Evaluation of Medical Device Suppliers - Categories when Initially Evaluated

I

Ironcountry

#1
I'm looking for examples of how medical device suppliers have categorized suppliers when evaluating initially. For example some companies may have critical and non critical however I'd like to explore further. To be included are suppliers of raw material, complete instrument, special processes, packaging, one man show consultants and the like. Any help would be appreciated.
 
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Sunday

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#2
I recommend using different categories corresponding to different supplier qual plans. In the same way you would qualify a critical supplier more rigorously than a non-critical supplier, you may qualify a raw material supplier differently. Let the qual plan determine the category.
 

Ajit Basrur

Staff member
Admin
#3
I'm looking for examples of how medical device suppliers have categorized suppliers when evaluating initially. For example some companies may have critical and non critical however I'd like to explore further. To be included are suppliers of raw material, complete instrument, special processes, packaging, one man show consultants and the like. Any help would be appreciated.
As per 21 CFR Part 820.50 (Purchasing Controls)

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:

(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.

(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.

(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.

(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.

You could also have a look at QSR - Section 10 on Purchasing and Acceptance Activities
 
F

freelovefest

#4
Most of the companies I have dealt with we have put in various levels of supplier classification based on risk. This is a very useful approach and helps to demonstrate you are meeting the 14971 requirements. Generally the calissifcations are "A", "B", "C", and "D" if it they have a diverse product line.

The first step is to set the criteria for classification which usually ties into the risk of the purchased item. Anything implanted almost always becomes an "A" as does sterilization and some testing services. Calibration often is an "A" as well. "B" suppliers are often people providing critical components which may cause a device to function incorrectly if they are not working properly and depending on your scale, "C" or "D" are off the shelf low risk items like screws, certain packaging materials, etc.

Following ISO you can make the classifications whatever you want as you can the criteria for evaluation. Generally "A" suppliers will require an on-site audit, or atleast ISO registration of some type, and "C" suppliers will just need to fill out a survey or at the very least pass a D&B report.

Hopefully this will help you a little. Remember that ISO allows you to make the evaluation criteria as simple or as complex as you like so you don't want to overdo it, but a risk based approach will gain you a lot of points from your notified body or even the FDA.
 

Weiner Dog

Med Device Consultant
#5
Most of the companies I have dealt with we have put in various levels of supplier classification based on risk. This is a very useful approach and helps to demonstrate you are meeting the 14971 requirements. Generally the calissifcations are "A", "B", "C", and "D" if it they have a diverse product line.

The first step is to set the criteria for classification which usually ties into the risk of the purchased item. Anything implanted almost always becomes an "A" as does sterilization and some testing services. Calibration often is an "A" as well. "B" suppliers are often people providing critical components which may cause a device to function incorrectly if they are not working properly and depending on your scale, "C" or "D" are off the shelf low risk items like screws, certain packaging materials, etc.

Following ISO you can make the classifications whatever you want as you can the criteria for evaluation. Generally "A" suppliers will require an on-site audit, or atleast ISO registration of some type, and "C" suppliers will just need to fill out a survey or at the very least pass a D&B report.

Hopefully this will help you a little. Remember that ISO allows you to make the evaluation criteria as simple or as complex as you like so you don't want to overdo it, but a risk based approach will gain you a lot of points from your notified body or even the FDA.
Not only can you use this scale (or another scale such as a 100, 90, 80, 70% scale) to classify the types of suppliers, contractors, or consultants, you can also use it to evaluate them regarding quality issues too (i.e. to see if they are to remain as approved suppliers). Remember, 21 CFR 820.50 (purchasing controls) is linked to other areas, including 21 CFR 820.80(b) (raw material and incoming good acceptance) and 820.90 (non-conformances).
 
I

Ironcountry

#6
The input has certainly provided food for thought. Our group has hashed over FDA and ISO requirements to the nth degree, the key is how companies have applied the requirements into a workable system (of which categorization is a component). The real life application/examples of what works or doesn't work is of primary interest, I like the risk based approach.

Keep the comments coming!
 

Weiner Dog

Med Device Consultant
#7
The input has certainly provided food for thought. Our group has hashed over FDA and ISO requirements to the nth degree, the key is how companies have applied the requirements into a workable system (of which categorization is a component). The real life application/examples of what works or doesn't work is of primary interest, I like the risk based approach.

