What are ISO 9001 Nonconforming Outputs
Control of nonconforming outputs is one of the mainstay core ISO 9001 clauses (8.7). One of the key aspects of the clause and its requirements is that it interconnects with several other core management system processes such as Nonconformity & Corrective Action, Feedback and Complaints, and Performance Evaluation & Improvement. The fundamental purpose of this clause is to ensure that nonconforming outputs from processes aren’t inadvertently used to produce products or services and delivered to customers.
Nonconforming outputs include any and all products (including services) which fail to meet established specifications and requirements. These may include materials or services received from external providers, work in process within your control, or finished goods including those already delivered to the customer. Also, don’t forget that nonconforming product returned by customers for repair, refurbishment, replacement, or other action should also be controlled under your nonconforming output process. These items are often associated with customer complaints and should be linked to any associated complaint records.
Control of ISO 9001 Nonconforming Outputs
As your nonconforming outputs process is developed and implemented, you need to:
- Establish processes and controls to detect and identify nonconforming outputs (inspection / verification activities),
- Segregate and contain these nonconformities from good outputs (containment),
- Determine what to do with these nonconformities (disposition), and
- Evaluate what happened to prevent recurrence (correction).
Again, we see another application of the risk-based approach as products and services that fail to conform to requirements must be assessed to determine the impact they have or might have on the conformity of products and services, and customers. The actions we take to address nonconforming outputs should be appropriate for the associated impacts and risks.
As you develop your process for controlling nonconforming outputs, consider the following:
When nonconformities are identified, be sure to evaluate all upstream and downstream work to ensure that additional nonconforming outputs are not present or could become present. This might reach as far back as raw materials in inventory, products currently in shipment from external providers to your facility, or even your providers processes.
Looking upstream, are nonconforming outputs present in work in progress, finished goods inventory, or has nonconforming product even shipped to customers? If the possibility that customers have received nonconforming products or services exists, then ISO requires you to communicate and resolve the issue with the affected customers. This might require the recall, rework, refund, and/or replacement of the affected product or services.
All nonconforming outputs should be segregated and clearly identified as nonconforming to prevent inadvertent use. How this is done is up to you. You can use tags, labels, documentation, containers, locations, etc. to communicate that materials or products are nonconforming and prevent their use. Note that some companies even designate a locked cage or room to secure all nonconforming items with access limited to key personnel to prevent inadvertent use.
All instances of nonconforming outputs should be evaluated for the need to complete some type of root cause investigation and corrective action. The first step might be just that of correction to identify the immediate cause of the issue and restore production activities to normal operation. Additional controls might be required, at least on an interim basis, to ensure nonconformities are prevented or identified, until longer term corrective actions can be established. Sometimes the issue is evident and can be corrected immediately without the need for formal investigation and corrective actions. Once the immediate issue is contained and corrected, then determine whether there is a need for a formal investigation and corrective action following your established corrective action process.
So you have identified and segregated some nonconforming outputs. What should you do with all this stuff? In most cases, you can evaluate the nature of the nonconformity and take one of the following actions:
- Use As Is (Concession): Sometimes the nonconforming product or service can be still be used or accepted in its current state, especially if the issues are superficial and don’t effect overall product function or performance. If nonconforming outputs which fail to meet all specifications and requirements are to be delivered to customers, you must inform the customer of the nonconformity and obtain customer approval (concession) for delivery and acceptance of the outputs.
- Return: Nonconforming materials, components, supplies, etc. received from external providers might be returned for repair, replacement, or refund.
- Suspension: This is stopping a process or activity that is producing nonconforming outputs and is usually applicable to services.
- Correction: This is probably the most used action to address nonconforming outputs and involves the rework of outputs to eliminate or remove the nonconformity. Rework activities should be completed using the level of controls and verification applied to normal production work. Where applicable, rework should be completed using approved and controlled processes, procedures, and work instructions. All reworked products or services should be verified to ensure that they meet specifications and requirements, and confirm that the nonconformity no longer exists.
- Scrap: This one isn’t part of the ISO 9001 requirements, but if product can’t be used, returned, reworked, or dispositioned in any other way, the last resort is probably to scrap and dispose of the nonconforming outputs. Ensure that products to be scrapped are done so in a manner that doesn’t allow inadvertent use or incorporation into conforming products or services.
Retained Documented Information
The final clause of this section of the standard (8.7.2) defines the requirements for records to be retained for nonconforming outputs.
- Nonconformity: Clearly describe the nature of the nonconformity and any other pertinent information.
- Actions Taken: Document what actions were used to contain, correct, and disposition identified nonconforming outputs. This should include or reference investigations and corrective actions associated with the issue.
- Concessions: When nonconforming outputs are “used-as-is”, document the state of the outputs as used, including how they fail to meet requirements, along with approval from customers demonstrating acceptance of these products or services under concession.
- Authority: Identify those personnel authorizing the actions taken to address nonconforming outputs.
Implementing a robust process to control and address ISO 9001 nonconforming outputs is crucial to ensure that product or services which don’t meet established specifications or requirements are contained and aren’t mixed with good product or delivered to customers. Once nonconforming outputs are detected, be sure to contain all instances of the nonconformance, appropriately disposition the items, and complete any necessary corrections and corrective actions. Trend analysis from nonconforming outputs should be completed periodically and reported to management, most likely through your management review process.