Purchasing Controls for a manufacturer of a low risk class II device

[kaitlyndc]

Hi all,

I am currently working on a procedure for the qualification of suppliers. We are the manufacturer of a low risk class II device that is very simple.

FDA 21 CFR 820.50 doesn’t give much guidance as to what type of products/services they are referring to that require documented purchasing controls. Do I need documented purchasing controls for off-the-shelf items we are buying from Uline? For example, we purchase small 3x5 poly bags from them that are used to hold accessories in our finished device.

Initially I was going about the entire procedure only recognizing suppliers that provide products/services that may directly impact the safety and performance of the device, but now I’m having a hard time drawing the line.

 

[Mazza]

We operate a tiered approach and classify suppliers as critical/key/non-critical/service.
Critical have a direct impact on product quality and would be subject to the highest level of control - quality/technical agreements, annual audit, mandatory certifications etc
Non-critical (no direct impact on product) might be a Supplier questionnaire, any relevant accreditations, 3 yearly review or something similar.
If you look in the Attachments List, there are some examples of procedures for supplier control & assessment.

 

[Ed Panek]

Use a risk based approach. Thats defendable