How do I show the benefits of a QMS to the Design Team?

JoCam

Trusted Information Resource
#1
Hi All,

I work for a Medical Device Company in the final stages of designing our first product. I have implemented a Quality Management System to ISO 13485, which is biased towards our upcoming manufacturing, distribution and Customer feedback processes due to 2 reasons. Firstly, the Research & Development team were far too busy to change their processes and document tasks accordingly, and secondly I am by no means a design expert, and only went so far as ensuring all relevant top level documents are in place. The result was successful, as we received certification back last June.

Although quite a few Employees utilise the QMS, a vast majority (mainly the design team) avoid it like the plague, and it has recently dawned on me that this may be due to the fact that they cannot see how it benefits them. This is where I need your help: -

What areas of the Design function can I concentrate on (and how) that doesn't produce too much additional paperwork or slow the process down, but does provide visible benefits of the QMS to the design team?

Areas that are already effectively controlled via the QMS, with input from the design engineers, are drawings, specifications and design changes.

Thank you in advance, your ideas will be very much appreciated.

Jo
 
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Sidney Vianna

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Admin
#2
I attempted to answer a similar question, albeit related to ISO 9001, in this post.

If you do a search here, you will find a number of threads around this subject. The product design/engineering function is one of the most critical pieces of a QMS. Unfortunately they are one of the functions that resist the most having established processes. Most of the time, due to misinformation.
 
M

MIREGMGR

#3
Heh. A medical device company getting through a certification audit without the auditor recognizing that your engineering department isn't integrated with your quality system, either reflects poorly on the competence of your NB or indicates that you did a lot of after-the-fact documentation creation.

Assuming that your Engineering Manager works for senior management, it also indicates that your senior management doesn't understand the relationship between being in the medical device business and mandatory quality system integration.

My suggestion would be that your educational efforts are better aimed at senior management. Getting them up to speed is more important, and once they're there, the Engineering Manager is likely to be more motivated to get on board.
 

yodon

Leader
Super Moderator
#4
Why does the design team avoid it? If you have your cert but your design team isn't really following the procedure, your success is likely short-lived.

I would recommend you sit down with the design team (maybe even 1-on-1, informally) and find out their reasons. A good QMS will be just documenting what is done as a natural course of the business. And a sustainable business really needs to include the aspects covered by the standard.

If your QMS is considered stricltly unnecessary overhead then you'll indeed have a hard time convincing anyone of the benefits. Without intending to get all zen on you, look first within (the QMS). Make sure it's NOT adding unnecessary overhead. Developers tend to do all these things so maybe there's just a disconnect.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#5
Typically, standards like ISO don't ask for much that other accrediting bodies ask for. So if your group functions well to a QMS written to comply with a standard like 13485 and you intend to sell your products to the U.S., you can hope to avoid FDA warning letters like this one. Being on the FDA's ugly baby list isn't any more desirable than being on another regulator's ugly baby list. Dealing with that is arguably more hassle than doing what they wanted the first time through.

But it's been rightly pointed out that your people should be consulted for what kind of methods they would be most comfortable with. Doing this is certainly like herding cats but it can be a big help. Even if they don't offer input, just asking can sometimes help get cooperation.

In the end, responses to your question may be, as they are in my organization, "Because our customers want it." Boom, that's it; if you want to stay in business you may have to sing the industry tune and establish a functioning QMS.
 

JoCam

Trusted Information Resource
#6
Heh. A medical device company getting through a certification audit without the auditor recognizing that your engineering department isn't integrated with your quality system, either reflects poorly on the competence of your NB or indicates that you did a lot of after-the-fact documentation creation.
The management system is robust enough to meet the requirements of ISO 13485, and as there are procedures and the associated processes in place for contol of specifications, design reviews, drawings and design changes that are being followed, certification was awarded. My problem is with the fact that these processes, that do take some of the design engineers time, are not really showing the department any benefits, other than the fact that they can now easily locate information. I need to hit upon a design function that is widely recognised as being difficult to harness and control, and whip it into shape so that the design engineers are suitably impressed with the management system.

I hope this has clarified my initial request.
 

JoCam

Trusted Information Resource
#7
I feel I've inadvertently slated my own management system, and blamed the design engineers in the process. These guys and gals are extremely professional, and need to see the value in something before buying in. I am pretty much the same as I hate wasting my valuable time, hence the need to seek out the processes that can show benefit here. My experience is mainly in manufacturing, and it is easy to show the benefits of a management system there. However, due to my lack of experience in design I am struggling to establish methods of showing the same benefits in this area.
 
D

DrM2u

#9
I feel I've inadvertently slated my own management system, and blamed the design engineers in the process. These guys and gals are extremely professional, and need to see the value in something before buying in. I am pretty much the same as I hate wasting my valuable time, hence the need to seek out the processes that can show benefit here. My experience is mainly in manufacturing, and it is easy to show the benefits of a management system there. However, due to my lack of experience in design I am struggling to establish methods of showing the same benefits in this area.
If I may suggest, form a team of representatives (or all) from your design group, the department manager and yourself. Let the department manager lead the team (be the captain) and you be the coach. Educate them on why this is important then go over the requirements with them and ask what about they are doing to satisfy the requirements. Let them tell you what they should do and you just evaluate if they comply with the requirements and provide feedback. Provide support (definitions, interpretations, examples and ideas) when asked. Coach them toward compliance instead of pushing it onto them. This way they will take ownership in the process and eventually follow a process defined by themselves with no one else to blame. Just a thought ...
 

Sidney Vianna

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#10
I am struggling to establish methods of showing the same benefits in this area.
Do you have product failures that are traced back to poor design?
Do new products get to market on time, on budget, on quality?
Do you have manufacturability problems because the design package is not adequately reviewed/critiqued?
Do you have a hard time having the technical files reviewed and approved by the Notified Body?
Do your products have to be constantly re-engineered to fix design problems?
Are any of your products denied access to a market for lack of regulatory compliance?
Do you have embedded software in the product which needs constant revisions?
Do users of the product have a hard time following the instructions and/or manual?
Etc.

If none of these problems exist within your organization, chances are, you have a world class, robust engineering function that is working very effectively. And anyone would be hard pressed to improve on that level of performance. Or convince people something needs improving.

But in the real world, these
 
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