Danish physicist Niels Bohr once said, “Every great and deep difficulty bears in itself its own solution. It forces us to change our thinking in order to find it.”
Bohr’s work was instrumental in the discovery of the electron, an elusive subatomic particle whose location, even now, we can only describe in terms of a field of probability.
Within this context, today’s post looks at how we can change our thinking to pin down similarly elusive solutions to problems requiring corrective action. The trick is to ask detailed questions about the problem and the corrective action process, ensuring you’re not just going through the motions.
1. What’s the Real Problem Here?
Creating a corrective action plan that works all starts with an accurate and descriptive problem statement. Getting the problem statement right will help orient everyone towards a solution as well as help to validate that solution at the end.
To write a strong problem statement:
- Be concrete about the who, what, when, where and why of the problem.
- Provide context and definitions of unclear terms to better communicate with upper management.
- Include clear validation criteria that will help the team evaluate whether the problem is actually fixed at the end.
2. Is This the True Root Cause?
People often take the “check the box” approach to corrective action, and nowhere is this more problematic than root cause analysis. Effective root cause analysis is essential to actually fixing the problem, and it’s not helpful just to attribute everything to operator error or inadequate employee training.
Customers see through this, and many won’t accept weak solutions like informing operators and shift leaders of the correct protocol. Instead, you need to ask deeper questions. Is the process moving too quickly, leading to mistakes? Do you have proper error-proofing procedures? Is there something making the process overly complex?
3. What’s the Priority Level?
Due dates on corrective actions can be somewhat arbitrary based on the person assigning them and/or company policies about how long they should take. As a result, you often end up looking at your list of corrective actions and think you need to deal with those that have been overdue longest.
And as annoying as it is to see that backlog of overdue corrective action requests, your first priority needs to be mitigating quality and safety risks. By adding risk assessment to open corrective actions, you can quickly find the problems that represent the greatest risk of recurrence or potential damage.
This isn’t to say a backlog of corrective actions isn’t a problem, because it’s definitely a warning sign of problems ahead. The solution is to correct your corrective action process, not try to fight fires faster.
4. Who’s Responsible?
Essential to your corrective action plan is asking who will be responsible for seeing the process through to completion. Critical questions to ask include:
- Who is the owner of this corrective action?
- Is the same person responsible for each step, or does the corrective action need to be routed among multiple individuals?
- Who will monitor progress, and who needs to be notified if problems arise with completing the request?
- Who is responsible for verifying the effectiveness of the corrective action and signing off on it?
If you use CAPA software through an automated Quality Management System (QMS) or Environmental, Health and Safety (EHS) Management System, there are ways to streamline this step. For instance, you can create dedicated workflows for different categories of corrective actions that already list who’s responsible for each step. These workflows allow you to automatically route requests from one step to another without having to rely on error-prone email.
5. How Will You Verify Effectiveness?
The final question for ensuring your corrective action plan will actually work is asking how you will judge effectiveness. Missing this critical step could mean closing out a corrective action before the problem is truly solved, allowing the root cause to persist unchecked.
Focus on steps such as:
- Looking at your problem statement: Compare the result against the criteria you outlined in your problem statement. Can you link the results directly to your original goal?
- Calculating residual risk: A final risk assessment will tell you whether corrective action has lowered risk to an acceptable level.
- Building in future checks: To make sure the corrective action holds, you’ll want to add a question to your informal walkthroughs or audits related to the fix.
Corrective action is often seen as just another task to check off the list. But if you’re not doing it effectively, that only means more work (and problems) later on down the line. Ask these five questions of every action to ensure you’re not just spinning your wheels, and are instead taking meaningful action towards a long-term solution.
