Supplier Audit - Supplier of Haemodialysis machines

T

Tiffany

#1
Dear Mates,

I may going to conduct a supplier audit next month where the medical devices is a machine for haemodialysis.

I am wondering what is the important aspect that I should more focus on and whether any supplier audit checklist to be use for during this supplier audit.

What would be the product standards and testing would be applied for this haemodialysis machine?

Thanks.

:magic:
 
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#2
Re: Supplier Audit

Hi, matey.

What is the purpose of the audit? Are you focusing on the systems or the product or the manufacturing process?
 

harry

Super Moderator
#3
..................... I may going to conduct a supplier audit next month where the medical devices is a machine for haemodialysis. ...........................
Since you are to conduct an audit, there must be an objective or purpose.

If your purpose is to be an agent for the supply of these machines in your country, there are a set of things to look through (you don't audit in this case but evaluate) compared to a case where you are going to get some one as a contract manufacturer.

My local service club runs a dialysis center and from the end-user angle, we have some specifics to look at when evaluating new purchases. We look at:
1. technical support - availability of spares, service response time, cost of service and parts.
2. standardization - over the years, we learned the importance of standardization. Old machines were often cannibalized for its parts before being scrapped because up to a certain usage hours, it is not feasible to carry on repairing.
3. we have both formal and informal groupings and we consult each other on the performance of different brands/models. We learn from each other.
4. we are always interested in the overall cost (machine, service, repairs, consumables, system or technology, etc) and not just initial purchase cost.
5. over the years we had some not popular brands (donated to us by well-wishers) and they proved to be problematic and expensive to run.
6. To my knowledge, all machines sold in the country comes with approval from the health ministry.
 
#4
Dear Mates,

I may going to conduct a supplier audit next month where the medical devices is a machine for haemodialysis.

I am wondering what is the important aspect that I should more focus on and whether any supplier audit checklist to be use for during this supplier audit.

What would be the product standards and testing would be applied for this haemodialysis machine?

Thanks.

:magic:
It's good to be asking these questions, but it seems to me that you're potentially headed for a problem. If you have to ask here, does it mean you are unfamiliar with what this supplier does? As has been mentioned, having an objective is most important, however even more important is the competency of the auditor o perform the audit.

Without you being competent, not just in the performance of auditing, you may not perform the audit as well as someone who is more familiar with the product etc. So, it is risky for you and your company. One thing you can do is find someone in your organization who does know the product and applicable regs/standards, have them help you plan the audit or even take them with you!
 
T

Tiffany

#5
Hi mates,

Thanks for the clarification here.

The objectives of the supplier audit is basically on the assembly and manufacturing / application of the machine. As we are purchasing the machine for our haemodialysis centre. I believe no one in my company is familiar with the standard/ requirements applied. Whereas myself is a qualified QMS auditor with the competence in the QMS ISO 13485.

I am looking forward what kinda product testing and product requirements as these machine have to comply to.

Tiff

:read:
 
C

cclee

#6
Based on your described objectives, you intend to perform a process quality audit where the the boundaries/scope are quite focus that covers a potion of the total system, mainly the assembly and manufacturing of the machine.

I assume this is an existing supplier where you have assessed their QMS (systems audit) to verify their capabilities or you are relying on the supplier's third party registration to ensure satisfactory QMS and hence the narrowly focus second party process audit.

Your audit checklist should be based on your stated audit criteria; requirements which the audit evidence will be compared against. The requirements may be either or both:

External (requirements originate from outside the location being audited): ISO standard guidelines, industry standards, local regulatory standards for the device, etc.
Internal (documents that tell how to apply the external requirements to specific process): SOP, work instructions, contracts, specifications, etc.

Hope this helps,
cclee
 
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