Control of Nonconforming Product

Clause 8.3.  Your company ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.  The controls and related responsibilities and authorities for dealing with nonconforming product (and of course, or service) are defined in a documented procedure.

Yep, it is one of the mandatory requirements for a procedure and a good one too.  It is so important that you have this clause under control, to have this process under control.  The standard is quite prescriptive as to what you have to do.  You must do one or more of the following; take action to eliminate the detected nonconformity; authorise its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; and lastly, take action to preclude its original intended use or application.

A nice hierarchy of control.  Eliminate the problem, accept the problem or stop the problem by either of the first two. Once you have done this, you need to demonstrate via appropriate records that anything that you have done, has been done as per the procedure.  Full stop.  The standard goes on to say that if you fix a problem, then the ‘fixed’ product or service is again tested and verified to the requirements and of course, all the while keeping records to show it now confirms.

The quirkiest part of this clause is to describe what you have to do if the problem is detected after delivery or use has started.  You need to define what you do with the ‘knock on’ ramifications of the problem.  Do you recall?  Do you compensate, replace, credit, etc.  How far back do you go.  When do you deem remaining stock is OK.  This is a very large ‘piece of string’ scenario and can only be truly reviewed and controlled by thoughtful risk assessment, management and mitigation.  For high risk industries, such as automotive, this is often described in legislation, codes, best practices.  For the rest of us, listen to your customers and develop policy and process from their feedback.

Because of the importance of this clause I like to keep this procedure a separate procedure just to make sure that you are giving the importance to each of the aspects of this clause.  This does not mean you cannot merge this procedure with others, such as corrective action, just make sure that you address every aspect, even if not applicable to your company.