ISO9001 in 2021 Week by Week - Week 34 - 8.3.6 Design and development 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!

8.3.6 Design and development changes

One thing is for certain, change happens!

This week, we’ll look at the final section of 8.3 Design and development of products and services.  8.3.6 Design and development changes.  Along with a very specific and disciplined list of required inputs, controls and outputs, we must always consider the importance of controlling changes to these as we move through the design process.

While the previous sections were wordy and repetitive, (but I think appropriately so), this section uses an economy of words to describe a very important part of the design process – dealing with change.

Change happens, and happens often.  Unfortunately, as we become more and more nimble and innovative, we can sometimes introduce difficulty when we do not adequately manage change.  As important to inputs, controls, and outputs are, any changes to these must be carefully assessed for their potential impact on other characteristics of design.

Change to documents, change to processes, change to procedures, change to policies, change to products and services are almost certainly done with the intent of improvement.  However, improvement is most often successfully achieved when these changes are carefully controlled, communicated and carefully implemented.

The requirements read, “The organization shall identify, review and control changes made during, or subsequent to, the design and development of products or services, to the extent that there is no adverse impact on conformity to requirements.

The organization shall retain documented information on:

a)  Design and development changes;

b)  The results of reviews;

c)  The authorization of the changes;

d)  The actions taken to prevent adverse impacts.

That’s it.  Like I said, it’s very simply stated.  The most important bits of the requirement are “shall review, control and identify changes”.  And remember, there is a requirement for “documented information” as well.  So, the organization must ensure their process includes a definition of how changes are to be reviewed, controlled and identified.

Within the “controlled” requirement, it might have been nice to have included specifically the ideas of containment and transition.  A change may be satisfactorily controlled through the use of revision levels, distribution of information and communication.  But one must also not forget to include a positive containment/recall of product or services when changes are made.

For example, if a product is changed through a tool change, it is critical that any work in process be contained and decisions made about when a permanent transition will be completed.  It is too easy to forget about components up and downstream, which can result in mixing or comingling of different versions of the product or service.  This can actually create a problem short term as it attempts to improve a product long term.

THIS WEEK’S HOMEWORK

Review your design process (and again, remember to consider whether you have more than one “design” process) for the inclusion of the control of changes.  Be sure the process includes not only how the design documents and infrastructure are controlled, but also how the changed or transitioning products or services are managed as well.  Good luck!

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• A clear understanding of the requirements of ISO9001:2015
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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. 

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