8.7 Control of Nonconforming Outputs [ISO 9001 Procedure]

Non-Conformance Action Log, or NCR

Nonconformity will be recorded by filling out a Nonconformity Action Log, or NCR. The NCR should be a detailed report that clearly states the violation and how it can be fixed.

A Nonconformity Action Log is included with our Defective Services Procedure and Defective Products Procedure.

The control of the nonconformity must include a specific outline of the actions that will be taken to correct it and control it during future business operations.

While prompt correction of a nonconformity is needed within any organization, maintaining this process is key. Without following up on the specific issue after it has been handled, the nonconformity is more likely to happen again, which would defeat the entire purpose of correcting it in the first place.

How To Handle Nonconforming Products and Outputs

When a product or output does not meet the guidelines and requirements outlined by ISO 9001, it is considered to be nonconforming.

Product refers to anything designed and developed by the organization for purchase and distribution to its customer base. Output, on the other hand, refers to the result of a process that does not meet the requirements outlined by ISO 9001.

In either case, the nonconformity issue must be quickly identified, corrected, and prevented in the future so that the business's operations can continue running smoothly.

Since the requirements of ISO must be strictly adhered to in order to maintain the quality standards of a business, any product or service that does not fit into these processes will need to be eliminated.

If a product is not compliant with ISO 9001, it will not be able to be distributed to the business's customers, and it must be stopped quickly before any mistakes of that nature occur.

The list below explains the process for handling nonconforming products.

Handling Nonconforming Products

1. Documented procedure should indicate the plan of action for controlling products
2. Nonconforming product is identified and separated from other conforming products
3. Nonconforming product must be reviewed and approved before release
4. Details of nonconformity must be documented
5. If nonconformity is identified after delivery, separate actions taken
6. Re-processed nonconforming products should be re-validated before release

When it comes to controlling and handling products that do not conform to ISO 9001 guidelines, there is a specific procedure that must be carefully followed to ensure that the wrong product is not given out to consumers.

First and foremost, the organization should already have a documented procedure that indicates the method they will use or plan of action that will be taken in order to control the products in question.

In addition to these guidelines already in place, the product that does not conform to the requirements must be immediately identified and separated from the other conforming products.

Upon removing the product that does not qualify under ISO 9001 guidelines, the organization will ensure that it is not mixed up with the quality products that are on their way to be distributed to the masses.

Once the product has been effectively identified and removed from the others, it must be properly reviewed and approved before release. An authorized person can release a nonconforming product under concession. Any release of this kind should be properly documented after completion.

The other details of the nonconformity must also be documented in detail. This should include the exact nonconforming characteristics that were identified, as well as the procedures that were followed to eliminate them and prevent them from happening again.

The documentation of the nonconforming product should help all company personnel understand the nature of the event, why the product did not conform to the specified standards, and what was done to eliminate the issue.

If a nonconforming product is identified after it has already been distributed or delivered, a separate set of actions must be taken to solve the problem at hand. These actions will depend on the severity of the nonconformity and will be determined by the company leaders at their discretion.

When a nonconforming product has been identified and a plan of action has been established to solve the problem, it can either be permanently removed or altered to fit the guidelines and be considered a qualifying product.

When any nonconforming product is reprocessed, it must undergo a revalidation process by someone of proper authority before being approved for release.

Nonconforming Service Output Procedure

The Nonconforming Service Output Procedure deals with correcting nonconforming/defective services arising from operational activities.

This procedure only applies to ISO 9001, Clause 8.7.

Nonconformity & Corrective Action Procedure

The Nonconformity and Corrective Action Procedure analyzes repeated/high-risk nonconformities that might involve repeated product failures (e.g., staff not following procedures, or processes not performing) and implements appropriate corrective action to prevent these problems from recurring in the future.

This procedure applies to ISO 9001, Clause 10.2.