Clause 8.7 Control of Non-conforming Outputs (secrets)

Table of Contents

• The Definition Of A Non-Conformance
• How To Deal With A Non-Conformance
• Verification & Correction
• 8.7.2 Documentation Requirements
• For auditors:

Even the best of services, designs and production plans fail from time to time. This clause is focused upon what your organisation does to control any failures before they can affect the customer. Failures can happen during production and can sometimes be corrected quickly and simply before they reach the customer. Failures that occur during or post-service delivery are more serious because they are often closer to the customer. Dealing with non-conforming outputs is very similar to the corrective actions process. The actions you decide to implement will vary according to the severity of the non-conformance. For example, a faulty accelerator pedal that sticks in the down position while driving could have life or death consequences and would result in an immediate product recall. However, a fault in the rubber that houses the top of the accelerator pedal identified during production would not be catastrophic.

The Definition Of A Non-Conformance

There are no set rules for identifying a product or service as being a non-conforming output as the definition will depend upon the design specifications and customer requirements. If during inspection, verification and validation the product or service does not meet design or customer requirements, then you might decide to class it as a non-conforming output. The definition of a non-conforming output might include:

• Release; the final release of products and services would involve verification, validation and inspection processes that compare the product or service to the design specifications and customer requirements. Any failure at this stage could result in you classifying the product or service as non-conforming.
  
  
• Operational context; in manufacturing, you might produce a prototype for test purposes. The prototype and the testing procedures might occur outside of the product’s normal function and so the results would not be included in the non-conformance process. The danger here is one of segregation and identification. You must be sure to make all protypes easily identifiable as such and keep them well separated from the final production products.
  
  
• Risk-based approach; for high-risk products or services, your organisation can apply the non-conformance status at any time during manufacturing or service delivery if the potential consequences of failure are considered to be serious. I suppose this is a reflection of the phrase ‘airing on the side of caution’ and on a practicable level might involve multiple testing, inspecting and verification processes being performed across various stages of manufacturing or service delivery.
  
  

How To Deal With A Non-Conformance

There are many different ways to design a process that deals with non-conforming outputs. ISO 9001:2015 describes the requirements that must be considered from bullet points (a to d):

1. Correction; you might repair or rework the product until it meets the design or customer requirements. This might involve adjustments to machines, changing materials, retraining workers or re-imagining designs etc. In manufacturing, corrections can happen during any stage of the production process and the need for corrections will be identified by your verification and testing processes. In service delivery, corrections might be required based on testing, observations and/or customer feedback. Whether in manufacturing or service industries, this is referred to as iterative design.
   
   
2. Segregation; by using containment of products or through the suspension or cancellation of services, non-conforming outputs should be made clearly identifiable. For physical products, this could be achieved using location to separate faulty products in a different room, cage or part of the factory. Non-conforming products should be clearly identifiable using labels, stickers or tags etc. Non-conforming services can be cancelled or temporarily suspended in clear and confirmed communication with the customer. Notices such as ‘suspension of service’ can be displayed both physically and online.
   
   
3. Customer communication; where you inform the customer regarding the severity of the non-conformance. If the product has not left the factory, then the customer can communicate with you and maybe issue you with a concession if the non-conformance is acceptable to them. If the product has already been delivered and could pose a danger to the user then communication with the customer is essential so that a product recall can be performed quickly. For example, a food product might require a recall due to incorrect labelling etc. A service might need to be stopped immediately due to a faulty batch of parts being used in the service procedure.
   
   
4. Concession; obtaining authorisation by an authorised person for the continued use of a product or service that has been identified as non-conforming. Authorisation must be provided by the customer or by a person acting on behalf of the customer. For example, the delivery of goods is going to be delayed due to unforeseen bad weather conditions. When communicating with the customer, a concession was agreed that the goods were still required, even with a 2-day late delivery. Another example might be that you have agreed to manufacture an amount of product, but you can only deliver 70% of the agreed amount on the expected due date. The customer has granted you a concession to deliver the remaining 30% at a later date.
   
   

Verification & Correction

When a non-conforming product or service has been identified, it should be corrected and verified against the design or customer requirements without delay. For the service industry, detection of the non-conformance might occur during the service delivery or soon after the service has been performed. A correction might involve performing the service again, correcting the parts of the service that caused the non-conformance and/or providing the customer with compensation or the reward of a free, future service. I recently had my windows cleaned, but upon inspection, I found that one window had been missed completely and other windows had dried water stains running down them. After complaining, it transpired that a new employee had performed the cleaning. That same day, my windows were cleaned again and I was given a free clean on the next occasion.

If the cleaning company were subscribed to ISO 9001:2015, then a corrective actions process would occur, corrects would be applied to the process and the lessons learned would contribute to the continual learning process. As mentioned earlier, identifying non-conforming products and classifying them as such can be achieved by using labels, tags, signs, bar scanning codes and physical separation. Non-conforming services can be classed as such by recording comments onto worksheets, customer sign-off sheets or electronic input devices such as an IPad or a web page. A customer complaint might be used to identify a non-conformance such as my window cleaning example.

8.7.2 Documentation Requirements

The intent of this clause is to focus on the required documentation for recording non-conforming outputs. You are required to retain documented information that describes:

1. The nature of the non-conformance; did the product match the design criteria, or upon inspection, was it the wrong size? Did the garage mechanic who performed your annual car service use the correct oil filter or was it a cheap substitute? Try to describe the nature of the non-conformance in as few words as possible. By doing this you will minimise the possibility of the description being misinterpreted. Is the non-conformance against a requirement of the ISO 9001:2015 standard or one of your internal requirements? If it’s against a clause requirement, be sure to name the clause and provide a brief description of the clause requirement.
   
   
2. Corrective actions; what actions did you take to correct the non-conformance? Were the actions temporary or permanent? Who performed the corrections and were they authorised to do so? Has anyone reviewed the corrective actions for effectiveness? Did the results of the corrective action become a permanent change that was written into a process and result in the management system being updated? Has the corrective action been discussed in a management review and has the output contributed to the continual improvement process?
   
   
3. Concessions; were any concessions granted by the customer applied? Who granted the concession and were they correctly authorised to do so? Did you obtain written information regarding the concession from the customer?
   
   
4. Authority; this describes the authority of the person who decides and implements any corrective actions that are necessary to correct the non-conformance. This is something that should be decided early and written into the process that controls non-conforming outputs. The authority should be clearly defined and communicated as part of the process training. I once got into hot water regarding this issue. I was working as a training manager and was using a form to record testing and verification data. I thought the form could be improved and so I made some changes to it. Little did I realise that the form was meeting certain legal requirements. My changes were in breach of some of these requirements and I was spoken to quite firmly as a result of this.
   
   

Maintaining and retaining documented information related to non-conforming outputs can be quite useful for use in the continual improvement process. It might also reveal trends over time that can be used to produce data for statistical analysis. This type of retained information can also indicate the need for training requirements, process reviews, changes in technology and communication strategies with the customer.

For auditors:

• Check for the existence of a process for dealing with non-conformances.
• Check for roles, responsibilities and authorities in relation to the process.
• Check for retained information that describes the; nature of the NC, actions taken, any concessions obtained and the authority of persons performing the corrective action.
• Investigate a recorded NC output through to communication with the customer (if applicable), the corrective action, management review and the continual improvement process.
  
  

Other questions that I will answer in future articles:

• What is control of nonconforming outputs?
• What is the meaning of non-conforming?
• How do you determine non conformity?
• What is non-conformance example?
• What is non-conforming equipment?