You must clearly describe the problem if you hope to solve it. Document as much as possible in the problem statement. For example:
- Identify the defect, compare the actual measured value or output to the acceptance criteria, and make it clear what specification was not met.
- Identify all affected product and potentially suspect product. Provide a specific time frame during which the problem was known to occur or provide specific lot number(s).
- Bracket suspect lots to be included in the CAPA with appropriate rationale.
- Where known, identify the affected equipment, processes, systems, and/or software.
- Describe the circumstances that led you to recognize the problem and why is it important to investigate the problem.
In addition to the problem statement, the background or introduction of the CAPA record should also explain any known or obvious risks, such as actual or potential harm to patient or user, security issues, compromise to intended use, risk to supply chain, or regulatory risk.
The problem statement should be clear and unambiguous. This is important because the original problem statement will eventually drive the acceptance criteria for determining effectiveness. Verification of effectiveness following implementation of corrective and preventive action is based on demonstrating that the original problem no longer exists. So, defining the problem clearly will facilitate your ability to later demonstrate your actions effectively resolved the problem.