The requirement for preventive action (the PA - PREVENTIVE ACTION from the CAPA) is included within chapter 8.5 – Improvement. Within the most basic requirement, the purpose of the preventive action is to:
In this article we will review only the requirements for PA (preventive action) out of the CAPA. The CA (preventive action) would be reviewed within another article.
- Eliminate problems/Nonconformities
- Achieve improvement within processes
The organization is required to take actions to eliminate potential Nonconformities - this is improvement. Why? Something could go wrong; you detected it, eliminated it and made sure it would not happen. How to achieve? With the PA (from the CAPA). The ISO 9001 Standard requires you to locate the potential Nonconformities and to eliminate the cause. The purpose is to prevent them from happening before they occurred. And yes, you are required to maintain a procedure describing the process of preventing the Nonconformities and to document the process itself. It is not a recommendation but an ISO 9001 Standard requirement.
THE PREVENTIVE ACTION DOCUMENTATION
The description for Preventive action – an action taken to eliminate a potential event that might cause Nonconformity. In this case the Nonconformity has not occurred yet. After you identified the cause that would generate Nonconformity, you are required to initiate an action to eliminate it: The Preventive action. You must also document it. Why must you document it? For supervision. After a defined period of time (documented within a procedure) you must examine whether the Preventive action was sufficient, effective and the Nonconformity had not occurred like expected.
Preventive action objectives – you must define what is required by the preventive action taken. The objective could be a numerical, quantitative or a quality requirement – whatever is appropriate for your organization. It is not a recommendation but an ISO 9001 Standard requirement.
Before executing the preventive action, it is required to consider cost effective of the preventive action. Some action may cost a lot. You must examine whether it is cost effective to carry out the action. Sometimes it would not be worth taking an action. It would be too expensive. The organization would rather live with the nonconformity – as long as the customer's requirements are maintained!! But, you must document the fact that you initiated a preventive action, examined it and decided to withdraw. Again, documentation here is required by the ISO 9001 Standard.
Closing date for the preventive action – All preventive actions should be limited within time frames in order to measure its effectiveness. You performed a preventive action. That is good but not enough. According to the ISO 9001 Standard requirements, you must define time frames (according to your needs) to examine its effectiveness. The date indicates when the preventive action would be examined.
The preventive action results – the ISO 9001 Standard requires you to observe the preventive action taken and to verify its objectives. You must indicate (and document) the preventive action's status. You must document what are its results: success, failure or perhaps more time is required to examine its effectiveness - that is also possible. Bottom line, you must examine (and document) that the predicted nonconformity was indeed prevented. Then and only then, you may close the preventive action. When a preventive action was found as not successful it is recommended to open a new one. It is not required by the ISO 9001 Standard but an unsuccessful preventive action indicates that a potential Nonconformity is still hanging over your heads – and that is forbidden by the ISO 9001 Standard (unless you defined it otherwise – that you considered and reached a decision – the cost effective topic).
We remind you again; you must maintain a documented procedure defining the process of initiating a preventive action:
- Recognizing a potential Nonconformity
- Where and how to document it
- The investigation of the cause
- The action taken
- The closing
This procedure would be one of your Quality procedures required to maintained by the ISO 9001 Standard.
You must also maintain documentation of the process itself:
- The nonconformity detected
- The cause
- The preventive action taken
- Its objectives (including time frames)
- The results
So, two documentations are required; a procedure and the records. We refer you to the next site: QualiytManualTemplates.com - they provide an effective template solution that holds against the ISO 9001:2008 Standard requirements. Give them a try.