R&D Product Development Management

J

JodiB

#1
Good morning! I've come out from under my rock in yet another mutation: this time I'm the process owner for R&D's product development. I guess this brings me back closer to quality management, as product design, verification, and validation, are all key components.

I've been doing this for a year now (and apologize for taking so long to come back here), but have had to start from scratch in getting a stage-gate process in place, project/product documentation, establishing process metrics, etc. so we're not too far along. Very surprising considering we're ISO9001 registered, but we won't go there :rolleyes:

There's a bit of resistance to "bureaucracy" within the ranks of the R&D who want to go about playing with their toys and being 'creative' without rigors of accountability, structure, planning, portfolio concerns,......

At any rate, what I'd like to do is tag up with some other folks who deal with product development so we can bounce process and program ideas around. Anyone out there?
 
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Paul Simpson

Trusted Information Resource
#2
Hi, Lucinda. A favourite topic of mine. I have just finished a bit of work on people aspects of ISO 9001 and will post it on the forum shortly. The people issues with the design clauses were as follows:

7.3.1 Design and development planning is not carried out effectively – stages are not clearly identified. Review verification and validation are put in place at inopportune stages.

Responsibilities and authorities are not adequately defined. Interface issues are not addressed. Poor communication between stakeholders of the design process.

Little review of design progress or tracking of issues – updating of plans.

The “ivory tower” approach to design.
7.3.2 Design input mechanistic. Little attempt to understand product and its usage. Focus on features rather than benefits.

Lack of buy in to design inputs from other parties in the organization.
7.3.3 Lack of consideration of the users of the output from design process – what are their needs and how can designers best provide this information.

Acceptance criteria often based on designer “standard” criteria rather than needs of the product / design output.
7.3.4 Design reviews are “bolted on” to the design process rather than key stages of evaluation of product suitability.

Design review participants are not the most appropriate to evaluate suitability.
7.3.5 Lack of understanding of design verification. Inappropriate verification tools chosen. Verification ineffective.

Unwillingness to “interrupt” design process – focus on launch date before quality.
7.3.6 Lack of understanding of design validation. Inadequate understanding of “real world” usage.

Unwillingness to “interrupt” design process – focus on launch date before quality.
7.3.7 Design changes are treated as less important than new designs. Design process cut short for changes.
The solutions bit is a little more vague but is as follows:
Guidance on effective project management and managing knowledge workers.

Provide guidance on identification of project risk

Communications again!

Guidance on design focusing on benefits not features.
As above, effective communication of needs and wants.

Guidance on project management to focus on handover from design to users.
Guidance on control of design.
Guidance on effective reviews by independent parties. Link to plans and inputs vs. outputs.
Guidance on role of design checks in ensuring product meets needs.
Improve communication of needs and wants between customer and the organization – a tricky field in that it looks into the future.

Guidance on effective project management
Provide guidance on identification of project risk for changes
Sorry the clause numbers didn't carry over to the solutions column. Have a look out for tyhe pdf file on the ISO 10018 thread!
 
Last edited:

Stijloor

Staff member
Super Moderator
#3
At any rate, what I'd like to do is tag up with some other folks who deal with product development so we can bounce process and program ideas around. Anyone out there?
Hello Lucinda,

I am not directly involved with product development. However, I looked around and found this. There's some interesting stuff about this topic.

Stijloor.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Good morning! I've come out from under my rock in yet another mutation: this time I'm the process owner for R&D's product development.

There's a bit of resistance to "bureaucracy" within the ranks of the R&D who want to go about playing with their toys and being 'creative' without rigors of accountability, structure, planning, portfolio concerns,......
Welcome back, Lucinda. I still work for the same outfit, one of your past competitors, you know ;).

Even though I do not work directly with Research & Development, that is one of my favorite subjects as well, as it relates to a QMS. One of the typical problems is to differentiate pure research from development. Most people tinkering with new concepts and ideas do need some "freedom" to play around and discover the viability and feasibility of new features, gadgets, etc. However, the development part of the R&D equation must be structured. As an external auditor, I have interacted with many organizations that experienced significant financial losses for not keeping their product development structured. I have seen, more than once, organizations that bring products into the marketplace with the product significantly under-performing in comparison to the initial design input specifications. Recent cases of drugs being re-called and banned, even though approved by the FDA, following clinical trials show examples of product development validation gone wrong. Some of these cases are measured in the Billions of dollars. Look at the AIRBUS A380 fiasco. Over two years late, hundreds of millions of Euros over budget, all freight version orders cancelled. Make no mistake, a New Product Introduction process is critical. Time to market is essential, but different than Rush to marketÔ. The checks and balances in the process are key.
 
J

JodiB

#6
Thanks for the link! A very nice site. I've been googling and dogpiling and trying to locate material, but mostly hit up on skimpy sites, and have located absolutely no forums like this one to actually exchange dialog.
So it looks like y'all are stuck with me again!
 
J

JodiB

#7
Not to ignore the rest of you!! Thanks to everyone who has responded so far. I find value in everything that has been said so far.
 

harry

Super Moderator
#8
Welcome back Lucinda,

Your problem with 'resistance' among the ranks sounds familiar and parallels those found in the IT industry. Maybe we can learn something from them (the industry). I think 'Project Management' is a popular tool used.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#9
Hello Lucinda,

I sent a note to Marc regarding a gentleman I work with who sent me a link to this "awesome site" he found...the Cove. I got quite a chuckle out of it. I have to agree that this site is still far better than anything I've come across. Actually, I stopped looking long ago as I'm a loyal subscriber to this place and the folks here are thoughtful and helpful!! Welcome back!

Was there anything in particular you wish to start with?

Working in the medical device arena, the attention to Design Control is significantly improved over other industries I've worked in. One thing we've recently done was to unbundle the QMS process from the busines process. In my experience, in an unregulated industry it isn't uncommon to bundle the two together. I'd have to say though that there are pros and cons to either approach. Perhaps a topic worth exploring with the group here.

One thing I've noticed though is that the R&D folk seem to be cut from the same cloth: they are indifferent at best at the idea of a structured approach. Consistent with the folks above, there are areas where a structured approach isn't needed and ultimately areas where it is. Given your audience, it might be wise to create enough "play space" within your documented process to allow for "creativity" to take place. For this reason, you might find it useful to create a parallel system/process that lives outside of the QMS world which provide loose structure but still connects activities to the design effort. I've long promoted this concept and its finally being realized in the business I'm currently with. What is best, the Engineering body has begun to leverage against it giving the idea their endorsement. So far, it appears that folks like the idea and it has improved relationships between groups to everyones advantage.

Regards,

Kevin
 
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