The action taken to eliminate the causes of existing nonconformity (i.e., “what caused the fire”) to prevent recurrence.
- Preventive Action: The action taken to eliminate the causes of potential nonconformity to prevent occurrence. This would “stop the fire from ever happening at all.”
There are a number of factors responsible for redundant CAPAs. Initially, users must respond to critical and systemic issues through investigation and root cause identification. Once the event is fully understood, organizations can see the issue for what it is and set controls. Without this step, each event is treated in the same manner.
Where the CAPA Begins
If every event is issued a CAPA, the process becomes weak. With so many actions and processes to investigate, it is important to recognize exactly where and when a CAPA is needed. Often, events in the system are assigned a corrective action by default, regardless of criticality. This is because some companies may choose the “better safe than sorry” approach, which actually does more harm than good. Taking this approach may appear effective at first, but can be detrimental in the long run. If a corrective action is opened for all events within the system, it soon becomes impossible to keep track of which are most critical and should take priority. Soon, the system is overloaded with minor, easily correctable events that are keeping the most crucial events hidden from view.
Keep the CAPA Process Healthy
For an effective corrective action process, it is necessary to determine which events are most critical to business and ensure they are made visible. The corrective action system facilitates this with investigations or pre-corrective actions to record adverse events without having to go through the entire process.
Once a corrective action system can tell the difference between minor and detrimental events, it speeds up the system. Opening too many corrective actions can work against the process, hindering the visibility of critical events. This is not to say that all events do not deserve resolution, but rather organizations must have the tools necessary to recognize more crucial events. Before a company can effectively handle detrimental events, it must first determine the risks and identify any trends in those risks.
How to Leverage Risk Tools to Break the Cycle
Risk tools are not new, but they are becoming more frequent in relation to recent ISO standards and other regulations. If used effectively to identify critical events as they are recorded in the system, they can initiate an investigation and a CAPA to properly solve the problem and reduce the chance of recurrence.
Many events entering the system can be fixed immediately without initiating a corrective action. These minor events that pose no systemic threat to the company should have their own process for elimination. For events that do pose a threat, there is a certain level of priority that should be followed—this is where risk tools come into play.
Risk management tools allow organizations to assign parameters to the events flowing into the system such as the consequence, frequency, and potential outcome of the situation. Through the risk-based filtering that these tools offer, the system can automatically assign a priority level to incoming events. This capability ensures that users see which events are most detrimental with enough time to solve them before they strike, and ensures the process is objective and becomes systematic over time.
How to Use CAPA Effectively
Once a system can determine differences between events, problems can be fixed permanently. Part of the CAPA process is accomplished through action plans, which drive the action process. An action plan identifies the people involved in each role and assigns them deliverables and necessary actions to prove the system’s success.
Workflows and intelligent business rules help to streamline the process and ensure goals are met on time. Action plans outline the process that must be followed to complete tasks correctly and in a timely manner during the root cause and corrective action phases. It is important not to assign too many CAPAs to the same owner; this can overwhelm the system and cause distraction. It is also important to drive CAPAs based on realistic deliverables (rather than nebulous timelines) and set sensible timeframes. Delays in decisions and actions can occur during the CAPA process, but remember not to lose sight of the end goal.
Verification of Effectiveness
Once a corrective action is linked to the process, employees must identify and measure its effectiveness. Did the first plan work? Risk tools again become evident here to prove if the action was effective and whether more steps to correction should be issued. The corrective action’s ability to integrate with risk management applications ensures that any corrective actions were made within correct risk parameters. If not, the action taken will have to be revisited.
Importance of Reporting on All Events
Reporting on events is critical to success. There is often so much information flowing into corrective actions that reporting becomes necessary to keep track of it all. Integrating corrective actions with automated reporting functionality enables users to see the status of all corrective actions in real-time, which phase the action is in, and the associated risks of each.
Keeping all of this information on display with charts that drill down information to the core helps protect the enterprise in future situations. An extensively granular report illustrates the success of the approach to managing the actions. It also relates future similar events to past events for simplified clarification and clearing away.
The life sciences industry is data-driven. At any given point, employees could be faced with decisions that cannot be improved or changed without data in front of them. Reporting and analytic tools are designed to help organizations make sense of data in order to make better decisions.
Logical tools help organize data, as well as create configurable views to visualize it in various ways that make sense to the team. Keeping data in a centralized platform lets users locate data anywhere, at any time, and allows deeper digging into compliance.
Knowing about problems as they happen, or even before, is something that automated software helps to regulate. The trouble is that reporting is typically designed to analyze existing events. This is useful for continuous improvement, but if users want to be notified about specific events as they happen, an alert tool helps to get the job done. Setting the criteria for certain events notifies users when a specific event is encountered. This allows employees to:
- Set exception criteria and notification rules when events occur
- Build out multiple reports on event notification types
- Automatically initiate corrective action or activities when specific events occur
When issued correctly, corrective action processes endow organizations with greater confidence in dealing with critical and minor events. The ability to see systemic issues and ensure that all actions have been corrective to the process enables compliance.
Creating an inherent workflow in the corrective action process results in an effective corrective action solution. Corrective action is an essential part of any system
because it helps to identify the source of adverse events and pinpoint any other issues in need of resolution. However, the corrective action performs more effectively when paired with like tools, such as risk management and reporting.
Last, but not least, not every event needs to be a CAPA—only those that are systemic issues and pose a critical impact on the business. If an event can be corrected immediately, correct it and don’t waste time.
Conclusion
Corrective actions are a very important part of compliance, especially when implemented and used efficiently. Too many corrective actions, not enough data, or a disjointed workflow can hinder the success of a corrective action. Therefore, it is important to maintain the proper elements: workflow types for different types of corrective actions; integrating adverse events into corrective action processes; specifically creating CAPAs when (and only when) necessary; filtering; action plans; the measurement of effectiveness; the linkage of corrective action to change management; and last, but of utmost importance, traceability and reporting.
A corrective action system is meant to be an effective tool, essential to business needs today. It is the best method for tracking the source and cost of all adverse events by providing the visibility needed to filter events. Filtering and prioritizing events by level of urgency can take time to get started, but is well worth it in the end. Implementing a corrective action system integrated with other automated solutions helps an organization ensure that the corrective action process works efficiently. Automated software solutions provide the flexibility, integration, intuitiveness, and means for operating systematically—all of which help put a stop to repeat CAPAs.
Emily Ysaguirre is a writer for VERSE Solutions, a cloud-based compliance management software solution that helps automate the processes surrounding quality, compliance, and environmental health and safety. Learn more about VERSE by visiting www.versesolutions.com or blog.versesolutions.com