Keep the comments coming!
The key is not to copy what someone else has done blindly (such as using a "canned" purchasing controls SOP), but to modify these templates accordingly to suit your needs. For example, the QSR (21 CFR 820) does not state how detailed one needs to be when writing, implementing, acting upon, and documenting procedures, just that the QSR information be "established" (where stated as such in the reg). Additionally, the QSR is not the maximum, but minimum. If one conducts operations only to meet the minimum (i.e. 21 CFR 820 or an ISO standard) without understanding the purpose of these regs/standards (and it's not to please FDA or a notified body), then there will be all kinds of problems down the road (including numerous quality and business management, marketing/ sales, accounting/ financial, et al problems).

As an example, depending upon the number of employees at the firm, the type of products (class I v class III), the type of operations (such as hand relabeling v. automated sterilization), and other criteria (such as language, people validation, training, business risks, etc.), you may or may not need an encyclopedia sized SOP to determine whether the suppliers of raw material "X" have met your predetermined specs.
 

Steve McQuality

Quality Engineer
#8
Most of the companies I have dealt with we have put in various levels of supplier classification based on risk. This is a very useful approach and helps to demonstrate you are meeting the 14971 requirements. Generally the calissifcations are "A", "B", "C", and "D" if it they have a diverse product line.

The first step is to set the criteria for classification which usually ties into the risk of the purchased item. Anything implanted almost always becomes an "A" as does sterilization and some testing services. Calibration often is an "A" as well. "B" suppliers are often people providing critical components which may cause a device to function incorrectly if they are not working properly and depending on your scale, "C" or "D" are off the shelf low risk items like screws, certain packaging materials, etc.

Following ISO you can make the classifications whatever you want as you can the criteria for evaluation. Generally "A" suppliers will require an on-site audit, or atleast ISO registration of some type, and "C" suppliers will just need to fill out a survey or at the very least pass a D&B report.

Hopefully this will help you a little. Remember that ISO allows you to make the evaluation criteria as simple or as complex as you like so you don't want to overdo it, but a risk based approach will gain you a lot of points from your notified body or even the FDA.
I was searching for some guidance today and this was closest to what I was looking for - maybe someone can expand on this discussion a little...

In ISO 14971, in the Appendices, there are good lists of potential questions for assessing Risk Probability and Severity as related to Safety. We have a pretty good Risk Management system for our Medical Device Risk assessment. What I'm wondering is - has anyone taylored the Risk Assessment with similar types of questions, etc. as related to Supplier Risk Assessment.

My goal is to develop a "Risk Based" Supplier assessment in order to categorize our suppliers based on material supplied, risk to safety, etc. but also including "business risk" - i.e. Sole Supplier, Critical Material, etc. The product (or end result) of the assessment would be a way to show justification for why we are monitoring some suppliers more closely than others based on their risk to the end product or to our business in general. I'm hoping someone has taylored an assessment toward supplier evaluation using the ISO 14971 thought process. Anyone??? :truce:
 
F

freelovefest

#9
I am not sure of any specifc way to direct you to proceed; it would vary from organization to organization. The way I have seen it work best is by utilizing the Risk Management Plan as the basis for determining the categorization and control levels for the suppliers. Generally your risk analysis should provide you with certain hazards that might arise from specific malfunctions or scenarios. These are often related to certain components, or even services (Coatings, calibration, sterlization,etc.) which you receive from suppliers. If your Risk Plan does not have this, it should be updated to include this. A risk plan can also include business risk as well in that inability to receive product can prevent you from manufacturing and may result in a risk to the public health, depending on your device.

If the risks arising from the failure of a component or service are severe or high, depending on how you structure your risk management plan, you will want to focus more on those suppliers. This will give you a nice closed loop system for risk assessment from Design to Manufacture. You just have to make sure you have cross-functional teams at all stages to ensure the proper risk info gets to the proper people.

By focusing on your Risk Management Plan as the basis for determining supplier control, you can also demonstrate due dilligence in mitigating hazards by use of supplier control. This will show a very strong integrated quality system to most any investigator. Hope this helps answer your question some.
 
#10
Hello "freelovefest"...

The answer above does help. You've confirmed for me what my intentions are by using risk assessment to classify suppliers. The additional tidbit I was seeking in the forum was a "starting template" where someone had already done some of the work for me. Making a "generic" questions list is always a daunting task - no two companies of assessments are going to fit into the same cubby-hole... I have some thoughts as to how I want to "structure" the "standard questions to ask" portion. I'm just going to have to bite the bullet and give it a go.

Thanks again for the insights and response!! ~Steve
 
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