ISO9001 in 2021 Week by Week - Week 13 – 6.3 Planning of changes

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!

6.3 Planning of changes

Our discussion the past several weeks has been about building infrastructure – “pouring footings” - for the quality management system. We’ve drawn a line in the sand by clearly stating our quality policy.  We’ve declared our objectives and organized our team communicating exactly what our objectives are and our strategy for accomplishing them.  We’ve issued marching orders and orders to report back periodically on their progress toward the objectives.  But, what if we determine there is a need for change to the system?

This area is particularly challenging for many organizations for a number of reasons.  First, change is almost always a gradual process of a system degrading unnoticed until some negative effect is realized.  This is followed by many well-intentioned people offering their ideas for improvement and “throwing darts” at a solution until something begins to work.  This is rarely a planned, controlled or disciplined process and can have unintended consequences or may affect other processes.  So, it is nice to see this addressed directly in ISO9001:2015.

The standard requires that the organization consider:

a) the purpose of the change and its potential consequences

b) the integrity of the quality management system

c) the availability of resources

d) the allocation or reallocation of responsibilities and authorities

Starting with a) the purpose of the change – it is important to consider and decide why a change should happen in the first place, and if implemented, if it will affect other processes.  This requirement strongly supports a “process focus”, which was introduced in ISO9001:2008, and which has been further emphasized in the 2015 draft.

Moving onto b) the integrity of the QMS – again, this simply supports a “process focus” wherein changes must be considered in their interaction with other processes.  A change in one area must not negatively impact another area.  If constructed properly, the system would consider the quality policy, the critical processes identified as well as the objectives of the processes.  If gains in one area create losses in another area, this is unacceptable and an alternative must be found.

Next is c) availability of resources – WOW, I really like this one!  As a “lean” practitioner, I appreciate this consideration.  Too often, “improvements” add layers to a process, rather than simplify it to make it more effective and efficient.  This requirement states that the organization must consider the resources required to support a change and ties it back nicely to 6.2.2 planning how to achieve the quality objectives.  Nice!

And finally, d) the allocation or reallocation of responsibilities and authorities – this reinforces the tie back to 6.2.2 and requires that changes be carefully planned, assigned and executed to ensure their successful implementation.

Another problem with change, overall, is that it just plain difficult to do.  A universal anecdote every organization has is a time they’ve tried to implement a good idea only to have it atrophy and return to the “old way” of doing things, or into something worse than the original process. Change management is its own industry, because it is so challenging, and so many organizations struggle with it.  So, having a system for planning and implementing change in your organization is critical.  The requirements listed here do a fairly good job at defining the minimum components of an effective change management system.

THIS WEEK’S HOMEWORK

Review your change management process.  This does not only include your document change management system, but actual changes to your quality management system.  What happens when a change is needed?  Is it discussed?  How are decisions made?  Is everyone involved (or potentially impacted) in the discussion?  How are changes ultimately communicated?  When a change is made, is there any check/audit and feedback system to confirm the change is fully implemented and achieving its desired result?  If your current system isn’t strong enough or does not address each of the requirements, shore it up with whatever it needs.

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Maybe you're ready for more and ready to dig into your quality system.  ISO9001 certification, lower costs and higher yields are just the beginning of the benefits of a robust quality system.  Connect with us today and LET'S GET STARTED!

How about LIVE or VIRTUAL support on this week's topic "6.2 Planning of Changes",  Connect with us today and we'll create an exciting and engaging experience for your team on:

• Change management in a quality system - We'll facilitate and help your team define a simple system for managing and implementing changes to your quality system.

Or perhaps your organization is more advanced and is ready for some training that will transform your organization and start solving problems and diving deep into identifying and reducing your risks:

• Problem Solving Training - We'll teach your team 3 powerful problem solving techniques ("5 Why", "Fishbone" and "Pareto") with a workshop to solve one of your organization's REAL LIFE problems
• 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

And the options don't stop there.  

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. 

We look forward to taking this YEAR LONG journey with you.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated. 

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