Examples of Quality Objectives for a Medtech start up

#1
Hi, Can someone please suggest quality objectives for a Medtech start up. We have outsourced product development to a supplier and are planning to do the same for manufacturing too. Some examples of quality objectives will be really helpful.
 
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shimonv

Trusted Information Resource
#2
Quality objectives for startups is a difficult thing. One example for development quality objective would be to complete the product development or design freeze on schedule. With regards to manufacturing, a quality objective could be production yield of 95%.
 

Philip B

Involved In Discussions
#3
The only way I got my head around quality objectives is to understand that they should be linked to policy statements. Most policies contain motherhood and apple pie statements, the way to put some meat on those bones is to have measurable objectives. So start with your policy and see how you can create meaningful objectives from what you have said there.
 
#4
Depends on your company and specifically what field you are in. Some examples could be:
  • Improving patient outcomes for a certain disease (a rather high-level goal)
  • Shipping a product with features x, y, z by a certain date
  • Publishing scientific papers or filing patents
  • Achieving a certain accuracy if you're developing machine learning - based software
 

Enternationalist

Involved In Discussions
#5
Here are the mandatory aspects of what a quality objective is:
  • You need some to help you meet reg. requirements and product requirements (5.4.1, 7.1)
  • They need to be at appropriate functions and levels (5.4.1)
  • They need to be measurable and consistent with your policy (5.4.1)
  • They get reviewed at management review (5.6.1)
  • Personnel must be aware of how they contribute to them (6.2)
  • They must must be documented in statement(s) (4.2.1)
  • There must be sufficient planning to meet them (5.4.2)
At a fundamental level, therefore, each of these should be some measurable metric. I recommend you make these not one-off metrics if you can - try to make them something that you can measure and compare over a period of time - even a subjective rating is a suitable metric.

At minimum you will want to target regulatory requirements and product requirements. Things like the number of non-conformances in audit might be a reasonable objective. It's OK for objectives to be small and in different places. Try to establish metrics that reward improvement but that don't hold you to an arbitrary line (e.g., an objective to "improve" a number rather than to get some absolute amount).
 
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