ISO9001:2015 52-Wk Challenge (Wk 44) 8.7 Control of nonconforming outputs

rejected8.7 Control of nonconforming outputs

This week’s topic is one that is very clearly defined and universally applicable.  There is very little subjectivity in the requirements and they are listed in a logical and easy to understand way.

“8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.” Most companies operate with a quarantine area for tangible goods or a positive or confirmed interruption in processing for services or other outputs.  When something isn’t right, there must be a sure way to contain the output until the problem can be corrected.

“The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services.  This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.”  It is clear that if there is to be any quality system at all, taking action when a nonconformity is discovered is bedrock.

“The organization shall deal with nonconforming outputs in one or more of the following ways:

a)  correction;

b)  segregation, containment, return or suspension of provision of products and services;

c)  informing the customer;

d)  obtaining authorization for acceptance under concession.”

These are the simple actions that should be taken when dealing with a nonconformity.  One or all of them may be appropriate to employ.  Moving onto the next thought creates a closed-loop system for dealing with and putting to rest any nonconforming outputs.

“Conformity to the requirements shall be verified when nonconforming outputs are corrected.”  This is such a common breakdown of an effective nonconformity process.  Even when teams are successful at containing an issue and even tracking down the cause, the verification step is often incomplete.  Action items are assigned and completed and the issue is thought to have been solved.  But many times, the problem may reappear immediately, because the action item, however well intended may not actually solve the problem.  This should always be verified.

“8.7.2 The organization shall retain documented information that:

a)  describes the nonconformity;

b)  describes the actions taken;

c)  describes any concessions obtained;

d)  identifies authority deciding the action in respect of the nonconformity.”

Retaining documented information on nonconformities is practical and makes sense, of course.  But it will also come into play later in the requirements for 9 Performance evaluation and 10 Improvement.  Most organizations retain a database of some sort which contains much more than the requirements listed here, making it easy to maintain, easy to extract information and trends, and finally, very easy to audit from a compliance standpoint.


Take a moment to review your system for nonconformances.  Is it complete?  Is it effective in steering improvement efforts?  Do nonconformities recur frequently?  Is there room for improvement of the system (including a robust verification activity)?  A good process for dealing with nonconformities can be extremely valuable to get the real improvement we all look for.  After all, it’s the whole purpose of having a quality system at all – to actually IMPROVE the QUALITY of our output.

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