ISO9001 in 2021 Week by Week - Week 51 - 10-10.2 Nonconformity and corrective action

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!

“10 Improvement

10.1 General

The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.” 

Our previous weeks’ discussions have focused on the core management system, its components and processes and establishing objectives and achieving them.  Now what?  Improvement, of course.

“These shall include:

a)  improving products and services to meet requirements as well as to address future needs and expectations.” 

This is just one example of many where all areas of the organization should be involved in the management system.  Areas such as engineering and sales have many opportunities to address (such as future needs and expectations), and effectively do address them throughout the year.  But by forgetting to include this in the management system, the work gets done, but the leaders of the management system may forget to connect the dots and realize this.

“b)  correcting, preventing or reducing undesired effects;” 

This is a rather significant change from ISO9001:2008 in that corrective and preventive action have been discussed in a different way.  The traditional preventive action is now linked to risk-based thinking.  But, the requirements for improvement include correcting, preventing or reducing undesired effects.

“c)  improving the performance and effectiveness of the quality management system.” 

This is mainly referring to the objectives of the management system and whether or not the organization is meeting them.  Action is expected to continually improve the management system.  But there are also opportunities to improve the effectiveness of the management system such as improving the internal audit process, for example.

“NOTE:  Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.” 

This is a nice clarification because demonstrable continual improvement can sometimes be elusive.  This list provides the user with some examples to help them define their own improvement.  

“10.2  Nonconformity and corrective action

10.2.1  When a nonconformity occurs, including any arising from complaints, the organization shall:

 a)  react to the nonconformity and, as applicable:

1)  take action to control and correct it;

2)  deal with the consequences;”

This is a nice restructuring of the corrective action requirements in my opinion, because it clearly states the allowance that not every single nonconformance necessarily requires a root cause analysis and elaborate investigation and action plan.  Many organizations have struggled with this and have wasted resources maintaining a burdensome corrective action process because they are fully employing all resources to every problem, without consideration of importance, significance or impact.

“b)  evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

1)  reviewing and analysing the nonconformity;

2)  determining the causes of the nonconformity;

3)  determining if similar nonconformities exist, or could potentially occur;”

Following the logic discussed above, the organization should evaluate how far to take each of its corrective action investigations.  This allows the organization to more effectively execute their corrective action process.  If we can weed through the significant issues and dedicate some serious time and resources to them, we can have a meaningful impact on our overall quality.  But if we spend our time running each and every problem through a full root cause analysis, we lose the ability to distinguish between the levels of significance, and also are likely to lose the engagement of the people required to work on corrective actions as well.

“c)  implement any action needed;

d)  review the effectiveness of any corrective action taken;”

These are two distinctly different concepts and, in many cases, this can be the weak link in an effective corrective action process.  Not only must the organization identify a cause and ensure that the prescribed actions are taken, but that the actions actually worked.  Many corrective actions’ closure process includes confirmation that all the action items were completed, but miss the critical step of confirming that the action items actually solved the problem.

“e)  update risks and opportunities determined during planning, if necessary;

f)  make changes to the quality management system, if necessary;”

These two areas take time to evolve within a management system.  These are learnings from our management system – where we are successful and where we fail.  We should learn from our failings and implement changes to our management system so that it can mature and improve.

“Corrective actions shall be appropriate to the effects of the nonconformities encountered.”  This is, of course, self explanatory.

"10.2.2  The organization shall retain documented information as evidence of:

a)  The nature of the nonconformities and any subsequent actions taken

b)  The results of any corrective action"

This gives us the opportunity to simplify our corrective action process by creating prioritized effort toward each nonconformity.  Some will require a “fix and move on”, and others will require more in-depth actions.  Be sure your quality system allows for both types.

THIS WEEK’S HOMEWORK

Have a look (first) at your corrective action system.  (“Continual Improvement” will be addressed next week in our final week of 2021.)

Focus just on corrective action.  A solid nonconformity and corrective action process will:

• Provide a simple method for collecting data on defects. Be sure to consider many sources of defects – customer complaints, returns, internal audit findings, receiving inspection defects, in-process inspection defects, final inspection defects, even process nonconformances related to training failures or lack of employee competence.  And remember, this isn’t to suggest that an elaborate root cause analysis be performed on each one.  Quite the contrary.  A simple collection method, along with proper analysis, guides more targeted and surgical actions by clearly identifying the significant issues that introduce the most risk and need attention.
• Clearly identify negative trends, repeat nonconformity types, trouble areas of performance which should be prioritized for action.
• Provide historical information to prevent “death by 1000 cuts”, meaning seemingly simple defects, which individually are no big deal, can accumulate causing bigger issues. A simple data collection method will more easily reveal when an “isolated incident” is, in fact, NOT isolated but RECURRENT.
• Easily trigger “when to act”, which may be a root cause analysis.
• Provide a simple system of dealing with both simple nonconformities and larger issues.
• Provide more assurance that problems will be solved properly and STAY SOLVED. Poor systems typically show the same problems being “solved” over and over.

And while you’re thinking about your nonconformity and corrective action system, ask the very hard question, “When we know we need to do corrective action or root cause analysis, have we really done a good job at training our people in this area?”  Many organizations’ corrective action systems are fine in terms of tools, technology, data collection and even reporting.  But, they fail in that, though well reported, the actual performance of the system is lacking.  This is often because people are being expected to solve problems without having the necessary:

1. Training
2. Practical experience actually solving problems

If this is a problem area for your organization, connect with us today and we'll help you create a targeted training program.

Want your team to have a better understanding of Problem Solving?  Let us help you curate specialized training including 3 powerful problem solving techniques ("5 Why", "Fishbone" and "Pareto") with a workshop to solve one of your organization's REAL LIFE problems.  OR,

Want your team to have a better handle on risk-based thinking and learn how to break a process down to identify its pitfalls and risk points?  Connect with us today and we'll create a custom training session on FMEA Failure Mode & Effects Analysis.  We'll lead a dynamic, hands-on workshop to teach your team how to perform an FMEA and how that tool can be leveraged to launch powerful lean, Six Sigma and Continuous Improvement.

Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

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. 

Or for targeted, personalized support and coaching, let’s partner together to talk through your issues, learn more about specific tools and applications and enrich your personal development through professional coaching.  Available weekly, monthly or whatever best suits your needs!

We look forward to finishing this YEAR LONG journey with you next week, with more great content to come in 2022.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated. 

And join me on my journey to always keep improving!