As soon as nonconformity is detected within the organization, it must be recorded. The ISO 9001 Standard requires that any non conforming product would be identified and controlled. The purpose is to prevent using this product or delivering it to your customers. The process of identifying and controlling shall be documented within a procedure. The documentation of the treatment must include authorities and responsibilities.

• Performing an action in order to eliminate nonconformities that were detected (according to the procedure that was determined).
• The organization shall maintain a documented procedure that describes the process of controlling non conformed products. The documentation of the procedure must be controlled and introduced to the documents control process in the organization as required in paragraph 4.2.3 – control of documents.
• The organization must take action in order to identify and eliminate the use of non conforming products.
• Releasing a non conforming product must be approved by a prior authorized function. The release would be under concession.
• Concession can be made by an authorized person or by the customer.
• The concessions made must be documented as well.
• The organization is required to maintain records that describe the nonconformities detected and the actions that were taken to eliminate them. The records are to be introduced to the records control process as required in paragraph 4.2.4– control of records.
• When a nonconforming product was re-processed, it must be verified again to meet the requirements (customer's or regulatory).
• When nonconformity is detected after delivering the product, actions must be taken relevant to the nature of the nonconformities.  

• Customer's requirements
• Regulatory requirements
• Intended use requirements

• Identifying the nonconforming product in order to eliminate the use or delivery of this product
• Separating the nonconforming product form the other conforming products.

The requirement includes both products that were detected in house and products that were already delivered to the customer. This paragraph relates to nonconforming products and not general non conformances.

THE PROCEDURE

The ISO 9001 Standard requires defining and maintaining a documented procedure to describe precisely how a nonconforming product or any other component of the product shall be handled when one is detected. This procedure is one of the obligatory quality procedures. The process shall include the steps while handling a nonconforming product. Of course, as any other required procedure, the process of controlling nonconforming product shall be controlled under the documents control process within the organization.  In other words, this process is under the quality management system, required to be controlled and would appear on the list of the controlled procedures in your quality manual guide.   

RESPONSIBILITIES AND AUTHORITIES 

The organization is required to determine the authorities and responsible parties to handle nonconforming products. The definition shall refer to all stages of the process; from the detection of the nonconforming product until the closure of the case. The definition shall be documented on the required procedure mentioned above.

IDENTIFICATION OF NONCONFORMING PRODUCT

The identification shall differentiate nonconforming product from the conforming products in an explicit manner. The identification shall include physic segregation from the conforming products. You may determine a special area or just special shelves for nonconforming products, but they must be apart from the conforming products. When the non - conformed part is a software element, it is possible to relocate the element from the development area or from the test area.  

DETERMINATION OF DISPOSITION 

This requirement refers to the immediate act required to be made regarding the nonconforming product:

• Segregation of the nonconforming product
• Reply to the customer
• Notifications to the relevant parties
• Short term corrective action

What suits your organization is fine by me. But it is required to be defined and documented. Everybody must know what they are required to do when a nonconforming product is detected; service call center, the logistics, salesmen, CEO, production manager, quality manager – everybody who is related and has a part in handling the defected product.

EVALUATION OF THE NONCONFORMANCE 

The purpose of the evaluation is to determine the type of the non conformance and its severity. It is recommended to define the types of non conformances in order to categorize them. Non conformance may appear as:

• a nonconforming product – something tangible  - that the organization provides to its customers and that it does not meet the prior planned requirements.
• a nonconforming process – when there it is not possible to execute or perform according to specific instructions (documented or not).    

The evaluation shall include a reference to whether the nonconformance requires a further investigation of the root cause and notification to the responsible parties. The evaluation shall include which other component in the product could be affected from the occurred non- conformance.

DOCUMENTATION OF THE NONCONFORMING PRODUCT

The record can appear in any form: form, software, e-mail; whatever is appropriate for your organization. But bear in mind that this documentation is the first step for a later corrective action process. Thus, it is recommended to document it where you would be able to trace and document the next steps.

The first level of documentation is primary information gathered about the Nonconformity. By the way, customer's complaints are considered as Nonconformities.

