8.7 Control of Nonconforming Outputs [ISO 9001 Procedure]

What is Control of Nonconforming Process Outputs, Products and Services?

Control of Nonconforming Process Outputs, Products, and Services occurs when outputs from the business do not confirm with quality guidelines. These products and outputs must be identified and corrected.

The three basic steps when it comes to controlling nonconformity are identifying the problem or violation, recording it, and taking the appropriate action to put a stop to it.

Contents

Stormtrooper non-conformance

What is a Nonconformity?

The term “nonconformity” within ISO 9001 refers to one or more requirements being broken or ignored within an organization.

What is Non-conformance? - more detail

A Nonconforming Process or Output

From the moment that a nonconforming process or output is noticed within the company, there is a series of steps that must be followed in order to come up with a solution for the issue and prevent it from happening again.

This is where the Control part comes in within the Control of Nonconforming Process Outputs, Products, And Services clause.

3 Steps to Control Nonconformity Process

  1. Identify the nonconformity
  2. Record the nonconformity
  3. Control the nonconformity

The three basic steps when it comes to controlling nonconformity are identifying the problem or violation, recording it, and taking the appropriate action to put a stop to it.

In order to be able to properly deal with the issue that is at hand, the nonconformity must first be identified. This process will include determining which specific ISO 9001 requirement has been broken to move on to the next step of solving the problem.

Non-conformance Action Log Example

Non-Conformance Action Log, or NCR

Recording the nonconformity will be done by filling out a document called a Nonconformity Action Log, or NCR. The NCR should be a very detailed report that clearly states what the violation was and how it can be fixed.

A Nonconformity Action Log is included with our Nonconforming Service Outputs Procedure.

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

While the prompt correction of a nonconformity is needed within any organization, the maintenance of 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 fit into the guidelines and requirements that are outlined by ISO 9001, it is considered to be a nonconforming product or output.

The term product refers to anything that is designed and developed by the organization for purchase and distribution to their customer base. Output, on the other hand, refers to the result of a process that does not fit into the requirements that are outlined by ISO 9001.

In either case, the issue of nonconformity must be quickly identified, corrected, and prevented in the future in order for the operations of the business to 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.

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

Take a look at the list below to find an explanation of the process that goes into handling nonconforming products.

Stormtrooper non-conforming

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.

Following along with these guidelines that have already been put into place, the product that does not conform to the requirements must be immediately identified and separated from the other conforming products.

Upon the removal of the product that does not qualify under ISO 9001 guidelines, the organization will ensure that it does not get 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 it can be released. The release of a nonconforming product can be made under concession by an authorized person. Any release of this kind should be properly documented after it has been completed.

The other details of the nonconformity must also be documented in detail. This should include the exact non-conforming characteristics that were identified, as well as the procedures that were followed in order to get rid of it and prevent it from happening in the future.

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

In the event that a nonconforming product is identified after it has already been distributed or delivered, there will be a separate set of actions that 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 discretion of the company leaders.

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 possibly altered in order to fit the guidelines and be considered a qualifying product.

When any nonconforming product is reprocessed, it must go through a revalidation process by someone of proper authority in order to be approved for release.

‘Nonconforming Service Output’ Vs ‘Nonconformity and Corrective Action' Procedures

The 'Nonconforming Service Output' procedure deals with correcting nonconforming/defective services arising from the operational activities. This procedure only applies to ISO 9001, Clause 8.7.

Whereas, the 'Nonconformity and Corrective Action’ procedure deals with analyzing repeated/high risk non-conformities that might involve repeated product failures, staff not following procedures, or processes not performing, for example; and implementing appropriate corrective action to stop these problems recurring in the future. This procedure applies to ISO 9001, Clause 10.2; ISO 14001 and ISO 45001.

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Updated: 12th May 2022
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Nonconforming Product Outputs Procedure

This procedure is applicable to all nonconforming product outputs. Any corrective action taken to eliminate the cause of nonconformity is appropriate to the magnitude of the problem whilst also being in proportion to the risks presented by the nonconformity.

This procedure applies to all purchased and in-house manufactured materials, components, subassemblies, and finished products.

This procedure focuses satisfying ISO 9001 Clause 8.7 which requires our organization to correct product outputs that fail to conform to specified requirements during manufacture and after distribution.

Forms & Reports also included:

  • Nonconforming Product Outputs Process Turtle Diagram
  • Authority Matrix
  • Nonconforming Product Outputs Process Map
  • Concession Request
  • Concession Request Log
  • Nonconforming Product Report
  • NC & Corrective Action Log

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Nonconforming Service Outputs Procedure

The purpose of this procedure is to establish the process for identifying and documenting service outputs that do not conform to requirements and to ensure they are controlled to prevent reoccurrence.

This procedure also lists the specific steps required for the documentation of service deficiencies, the evaluation of root-causes, and the assignment of specific corrective action as required.

Forms & Reports also included:

  • Nonconforming Service Outputs Process Turtle Diagram
  • Authority Matrix
  • Nonconforming Services Process Map
  • Concession Request
  • Concession Request Log
  • Defective Service Report
  • NC & Corrective Action Log

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