Supplier Qualification- Missing Information

[jweaveman1]

Hello All, I work at a medical device manufacturing company and we are trying to get a supplier qualified and we generally ask for our Evaluation form, a copy of their Quality Manual (or at a minimum table of contents as some companies cannot share their manual due to company policy), and and QMS certificates (generally our suppliers are ISO 9001). The issue I'm having is this supplier filled out our evaluation form and indicated that they do have a quality manual; but then they are telling me that they do not have a quality manual. We asked for their procedures on certain policies that we deem critical and appear to not have that information available either. Is there any other way we can get them qualified, short of doing an on-site audit because of their location.

 

[yodon]

Red flags popping up on this one! Do they have a 9001 certification? If so, be sure the certifying body is accredited. There *could* be some misunderstanding about what the "quality manual" is (but I doubt it).

Is there a compelling reason to use this supplier? Do you have a history with them? Are they being recommended? How critical (to safety, etc.) are the products / services they'd provide?

 

[Golfman25]

Hello All, I work at a medical device manufacturing company and we are trying to get a supplier qualified and we generally ask for our Evaluation form, a copy of their Quality Manual (or at a minimum table of contents as some companies cannot share their manual due to company policy), and and QMS certificates (generally our suppliers are ISO 9001). The issue I'm having is this supplier filled out our evaluation form and indicated that they do have a quality manual; but then they are telling me that they do not have a quality manual. We asked for their procedures on certain policies that we deem critical and appear to not have that information available either. Is there any other way we can get them qualified, short of doing an on-site audit because of their location.

Try an online "audit." Sounds like there might be miscommunication. Do they have an ISO 9001 cert? Have a conversation about those areas you have a concern. Ask them how they do this? How they do that? And see if they comply with whatever standard you need them to comply to.

 

[Sidney Vianna]

The issue I'm having is this supplier filled out our evaluation form and indicated that they do have a quality manual; but then they are telling me that they do not have a quality manual.

You mentioned being potentially happy with a table of contents. 9001 does not mandate a manual. Supplier evaluation forms and $5 buy you a cup of coffee at Starbucks without change being provided. Many times such evaluation forms are “answered” by someone who has no idea of what they are doing and have been told: check yes on ALL yes/no questions

We asked for their procedures on certain policies that we deem critical and appear to not have that information available either.

The “appear” has to be confirmed before any conclusion. Do they really want the business? Detailed procedures on critical processes might contain sensitive intellectual property and they might be rightfully concerned with sharing such information without an NDA or similar arrangement.

Is there any other way we can get them qualified, short of doing an on-site audit because of their location.

Supplier qualification SHOULD ALWAYS be performed based on the (potential) risks that business relationship will bring in terms of product performance and conformity, business continuity, profitability and brand management. A one size fits all approach to supplier engagement is silly.

 

[Jen Kirley]

Hello All, I work at a medical device manufacturing company and we are trying to get a supplier qualified and we generally ask for our Evaluation form, a copy of their Quality Manual (or at a minimum table of contents as some companies cannot share their manual due to company policy), and and QMS certificates (generally our suppliers are ISO 9001). The issue I'm having is this supplier filled out our evaluation form and indicated that they do have a quality manual; but then they are telling me that they do not have a quality manual. We asked for their procedures on certain policies that we deem critical and appear to not have that information available either. Is there any other way we can get them qualified, short of doing an on-site audit because of their location.

One of the biggest risks of using an evaluation form is it being filled out by someone with wrong or incomplete information. I wonder who that was since you described being told different things on such questions as having a Quality Manual and procedures you deem critical - what are such procedures, by the way?

@Sidney Vianna makes a good point that procedures might have sensitive information in them. It might help if you stick with procedures involves with the product and/or services they provide to you. There is still a chance they will feel their processing methods are a secret - I have a supplier that does - but you should be able to get information regarding things like handling nonconforming product.

If they don't have a procedure for final inspection/test and your product is a critical one, you may want to make a specific inspection/test procedure for them, for this specific product.

@Golfman25 makes a good point that a remote audit could work. If you do this I suggest using phone cameras to livestream views of areas where the processing happens. One needs to be careful with medical devices.

If they can't, or won't do any of this I strongly suggest you have the wrong choice of supplier.

 

[jweaveman1]

Thank you for the responses. This supplier is not 9001 certified. When I asked for procedures they said they do not have them. We are looking at using them because our chief technology officer thinks they have a great product. However, with a lack of procedures we do not think we will be able to qualify them.

 

[ChrisM]

We are looking at using them because our chief technology officer thinks they have a great product.

.... based on what? Personal opinion?
This looks like an ideal case for justifying an in-person visit (or audit) to this proposed new supplier - under "due diligence" if nothing else.

 

[Golfman25]

Thank you for the responses. This supplier is not 9001 certified. When I asked for procedures they said they do not have them. We are looking at using them because our chief technology officer thinks they have a great product. However, with a lack of procedures we do not think we will be able to qualify them.

You may want to explore this further. I guarantee you they have "procedures." They just may not be in a form they can send you -- i.e.; written. Someone, somewhere in their facility knows what they need to do for a certain process.

What procedures to you feel are critical?