Control of Nonconforming Product in an ISO9001:2000 Quality

The ISO9001:2000 Quality Standard states, in essence:

1. Your organization must ensure that any material or product that does not conform to your specifications is properly identified and controlled so that it can not be used or shipped to a customer.

2. You must have a documented procedure for dealing with nonconforming products or materials.

You may deal with nonconforming product in one of the following ways:

1. Do whatever is necessary to eliminate the nonconformity. (Repair, rework, etc.)

2. Get documented approval from the appropriate person or organization (such as the company owner or your customer) to accept the product as-is. You’d better make sure you have accurate documentation if you do this. You don’t want your customer or your boss coming back to you later with a problem.

3. Do something to prevent the product or material from being used for its original purpose. Destroying the item is one example of this.

You must keep records of nonconformities, and how you dealt with them.

If you’ve done something to correct the nonconformity, you must re-verify that the item meets your requirements.

For example, let’s say you’re making aircraft windows that go through a polishing process, then are visually inspected to make sure there are no defects such as scratches or hazy spots. After polishing, one window is accidentally dropped and scratched. This defective (or nonconforming) window must immediately be segregated from good production, to prevent it from being shipped to the customer. At some point (perhaps immediately) the defective window will be examined to determine if it can be reworked or if it must be destroyed.

There must be an authorized person (or persons) who will inspect the defective window and decide if it can be reworked, or must be scrapped. If the decision is to rework it, once the unit has been repaired it must go through an inspection process to determine (and document) that the unit meets your requirements.

If the unit can not be repaired, it should be destroyed. Perhaps in this case it could be melted down to make a new unit.

No matter how you resolve the nonconformity, you must keep records of each nonconformity and how you resolved it. Records of product nonconformity should be periodically reviewed to determine if you have a chronic problem with your production process. ISO9001:2000, after all, is about “continuous improvement”. By keeping records of your nonconformities it is easier to spot negative trends, examine the root cause, and eliminate the cause of your problems. This, in turn, should result in fewer defective products, happier customers, increased sales, a happier boss, and a nice healthy pay raise during your next review!

We can dream, can’t we?

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