Whether it’s a list of observations on an FDA 483 or the more immediate threat of a Warning Letter, effective compliance remediation means fully understanding the problems at hand and addressing the root causes of those issues.
But getting to the bottom of a particular problem can be a difficult task. Often, it requires you to string together multiple indicators to reveal an underlying issue. Think of it like a doctor diagnosing an illness by examining each of the symptoms in aggregate.
[Read also:] 5 Common Mistakes to Avoid in Your FDA 483 Response
Many companies take the cheaper, less intensive way out by going through the list of observations and treating the symptoms one-by-one. But easy fixes like this only kick the can down the road. Without resolving the root causes of compliance issues, problems will happen again, likely costing even more to fix.
When determining what larger problems lie at the heart of your observations, we suggest using the following tips to guide your analysis:
1. Perform a system-wide gap assessment
In order to get at the root cause of a problem, you’ll need to open your entire system up for scrutiny. Don’t assume an issue is confined to a particular system or process.
[Free Whitepaper:] The Complete Guide to Compliance Remediation
Work as a team to gather evidence and formulate conclusions based on what you’re able to document and explain in detail. Don’t assume any part of your manufacturing or quality system processes are off limits as this can blind you to bigger problems.
2. Realize that observations may be the product of more than one root cause
All too often companies will launch an investigation into a particular process or procedural issue only to stop short of uncovering the full extent of the problem.
It is critical to understand the scope of the problem no matter how much effort, time or resources it takes. If a problem seems to persist, it’s more than likely that whatever was done to correct it in the past didn’t completely solve the problem, which means that the true root cause was not identified.
3. Identify all possible solutions to a problem
While some observations may stem from multiple root causes, it may also be the case that those root causes have a variety of solutions.
[Read also:] 5 Indirect Costs of an FDA Warning Letter
Step back and take inventory of all the possible ways to go about solving the core problem. Compare and contrast them in terms of risk, time to implement, and overall effectiveness before you put a corrective action plan in place.
4. Be thorough when defining the problem
It’s next to impossible to find the true cause of a problem if you haven’t defined it properly first.
Use the observations as a starting point to distill the real issue at hand before setting out on your investigation into the cause. In most cases, a true gap assessment should be completed to determine all areas that may also need remediation.
5. Visualize your path to the root
Getting to the root cause means examining problems and tracing them back to an endpoint.
If you’re having trouble following this “path” as you investigate internally, try creating a graph or visual chart to help you conceptualize where your investigation is going as you progress.
If you’re struggling to identify the root causes of compliance issues, or need assistance from someone experienced in planning and executing a successful remediation project, contact an expert consultant.
These are just a few ways to ensure your remediation program is successful. Interested in learning how to carry out a full remediation project from start to finish? Grab our free whitepaper: The Complete Guide to Compliance Remediation.