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Non-conformance

A non-conformance means that something went wrong and the specifications or requirements (for the product, service, process) were not met.

Tags: non-conformances corrective actions nonconformity issue CAPA

A non-conformance (or 'nonconformity') occurs when something does not meet the specifications or requirements in some way - in a service, a product, a process, goods from a supplier, or in the management system itself. These requirements might be defined by the customer, a regulatory body, or in the internal procedures of the company.

Here are some example non-conformances:

• You need to manufacture steel plates with a hole of size 10mm, but on inspection the hole measures 9mm.
• You supplied product to a customer that was not the colour they ordered.
• As a labour hire company you sent a worker to a client without the correct induction.
• Your consulting office sent a report to a client that is missing a section of work
• Your testing company misplaced some client samples
• A supplier has sent you the wrong product
• Your batch records are missing temperature information and the supervisor's signature
• Sales staff are sending out an old version of a product specification sheet
• You shipped product to a customer but sent it to the wrong address
• Your help desk did not respond to a customer within the 24 hour response time in your service agreement

Even if the problem is quick and easy to fix, it's still a non-conformance and you should still keep a record of it. Otherwise it's easy to miss that the same minor nonconformity has been fixed over and over again.

Any of these example nonconformities could be identified through customer complaints, internal audits, external audits, incoming material inspection, or simply during normal testing and inspection activities.

Corrective Action

Nonconformity is addressed with corrective actions, which are all the things you do to fix the problem. This includes preventing the problem from continuing or getting worse, doing the quick 'patch-up' fix, investigating why it happened, and any changes to the process to fix the problem 'once and for all' so that the same nonconformity does not occur again.

ISO 9001 requirements for Nonconformity and Corrective Action

Nonconformity and Corrective Action are both in the same clause in ISO 9001:2015 (10.2). There's no requirement in the standard for a documented procedure, but you must keep records ("retain documented information") of the nonconformity and what was done to correct it.

You must establish a process (documented or not) for how your organisation will deal with non-conformance and how you will keep records of what happened.

Control of nonconforming output

If you make and/or sell goods, then you also need to work out how to deal with nonconforming product. The highest priority is to stop nonconforming goods reaching the customer or being processed any further, in order to minimise the cost of nonconformance.

In establishing a process for dealing with nonconformity you'll need to decide:

• who has authority to determine what immediate actions will be taken to correct the problem, and what kinds of actions should be taken.
• how reworked items should be checked (if it is different from normal inspection)
• how and where a non-conformance should be recorded
• what steps should be taken to identify any defective product released to a customer
• what, if any, concessions/discounts will be given to the customer
• how a decision will be made on whether further corrective action is necessary

Immediate corrective actions can be seen as 'damage control' and need to:

• stop further non-conformance
• contain the items affected and prevent further processing of defective items- e.g. quarantine
• assess the effects of the problem - how much, how bad, what to do (e.g. scrap / rework),
• notify affected customers, if necessary

Nonconformance process

A basic nonconformance process for a manufacturing company might go something like this:

1. All staff are responsible for reporting a nonconformity to their supervisor.
2. Staff or supervisor must fill out a Nonconformance Report with the details of the non-conformity. **
3. Also add summary details to the NCR register and note the assigned NCR number on the Nonconformance Report Form.**
4. Check any previous production to ensure conformity. Follow recall process if any defective product was released to customers.
5. Move all affected goods to the designated quarantine area and attach a "non-conforming goods" label.
6. Investigate the source of the problem and correct it before resuming production.
7. Supervisor to determine what action should be taken with nonconforming goods - rework, scrap, etc,
8. Supervisor to record decision on the Nonconformance Report Form. **
9. If the scheduled delivery date will be affected, inform the customer
10. Reworked items will be checked as per normal inspection with doubled sampling rates
11. See corrective action for more details on what else needs to happen to address a nonconformity, i.e. actions to investigate and eliminate the root cause(s).
12. All corrective actions to be recorded on the Nonconformance Report Form.**
13. When root cause has been addressed and verification of effectiveness has been completed, manager to review and sign-off NCR as closed on the NCR register. **
14. Manager and supervisor to review the NCR register on a monthly basis and followup outstanding tasks.

All the items marked with ** can be handled in Quality Systems Toolbox software, which eliminates the need for both a NCR/CAPA form and a NCR register because they are built in. The 'Issues' module provides a place to retain documented information on both the non-conformance and the corrective actions taken with the full story in the one place. You only enter the information once, capture all the evidence together with the problem description, there's an easy corrective action process to follow built-in to the software, and Toolbox automatically charts the data for you.

Nothing to figure out. Just start using it.

Have a look in the Quality Systems Toolbox user guide to see how you would report a nonconformance, and what the corrective action process looks like. The same process is used to manage other issues like customer complaints, supplier problems, audit findings, improvement requests, maintenance issues, document change requests, and any number of other issue types you'd like to configure.

If you're stuck with a manual / paper-based system for now, or are just beginning with a small system, save some time and download a Nonconformance Form AND a Register, all ready to go.