ISO9001 in 2021 Week by Week - Week 33 - 8.3.5 Design and development 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!

This week, we finish up clause 8.3 with “8.3.5 Design and development outputs

The organization shall ensure that design and development outputs:

a)  meet the input requirements;”

It’s important to note the cascade effect this section creates as it lists its criteria.  Inputs are defined.  Controls for the inputs are created.  And outputs are evaluated to ensure they meet the original inputs.  A closed loop system including inputs-controls-outputs will ensure this is compliant.

“b)  are adequate for the subsequent processes for the provision of products and services;”

This begins to shed light on a very important part of design and development, and that is feasibility in “real life”.  Many products have been successfully designed and validated, but after a team of engineers completes the process, there is sometimes an awkward handoff of the project to operations and quality personnel who, without intimate involvement in the design process, may have to fumble through setting up a production and control plan.  Having one of the required outputs from design be that the outputs are helpful in the provision of those products/services is a great way to bridge that gap and provide a smooth transition.

“c)  include or reference monitoring and measuring requirements, and acceptance criteria;”

This too is important that the intent of the design be carried through the lifetime of a product/service to ensure the monitoring and measuring requirements support the ongoing suitability of the product/service.  A robust monitoring and measuring plan will ensure the long term viability of the product. 

“d)  specify the characteristics of the products and services that are essential for their intended purposes, and their safe and proper provision. ”

This is more of the same language to ensure that the product or service not only meet the specifications, but that it meets its intended use (and is of course, safe).

“The organization shall retain the documented information resulting from the design and development process.”

This is a clear call for records of all phases of the design process.

We noted a couple of weeks ago, the importance of a design process overall.  Whether the design process apply to a specific product/service, or a provision or realization process, it is important to ensure we tick all the boxes and people work together to not only accomplish their part of the process, but to ensure that as responsibilities are transferred from one area to the next, that the original inputs and intents stay consistent from beginning to end.  I think the language here is clearly written and easily understood and implemented.

THIS WEEK’S HOMEWORK

Take a final look at your design process (being sure to once again consider whether there is more than one process applicable to product/service v process).  Are all inputs-controls-outputs in place and compliant?  Now, look at your records or “documented information” and ensure there is evidence to support the requirements defined here.  Good luck!

If you decide that your Design and Development process needs a reboot, with LIVE or VIRTUAL options,  Connect with us today  and we'll help you build a simple yet robust Design and Development process which will yield consistently successful outcomes.

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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. 

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