Design Control - Ways of capturing inputs from manufacturing

Chef100

Starting to get Involved
#1
Hi all
In the design control process, I have seen different ways of capturing inputs from manufacturing. When I say inputs I am referring to e.g. an input from manufacturing regarding including a new specification on e.g. a drawing etc.
How do you guys capture this? I have seen models where this is included through the process risk assessment but I have also seen alternative models. How do you capture this in your systems?
 
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Marcelo

Inactive Registered Visitor
#2
Hi all
In the design control process, I have seen different ways of capturing inputs from manufacturing. When I say inputs I am referring to e.g. an input from manufacturing regarding including a new specification on e.g. a drawing etc.
How do you guys capture this? I have seen models where this is included through the process risk assessment but I have also seen alternative models. How do you capture this in your systems?
Hi, a "design control process" does not exist. What you have is a design process, then you would put "controls" in the design process (which is the regulatory name for specific records you need to make in certain stages of the design process).

In the case you mentioned, you usually do not capture design input requirements from manufacturing, because design input requirements must come from user needs (which are derived from voice of the costumer and other related sources). Manufacturing is usually involved on the design solutions (and related design output requirements), not design input requirements. This, in the case of a usual design process.
 

Chef100

Starting to get Involved
#3
Hi
I was not referring to "Design inputs". I am referring to "inputs" as a general thing. So yes, it would be inputs to "Design Outputs". But still, if the production think they need somehow a specification in order to better control the process, it could be that this particular specification isn't needed from a design perspective.
Some of cause does this as a specific "Design for manufacturing" exercise but not all does that. A parallel question could be if your records distinguish between "design specifications" and "process specifications".
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
How do you guys capture this?
In my experience, most of the time, Manufacturing provides input during Design Reviews where manufacturability issues are discussed vis a vis the in-house and contracted manufacturing capabilities. Also during PFMEA, Manufacturing goes over potential production failure modes and ways of avoiding them.
 

Marcelo

Inactive Registered Visitor
#5
Hi
I was not referring to "Design inputs". I am referring to "inputs" as a general thing. So yes, it would be inputs to "Design Outputs". But still, if the production think they need somehow a specification in order to better control the process, it could be that this particular specification isn't needed from a design perspective.
Some of cause does this as a specific "Design for manufacturing" exercise but not all does that. A parallel question could be if your records distinguish between "design specifications" and "process specifications".
Ah ok, sorry, my bad. This case you mentioned is usually captured by an engineering change request or engineering changing order. but from your comments, it seems that you want to identify processes where manufacturer can identify the inputs, right? These really depend on how you set-up your system. for example, the mentioned risk assessments are one way, but you would really need a feedback system for manufacturing info be reviewed, usually by triggers and if the defined triggers do not happen, by a time trigger. This is related (in particular in the medical device field) to post-market surveillance systems (see my post here, for example, when some of the the feedbacks I mentioned are
improvement of product quality and detection of manufacturing problems - http://www.medicaldevice.expert/uncategorized/creating-a-post-market-surveillance-pms-system-for-medical-devices-part-1/).
 

Ronen E

Problem Solver
Staff member
Moderator
#6
ISO 13485:2016, s. 7.3.3 Design and development inputs, says "These inputs shall include: ... e) other requirements essential for design of the product and process."

That's quite open-ended. IMO design inputs should come from all relevant stakeholders. It's the designer's onus to collect and include as many relevant inputs as practical, and personally, as a designer, I always target manufacturing at that stage because I'd hit it sooner or later anyway. Generally speaking, if something is important to the design it is better addressed as soon as practicable because as the design process progresses it becomes more difficult, complicated and costly to introduce changes, and if something is important we'll have to address it anyway.

In some organisations the first round of risk management indeed takes place in parallel with (or prior to) creating the first design input draft, and through this process some input from manufacturing is sometimes gathered, but typically at this early stage the net effect is additional/revised design input requirements.

Later on of course I would encourage manufacturing contribution through design reviews and even hands-on involvement in creating the design itself.
 
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