Supplier Evaluation Process

[ire88]

Hello,

I would need your help. I am part of the QA dep, and I have been assigned the review of the supplier evaluation process; at the moment, this process is causing us a bit of trouble; for example, we use a very detailed supplier evaluation form to complete for every supplier that we believe could affect the quality of our medical device product or the service we provide. ( I have attached the example of our supplier evaluation form to give you an idea); another issue we have is related to the continuous monitoring of the performance of the suppliers. During a re-certification audit, we got a Non-conformity because it looked like we could not demonstrate that we were conducting continuous monitoring of the suppliers. I wonder how you do that in your company. In my company, we ask for feedback about the suppliers, and if anything goes below our pre-defined expectations, we raise a finding.

In addition, we have to do an annual review of all the critical suppliers and, every three years, a check for all those that are not critical. There are years like this year where we have an incredibly high number of re-evaluations due between Oct and Nov. We don't know how to handle them on time.



I have also attached our procedure to give you a flavour of what we do and see if you have any valuable advice.

 

[Jen Kirley]

Hello ire88, I am sorry for the delay in this response.

This looks like a very well defined yet very complex supplier evaluation process. It is true that we need to be careful for suppliers to medical device manufacturers, but the process either needs to be designed to be manageable or hire enough personnel to keep it up. I have questions:

1. How many suppliers do you have?
2. Why is the review repeated every 3 years?
3. If a supplier maintains certification to a standard by an accredited registrar, could that be suitable for non-critical suppliers?
4. Why do so many reviews come due in the October-November time frame? Isn't there a way to "stagger" them?
5. How does this data get collected? I can imagine it could be very difficult to research things like information breaches.
6. Have you studied how long it takes to do these reviews, including the portions of the review that require more time?
7. Do you have a digitized data collection method for routine criteria such as nonconforming product received and on time delivery? The process needs to be adequately supported or made more easily performed.

 

[ire88]

Hello,

I am really sorry, I didn't see this response.

Here below my comments:


How many suppliers do you have? 160
Why is the review repeated every three years?
According to our internal procedure, non-critical suppliers' re-evaluations are due every three years. ( critical every year, moderately critical every 2)


If a supplier maintains certification to a standard by an accredited registrar, could that be suitable for non-critical suppliers?

I guess this would be enough, it looks like our process ties us up, and we go through a long re-evaluation despite the type of supplier.

Why do so many reviews come due in the October-November time frame? Isn't there a way to "stagger" them?
Three years ago, when this process was born, we qualified many suppliers in that period, and here we come. I guess also this is a historical problem. A couple of years ago, an external auditor raised a non-conformity because one of the supplier re-evaluations was two days overdue. So we have the idea that we must re-evaluate the supplier within the due date.

How does this data get collected? I can imagine it could be tough to research things like information breaches. - We usually send out a list of relevant questions to the suppliers ( most of the delays are because they don't respond)

Have you studied how long it takes to do these reviews, including the portions of the review that require more time? More or less a working day for a dedicated employee.

Do you have a digitized data collection method for routine criteria such as nonconforming prod? No, we don't

thanks for your help

 

[Jen Kirley]

I am seeing a pattern here:

"It is our process."
"That's a schedule based on what happened 3 years ago."
"We send out surveys but they don't respond."

Now I have another question: Why not try something different?

1) Collect data about things you care about:

• Quality of goods and services - or, defects
• On-time delivery - or, late deliveries (unless they warn you of delay due to problems)
• Responsiveness - do they answer the phone when you call?

2) Identify which suppliers are not a problem and which need more attention
3) Send the non-critical parts and goods from good suppliers to "Ship-To-Stock"
4) If you are comfortable with it, consider whether they can remain qualified based on independent certification or accreditation.

 

[Zero_yield]

Re: Staggering - I would recommend documenting a range (i.e., +/- 3 months) for your reviews. That way, you can stagger them out through the year and make it easier on yourselves next time.

Procedures exist for a reason. One of those reasons is to be able to change them in a controlled manner. Don't make your process fit the needs of your procedure; make the procedure fit the needs of your process.