ISO9001 in 2021 Week by Week - Week 45 - 8.7 Control of nonconforming outputs

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

8.7 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 requirements go on to suggest multiple ways an organization might take action.  

“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.  So, taking an initial action to contain the problem is done immediately.  Then, further investigation, disposition and final actions are identified.  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 a fairly simple statement, but some companies miss the small point of this requirement.  The idea is to ensure an additional verification be performed after rework or a change in process.  In some cases, companies can skip this step in the interest of expediting a solution.  But, the requirements clearly state that when an alternate path or control plan is deployed, that proper verification also be included in the solution.  

Another common breakdown of an effective nonconformity process is verification of the solutions after root causes have been identified.  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 then closed by virtue of the fact that the action item was completed.  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.  

A typical case in point is when "training" is identified as a root cause.  Often times, "retraining" is assigned as the action item, the retraining is completed (including signoff sheets of attendance), and the issue is considered closed.  Only to have the issue recur because retraining was not, in fact, a robust solution to the issue.  Action items should be verified AND their outcomes should be validated.   

“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.

THIS WEEK’S HOMEWORK

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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Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine had to say about it. 

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