Root cause analysis
- Make sure that the investigation is performed correctly so that the root cause analysis is identified clearly.
- Avoid root cause processes that will support your initial theories regarding the investigation.
- Avoid ignorance of other possible causes of nonconformities. Focus on the process itself, rather than factors such as employees in general or specific employees, in particular concerning the root cause of a nonconformity.
- Avoid focusing on a single cause. There may be several factors together that are the source of the nonconformity.
- First, understand what is causing the problem. Then, continue investigating until the root cause can be identified. Focus on the whole process instead of on the direct cause of the nonconformity.
- Use statistical and other relevant tools such as a Pareto chart, risk analysis, 5 Why’s, fish bone diagrams, flowcharts, etc.
Many CAPA systems are managed manually. But sometimes, to make the CAPA system more efficient, we need to use quality management software.
CAPA investigations should include an orderly flow chart describing the various stages of the process. Quality management systems can also provide a clear indication for the status of a specific CAPA and the general status of the whole CAPA process, which activities were carried out, who is responsible, etc.
Organizational culture has a crucial influence on successful CAPA system implementation. It is recommended that employees understand the importance of the CAPA system and its great contribution to the GMP compliance of the company.
In order to initiate the CAPA process correctly when a nonconformity is discovered, the manufacturer needs to ask the following questions:
• What is the nonconformity?
• Where does/did the nonconformity occur?
• How often does it happen, and what is the scope of the nonconformity?
Once we know what the cause of the nonconformity is, we can move forward to the next step of tests and experiments.
Companies should ensure that investigations are performed according to the CAPA system, should examine all possible causes, and explore the most suspected ones, to determine beyond any doubt the real reason for the nonconformity.
After identification of the root cause, corrective and preventive actions will be implemented to complete the entire CAPA process.
The company must distinguish between the symptoms and the root cause.
Organization employees should remember that the CAPA system is a tool which improves product quality and the business bottom line.
- Understand what the real problem is that caused the nonconformity.
- Document a clear description for what was observed, why, where, when, what, etc.
- Avoid identifying the solutions. First, focus on identifying the problem.
- Record your observations and collect as much as data as you can for decision makers.
- Analyze the data using charts, graphs and/or images to clearly describe the nonconformity.
- Describe the nonconformity clearly and document your description.
- Avoid including suggestions for solutions in the description of the nonconformity.
- Corrective actions which must be repeated indicate that the problem was not resolved the first time, and therefore that the CAPA process was ineffective and should be revised.
- Identify what action(s) was/were implemented to correct the nonconformity, and what happened as a result.
- Try to examine the effect of the CAPA on the whole process and not only on part of it. Remember that action(s) may have an impact on the whole process.
Bio-Chem has been advising biomedical companies for more than 13 years.
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