|
Is it just to be trained for the manufacturing step? Yes, and much more.
Whether you are having manufacturing in-house, or using a contract manufacturer or a mixture of methods, WHO makes your product is of paramount importance. Not all things can be automated, and invariably the variance of human performance is one part of production variance (the others being materials, and the environment).
Several factors for consideration:
- The appropriate mix of in-house, and outsourced. Be it engineers, supervisors, test-ers, assemblers.
- Knowledge and experience of the resources. What if the device is really new and no one seem such a thing before? Being able to leverage existing expertise to satisfying the manufacturing need, is truly important. Is there a steep learning curve?
- Availability – can you afford them? Are they available at the times you need?
Are there seniors or product owners that knows the product very well, able to act as trainers? How to assess effectiveness? Mentorship or buddy system? Note that ISO13485 assesses on the competence of the human resources.
Automation can only do so much.
|
