Many organizations struggle with how to determine what constitutes a preventive action. To determine what should trigger a Preventive Action investigation, ask the question “What If”.
What if weI only have one piece of equipment?
What If we only have one set of tools for a critical process?
What if we only have one person with the skills to do a certain process?
What if one of our key suppliers goes out of business or is destroyed by a natural disaster?
Any of these criteria may point you to a potential opportunity for a preventive action. When investigating a preventive action it is important to identify all the risks and costs of having the problem and weigh it against the likelihood of it happening. The benefit to the process and or company if you were to implement the improvement and the legal and ethical reasons for implementing the action regardless of the cost or potential benefit should always be considered prior to implementation. ISO 9001 software and as9100 software packages can aid you in collecting and evalateing this information you gateher from this prcess.