The documentation shall include the records of the problem occurred by the nonconforming product - why does it fail to meet the requirements – and the affect the problem on other components of the product.

I recommend you to document any characteristic of the product (or the service) where you detected the Nonconformity. Why? Because when you can examine all the characteristic of the product, you would be able to understand the Nonconformity better, you would be able to understand the cause, and far more important, to may come up with an efficient corrective action later on.

The Nonconformity record – which details are to be documented:

• The Nonconformity details – you are required to document any identifying details regarding the Nonconformity: customer's name, product's name, catalogue number, name of the employee that detected the Nonconformity – any information that would help you to investigate the Nonconformity latter on.
• Description of the Nonconformity – you can put here a literal description or even attach another document. Whatever suits your organization.
• Categorization of the Nonconformity – it is not required by the ISO 9001 Standard but it is highly recommended. The categorization would assist you later with a statistical analysis.
• Investigation Details – any Nonconformity must be followed with an investigation. The purpose of the investigation is to identify the root cause for the Nonconformity. This is the essence of the corrective action.
• The organization is required to document the responsible party for the nonconforming product in order to maintain supervision that a solution is being implemented.  
• Documentation regarding status of the product is required as well:
  • Repair or rework
  • Acceptance or rejection
  • Corrective action required – the product must be submitted to the corrective action process.

Records of nonconforming products must be kept and included under the records control procedure (the famous 4.2.4). In other words, include the documentation of the nonconforming product under your records control process.

SUMMARY

• As soon as nonconformity is detected within the organization, it must be recorded. The purpose is to prevent using this product or delivering it to your customers.
• A Nonconforming product: a product that does not conform to its specified requirements: Customer's requirements, Regulatory requirements, Intended use requirements.
• The main idea of controlling a nonconforming product is to separate it from the other conform products.
• The ISO 9001 Standard requires defining and maintaining a documented procedure to describing how a nonconforming product or is detected.
• The organization is required to determine the authorities and responsible parties to handle nonconforming products.
• The identification shall differentiate nonconforming product from the conforming products in an explicit manner.
• Evaluation of the nonconformance is required to determine the type of the non conformance and its severity.
• Records of nonconforming products must be kept and included under the records control procedure (the famous 4.2.4).

• Performing an action in order to eliminate nonconformities that were detected (according to the procedure that was determined).
• The organization shall maintain a documented procedure that describes the process of controlling non conformed products. The documentation of the procedure must be controlled and introduced to the documents control process in the organization as required in paragraph 4.2.3 – control of documents.
• The organization must take action in order to identify and eliminate the use of non conforming products.
• Releasing a non conforming product must be approved by a prior authorized function. The release would be under concession.
• Concession can be made by an authorized person or by the customer.
• The concessions made must be documented as well.
• The organization is required to maintain records that describe the nonconformities detected and the actions that were taken to eliminate them. The records are to be introduced to the records control process as required in paragraph 4.2.4– control of records.
• When a nonconforming product was re-processed, it must be verified again to meet the requirements (customer's or regulatory).
• When nonconformity is detected after delivering the product, actions must be taken relevant to the nature of the nonconformities.  

• Customer's requirements
• Regulatory requirements
• Intended use requirements

• Identifying the nonconforming product in order to eliminate the use or delivery of this product
• Separating the nonconforming product form the other conforming products.

The requirement includes both products that were detected in house and products that were already delivered to the customer. This paragraph relates to nonconforming products and not general non conformances.

THE PROCEDURE

The ISO 9001 Standard requires defining and maintaining a documented procedure to describe precisely how a nonconforming product or any other component of the product shall be handled when one is detected. This procedure is one of the obligatory quality procedures. The process shall include the steps while handling a nonconforming product. Of course, as any other required procedure, the process of controlling nonconforming product shall be controlled under the documents control process within the organization.  In other words, this process is under the quality management system, required to be controlled and would appear on the list of the controlled procedures in your quality manual guide.   

RESPONSIBILITIES AND AUTHORITIES 

The organization is required to determine the authorities and responsible parties to handle nonconforming products. The definition shall refer to all stages of the process; from the detection of the nonconforming product until the closure of the case. The definition shall be documented on the required procedure mentioned above.

