T
tschones
In an ISO 9000:2000 preassessment audit, our external auditor hit us hard for not having what he thought were enough records showing we do preventive action. So we are trying to determine what should constitute our preventive action records, but before we can do that, we have to sort out what really constitues a preventive action and when something is a corrective action. Here's how ISO defines the two:
Corrective Action: The action to eliminate the cause of a detected nonconformity or other undesirable situation.
Preventive Action: The action to eliminate the cause of a potential nonconformity or other undesirable potential situation. Preventive actions shall be specified or implicit in the appropriate development, planning, release, and process development procedures.
IMO, corrective and preventive actions are on the opposite ends of a continuum. Obviously true preventive action occurs in the product development phase when tools such as FMEA and fault tree analysis identify potential problems that haven't even surfaced. Moving away from that point of true preventive action, you can have situations where nonconformities have been observed on existing products, and then design the sources of those nonconformities out on a new product and consider it preventive action.
But from there it seems like things get gray quickly. Some of the questions I have are:
* when/where does a potential nonconformity become a detected nonconformity? Is it when it reaches a customer or is it when you first identify it internally? Could you identify a nonconformity internally, capture it, prevent from reaching a customer, put a permanent fix in place, and call that fix a preventive action?
* could the implementation of SPC be considered a preventive action?
I am curious to hear how other organizations address this issue and make this differentiation. What are some examples of preventive actions that your organization has done that aren't in the category I have called "true P.A."?
Our preventive action procedure is really just a list of responsibilities for engineers and others. There is no " process flow" to it, like we have for our corrective action prcedure. What does your preventive action procedure look like?
Tom
Corrective Action: The action to eliminate the cause of a detected nonconformity or other undesirable situation.
Preventive Action: The action to eliminate the cause of a potential nonconformity or other undesirable potential situation. Preventive actions shall be specified or implicit in the appropriate development, planning, release, and process development procedures.
IMO, corrective and preventive actions are on the opposite ends of a continuum. Obviously true preventive action occurs in the product development phase when tools such as FMEA and fault tree analysis identify potential problems that haven't even surfaced. Moving away from that point of true preventive action, you can have situations where nonconformities have been observed on existing products, and then design the sources of those nonconformities out on a new product and consider it preventive action.
But from there it seems like things get gray quickly. Some of the questions I have are:
* when/where does a potential nonconformity become a detected nonconformity? Is it when it reaches a customer or is it when you first identify it internally? Could you identify a nonconformity internally, capture it, prevent from reaching a customer, put a permanent fix in place, and call that fix a preventive action?
* could the implementation of SPC be considered a preventive action?
I am curious to hear how other organizations address this issue and make this differentiation. What are some examples of preventive actions that your organization has done that aren't in the category I have called "true P.A."?
Our preventive action procedure is really just a list of responsibilities for engineers and others. There is no " process flow" to it, like we have for our corrective action prcedure. What does your preventive action procedure look like?
Tom
