Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPS team, 

Most of questions in my current Supplier Quality Audit Template as per ISO 9001 and 13485 clause and when I go to perform audit to my suppliers I usually struggle to get all required details mentioned on the form.

And some suppliers even do not have ISO certificates and thus to audit them is bit challenging. 

Some suppliers do argue, as long as we are providing parts as per specifications, why you're checking other process which are not applicable to you.
Let's say, when I go to perform audit, suppliers are doing operations on other suppliers parts. 
And I wanna see processes as per clauses but even they are doing incorrectly I cannot raise NC as they say, these parts are not your so why you worry.

Does any body have supplier quality audit template which covers all above situations?

Would highly appreciate your valuable feedback.

Thanks

Good morning, Anonymous.

Unfortunately, I do not have a medical device supplier audit template to offer you. But I do have the attached white paper which outlines quality requirements you are expected to assess for your suppliers. I also have some suggestions for responding to your suppliers.

"Some suppliers do argue, as long as we are providing parts as per specifications, why you're checking other process which are not applicable to you." I would respond to this by saying that a supplier's attitude toward quality should not be customer- or part-specific, and the FDA requires an assessment of a supplier's Quality Management System, not just of the parts we are purchasing.

Additionally, since you likely give advance notice of your audits, it sounds to me like the supplier may be putting on a show for the audit and will revert to the other practices you observed when you are gone. I would strongly suggest you look for alternative suppliers and begin implementing rigorous Quality Agreements with every one of your suppliers, current and future. Quality Agreements are a regulatory requirement (820.50), so if a supplier rejects the idea you are well within your rights to take your business elsewhere.

Your company is ultimately responsible for all outsourced materials and activities, regardless of the difficulty of dealing with those suppliers. Anything negative detected by regulators at a supplier you engage can have a very direct impact on your company. 

Best of luck,

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC
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Original Message:
Sent: 17-Apr-2024 19:11
From: Anonymous Member
Subject: Supplier Quality Audit Template

This message was posted by a user wishing to remain anonymous

Hello RAPS team, 

Most of questions in my current Supplier Quality Audit Template as per ISO 9001 and 13485 clause and when I go to perform audit to my suppliers I usually struggle to get all required details mentioned on the form.

And some suppliers even do not have ISO certificates and thus to audit them is bit challenging. 

Some suppliers do argue, as long as we are providing parts as per specifications, why you're checking other process which are not applicable to you.
Let's say, when I go to perform audit, suppliers are doing operations on other suppliers parts. 
And I wanna see processes as per clauses but even they are doing incorrectly I cannot raise NC as they say, these parts are not your so why you worry.

Does any body have supplier quality audit template which covers all above situations?

Would highly appreciate your valuable feedback.

Thanks

First, you need to determine why you are auditing suppliers. Does a QMS audit add value and help ensure conforming parts? In most cases the answer is no.

Suppliers fall into two categories those that have QMS to a standard with a third party certificate and those that do not.

If the supplier has a third certificate, then your audit is just duplicating the third party audit and unnecessarily expending resources. A better strategy is to get the third-party audit reports in place of conducting a second party audit. You and your supplier will come out ahead.

If your supplier doesn't have a third party certificate, then your company didn't require it before selecting the supplier. You should not be auditing a supplier to a standard they are not obligated to meet. Again it is bad utilization of resources.

If you want to audit the supplier's production of your parts then you need to schedule a process audit or product audit when your parts are running, not a QMS audit.

The argument that the supplier provides conforming product is cogent. If this is the case, then what is the value of the QMS. For example, supposed they missed a scheduled Management Review but, in spite of this, still ship good parts.

Rather than an audit template, I recommend that you rethink the reason you are conducting the audits.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 17-Apr-2024 19:11
From: Anonymous Member
Subject: Supplier Quality Audit Template

This message was posted by a user wishing to remain anonymous

Hello RAPS team, 

Most of questions in my current Supplier Quality Audit Template as per ISO 9001 and 13485 clause and when I go to perform audit to my suppliers I usually struggle to get all required details mentioned on the form.

And some suppliers even do not have ISO certificates and thus to audit them is bit challenging. 

Some suppliers do argue, as long as we are providing parts as per specifications, why you're checking other process which are not applicable to you.
Let's say, when I go to perform audit, suppliers are doing operations on other suppliers parts. 
And I wanna see processes as per clauses but even they are doing incorrectly I cannot raise NC as they say, these parts are not your so why you worry.

Does any body have supplier quality audit template which covers all above situations?

Would highly appreciate your valuable feedback.

Thanks