Good Acceptance Activity/Inspection flowchart for reference - Wanted Please


Starting to get Involved
I am working on building a procedure for Acceptance activity that requires me to design a flowchart for
1. Receiving Inspection​
2. In process Inspection and​
3. Finished Product Inspection.​

I am having some difficulty envisioning every component of this process together in one frame such as risk analysis, statistical sampling, inspection, correction and release.

It will be a great help for me if I can see a comprehensive flowchart for reference. Its for medical devices, so the procedure needs to be compliant to 21 CFR and 13485.


Quite Involved in Discussions
Rarely have I observed inspections on a single flowchart / process map. Consider identifying the inspection points with respect to other process steps. For example, receiving inspection occurs after receipt of goods. In all cases, your risk management program will help you identify the characteristics to inspect. Your inspections must be defendable from a sampling point that is aligned to your risk management program. When inspections detect issues, that is a trigger for your nonconforming procedures with consideration for escalation to CAPA. The overall process map you may be thinking about is related to 13485:2016 4.2.2 part c that talks about interactions of processes in your QMS. You can include, at a high level, inspections in the map you create for your org. Good luck.
Top Bottom