The processes described in the previous articles aim to provide a structured and systematic approach to managing organizational risks. Once the baseline of these procedures is implemented, your organization will gain clarity and have an accurate understanding of issues. This will provide the necessary information to make informed decisions on how to mitigate, or even eliminate risks. In this last article, we will focus on corrective actions and how to monitor the efficacy of your Issue Management Program, highlighting the best approaches to help you remediate any issues.
So far in our series, we’ve covered:
- Creating an issue management program
- Issue identification and categorization
- Building a risk registry
- Issue ownership and management methodologies
Once an issue is identified, ownership assigned, and root-cause analysis completed, it is time to fix the problem!
One of the most well-known approaches is CAPA (Corrective and Preventive Actions). CAPA refers to an approach to improving processes by reducing the risks of undesirable events and non-conformities. As a vehicle of risk-based thinking, it is a vital part of any Management System, and it should be adopted as a unified approach to issue resolution as part of your Governance Program.
Corrective actions must be defined by the issue owner, and they are set to correct any ad-hoc or systemic nonconformity and risk. Most importantly, Corrective Action Plans must include:
- A description of what will be done to correct the issue;
- Who will be involved in the project;
- Milestones; and
- Acceptance Criteria.
Correcting an issue or mitigating a risk might involve one simple task or a highly complex project with dependencies and several stakeholders involved.
The essential difference between corrective action and preventive action is that preventive actions are, by definition, proactive changes necessary to avoid undesirable situations. Preventative action focuses on the root causes of identified problems to prevent their occurrence, while corrective action prevents an issue from recurring. Preventative action seeks to determine potential issues and prevent them before they occur.
A common misconception is that preventative action seeks to prevent issues from recurring. This is all part of corrective action because an issue has taken place and steps must be taken to prevent similar problems from recurring.
Preventative action is aimed at predicting problems that have not yet taken place. Preventative action acts on the root cause of the problem from a hierarchical perspective. It is important to predict and understand what events could take place in an organization, where, and why. When issue owners define the preventive strategy, they can prioritize adding steps aimed in anticipation of these kinds of issues.
After having created a centralized Issue Management Program, and communicated with and trained all stakeholders, it is equally important to monitor the work being done.
Issue Monitoring Process (or Issue Control Process) is a description of how you keep track of open response plans. It describes how these plans (corrective actions and preventive actions) are performing against the expected results, including:
- Task execution (progress)
- Acceptance Criteria
It is also important that the Compliance Program Manager defines the following items as part of the Issue Monitoring Process:
- Frequency of revisions
- Metrics used to evaluate progress
- Structure of revision committee
- Authorized approvers for any deviations
Standardized monitoring techniques are critical to ensure the success of the Issue Management Program.
Now that all the hard work has been done, it is time to report the results to leadership. Reporting can be tricky if you don’t set specific objectives as part of the reporting structure. Reporting results with leadership is an important step in the process as it keeps senior management informed and engaged. When executives and employees are sharing information, there is improved communication between them to identify problem areas, find solutions, and ensure support and sponsorship for new implementations.
Another benefit of a good management reporting system can be seen at a more functional level. Effective reports promote cross-functional cooperation and decrease any duplicate efforts. This will limit resolution time and costs, thereby increasing productivity.
When reporting the results of actions taken in issue resolution, it is also important to make sure that all the information is logged into the issue registry and the appropriate status is assigned to individual risks and nonconformities. Workflow status can vary between:
- In progress
- Ready for approval
An Issue Management Program can be a powerful yet complicated system. It is a structured and documented Program that must be communicated and followed across the organization.
Being able to identify and properly categorize the various issues that might arise in a register are critical steps in managing them. Assigning ownership to risks and nonconformities will ensure the appropriate actions are being taken and escalated to mitigate, or even eliminate internal and external threats. A huge advantage to having a centralized registry is being able to manage the resolution progress based on a prioritization system.
As your Issue Registry scales with your growing organization, leadership would expect a periodic revision of risks, portraying how your Governance Program identifies improvement opportunities and proactively prevents the recurrence of critical issues.
How Can StandardFusion Help?
StandardFusion streamlines the management of your Issue Management Program. You can create a centralized database of your nonconformities and risks, assign ownership, and perform root-cause analysis. Once an issue is identified, you can create tasks with the corresponding corrective/preventive work, assign them accordingly, track progress, and upload any necessary documents. StandardFusion can give you an overview of all completed and pending actions and it allows you centralized visibility of your program with customizable reports in different formats.