ISO9001 in 2021 Week by Week - Week 30 - 8.3.2 Design and development planning

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!

8.3.2 Design and development planning

When tackling this clause, it is important to clearly identify how and where it is applicable within your organization to avoid confusion.  For example, last week we discussed how many organizations do not actually do any type of design or development of their product/service, but may defer to their customer’s design.  But, we also discussed that while we may not do product design, we do design our processes for our QMS and “product realization” or order fulfillment, and therefore, we do, in fact, have a design process of sorts.

The design process may be the same for both types of design, or they may be quite different.  Designing a process may be (or may have been) a one-time thing when the organization was established.  There may be periodic reviews of the process to look for opportunities for improvement.  And the organization may choose to employ the same process should additional products/services be added to their offerings.  However, design of a process may differ significantly from design of a product/service, and these two ideas should therefore be addressed separately, depending on their complexities.

In any case, the requirements are these:

“In determining the stages and controls for design and development, the organization shall consider:

a)  the nature, duration and complexity of the design and development activities;”

Again, there is no longer an option to “exclude” this requirement, even if the organization does not design its products/services, there is an expectation that some type of design process be defined for design of processes.

“b)  the required process stages, including applicable design and development reviews;”

This may be very simple or complex depending on its applicability (what is being designed).

“c)  the required design and development verification and validation activities;”

This is obviously a very important requirement in design, because every design should be verified and validated.

“d)  the responsibilities and authorities involved in the design and development process;”

This can mean the gateways between the organization and the customer in the approval process.  Or, for simple internal process design, it may simple indicate the process owner(s).

“e)  the internal and external resource needs for the design and development of products and services;”

Where outsourcing is needed for any design or development (including equipment, tooling, fixtures, CAD design, programming, etc), there must be controls implemented on those resources (see also 8.4 Control of externally provided products and services). 

“f)  the need to control interfaces between persons involved in the design and development process;”

This is an important step for larger organizations or for those organizations managing larger customers or supply chains.  The idea is to establish lines of communication and protocols that will prevent competing verbal direction between parties.  Who hasn’t experienced the engineer saying to do one thing, and the ops person or purchasing person giving different direction?  This can complicate the process, therefore the “control of interfaces” is an important consideration. 

“g)  the need for involvement of customers and users in the design and development process; ”

As in any process, responsibilities and interactions should always be clearly defined to ensure the integrity of the process.  Will the customer be involved in any collaboration of design or simply the approval process? 

“h)  the requirements for subsequent provision of products and services;”

Once a design has been completed and validated, this step is about how the products and services will actually be created – (agreed upon) designated materials, methods, process steps, acceptance criteria, control plans, statistical process control and data collection methods, etc.

“i)  the level of control expected for the design and development process by customers and other relevant interested parties;”

This is identifying who does what in the process (including who is involved in the approval gateways and for changes going forward).

“j)  the documented information needed to demonstrate that design and development requirements have been met.”

This is a reference to what type of records will be kept, and it is at the discretion of the organization to define this for themselves (in the absence of regulatory, statutory or customer requirements). 

THIS WEEK’S HOMEWORK

First, take a look at your current QMS structure.  Did your organization previously “exclude” the design clauses?  If so, it’s time to get to work defining a design process that would be applicable to the design of processes within your organization.  It needn’t be complicated, wordy, over-documented or cumbersome.  But it should clearly lay out the steps that you and your organization would determine to be appropriate to your needs.  Be sure to address each of the bulleted items above and you’ll have what you need to ensure your compliance.

If your organization did historically have a formal design process, be sure these requirements are all included.  And also have a look to see whether that design process would apply to the design of processes as well.  Make modifications where necessary.

And finally, do a quick check of your “documented information” to ensure you’re following your system and everything is in order. 

But as always, I will make the reminder not to overcomplicate the process.  A well- designed checklist (or checklists for different types or complexities of designs) or workflow may suffice, provided the instructions at each step are clearly defined.  If the bulleted items are built into the design process, the process will be both robust and compliant. 

Good luck!

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To learn even more about ISO9001, 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:

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