When it comes to solving problems that arise in manufacturing, identifying the cause of what went wrong is top priority. But what about once you’ve pinpointed the root cause of the issue? That’s when the real work starts, and you have to make a corrective action plan capable of fully resolving the problem.
In this post, we look at the most important elements of your corrective action plan, and how you can ensure an effective, streamlined corrective action process.
1. Link to Compliance Record
Corrective actions don’t exist in a vacuum. Rather, they should connect to relevant areas of the compliance record to communicate the full context of the problem. Each corrective action should be linked to the appropriate source, such as:
- Audit results.
- Nonconforming Materials.
- Safety incidents.
- Customer complaints.
2. Action Items
Central to the corrective action plan are the action items aimed at addressing the problem at hand. You’ll want to break it down into discrete steps, providing added details where necessary to help users understand what to do. For instance, you might include:
- A photo from the audit or incident record that illustrates the problem and how to fix it.
- Any specific metrics or required conditions for closure.
- Instructions on necessary updates to related areas such as Document Control or Employee Training
3. Defined Workflow
Each of the corrective action steps must pass through several key waypoints. The process starts before you even form the corrective action plan, with someone reviewing the initiating event and investigating the root cause. Executing the plan itself may require participation from multiple people, creating opportunities for the problem to fall through the cracks.
A truly robust corrective action process prevents this from happening, also eliminating the back-and-forth emails that suck so much time out of the average day.
Leveraging CAPA software from a QMS or EHS Management System, you should be able to:
- Create unique workflows for different corrective action types to better standardize your processes.
- Set due dates according to your own internal business rules.
- Automatically route the corrective action plan from one step to the next.
4. Responsible Party
Assigning a responsible party is an essential part of writing a corrective action plan. It sounds obvious, but there are a few ways you can power up this process.
First, you can schedule deliverables by role, streamlining the process while creating accountability around your action items. You also should consider what the process is if that person doesn’t follow through. You’ll need to create rules for who’s responsible if a deliverable falls on a scheduled vacation, as well as for notifying a supervisor when someone drops the ball altogether.
5. Risk Assessment – The most essential element in in a corrective action plan
Risk is the final essential element of any corrective action plan that works. In fact, you can leverage a risk assessment at both the beginning and the end of the process.
In the beginning, each corrective action request can include a criticality level, calculating risk based on your internally developed risk matrix. This lets you filter out the most high-risk issues that need to be addressed immediately before they have the chance to cause further problems.
Risk is also critical to assess before closing out the request, since that’s what tells you whether or not the action performed acceptably reduces risk. When it doesn’t meet that requirement, you know it’s time to put it back to the start of the corrective action process.
Outside of the plan itself, reporting is what ties it all together, giving you a high-level picture of the overall health of your corrective action program. You’ll be able to immediately see elements such as which high-risk items are overdue, average time to closure and any bottlenecks in the process.
And when you can manage the details in the context of the bigger picture, that’s when you really start seeing improvements in corrective action effectiveness.