Medical Device Manufacturer: Incoming Raw Material Inspection

[hitesh]

Hi,

We are in a process of implementing incoming inspection plan as per ISO 2859-1. In order to implement the sampling plans, we need to determine what AQL values to be used.

We would like to select three AQL values

1. for Critical Characteristics
2. for Major Characteristics
3. for Minor Characteristics

Based on nature of characteristic, engineering can choose AQL value from above three catagory. I would like to know what are the standard or most commonly used AQL values in Medical Device Manufacturing Industry for Class II devices.

Does anyone know if FDA has any guideline for AQL selection for inspection of Class II Medical Equipments or raw material used to manufacture the equipment?

I will appreciate if I can get a quick response from any Cove member.

Regards,

[maxenix]

The standard or most commonly used AQL values range in Medical Device is
0.01-0.1,the exact values of AQL selected depending on your products risk.

[hitesh]

Hi Maxenix,

I appreciate for your feedback. Please let me the AQL values you mentioned are for the final device or incoming raw material inspection. The values seems too low for raw material inspection.

Regards,
Hitesh Sutaria

[maxenix]

In Reply to Parent Post by hitesh

Hi Maxenix,

I appreciate for your feedback. Please let me the AQL values you mentioned are for the final device or incoming raw material inspection. The values seems too low for raw material inspection.

Regards,
Hitesh Sutaria

Hi Hitesh SUtaria,

Sorry for the fault,yes,it is for the final device,about incoming raw materials we use different value for different type materials,use 0.3 for electronic materials, use 0.9 for plastic parts or accessories and other metal parts.

Best regards
Maxenix

[hitesh]

Hi Maxenix,

Please let me whether you are manufacturing Class 1, 2 or 3 medical devices?

Sincerely,
Hitesh Sutaria

[maxenix]

We make class Ⅰand classⅡ MD.