ISO9001 in 2021 Week by Week - Week 32 - 8.3.4 Design and development controls

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!

8.3.4 Design and development controls

Following the theme, there’s not much to debate about in this section, because it is very easy to understand and structured in a sensible way for the organization to understand and implement processes for compliance, and for the criteria to be clearly understood in terms of evaluation criteria.  Last week, we worked through a list of inputs that should be considered as part of the design process.  As part of the consideration of each of these inputs, we should consider what controls are in place to ensure each input is known and controlled in some way.  Let’s get right to it.  The section reads:

“8.3.4 Design and development controls

The organization shall apply controls to the design and development process to ensure that:

a)  the results to be achieved are defined”

This points right back to “inputs” in that the results should clearly be understood before an effective design process can take place.

“b)  reviews are conducted to evaluate the ability of the results of design and development to meet planned arrangement;”

This was defined in the “inputs” phase, but it is listed here again to ensure the proper controls are actually implemented in the design process.

“c)  verification activities are conducted to ensure that the design and development outputs meet the input requirements;”

This is where the standard emphasizes the distinction between “verification” and “validation”. 

“d)  validation activities are conducted to ensure that the resulting products and services are meet the requirements for the specified application or intended use;”

This can be a sticky issue and requires a well-defined and well-disciplined relationship with the customer.  Not only must the specifications be met, but the intent of the product/service as well.  I know I’m not the only one who has experienced a successful launch of a product which completely met specification, but did not perform as intended, meet up with a mating part, match an adjacent component in color/texture, etc until the validation phase.

“e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities;”

It is important that during the verification and validation activities, that any disconnects be fixed – this includes clarification of requirements, tolerances, changes to drawings/specifications, etc – and memorialized in the documentation.  Final drawings, specs, contracts, etc should clearly reflect the final expectations and criteria for the product/services.  Should a change be required, there should be a disciplined change procedure (more on that next week).

“f)  documented information of these activities is retained”

This needn’t be overly cumbersome, but these discoveries, decisions and outcomes should be documented in some way to ensure clarity in the final requirements. 

“NOTE  Design and development reviews, verification and validation have distinct purposes.  They can be conducted separately or in any combination, as is suitable for the products and services of the organization.”

This note is helpful to reinforce the idea that the process needn’t be lengthy or complex, but that review, verification and validation are each unique in their nature and there should be a clear understanding of the differences.  If these points are understood, there may be opportunity to combine some of these activities, as long as the spirit of the requirements isn’t lost.

THIS WEEK’S HOMEWORK

Take a 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 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!

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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
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• 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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