How to decide what characteristics need to be verified during incoming inspection?

silentmonkey

Starting to get Involved
#1
Hello fellow Covers,

I will start this thread with a high-level question to get the conversation rolling. I understand the decision needs to be based on risk of the part not meeting product requirements, as well as the supplier evaluation, but I have some more specific questions about the logistics of where and how to get the necessary information to feed into this decision-making process.

In general, what is the best practice for documenting and making the decisions on what needs to be verified at incoming inspection?
 
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William55401

Involved In Discussions
#2
Critical Feature Identification (CFI) done in a cross functional manner. Yes, alignment to Risk Mgmt is key. You need design, mfg, and the quality (or other function) responsible for the RI process to identify these features. It is best if the features are coded / flagged on the specs so that the supplier is aware also. Think about critical to safety (user & patient) as well as critical to function. Mfg may have key features important to the process
 

silentmonkey

Starting to get Involved
#3
Critical Feature Identification (CFI) done in a cross functional manner. Yes, alignment to Risk Mgmt is key. You need design, mfg, and the quality (or other function) responsible for the RI process to identify these features. It is best if the features are coded / flagged on the specs so that the supplier is aware also. Think about critical to safety (user & patient) as well as critical to function. Mfg may have key features important to the process
What does this look like on paper? I envision a document very similar to a FMEA where each feature of a part is analysed to determine the effects of each defect which are then somehow rated to determine criticality?
 

yodon

Staff member
Super Moderator
#4
Here's one case that demonstrates the challenges, I think. We developed a system to treat pain with lasers. Everything was working as planned until the diode manufacturer made some changes resulting in less power to deliver the same energy. Part number didn't change and nothing on the labeling changed. Devices started delivering too much energy and causing (luckily only) mild burns. We finally found the change buried in the spec sheet. So, yes, the FMEA provided support but the change drove an update to how incoming inspection reviewed / accepted the parts.
 

William55401

Involved In Discussions
#5
There are many options to getting this on paper. FMEA model is common. Spend thoughtful time aligning your severity definitions (or better yet, adopting) the severity definitions in your existing risk management process. These assigned severity levels will drive your level of assurance (read as sample size) at RI.

Edit: A direct model where Design Outputs (specifications) have the critical features marked as part of design process is simplest.

Edit 2: While RI is important, also think about process control at your supplier. The best material controls leverage what your supplier is doing. RI, for the most part, can be viewed as non value added. Process control at the source will better serve the business. IMHO.
 
Last edited:

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
Do not forget past performance and history. All of what has been offered above is good advice, but focus and frequency of characteristics to be examined at receiving inspection should also be adjusted for history/performance during the device life cycle.

Also, supplier's stability and performance could/should lead to adjustments. How many horror stories do we have about product conformity headaches due to suppliers changing sub-suppliers without customer awareness?
 
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