Regulatory Open Forum

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

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Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
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Suppliers may be classified based on their criticality. The criticality has to be defined by the organization. Organization has to identify what is critical for them e.g., supplier performs manufacturing for the organization or supplying critical component or material etc.

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Srikanth Kondayil
Gurgaon
India

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

To expand on Srikanth's suggestion, you could set-up different supplier risk categories depending on the criticality, complexity, type of service, impact on product quality, safety, business, etc.

I typically define 3 or 4 categories. For example: Critical, Major, Minor and Trivial.

Critical may be a supplier that provides and/or develops complete medical products, or services for/on behalf of your company.

Major may be a supplier that provides and/or manufactures custom sub-system, tool or components of the product or custom service for an important process where you have limited control over the supplier’s processes or services.

Minor may be a supplier that provides a product related service (e.g. development/ support/product test) or a customized off-the-shelf product.  This category could also  include contractors or consultants who follow your processes or where your company has moderate control over the output of the service provided.

Trivial would be everything else. For example, suppliers that provide standard off-the-shelf products, or services not directly impacting product quality.

Then, you can determine amount of work required to qualify each of the types of suppliers. 

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Michael Zagorski RAC
Pittsburgh PA

Original Message:
Sent: 19-Oct-2016 01:48
From: Srikanth Kondayil
Subject: Classifying Suppliers

Suppliers may be classified based on their criticality. The criticality has to be defined by the organization. Organization has to identify what is critical for them e.g., supplier performs manufacturing for the organization or supplying critical component or material etc.

------------------------------
Srikanth Kondayil
Gurgaon
India

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
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Health Canada, Guidance Document GD211: Guidance on the Content of QMS audit reports, defines "Critical Suppliers".  Your definition of critical should align with theirs, if applicable.

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Tim White
Leadership, Quality Assurance
Abrasive Technology, Inc.
United States

Original Message:
Sent: 19-Oct-2016 01:48
From: Srikanth Kondayil
Subject: Classifying Suppliers

Suppliers may be classified based on their criticality. The criticality has to be defined by the organization. Organization has to identify what is critical for them e.g., supplier performs manufacturing for the organization or supplying critical component or material etc.

------------------------------
Srikanth Kondayil
Gurgaon
India

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

Tim, when you say "Critical Supplier" do you mean the description in section 2.3.2.4 describing suppliers as it relates to decision whether a registrar should audit that supplier, which is based on how the manufacturer evaluated the competence of the supplier?

1. Whether the supplier has a substantial involvement with the manufacture or design and manufacture of the medical device;
2. Whether the supplier is undertaking the supply of a part, material or service, which may affect the conformity of the medical device with the Safety and Effectiveness requirements of the MDR;

The guidance also provides several examples of control and risk mitigations:

• specifying design and product requirements;
• specifying personnel qualifications;
• verifying that subcontracted products meet specified requirements;
• specifying a QMS under which the subcontracted products are designed and manufactured;
• performing on-site inspections;
• validating processes; and,
• specifying a QMS certificate with which the Health Canada recognized registrar has confidence.

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Michael Zagorski RAC
Pittsburgh PA

Original Message:
Sent: 20-Oct-2016 08:59
From: Timothy White
Subject: Classifying Suppliers

Health Canada, Guidance Document GD211: Guidance on the Content of QMS audit reports, defines "Critical Suppliers".  Your definition of critical should align with theirs, if applicable.

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Tim White
Leadership, Quality Assurance
Abrasive Technology, Inc.
United States

Original Message:
Sent: 19-Oct-2016 01:48
From: Srikanth Kondayil
Subject: Classifying Suppliers

Suppliers may be classified based on their criticality. The criticality has to be defined by the organization. Organization has to identify what is critical for them e.g., supplier performs manufacturing for the organization or supplying critical component or material etc.

------------------------------
Srikanth Kondayil
Gurgaon
India

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

Thank you all for the feedback and to help me clarify my doubts!

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Brenda Miller
Combat Medical Systems
Harrisburg NC
United States

Original Message:
Sent: 19-Oct-2016 01:48
From: Srikanth Kondayil
Subject: Classifying Suppliers

Suppliers may be classified based on their criticality. The criticality has to be defined by the organization. Organization has to identify what is critical for them e.g., supplier performs manufacturing for the organization or supplying critical component or material etc.

------------------------------
Srikanth Kondayil
Gurgaon
India

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

Brenda, you do have a significant challenge ahead of you. Just creating the system is a challenge; making it meaningful to your business is the hard part. 

If your company is a small one, I encourage you to keep your system simple. It is easy to design systems that overly complicated but don't add value. Your eventual system should guide your own company and emphasize the values you want your suppliers to demonstrate. When it comes to performance I prefer a simple three grade system:1) Acceptable, 2) Needs Improvement, and 3) Unacceptable. 

Acceptable suppliers would be those operating without fault for a period of time. Unacceptable performers would would be those on their way out (or operating under an improvement plan). Suppliers in the Needs Improvement category would be operating under the company's normal controls, with improvement topics discussed periodically until they had been resolved.

Here are a few questions that might be useful as you consider your options:

1. What supplier behaviors do we value most (in addition to meeting specification and delivery targets)?
2. What are signs of a strong quality system?
3. What are signs of a strong corrective action system?
4. Who has lead responsibility for supplier quality in our company; Purchasing or the Quality Group?
5. How will we work with suppliers on changes initiated by us? Initiated by them?
6. When a supplier provides a critical product or service (validated processes, test services, certifications, etc.) how can we highlight those items and keep them in the front of our relationship?

I wish you the best in your endeavor. 

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David Ledwig, RAC, CQA
Principal Consultant
Practical Compliance, LLC
ledwigd@practicalcompliance.com
O (828) 862-8555
M - (828) 508-6535

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

There are many, many ways to do this - and probably none is the "right" way. There are a few examples at AdvaMed's Quality Library site

Supplier Quality & Purchasing Controls | AdvaMed

The trick is to one that fits your products and your business.

g-

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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States

Original Message:
Sent: 18-Oct-2016 14:17
From: Brenda Miller
Subject: Classifying Suppliers

One of my biggest challenges right now is how to classify a supplier and give them a grading system, in order to make a quantifiable determination of the approval process and criteria for classification. What has worked for you in terms of classifying suppliers and giving them a grading system?

 

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------