ISO9001 in 2021 Week by Week - Week 31 - 8.3.3 Design and development inputs

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!

8.3.3 Design and development inputs

Many companies rely on their customers for the design of their products and services, and therefore, do not provide design services as they are defined here.  But, while there is no option to “exclude” this clause, there is still the option to address last week’s topic of design planning as it applies to processes.

Regardless, if the organization provides design support for any products or services, or they design realization processes in order to provide products or services, there must be clearly defined processes which address the following requirements:

“The organization shall determine the requirements essential for the specific type of products and services being designed and developed.   The organization shall consider:

a) functional and performance requirements:”

The organization is responsible for determining these “essential” requirements and including them in the design of the product/service.  “Functional and performance requirements” means that designs should also be validated to ensure their suitability.

“b)  information derived from previous similar design and development activities;”

This is an important requirement, and it is also something that many companies consider an opportunity for improvement.  A robust design process should include a consideration of “lessons learned” from previous experience.  And this is an area sometimes also tied to “organizational knowledge” that is often poorly captured, disseminated and managed. 

“c)  applicable statutory and regulatory requirements;”

This requirement explains that while the product/service is being designed and developed, that the customer’s requirements are not the only thing to be considered.  All applicable requirements must be known and addressed during the design and development phases.

“d)  standards or codes of practice that the organization has committed to implement;”

This should clearly be defined in the contract or purchase order so that neither party assumes the other has included them.  There may be assumptions on the customer’s part that applicable standards or codes of practice typical in their industry would be included.  It should be specifically stated and agreed upon.

“e)  potential consequences of failure due to the nature of products and services;”

The standard once again sneaks “risk” into this bullet point.  Potential consequences of failure (or risk) is expected to be known, defined and addressed in the design/development phase.

“Inputs shall be adequate for design and development purposes, complete and unambiguous.”

The gateways referred to above should have specific resolution processes to ensure that development, validation and approval are satisfactorily completed to produce a product/service that meets its intent.

Each of these requirements should be specifically addressed in any defined process for design/development.

“Conflicting design and development inputs shall be resolved.”

This is an important step that should be institutionalized into the formal design process, including documenting the history of those resolutions.

“The organization shall retain documented information on design and development inputs”.

This clearly states that there must be a formal design process, including the inputs listed above (as well as the controls and outputs that will be discussed in the coming weeks).

THIS WEEK’S HOMEWORK

Review your quality management system and how it addresses Design and development.  Whether it applies to recurring actual product design or infrequent process design for product provision, is there a system?  How/where is it described?  Does it clearly include the inputs above?  Are lessons learned captured from your organization's design and development activities?  This is valuable information, both from a design standpoint (continually improving your product capabilities) and from an asset standpoint (knowledge should be continually captured and transferred throughout the organization to reduce the waste of many individuals repeating the same learning curve(s)).

This needn’t be exhaustive or overly complicated, but the spirit of the requirements must be addressed to ensure that when designing products or processes, all the appropriate considerations are made.

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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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