IDENTIFICATION OF NONCONFORMING PRODUCT

The identification shall differentiate nonconforming product from the conforming products in an explicit manner. The identification shall include physic segregation from the conforming products. You may determine a special area or just special shelves for nonconforming products, but they must be apart from the conforming products. When the non - conformed part is a software element, it is possible to relocate the element from the development area or from the test area.  

DETERMINATION OF DISPOSITION 

This requirement refers to the immediate act required to be made regarding the nonconforming product:

• Segregation of the nonconforming product
• Reply to the customer
• Notifications to the relevant parties
• Short term corrective action

What suits your organization is fine by me. But it is required to be defined and documented. Everybody must know what they are required to do when a nonconforming product is detected; service call center, the logistics, salesmen, CEO, production manager, quality manager – everybody who is related and has a part in handling the defected product.

EVALUATION OF THE NONCONFORMANCE 

The purpose of the evaluation is to determine the type of the non conformance and its severity. It is recommended to define the types of non conformances in order to categorize them. Non conformance may appear as:

• a nonconforming product – something tangible  - that the organization provides to its customers and that it does not meet the prior planned requirements.
• a nonconforming process – when there it is not possible to execute or perform according to specific instructions (documented or not).    

The evaluation shall include a reference to whether the nonconformance requires a further investigation of the root cause and notification to the responsible parties. The evaluation shall include which other component in the product could be affected from the occurred non- conformance.

DOCUMENTATION OF THE NONCONFORMING PRODUCT

The record can appear in any form: form, software, e-mail; whatever is appropriate for your organization. But bear in mind that this documentation is the first step for a later corrective action process. Thus, it is recommended to document it where you would be able to trace and document the next steps.

The first level of documentation is primary information gathered about the Nonconformity. By the way, customer's complaints are considered as Nonconformities.

The documentation shall include the records of the problem occurred by the nonconforming product - why does it fail to meet the requirements – and the affect the problem on other components of the product.

I recommend you to document any characteristic of the product (or the service) where you detected the Nonconformity. Why? Because when you can examine all the characteristic of the product, you would be able to understand the Nonconformity better, you would be able to understand the cause, and far more important, to may come up with an efficient corrective action later on.

The Nonconformity record – which details are to be documented:

• The Nonconformity details – you are required to document any identifying details regarding the Nonconformity: customer's name, product's name, catalogue number, name of the employee that detected the Nonconformity – any information that would help you to investigate the Nonconformity latter on.
• Description of the Nonconformity – you can put here a literal description or even attach another document. Whatever suits your organization.
• Categorization of the Nonconformity – it is not required by the ISO 9001 Standard but it is highly recommended. The categorization would assist you later with a statistical analysis.
• Investigation Details – any Nonconformity must be followed with an investigation. The purpose of the investigation is to identify the root cause for the Nonconformity. This is the essence of the corrective action.
• The organization is required to document the responsible party for the nonconforming product in order to maintain supervision that a solution is being implemented.  
• Documentation regarding status of the product is required as well:
  • Repair or rework
  • Acceptance or rejection
  • Corrective action required – the product must be submitted to the corrective action process.

Records of nonconforming products must be kept and included under the records control procedure (the famous 4.2.4). In other words, include the documentation of the nonconforming product under your records control process.

SUMMARY

• As soon as nonconformity is detected within the organization, it must be recorded. The purpose is to prevent using this product or delivering it to your customers.
• A Nonconforming product: a product that does not conform to its specified requirements: Customer's requirements, Regulatory requirements, Intended use requirements.
• The main idea of controlling a nonconforming product is to separate it from the other conform products.
• The ISO 9001 Standard requires defining and maintaining a documented procedure to describing how a nonconforming product or is detected.
• The organization is required to determine the authorities and responsible parties to handle nonconforming products.
• The identification shall differentiate nonconforming product from the conforming products in an explicit manner.
• Evaluation of the nonconformance is required to determine the type of the non conformance and its severity.
• Records of nonconforming products must be kept and included under the records control procedure (the famous 4.2.4).